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780.11 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon the surveillance of post and telecommunications(spto)of 15 november 2017 (status as of 3 december 2019) the swiss federal council,based on the federal act of 18 march 20161 on the surveillance of post and telecommunications (spta), on articles 269bis paragraph 2, 269ter paragraph 4 and 445 of the criminal procedure code (crimpc)2 and on articles 70bis paragraph 2, 70ter paragraph 4 and 218 of the military criminal procedure code of 23 march 19793 (mcpc),ordains:1 sr 780.12 sr 312.03 sr 322.1chapter 1 general provisions section 1 introduction art. 1 subject matter and scope of application 1 this ordinance regulates the organisational aspects of and procedure for the surveillance of post and telecommunications and the provision of information on postal and telecommunications services.2 it applies to:a. ordering authorities and the authorities directing proceedings;b. approval authorities;c. federal, cantonal and communal police forces;d. the federal intelligence service (fis);e. the state secretariat for economic affairs (seco);f. federal and cantonal authorities competent to deal with administrative criminal cases;g. the post and telecommunications surveillance service (ptss);h. postal service providers (psps);i. telecommunications service providers (tsps);j. the providers of services based on telecommunications services and that enable one-way or multi-way communication (providers of derived communication services);k. operators of internal telecommunications networks;l. persons who allow third parties to use their access to a public telecommunications network;m. professional retailers of cards and similar means of gaining access to a public telecommunications network.art. 2 terms and abbreviations the terms and abbreviations used in this ordinance are defined in the annex.section 2 surveillance order art. 3 submissions to the ptss 1 the ordering authority shall use one of the following transmission channels to submit surveillance orders and orders for their extension or termination to the ptss and to notify it of the access rights to be established:a. a secure means of transmission authorised by the ptss;b. post or fax, if a means of transmission in accordance with letter a is unavailable for technical reasons; orc. telephone in urgent cases, provided the surveillance order is submitted in accordance with letter a or b within 24 hours.2 the ptss may replace the means of transmission of submissions in accordance with paragraph 1 letter a with online-access to the service's processing system.art. 4 conduct of surveillance 1 the ptss shall determine in specific cases the technical and organisational measures for conducting surveillance, unless these are directly specified in the applicable regulations, in particular for standardised types of information and surveillance.2 if as a result of operational problems a person or entity required to cooperate is unable to meet its obligations for the surveillance of post or telecommunications, it shall report this to the ptss without delay and thereafter submit a written statement of the reasons. the ptss shall inform the person or entity required to cooperate without delay if surveillance cannot be carried out because of operational problems on its side.3 irrespective of where the cause of the error lies, the person or entity required to cooperate must temporarily store at least the undelivered secondary telecommunications data from real-time surveillance and deliver it without delay. if the secondary telecommunications data from real-time surveillance is no longer available or incomplete, the person or entity required to cooperate must deliver without delay the secondary telecommunications data from retroactive surveillance in accordance with the instructions of the ptss.art. 5 protection of official or professional secrecy if the ptss establishes that the surveillance relates to a holder of official or professional secrets but that the statutory measures to protect these secrets have not been taken, it shall in the following situations notify the ordering authority and the approval authority without delay and initially shall not allow the former and the persons named in the surveillance order access to the surveillance data:a. if surveillance has been ordered by a civilian prosecution authority: in the case of persons from the professional groups specified in articles 170-173 crimpc unless measures have been taken in accordance with article 271 crimpc;b. if surveillance has been ordered by a military prosecution authority: in the case of persons from the professional groups specified in article 75 letter b mcpc unless measures in accordance with article 70b mcpc have been taken;c. if surveillance has been ordered by the fis: in the case of persons from the professional groups specified in articles 171-173 crimpc unless measures have been taken in accordance with article 58 paragraph 3 of the intelligence service act of 25 september 20154 in conjunction with article 23 of the intelligence service ordinance of 16 august 20175.4 sr 1215 sr 121.1art. 6 duty of confidentiality the surveillance or the provision of information shall be carried out so that neither the person concerned nor unauthorised third parties are aware of it.art. 7 technical data sorting (filtering) the ptss shall at the request of the ordering authority carry out automated filtering if it is technically able to so and the cost and workload involved is not disproportionate.art. 8 recording telephone calls as evidence 1 the ptss shall record as evidence the telephone calls made in connection with its duties.2 any evaluations of the recording shall be carried out by data protection commissioner or the ptss data protection commissioner.3 the ptts shall retain the recorded telephone calls for two years and thereafter destroy the recordings.art. 9 surveillance file 1 the ptss shall open a file in the processing system for each surveillance order.2 the file contains all the documents on the case concerned, namely:a. the surveillance order and its attachments;b. the surveillance assignment or assignments issued to the relevant person or entity required to cooperate;c. the confirmation or confirmations of when the assignment was issued to the person or entity required to cooperate;d. the written acknowledgment from the person or entity required to cooperate that the surveillance assignment or assignments has or have been carried out;e. the rulings from the approval authority on the approval or non-approval of the surveillance order together with any appeal decisions;f. any extension orders and rulings from the approval authority;g. the termination order;h. the correspondence relating to the measure;i. the protection measures specially ordered;j. the accounting records.3 the surveillance data shall be stored in accordance with article 11 spta and destroyed in accordance with article 14 of the ordinance of 15 november 20176 on the processing system for the surveillance of post and telecommunications (pso-ptss).6 sr 780.12section 3 working hours and on-call arrangements art. 10 normal working hours and public holidays 1 normal working hours for the ptss and the persons or entities required to cooperate are monday to friday continuously from 8am to 5pm.2 normal working hours do not apply on public holidays. these are 1 and 2 january, good friday, easter monday, ascension day, whit monday, 1 august, 24 december from noon, 25 and 26 december and new year's eve (31 december) from noon.art. 11 services outside the normal working hours 1 outside normal working hours and on public holidays, the ptss shall provide the following on-call services:a. the forwarding of requests for information specified in articles 35-43;b. issuing assignments for the activation of real-time surveillance in accordance with articles 54-59;c. issuing assignments for the conduct of retrospective urgent surveillance activities in accordance with articles 60-63, 65 and 66;d. issuing assignments for missing and wanted person searches in accordance with articles 67 and 68, with the exception of the network coverage analysis in preparation for an antenna search in accordance with article 64;e. the rectification of faults.2 the tsps, with the exception of those with reduced surveillance duties in accordance with article 51, and providers of derived communication services with more extensive surveillance duties in accordance with article 52 must be able to support the ptss so that it may provide the services in accordance with paragraph 1 at any time. the ptss must be able to contact them at any time.3 the ordering of special surveillance activities and requests for special information (art. 25) shall not be accepted or processed outside normal working hours.section 4 statistics art. 12 statistics on surveillance measures and information 1 the ptss shall publish statistics every year about the surveillance activities ordered in the previous calendar year and the information provided. these shall indicate in particular the number:a. of surveillance measures in real time;b. of retroactive surveillance measures;c. of instances in which information was provided;d. of missing person searches;e. of wanted person searches.2 the statistics in accordance with paragraph 1 shall indicate:a. the type of offence;b. the canton of the ordering authority, the ordering federal authority or, in the case of missing person searches, also an authority from the principality of liechtenstein, and in the case of information, the competent cantonal or federal authority (art. 1 para. 2 lets c-f);c. the type of information, surveillance, missing person search or wanted person search;d. the duration of surveillance, if applicable;e. the fees;f. the compensation.art. 13 statistics on surveillance measures with special technical devices and special it programs 1 public prosecutor's offices and military examining magistrates shall keep annual statistics on the special technical devices and special information technology programs used in the previous calendar year for surveillance activities (art. 269bis para. 2 and 269ter para. 4 crimpc and art. 70bis para. 2 and 70ter para. 4 mcpc respectively). the statistics shall indicate the type of offence.2 public prosecutor's offices and the office of the military attorney general at the ddps shall submit the statistics to the ptss in the first quarter of the following year. the statistics shall indicate only assignments concluded in the year concerned.3 the ptss shall publish consolidated statistics every year. these do not contain any details of the canton of the ordering authority or the federal ordering authority.chapter 2 postal deliveries art. 14 obligations of psps 1 each psp must be able to provide the information specified in article 20 spta and conduct the types of surveillance specified in article 16 insofar as the information and surveillance activities relate to services that the psp provides.2 each psp must ensure that it can accept and execute the requests for information and surveillance orders during normal working hours.art. 15 order to conduct surveillance of postal deliveries the surveillance order submitted to the ptss shall contain the following information:a. contact details for the ordering authority;b. contact details for the persons authorised to be the recipients of the surveillance data;c. if known, the surname, first name, date of birth, address and occupation of the person to be placed under surveillance;d. reference numbers and case names for the surveillance activities;e. the reason for surveillance, in particular the criminal offence to be investigated by means of surveillance;f. the name of the psp;g. the types of surveillance ordered;h. if necessary, additional information on a person's postal traffic;i. the start and duration of surveillance;j. in the case of persons bound by professional secrecy in accordance with article 271 crimpc or article 70b mcpc: a note on this aspect;k. if need be, the measures to protect persons holding professional secrets and further protection measures that the authorities, the psp and the ptss must take.art. 16 types of surveillance the following types of surveillance may be ordered:a. the interception of postal deliveries (real time-surveillance; surveillance type po_1_rt_interception);b. the provision of the following secondary telecommunications data (real-time surveillance; surveillance type po_2_rt_delivery), insofar as they are available:1. the addressee,2. the sender,3. the type,4. the mailing location,5. the delivery status,6. the recipient's signature;c. the provision of the following secondary telecommunications data (retroactive surveillance; surveillance type po_3_hd):1. for postal deliveries with proof of delivery: the recipient and the sender as well as the type, the mailing location and the delivery status of the postal delivery, if available,2. if the psp has recorded any additional secondary telecommunications data: all available data.chapter 3 telecommunications section 1 general provisions on information and surveillance activities art. 17 requests for information 1 requests for information from the authorities specified in article 15 spta to tsps, providers of derived communication services and operators of internal telecommunications networks as well as the information returned to the authorities are transmitted in the online request procedure or via the interfaces using the processing system specified in the pso-ptss7.2 if the online request procedure using the processing system is unavailable for technical reasons, requests for information and the information returned to the authorities may be submitted to the ptss by post or fax.3 in urgent cases, the authorities may submit requests for information by telephone to the ptss, and submit the request for information specified in paragraph 1 or 2 subsequently.4 the request for information must indicate, in addition to the details required for the type of information concerned, the maximum number of data records to be supplied and, if available, the reference numbers and case names.7 sr 780.12art. 18 obligations for the supply of information 1 tsps and providers of derived communication services with more extensive duties to provide information in accordance with article 22 must be able to provide the information specified in articles 35-37 and 40-48 as well as in article 27 in conjunction with articles 35, 40, 42 and 43 that relates to services that they provide. they may enlist the support of third parties to do so.2 they shall provide the information specified in articles 35-37 and 40-42 and in article 27 in conjunction with articles 35, 40 and 42 in an automated process via the query interface of the ptss processing system. they may also provide the information specified in articles 43-48 and in article 27 in conjunction with article 43 manually.3 tsps with reduced surveillance duties in accordance with article 51 may also provide information of all types outside of the processing system in writing.4 tsps, with the exception of those with reduced surveillance duties in accordance with article 51, and the providers of derived communication services with more extensive surveillance duties in accordance with article 52 must be able to provide the information specified in articles 38 and 39 that relates to services that they provide via the query interface of the ptss processing system. they may enlist the support of third parties to do so.5 providers of derived communication services without more extensive duties to provide information and conduct surveillance and operators of internal telecommunications networks are not required to provide information of the types specified in articles 35-48 and in article 27 in conjunction with articles 35, 40, 42 and 43. they shall supply the information available to them via the processing system or by a different method in written form.6 if the number the data records found exceeds the maximum value specified in the request, the provider shall only disclose their number.art. 19 identification of the participants 1 tsps, providers of derived communication services with more extensive duties to provide information in accordance with article 22, providers of derived communication services with more extensive surveillance duties in accordance with article 52 and retailers in accordance with article 2 letter f spta must ensure that subscribers are identified by suitable means.2 in the case of professionally operated public wlan access points, tsps must ensure that all end users are identified by suitable means.art. 20 recording personal details in the case of mobile services 1 in the case of mobile services, tsps and retailers in accordance with article 2 letter f spta must, on supplying the means of access or on the initial activation of the service, verify the identity of the subscriber by means of a passport, an identity card or a foreign national identity card in accordance with article 71 and 71a of the ordinance of 24 october 20078 on admission, period of stay and employment. they must retain an easily legible copy of the identity document.2 in the case of the natural persons, the following details must be recorded:a. surnames and forenames;b. date of birth;c. type of identity document, identity document number and the issuing country or issuing organisation;d. address;e. if known, occupation;f. nationality.3 in the case of legal entities, the following details must be recorded:a. name, registered office and contact details for the legal entity;b. business identification number (uid) in accordance with the federal act of 18 june 20109 on the business identification number;c. if available, the names and forenames of the persons who will use the provider's services.4 in the case of customer relationships that are not based on a subscription contract, the following details must also be recorded:a. the time at which the means of access was supplied;b. the point of supply (name and complete address);c. the name of the person supplying the means of access.8 sr 142.2019 sr 431.03art. 21 retention periods 1 tsps and providers of derived communication services with more extensive duties to provide information and conduct surveillance (art. 22 and 52) must retain and be able to supply the information about the telecommunications services and the information recorded for the purpose of identification for the duration of the customer relationship and for 6 months after its termination. tsps must retain and be able to supply identification data in accordance with article 19 paragraph 2 for as long as the right to access the public wlan access point applies and for 6 months after its expiry.2 tsps, with the exception of those with reduced surveillance duties in accordance with article 51, and providers of derived communication services with more extensive surveillance duties in accordance with article 52 must retain and be able to supply the following data for the purpose of identification for 6 months:a. the secondary telecommunications data relating to the device identifiers actually used, in order to be able to provide the information specified in article 36 paragraph 1 letter d and article 41 paragraph 1 letter d; andb. the secondary telecommunications data relating to the assignment and translation of ip addresses and port numbers, in order to be able to provide the information specified in articles 37, 38 and 39.3 the secondary telecommunications data under paragraph 2 must be destroyed as soon as the retention period has expired, unless other legislation requires or permits such data to be retained for longer.art. 22 providers of derived communication services with more extensive duties to provide information 1 the ptss shall declare a provider of derived communication services to be a provider with more extensive duties to provide information (art. 22 para. 4 spta), if it has met one of the following criteria:a. 100 requests for information in the past 12 months (effective date: 30 june);b. annual turnover in switzerland of chf 100 million in two successive financial years, provided a large part of its business operations provides derived communication services and 5,000 subscribers use the provider's services.2 if a provider controls one or more undertakings required to file financial reports as defined in article 963 paragraph 2 of the code of obligations10, the provider and the controlled undertakings must be regarded as a single unit when calculating the values in accordance with paragraph 1.3 providers that exceed or fail to meet the criteria in paragraph 1 letter b must notify the ptss of this in writing within three months of the end of their financial year and submit related supporting documents.4 providers must on request provide the ptss with the information and supporting documents for assessing the criteria under paragraph 1 letter b. the ptss may rely on data obtained in implementing the legislation relating to the surveillance of post and telecommunications or by other authorities in implementing federal law.5 a provider that is declared to have more extensive duties to provide information must ensure that it can store the data required for providing information within 2 months and provide the information within 12 months of the declaration.10 sr 220art. 23 assistance in providing information and conducting surveillance activities if third parties are engaged by the provider to assist in providing information or conducting surveillance activities, they shall be subject to the same requirements as the provider. the provider remains responsible for providing information and conducting the surveillance activities ordered to the extent specified; in particular it shall take the measures required to ensure that suitable contact persons for providing information and conducting the surveillance activities ordered are available to the ptss at all times. both the provider assigned the task by the ptss and its assistants serve as contact points for the ptss.art. 24 standardisation of types of information and surveillance 1 the federal justice and police department (fdjp) shall standardise the types of information and surveillance that are defined in this ordinance.2 if, based on the international standards and the enquiries made of the persons or entities required to cooperate, it proves impossible or unreasonable to standardise a type of information or surveillance, the fdjp shall dispense with doing so.art. 25 special information and surveillance activities in the case of information and surveillance activities that do not correspond to a standardised type of information or surveillance, tsps and providers of derived communication services shall provide the ptss with all already available interfaces and connections to the ptss processing system. the content and the secondary telecommunications data of the telecommunication of the person under surveillance must be supplied as far as possible in accordance with article 26 paragraph 1 spta. the ptss shall determine the modalities in specific cases.art. 26 types of information in general 1 the providers concerned shall provide the following types of information on telecommunications services or derived communications services:a. information on subscribers (art. 35, 40, 42 and 43 together with art. 27 in conjunction with art. 35, 40, 42 and 43);b. information on services (art. 36-39 and 41);c. other information:1. information on the method of payment (art. 44),2. requests for copies of identity documents (art. 45),3. requests for copies of invoices (art. 46),4. requests for copies of contracts (art. 47),5. information on technical data relating to telecommunications systems and network elements (art. 48).2 the authorities may only request the information that providers are required to provide in accordance with the procedures defined in this ordinance.art. 27 obtaining information with a flexible name search 1 requests for types of information specified in articles 35, 40, 42 and 43 may be complied with by carrying out a search that tolerates errors and finds phonetic matches (flexible name search). in this case, the suffix "flex" shall be added to the abbreviation for the relevant information request type: ir_5_na_flex, ir_11_tel_flex, ir_14_email _flex and ir_16_com_flex.2 the request for information shall in each case contain the first and at least one additional query criterion for the underlying information request type.art. 28 types of surveillance 1 the providers concerned must conduct the following types of real-time surveillance for telecommunications services and derived communications services:a. real-time surveillance of secondary telecommunications data in the case of network access services (art. 54);b. real-time surveillance of content and secondary telecommunications data in the case of network access services (art. 55);c. real-time surveillance of secondary telecommunications data in the case of applications (art. 56 and 58);d. real-time surveillance of content and secondary telecommunications data in the case of applications (art. 57 and 59).2 the providers concerned must conduct the following types of retroactive surveillance activities for telecommunications services and derived communications services:a. retroactive surveillance in the case of network access services (art. 60);b. retroactive surveillance in the case of applications (art. 61 and 62);c. locating the last active position of the mobile terminal device (art. 63);d. an antenna search (art. 66) and the corresponding preparations (art. 64 or 65).3 the providers concerned must conduct the following types of missing person searches (art. 67):a. locating the last active position of the mobile terminal device (art. 67 let. a);b. real-time surveillance of content and secondary telecommunications data in the case of network access services and telephony and multimedia services (art. 67 let. b);c. real-time surveillance of secondary telecommunications data in the case of network access services and telephony and multimedia services (art. 67 let. c);d. retroactive surveillance in the case of network access services and telephony and multimedia services (art. 67 let. d).4 the providers concerned must conduct the following types of searches (art. 68):a. locating the last active position of the mobile terminal device (art. 68 let. a);b. real-time surveillance of content and secondary telecommunications data in the case of network access services or applications (art. 68 let. b);c. real-time surveillance of secondary telecommunications data in the case of network access services or applications (art. 68 let. c);d. retroactive surveillance in the case of network access services or applications (art. 68 let. d).section 2 quality assurance art. 29 quality of the data transmitted 1 the quality of the data transmitted is acceptable if:a. the data delivery meets the requirements specified by the fdjp;b. the data is delivered without loss of data and without interruptions; andc. the transmitted surveillance data or information data correspond to that specified in the surveillance order or request for information.2 the persons or entities required to cooperate are responsible for the quality of the transmitted information and surveillance data up to the point of delivery.3 if a provider or the ptss identifies any defects in the quality of the data transmitted, they shall inform each other without delay. the ptss shall determine the seriousness of the defects and the procedure for their rectification after consulting the provider. the provider and the ptss shall inform each other regularly and promptly about the status of the rectification of defects.art. 30 test surveillance 1 the ptss may conduct test surveillance; in doing so, it may work with the prosecution authorities and the fis. the tests serve the following purposes in particular:a. assuring the quality of the data diverted to the ptss and the prosecution authorities by the persons or entities required to cooperate;b. verifying the ability of the persons or entities required to cooperate to provide information and conduct surveillance;c. testing the ptss processing system;d. training purposes;e. generating reference data.2 the ptss may instruct the persons or entities required to cooperate to participate in generating the test data. the ptss shall draw up a test plan after consulting the persons or entities required to cooperate.3 the persons or entities required to cooperate shall provide the ptss with the required test targets and the required telecommunications services or derived communications services at its request free of charge and permanently.4 the prosecution authorities and the fis may also conduct circuit trials at their own expense for the purpose of quality assurance and the training. to this end, they shall submit orders to the ptss and pay fees.section 3 ensuring ability to provide information and conduct surveillance art. 31 verifying ability to provide information and conduct surveillance 1 tsps and providers of derived communication services with more extensive information (art. 22) or surveillance duties (art. 52) shall in accordance with article 33 paragraph 1 spta provide proof of their ability to provide information and conduct surveillance.2 proof is provided if:a. the tests that must be conducted in accordance with ptss requirements have been successfully completed; andb. the provider confirms in a questionnaire drawn up by the ptss it meets the requirements in relation to standardised information and surveillance activities that cannot be proven by testing.3 the ptss shall ensure that it conducts the verification process promptly and does not cause any delay in market introduction. to do so, it shall carry out the following tasks:a. it shall check the results of the tests in accordance with paragraph 2 letter a.b. it shall evaluate the questionnaire in accordance with paragraph 2 letter b.c. it shall keep a record of the test procedures.d. it shall issue the providers with confirmation in accordance with article 33 paragraph 6 spta.e. it shall retain the records for as long as the confirmation remains valid and for ten years after its expiry.4 the ptss shall state in the confirmation that the provider has proven its ability to provide certain types of information and conduct certain types of surveillance activities.art. 32 term of validity of the confirmation 1 the confirmation of ability to provide information and conduct surveillance is valid for three years.2 on expiry of the term of validity, the ptss may extend the confirmation by a further three years if the person or entity required to cooperate certifies that since confirmation was granted no modifications have been carried out that influence data delivery or the ability to provide information or conduct surveillance.3 if a provider can no longer provide information or conduct surveillance, it shall notify the ptss immediately.art. 33 acceptance procedure the fdjp shall regulate the procedure for verifying ability to provide information and conduct surveillance.art. 34 declaration of invalidity of the confirmation of ability to provide information and conduct surveillance the ptss shall immediately declare a confirmation of ability to provide information and conduct surveillance that has already been issued to be invalid for the relevant types of information or surveillance if:a. the provider gives notice that it can no longer provide information or conduct surveillance;b. the provider is unable on two or more occasions to deliver data, provide information or conduct surveillance;c. the information on the provider that underlies the confirmation is untrue. section 4 types of information requests for network access services art. 35 information request type ir_4_na: information on subscribers to network access services 1 information request type ir_4_na comprises the following information about subscribers to network access services:a. if available, the unique subscriber identifier (e.g. customer number);b. in the case of mobile services, the details of the natural person or legal entity in accordance with article 20 and, if known, further contact details and the sex of the natural person;c. in the case of the other network access services, the identification information specified in article 19 and, if known, the details of the natural or legal entity, further contact details and the sex of the natural person;d. the following information about each network access service that the subscriber obtains from the provider:1. the unique identifier for the provider (e.g. tsp number),2. the unique service identifier (e.g. user name, msisdn, dsl identifier),3. the period over which the service was used (start, first activation and, if applicable, termination),4. if applicable, further information about additional options or restrictions on the network access service,5. if applicable, the installation addresses of the fixed location access to the network and their period of validity in each case,6. the statuses of the service as designated internally by the provider (e.g. active, suspended, blocked) and their period of validity in each case,7. if applicable, all static ip addresses, ip prefixes, ip address ranges and net masks or prefix lengths assigned to network access service concerned and their period of validity in each case,8. in the case of customer relationships that are not based on a subscription contract, the time and the point of supply (name and complete address) for the means of access and the name of the person who made the supply,9. if applicable, the sim number (iccid) at the time of its supply,10. if applicable, the imsi,11. the type of the service (e.g. prepaid, subscription),12. if applicable, the alternative subscriber identifier for the network access service.2 the request for information shall specify the period to which the request relates. it shall contain at least one of the following query criteria. if letters a-e are used, a second query criterion must be added. if searching for character strings (lets a, c, d and f), the provider must search only for the specified spelling of the term in accordance with the applicable fdjp regulations:a. surname(s), first name(s);b. date of birth;c. country and postcode or country and place;d. street and, if possible, house number;e. identity document number and, optionally, the type of identity document;f. name and, optionally, the registered office of the legal entity;g. business identification number (uid);h. subscriber identifier (e.g. customer number);i. service identifier other than ip addresses (e.g. user name, msisdn, dsl identifier);j. imsi;k. sim number (iccid).art. 36 information request type ir_6_na: information on network access services 1 information request type ir_6_na comprises the following information about network access services. for information specified in letters b, c and e, details of the common period of validity shall be provided:a. if available, the unique subscriber identifier (e.g. customer number);b. the unique service identifier (e.g. user name, dsl identifier);c. if applicable, the imsi and msisdn;d. the list of unique device identifiers in accordance with international standards (e.g. imei, mac address) of the devices used in connection with this service from the provider as well as, if available, their name in text form;e. if applicable, the sim numbers (iccid);f. if applicable, the puk and puk2 codes.2 the request for information shall specify the period to which the request relates. it shall contain at least one of the following query criteria:a. the service identifier, other than ip addresses (e.g. user name, msisdn, dsl identifier);b. the imsi;c. the unique device identifier in accordance with international standards (e.g. imei, mac address);d. the installation address of the fixed location access to the network.art. 37 information request type ir_7_ip: identification of the users in the case of uniquely assigned ip addresses 1 information request type ir_7_ip comprises the following information about the identified subscriber if this person was assigned a unique ip address at the time in question:a. if available, the unique subscriber identifier (e.g. user name);b. the unique service identifier (e.g. user name, msisdn, dsl identifier) of the network access service;c. the unique identifier that designates the provider of the network access service (e.g. tsp number).2 the request for information shall contain the following information:a. the ip address;b. the date and time.art. 38 information request type ir_8_ip (nat): identification of the users in the case of ip addresses that are not uniquely assigned (nat) 1 information request type ir_8_ip (nat) comprises the following information about the identified subscriber if this person was not assigned a unique ip address (nat) at the time in question:a. if available, the unique subscriber identifier (e.g. user name);b. the unique service identifier (e.g. user name, msisdn, dsl identifier) of the network access service.2 the request for information shall contain information about the nat translation procedure for the purpose of identification:a. the public source ip address;b. if required for identification, the public source port number;c. if required for identification, the public destination ip address;d. if required for identification, the destination port number;e. if required for identification, the type of transport protocol;f. the date and time.art. 3911 information request type ir_9_nat: information on nat translation procedures 1 information request type ir_9_nat comprises the following information for the purpose of identification in connection with nat translation procedures if required for identification:a. the source ip address before or after the nat translation procedure, as the case may be;b. the source port number before or after the nat translation procedure, as the case may be.2 the request for information shall contain the following information about the nat translation procedure:a. the source ip address after or before the nat translation procedure, as the case may be;b. the source port number after or before the nat translation procedure, as the case may be;c. if required for identification, the public destination ip address;d. if required for identification, the destination port number;e. the type of the transport protocol;f. the date and time of the nat translation procedure.11 the correction of 9 april 2019 relates to the french text only (as 2019 1201).section 5 types of information on applications art. 40 information request type ir_10_tel: information on subscribers to telephony and multimedia services 1 information request type ir_10_tel comprises the following information about subscribers to telephony and multimedia services:a. if available, the unique subscriber identifier (e.g. customer number);b.12 in the case of mobile services, details of the natural person or legal entity in accordance with article 20 and, if known, further contact details and the sex of the natural person;c. in the case of the other telephony and multimedia services, the identification information specified in article 19 and, if known, details of the natural person or legal entity, further contact details and the sex of the natural person;d. the following information about each telephony and multimedia service obtained by the subscriber from the provider:1. the unique identifier designating the provider (e.g. tsp number),2. the unique service identifier (e.g. telephone number, sip uri),3. the period over which the service was used (start, first activation and if applicable, termination),4. the type of the service (e.g. private telecommunications installation, public call station, fixed location or mobile location service),5. if applicable, the installation addresses of the fixed location network access to the service and their period of validity in each case,6. the statuses of the service as designated internally by the provider (e.g. active, suspended, blocked),7. if applicable, the list or range of other addressing elements or identifiers registered in connection with this service (e.g. telephone numbers, impu),8. in the case of customer relationships that are not based on a subscription contract, the time and the point of supply (name and complete address) of the means of access and the name of the person who made the supply,9. if applicable, details of predetermined free choice of service provider for connections,10. if applicable, the imsi,11. if applicable, the sim number (iccid) at the time of supply.2 the request for information shall specify the period to which the request relates. it shall contain at least one of the following query criteria. if using letters a-d, a second query criterion must be added. if searching for character strings (let. a, c, d and f), the provider must search only for the specified spelling of the term in accordance with the applicable fdjp regulations:a. surname(s), first name(s);b. date of birth;c. country and postcode or country and place;d. street and, if possible, house number;e. identity document number and optionally, the type of identity document;f. name and optional registered office the legal entity;g. business identification number (uid);h. subscriber identifier (e.g. customer number);i. addressing elements or identifiers (e.g. telephone number, sip uri, tel uri, impu);j. imsi;k. sim number (iccid).12 the correction of 3 dec. 2019 relates to the french text only (as 2019 4085).art. 41 information request type ir_12_tel: information on telephony and multimedia services 1 information request type ir_12_tel comprises the following information about telephony and multimedia services. . for information specified in letters b, c and e, details of the common period of validity shall be provided:a. if available, the unique subscriber identifier (e.g. customer number);b. the addressing elements or identifiers registered for this service (e.g. telephone numbers, sip uri, impi);c. if applicable, the imsi;d. for the purpose of identification, the list of unique device identifiers in accordance with international standards (e.g. imei, mac address) of the devices user in connection with this service from the provider as well as, if available, their designation in text form;e. if applicable, the sim numbers (iccid);f. if applicable, the puk and puk2 codes.2 the request for information shall specify the period to which the request relates. it shall contain at least one of the following query criteria:a. the addressing element (e.g. telephone number, sip uri, msisdn, tel uri);b. the imsi;c. the unique device identifier in accordance with international standards (e.g. imei, mac address);d. the installation addresses of the fixed location access to the network;e. the service identifier (e.g. impi).art. 42 information request type ir_13_email: information on subscribers to email-services 1 information request type ir_13_email comprises the following information about subscribers to email services:a. if available, the unique subscriber identifier (e.g. customer number);b. the identification information specified in article 19 and, if known, the details of the natural person or legal entity, additional contact details and the sex of the natural person;c. the following information about each email service that the subscriber obtains from the provider:1. the unique identifier that indicates the provider of the service,2. the unique service identifier (e.g. email address, user name),3. the period over which the service was used (start, first activation and if applicable, termination),4. if applicable, the list of all additional addressing elements (e.g. alias address) that pertain to this service,5. if applicable, the list of all addresses, to which messages addressed to the requested address are forwarded (e.g. mailing list);d. if applicable, the additional addressing elements recorded by the provider in connection with this service (e.g. email address, msisdn).2 the request for information shall specify the period to which the request relates. it shall contain at least one of the following query criteria. if using letters a-d, a second query criterion must be added. if searching for character strings (let. a, c, d and f), the provider must search only for the specified spelling of the term in accordance with the applicable fdjp regulations:a. surname(s), first name(s);b. date of birth;c. country and postcode or country and place;d. street and if possible house number;e. identity document number and, optionally, the type of identity document;f. name and, optionally, registered office of the legal entity;g. business identification number (uid);h. subscriber identifier (e.g. customer number);i. service identifier (e.g. email address, user name).art. 43 information request type ir_15_com: information on subscribers to other telecommunications or derived communications services 1 information request type ir_15_com comprises the following information about subscribers to other telecommunications or derived communications services (e.g. messaging services, communications services in social networks, cloud and proxy services):a. if available, the unique subscriber identifier (e.g. customer number);b. the identification information specified in article 19 and, if known, details of the natural person or legal entity, additional contact details and the sex of the natural person;c. the following information about each additional telecommunications service or derived communications service that the subscriber obtains from the provider:1. the unique identifier that designates the provider,2. the unique service identifier (e.g. user name),3. the period over which the service was used (start, first activation and if applicable, termination),4. the statuses of the service as designated internally by the provider (e.g. active, suspended, blocked) and their period of validity in each case,5. the list of other addressing elements or identifiers registered in connection with this service.2 the request for information shall specify the period to which the request relates. it shall contain at least one of the following query criteria. if using letters a-d, a second query criterion must be added. if searching for character strings (let. a, c, d and f), the provider must search only for the specified spelling of the term in accordance with the applicable fdjp regulations:a. surname(s), first name(s);b. date of birth;c. country and postcode or country and place;d. street and, if possible, house number;e. identity document number and, optionally, the type of identity document;f. name and, optionally, the registered office of the legal entity;g. business identification number (uid);h. subscriber identifier (e.g. customer number);i. addressing element or identifier (e.g. user name).section 6 further types of information art. 44 information request type ir_17_pay: information on the method of payment used by subscribers to telecommunications and derived communications services 1 information request type ir_17_pay comprises the following information about the method of payment used by subscribers to telecommunications and derived communications services:a. the unique identifier that designates the provider;b. the unique subscriber identifier (e.g. customer number);c. the unique identifier that the provider has assigned to the subscriber for accounting or billing purposes;d. the unique service identifier (e.g. telephone number, sip uri, user name);e. the method of payment (debit, bank transfer or prepaid);f. the account information that the subscriber has given to the provider, consisting of the name of the bank, account holder and iban (or bic and account number) or national bank number and account number;g. the billing addresses (house number, street, po box, postcode, place, country) and their period of validity (start and if applicable, termination).2 the information specified in with paragraph 1 must be supplied if the provider has it.3 the request for information shall specify the period to which the request relates. it shall contain at least one of the following query criteria:13a. the subscriber identifier (e.g. customer number);b. the service identifier (e.g. telephone number, sip uri, user name);c. the identifier that the provider has assigned to the subscriber for accounting or billing purposes;d. the subscriber's bank account information: iban (or bic and account number) or national bank number and account number;e. the billing address (house number, street, po box, postcode, place, country).13 the correction of 6 march 2018 relates to the french text only (as 2018 989).art. 45 information request type ir_18_id: copy of official id 1 information request type ir_18_id comprises the provision of an electronic copy of the subscriber's identification document recorded in accordance with article 20.2 the request for information shall specify the period and subscriber or service identifier, sim number (iccid) or imsi or, if applicable, device identifier to which it relates.art. 46 information request type ir_19_bill: copy of invoice 1 information request type ir_19_bill comprises the provision of electronic copies of all available billing records pertaining to the subscriber, not including secondary telecommunications data on telecommunications services and derived communications services.2 the request for information shall specify the period and unique subscriber or service identifier or unique identifier for accounting or billing to which it relates.art. 47 information request type ir_20_contract: copy of contract 1 information request type ir_20_contract comprises the provision of electronic copies of all available contract documents pertaining to the subscriber to telecommunications services and derived communications services.2 the request for information shall specify the period and subscriber or service identifier, the sim number (iccid) or imsi or, if applicable, the device identifier to which it relates.art. 48 information request type ir_21_tech: technical data 1 information request type ir_21_tech comprises the provision of technical data relating to telecommunications systems and network elements, in particular the location data for mobile radio cells and public wlan access points.2 the location data comprise:a. the identifiers of network elements (e.g. cgi, ecgi, sai, rai, tai, bssid) and the geographical coordinates or other details of the location in accordance with international standards;b. if applicable, the postal address of the location;c. if applicable, the main directions of emission of the antennae; andd. if applicable, other available location features.3 the request for information shall specify the period to which the request relates. it shall contain at least one of the following query criteria:a. the geographical coordinates of the location of the network element;b. the identifier of the network element (e.g. cgi, ecgi, bssid).section 7 general provisions on the surveillance of telecommunications art. 49 order to conduct surveillance of telecommunications 1 the surveillance order submitted to the ptss shall contain the following information:a. the contact details of the ordering authority;b. the contact details of the authorised persons envisaged as recipients of the surveillance data;c. if known, the surname, first name, date of birth, address and occupation of the person to be placed under surveillance;d. the reference numbers and case names for the surveillance activities;e. the reason for surveillance, in particular the offence to be investigated by means of surveillance;f. the names of the persons or entities required to cooperate;g. the types of surveillance ordered or the type of special surveillance;h. the identifiers subject to surveillance (target id);i. if necessary, an application for general authorisation for the surveillance of several connections without authorisation in specific cases (art. 272 para. 2 and 3 crimpc or art. 70c para. 2 and 3 mcpc);j. the starting date and the duration of the surveillance;k. in the case of persons bound by professional secrecy in accordance with article 271 crimpc or article 70b mcpc: a note to this effect;l. if need be, measures to protect persons holding professional secrets and further protection measures that the authorities and the ptss must take.2 if conducting the surveillance so requires, the fdjp may provide that the surveillance order submitted to the ptss must include further technical details.art. 50 surveillance duties 1 each tsp and each provider of derived communication services with more extensive surveillance duties in accordance with article 52 must be able to conduct the surveillance activities in accordance with sections 8-12 of this chapter (art. 54-69) that relate to services that they provide, or they must be able to arrange for third parties to conduct the surveillance. the foregoing does not apply to tsps with reduced surveillance duties in accordance with article 51.2 the provider shall ensure its ability to conduct surveillance of telecommunications from the commercial launch of a service provided to customers.3 it shall ensure that it can accept surveillance assignments outside normal working hours in accordance with article 10 and can conduct them or arrange for third party to do so in accordance with the fdjp requirements.4 it shall guarantee that within the period specified in the surveillance assignment surveillance will be conducted of all telecommunications traffic carried on the infrastructures under its control provided the traffic is part of the services under surveillance and can be assigned to the identifier under surveillance (target id).5 it shall support the ptss, if necessary, in order to ensure that the transmitted surveillance data actually corresponds to the telecommunications traffic specified in the surveillance assignment.6 if additional identifiers are associated with the identifier under surveillance (target id) (e.g. impi with impu, email address with alias address), the provider shall ensure that these identifiers are also monitored as part of the type of surveillance.art. 51 tsp with reduced surveillance duties 1 at the request of a tsp, the ptss shall declare it to be a tsp with reduced surveillance duties (art. 26 para. 6 spta) if it:a. only offers its telecommunications services in the field of education and research; orb. meets neither of the following criteria:1. surveillance assignments for 10 different surveillance targets in the past 12 months (effective date: 30 june),2. annual turnover in switzerland from telecommunications services and derived communications services of chf 100 million in two successive financial years.2 article 22 paragraph 2 applies to the calculation of the values specified in paragraph 1 letter b.3 tsps with reduced surveillance duties are required to give written notice to the ptss with supporting documents if they:a. no longer offer their services exclusively in the field of education and research; orb. achieve the value specified in paragraph 1 letter b number 2 for a second successive financial year; notice must be given within three months of the end of the financial year.4 the ptss may rely on data obtained in implementing the legislation relating to the surveillance of post and telecommunications or by other authorities in implementing federal law.5 a provider that is declared to have more extensive duties to provide information must ensure that it can store the data required for providing information and provide the information within 2 months and 12 months of the declaration respectively.art. 52 providers of derived communication services with more extensive surveillance duties 1 the ptss shall in a ruling declare a provider of derived communication services to have more extensive surveillance duties (art. 27 para. 3 spta) if it has met one of the following criteria:a. surveillance assignments for 10 different surveillance targets in the past 12 months (effective date: 30 june);b. annual turnover in switzerland of chf 100 million in two successive financial years, provided a large part of its business operations is providing derived communication services, and 5000 subscribers use the provider's services.2 article 22 paragraphs 2-5 apply mutatis mutandis.art. 53 access to the installations 1 the persons or entities required to cooperate that must allow the ptss or the third parties that it instructs access to its installations shall allow the ptss access to buildings, devices, lines, systems, networks and services to the extent required for surveillance.2 they shall make existing means of network access to public telecommunications networks available free of charge. in consultation with the ptss or the third parties that it instructs they shall provide new means of network access at the expense of the ptss to the extent that this is required for surveillance.section 8 types of real-time monitoring of network access services art. 54 surveillance type rt_22_na_iri: real-time monitoring of secondary telecommunications data in the case of network access services 1 surveillance type rt_22_na_iri comprises the real-time surveillance of a network access service in the mobile communications sector.2 the following secondary telecommunications data of telecommunications traffic sent or received via the network access service under surveillance must be transmitted in real time:a. when access to the network is established or disconnected: the date, the time, the type of event and the reason for disconnection;b. the type of current access to the network;c. the aaa information used by the network access service under surveillance, in particular the subscriber identifier and the imsi in the case of mobile communications;d. the ip addresses or address ranges assigned to the network access service under surveillance and the date and time of each assignment;e. the available addressing elements of the network access service under surveillance, in the case of mobile communications, for example, the msisdn or the imsi;f. the unique device identifiers in accordance with international standards for the current terminal devices of the network access service under surveillance (e.g. imei, mac address);g. the type, date and time of the start and if applicable the end of technical modifications of access to the network (e.g. location update, change in mobile communications technology) and, if known, its causes;h. the target's available current location data or the cell used by the target or of the wlan access point used by the target in accordance with paragraph 3.3 the location data comprise:a. the identifiers or a combination of identifiers (e.g. cgi, ecgi, sai, rai, tai, bssid) and the geographical coordinates, and, if applicable, the main direction of emission of the cell or of the wlan access point, and, if available, the type of mobile communications technology used;b. the position of the target determined by the network, for example in the form of geographical coordinates and the related uncertainty value, or in the form of polygons with details of the geographical coordinates of each polygon point, and, if available, the type of mobile communications technology used; orc. if available, other details in accordance with international standards of the location of the target or of the cell or of the wlan access point, and, if available, the type of mobile communications technology used.art. 55 surveillance type rt_23_na_cc_iri: real-time monitoring of content and secondary telecommunications data in the case of network access services surveillance type rt_23_na_cc_iri involves the real-time surveillance of a network access service. the content of the telecommunication sent or received via the network access service under surveillance, and the related secondary telecommunications data in accordance with article 54 paragraphs 2 and 3 must be transmitted in real time.section 9 types of real-time monitoring of applications art. 56 surveillance type rt_24_tel_iri: real-time monitoring of secondary telecommunications data for telephony and multimedia services 1 surveillance type rt_24_tel_iri comprises the real-time surveillance of a telephony and multimedia service and, if applicable, converging services, in particular sms, voice mail and rcs. the following secondary telecommunications data of the telecommunication that is sent, processed or received via the services under surveillance must be transmitted in real time:a. the date and the time of logging-in and logging-out processes and their result;b. the aaa information used by the services under surveillance and the information on registration and subscription events and the corresponding responses, in particular the subscriber identifier (e.g. sip uri, impi), the imsi in the case of mobile communications and - if applicable - the customer's and server's ip addresses and port numbers as well as details of the protocol used;c. the signalling information, in particular on the serving system, on subscriber status and on service quality;d. if applicable, the presence information;e. in the case of communications, communication attempts and technical modifications (e.g. inclusion of additional services, inclusion of or change to converging services, changes in mobile communications technology, location updates), if applicable:1. their type, the date and the time of their start and if applicable their end,2. the addressing elements (e.g. msisdn, e.164-number, sip uri, impu) of all subscribers in communication and their role,3. the actual known destination address and the available intermediate addresses where the communication or the communication attempt is diverted or forwarded,4. the unique device identifiers in accordance with international standards for the terminal devices of the services under surveillance (e.g. imei, mac address),5. the other available identifiers,6. the reasons for the termination of communication or its non-materialisation or for the technical modification,7. the signalling information on additional services (e.g. conference calls, call forwarding, dtmf),8. the status of the communication or of the communication attempt,9. and in the case of mobile location services, the available current location data for the target or the cell used by the target or for the wlan access point used by the target in accordance with paragraph 2.2 the location data comprise:a. the identifiers or a combination of identifiers (e.g. cgi, ecgi, sai, rai, tai, bssid) and the geographical coordinates of the cell or the wlan access point and, if available, the type of mobile communications technology used;b. the position of the target determined by the network, for example in the form of geographical coordinates and the related uncertainty value, or in the form of polygons, with details of the geographical coordinates of each polygon point as well as the type of mobile communications technology used; orc. if available, other details in accordance with international standards relevant to the location of the target or the cell or of the wlan access point, and the type of mobile communications technology used.art. 57 surveillance type rt_25_tel_cc_iri: real-time surveillance of content and secondary telecommunications data in the case of telephony and multimedia services surveillance type rt_25_tel_cc_iri comprises the real-time surveillance of a telephony and multimedia service and, if applicable, converging services, in particular sms, voice mail and rcs. the content of the telecommunications traffic sent, processed or received via the services under surveillance, as well as the related secondary telecommunications data in accordance with article 56 must be transmitted in real time.art. 58 surveillance type rt_26_email_iri: real-time monitoring of secondary telecommunications data on email services surveillance type rt_26_email_iri comprises the real-time surveillance of an email service. the following secondary telecommunications data on the telecommunications traffic sent, processed or received via the service under surveillance must be transmitted in real time:a. the date and the time of logging-in and logging-out processes and their status;b. the aaa information used by the service under surveillance, in particular the subscriber identifier and, if applicable, the alias address;c. the customer's and server's ip addresses and port numbers as well as details of the protocol used;d. the date, time, volume of data, email addresses of the sender and the recipient of the message and the ip addresses and port numbers of the sending and receiving email servers for the following events:1. sending or forwarding of a message,2. receipt of a message,3. processing of a message in the mailbox,4. downloading of a message from the mailbox,5. uploading of a message to the mailbox.art. 59 surveillance type rt_27_email_cc_iri: real-time monitoring of content and secondary telecommunications data on email services surveillance type rt_27_email_cc_iri comprises the real-time surveillance of an email -service. the content of the telecommunications traffic sent, processed or received via the service under surveillance, as well as the related secondary telecommunications data in accordance with article 58 must be transmitted in real time.section 10 types of retroactive surveillance art. 60 surveillance type hd_28_na: retroactive surveillance of secondary telecommunications data in the case of network access services surveillance type hd_28_na includes the retroactive surveillance of secondary telecommunications data of a network access service. the following secondary telecommunications data of the past telecommunication that has been sent or has been received via the network access service under surveillance must be transmitted:a. the date and the time of the start and if applicable the end or the duration or the session;b. the type and status of the network access;c. the identifier that was used for authenticating the user at the access point under surveillance, for example the user name;d. the ip addresses or address ranges assigned to the target and their type;e. if available, the unique device identifier of the terminal device used by the target in accordance with international standards (e.g. mac address, imei in the case of mobile communications);f. if available, the volumes of data that were uploaded and downloaded during the session;g. in the case of access to the network via mobile communications: the gprs or eps information (in particular imsi or msisdn) and the following location data at the beginning and the end of the session as well as during the session if available; if known, additional location information from maritime navigation or aviation must be transmitted:1. the cell and region identifiers as well as the geographical coordinates, the postal addresses and if applicable the main directions of emission the cells used by the target, or2. the positions of the target determined by the network (e.g. in the form of geographical coordinates and the related uncertainty value, or in the form of polygons with details of the geographical coordinates of each polygon point) as well as the related postal addresses, or3. other details in accordance with international standards of the target's locations or the cells that he or she used, as well as the related postal addresses;h. in the case of access to the network via a public wlan: the bssid, and, if available, the ssid and the location data in the form of geographical coordinates and the postal address of the wlan access point used by the target; the user name, the type of authentication, the available additional information on user authentication (telephone number, mac address, imsi, user identifier and password used for authentication) and the ip address of the wlan access point. if available, additional location information from maritime navigation or aviation must be transmitted;i. in the case of fixed network access: the addressing elements of the access to the network and. if available, the postal address.art. 61 surveillance type hd_29_tel: retroactive surveillance of secondary telecommunications data relating to telephony and multimedia services surveillance type hd_29_tel comprises the retroactive surveillance of secondary telecommunications data of a telephony and multimedia service and, if applicable, converging services, in particular sms, mms and voice mail. the following secondary telecommunications data of the past telecommunications traffic in communications and communication attempts using the services under surveillance must be transmitted:a. their type, the date and time of the start and, if applicable, the end or their duration;b. the addressing elements (e.g. msisdn, e.164-number, sip uri, impu) of all subscribers in communication and their roles;c. the reason for the end of the communication or the communication attempt;d. in the case of mobile communications (multimedia services if available): the imei of the terminal device used by the target and the imsi of the target;e. if applicable, the type of carrier service;f. in the case of sms and mms: the information on the event, the type (only in the case of sms) and the status;g. in the case of mobile communications: the location data for the cell used by the target at the beginning and at the end of the communication or of the communication attempt. if known, additional location information from maritime navigation or aviation must be transmitted:1. the cell and region identifiers, the geographical coordinates and if applicable the main directions of emission and the postal address, or2. the positions of the target determined by the network (e.g. in the form of geographical coordinates and the related uncertainty value or in the form of polygons with details of the geographical coordinates of each polygon point) as well as the related postal addresses, or3. other details in accordance with international standards of the target's locations or the cells that he or she used, as well as the related postal addresses;h. in the case of multimedia services:1. the customer's ip address and its type and the port number,2. the communication correlation identifier,3. the types of multimedia content,4. information on the multimedia components (time, name, description, initiator, access-correlation identifier), and5. if applicable, information on the ims services (type of ims service used, role of the network element from which the secondary telecommunications data come); andi. in the case of multimedia services: information on the target's network access:1. the access type,2. the access class,3. whether the information on access to the network comes from the network, and4. the location data relating to the network access at the beginning and the end of the multimedia session, and, if available, during the multimedia session:- in the case of access to the network via mobile communications: the location data for the cell used by the target in accordance with letter g, or- in the case of access to the network via wlan: the available location data of the wlan access point used by the target (geographical coordinates, postal address), or- in the case of fixed network access: the available postal address of the access used by the target.art. 62 surveillance type hd_30_email: retroactive surveillance of secondary telecommunications data in the case of email services surveillance type hd_30_email comprises the retroactive surveillance of secondary telecommunications data of an email -service. the following secondary telecommunications data of the past telecommunication sent, processed or received via the service under surveillance must be transmitted:a. the date, the time, the type of event, the subscriber identifiers, if applicable the alias address, the sender and recipient addresses, the protocol used, the ip addresses of the server and the client, and, if applicable, the delivery status of the message in the case of the following events: sending, receipt, mailbox log-in, mailbox log-out and in the case of the following events, if available: downloading, uploading, deletion, processing, addition of a message;b. the ip addresses and names of the sending and receiving email servers.art. 63 surveillance type hd_31_paging: identifying most recent activity on the mobile terminal device of the person under surveillance surveillance type hd_31_paging comprises the identification of the most recent activity detected by the mobile telephony provider (network access services, telephony and multimedia services) on the mobile terminal device of the person under surveillance and providing the msisdn, imsi, imei (if available), the type of mobile communications technology, the frequency band, the unique identifier of the mobile network, the date and time of most recent activity detected, as well as one of the following details required to determine the location:a. information about the cell used: the identifier or a combination of identifiers (e.g. cgi, ecgi, sai, rai, tai), the postal address, the main direction of emission or, in the case of complex cells, the main directions of emission and the type of cell, the geographical coordinates;b. the postal address and details of the position of the terminal device during its most recent activity as determined by the network, for example in the form of geographical coordinates and the related uncertainty value or in the form of a polygon together with details of the geographical coordinates of each polygon point; orc. the postal address and other standardised details determined by the network of the position of the terminal device during its most recent activity or of the location of the cell used.art. 64 surveillance type as_32_prep_cov: network coverage analysis in preparation for an antenna search 1 surveillance type as_32_prep_cov comprises the network analysis in preparation for an antenna search in accordance with article 66. it is carried out by the tsps and serves to identify the mobile radio cells or public wlan access points that most probably cover the location described by the ordering authority in the form of geographical coordinates or by means of postal address, if applicable taking account of additional information (e.g. time of day, weather, day of the week, location within or outside of a building).2 the tsps shall supply the ptss with a list of cell identifiers (e.g. cgi, ecgi) or the bssid for the mobile radio cells or public wlan access points identified.art. 65 surveillance type as_33_prep_ref: reference communications or instances of reference network access in preparation for an antenna search 1 surveillance type as_33_prep_ref comprises the identification of mobile radio cells or public wlan access points on the basis of reference communications and instances of reference network access in preparation for an antenna search in accordance with article 66.2 the ordering authority shall itself arrange for reference communications to be made and the reference network to be accessed at the location concerned and shall send the ptss a list with the following related details:a. the type of communication or of access to the network;b. the date and the time of the communication or access to the network;c. the addressing element of the telephony and multimedia service used or of the network access service;d. if applicable, the name of the mobile network used.3 the ptss shall instruct the tsps, on the basis of the secondary telecommunications data relating to previous telecommunications traffic, to identify the mobile radio cells or public wlan access points used in each case base at the beginning and at the end of the reference communications and instances of reference network access in accordance with paragraph 2 and to provide it with a list of the corresponding cell identifiers (e.g. cgi, ecgi) or bssid completed in accordance with paragraph 2.art. 66 surveillance type as_34: antenna search 1 surveillance type as_34 comprises the retroactive surveillance of all communications, communication attempts and instances of network access that have taken place via a specific mobile radio cell or a specific public wlan access point over a period of up to two hours.142 the tsp shall supply the secondary telecommunications data resulting from paragraph 1 relating to previous telecommunications traffic in accordance with article 60 and 61.14 the correction of 3 july 2018 relates to the italian text only (as 2018 2551).section 11 missing person and wanted person searches art. 67 types of surveillance ep: missing person search the following types of surveillance may be ordered for a missing person search in accordance with article 35 spta:a. type ep_35_paging: determining the most recent activity detected by the mobile telephony provider (network access services and telephony and multimedia services) of the mobile terminal device belonging to the missing person or a third party and provision of the msisdn, the imsi, the imei (if available), the type of mobile communications technology, the frequency band, the unique identifier of the mobile network, the date and the time of the most recent activity detected as well as any one of the following details required to determine the location:1. information about the cell used: the identifier or a combination of identifiers (e.g. cgi, ecgi, sai, rai, tai), the postal address, the main direction of emission or, in the case of complex cells, the main directions of emission and the type of cell, the geographical coordinates,2. the postal address and the details of the position of the terminal device determined by the network during its most recent activity, for example in the form of geographical coordinates and the related uncertainty value or in the form of a polygon together with details of the geographical coordinates of each polygon point, or3. the postal address and other standardised details determined by the network of the position of the terminal device during its most recent activity or of the location of the cell used;b. type ep_36_rt_cc_iri (real-time surveillance of content and secondary telecommunications data): the combination of types of surveillance in accordance with article 55 (network access services) and in accordance with article 57 (telephony and multimedia services);c. type ep_37_rt_iri (real-time surveillance of secondary telecommunications data): the combination of types of surveillance in accordance with article 54 (network access services) and in accordance with article 56 (telephony and multimedia services);d. type ep_38_hd (retroactive surveillance of secondary telecommunications data): the combination of types of surveillance in accordance with article 60 (network access services) and in accordance with article 61 (telephony and multimedia services).art. 68 wanted person search the following types of surveillance may be ordered for a search for convicted persons in accordance with article 36 spta; "wanted person search" must be indicated in the surveillance order as the reason for surveillance (art. 49 para. 1 let. e):a. one of the types of real-time surveillance of the content and secondary telecommunications data of network access services or applications in accordance with articles 55, 57 or 59;b. one of the types of real-time surveillance of secondary telecommunications data of network access services or applications in accordance with articles 54, 56 or 58;c. one of the types of retroactive surveillance in accordance with articles 60-63;d. an antenna search in accordance with article 66 and the corresponding preparations in accordance with article 64 and 65.section 12 off-network identifiers art. 69 surveillance in accordance with articles 56-59, 61 and 62 also includes telecommunication carried out via the services under surveillance that can be assigned to the identifier under surveillance (target id) even if the identifier under surveillance is not administered by the provider given the assignment.chapter 4 final provisions art. 70 organisational, administrative and technical regulations the fdjp shall issue the organisational, administrative and technical regulations on conducting surveillance of post and telecommunications. in particular, it shall determine the deadlines within which the relevant data must be supplied.art. 71 implementation 1 the ptss shall provide electronic forms and interfaces to be used by those concerned. the forms and interfaces shall make it possible in particular for:a. the ordering authorities:1. to submit a surveillance order to the ptss,2. to instruct the ptss to grant or amend rights of access;b. the ptss:1. to instruct the persons or entities required to cooperate with the conduct of a surveillance measure,2. to pass on a request for information to the persons or entities required to cooperate and to forward their answers to the requesting authority;c. the authorised authorities to submit a request for information to the ptss.2 the ptss may at the appropriate time replace the electronic forms with online access to the service's processing system and introduce an electronic approval process for orders requiring approval. the electronic forms may continue to be used if online access to the processing system is impossible for technical reasons or if the processing system fails.art. 72 repeal of another enactment the ordinance of 31 october 200115 on the surveillance of post and telecommunications is repealed.15 [as 2001 3111; 2004 1431, 2021 art. 7, 3383; 2006 4705 no ii 77; 2007 4029; 2011 5955; 2016 4337 no ii; 2017 4151 annex 4 no ii 11]art. 73 amendment of other enactments the ordinances below are amended as follows:1. and 2. .1616 the amendments may be consulted under as 2018 147.art. 74 transitional provisions 1 surveillance activities ordered before this ordinance comes into force shall continue unchanged. these activities shall be extended or terminated in accordance with the previous law applicable to those types of surveillance.2 circuit trials ongoing in accordance with the previous practice when this ordinance comes into force shall be terminated.3 tsps that submit an application to the ptss for categorisation as a tsp with reduced surveillance duties in accordance with article 51 within three months of this ordinance coming into force shall be deemed to be such from the date on which this ordinance comes into force and for the duration of the procedure. the ptss may revoke this categorisation for the duration of the procedure if approval of the application is unlikely. article 51 paragraph 5 does not apply to tsps previously required to report.4 within 3 months of this ordinance coming into force, tsps and providers of derived communication services with more extensive duties to provide information in accordance with article 22 shall modify their systems in order to implement the new requirements on the identification the subscribers (art. 19) and recording persons' details in the case of mobile services (art. 20).5 within 6 months of this ordinance coming into force, tsps, with the exception of those with reduced surveillance duties in accordance with article 51, and providers of derived communication services with more extensive surveillance duties in accordance with article 52 shall modify their systems in order to be able to supply the information specified in articles 38 and 39.6 within 24 months of this ordinance coming into force:a. it must be possible to supply the secondary telecommunications data on communication attempts in the case of retroactive surveillance activities;b. tsps must make technical modifications to the systems they have available in order to be able to supply the data on email services specified in articles 58, 59 and 62. before then, they must supply the data on email services in the same way as before.7 until the new processing system procured under the telecommunications surveillance17 programme comes into operation:a. the ptss may continue to compile statistics (art. 12) in accordance with the previous law;b. information provision (art. 35-48) and surveillance activities (art. 54-68) shall continue to be carried out with the existing system, the previous formats and the corresponding forms. they shall be transmitted using a secure means of transmission authorised by the ptss, by post or fax; article 17 paragraphs 1-2 does not apply;c. information provision based on a flexible name search in accordance with article 27 in conjunction with articles 35, 40, 42 and 43 is not possible; from the date on which the new system comes into operation, it will only be carried out by tsps and providers of derived communication services with more extensive duties to provide information in accordance with article 22 that have modified their systems accordingly.8 within 12 months of the new processing system coming into operation, tsps and providers of derived communication services with more extensive duties to provide information in accordance with article 22 shall modify their systems in order to supply the information specified in articles 35-37 and 40-42 and in article 27 in conjunction with articles 35, 40 and 42 automatically via the query interface of the processing system (art. 18 para. 2) and in order to be able to carry out the flexible name search in accordance with article 27 in conjunction with articles 35, 40, 42 and 43.17 bbl 2015 3033art. 75 commencement this ordinance comes into force on 1 march 2018.annex (art. 2)terms and abbreviations 1. ip address (internet protocol address): address that identifies all devices connected to a network that communicate using the internet protocol; there are version 4 (ipv4) and the version 6 (ipv6) ip addresses;2. subscribers: persons who have entered into a contract with a provider of telecommunications or derived communications services on using its services or who have registered for its services or received a means of access to its services;3. multimedia services: communications services which in addition to speech integrate other types of media and functions, such as video, file transfer, images, audio, parts of content, presence information (examples: video telephony, unified communication, rcs, multimedia telephony device);4. identifier: addressing element, identification number or other unique indicator of a specific subscriber, a specific service or a specific device;5. msisdn (mobile subscriber integrated services digital network number): unique telephone number on which subscribers to a mobile network can be called;6. dsl identifier (digital subscriber line identifier): identifier of a digital subscriber line, i.e. of a broadband access to the network by means of which data can be sent and received via copper wires;7. ip prefix: part of the ipv6 address that identifies network concerned;8. ip address range: a number of successive ip addresses;9. net mask: in internet protocol version 4 (ipv4), describes how many bits at the start of the ip address displayed identify the network concerned;10. prefix length: in internet protocol version 6 (ipv6), describes how many bits at the start of the ip address displayed identify the network concerned;11. sim (subscriber identity module): smart card or chip permanently built into to the terminal device on which the imsi and the related key are securely stored; the sim is used to authenticate the subscribers to a mobile network, and includes the usim (universal subscriber identity module), uicc (universal integrated circuit card) and esim (embedded sim);12. iccid (integrated circuit card identifier): series-number of a built-in chip (e.g. esim) or of a smart card (e.g. sim card) that uniquely identifies the chip;13. imsi (international mobile subscriber identity): number that allows the unique international identification of mobile communication subscribers;14. imei (international mobile equipment identity): number that allows the unique international identification of mobile communication terminals;15. mac address (media access control address): hardware address that is stored in a network card or a network adapter and that is used as the unique address at the level of osi layer 2;16. puk code (personal unblocking key): unchangeable pin assigned to the sim used to unblock the sim if the pin code has been entered incorrectly on several occasions;17. puk2-code (personal unblocking key 2): same as the puk code, but assigned to the pin2 code;18. nat (network address translation): procedure for translating network addresses. the address information in ip packages is automatically replaced with other address information by a network element (e.g. router);19. source ip address: ip address that is assigned to the communication end point (normally the client) that establishes the connection;20. port number: address of a port; a port is the logical end point for communications with or within a computer system. a port is linked to an ip address and the communication protocol type;21. source port number: port number that is assigned to the communication end point (normally the client) that establishes the connection;22. destination ip address: ip address that is assigned to the communication end point (normally the server) with which the connection is established;23. destination port number: port number that is assigned to the communication end point (normally the server) with which the connection is established;24. sip (session initiation protocol): communication protocol that is used for signalling and maintaining multimedia communication sessions;25. sip uri (sip uniform resource identifier): uri scheme for addressing the sip. the sip uri are addressing elements in the format [email protected];26. impu (ip multimedia public identity): in addition to the impi, a subscriber to the ims has one or more impus that are used to communicate with other subscribers. one impi may be assigned several impus. conversely an impu may also be shared with other subscribers;27. tel uri (telephone uniform resource identifier): uri scheme for telephone numbers. the tel uri are addressing elements in the format tel:number, e.g. tel:+41-868-868-868;28. impi (ip multimedia private identity): globally unique identifier, assigned by providers to their subscribers, which is used inter alia for registration and aaa events. every subscriber to ip multimedia subsystems (ims) has an impi. the ims is telecommunications system based on the internet protocol that integrates mobile voice services and internet functions;29. alias address: additional email address that the subscriber can set up, change and delete at will. the email provider determines the maximum number of alias addresses and their structure. the alias addresses are linked to the email account. an email sent to an alias address is delivered to the same email box as used for the subscriber's related main email address;30. mailing list: list of email addresses, also known as a distribution list or distribution group. the list has its own email address. the messages that are sent to the mailing list address are forwarded on to the email addresses of its members;31. messaging services: message transmitting services that are independent of from telephony and multimedia services. they include instant messaging, ims messaging and messaging applications (apps) and sms services from third-party providers (i.e. sms services not provided by the subscriber's tsp). these services may also include additional functions such as multimedia communication, data transmission and presence information (e.g. a subscriber can see the current status and potentially the location of the other subscribers);32. cloud-services: derived communications services such as storage services and applications that are available online and hosted in data centres around the world depending on the need for resources;33. proxy services: communication interface in a network. it works as an intermediary that accepts requests on one side in order to establish a connection via its own address with the other side. proxy services are therefore relevant for the purposes of identification;34. public wlan access point: public wireless access point to a public telecommunications network that can be found both in public and in private spaces;35. cgi (cell global identity): unmodified cell identifier in second and third generation mobile networks (2g and 3g) (see 3gpp ts 23.003, clause 4.3.1); 36. ecgi (e-utran cell global identity): unmodified cell identifier in fourth generation mobile networks (4g) (see 3gpp ts 23.003, clause 19.6);37. sai (service area identity): unmodified identifier for a service area that is used in mobile networks for mobility management (see 3gpp ts 23.003, clause 12.5);38. rai (routing area identity): unmodified identifier for a routing that is used in mobile networks for mobility management related to packet-switched data transmission (see 3gpp ts 23.003, clause 4.2);39. tai (tracking area identity): unmodified identifier for a tracking area that is used for mobility management in fourth generation mobile networks (see 3gpp ts 23.003, clause 19.4.2.3);40. bssid (basic service set identifier): unique identifier (mac address) of the wlan access point;41. target id: identifier under surveillance, i.e. the identifier of the target of the surveillance;42. aaa (authentication, authorisation and accounting) information: information on which subscribers are allowed to use which services and which is used to bill subscribers for service usage. for the purposes of this ordinance, passwords are not regarded as aaa information. authentication is the process by which a subscriber is identified before the access is granted. authorisation determines which rights of access to resources or services that a subscriber holds and also guarantees access control. the subscriber's use of resources is measured for accounting purposes;43. sms (short message service): messaging service for transmitting short text messages;44. voice mail: storage devices used in telecommunication networks that offer answering services (e.g. receiving, forwarding and storing voice messages). there are also extensions for various types of media and services, such as sms, email, fax or video messages as well as function extensions such as converting from one type of media to another and the sending of messages;45. rcs (rich communications services): (originally: rich communication suite) specification of the international industry organisation for mobile telephony providers (gsm association, gsma) for the ims based provision of interoperable (i.e. cross-provider and cross-terminal) multimedia services with extended functional scope. various types of media (e.g. language, music, photographs, videos) and services (e.g. chat, chat groups, calls, multimedia messages, short messages, instant messages, presence information, transmission of files, address books) can be combined; the rcs services are provided to subscribers by their mobile telephony provider;46. e.164 number: telephone number in accordance with international numbering plan e.164 of the itu-t;47. dtmf (dual-tone multi-frequency): a signalling procedure, i.e. during a telephone conversation, signals can be sent by pressing the telephone keypad, for example to interact with answering machines or automatic voice response systems;48. mms (multimedia messaging service): messaging service for transmitting messages in different types of media (multimedia) in mobile networks.

783.1 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton the organisation of swiss post(post organisation act, poa)of 17 december 2010 (status as of 19 december 2020)the federal assembly of the swiss confederation,on the basis of article 92 of the federal constitution1,and having considered federal council dispatch dated 20 may 20092decrees:1 sr 1012 bbl 2009 5265section 1 general provisions art. 1 aim this act governs the organisation of swiss post and its change of legal form.art. 2 legal form and name 1 swiss post is a company limited by shares subject to a special statutory regime.2 it shall be entered in the commercial register under the names die schweizerische post ag, la poste suisse sa, la posta svizzera sa, la posta svizra sa.art. 3 objects 1 the objects of swiss post are to provide the following services both domestically and abroad:a. conveyance of postal items and small consignments in standardised containers, as well as all related services;b.the following financial services:1.payment services,2.accepting customer deposits,3.account services and other related services,4.investments in its own name,5.other financial services on behalf of third parties;c.regional passenger transport services and related services.2 it may engage in all legal transactions which serve the objects of the undertaking, and in particular:a. acquire and dispose of real estate;b. form companies;c. take equity interests in companies;d. borrow and invest funds from and in money and capital markets. 33 it may not, however, grant loans or mortgages to third parties. it is entitled to continue the loans granted on the basis of article 19 of the covid-19 financial guarantees ordinance of 25 march 20204 at the latest until they are fully repaid in accordance with article 3 of the covid-19 financial guarantees act of 18 december 20205.64 within the normal use of its infrastructure, it may provide services on behalf of third parties.34 [as 2020 1077 1207 1233 art. 21 3799]5 sr 951.266 second sentence inserted by art. 28 no 2 of the covid-19 financial guarantees act of 18 dec. 2020, in force from 19 dec. 2020 until 31 dec. 2032 (as 2020 5831; bbl 2020 8477 8819).art. 4 applicable law unless this act provides otherwise, swiss post is subject to the provisions of the swiss code of obligations governing companies limited by shares7.7 sr 220section 2 share capital and ownership strategy art. 5 share capital the amount of the share capital, as well as the type, nominal value and number of shares shall be set out in the articles of association.art. 6 circle of shareholders the swiss confederation is the shareholder of swiss post. it must hold a majority of the capital and voting rights. art. 7 ownership strategy 1 every four years, the federal council shall determine the strategic goals that the swiss confederation aims to achieve as owner of swiss post.2 prior to adopting the strategic goals, the federal council shall consult the competent committees of the federal parliament.3 the board of directors shall ensure implementation of the strategic objectives, report to the federal council with regard to their attainment, and make available to it such information as is necessary for the purpose of verification.section 3 corporate bodies and personnel art. 8 corporate bodies 1 the corporate bodies of swiss post are the general meeting of shareholders, the board of directors, and the auditors.2 no member of the board of directors may belong to the executive management.3 swiss post personnel must be appropriately represented in the board of directors.art. 9 employment relationship 1 swiss post personnel are employed under private law.2 swiss post shall conduct negotiations with the staff associations for the purpose of concluding a collective employment contract; the obligation to conduct negotiations on a collective employment contract pursuant to article 4 paragraph 3 letter c of the postal services act of 17 december 20108 is reserved.3 in its capacity as employer, swiss post shall promote the diversity and equality of its employees, in particular equality for employees with disabilities.4 the federal council shall ensure that at swiss post and the undertakings it controls, article 6a paragraphs 1-5 of the federal personnel act of 24 march 20009 shall apply mutatis mutandis to members of the management bodies and to other personnel who are remunerated at a comparable level.8 sr 783.09 sr 172.220.1section 4 tax liability art. 10 swiss post has the same tax liability as companies.section 5 legal relationships and liability art. 11 1 swiss post's legal relationships are governed by the provisions of private law.2 the liability of swiss post, its corporate bodies and personnel is governed by the provisions of private law. the government liability act of 14 march 195810 does not apply.10 sr 170.32section 6 final provisions art. 12 implementation the federal council shall implement this act.art. 13 change in legal form 1 the autonomous institution is converted to a company limited by shares subject to a special statutory regime under the provisions of this act. its legal relationships are not changed thereby.2 the federal council shall determine the date of the change in legal form. prior to the change, it shall consult the competent committee of the federal parliament. the federal council shall adopt such decrees as are necessary for the change of legal form:a.it shall decide as to the opening balance of the company limited by shares;b.it shall select the board of directors, appoint its chairperson, and adopt the first articles of association;c.it shall appoint the auditors.3 when deciding on the opening balance, it shall approve the institution's final accounts and management report; the institution's board of directors shall make a corresponding motion.4 when deciding on the opening balance, it may convert the institution's endowment capital into the equity capital of the company limited by shares in order to attain a reasonable level of equity capital. the state accounts of the swiss confederation and the swiss post balance sheet shall be adjusted accordingly.5 the board of directors of the institution shall prepare for the conversion to the new legal form, as well as the spin-off of postfinance and the transfer of postfinance's assets. as of the date of the change of legal form, the board of directors of the company limited by shares shall issue the organisational regulations and shall perform its other tasks in accordance with the code of obligations11 and the articles of association.6 in its capacity as employer, the company limited by shares shall continue the existing employment relationships. the public law employment relationships of the personnel shall be converted into private law employment relationships at the time that the new collective employment contract takes effect, or no later than two years following the change of legal form. 7 any entries in the land register, the commercial register and any other public registers in connection with the change of legal form shall be exempt of taxes and charges.8 the provisions of the mergers act of 3 october 200312 apply to the change of the legal form of the institution into a company limited by shares.11 sr 22012 sr 221.301art. 14 spin-off of postfinance 1 the unit of the swiss post ltd. group that provides payment services under the postal service legislation shall be spun-off into a private company limited by shares known as postfinance ltd.2 swiss post ltd. is the shareholder of postfinance ltd. it must hold a majority of the company's equity capital and voting rights.3 existing contractual relationships relating to payment services shall be transferred at the time of the spin-off to postfinance ltd.4 in its capacity as employer, postfinance ltd. shall continue the existing employment relationships. the public-law employment relationships shall be converted into private-law employment relationships at the time of the spin-off of postfinance, or no later than two years thereafter.5 any entries in the land register, the commercial register, and any other public registers in connection with the deconsolidation and the transfer of assets shall be exempt of taxes and charges.6 the provisions of the mergers act of 3 october 200313 apply mutatis mutandis to the spin-off of postfinance and the transfer of assets; the federal council may declare individual provisions as not applicable.7 the spin-off requires the approval of the federal council.13 sr 221.301art. 15 transitional provisions 1 the federal department of the environment, transport, energy and communications may:a.correct allocations of immovable property and rights in rem on the basis of article 20 paragraph 2 letter b of the postal services organisation act of 30 april 199714 until the end of 2013;b.correct register entries which were made on the basis of article 13 paragraph 7 as well as article 14 paragraph 5 for a period of five years following the commencement of this act, by decree, free of taxes and charges.2 complaints made by personnel filed prior to the commencement of this act are adjudicated under the previous law.3 where postfinance ltd.'s own financial resources and those of swiss post ltd. are insufficient, the swiss confederation is liable:a.for customer deposits up to chf 100,000 per creditor for a period of 5 years following the commencement of this act;b.for bonds still outstanding after the expiry of the five-year period until their maturity date;c. for all remaining obligations until their final maturity date or for the duration of the termination notice period, but no later than 5 years following the commencement of this act.4 swiss post ltd. and postfinance ltd. are authorised for a period of three years following the commencement of this act and on becoming liable to pay tax to valorise any existing hidden reserves in a tax-neutral manner.14 [as 1997 2465]art. 16 repeal and amendment of the laws currently in force the repeal and amendment of the laws currently in force are governed by the annex.art. 17 referendum and commencement 1 this act is subject to optional referendum.2 it comes into force together with the postal services act of 17 december 201015. the federal council may bring certain provisions into force at an earlier date where necessary for the change of legal form.commencement date: 1 october 20121615 sr 783.016 fcd of 29 aug. 2012.annex (art. 16)repeal and amendment of existing legislation ithe federal act of 30 april 199717 on the organisation of federal postal services is repealed.iithe following acts are amended as follows:.1817 [as 1997 2465, 2000 2355 annexe no 22, 2001 707 art. 31 no 3, 2003 3385, 2007 4703]18 the amendments may be consulted under as 2012 5043.

784.10english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.telecommunications act(tca)of 30 april 1997 (status as of 1 july 2021)the federal assembly of the swiss confederation,based on article 92 of the constitution1,2and having regard to the federal council dispatch of 10 june 19963,decrees:1 sr 1012 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).3 bbl 1996 iii 1405chapter 1 general provisions art. 1 aim 1 the aim of this act is to ensure that a range of cost-effective, high quality, and nationally and internationally competitive telecommunications services is available to private individuals and the business community.2 it shall in particular:a. ensure that a reliable universal service is provided, at affordable prices, for all sections of the population in all parts of the country;b. ensure that telecommunications traffic is free from interference and respects personal and incorporeal property rights;c. allow effective competition in the provision of telecommunications services;d.4 protect users of telecommunications services from unfair advertising and from abuse associated with value-added services;e.5 protect children and minors from the risks that arise from using telecommunications services.4 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). amended by no i of the fa of 22 march 2019, in force since 1 july 2021 (as 2020 6159; bbl 2017 6559).5 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 26 subject this act shall regulate the transmission of information by means of telecommunications techniques, including the transmission of radio and television programme services, provided the federal act of 24 march 20067 on radio and television (rtva) does not prescribe otherwise.6 amended by annex no ii 2 of the fa of 24 march 2006 on radio and television, in force since 1 apr. 2007 (as 2007 737; bbl 2003 1569).7 sr 784.40art. 3 definitions in this act:a. information means signs, signals, characters, images, sounds and any other form of representation addressed to human or other living beings or to machines;b. telecommunications service means transmission of information for third parties by means of telecommunications techniques;c. transmission by means of telecommunications techniques means sending or receiving of information, by lines or radio, by means of electrical, magnetic or optical signals or other electromagnetic signals;cbis.8 public telephony service means a telecommunications service for the transmission of speech in real time by means of one or more addressing resources provided for this purpose in a national or international numbering plan;cter.9 value-added service means a service provided by means of a telecommunications service and charged to the customers by their telecommunications service provider in addition to telecommunications services;d. telecommunications installations means apparatus, lines or equipment intended for the transmission of information by means of telecommunications techniques or used for that purpose;dbis. and dter.10 .e.11 interconnection means establishment of access by the connection of the installations and services of two telecommunications service providers, enabling them to operate together logically and in accordance with telecommunications techniques and allowing access to the services of third parties;ebis.12 leased lines means provision of transparent transmission capacities via point-to-point connections;eter.13 cable ducts means underground pipes in which lines for transmission of information by telecommunications techniques are conveyed, including the access shafts;f.14 addressing resource means a sequence of digits, letters, signs or other information that enable the persons taking part in a telecommunications operation, as well as the computer processes, machines, apparatus or telecommunications installations involved, to be identified;g.15 directory data means information that identifies or designates a customer in relation to an individually assigned addressing element and which is used in order to publish a directory or is required for the provision of a telecommunications service;h.16 radio and television programme service means sequence of programmes as defined in article 2 rtva17.8 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).9 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).10 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). repealed by no i of the fa of 22 march 2019, with effect from 1 jan. 2021 (as 2020 6159; bbl 2017 6559).11 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).12 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).13 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).14 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).15 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).16 inserted by annex no ii 2 of the fa of 24 march 2006 on radio and television, in force since 1 apr. 2007 (as 2007 737; bbl 2003 1569).17 sr 784.40chapter 2 telecommunications services section 1 common provisions art. 3a18 evaluation report 1 the federal council shall submit a report to the federal assembly every three years on:a. the development of investments made throughout switzerland;b. the development of the universal provision of services;c. the quality and the prices of the telecommunications services on offer;d. the development of network competition;e. the costs and granting of access to the local loop, irrespective of the technology underlying these connections.2 if required, the federal council shall submit proposals to the federal assembly for promoting effective competition.18 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 419 registration of telecommunications service providers 1 the federal office of communications (ofcom) shall register telecommunications service providers that use any of the following resources intended for providing telecommunications services:a. radio frequencies whose use requires a licence;b. addressing resources that are managed at national level.2 registered providers may allow other telecommunications service providers to use resources under paragraph 1 only if these other providers have registered beforehand.3 ofcom shall maintain and publish a list of registered providers and the telecommunications services that they offer.4 the federal council shall regulate the details of registration.19 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 520 telecommunications service providers organised under foreign law the competent authority may, subject to any international obligations to the contrary, prohibit telecommunications service providers organised under foreign law from using radio frequencies or addressing resources under article 4 paragraph 1 unless reciprocal rights are granted.20 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 621 telecommunications service providers with registered office or permanent settlement in switzerland telecommunications service providers with a registered office or permanent settlement in switzerland must:a. comply with the employment regulations and guarantee the conditions of employment customary in the industry;b. offer an appropriate number of vocational education and training places for apprentices.21 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 6a22 blocking access to telecommunications services providers of telecommunications services must block the access to telephone and internet services for persons who have established a customer relationship that is not based on a subscription where these persons on establishing the customer relationship:a. have used the identity of a person who does not exist or who has not previously consented to establishing the customer relationship; orb. has failed to provide a document that meets the requirements imposed by the federal council under article 23 paragraph 1 of the federal act of 18 march 201623 on the surveillance of postal and telecommunications traffic.22 inserted by annex no ii 3 of the fa of 18 march 2016 on the surveillance of postal and telecommunications traffic, in force since 1 march 2018 (as 2018 117; bbl 2013 2683).23 sr 780.1art. 7-1024 24 repealed by no i of the fa of 24 march 2006, with effect from 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 1125 granting of access by dominant providers 1 providers of telecommunications services that have a dominant position in the market must provide access to other providers in a transparent and non-discriminatory manner at cost-oriented prices in the following forms to their facilities and services:26a.27 fully unbundled access to the local loop in order to use the entire frequency spectrum of the twisted pair metallic line;b. and c.28 .d. interconnection;e. leased lines;f. access to cable ducts, provided these have sufficient capacity.2 they shall disclose the conditions and prices for their individual access services separately.3 the federal council regulates the details.4 providers of telecommunications services shall provide ofcom29 with a copy of their access agreement. unless there is some overriding public or private interest not to do so, ofcom shall allow agreements to be consulted.5 there is no obligation to guarantee access in relation to the broadcasting of radio and television programme services.25 amended by art. 106 para. 2 of the fa of 24 march 2006 on radio and television, in force since 1 apr. 2007 (as 2007 737; bbl 2003 1569).26 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).27 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).28 repealed by no i of the fa of 22 march 2019, with effect from 1 jan. 2021 (as 2020 6159; bbl 2017 6559).29 term in accordance with no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559). this change has been made throughout the text.art. 11a30 disputes regarding access 1 if providers of telecommunications services do not agree within three months on the access conditions, the federal communications commission (comcom) shall decide at the request of one party and based on the proposal made by ofcom.31 it shall take particular account of the conditions which promote effective competition, as well as the effects of its decision on competing companies. it may accord interim legal protection.2 if the question of dominance in the market must be assessed, ofcom shall consult the competition commission. the latter may publish its position.3 comcom32 shall decide within seven months of receipt of the request.4 it shall regulate the type and form of accounting and financial information which dominant providers of telecommunications services must submit in the procedure in accordance with para. 1.30 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).31 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).32 term in accordance with no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559). this change has been made throughout the text.art. 11b33 disputes arising from agreements and decisions regarding access disputes arising from agreements and decisions regarding access shall be judged by the civil courts.33 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 1234 bundling of services 1 dominant providers of telecommunications services may bundle their services, provided they also offer the services included in the bundle individually.2 services need not be offered individually if they can only be offered in the bundle for technical, economic, quality or security reasons.3 if a provider of telecommunications services bundles its own services with services of a third party undertaking which this provider controls or is controlled by, paragraphs 1 and 2 apply.34 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 12a35 obligations of transparency and to provide information 1 the telecommunications service providers must guarantee that their prices are transparent to their customers.2 they shall inform the public concerning the quality of the telecommunications services that they provide.3 the federal council shall specify the information that the providers must publish.4 ofcom may inform the public about the various telecommunications services offered by the providers.35 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 12abis 36 international roaming 1 the federal council may issue regulations on international roaming in order to avoid unreasonably high end customer tariffs, and may take measures to encourage competition. it may in particular: a. issue regulations on billing procedures;b. require mobile telephony providers to allow their customers to use the roaming services of third-party providers when abroad;c. fix price limits based on international agreements;d. require mobile telephony providers to offer bundled services including roaming services as well as options that allow the use of roaming services at fixed prices or reduced standard prices.2 ofcom shall conduct market monitoring procedures and analyse technical and price-related developments. in doing so, it shall rely in particular on the information obtained from providers under article 59 paragraph 1 and shall work with the price supervisor.36 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 12b37 value-added services to prevent abuses, the federal council shall regulate value-added services by taking the following measures in particular:a. fixing price limits;b. issuing regulations on the recognisability of value-added services;c. fixing the amounts above which a charge may only be made with the express consent of the users;d. subject to compliance with international obligations, requiring that providers of value-added services have their registered office or a permanent settlement in switzerland.37 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 12bbis 38 reasons for blocking a connection if a customer disputes an invoice from their telecommunications service provider for services other than telecommunications services, the provider is not permitted for this reason to block access to telecommunications services nor to terminate the contract before the dispute is settled.38 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 12c39 dispute resolution 1 ofcom shall establish a dispute resolution service or shall entrust this to third parties. in the event of disputes between customers and providers of telecommunications services or value-added services, either party may invoke the service.2 the party invoking the dispute resolution service shall pay a handling fee. the provider of telecommunications services or value-added services shall bear the costs of the procedure minus the handling fee.3 the parties are not bound by the dispute resolution decision.4 the federal council regulates the details.39 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 12d40 public directories 1 customers of telecommunications services shall have the option of having their details recorded in the public directories. they may within the limits set under paragraph 2 decide which directory data pertaining to them may be published.2 the federal council may specify which data a directory entry must include as a minimum. it may regulate the details of publication and the use of the data.40 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 12e41 open internet 1 the providers of internet access shall transmit information without making any technical or commercial distinction between senders, recipients, content, services, service classes, protocols, applications, programmes or terminals.2 they may transmit information by different methods if this is required in order to:a. comply with a statutory requirement or court decision;b. guarantee the integrity or security of the network, the services provided on this network or the terminals connected to it;c. comply with an express request from the customer; ord. overcome temporary and exceptional network congestion; in doing so, equivalent forms of data traffic shall be treated equally.3 in addition to internet access, they may offer other services via the same connection which must be optimised for specific content, applications or services in order to meet the quality requirements of customers. these other services must not be usable or offered as a substitute for internet access services, and they must not degrade the quality of internet access services.4 if they handle information in a different technical or economic manner during transmission, they must inform their customers and the public of this.41 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 1342 provision of information by ofcom 1 unless there is an overriding public or private interest in not doing so, ofcom shall on request provide the name and address of the provider of telecommunications services or value-added services, and information on the services provided by it and any administrative or criminal prosecutions and penalties.2 it may publish this information and make it accessible online if there is a public interest.3 only in the case of overriding public or private interest may it provide information on ongoing administrative or criminal prosecutions, publish that information or make it accessible online.42 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 13a43 processing of data 1 comcom and ofcom may process personal data, including data concerning administrative or criminal prosecutions and penalties and personality profiles, provided that this is indispensable for the fulfilment of the tasks imposed on them by the telecommunications legislation. they may use an information system for this purpose.2 they shall take the technical and organisational measures necessary for data protection and security during processing, and in particular during transmission.3 the federal council may issue complementary provisions, namely concerning the organisation and operation of the information system, the categories of the data to be processed, access and processing authorisations, the term of conservation as well as the archiving and destruction of data.43 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 13b44 administrative assistance 1 comcom and ofcom shall provide to other swiss authorities data which these authorities need in order to fulfil their legal duties. this data also includes sensitive data and personality profiles obtained in administrative or administrative criminal procedures. the data shall be made accessible individually, in lists or on electronic media.2 subject to international agreements to the contrary, comcom and ofcom may only transfer data to foreign surveillance authorities in the telecommunications sector, including sensitive personal data and personality profiles obtained in administrative or administrative criminal procedures, if these authorities:a. use such data exclusively to conduct surveillance of telecommunications service providers or for purposes of market surveillance;b. are bound by official or professional secrecy; andc. forward this data to competent authorities and bodies which are entrusted with surveillance tasks in the public interest only with the prior consent of comcom or ofcom or on the basis of a general authorisation in a treaty.3 comcom and ofcom shall not forward data to foreign prosecuting authorities if legal assistance is excluded in criminal matters. comcom or ofcom shall decide in agreement with the federal office of justice.4 swiss authorities shall forward to comcom and ofcom without charge such data as may be important for the enforcement of telecommunications legislation, including sensitive personal data and personality profiles. the data shall be made accessible individually, in lists or on electronic media.44 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).section 2 universal service licence45 45 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951). art. 1446 the licence 1 comcom shall ensure that the universal service is guaranteed for all sections of the population in all parts of the country. to this end, it shall periodically grant one or more universal service licences.2 the licence shall be tied to the condition that all or specific services of the universal service (art. 16) are provided to all sectors of the population within the area covered by the licence.3 an invitation to tender shall be issued for the granting of the licence. the procedure shall be conducted in accordance with the principles of objectivity, non-discrimination and transparency. the federal council regulates the details. the law on public procurement does not apply.474 if it is clear in advance that the invitation to tender cannot proceed under conditions of competition, or if it does not produce any suitable candidates, comcom may appoint one or more providers of telecommunications services to guarantee the universal service.5 licences are generally limited to the same term.46 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).47 fourth sentence inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 15 conditions for granting the licence any person wishing to obtain a universal service licence must:a. have the necessary technical capacities;b.48 furnish convincing proof that the service can be offered, particularly with regard to finance, and the service operated for the entire duration of the licence, and state what financial compensation, in accordance with article 19, will be required;c. undertake to comply with the applicable legislation, in particular this act and its implementing provisions, and the licence conditions;d.49 undertake to comply with employment legislation and to guarantee the working conditions that are customary in the sector.48 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).49 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 16 scope of the universal service50 1 the universal service licensee shall provide one or more of the following services to meet demand in the area covered by the licence, in accordance with the state of the art:51a.52 a public telephone service, i.e. transmission of speech in real time by means of telecommunications techniques, including transmission of data employing transfer rates compatible with the channels for transmitting speech, as well as the connection and additional services;b. access to emergency call services;c. public pay telephones in sufficient numbers;d.53 access to the swiss directories of subscribers to the public telephone service; the federal council may require a universal service licensee to maintain a directory of all customers of services of the universal service (general directory);e.54 .551bis services of the universal service must be ensured in such a way that persons with disabilities are offered comparable terms and conditions with respect to quality, quantity and prices as those without disabilities. in this respect the universal service licensee must ensure in particular that:a. public call boxes meet the requirements of the sensory impaired and those with reduced mobility;b. a relay service is provided for the hearing impaired;c. a directory enquiry and operator service is provided for the visually impaired.562 the federal council shall fix the detailed rules for implementation. it may lay down special provisions for connections outside built-up areas. it may delegate its powers in this regard to the federal department of the environment, transport, energy and communications (detec).573 the federal council shall periodically adapt the content of the universal service in accordance with the state of the art and social and economic requirements.50 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).51 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).52 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).53 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).54 repealed by annex no 5 of the fa on equality for disabled persons of 13 dec. 2002, with effect from 1 jan. 2004 (as 2003 4487; bbl 2001 1715).55 the list is no longer up-to-date. see now: para. 3 and art. 15 of the o of 9 march 2007 on telecommunications services (sr 784.101.1).56 inserted by annex no 5 of the fa on equality for disabled persons of 13 dec. 2002, in force since 1 jan. 2004 (as 2003 4487; bbl 2001 1715).57 third sentence amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 17 quality and price 1 services of the universal service must be of a certain quality throughout the country. the federal council shall decide the quality criteria.2 the federal council shall endeavour to ensure that charges do not depend on distance. it shall periodically fix upper limits for the prices of the services of the universal service. these upper limits shall apply uniformly over the whole area and shall be determined by the development of the market.art. 1858 58 repealed by no i of the fa of 24 march 2006, with effect from 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 1959 financial compensation 1 if it is clear before the granting of the licence that, even with efficient management, it will not be possible to cover the costs of provision of the universal service in a given area, the licensee shall be entitled to financial compensation.2 any licensee in receipt of financial compensation must present all the information required for cost evaluation and cost control, in particular the accounting and finance information, to ofcom each year.3 the federal council regulates the details.59 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 19a60 transfer and amendment of the licence 1 the licence may only be wholly or partly transferred to a third party with comcom's approval.2 article 24e applies to the amendment of the licence.60 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 19b61 publication by ofcom unless there is some overriding public or private interest not to do so, ofcom shall publish the name and address of the licensee, the subject of the licence and the rights and obligations deriving from the licence.61 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).section 3 obligations deriving from the provision of specific services62 62 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 2063 emergency call service 1 the telephone service providers must offer a service that enables users to contact the appropriate emergency call centre in the event of danger to life and limb, health or property (emergency call service).2 they must guarantee routing and location identification for emergency calls. the federal council may, after weighing-up the interests of public and the providers and taking account of technical developments and international harmonisation, specify exceptions and permit the use of the positioning functions of terminals even without the express consent of the user.3 the federal council may extend the obligation provide the emergency service to other telecommunications services that are publicly accessible and widely used.63 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 2164 collecting and providing directory data 1 the telephone service providers shall collect and update the directory data of their customers. in doing so, the following applies:a. the telephone service providers are not required to check the accuracy of the data.b. they must ensure that the data corresponds to the information provided by the customers.c. they may refuse to include information in the directory data that is obviously incorrect or that serves an unlawful purpose; they may remove such information from the directory data.2 they shall allow other providers of telecommunications services or of services which are based on directory data to access the minimum content of the directory data pertaining to their customers; they shall make the data electronically accessible to them.3 they shall grant access to the data in a transparent and non-discriminatory manner at prices based on the costs of providing the directory data. in doing so, they shall take account of international technical standards. in the event of any dispute, articles 11a and 11b apply by analogy.4 the providers of services based on the directory data must safeguard the integrity of the data. they may only modify the data with the consent of the telephone service provider responsible for collecting the data. they must modify or delete the data according to the changes sent by the telephone service providers. the federal council may issue regulations on the processing of directory data.5 the telephone service providers may delegate the fulfilment of their obligations to third parties.6 the federal council may extend the application of the provisions of this article to other telecommunications services that are publicly accessible and widely used.64 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 21a65 interoperability 1 telephone service providers must ensure that all users can communicate with each other (interoperability).662 the federal council may extend the obligation under paragraph 1 to other telecommunications services that are publicly accessible and widely used.67 it may prescribe interfaces for access to the service in accordance with international standards. ofcom shall issue the required technical and administrative regulations.3 providers required to guarantee interoperability must also offer interconnection even if they are not dominant in the market. articles 11a paragraphs 1 and 3 and 11b apply by analogy to disputes regarding the conditions for interconnection.68 the federal council may impose further obligations on providers who are obliged to provide interoperability.65 inserted by no i of the fa of 24 march 2006, in force since 1 april 2007 (as 2007 921; bbl 2003 7951).66 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).67 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).68 second sentence amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 21b69 69 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). repealed by no i of the fa of 22 march 2019, with effect from 1 jan. 2021 (as 2020 6159; bbl 2017 6559).chapter 3 radiocommunications art. 2270 use of the radiocommunications frequency spectrum 1 the radiocommunications frequency spectrum may be freely used subject to compliance with the regulations on use.2 the federal council may provide that the use of certain frequencies is only permitted:a. with a licence from ofcom or, in the cases under article 22a, comcom;b. after giving notice to ofcom;c. with a proficiency certificate.3 it shall impose restrictions under paragraph 2 solely:a. to avoid radio interference;b. to guarantee the technical quality of telecommunications services and other radio applications;c. to guarantee efficient use of the radiocommunications frequency spectrum; ord. in cases in which other legislation or international treaties provide that the frequency spectrum may only be used with the approval of the responsible authority.4 in the case of frequency bands the allocation of which is the responsibility of the armed forces or civil defence in accordance with the national frequency allocation plan, the federal council shall not impose any restrictions in accordance with paragraph 2.5 it shall specify the regulations on use and the requirements for granting proficiency certificates.70 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 22a71 radio communications licences for the provision of telecommunications services 1 comcom shall issue the licences for using the radiocommunications frequency spectrum required to provide telecommunications services.2 if it is anticipated that there will be a shortage of frequencies, it shall normally conduct a public tendering process.3 it may delegate to ofcom the power to grant radio communications licences for which no shortage of frequencies under paragraph 2 exists or is anticipated in specific cases or in general for entire frequency bands.4 the federal council shall regulate the principles for granting radio communications licences that are wholly or partly intended for the broadcasting of radio and television programme services.71 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 23 conditions for granting the licence 1 any person wishing to obtain a radiocommunications licence must:a.72 have the necessary technical capacities and, insofar as required for using the relevant frequencies (art. 22 para. 2 let. c), hold the relevant proficiency certificate;b.73 undertake to comply with the applicable legislation, in particular this act, the rtva74, their implementing provisions, and the licence conditions.2 subject to any international obligations to the contrary, the licensing authority may refuse to grant a licence to undertakings incorporated under foreign law unless reciprocal rights are granted.3 a licence shall be granted only if, having regard to the national frequency allocation plan, enough frequencies are available.4 the granting of a radiocommunications licence must not eliminate or constitute a serious obstacle to effective competition unless an exception can be justified on grounds of economic efficiency. where the issue of the elimination or serious restriction of effective competition must be assessed, the licensing authority shall consult the competition commission.7572 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).73 amended by annex no ii 2 of the fa of 24 march 2006 on radio and television, in force since 1 apr. 2007 (as 2007 737; bbl 2003 1569).74 sr 784.4075 second sentence amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 2476 procedure for granting the licence 1 the federal council shall regulate the procedure for granting radio communications licences. it shall be conducted in accordance with the principles of objectivity, non-discrimination and transparency. all information provided by applicants shall be treated as confidential.2 the public law on public procurement does not apply.3 for the first-instance procedure concerning the public tendering process and for the appeals procedure, in particular with regard to evaluation of the submissions and in order to guarantee commercial secrecy, the federal council may deviate from the following provisions of the federal act of 20 december 196877 on administrative procedure (apa):a. determination of the circumstances (art. 12 apa);b. co-operation of the parties (art. 13 apa);c. inspection of documents (art. 26-28 apa);d. right to a hearing (art. 30 and 31 apa);e. notification and justification of decisions (art. 34 and 35 apa).4 in the procedure concerning the public tendering process, interim decisions are not in themselves contestable by means of appeal.76 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).77 sr 172.021art. 24a78 78 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). repealed by no i of the fa of 22 march 2019, with effect from 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 24b79 special licensing regulations if no licensing regulations exist for specific circumstances requiring a licence, the licensing authority shall define these on a case-by-case basis.79 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 24c80 term of the licence the licence is granted for a specific period of time. the licensing authority shall determine the term according to the type and importance of the licence.80 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 24d81 transfer of licences and cooperation between licensees 1 licences are wholly or partly transferable.2 transfers are only permitted with prior consent of the licensing authority. consent may only be refused if:a. the licence requirements under article 23 are not complied with; orb. the efficient use of frequencies free from interference is not guaranteed.3 the licensing authority may permit exceptions from the requirement of consent for individual frequency bands if it is anticipated that the efficient use of frequencies free from interference will be guaranteed and if effective competition is neither eliminated nor seriously restricted. advance notice must be given to the licensing authority of transfers that do not require consent.4 if the licence has been granted by comcom, paragraph 2 applies by analogy to the economic transfer of the licence. an economic transfer occurs when a company has taken over control of the licensee in accordance with the law on cartels.5 where holders of licences granted by comcom make joint use of components of radio communications networks, they must give advance notice of this to comcom. the joint use of frequencies requires consent under paragraph 2.81 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 24e82 amendment and revocation of the licence 1 the licensing authority may amend or revoke the licence due to changes in actual or legal conditions if the amendment or revocation is necessary to guarantee important public interests.2 the licensee shall be appropriately compensated if the transferred rights are revoked or substantially reduced.82 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 24f83 provision of information by ofcom 1 provided there are no overriding public or private interests, ofcom shall provide the name and address of the licensee, and information on the subject of the licence, the rights and obligations attached to the licence, the frequency assignments and the transmitter locations.842 it may publish this information and make it accessible online if there is a public interest.83 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).84 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 25 management of frequencies 1 ofcom shall manage the frequency spectrum and the swiss utilisation rights and orbital positions of satellites in accordance with the relevant international agreements. it shall take appropriate measures to ensure that these resources are used efficiently and without interference and to provide equitable access to them on the basis of the national frequency allocation plan.1bis it shall issue the national frequency allocation plan. in doing so, it shall take appropriate account of the frequency requirements for armed forces and civil protection operations; it shall work with the responsible armed forces office.852 the national frequency allocation plan is subject to approval by the federal council.863 in the event of a mobilisation of troops, the federal council may allocate the armed forces additional free or already licensed frequencies for the duration of operations.8785 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).86 amended by annex no ii 2 of the fa of 24 march 2006 on radio and television, in force since 1 apr. 2007 (as 2007 737; bbl 2003 1569).87 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 26 technical monitoring 1 ofcom shall monitor the frequency spectrum for planning and surveillance purposes.2 it shall carry out these checks alone or in co-operation with other authorities. the federal council shall fix the detailed rules for such co-operation.3 ofcom may intercept or record radiocommunications traffic if this is necessary to ensure that telecommunications and broadcasting are free from interference and if other measures have proved ineffective or entail unreasonable expenditure.4 any data that is recorded may be used only to determine the cause of the interference or identify the person or persons responsible for it.5 if there is reason to suspect that an offence has been committed that is punishable under this act, any recordings that may constitute evidence shall be passed to the competent authority. any other recording must be destroyed immediately.art. 2788 processing of data and administrative assistance articles 13a and 13b concerning processing of data and administrative assistance shall apply.88 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).chapter 4 addressing resources art. 2889 management of addressing resources 1 ofcom shall manage the addressing resources that must be managed at national level. it shall ensure that sufficient addressing resources are available; in doing so it shall take account of technical developments and international harmonisation.2 the federal council shall specify which addressing resources ofcom must manage.3 it may prescribe a mandatory alternative dispute resolution procedure between the holders of addressing resources and third parties. it shall regulate the procedure, its consequences and its effects on the procedure under civil law, particularly the suspension of the period of limitation and the burden of proof. the right of holders of addressing resources and third parties to bring civil actions is reserved.4 no one has the right to a specific addressing resource. the federal council may permit exceptions.5 providers of telecommunications services shall ensure number portability.6 the federal council shall issue regulations on the management of addressing resources, and in particular on:a. their allocation, use, blocking, transfer and withdrawal; b. the issuing of numbering plans; c. the delegation of management to third parties, the termination of the delegated activity and the supervision of the same;d. sub-allocation;e. number portability.89 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 28a90 delegation of the management of addressing resources to third parties 1 ofcom may in special cases delegate the management of certain addressing resources to third parties. 2 it shall select the third parties based on a tender or invitation procedure. if there is good cause, it shall appoint them directly.3 if the tender or invitation procedure does not result in any suitable applications or if the delegated parties can no longer fulfil their obligations, ofcom may require third parties to carry out the task. these third parties may charge prices for their activities that cover the relevant costs and allow an appropriate profit to be made. 4 article 24 applies by analogy to the selection process.90 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 28b91 internet domains this act applies to the following internet domains:a. the country-specific domain .ch and, insofar as the management of the domain is the responsibility of the confederation, all other internet domains that designate switzerland alphanumerically, including transpositions in other alphabets or graphical systems;b. generic domains, if swiss public corporations are responsible for their management;c. generic domains, if persons resident or with registered office in switzerland are responsible for their management;d. generic domains which, because of their name, are of particular political, cultural, geographical or religious significance for switzerland.91 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 28c92 management of internet domains: responsibility 1 ofcom shall manage internet domains if the confederation is responsible for their management.2 it may provide commercial services to third parties provided this is necessary for managing domain names and the requirements of article 41a paragraphs 2 and 3 of the financial budget act of 7 october 200593 are met.92 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).93 sr 611.0art. 28d94 management of internet domains: principles the management of internet domains and their subordinate domain names is governed by the following principles:a. the security and availability of the infrastructure and the services required for the domain name system to function are guaranteed.b. the internet domains are managed in a transparent and non-discriminatory manner if they are the responsibility of public corporations.c. the proprietors of and applicants for domain names are protected from the misuse of their personal data.94 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 28e95 management of internet domains: modalities the federal council shall regulate the modalities for managing internet domains and their subordinate domain names; in doing so, it shall take account of the rules applied internationally. it may in particular:a. lay down the conditions for the allocation, use, blocking, transfer and withdrawal of domain names that are subordinate to the domains that are the responsibility of the confederation;b. regulate the processing of personal data in connection with domains that fall within the scope of this act, including the provision of a publicly accessible database that guarantees everyone access to information about the proprietors of domain names;c. provide for measures that prevent the unlawful use of domain names or the use of domain names that is contrary to public order, and regulate cooperation with specialised private or public bodies in this sector;d. determine the institutional, functional and operational organisation of the domains that are the responsibility of the confederation;e. regulate the management of domains for which public corporations other than the confederation or private individuals resident in switzerland are responsible;f. issue provisions relating to generic domains of particular political, cultural, geographical or religious significance, provided this is necessary in order to safeguard switzerland's interests.95 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 29 obligation to provide information any holder of addressing resources shall be required to provide the competent authority with the information it needs to manage the addressing resources that have been assigned.art. 3096 exclusion of compensation modification by the authorities of numbering plans or regulations for the management of addressing resources shall not constitute grounds for any claim for compensation.96 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 30a97 data processing and administrative assistance articles 13a and 13b on data processing and administrative assistance apply.97 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).chapter 5 telecommunications installations art. 3198 import, offering, making available on the market and putting into service99 1 the federal council may adopt technical regulations on the import, offering, making available on the market and putting into service of telecommunications installations, in particular in respect of basic technical requirements with regard to telecommunications, evaluation of conformity, certification of conformity, declaration of conformity, markings, registration and the obligation to provide proof (art. 3 of the federal act of 6 october 1995100 on technical barriers to trade).1012 if the federal council has laid down basic technical requirements with regard to telecommunications within the meaning of paragraph 1, ofcom shall generally, in order to concretise them:102a. designate technical standards, compliance with which shall be deemed to constitute fulfilment of the basic requirements; orb.103 declare technical standards, european union legal instruments or other rules binding.3 in implementing paragraph 2, ofcom shall take the relevant international standards into account; any derogations shall require the consent of the state secretariat for economic affairs.3bis ofcom may draw up and publish technical standards.1044 if the federal council has not adopted any basic technical requirements with regard to telecommunications within the meaning of paragraph 1, or if ofcom has not concretised them in accordance with paragraph 2, the person offering, making available on the market105 or putting into service a telecommunications installation must ensure that it complies with the recognised rules of telecommunications engineering. these shall be deemed to include, first and foremost, any internationally harmonised technical standards. in the absence of such standards, the technical specifications of ofcom or, in the absence of such specifications, the national standards shall apply.5 if it is necessary for technical telecommunications security reasons, ofcom may rule that certain telecommunications installations may be entrusted only to specially qualified persons. it may regulate the detailed rules of such entrusting.98 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).99 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).100 sr 946.51101 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).102 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).103 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).104 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).105 term in accordance with annex no 4 of the fa of 16 june 2017, in force since 1 jan. 2018 (as 2017 5607; bbl 2016 7133). this amendment has been made throughout the text.art. 32 installation and operation a telecommunications installation may only be installed and operated if it complied with the regulations in force when it was first made available on the market, installed or put into service and if it has been kept in that state. the federal council may define exceptions.106106 second sentence inserted by virtue of no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 32a107 telecommunications installations to guarantee public safety the federal council shall regulate the import, offering, making available on the market, putting into service, installation and operation of telecommunications installations which must be used by authorities in the interest of public safety.107 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 32b108 prohibition of installations and devices that cause interference 1 it is prohibited to manufacture, import, offer, make available on the market, possess, put into service, install or operate telecommunications installations and other devices that are intended to interfere with or prevent telecommunications or broadcasting.2 article 32a is reserved.108 amended by annex no 4 of the fa of 16 june 2017, in force since 1 jan. 2018 (as 2017 5607; bbl 2016 7133).art. 33 surveillance 1 in order to check compliance with the regulations on the import, offering, making available on the market, putting into service, installation and operation of telecommunications installations, ofcom shall have access during normal working hours to the premises where such installations are located.1092 the federal council shall regulate the right of access to telecommunications installations that are subject to military secrecy regulations.3 if a telecommunications installation fails to comply with the regulations, ofcom shall take the necessary measures. it may, in particular, restrict or prohibit the installation, operation, import, offering and making available on the market of such an installation, order it to be restored to a state that complies with the regulations or returned, or confiscate it without compensation.1104 ofcom may publish the information on measures under paragraph 3 and make it accessible online if there is a public interest in doing so.1115 it may provide, publish or make accessible online information on ongoing administrative or criminal proceedings only if there is an overriding public or private interest in doing so.1126 it may participate in international databases for the exchange of information between market surveillance authorities. it may only record data in such databases if their transmission to foreign authorities would be permitted under article 13b.113109 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).110 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).111 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).112 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).113 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 34 interference 1 if a telecommunications installation causes interference to telecommunications or broadcasting, ofcom may require the operator to modify it at his own expense or to suspend operation of the installation, even if it complies with the regulations on the import, offering, making available on the market, putting into service, installation and operation applicable to it.1141bis if telecommunications installations disrupt or may disrupt the use of frequency spectrums that require increased protection, the office may restrict or forbid the offering and making available on the market of such installations, even if they comply with the regulations concerning their offering and making available on the market.1151ter the federal council shall regulate the conditions under which the following authorities may for the following purposes install, put into service or operate a telecommunications installation which causes interference:a. the police and the law enforcement authorities, in order to guarantee public safety and security;b. the federal intelligence service, in order to guarantee the protection and security of its employees, information and installations.1161quater if lawful interference disproportionately disrupts other public or third-party interests, paragraph 1 applies.1172 in order to determine the source of the interference to telecommunications or broadcasting, ofcom shall grant access to all telecommunications installations.118114 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).115 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). amended by annex no 2 of the fa of 12 june 2009, in force since 1 july 2010 (as 2010 2617; bbl 2008 7275)116 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). amended by annex no ii 13 of the intelligence service act of 25 sept. 2015, in force since 1 sept. 2017 (as 2017 4095; bbl 2014 2105).117 inserted by annex no ii 13 des intelligence service act of 25 sept. 2015, in force since 1 sept. 2017 (as 2017 4095; bbl 2014 2105).118 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 34a119 processing of data and administrative assistance articles 13a and 13b concerning processing of data and administrative assistance shall apply to articles 31-34.119 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 35 use of land 1 owners of land in public use (such as roads, footpaths, squares, waterways, lakes and banks and shorelines) are required to allow providers of telecommunications services to use that land to install and operate lines and public pay telephones, provided those installations do not interfere with the public use of the land.1202 providers of telecommunications services shall take account of the purpose and the use to which the property in question is put and shall bear the cost of restoring it to its original state.121 they shall be required to move their lines if the owner of the property wishes to use it for a purpose that is incompatible with their presence.3 the federal council shall regulate the details, in particular the providers' duty of co-ordination and the conditions governing the relocation of lines and public pay telephones.1224 the authorisation procedure shall be simple and rapid. no compensation other than an administrative charge to cover costs may be levied for the use of the land, provided that it does not interfere with its public use.120 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).121 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).122 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 35a123 other connections 1 building owners and must tolerate, insofar as it is reasonable, additional connections to dwellings or business premises other than the connection of their choice, if a telecommunications service provider so requests and pays the costs thereof.1242 connection of buildings in accordance with the cantonal development stipulations is reserved.3 no charge for utilisation shall be levied if:a. the tenant directly forgoes use of a new connection;b. the connection contract is cancelled; the telecommunications service provider or the lessor shall allow a reasonable cancellation period.1254 the telecommunications service provider or the lessor may place under seal and verify unused connections. no costs may be charged for sealing and removing seals.126123 inserted by annex no ii 2 of the fa of 24 march 2006 on radio and television, in force since 1 apr. 2007 (as 2007 737; bbl 2003 1569).124 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).125 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).126 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 35b127 access to the building entry point and joint use of installations within buildings 1 every telecommunications service provider shall have a right of access to the building entry point and of joint use of the installations within the building intended for telecommunications transmission provided this is technically justifiable and there is no other good cause for refusal.2 building owners and telecommunications service providers must allow the joint use of the installations within the building in a transparent and non-discriminatory manner. 3 building owners and shall make the required information on the installations within the building available to the providers on request. 4 providers who have financed an installation must be compensated appropriately.5 if requested to do so, comcom shall rule on disputes between telecommunications service providers relating to access to the building entry point or the conditions for joint use. article 11b applies by analogy.127 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 36 right of compulsory purchase and joint use 1 if the establishment of a telecommunications installation is in the public interest, detec128 may grant the right of compulsory purchase. the procedure shall be conducted in accordance with the federal act of 20 june 1930129 on compulsory purchase.2 ofcom may on application, for reasons of public interest, in particular to take account of technical problems or the planning needs or protection of the countryside, national heritage, the environment, nature or animals, require providers of telecommunications services to accord to a third party, in return for appropriate compensation, the right to make joint use of its telecommunications installations and other installations, such as cable ducts and transmitter locations, if they have sufficient capacity.1303 under the same conditions, ofcom may require providers of telecommunications services to co-install and joint use of telecommunications installations and other installations, such as cable ducts and transmitter locations.131128 name in accordance with no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559). this change has been made throughout the text.129 sr 711130 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).131 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 36a132 protection of existing lines lines owned by telecommunications service providers that are in existence when the amendment of 22 march 2019 comes into force and are located in sewers which were constructed for the purpose of spatial planning development may only be removed from the sewers for good cause. providers of telecommunications services shall, where possible, be offered alternative ducts for their lines.132 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 37133 ownership of lines 1 lines for the transmission of information by means of telecommunications techniques and cable ducts shall be the property of the providers of telecommunications services who have installed them or acquired them from third parties.2 any owner of land who wilfully or through gross negligence damages a telecommunications service provider's line or cable duct on his property shall be liable for the damage.133 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 37a134 amateur radio 1 the authorities may provide a simplified licensing procedure for simple wire and rod antennas and for antennas on light masts with a similar appearance to flagpoles.2 the maintenance of an antenna or its replacement with an antenna of a similar size does not require authorisation.134 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).chapter 6 fees art. 38135 fee for financing the universal service 1 ofcom shall collect from providers of telecommunications services a fee, the revenue from which shall be used exclusively to finance the uncovered costs of the universal service in accordance with article 16 and the costs for the administration of the financing mechanism.2 the total amount of the fees must cover the costs listed in paragraph 1; the fee shall be fixed in proportion to the turnover of the telecommunications services provided.3 the federal council may exempt from the fee those providers whose turnover from the telecommunications services provided is below a defined amount.4 it shall regulate the detailed rules for provision of the information which is required for the apportionment and monitoring of the costs listed in paragraph 1.135 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 39136 licence fees for radiocommunications 1 the licensing authority shall charge a fee for radiocommunications licences. no fee shall be charged for radiocommunications licences intended for broadcasting licensed radio or television programme services in accordance with the rtva137.1382 the amount of the fees shall be calculated on the basis of:a. the frequency range allocated, the class of frequency and the value of the frequencies;b. the bandwidth allocated;c. the territorial scope; andd. the temporal scope.3 if a frequency may also be used to broadcast both licensed radio or television programme services and to transmit other radio and television programme services and information, the latter is subject to a licence fee proportional to usage.1393bis in order to facilitate the introduction of new broadcasting technologies in terms of article 58 rtva, or to safeguard the diversity of programming in areas inadequately covered by wireless terrestrial services, the federal council may reduce the licence fee for broadcasting radio and television programme services.1404 if the radiocommunications licence is granted by auction, the licence fee shall correspond to the amount of the bid, less administrative charges for the invitation to tender and the granting of the licence. the licensing authority may fix a minimum bid.5 the federal council may waive payment of the radiocommunications licence fee in the case of the following bodies, provided that they do not supply telecommunications services and that they make rational use of frequencies:a. authorities and public law bodies and establishments of the confederation, cantons and communes, provided that they use the frequency spectrum exclusively for tasks for which they bear sole responsibility;b. public transport undertakings;c.141 the institutional beneficiaries of preferential rights, immunities and facilities under article 2 paragraph 1 letters a, b and d-l of the host state act of 22 june 2007142;d.143 legal entities under private law, provided they perform public tasks on behalf of the confederation, cantons or communes.136 amended by annex no ii 2 of the fa of 24 march 2006 on radio and television, in force since 1 apr. 2007 (as 2007 737; bbl 2003 1569).137 sr 784.40138 amended by annex no 4 of the fa of 26 sept. 2014, in force since 1 dec. 2017 (as 2016 2131, 2017 5929; bbl 2013 4975).139 amended by annex no 4 of the fa of 26 sept. 2014, in force since 1 dec. 2017 (as 2016 2131, 2017 5929; bbl 2013 4975).140 inserted by annex no 4 of the fa of 26 sept. 2014, in force since 1 dec. 2017 (as 2016 2131, 2017 5929; bbl 2013 4975).141 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).142 sr 192.12143 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 39a144 funding of accompanying measures the federal council may use part of the proceeds from licence fees under article 39 for accompanying measures such as research and surveys in connection with radio-based technologies.144 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 40145 administrative charges 1 the competent authority shall make an administrative charge for its decisions and services to cover its expenses, in particular in connection with:a.146 the surveillance of providers of telecommunications services;b.147 the decisions concerning access, provision of directory data, interoperability and the joint use of installations;c. the resolution of disputes between customers and providers of telecommunications services or value-added services;d.148 the granting, amendment and cancellation of universal service licences and radiocommunications licences, surveillance thereof and registration for the use of frequencies;e. the management and technical monitoring of the frequency spectrum and satellite orbital positions;f. the management, assignment and revocation of addressing resources;g. the registration and surveillance of telecommunications installations.1bis no administrative fees in terms of paragraph 1 letters d and e shall be charged for radiocommunications licences issued to the armed forces, civil defence, the border guard, the police, the fire brigade, emergency and rescue services operating exclusively in the public interest and civilian command staffs.1492 if an activity as defined in paragraph 1 concerns telecommunications services or radiocommunications licences which are used in whole or in part for the broadcasting of radio or television programme services, the authority may take account of the limited financial resources of the broadcaster who holds the right of access and who is directly or indirectly affected by the charge.3 if responsibility for any of the activities listed in paragraph 1 has been delegated to a third party, that party may be required to submit the prices of its services to ofcom for approval, in particular if no competition exists for these services.4 detec may set upper price limits, in particular if the price level in a specific market implies abuse.145 amended by art. 106 para. 2 of the fa of 24 march 2006 on radio and television, in force since 1 apr. 2007 (as 2007 737; bbl 2003 1569).146 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).147 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).148 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).149 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 41150 fixing and collection of fees the federal council shall regulate the detailed arrangements for the collection of fees and the financing of the universal service and fix the amount of the fees for radiocommunications licences and the administrative charges.150 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 42 guarantees the authority responsible for collecting the fees may require the person responsible for paying them to provide appropriate guarantees.chapter 7 telecommunications confidentiality and data protection and protection of children and minors151 151 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 43 obligation of confidentiality no person who is or has been responsible for providing a telecommunications service may disclose to a third party information relating to subscribers' communications or give anyone else an opportunity to do so.art. 44152 152 repealed by no ii 31 of the fa of 20 march 2008 on the formal revision of federal legislation, with effect from 1 aug. 2008, with effect from 1 aug. 2008 (as 2008 3437; bbl 2007 6121).art. 45 disclosure of information to subscribers 1 the customer may require the provider of telecommunications services to inform him of the data on which invoices are based, in particular the addressing resources, the times when calls were made and the payment due.2 any person requiring this data to trace nuisance calls or unfair mass advertising may require the provider of telecommunications services to inform him of the name and address of the subscribers whose lines were used to make the calls in question.153153 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 45a154 unfair advertising155 1 providers of telecommunications services shall combat unfair advertising in accordance with article 3 paragraph 1 letters o, u und v of the federal act of 19 december 1986156 on unfair competition.1572 the federal council may define measures that are appropriate and necessary to combat unfair advertising.154 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).155 amended by no i of the fa of 22 march 2019, in force since 1 july 2021 (as 2020 6159; bbl 2017 6559).156 sr 241157 amended by no i of the fa of 22 march 2019, in force since 1 july 2021 (as 2020 6159; bbl 2017 6559).art. 45b158 location data providers of telecommunications services may process data concerning locations of customers only for the telecommunications services and charging purposes; they may only process it for other services if they have first obtained the consent of customers, or in anonymised form.158 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 45c159 data on external equipment processing of data on external equipment by means of transmission using telecommunications techniques is permitted only:a. for telecommunications services and charging purposes; orb. if users are informed about the processing and its purpose and are informed that they may refuse to allow processing.159 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 46 protection of privacy the federal council shall regulate, in particular, the identification of the caller's line, call forwarding, the use of data relating to telecommunications traffic and the security of telecommunications services with regard to interception and interference by unauthorised persons. in so doing, it shall take account of the need to protect the privacy of telecommunications users and of overriding public interests.art. 46a160 protection of children and minors 1 the federal council may issue regulations to protect children and minors from the dangers arising from the use of telecommunications services. in particular, it may require providers of internet access to advise their customers on the options for the protection of children and minors.2 in order that information with pornographic content in accordance with article 197 paragraphs 4 and 5 of the criminal code161 may be quickly and globally deleted, ofcom, the federal office of police and the competent cantonal bodies shall coordinate suitable measures. for this purpose, reporting offices operated by third parties and foreign authorities may be consulted and supported. the federal council shall regulate the details.3 telecommunications service providers shall block information with pornographic content in accordance with article 197 paragraphs 4 and 5 of the criminal code that is brought to their attention by the federal office of police. telecommunications service providers shall report to the federal office of police suspected cases of information with pornographic content in accordance with article 197 paragraphs 4 and 5 of the criminal code which they have come across by chance in the course of their activities or which have been brought to their attention in writing by third parties.160 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).161 sr 311.0chapter 8 vital national interests art. 47162 security communication 1 the federal council shall determine the telecommunications services that telecommunications service providers must provide in order that the armed forces, civil defence, border guard, police, fire brigade, the rescue services and the civilian authorities can fulfil their duties in all circumstances.2 it may require providers with a view to and in special and exceptional situations to make premises and installations available and to tolerate exercises. 3 it shall regulate the compensation for these services, having due regard to the interests of the provider.4 it may require the necessary personnel to serve if a special situation so requires.5 the provisions on requisition and the general's powers under armed forces act of 3 february 1995163 are reserved.162 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).163 sr 510.10art. 48 restriction of telecommunications 1 the federal council may order the surveillance, restriction or interruption of telecommunications in extraordinary circumstances or when vital national interests require it. it shall regulate the question of any indemnity payable for carrying out these tasks, having due regard to the interests of the persons required to perform them.1642 the measures described in paragraph 1 shall not constitute grounds for any claim for damages or reimbursement of fees.164 second sentence amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 48a165 security 1 telecommunications service providers shall take action against the unauthorised manipulation of telecommunications installations by telecommunications transmissions. they are entitled to reroute or block connections and to suppress information in order to protect the installations.2 to protect against hazards, avoid damage and minimise risks, the federal council may issue provisions on the security of information and of telecommunications infrastructures and services, in particular in relation to:a. availability;b. operation;c. securing redundant infrastructures;d. reporting interference;e. tracing processes;f. rerouting or blocking connections and suppressing information in accordance with paragraph 1.165 inserted by no i of the fa of 24 march 2006 (as 2007 921; bbl 2003 7951). amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).chapter 9 criminal provisions art. 49 falsification or suppression of information 1 any person carrying on an activity in connection with a telecommunications service shall be liable to a custodial sentence not exceeding three years or to a monetary penaltyif he:166a. falsifies or suppresses information;b. gives any third party the opportunity to do so.2 any person who deceives a person carrying on an activity in connection with a telecommunications service into falsifying or suppressing information shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.167166 amended by art. 333 of the criminal code in the version contained in the federal act of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).167 amended by art. 333 of the criminal code in the version contained in the federal act of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).art. 50 misuse of information any person who by means of a telecommunications installation receives private information that is not intended for him and who uses it or communicates it to third parties without permission shall be liable to a custodial sentence not exceeding one year or to a monetary penalty.168168 amended by art. 333 of the criminal code in the version contained in the federal act of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).art. 51169 169 repealed by annex no 4 of the fa of 16 june 2017, with effect from 1 jan. 2018 (as 2017 5607; bbl 2016 7133).art. 52 contraventions 1 any person who:a.170 .b.171 uses the frequency spectrum:1. without the required licence,2. without the required advance notice,3. without holding the required proficiency certificate, or4. in breach of the regulations on use or the licence;c.172 puts addressing resources that are managed at national level into service without being entitled to do so;d.173 imports, offers, makes available on the market or puts into service telecommunications installations that do not comply with the regulations in force;e. installs or operates telecommunications installations that do not comply with the regulations in force;f. hands over telecommunications installations to unauthorised persons;g.174 manufactures, imports, offers, makes available on the market, possesses, puts into service, installs or operates telecommunications installations or other devices that are intended to interfere with or prevent telecommunications or broadcastingshall be liable to a fine not exceeding chf 100,000.1752 if the offence is committed through negligence, the fine shall not exceed chf 50,000.170 repealed by no i of the fa of 22 march 2019, with effect from 1 jan. 2021 (as 2020 6159; bbl 2017 6559).171 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).172 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).173 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).174 inserted by annex no 4 of the fa of 16 june 2017, in force since 1 jan. 2018 (as 2017 5607; bbl 2016 7133).175 amended by art. 333 of the criminal code in the version contained in the federal act of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).art. 53 failure to comply with regulations any person who, intentionally or through negligence, infringes any other provision of the telecommunications legislation, a treaty or international agreement on the subject, or violates a decision taken on the basis of such provisions and notified to him with an indication of the penalties available under this article, shall be liable to a fine not exceeding chf 5000.art. 54 other criminal provisions articles 14 to 18 of the federal act of 22 march 1974176 on administrative criminal law apply.176 sr 313.0art. 55 jurisdiction 1 offences within the meaning of articles 52 to 54 shall be prosecuted and adjudicated by detec in accordance with the provisions of the federal act of 22 march 1974177 on administrative criminal law.2 detec may delegate to ofcom the tasks of prosecution and adjudication of offences, as well as the enforcement of decisions.177 sr 313.0chapter 10 comcom art. 56 comcom 1 the federal council shall elect a federal communications commission consisting of five to seven members and shall appoint the chairman and vice-chairman. the members must be independent specialists.2 comcom shall not be required to follow instructions from the federal council or detec when taking its decisions. it shall be independent of the administrative authorities. it shall have its own secretariat.3 comcom shall adopt rules relating to its organisation and management, which must be approved by the federal council.4 comcom shall be funded by administrative charges. the federal council shall regulate the details.art. 57 duties of comcom 1 comcom shall perform the duties and take the decisions for which it is responsible in terms of this act and its implementing provisions. it shall inform the public of its activities and produce a report each year for the federal council.2 for the purpose of implementing telecommunications legislation, comcom may seek the assistance of ofcom and give it instructions.chapter 11 surveillance and legal remedies art. 58178 surveillance 1 ofcom shall ensure that international telecommunications law, this act, its implementing provisions, and licences are complied with. it may assign certain surveillance tasks to organisations incorporated under private law and co-operate with such organisations.2 if ofcom detects an infringement of the law, it may:179a. call on the legal or natural person responsible for the infringement to remedy the infringement or take measures to prevent any repetition of it; the person responsible for the infringement must inform ofcom of the measures it has taken;b. require the legal or natural person responsible for the infringement to surrender to the confederation any revenue generated during the infringement;c. make the licence subject to conditions;d. restrict, suspend, revoke or withdraw the licence or restrict, suspend or totally forbid the activity of the legal or natural person responsible for the infringement;e.180 withdraw the proficiency certificate from the holder or make it subject to conditions.3 ofcom shall withdraw the licence if essential conditions for granting it cease to be fulfilled.4 if the licence has been granted by comcom, comcom shall take the corresponding measures based on the proposal made by ofcom.5 the competent authority may take precautionary measures.178 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).179 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).180 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 59 obligation to disclose information 1 the persons subject to this act shall be obliged to provide the competent authority with the information required to implement and evaluate this act.1812 they must provide ofcom regularly with the necessary information to produce official telecommunications statistics.1822bis data collected or submitted for statistical purposes may be used for other purposes only if:a. a federal act explicitly allows this;b. the person concerned consents in writing;c. this serves the evaluation of telecommunications legislation; ord. this serves as a basis for necessary regulatory decisions.1832ter ofcom may publish market shares.1843 the federal council shall regulate the details.181 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).182 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).183 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).184 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 60185 administrative penalties 1 if an enterprise infringes the applicable law, the licence or a decision having force of law, it may be required to pay an amount up to 10 percent of the amount of its average turnover in switzerland in the last three financial years.2 cases of failure to comply shall be investigated by ofcom. it shall judge the cases which do not lie within the competency of comcom in accordance with article 58 paragraph 4.3 when assessing the penalty, the competent authority shall take account in particular of the gravity of the infringement and the enterprise's financial situation.185 amended by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 61186 186 repealed by annex no 86 of the administrative court act of 17 june 2005, with effect from 1 jan. 2007 (as 2006 2197; bbl 2001 4202).chapter 12 final provisions section 1 implementation and repeal of existing legislation art. 62 implementation 1 the federal council shall implement this act. the responsibility of comcom is reserved.2 the federal council may delegate to ofcom the duty of adopting the necessary administrative and technical regulations.art. 63187 187 repealed by annex no 86 of the administrative court act of 17 june 2005, with effect from 1 jan. 2007 (as 2006 2197; bbl 2001 4202).art. 64 international cooperation and agreements188 1 the federal council shall have authority to conclude international agreements on matters falling within the ambit of this act.2 it may delegate that authority to ofcom in the case of international agreements relating to technical or administrative matters.3 comcom shall carry out the tasks within the scope of its responsibilities at an international level and shall represent switzerland in the related international organisations.1894 ofcom shall represent switzerland's interests in international forums and organisations, in particular in relation to internet governance.1905 in order to strengthen the representation of swiss interests, ofcom may on request grant organisations in its areas of responsibility financial assistance that is not granted under international agreements in accordance with paragraphs 1 and 2.1916 the amount of financial assistance is determined by the importance of the organisation, project or measure to the representation of swiss interests and by the other funding options available to the recipient. the financial assistance may not exceed 66 per cent of the total cost of the service funded.192188 amended by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).189 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).190 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).191 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).192 inserted by no i of the fa of 22 march 2019, in force since 1 jan. 2021 (as 2020 6159; bbl 2017 6559).art. 65 repeal of existing legislation the federal telecommunications act of 21 june 1991193 is repealed.193 [as 1992 581, 1993 901 annex no 18]section 2 transitional provisions art. 66-68194 194 repealed by no ii 31 of the fa of 20 march 2008 on the formal revision of federal legislation, with effect from 1 aug. 2008, with effect from 1 aug. 2008 (as 2008 3437; bbl 2007 6121).art. 68a195 transitional provisions concerning the amendment of 24 march 2006 1 the services provided on the commencement of the amendment of 24 march 2006 as part of a telecommunications services licence are deemed to have been notified as defined in article 4 paragraph 1. the radiocommunications licences which are included in the rescinded telecommunications services licences remain valid and acquire the terms and conditions associated therewith.2 the existing conditions for the universal service licence under the old law shall apply until the expiry of its term.195 inserted by no i of the fa of 24 march 2006, in force since 1 apr. 2007 (as 2007 921; bbl 2003 7951).art. 69196 196 repealed by no ii 31 of the fa of 20 march 2008, with effect from 1 aug. 2008 (as 2008 3437; bbl 2007 6121).section 3 referendum and commencement art. 70 1 this act is subject to an optional referendum.2 the federal council shall determine the commencement date.3 .197commencement date:198art. 56, 57, 64, 67, 68 on 20 october 1997all other provisions on 1 january 1998197 repealed by no ii 31 of the fa of 20 march 2008 on the formal revision of federal legislation, with effect from 1 aug. 2008 (as 2008 3437; bbl 2007 6121).198 fcd of 6 oct. 1997.annex amendment of existing legislation .199199 the amendments may be consulted under as 1997 2187.

784.104.2english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon internet domains(oid)of 5 november 2014 (status as of 1 january 2021)the swiss federal council,based on articles 13a paragraph 3, 28 paragraphs 2, 3, 4 und 6, 28e, 48a paragraph 2, 59 paragraph 3, 62 and 64 paragraph 2, of the telecommunications act of 30 april 19971 (tca),2ordains:1 sr 784.102 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).chapter 1 general provisions art. 1 aim 1 the aim of this ordinance is to ensure that private individuals, businesses and public bodies in switzerland are offered a sufficient, reasonably priced, high quality range of internet domain names that fulfils their requirements.2 it must in particular:a.ensure the efficient, transparent and judicious use of the top-level domains that switzerland is responsible for managing;b.preserve the security and availability of the infrastructure and the services necessary for the operation of the domain name system (dns);c.ensure that swiss law and the interests of switzerland are respected during the management and use of the top-level domains that have an effect in switzerland.art. 2 scope 1 this ordinance governs:a.the country code top-level domain [cctld]) .ch and its transpositions in other alphabets or graphic systems;b.the generic top-level domain [gtld]) .swiss;c.the generic top-level domains the management of which has been entrusted to swiss public bodies other than the confederation.2 it applies to the situations which have an effect on these domains, even if they occur abroad.art. 3 definitions the terms and abbreviations used in this ordinance are explained in the annex.art. 4 general tasks 1 unless this ordinance provides otherwise, the federal office of communications (ofcom) exercises all the powers, functions or tasks which are related to the top-level domains managed by the confederation.2 it ensures that switzerland's sovereignty and of the interests are safeguarded in the dns and in the management and use of top-level domains and of domain names subordinate to them.3 it may take any measures in order to contribute to the security and availability of the dns.art. 5 international relations 1 ofcom safeguards the interests of switzerland in the international forums and organisations which deal with questions associated with domain names or other internet addressing resources.2 it may invite delegates (art. 32 para. 1) and other persons entrusted with all or some of the functions or tasks which are associated with a top-level domain managed by the confederation or other swiss public bodies to take part in the work of the international forums and organisations, where they shall safeguard the interests of switzerland. it may give them instructions.art. 6 provision of information by ofcom ofcom shall inform interested parties about the dns and of the evolution of the international regulations and of the global domain name market.chapter 2 general provisions for the domains managed by the confederation section 1 object and organisation art. 7 object the provisions of this chapter govern the top-level domains managed by the confederation, as well as the management and the allocation of second-level domain names which are subordinate to them.art. 8 organisation 1 domains are managed by the registry and by registrars.2 ofcom acts as the registry or delegates this task to a third party.3 it may act as a registrar if no satisfactory registration services are offered on the market.section 2 registry art. 9 general 1 the registry manages the domain in a rational and judicious manner. it acts in a transparent and non-discriminatory manner.2 it has personnel who have the professional qualifications and knowledge necessary to fulfil its various tasks. it shall appoint a technical manager.3 ofcom may issue regulations on the quality and security of the registry services and the methods of monitoring the security and resilience of the infrastructures.art. 10 tasks 1 the registry has the following tasks:a.to provide the services, operations and functionalities of the dns required in accordance with the rules which apply at an international level, in particular:1.keeping a log of activities,2.administering and updating the databases, including all information relating to the domain in question which is necessary for carrying out its tasks,3.managing the primary and secondary name servers while ensuring the distribution of the zone file to these servers,4.allocating domain names to ip addresses,5.installing, managing and updating a rdds database (whois)3,6.4granting access to the information contained in the zone file for the purposes of combating cybercrime or for scientific or social research, or for other purposes that are in the public interest;b.providing the registrars with a system for the submission and administration of applications for the registration of domain names (registration system) and specifying the procedures and technical and organisational conditions relating to the registration and management of domain names by the registrars;c.assigning and revoking rights of use of domain names;d.providing a technical and administrative procedure allowing an easy transfer between registrars of the management of domain names, when this is required by their holders;e.establishing the dispute resolution services (art. 14);f.ensuring the acquisition, installation, operation and updating of the necessary technical infrastructure;g.taking appropriate measures to ensure the reliability, resilience, accessibility, availability, security and operation of the infrastructure and the necessary services;h.advising the registrars concerned immediately of any interruption in the operation of the dns, its infrastructure or its registration services;i.combating cybercrime in accordance with the provisions of this ordinance;j.5providing a specific and easily accessible website featuring all useful information on the activities of the registry;k. 6.2 the registry does not monitor the activities of registrars and holders in a general and continuous manner. subject to article 51 letter b, it is not required to actively investigate facts or circumstances suggesting that illegal activities have been carried out using domain names.3 term in accordance with no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251). this modification has been made throughout the text.4 inserted by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).5 amended by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).6 repealed by no i of the o of 15 sept. 2017, with effect from 1 nov. 2017 (as 2017 5225).art. 11 log of activities 1 the registry shall enter in a log the activities in connection with the registration and allocation of domain names, changes thereto, transfers thereto, decommissioning and revocations thereof.2 it shall archive the data entered and the corresponding supporting documentation for ten years starting from the revocation of a domain name.3 any person who credibly claims to have an overriding legitimate interest has the right to consult the file in the activities log relating to a specific domain name. the registry lays down the technical and administrative methods of consultation. it may request a fee for allowing consultation.77 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).art. 12 backup of the registration and management system 1 when the registry function is delegated, the registry may be obliged by ofcom to conclude with an independent nominee a contract under private law which relates to the backing up for the benefit of ofcom of the system of registration and management of a top-level domain including all the data and information relating to the holders and to the technical characteristics of allocated domain names in particular.2 ofcom may give instructions to the nominee and use or allow the use of the system, the data and the information backed up only in the following circumstances:a.the registry is subject to bankruptcy, liquidation or debt-restructuring proceedings;b.the registry ceases its activity but does not transmit to the new registry or ofcom the data or information necessary to manage the domain;c.the registry is no longer able to perform its function or one of its tasks;d.extraordinary circumstances, such as a natural disaster, so require.art. 13 personal data 1 the registry may process personal data concerning registrars, applicants and holders of domain names, the dispute resolution service and their experts or any other person involved in the management of the domain concerned to the extent that and for as long as is necessary:a.to manage the domain concerned;b.to accomplish the registry function and fulfil the obligations which derive for it from this ordinance, its implementing provisions or its delegation contract;c.for the stability of the dns;d.to obtain payment of the amounts due for registry services.2 subject to article 11 paragraph 2, the registry may process personal data for a maximum of 10 years.art. 14 dispute resolution services 1 the registry shall establish the required dispute resolution services. it shall regulate the organisation of and the procedure for these services while respecting the following rules and principles:a.the services provide extrajudicial dispute resolution processes conducted by neutral and independent experts;b.the services are responsible for ruling on disputes between holders of domain names and holders of trademark rights;c.the decisions of the experts concerning domain names have mandatory force for the registry concerned, unless a civil action is raised within the deadline allowed by the rules of procedure;d.the decisions of the experts relate to the legitimacy of the allocation of a domain name; they may not award damages or pronounce on the validity of a claim under trademark law;e.the rules governing the resolution of disputes must be based on accepted best practice;f.the procedure must be fair, transparent, rapid and beneficial; the experts mandated by the services may not be subject to any general or particular directive on the solution of a dispute; they may take all steps necessary for the resolution of a dispute;g.the dispute resolution procedure ends with the withdrawal of the application, the conclusion of an agreement between the parties, the decision of the experts or the opening of a civil action. 2 the structure of the organisation, the rules governing the resolution of disputes, the rules of procedure and the appointment of the experts called upon to come to a decision require the approval of ofcom. beforehand, the latter shall seek the opinion of the swiss federal institute of intellectual property and, if the case relates to the structure of the organisation or the procedural rules, the federal office of justice.83 on request, the registry shall transmit to the acting dispute resolution service all the personal data in its possession which is necessary for the resolution of a dispute.4 it may publish or arrange to have published the decisions taken by the experts. the parties' names and other personal information may only be published if such details are essential in order to understand the decisions.98 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).9 amended by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).art. 1510 measures on suspicion of abuse: blocking 1 the registry may block a domain name technically and administratively for a maximum of five days if there is reason to believe that the domain name in question is being used to:a.access critical data by illegal methods;b.distribute or use malicious software; orc.support the acts mentioned in letters a or b.2 it may extend the period in which the domain name is blocked for a maximum of 30 days if:a.there is justifiable suspicion that the holder has provided false identification information or is unlawfully using the identity of a third party; andb.there is an urgent need to avert imminent prejudice that cannot easily be remedied. 3 a service to combat cybercrime recognised by ofcom may extend the period in which the domain name is blocked for a maximum of 30 days if the requirements in accordance with paragraph 1 are met.4 the blocking of a domain name for longer than the maximum periods specified in this article is only permitted if ordered by ofcom.1110 amended by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).11 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).art. 15a12 measures on suspicion of abuse: redirecting of data traffic 1 the registry shall redirect data traffic sent to or via a domain name if the following requirements are met:a.the domain name concerned is blocked in accordance with article 15;b.the processing of information serves only to identify and notify persons affected by acts under article 15 paragraph 1 and to analyse the process so that techniques may be developed to recognise, stop, limit or track such acts; recorded information that is not related to these acts may not be used and must be deleted immediately;c.the redirecting of data traffic for analysis shall be requested by a service under article 15 paragraph 3 for a maximum of 30 days.2 it shall redirect the data traffic to an analysis tool or to an information page containing the following:a.information on the relevant suspicion of abuse;b.the names and the contact data of the service or authority that requested the measure.3 redirecting data traffic for longer than the maximum periods specified in this article is only permitted if ordered by ofcom.12 inserted by no i of the o of 15 sept. 2017 (as 2017 5225). amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).art. 15b13 measures on suspicion of abuse: notification and request for identification 1 the registry shall immediately notify the holder of the domain name concerned electronically about the blocking of a domain name or the redirecting of data traffic.2 it shall simultaneously ask the holder to indicate, if required, a valid correspondence address in switzerland and to identify itself within 30 days.3 notification to the holder may be given at later time if this is necessary in order to protect overriding public or private interests. 13 inserted by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).art. 15c14 measures on suspicion of abuse: decision and revocation 1 ofcom shall issue a decision on the blocking or redirecting of data traffic if the holder, within the 30 days following notification of the measure by the registry:a.requests such a decision;b.identifies itself correctly; and c.indicates a valid correspondence address in switzerland if it or its registered office or place of residence is located abroad.2 if holder fails to identify itself correctly or to indicate a valid correspondence address in switzerland within the period specified in article 15b paragraph 2, the registry shall revoke the allocated domain name.14 inserted by no i of the o of 15 sept. 2017 (as 2017 5225). amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).art. 15d15 measures on suspicion of abuse: unallocated domain names the registry may on its own initiative or must on request from a service in terms of article 15 paragraph 3 take the following measures in respect of unallocated domain names if there is reason to believe that the name could be allocated or used unlawfully or for an unlawful purpose:a.it shall allocate the domain name to itself or to a third party that offers to assist in combating cybercrime;b.it shall redirect data traffic sent to or via the domain name for analysis.15 inserted by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).art. 15e16 measures on suspicion of abuse: documentation and report 1 the registry shall document the blocking of a domain name and the redirecting of data traffic.2 it shall submit a report to bakom periodically or on request. the registry may also pass on the report to services recognised in terms of article 15 paragraph 3.16 inserted by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).art. 16 administrative assistance and co-operation 1 the registry may collaborate with any third party which provides assistance in identifying and evaluating threats, abuses and dangers which affect or might affect the management of the domain for which it is responsible, the infrastructure dedicated to this management or the dns. it shall ensure that the third parties concerned can, on a voluntary basis, exchange with it in a secure manner personal information and data on these threats, abuses or dangers. it may disclose such personal information and personal data to them, if necessary without the knowledge of the persons concerned. this disclosure may take place in the retrieval procedure.172 it shall report to the specialist federal services incidents concerning security of information that affect the domain for which it or the dns is responsible. it may process personal data in connection with these incidents and communicate it to the specialist services, if necessary without the knowledge of the persons concerned. this disclosure may take place in the retrieval procedure or by means of the block transmission of data.183 at the request of a swiss authority intervening within its sphere of competence, the registry shall request the holder of a domain name without a valid swiss correspondence address to indicate such an address and to disclose its identity within 30 days. the registry shall revoke the domain name if the holder does not comply within the time limit; it shall notify the requesting swiss authority of the revocation.194 otherwise, article 13b tca applies by analogy to the administrative assistance guaranteed by the registry.17 amended by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).18 amended by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).19 amended by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).section 3 registrars art. 17 registrar contract 1 a registrar may offer registration services only if it:a.can provide evidence that it has concluded a registration contract with icann when the rules which apply at international level so require for the domain concerned; and if itb.has concluded with the registry a contract relating to the registration of domain names (registrar contract).2 the registry must conclude a registrar contract when the applicant meets the following conditions:a.it undertakes to comply with swiss law, in particular this ordinance and its implementing provisions as well as its registrar contract;b.it has a valid correspondence address in switzerland;c.it masters the hardware and software as well as the technical rules making it possible to carry out registrations and other administrative operations with the registry;d.it has put in place a procedure for verifying the identification data provided by applicants for domain names;e.it has the human and technical resources necessary to ensure the maintenance and updating of the administrative and technical data provided by applicants for or holders of domain names;f.it has the information technology hardware and software necessary to ensure the security of the personal data provided by applicants for domain names and archives the latter in conformity with the provisions of the federal act of 19 june 199220 on data protection;g.it has provided the required guarantees in the event of doubtful solvency or of non-payment; the amount of these guarantees, attracting a rate of interest that applies to savings accounts, shall not exceed the anticipated risk to the registry.3 the application to conclude a registrar contract is addressed to the registry. it includes all the documents, data and information that make it possible to assess compliance by the applicant with the prescribed conditions.4 any change in the facts on which the registrar contract is based must be communicated to the registry.5 the registrar contract may not derogate from the rules prescribed by this ordinance and its implementing provisions. in addition, the registry shall comply with the principles of non-discrimination and transparency in its contractual relations with registrars.6 the registrar contract is governed by public law when the registry function is exercised by ofcom (contract under administrative law) and by private law when the registry function is delegated (contract under private law).7 the registry terminates the registrar contract without compensation when a registrar so requests, no longer meets the conditions imposed on the exercise of its function, ceases all activity or is subject to bankruptcy or liquidation proceedings. it must inform the holders of the domain names managed by the registrar concerned of the cancellation of a registrar contract in the appropriate manner.8 article 40 paragraphs 1, 3 and 4, and article 41 apply by analogy to the surveillance of registrars exercised by ofcom.20 sr 235.1art. 18 information of the public 1 the registry shall provide the public with the details of the requirements for a registrar contract and the list of registrars that have concluded a contract, with their name and corporate name, their postal address, their telephone number and their email and internet site addresses.2 it shall supply registrar contracts to third parties which request them. the clauses and annexes containing confidential commercial information are not published.art. 19 right of access to the registration system 1 registrars which have concluded a contract may access the registry's registration system and register and administratively manage domain names in the name of and on behalf of third parties. they may allocate domain names to themselves on their own behalf for their own needs.2 they may claim their right only insofar as the access is carried out in accordance with the technical or organisational procedures and conditions specified by the registry.art. 20 obligations of registrars 1 registrars must propose an offering consisting exclusively of the allocation of a domain name (unbundled offering).2 they must guarantee their customers at all times the opportunity to transfer the administrative management of a domain name to a new registrar. civil claims for non-execution of the contract are reserved.3 registrars must retain commercial correspondence, supporting documentation, titles and log files classified according to domain names for a period of 10 years from the end of registration of a domain name. they shall present them, on request, to the registry within 3 working days at the latest.4 registrars must:a.collaborate with the registry and provide it with all necessary technical and organisational assistance and support in order to ensure the continuity and the security of the administration of the domain names;b.ensure that holders of the domain names for which they provide administrative management are informed of the cessation of any registrar's activities and of the steps to be taken to safeguard their claims.art. 21 duties to provide information 1 registrars shall report to the registry any requested or registered domain names of a nature which is manifestly illegal or contrary to public order as soon as they are aware of them.2 they shall immediately report to the registry any technical disturbance which they detect on their systems, the registration services of the registry or the operation of the dns.3 they shall immediately forward or arrange for the forwarding of all the information on the registry to the holders or the applicants. registrars shall notify their clients of any refusal to allocate domain names three days at the latest after the receiving the information from the registry.214 they do not monitor the activities of holders in a general and continuous manner. they are not required to actively investigate facts or circumstances suggesting that illegal activities have been carried out using domain names.22 21 amended by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).22 inserted by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).art. 22 legal relations 1 the legal relations of registrars with applicants and holders of domain names are governed by the provisions of private law. the rules laid down by this ordinance and its implementing provisions are reserved.2 subject to article 40 paragraph 4 tca, registrars are free to fix the price of their registration services.3 registrars shall publish the prices and the general conditions for their services.art. 23 obligation to collaborate 1 registrars shall work with the registry in order to identify or to assess threats, abuses and dangers which affect or might affect the management of the domain and of the domain names which are subordinate to it, the management infrastructure or the dns. they may process personal data in connection with these incidents, if necessary without the knowledge of the persons concerned.2 they shall report to the specialist federal services incidents concerning security of information which affect their management systems and infrastructures or the dns. they may process and communicate personal data in connection with these incidents to the services concerned, if necessary without the knowledge of the persons concerned.3 .234 on request, the registrars shall transmit to the acting dispute resolution service all the personal data in their possession which is necessary for the resolution of a dispute.23 repealed by no i of the o of 15 sept. 2017, with effect from 1 nov. 2017 (as 2017 5225).section 4 allocation art. 24 application for registration 1 when a registrar submits a registration application on behalf of an applicant, the registry shall initiate a domain name allocation process.2 it shall process the registration application when the latter:a.has been validly submitted via the registry's registration system;b.includes all the information, elements and documents necessary to authorise the allocation of a domain name, in particular:1.the designation desired as a domain name,2.up-to-date, complete and correct information on the applicant, in particular their name and postal and email addresses,3.current, complete and correct information enabling verification of compliance with the general and particular conditions of allocation of the requested domain name.3 ofcom shall determine the information, elements and documents which may be required by the registry or registrars in order to verify the name, address and legal existence of an applicant or compliance with the conditions of allocation of a domain name, in particular:a.if the applicant is an individual: a copy of a national identity document or a valid passport and a current certificate of residence;b.if the applicant is an association or a foundation with its headquarters in switzerland and not entered in the commercial register: a certified copy of the articles of association or the foundation charter;c.if the applicant is a legal entity or a partnership with its headquarters abroad: an attested up-to-date extract from the foreign commercial register or, when the extract does not contain sufficient information or if there is no corresponding institution in the commercial register, an official document attesting that the entity exists legally in accordance with the provisions of the applicable foreign law;d.the business identification number (bin) within the meaning of the federal act of 18 june 201024 on the business identification number.4 if necessary, it shall regulate the modalities for submitting registration applications. it may demand the use of set forms for registrations and amendments.24 sr 431.03art. 25 general conditions of allocation 1 a domain name shall be allocated when:a.25the required designation, or the corresponding ace string, consists of 3 to 63 authorised characters; ofcom shall determine the authorised characters and may provide for exceptions concerning the minimum number of characters when an overriding public interest justifies this; the abbreviations consisting of two characters which designate the cantons and the names of political communes and places that consist of two characters are reserved in accordance with article 26 paragraph 1 letter b and may be allocated to the public bodies concerned;b.the requested designation is not the subject of a reservation under this ordinance, unless the reservation was made by the person making the application;c.the particular conditions of allocation for the domain concerned are met.1bis the registry shall allocate a domain name and prevent any configuration of the name servers associated with it in the zone file that enables the domain name to be activated if an authority intervening within the scope of its responsibilities notifies the registry that there are reasonable grounds to believe that the applicant will use the requested domain name for an unlawful purpose or in an unlawful manner.261ter the registry may allocate a domain name and prevent any configuration of the name servers associated with it in the zone file that enables the domain name to be activated if there are reasonable grounds to believe that the applicant:a.is providing false identification information or unlawfully using the identity of a third party; andb.the requested domain name will be used for an unlawful purpose or in an unlawful manner.271quater if the holder in the cases in paragraphs 1bis and 1ter fails to disclose their correct identity within 30 days, the registry shall revoke the allocation of the domain name.282 the registry shall refuse to allocate a domain name when:a.the chosen designation is contrary to public order, morality or the law in force;b.technical reasons so require;c.29a swiss authority intervening within its sphere of competence notifies it that there is reason to believe that the applicant will use the requested domain name unlawfully or for an unlawful purpose;d.30an applicant whose domain name has been revoked under article 15c paragraph 2 or article 16 paragraph 3 requests to be allocated the same domain name again without indicating a valid correspondence address in switzerland.3 it may refuse to allocate a domain name when the applicant is in a state of bankruptcy, liquidation or in administration proceedings.25 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).26 inserted by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).27 inserted by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).28 inserted by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).29 inserted by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).30 inserted by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).art. 26 reserved designations 1 the following designations or categories of designations are subject to reservation:31a.designations of federal institutions and units of the federal administration, names of federal councillors and of chancellors of the confederation, designations of official buildings and other designations associated with the state which appear in the central list of designations deemed worthy of protection as domain names; this list is drawn up by the federal chancellery;b.32the names of the swiss cantons, political communes und places in accordance with article 3 of the ordinance of 21 may 200833 on geographical names, and the abbreviations consisting of two characters which designate the cantons;c.names and abbreviations of the international organisations protected by swiss legislation;d.designations which must be reserved in the generic top-level domains in accordance with the rules which apply at the international level;e.designations necessary for the activity of the registry, in particular for its communication.2 reserved designations or categories of designations may be allocated as domain names only to those persons or categories of persons for whom they are reserved, unless the persons or categories of persons have permitted allocation to third parties; the foregoing does not apply to designations allocated to third parties before the designation is reserved or before this ordinance comes into force. in the absence of agreement, homonymous canton and political commune designations are allocated to the commune concerned.31 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).32 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).33 sr 510.625art. 27 allocation process 1 the processing of a registration application by the registry concludes with the allocation or the refusal of allocation of the requested domain name.2 the registry allocates the right to use a domain name. the allocation takes effect on its confirmation in electronic form via the registry system to the registrar operating on behalf of the applicant concerned.3 the registry shall notify the registrar acting on behalf of the applicant concerned of the refusal to allocate a domain name via the registration system in electronic form or if necessary by other means. it shall directly notify the applicant of the refusal to allocate a domain name that must be allocated by means of a naming mandate under article 56 using an appropriate means of communication.344 ofcom shall make a decision on the refusal to allocate a domain name if, within 40 days of receiving notification of a refusal under paragraph 3, the applicant:35a.requests such a decision; andb.provides a valid correspondence address in switzerland if they are registered or domiciled abroad.34 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).35 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).section 5 domain names art. 28 holder's rights 1 the holder has the right to use the domain name which has been allocated to it within the prescribed limits and for purposes provided for by this ordinance and its implementing provisions. the right of use is governed by public law.2 it shall manage freely the domain names subordinate to the domain name allocated to it, unless this ordinance or its implementing provisions provide otherwise.3 it may transfer to a third party a domain name which has been allocated to it when the general and particular conditions of allocation are met by submitting, via the registrar which manages it, a change of holder request.4 it may give up its domain name at any time by submitting, via the registrar which manages it, a cancellation request. civil claims for non-fulfilment of the contract concluded with the registrar are reserved.5 the right to use a domain name automatically passes:a.to the undertaking originating from a merger which becomes the holder of the domain names allocated to the merged undertakings;b.in the event of a demerger or a transfer of assets governed by the mergers act of 3 october 200336, to the undertaking which takes over which then becomes the holder of the domain names allocated to the transferring undertaking mentioned in the inventory;c.to the heirs of the deceased holder.6 it reverts to the bankruptcy assets of the bankrupt holder.36 sr 221.301art. 29 holder's obligations 1 the holder must keep up to date and if necessary supplement or correct all the information relating to it which is necessary for the management of the domain name which it has been allocated.2 it is obliged to take part in a dispute resolution procedure initiated by the holder of a right attached to a distinctive sign.art. 30 measures37 1 the registry may, on its own initiative or at the request of the registrar concerned, revoke the allocation of a domain name:a.if the holder does not comply with this ordinance or its implementing provisions;b.if the general or particular conditions imposed on the allocation of a domain name are no longer being complied with;c.if the holder does not comply with its obligation to keep up to date, supplement or correct all the information relating to it which is necessary for the management of the domain name which it has been allocated;d.if a registrar so requests after terminating its contract with the holder and the latter has not transferred the management of the domain name to a new registrar within 30 days;e.if there are other important reasons, such as technical reasons, standards or international harmonisation measures.2 the registry shall revoke the allocation of a domain name:a.if an amendment to this ordinance or its implementing provisions so requires;b.if this proves necessary in order to protect the integrity or the stability of the dns;c.if the holder gives up its domain name voluntarily;d.if the registrar operating on behalf of the holder is in a state of bankruptcy, liquidation or has had its registrar contract terminated and the holder does not transfer the management of the domain name to a new registrar within 90 days; this period runs from the time the registry has informed the holder of the necessity of transferring management of the domain name to a new registrar; the quarantine period within the meaning of article 31 paragraph 3 is 90 days;e.if experts mandated by a dispute resolution service so request, unless a civil action has been filed within the period prescribed by the procedural rules of the dispute resolution service concerned;f.if a court or an arbitration tribunal so orders as part of a procedure which leads to an enforcement order or ruling in switzerland;g.if a swiss administrative or prosecuting authority so orders in accordance within its sphere of competence.3 a specialist appointed by a dispute resolution service, a court, an arbitration tribunal or a swiss administrative or prosecution authority may within the scope of its competence issue provisional orders to the registry; the registry may in particular be required to:a.suspend or modify a domain names technically by deleting the related name servers in the zone file, replacing them with new name servers or not re-entering them after their deletion;b.suspend a domain name administratively by prohibiting its allocation or re-allocation to a third party, its transfer or any change in technical or administrative parameters relating to it;c.transfer a domain names to a different registrar;d.correct, amend or delete any information or technical or administrative parameters relating to the management of a domain name;e.correct, amend, anonymise or delete any information in the rdds database (whois);f.allocate a domain name to itself or to a specific person;g.redirect data traffic leading to or via a domain name for analysis;h.38redirect data traffic leading to or via a domain name to an information page.394 the registry may take provisional measures in accordance with paragraph 3:a.if this is regarded as necessary in order to protect the integrity and stability of the dns and there is an urgent need to avert imminent prejudice that cannot easily be remedied;b.for a maximum of five working days when there is reason to believe that that the holder is using the domain name unlawfully or for an unlawful purpose and there is an urgent need to avert imminent prejudice that cannot easily be remedied.4037 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).38 inserted by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).39 amended by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).40 inserted by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).art. 31 effect of revocation 1 the revocation of a domain name takes effect as of its communication by the registry in electronic form to the registrar operating on behalf of the holder concerned via the registration system. it results in the revocation of the subordinate domain names.2 ofcom takes a decision on the revocation of a domain name if, within the 30 days following the communication of this revocation, the holder:a.requests such a decision; andb.provides a valid correspondence address in switzerland when it is registered or domiciled abroad.3 subject to a longer quarantine period granted by this ordinance, a revoked domain name may not be allocated to a new holder until 40 days after its revocation or the entry into force of a decision pursuant to paragraph 2. during this period, the revoked domain name must be reassigned from the date of revocation to its former holder if the latter so requests and the general and particular conditions of allocation are met.chapter 3 delegation of the registry function art. 3241 procedure and conditions for delegation 1 if the function of the registry is to be delegated on the basis of a tendering or invitation procedure (art. 28a para. 2 tca), ofcom shall evaluate and weight the offers according to the following criteria in particular:a.price, suitability and quality of the services;b.the qualifications and characteristics demanded of the delegates;c.public security and combating cybercrime;d.the protection of critical infrastructures; e.participation of the community concerned in the management of the delegated resources.2 the candidates must not be permitted to see the documents submitted by their competitors nor to comment on their bids or other documents submitted.3 ofcom decisions must not disclose the business secrets of candidates that have participated in the selection procedure.41 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).art. 33 form of delegation the delegation to third parties of the registry function of a domain managed by the confederation or of particular tasks related to this function shall take the form of a contract under administrative law (delegation contract).art. 34 term of the delegation 1 the delegation contract is drawn up for a specific term. its term is fixed according to the nature and importance of the delegated tasks.2 it may be extended or renewed.art. 35 essential activities or services the delegate requires ofcom's consent in order to delegate to third parties activities or services constituting an essential element of the function.art. 36 separation of interest 1 the delegate nay not at the same time exercise the function of registrar for the domain which it manages.2 if the delegate is linked legally or economically to an entity which exercises a registrar function for the domain, an independent execution of the tasks must be guaranteed in the delegation contract by suitable measures such as the prescription of specific forms of public communication or the obligation to guarantee the autonomy of the personnel employed.art. 37 delegation of tasks 1 the tasks of the registry are agreed in the form of a list of services; qualitative criteria are defined in order to verify the execution of the tasks. 2 other services of the registry may be agreed, in particular for collaboration in appropriate international forums and organisations or within the sphere of data protection and internet security.3 the registry must prove that it has adequate insurance to cover the risks related to its activities of domain name management and allocation.art. 38 price 1 the price which registrars must pay annually for the registration of a domain name and for administration of the data is fixed in the delegation contract. 2 when the delegation of tasks was the result of a tendering or invitation procedure under article 32, the following rules apply:42a.the price shall correspond to the offer;b.the offer price may be adapted during the term of delegation if the delegated tasks change; the difference in price is calculated based on the changes in costs arising from the change in tasks; the delegate submits an offer to ofcom and provides proof of the change in costs; in order to examine the offer, ofcom may use comparison values and may ask to be provided with any useful documents.3 when the delegation of tasks takes place directly, the price covers the relevant costs of the registry related to the catalogue of services agreed with ofcom and additionally makes it possible to make an appropriate profit. 42 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).art. 39 obligation to inform 1 delegates are obliged to provide ofcom with all the information and documents necessary for the execution of this ordinance and its implementing provisions.2 they are obliged to transmit free of charge to ofcom the information necessary for the compilation of official statistics. articles 97 to 103 of the ordinance of 9 march 200743 on telecommunications services apply by analogy.43 sr 784.101.1art. 40 surveillance 1 ofcom shall ensure that delegates comply with this ordinance and its implementing provisions, and with their delegation contract. 2 normally it verifies once every two years the manner in which delegates fulfil the delegated function or tasks. the delegates must grant access to their premises and their installations and must provide all the information required.3 if there is reason to suspect that a delegate is not complying with the obligations arising from this ordinance, its implementing provisions or the delegation contract, ofcom shall perform an audit. the delegate must guarantee access to its premises and its installations and must provide all the information required.4 if the audit establishes that the delegate is not fulfilling its obligations, the delegate bears the costs thereof.art. 41 surveillance measures 1 if a delegate does not fulfil its obligations, ofcom may:a.require it to remedy the shortcoming or to take appropriate measures to prevent any repetition; the delegate must inform ofcom of the measures taken;b.require it to transfer the unlawfully acquired revenue to the confederation;c.add conditions to the delegation contract;d.restrict or terminate the delegation contract with immediate effect or within a specific period.2 ofcom may order provisional measures.art. 42 modification of the delegation contract 1 ofcom may modify by administrative decision certain provisions of the delegation contract before the expiry of its period of validity if the de facto or de jure conditions have changed and if modification is necessary to preserve overriding public interests.2 the delegate shall receive appropriate compensation if modification of the delegation contract causes it a financial loss relating to the delegated function or tasks. this compensation does not include the compensation for loss of profits.art. 43 end of the delegated activity 1 ofcom shall terminate the delegation contract without compensation if a delegate no longer fulfils the conditions for exercising the delegated function or tasks, ceases all activity or is in a state of bankruptcy, liquidation or in administration proceedings.2 it may terminate the delegation contract by appropriately compensating the delegate if the de facto or de jure conditions have changed and if the termination is necessary to preserve overriding public interests. the compensation does not include compensation for loss of profits. it takes into account the amount received by the delegate under paragraph 5 letter b for the assistance provided.3 ofcom shall take over the delegated function or task or entrust it directly to a new delegate.444 holders retain their rights vis--vis the new registry to the domain names which have been allocated to them.5 the delegate is obliged to collaborate and to provide the new registry with all the technical and organisational assistance necessary to ensure the continuity and security of the management of the domain concerned and of the domain names subordinate to it. it is entitled to compensation based on the utility value of its assistance. the compensation is, on request, fixed by ofcom. the delegate must in particular make available:a.free of charge: the activities log and the entirety of the conserved data or information which relates to the domain concerned and to the holders of the allocated domain names or the management activities associated with these domain names and their characteristics, in particular their technical characteristics;b.in return for compensation for the asset value: the technical and data-processing infrastructure essential for the continuation of the function or of the delegated tasks.6 the delegate shall ensure that the persons affected are aware of the cessation of its activities and of the steps to be taken to safeguard their claims.44 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).chapter 4 the .ch domain art. 44 object the provisions of this chapter govern the management of the ch. top-level domain and the management and allocation of second-level domain names which are subordinate to it.art. 45 characteristics 1 the .ch domain has the following characteristics:a.it constitutes a top-level country domain managed by the confederation;b.the domain names which are subordinate to it may be allocated to or used by any physical and moral person;c.the registrar function is exercised in free competition by all the entities which have concluded a registrar contract with the registry.2 the registry establishes a dispute resolution service within the meaning of article 14.art. 4645 provision of data 1 the following data must appear in the rdds database (whois):a.the designation of the allocated domain name and corresponding ace string;bin the case of an activated domain name: the data relating to the allocated name server;c.the information according to which a domain name is or is not protected by the dnssec system;d.the date of the first allocation of the domain name;e.the name, address and contact data of the registrar acting on behalf of the holder of the domain name concerned.2 the registry may publish the following data in the rdds database (whois):a.the identification information and contact data of the holder of the domain name concerned if it is a legal entity;b.the identification information and contact data of the holder of the domain name concerned if the holder has consented to publication;c.information on how the holder of the domain name concerned may be contacted anonymously.3 it shall grant any person who credibly claims to have an overriding legitimate interest access free of charge to the personal data of the holder of the domain name concerned contained in the rdds database (whois).4 ofcom may, taking account of the rules that apply at international level, issue regulations on the modalities and procedures for access under paragraph 3.5 the registry shall take suitable measures, in particular technical measures, to prevent abuse of the data made available to the public, in particular its use for the purpose of advertising or sales promotion.45 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).art. 47 particular conditions of allocation 1 if a domain name is not yet allocated and the general conditions prescribed in article 25 are met, the registry shall allocate the name to the first applicant who applies for it.2 the registry does not check the merits of the rights to use the alphanumeric denominations of domain names. disputes relating to the rights attached to distinctive signs in relation to domain names are governed by civil law.art. 48 transposed .ch domains 1 .ch country domains that are transposed into another alphabet or graphic system are managed by their own specific registry. ofcom may entrust this management to the registry of the .ch domain.2 otherwise, the provisions of this ordinance which govern the .ch domain apply by analogy to the management of a transposed .ch domain.chapter 5 the .swiss domain section 1 general provisions art. 49 object the provisions of this chapter govern the management of the .swiss top-level domain and the management and allocation of second-level domain names which are subordinate to it.art. 50 characteristics the .swiss domain has the following characteristics:a.it is managed by the confederation;b.the domain and the domain names which are subordinate to it are intended to serve and promote the swiss community, its image and its political, economic, legal or cultural interests in switzerland and in the world;c.the subordinate domain names may be allocated only to entities located in switzerland or having a particular link with switzerland;d.the policy of assigning domain names must be implemented in a prudent manner protective of the interests of the swiss community; it may restrict the categories of designations that are available for allocation or the eligibility of persons who may require such an allocation;e.the registrar function is exercised in free competition by all the entities which have a valid registrar contract with the registry.section 2 registry art. 51 particular tasks in the exercise of its functions, the registry has the following particular tasks:a.to offer a single arrangement (a single point of contact) allowing any person to bring to the attention of the registry a domain name the allocation or use of which are likely to be illegal or contrary to public order;b.to monitor by random samples that the allocated domain names comply with the conditions of allocation and that their use is not manifestly illegal or contrary to public order;c.46to take commercial communication or sponsorship measures in order to promote the .swiss domain; for this purpose it may work with the authorities responsible, in particular the swiss federal institute of intellectual property, the swiss federal statistical office and the cantonal commercial registers.46 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).art. 5247 provision of data 1 the registry shall publish in the rdds database (whois) the data that are required in accordance with the rules that apply at international level.2 it may publish the following data there:the name of the organisation and the uid of the holder of the domain name concerned;b.the identification information and contact data of the holder of the domain name concerned if it is a legal entity;c.the identification information and contact data of the holder of the domain name concerned if the holder has consented to publication;d.information on how the holder of the domain name concerned may be contacted anonymously.3 the registry shall provide search facilities in the rdds database (whois) on the basis of criteria such as the domain name concerned, the registrar in charge of its management or the designation of the name server.4 it shall grant any person that has an overriding legitimate interest access to the personal data of the holder of the domain name concerned that are in rdds database (whois). it may request a fee for access in accordance with the rules and fees that apply at international level unless other legislation provides for access free of charge.5 the registrar shall, in accordance with the rules that apply at international level, ensure access to the personal data of the holder of the domain name concerned on whose behalf it is acting, in accordance with paragraph 4.6 the modalities and procedure for access in accordance with paragraphs 4 and 5 must comply with the rules that apply at international level. ofcom may provide for additional modalities and procedures and determine the level of the fee for access in specific cases.47 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).section 3 allocation art. 53 particular conditions of allocation 1 a domain name is allocated when the following particular conditions are met, in addition to the general conditions provided for by article 25:a.the applicant provides proof of a sufficient link with switzerland; this is in particular the case when its headquarters and an actual administrative site or its residence is in switzerland, or if the person concerned is a swiss citizen;b.the applicant belongs, at the time of submission of the registration application, to a category of persons entitled to request an allocation (eligibility);c.the requested designation belongs, at the time of submission of the registration application, to a category of designations which may be the subject of an allocation;d.the envisaged use complies with swiss law; if the domain name is used to offer or advertise products or services, a headquarters and an actual administrative site or domicile in switzerland are essential;e.the requested designation may legitimately be regarded as having an objective relationship with the applicant or the envisaged use of the domain name; this is in particular the case when the domain name meets one of the following conditions:1.it contains a designation to which the applicant has a claim under trademark law,2.it refers to a designation objectively linked to the state or to its activities which is required by the public body or the public law organisation concerned,3.it contains a geographical designation:-to which the applicant has a right or in which it has a legitimate interest,-to which it has a right or in which it has a legitimate interest in the public mind, or-that it is authorised to use by the public body or bodies or other organisations concerned,4.it refers to a designation in which the applicant has a legitimate interest or which is associated with this applicant in the public mind;f.the requested designation does not correspond to or is not related to a designation with a generic character, subject to the provisions relating to the naming mandate (art. 56).2 the registry may refuse the allocation of a domain name:a.48when the chosen designation may manifestly lead to confusion with a domain name already allocated or a reserved designation in accordance with article 26;b.when it is clear, on the basis of brief examination, that the chosen designation infringes third-party trademark rights; otherwise, the merits of the rights to use the alphanumeric designations of domain names is not verified; disputes relating to trademark rights in relation to domain names are governed by civil law;c.when the characteristics or values which underlie the domain oppose such allocation.3 in exceptional cases, the registry may allocate domain names which do not meet the particular conditions of allocation when the interest of this allocation for the swiss community so justifies.48 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).art. 5449 49 repealed by no i of the o of 15 sept. 2017, with effect from 1 nov. 2017 (as 2017 5225).art. 5550 eligibility and staggered opening the following are eligible to allocate a domain name:a.public bodies or other swiss public law organisations;b.entities entered in the swiss commercial register having their headquarters and an actual administrative site in switzerland;c.associations and foundations not entered in the swiss commercial register having their headquarters and an actual administrative site in switzerland.50 amended by no i of the o of 15 sept. 2017, in force since 1 nov. 2017 (as 2017 5225).art. 56 naming mandate 1 the domain names which correspond to or which are connected with designations of a generic character with a particular interest for all or part of the swiss community must be allocated under a naming mandate. ofcom may draw up and keep up to date a non-exhaustive list of the designations or categories of designation concerned.2 the registry may allocate domain names under a naming mandate:a.following a call for tenders; if necessary it regulates the modalities of the tendering procedure; the latter must conform to the principles of objectivity, non-discrimination and transparency, while guaranteeing the confidentiality of the data provided by the candidates; orb.on the basis of a spontaneous candidature.3 any candidate for a domain which is to be allocated under a naming mandate must:a.demonstrate that it complies with the general and particular conditions imposed on the allocation of a domain name;b.51demonstrate that it represents all or an important part of the community concerned with the requested designation or that its candidature benefits from the support of all or an important part of this community; guarantees of compliance with the principles of competitive neutrality, non-discrimination and transparency may be substituted for representation or support of the community if the name applied for does not refer to a specific community or the name applied for is not represented by an organised or constituted community;c.indicate the possible related domain names in german, french, italian or english which it wishes to integrate into the naming mandate;d.demonstrate that the envisaged use of the domain name and the performances or services offered in connection with this name benefit the whole of the community concerned; e.demonstrate the manner in which it will ensure that the requirements provided for under title 2 of the trademark protection act of 28 august 199252 are complied with by all the products offered using a domain name the designation of which refers to a product, to its characteristics or to a category of products;f.demonstrate the extent to which its project provides added value for the community concerned and for the swiss community;g.demonstrate that it meets the conditions prescribed by ofcom for the quality of the domain name or of the desired project;h.provide a draft of a naming mandate.4 the registry shall publish the candidatures. other applicants may submit an application for this same domain name within the 20 days following publication.5 in the event of a multiple candidature, the registry shall allocate the domain name to the candidate whose project provides added value for the community concerned and for the swiss community that is clearly greater than that of the other projects.6 if no project meets the requirement set out in paragraph 5 and the candidates cannot agree on a single or joint candidature, the registry shall decide on the allocation by drawing lots or holding an auction. the proceeds from the auction are paid into federal funds.7 a domain name under a naming mandate is allocated for a specified term. it must be used.8 the rules applicable to the supervision of persons that are delegated the registry function of a domain managed by the confederation (art. 40 to 43) apply by analogy to naming mandates, and in particular to their revocation.9 the registry shall disclose naming mandates to third parties which request them; it may also make them available by a consultation procedure or publish them in another manner. the clauses and annexes containing confidential commercial information may not be communicated.51 amended by no i of the o of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).52 sr 232.11art. 57 allocation process 1 the registry shall examine any application for registration of a domain name and publishes them, unless the application manifestly does not meet the general and particular conditions for allocation. other applicants may submit a registration application for this same domain name within the 20 days following publication.2 in the event of a multiple application, the registry allocates the domain name concerned in the following order of priority:a.in principle to the public body or to the public law organisation making the application when the latter is in competition with private applicants and the requested designation as such is of public interest;b.to the public body or public law organisation that intends to use the domain name concerned in a manner that provides added value which is manifestly greater for the swiss community compared to the other envisaged uses; if no project satisfies this requirement and the public bodies or public law organisations submitting the application cannot agree on a single or joint candidature, the registry does not allocate the domain name;c.in principle to the applicant which has a right to a trademark corresponding to the domain name concerned when it is in competition with applicants not benefiting from such a right;d.to the highest bidder in an auction when the applicants have competing rights under trademark law to the domain name concerned, unless holding an auction appears inappropriate in light of all the circumstances or the applicants concerned; the proceeds from the auction are paid into federal funds;e.to the applicant which was first to submit a registration application when all the applicants constitute non-profit-making entities and effectively pursue such aims;f.to the applicant that intends to use the domain name concerned in a manner that provides added value which is manifestly greater for the swiss community compared to the uses envisaged by the other applicants; if no project satisfies this requirement and the applicants cannot agree on a single or joint candidature, the registry decides on the allocation by drawing lots or holding an auction; the proceeds from the auction are paid into federal funds.3 subject to the prior examination under article 53 paragraph 2 letter b, the registry does not verify the merits of the rights to use the alphanumeric denominations of domain names. disputes relating to the trademark rights in relation to domain names are governed by civil law.section 4 revocation art. 58 the registry may, on its own initiative or at the request of the registrar concerned, revoke the allocation of a domain name:a.if it appears that a generic designation allocated as a domain name should have been allocated under a naming mandate; the beneficiary of the naming mandate shall pay the former holder compensation which includes all the costs of registration and management of the revoked domain name;b.if it is evident, on the basis of a brief examination, that the designation allocated as a domain name infringes a trademark right;c.if the domain name contains a geographical denomination which is of particular interest for all or part of the swiss community and is required by a public body or another public law organisation; the latter pays the former holder compensation which includes all the costs of registration and management of the revoked domain name;d.if there is reason to believe that the holder has applied for the registration for the sole purpose of harming the reputation of the holder of a legitimate interest in this name or a connected name, or that of a product or service associated with this name in the mind of the public;e.if there is reason to believe that the holder has applied for the allocation for the purpose of profiting from the reputation of the holder of a legitimate interest in this name or in a name or product associated with this name in the mind of the public;f.if the characteristics or values which underlie the domain so require.chapter 6 domains managed by other swiss public bodies art. 59 1 swiss public bodies may apply to acquire top-level generic domains of their choice from the icann.2 they shall comply with the following principles:a.they ensure that swiss law and the interests of switzerland are respected during the management and use of the domains and domain names which are subordinate to them;b.they ensure the security and availability of the infrastructure and the services necessary for the operation of the dns;c.they shall take measures to prevent abuse of the data made available to the public.3 ofcom shall monitor compliance by the public bodies concerned with the management principles prescribed in paragraph 2. if necessary, it shall stipulate the measures or requirements relating to the security and availability of the infrastructure and services necessary for the operation of the dns and to prevent abuse of the data made available to the public.4 if a public body which has acquired a generic domain has not laid down the necessary rules, it shall manage this domain in accordance with the provisions of this ordinance which govern the .ch domain.chapter 7 final provisions section 1 implementation art. 60 1 ofcom shall issue the necessary technical and administrative regulations.2 it is entitled to conclude international agreements relating to technical or administrative issues that fall within the scope of this ordinance.section 2 . art. 61-6453 53 repealed by no i of the o of 15 sept. 2017, with effect from 1 nov. 2017 (as 2017 5225).section 3 commencement art. 65 this ordinance comes into force on 1 january 2015.annex54 54 revised by no ii of the o of 15 sept. 2017 (as 2017 5225) and of 18 nov. 2020, in force since 1 jan. 2021 (as 2020 6251).(art. 3)terms and abbreviations in this ordinance:a.dns (domain name system) means a system implementing a collective organisation and a structured management in a hierarchical manner of domain names and their resolution into an ip address (and vice versa);b.domain or internet domain means a sub-set of the hierarchical structure of the dns which is the subject of joint management of the domain names which are subordinate to it;c.domain name means a unique communication parameter, composed of a series of alphanumeric, ideographic or other characters which make it possible to identify a domain;d.ace-string (ascii [american standard codes for information interchanges] compatible encoding-string) means a character string made up of the characters a to z (without accents or inflected vowels) and numerical characters 0 to 9 as well as hyphens which is established by means of technical processes. a domain name is registered in the form of the ace-string in the dns;e.internet protocol address or ip address means a numerical communication parameter, defined in the ip protocol, which identifies an element of the internet network;f.icann (internet corporation for assigned names and numbers) is a non-profit corporation under californian law which has in particular the task of assigning the ip address space, managing the top-level domains of the dns and ensuring the operation of its root servers;g.iso is the international organisation for standardisation;h.top-level domain [tld]) means a domain of the highest level of the dns which defines, by means of a character string authorised by icann, a particular namespace;i.generic top-level domain [gtld]) means a top-level domain the designation of which identifies a community, a distinctive sign, a sector of activity or a circle of particular interests;j.country code top-level domain [cctld]) means a top-level domain the designation of which, formed by a character string in conformity with iso standard 3166-1 alpha-2, identifies a country or a geographical area;k.rdds database (whois) means the registration data directory service database which guarantees to any interested person access in real time to information relating to allocated domain names;l.registry means an entity charged with the central organisation, administration and management of a top-level domain, and with the allocation and revocation of rights of use of the domain names which are subordinate to it;mregistrar means an entity entitled to undertake with the registry the technical and administrative operations permitting registration, on behalf of applicants, of the desired domain names and to ensure the administrative follow-up;n.registration means all the technical and administrative operations carried out by a registrar with the registry with the purpose of obtaining the allocation of a domain name for an applicant;o.allocation means the legal act by which the registry grants, via a registrar, the right to use a domain name to an applicant;p.holder means any physical or moral person allocated the right to use a domain name by the registry;q.designation with a generic character means a designation which refers to or generally describes a category or a class of goods, services, people, groups, organisations, products, techniques, sectors or activities;r.naming mandate means the legal act by which the registry allocates a generic domain name or a series of related generic domain names subject to compliance with the particular modalities of use;s.dnssec (domain name system security extensions) means a standardised protocol of the ietf (internet engineering task force) which makes data exchange within the dns secure;t.transfer means the legal act by which the registry allocates the administrative management of a domain name to a new registrar at the request of the holder;u.right attached to a distinctive sign means a right recognised by the legal order which derives from the registration or use of a sign and which protects its holder from attacks on its interests generated by the registration or use by third parties of an identical or similar sign.

810.11 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton medically assisted reproduction(reproductive medicine act, rma)of 18 december 1998 (status as of 1 september 2017)the federal assembly of the swiss confederation,on the basis of articles 119 paragraph 2 and 122 paragraph 1 of the federal constitution1,2and having considered the dispatch of the federal council dated 26 june 19963,decrees:1 sr 1012 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).3 bbl 1996 iii 205chapter 1 general provisions art. 1 subject and purpose 1 this act specifies the conditions under which the techniques of medically assisted reproduction may be used in humans.2 it protects human dignity, personality and the family and prohibits misuses of biotechnology and gene technology.3 it provides for the establishment of a national ethics commission.art. 2 definitions in this act:a.techniques of medically assisted reproduction (assisted reproductive techniques) means methods of establishing a pregnancy without sexual intercourse - in particular, insemination, in vitro fertilisation with embryo transfer and gamete transfer;b.insemination means the introduction, by means of instruments, of sperm cells into the female reproductive organs;c.in vitro fertilisation means the bringing together of an ovum and sperm cells outside the woman's body;d.gamete transfer means the introduction, by means of instruments, of sperm cells and ova into the uterus or a fallopian tube;e.reproductive cells (gametes) means sperm cells and ova;f.germline cells means reproductive cells (including their precursor cells), impregnated ova and embryonic cells whose genetic material can be passed on to offspring;g.impregnation means causing a sperm cell to penetrate into the cytoplasm of an ovum, in particular by insemination, gamete transfer or in vitro fertilisation;h.impregnated ovum means the fertilised ovum before pronuclear fusion;i.embryo means the developing offspring from the time of pronuclear fusion until the end of organogenesis;j.foetus means the developing offspring from the end of organogenesis until birth;k.surrogate mother means a woman who is prepared to become pregnant by means of an assisted reproductive technique, to carry the foetus to term and to surrender the child permanently to third parties after delivery;l.cloning means the artificial production of genetically identical organisms;m.chimera formation means the fusion of totipotent cells from two or more genetically different embryos. embryonic cells are totipotent if they are capable of developing into any type of specialised cell;n.hybrid formation means causing a non-human sperm cell to penetrate into a human ovum, or a human sperm cell into a non-human ovum.chapter 2 techniques of medically assisted reproduction section 1 principles art. 3 well-being of the child 1 assisted reproductive techniques may be used only if the well-being of the child is ensured.2 they may only be used in couples:a.where a basis for a parent-child relationship exists in accordance with articles 252-263 of the swiss civil code4 (cc) andb.5who, on the basis of their age and personal circumstances, are likely to be able to care for and bring up the child until it reaches the age of majority.3 only married couples may use donated sperm cells.4 reproductive cells or impregnated ova may not be used after the death of the person from whom they were obtained. the foregoing does not apply to sperm cells from sperm donors.65 impregnated ova and embryos in vitro may no longer be used following the death of any one oft he couple concerned.74 sr 2105 amended by annex no 20 of the fa of 19 dec. 2008 (adult protection, law of persons and law of children), in force since 1 jan. 2013 (as 2011 725; bbl 2006 7001).6 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).7 inserted by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 4 prohibited practices ovum and embryo donation and surrogate motherhood are prohibited.art. 58 authorisation requirements for reproductive techniques assisted reproductive techniques may be used only if:a.the aim is to enable a couple to overcome infertility and other treatment methods have failed or offer no prospect of success; orb.there is no other way of avoiding the risk of transmitting a serious disease to the offspring.8 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 5a9 analysis of the genetic material of reproductive cells and embryos in vitro and their selection 1 the analysis of the genetic material of reproductive cells and their selection to influence the sex or other characteristics of the child are only permitted in order to identify chromosomal properties that may inhibit the development capacity of the embryo to be created, or if there is no other way of avoiding the risk of transmitting a predisposition for a serious disease. article 22 paragraph 4 is reserved.2 the analysis of the genetic material of embryos in vitro and their selection according to sex or according to other characteristics are only permitted if:a.there is no other way of avoiding the risk of an embryo with a hereditary predisposition for a serious disease from implanting in the uterus;b.it is probable that the serious disease will occur before the age of 50;c.no effective or expedient therapy is available for combating the serious disease; andd.the couple have informed the physician in writing that they are not prepared to accept the risk in terms of letter a.3 they are also permitted in order to identify chromosomal properties that may inhibit the development capacity of the embryo.9 inserted by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 5b10 consent of the couple 1 reproductive techniques may only be used if the couple concerned have given their written consent after being given sufficient information and counselling. after three unsuccessful treatment cycles, renewed consent and a further period for reflection are required.2 the couple's written consent is also required for the reactivation of preserved embryos and impregnated ova.3 if an assisted reproductive technique involves an increased risk of multiple pregnancy, the procedure may be carried out only if the couple are prepared to accept a multiple birth.10 inserted by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 6 information and counselling 1 before an assisted reproductive technique is used, the physician must adequately inform the couple about:11a.the various causes of infertility;b.the medical procedure, including the prospects of success and the risks involved;c.the risk of a multiple pregnancy;d.possible psychological and physical stresses; ande.the legal and financial aspects.2 in the counselling session, appropriate reference should also be made to alternative ways of living and other family-building options.3 there must be an appropriate period for reflection, generally lasting four weeks, between the counselling session and treatment. it must be pointed out that the couple may also seek independent advice.4 psychological support must be offered before, during and after treatment.11 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 6a12 additional duties to provide information and counselling 1 before reproductive techniques with the analysis of the genetic material of reproductive cells or embryos in vitro or with the selection of donor sperm cells to prevent the transmission of a serious disease are carried out, the physician shall, in addition to the provision of information and counselling in accordance with article 6, ensure that the couple concerned receive non-directive, expert genetic counselling. in this connection, the couple must receive sufficient information on:a.the frequency, significance and probability of contracting the disease and its potential symptoms;b.prophylactic and therapeutic measures that may be taken against the disease;c.ways of organising the life of a child that suffers from the disease;d.the informative value of and risk of error in the analysis of the genetic material;e.risks that reproductive techniques carry for offspring;f.associations for parents of children with disabilities, self-help groups and information and counselling centres in terms of article 17 of the federal act of 8 october 200413 on human genetic testing (hgta).2 counselling may only concern the individual and family situation of the couple concerned and not the interests of society as a whole.3 the physician carries out the selection of one or more embryos for transfer to the uterus following a further counselling session.4 the physician must keep records of the counselling sessions.12 inserted by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).13 sr 810.12art. 6b14 protection and disclosure of genetic data the protection and disclosure of genetic data is governed by articles 7 and 19 hgta15.14 inserted by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).15 sr 810.12art. 716 16 repealed by no i of the fa of 12 dec. 2014, with effect from 1 sept. 2017 (as 2017 3641; bbl 2013 5823).section 2 licensing requirements art. 817 principles 1 a cantonal licence is required by any person who:a.uses assisted reproductive techniques;b.receives reproductive cells, impregnated ova or embryos in vitro for preservation or arranges the supply of donated sperm cells without personally using assisted reproductive techniques.2 laboratories that conduct analyses of genetic material in connection with reproductive techniques in terms of article 5a require a licence in terms of article 8 paragraph 1 hgta183 no licence is required for insemination using a partner's sperm cells.17 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).18 sr 810.12art. 9 use of assisted reproductive techniques 1 a licence in accordance with article 8 paragraph 1 letter a shall only be granted to physicians.192 they must:a.have the necessary training and experience in the methods of medically assisted reproduction;b.ensure that such activities are carried out with due care and in compliance with the law;c.together with staff, ensure that the persons to be treated receive comprehensive counselling and support with regard to the medical, reproductive biological and socio-psychological aspects of the procedure;d.have the necessary laboratory equipment;e.20ensure that the reproductive cells, impregnated ova and embryos in vitro are preserved according to the state of the art in science and practice.3 if the genetic material from reproductive cells or embryos in vitro is analysed as part of the reproductive technique, they must also:a.demonstrate they have sufficient knowledge of medical genetics; andb.guarantee that the procedure and cooperation with the laboratories concerned accords with the state of the art in science and practice.2119 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).20 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).21 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 10 preservation and supply of reproductive cells, impregnated ova and embryos in vitro22 1 a licence in accordance with article 8 paragraph 1 letter b shall only be granted to physicians.232 they must:a.ensure that such activities are carried out with due care and in compliance with the law;b.together with staff, ensure that sperm donors are carefully selected; andc.24ensure that reproductive cells, impregnated ova and embryos in vitro are preserved according to the state of science and practice.22 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).23 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).24 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 11 reporting 1 persons holding a licence in accordance with article 8 paragraph 1 must submit an annual report on their activities to the cantonal licensing authority.252 the report must provide information on:a.the number and type of treatments;b.the type of indications;c.the use of donated sperm cells;d.the number of pregnancies and their outcome;e.26the preservation and use of reproductive cells, impregnated ova and embryos in vitro;f.the number of surplus embryos.3 it must not contain any information revealing the identity of specific people.4 the cantonal licensing authority shall transmit the data to the federal statistical office for evaluation and publication.2725 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).26 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).27 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 1228 supervision 1 the licensing authority shall verify whether:a.the requirements for granting a licence have been met;b.the obligations and any conditions have been fulfilled2 it shall carry out inspections and may enter properties, business premises and rooms. the licence holder must provide the licensing authority with the required information and documents and any other support on request and free of charge.3 it may take any measures that are required to enforce this act. in particular, in the case of serious infringements of this act, it may prohibit the use of rooms or facilities, close business premises and suspend or revoke licences.4 the federal council may delegate enforcement tasks, and in particular inspection tasks, to public or private organisations and persons. it shall ensure that payment is made for the delegated tasks.28 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 1329 29 repealed by annex no 87 of the fa on the federal administrative court of 17 june 2005, with effect from 1 jan. 2007 as 2006 2197 1069; bbl 2001 4202).art. 14 implementing provisions the federal council shall enact the implementing provisions concerning the granting and withdrawal of licences, and reporting and supervision.section 2a30 evaluation 30 inserted by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823). art. 14a 1 the federal office of public health (foph) shall ensure that the impact of the provisions of this act relating to the analysis of the genetic material of embryos in vitro and their selection is evaluated.2 the evaluation shall relate in particular to:a.the compatibility of the indications reported in accordance with article 11 paragraph 2 letter b in respect of reproductive techniques with analysis of the genetic material of embryos in order to prevent transmitting the predisposition for a serious disease on the one hand with the authorisation requirements in accordance with article 5a paragraph 2 on the other;b.the survey of the number of couples and the procedures carried out as well as the results;c.the procedures relating to enforcement and supervision;d.the impacts on society.3 the holders of a licence in accordance with article 8 paragraph 1 must on request provide the foph and the person appointed to conduct the evaluation with the data required for the evaluation in anonymised form.4 the federal department of home affairs shall provide the federal council with a report on conclusion of the evaluation and make proposals for further action.section 3 handling of reproductive material art. 15 preservation of reproductive cells 1 reproductive cells may be preserved only with the written consent of the person from whom they were obtained, and for a maximum of five years. at the request of this person, the preservation period shall be extended by a maximum of five years.312 a longer preservation period may be agreed with persons who have their reproductive cells preserved with a view to producing their own offspring at a later date because medical treatment they undergo or an activity they carry out could lead to infertility or damage to their genetic material.3 the person from whom the reproductive cells are obtained may, at any time, in writing, revoke consent to their preservation and use.4 if consent is revoked or the preservation period expires, then the reproductive cells are to be destroyed immediately.31 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 16 preservation of impregnated ova and embryos in vitro32 1 impregnated ova and embryos in vitro may only be preserved if:33a.34the couple concerned give their written consent; andb.preservation is intended to permit subsequent establishment of a pregnancy.2 the preservation period is limited to five years. at the request of the couple concerned, the preservation period shall be extended by a maximum of five years.353 either partner may revoke his or her consent at any time in writing.4 if consent is revoked and the preservation period expires, then the impregnated ova and the embryos in vitro shall be be destroyed immediately. the provisions of the stem cell research act of 19 december 200336 are reserved.375 .3832 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).33 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).34 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).35 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).36 sr 810.3137 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).38 repealed by no i of the fa of 12 dec. 2014, with effect from 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 17 development of embryos 1 the number of impregnated ova developed into embryos outside the woman's body within one treatment cycle must not be greater than is required for medically assisted reproduction or for the analysis of the genetic material of the embryos; the maximum number shall be twelve.392 the embryo may only be developed outside the woman's body to the extent that is essential in order to permit implantation in the uterus.3 .4039 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).40 repealed by no i of the fa of 12 dec. 2014, with effect from 1 sept. 2017 (as 2017 3641; bbl 2013 5823).section 4 sperm donation art. 18 the donor's informed consent 1 donated sperm cells may only be used in legitimate assisted reproductive techniques and for purposes to which the donor has given his written consent.2 before donating sperm, the donor must be informed in writing about the legal situation, and in particular the right of the child to obtain information on the donor's records (art. 27).art. 19 selection of donors 1 donors must be carefully selected according to medical criteria; in particular, health risks for the recipient of the donated sperm cells must be excluded as far as possible. other selection criteria are prohibited.2 the donor may provide his sperm cells to only one centre; he must be expressly informed of this restriction prior to donation.art. 20 supply of donated sperm cells 1 donated sperm cells may only be supplied to persons who have a licence to use assisted reproductive techniques; the data specified in article 24 paragraph 2 is also to be provided.2 any person who receives donated sperm cells must ensure compliance with article 22 paragraph 2.art. 21 non-remuneration no payment shall be made for sperm donation as such.art. 22 use of donated sperm cells 1 sperm cells from different donors must not be used within one cycle. 2 sperm cells from one donor may be used to produce a maximum of eight children.3 when an assisted reproductive technique is used, the relationship between the persons from whom the reproductive cells are obtained must not constitute an impediment to marriage in accordance with article 95 cc41.4 when donated sperm cells are selected, only the donor's blood group and similarity in physical appearance to the man with whom filiation is to be established shall be taken into account.41 sr 210art. 23 filiation 1 a child conceived through sperm donation in accordance with the provisions of this act cannot contest filiation with the husband of his or her mother. an action contesting paternity by the husband is subject to the provisions of the cc42.2 if a child has been conceived through sperm donation, a paternity action against the sperm donor (art. 261 ff. cc) is not permitted; however, such an action is permissible if the donor knowingly donated sperm at the place of a person who was not licensed to use assisted reproductive techniques or to preserve and supply donated sperm cells.42 sr 210art. 24 documentation requirements 1 any person who receives or uses donated sperm cells must document the donation in a reliable manner.2 in particular, the following data about the donor is to be recorded:a.family name and first name, date and place of birth, place of residence, place of origin in switzerland or nationality, occupation and education;b.date of the sperm donation;c.results of the medical examination;d.information about physical appearance.3 concerning the woman for whom the donated sperm cells are used and her husband, the following data is to be recorded:a.family name and first name, date and place of birth, place of residence, place of origin in switzerland or nationality;b.date on which the sperm cells are used.art. 25 transmission of data 1 immediately after the birth of the child, the physician who carried out the reproductive procedure must transmit the data specified in article 24 to the federal civil status office (federal office).2 if the physician has not been informed of a birth, then he or she must transmit the data immediately after the calculated date of birth, unless it has been established that the treatment was unsuccessful.3 the federal council shall enact the necessary provisions on data protection.art. 26 retention of data the federal office shall retain the data for 80 years.art. 27 information 1 once the child has reached 18 years of age, he or she may request information from the federal office about the donor's physical appearance and personal data (art. 24 para. 2 lets. a and d).2 in addition, the child may at any time request information on all the data relating to the donor (art. 24 para. 2) if he or she has a legitimate interest in obtaining it.3 before the federal office discloses personal data, it shall inform the donor if possible. if the donor does not wish to have personal contact, then the child must be informed and made aware of the donor's rights of privacy and his family's entitlement to protection. if the child insists on his or her right to obtain information under paragraph 1, the information shall be provided.4 the federal council may assign responsibility for handling requests for information to a specialised federal commission.5 .4343 repealed by annex no 87 of the fa on the federal administrative court of 17 june 2005, with effect from 1 jan. 2007 (as 2006 2197 1069; bbl 2001 4202).chapter 3 national ethics commission art. 28 1 the federal council shall establish a national ethics commission.2 the commission shall monitor developments in assisted reproductive techniques and gene technology in the area of human medicine and comment from an ethical perspective, in an advisory capacity, on associated social, scientific and legal issues.3 in particular, the commission shall have the following tasks:a.to draw up additional guidelines relating to this act;b.to identify gaps in the legislation;c.to advise the federal assembly, the federal council and the cantons on request;d.to inform the public about important findings and to promote debate on ethical matters within society.4 the federal council shall determine the other tasks to be carried out by the commission in the area of human medicine. it shall enact implementing provisions.chapter 4 criminal provisions art. 2944 production of embryos for illegitimate purposes 1 any person who produces an embryo by impregnation with the intention of using it or having it used for purposes other than the establishment of a pregnancy shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.2 the same penalty shall apply to any person who preserves an impregnated ovum or an embryo in vitro with the intention of using it or having it used for purposes other than the establishment of a pregnancy.44 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 30 development of embryos outside the woman's body 1 any person who allows an embryo to develop outside the woman's body beyond the point at which implantation in the uterus remains possible shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.452 the same penalty shall apply to any person who transfers a human embryo to an animal.45 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 31 surrogate motherhood 1 any person who uses an assisted reproductive technique in a surrogate mother shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.462 the same penalty shall apply to any person who acts as an intermediary for surrogate motherhood.46 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 3247 misuse of reproductive material 1 any person who uses reproductive material obtained from an embryo or foetus to bring about impregnation or further development into an embryo shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.2 any person who purchases or sells human reproductive material or products derived from embryos or foetuses shall be liable to custodial sentence not exceeding three years or to a monetary penalty.3 if the offender acts in a professional capacity, the penalty shall be a custodial sentence not exceeding three years or to a monetary penalty. a custodial sentence must be combined with a monetary penalty47 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 3348 analysis of the genetic material and selection of reproductive cells and embryos in vitro any person who in the course of a reproductive technique analyses the genetic material of reproductive cells or embryos in vitro and selects them according to their sex or according to other characteristics without overcoming infertility or avoiding the transmission of the predisposition to a serious disease to the offspring shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.48 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 3449 acting without consent or a licence 1 any person who uses an assisted reproductive technique without the consent of the person from whom the reproductive cells are obtained or of the couple being treated shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.2 the same penalty shall apply to any person who, acting without a licence or having obtained a licence by fraudulent means, uses assisted reproductive techniques or preserves or supplies reproductive cells, impregnated ova or embryos in vitro or arranges analyses of the genetic material of embryos in vitro.49 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 35 germ-line modifications 1 any person who genetically modifies a germline cell or an embryonic cell shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.502 the same penalty shall apply to any person who uses a genetically modified reproductive cell for impregnation or uses a similarly modified impregnated ovum for further development into an embryo.3 paragraph 1 does not apply if the modification of germline cells is an unavoidable concomitant effect of chemotherapy, radiotherapy or another medical treatment that a person is undergoing.50 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 36 cloning, chimera and hybrid formation 1 any person who creates a clone, a chimera or a hybrid shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.512 the same penalty shall apply to any person who transfers a chimera or a hybrid to a woman or to an animal.51 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 37 contraventions any person who wilfully:a.uses an assisted reproductive technique in a woman in contravention of article 3 paragraph 2 letter a and paragraph 3;b.52uses reproductive cells obtained from a person who is deceased, with the exception of the sperm cells of a deceased sperm donor;bbis 53uses impregnated ova or embryos in vitro obtained from a couple one of whom is deceased;c.uses donated ova, develops an embryo using donated ova and donated sperm cells, or transfers a donated embryo to a woman;d.uses assisted reproductive techniques in the absence of a permissible indication;e.54.f.preserves reproductive material in contravention of articles 15, 16 and 42;g.develops embryos in contravention of article 17 paragraph 1;h.donates sperm cells to several holders of licences under article 8 paragraph 1;i.uses donated sperm cells in contravention of article 22 paragraphs 1-3;j.incorrectly or incompletely records data required in accordance with article 24;shall be liable to a fine not exceeding 100,000 francs.5552 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).53 inserted by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).54 repealed by no i of the fa of 12 dec. 2014, with effect from 1 sept. 2017 (as 2017 3641; bbl 2013 5823).55 amended by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).art. 38 competent authority the prosecution and adjudication of offences under this act is the responsibility of the cantons.chapter 5 final provisions section 1 amendment of current legislation art. 39 .5656 the amendment may be consulted under as 2000 3055.section 2 transitional provisions art. 40 licensing 1 any person who requires a licence according to article 8 paragraph 1 must submit an application, together with the required documents, to the licensing authority within three months after the commencement of this act.2 any person who does not submit the application within the specified period must discontinue the activities concerned.art. 41 information 1 articles 18 and 24-27 also apply if sperm cells have been donated before, but are only used after, the commencement of this act.2 in all other cases, physicians who have used assisted reproductive techniques using donated reproductive cells must provide information, with the provisions of article 27 applying mutatis mutandis.art. 42 storage of embryos 1 any person who is storing embryos when this act commences must inform the licensing authority accordingly within three months. article 11 applies.2 .5757 amended by no i of the fa of 3 oct. 2003, in force until 31 dec. 2008 (as 2003 3681; bbl 2003 1163).art. 43 filiation article 23 also applies to children conceived before the commencement of this act by means of an assisted reproductive technique using donor sperm.art. 43a58 transitional provision to the amendment of 12 december 2014 the submission of reports and proposals in accordance with article 14a paragraph 4 shall take place for the first time five years after the amendment of 12 december 2014 comes into force.58 inserted by no i of the fa of 12 dec. 2014, in force since 1 sept. 2017 (as 2017 3641; bbl 2013 5823).section 3 referendum and commencement art. 44 1 this act is subject to an optional referendum.2 the federal council shall determine the commencement date.commencement date: 1 january 20015959 federal council decree of 4 dec. 2000

810.112.2 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.reproductive medicine ordinance(rmo)of 4 december 2000 (status as of 1 january 2019)the swiss federal council,based on articles 14 and 25 paragraph 3 of the reproductive medicine act of 18 december 19981 (the act),ordains:1 sr 810.11chapter 1 licensing section 1 subject matter art. 12 a licence as specified in article 8 paragraph 1 of the act is required by any person who, as holder of a cantonal professional practising licence, independently or as a team leader:a.uses assisted reproductive techniques;b.receives reproductive cells, impregnated ova or embryos in vitro for preservation or arranges the supply of donated sperm cells without personally using assisted reproductive techniques.2 amended by no i of the o of 21 june 2017, in force since 1 sept. 2017 (as 2017 3651).section 2 licence requirements art. 23 evidence of qualifications for the use of assisted reproductive techniques 1 any person who uses assisted reproductive techniques requires:the swiss obstetrics and gynaecology specialist title with the gynaecological endocrinology and reproductive medicine specialty or an equivalent recognised foreign specialist title; and the cantonal licence to practise as an independent professional.2 any person who limits the activity to insemination with sperm cells from a third party requires:the swiss obstetrics and gynaecology specialist title or an equivalent recognised foreign specialist title; andthe cantonal licence to practise as an independent professional.3 amended by no i of the o of 21 june 2017, in force since 1 sept. 2017 (as 2017 3651).art. 34 evidence of qualifications to preserve and supply reproductive material any person who receives reproductive cells, impregnated ova or embryos in vitro for preservation or arranges the supply of donated sperm cells without personally using assisted reproductive techniques requires: a swiss or a recognised foreign medical specialist title; and the cantonal licence to practise as an independent professional.4 amended by no i of the o of 21 june 2017, in force since 1 sept. 2017 (as 2017 3651).art. 45 reproductive medicine laboratory 1 any person who uses reproductive techniques requires a reproductive medicine laboratory that meets the following requirements:a.it is managed by a person who:1.has completed a university course of studies in accordance with the medical professions act of 23 june 20066 or a masters in the field of biology or chemistry from a tier-one university accredited under the higher education act of 30 september 20117 or a state-recognised or accredited foreign tier-one university;2.has received postgraduate training that the supervisory authority regards as suitable; and3.is familiar with the current state of the art as a result of receiving suitable continuing professional training.b.the staff have the required professional skills and qualifications.c.the laboratory operates a quality management system that is commensurate with the procedures offered and which is based on the standards specified in annex 2.2 the federal department of home affairs may update annex 2 in line with international or technical developments. in consultation with the federal department of economic affairs, education and research, it shall make updates that may have the effect of being technical barriers to trade.5 amended by no i of the o of 21 june 2017, in force since 1 sept. 2017 (as 2017 3651).6 sr 811.117 sr 414.20art. 5 use of donated sperm cells 1 any person wishing to use assisted reproductive techniques using donated sperm cells must indicate in the application:a.how donors are to be recruited and informed about the legal situation (art. 18 para. 2 of the act); b.how health risks for the recipient are to be avoided.2 any person wishing to supply donated sperm cells must indicate:a.what charge will be made to defray expenses;b.how it will be ensured that data is duly recorded in accordance with article 24 of the act and article 17 of this ordinance.3 any changes are to be notified to the supervisory authority.art. 68 counselling and care 1 together with the application for a licence to use assisted reproductive techniques, plans must submitted for the provision of social psychological counselling and support, as specified in article 9 paragraph 2 letter c of the act.2 where it is planned to use reproductive techniques with an analysis of the genetic material of reproductive cells or embryos in vitro or with the selection of donor sperm cells to prevent the transmission of a serious illness, a proposal with regard to genetic counselling in accordance with article 6a of the act must be submitted.8 amended by no i of the o of 21 june 2017, in force since 1 sept. 2017 (as 2017 3651).art. 7 information on scientific staff 1 the personal data and training certificates of scientific staff must be enclosed with the application for a licence.2 any changes are to be notified. the supervisory authority may provide for exceptions in the licence.section 3 licensing and supervision art. 8 responsibility 1 the body responsible for licensing and supervision shall be the department responsible for healthcare in the canton where the activity specified in article 8 paragraph 1 of the act is carried out.2 the cantons may designate another authority which has the necessary expertise.art. 9 licensing 1 the licence to use assisted reproductive techniques may be restricted to certain techniques.2 the licence may be granted for a limited term and subject to conditions.3 .99 repealed by no i of the o of 21 june 2017, with effect from 1 sept. 2017 (as 2017 3651).art. 1010 supervision 1 within a year of granting a licence, the supervisory authority shall arrange for an inspection to be carried out by an expert. thereafter, an inspection shall be carried out as often as necessary, but at least once every three years.2 the supervisory authority may consult an independent expert.3 persons charged with carrying out an inspection shall be granted access at all times to the premises and facilities used to perform the activities concerned.3 if the laboratory is accredited under the accreditation and designation ordinance of 17 june 199611, the supervisory authority may dispense with all or part of the review of the quality management system.4 the swiss accreditation service shall notify the supervisory authority within an appropriate period of accreditations that have been granted or renewed as well as of any that have been suspended or revoked.10 amended by no i of the o of 21 june 2017, in force since 1 sept. 2017 (as 2017 3651).11 sr 946.512art. 11 and 1212 12 repealed by no i of the o of 21 june 2017, with effect from 1 sept. 2017 (as 2017 3651).art. 13 expiry the licence shall expire when the licensed activities are discontinued. discontinuation of activities is to be notified to the supervisory authority.art. 14 reporting 1 licence holders must submit an annual report on their activities, as specified in article 11 of the act, to the supervisory authority by no later than 1 may of the following year.2 the supervisory authority shall transmit the anonymised data to the federal statistical office by no later than 1 july of the year in question for evaluation and publication. the data must not include any indication of the centres of reproductive medicine.3 the federal statistical office shall provide the supervisory authorities with a form for standardised data collection. this may also be used for the annual report on activities referred to in paragraph 1.art. 14a13 evaluation the supervisory authority shall on request send the federal office of public health the data required for the evaluation in accordance with article 14a paragraph 2 letter c of the act together with the contact details for licence holders in accordance with article 8 paragraph 1 of the act.13 inserted by no i of the o of 21 june 2017, in force since 1 sept. 2017 (as 2017 3651).chapter 2 data on biological origins section 1 donor data register14 14 amended by no i of the o of 31 oct. 2012, in force since 1 jan. 2013 (as 2012 6097). art. 1515 competent authority 1 the federal civil status office (federal office) shall keep a register for storing the sperm donor data specified in article 24 of the act (donor data register).2 the federal office shall issue processing regulations governing the establishment and management of the donor data register, and defining in particular the structure, procedures and access rights.15 amended by no i of the o of 31 oct. 2012, in force since 1 jan. 2013 (as 2012 6097).art. 15a16 online management 1 the donor data register is kept electronically.2 the transmitted data are stored in electronic form.3 the electronic system for the management of the register and for storing the data must meet the following requirements:a.the long-term existence and quality of the data are guaranteed.b.the data are secured in accordance with recognised standards and the current state of the art;c.the programming and the file format for the data are documented.16 inserted by no i of the o of 31 oct. 2012, in force since 1 jan. 2013 (as 2012 6097).art. 15b17 structure of the donor data register 1 the register contains a directory of the sperm donors.2 each sperm donor file contains the following information:a.the data transmitted by the attending doctor with the registration form for the sperm donor data (art. 16 para. 1);b.the results of the medical examinations (art. 16 para. 1);c.other donor data stored at the request of the sperm donor (art. 17).17 inserted by no i of the o of 31 oct. 2012, in force since 1 jan. 2013 (as 2012 6097).art. 1618 transmission of the data to the federal office 1 the data are transmitted by the attending doctor to the federal office in accordance with articles 24 and 25 of the act at the same time as the report of the sperm donor data; the form may be transmitted on paper (art. 16a) or electronically (art. 16b); the federal office issues the form.2 the other data may be transmitted at a time later than that specified in paragraph 1.3 the registration form for sperm donor data contains the following data:a.relating to the donor:1.name and first name, date of birth and place of birth, place of residence, place of origin or nationality, occupation and education,2.date of the sperm donation,3.results of the medical examinations,4.description of the physical appearance: stature, size, hair colour, eye colour, skin colour, special features;b.relating to the recipient of the sperm donation and her husband:1.name and first name, date of birth and place of birth, place of residence, place of origin or nationality,2.date of the insemination or the embryo transfer;c.relating to the child, if known by the attending doctor: name and first name, date of birth and place of birth, sex, place of residence; if details of the birth are not known: the probable date of birth;d.relating to the doctor who stored or arranged the sperm donation, where this doctor is not the attending doctor: name and address.18 amended by no i of the o of 31 oct. 2012, in force since 1 jan. 2012 (as 2012 6097).art. 16a19 transmission in paper form 1 if the form is completed by hand, it must be completed legibly in block capitals and signed.2 if the form is illegible, incomplete, not signed or defective in some other way, the federal office may return it to the doctor, giving notice that he or she will be in breach of the obligation under article 25 of the act to transmit the data if the noted defects are not rectified.3 data may be transmitted in accordance with article 24 of the act and article 17 of this ordinance by registered post or by private courier.19 inserted by no i of the o of 31 oct. 2012, in force since 1 jan. 2012 (as 2012 6097).art. 16b20 transmission in electronic form 1 the federal office may request doctors who wish to transmit the data electronically that they register with a recognised platform for the secure service in accordance with article 2 the ordinance of 18 june 201021 on electronic service in civil and criminal proceedings and debt enforcement and bankruptcy procedures.2 the doctors shall use the electronic form provided by the federal office on its website, on the secure service platform or by post.3 the form must bear a qualified electronic signature in accordance with article 2 of the federal act of 18 march 201622 on electronic signatures.234 a certified electronic signature is not required if identification of the sender and the integrity of the transmission is guaranteed in some other suitable way.5 the result of the medical examinations is transmitted to the federal office in pdf/a format.6 the doctors shall send documents that are not electronically transmitted by registered post or by private courier to the federal office.7 the electronic files shall be transmitted to the electronic postal address of the federal office and encrypted using its public key.8 registration with the secure service platform is deemed to be consent to the federal office serving documents electronically. consent may be revoked at any time.9 the principles relating to the detection and rectification of defects in forms transmitted on paper (art. 16a para. 2) apply mutatis mutandis.20 inserted by no i of the o of 31 oct. 2012, in force since 1 jan. 2013 (as 2012 6097).21 sr 272.122 sr 943.0323 amended by annex no ii 8 of the o of 23 nov. 2016 on electronic signatures, in force since 1 jan. 2017 (as 2016 4667).art. 17 storage of additional donor data at the request of the sperm donor, additional donor data, in particular photographs of the donor, shall be stored as well as the data specified in article 24 of the act.art. 1824 updating of stored data at the request of the treated couple, the data held in the donor data register shall be updated. the couple shall provide the information required for this purpose.24 amended by no i of the o of 31 oct. 2012, in force since 1 jan. 2013 (as 2012 6097).art. 1925 security of stored data 1 the federal office shall ensure that the data in the donor data register and the data in accordance with article 15b paragraph 2 are securely stored in accordance with the principles of data protection legislation. 2 in particular, it shall ensure protection against fire, water, theft and unauthorised processing of the data.25 amended by no i of the o of 31 oct. 2012, in force since 1 jan. 2013 (as 2012 6097).art. 19a26 electronic data carriers 1 the files transmitted in paper form shall be digitalised and stored in electronic form. following digitalisation, the paper copies shall be destroyed.2 the federal office may delegate these duties to an external agency, which undertakes in terms of a written agreement to record all the data electronically, treat it as confidential and guarantee its security. article 10a of the federal act of 19 june 199227 on data protection applies mutatis mutandis.3 the federal office shall confirm on request that the digitalised documents correspond to their originals in paper form 26 inserted by no i of the o of 31 oct. 2012, in force since 1 jan. 2013 (as 2012 6097).27 sr 235.1art. 2028 archiving and destruction of the data 1 on expiry of the retention period of 80 years (art. 26 of the act), the data in the donor data register and the data under article 15b paragraph 2 shall be offered to the federal archives for archiving.2 the data regarded by the federal archives as not worthy of archiving shall be destroyed.28 amended by no i of the o of 31 oct. 2012, in force since 1 jan. 2012 (as 2012 6097).section 2 procedure for disclosure of information art. 21 request for information 1 the child must submit to the federal office a written request for information in accordance with article 27 paragraph 1 or 2, specifying the mother's personal data.2 the child must provide evidence of his or her identity in the form of a copy of a passport, identity card or an equivalent identity document and demonstrate that the requirements specified in article 27 paragraph 1 or 2 of the act are met.293 if the child is evidently incapable of acting on his or her own behalf, the federal office may request him or her to enlist a representative.3029 amended by no i of the o of 14 nov. 2018, in force since 1 jan. 2019 (as 2018 4681).30 amended by no i of the o of 14 nov. 2018, in force since 1 jan. 2019 (as 2018 4681).art. 22 notification of the sperm donor 1 if the child fulfils the requirements specified in article 27 paragraph 1 or 2 of the act and requests information on the personal data of the sperm donor, the federal office shall ascertain the latter's current address. in doing so, the federal office shall as far as possible avoid indicating the purpose of the inquiry.2 federal, cantonal and communal authorities that can provide the relevant information are obliged to assist the federal office at its request.3 the federal office shall inform the sperm donor of the fact that his personal data are to be disclosed to the child. it shall grant him an appropriate period to express his wishes concerning personal contact with the child.art. 2331 provision of information to the child 1 if the requirements of article 27 paragraph 1 or 2 of the act are met, the child may choose whether to be provided information:a.by communication by post;b.by a doctor, a person trained in social psychology, or a specialist organisation of the child's choice.2 the personal details of the sperm donor shall be provided to the child in a written report.3 if the requirement in article 27 paragraph 1 of the act is not met, the office shall inform the child in writing that he or she is not yet entitled to be provided with information.4 if the requirement in article 27 paragraph 2 of the act is not met, the office shall inform the child in writing that he or she has no legitimate interest and, provided the requirement in article 27 paragraph 1 of the act is met, that he or she may choose how information is provided in accordance with paragraph 1.5 the office shall notify the child if the donor could not be found or could not be reliably identified, failed to answer or declined any personal contact.6 it shall advise the child with regard to the counselling options available.31 amended by no i of the o of 14 nov. 2018, in force since 1 jan. 2019 (as 2018 4681).art. 2432 32 repealed by no i of the o of 14 nov. 2018, with effect from 1 jan. 2019 (as 2018 4681).art. 25 data protection 1 in any contacts with the sperm donor or with the child, strict confidentiality shall be observed by the persons and authorities concerned.2 before any contacts with the sperm donor, his identity must be securely established.art. 26 charges the charges and expenses in the disclosure procedure shall be based on the ordinance of 27 october 199933 on civil status fees.33 sr 172.042.110chapter 3 final provisions art. 27 amendment of existing legislation .3434 the amendments may be consulted under as 2000 3068.art. 2835 transitional provisions to the amendment of 21 june 2017 1 licence holders under article 8 paragraph 1 letter a of the act who are already using reproductive techniques when the amendment of 21 june 2017 comes into force and who wish to continue with such activities must submit an application to the supervisory authority within three years containing proof that they meet the requirements under article 4 paragraph 1 hereof. they may continue their activities until the decision of the supervisory authority takes full effect.2 licence holders under article 8 paragraph 1 letter a of the act who are already using reproductive techniques with analyses of genetic material from reproductive cells when the amendment of 21 june 2017 comes into force and who wish to continue with such activities must submit an application to the supervisory authority within three years containing proof that they meet the requirements under article 9 paragraph 3 of the act and articles 4 paragraph 1 and 6 paragraph 2 hereof. they may continue their activities until the decision of the supervisory authority takes full effect.35 amended by no i of the o of 21 june 2017, in force since 1 sept. 2017 (as 2017 3651).art. 29 commencement this ordinance comes into force on 1 january 2001.annex 136 annex 237 36 originally: annex. repealed by no ii of the o of 31 oct. 2012, with effect from 1 jan. 2013 (as 2012 6097).37 inserted by no ii of the o of 21 june 2017, in force since 1 sept. 2017 (as 2017 3651).(art. 4 para. 1 let. c)quality management system european standard iso/iec 17025:2005 (general requirements for the competence of testing and calibration laboratories) or iso 15189:2012 (medical laboratories - requirements for quality and competence)38.38 the standards may be inspected at the federal office of public health, schwarzenburgstrasse 157, 3003 bern, or obtained from the swiss association for standardisation, sulzerallee 70, 8404 winterthur; www.snv.ch.

810.12 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton human genetic testing(hgta)of 8 october 2004 (status as of 1 january 2014)the federal assembly of the swiss confederation, in accordance with article 98 paragraph 3, 110 paragraph 1, 113 paragraph 1, 117 paragraph 1, 119 paragraph 2 f, 122 paragraph 1 and 123 paragraph 1 of the federal constitution1, and having considered the dispatch of the federal council dated 11 september 20022,decrees:1 sr 1012 bbl 2002 7361 chapter 1: scope, purpose and definitions art. 1 scope 1 this act stipulates the conditions under which human genetic testing may be performed:a.in the medical context;b.in the context of employment;c.in the context of insurance;d.in the context of liability.2 it also regulates the creation of dna profiles for the purpose of determining the filiation or identity of an individual. the dna profiling act of 20 june 20033 applies to the use of dna profiles in criminal proceedings and for the purpose of identifying unknown or missing persons.3 this act does not apply to genetic testing performed for research purposes.43 sr 3634 amended by annex no 3 of the human research act of 30 sept. 2011, in force since 1 jan. 2014 (as 2013 3215; bbl 2009 8045).art. 2 purpose this act aims:a.to protect human dignity and personality;b.to prevent improper genetic testing and the improper use of genetic data;c.to ensure the quality of genetic tests and the way their results are interpreted.art. 3 definitions in this act:a.genetic test means cytogenetic and molecular genetic tests to determine hereditary characteristics of human genetic material or characteristics of human genetic material acquired during the embryonic phase, and all other laboratory tests whose immediate purpose is to provide such information about genetic material;b.cytogenetic tests means tests to determine the number and structure of chromosomes;c.molecular genetic tests means tests to determine the molecular structure of nucleic acids (dna and rna) and the immediate gene product;d.presymptomatic genetic tests means genetic tests whose purpose is to identify predisposition to disease before clinical symptoms emerge, with the exception of tests designed solely to determine the effect of a planned therapy;e.prenatal tests means prenatal genetic testing and prenatal risk assessment;f.prenatal genetic tests means genetic tests during pregnancy to determine characteristics of the genetic material of the embryo or foetus;g.prenatal risk assessment means laboratory tests which provide information about the risk of the embryo or foetus having a genetic anomaly, and investigations of the embryo or foetus using imaging techniques; h. testing for family planning purposes means genetic tests to determine a genetic risk for future offspring;i.screening means genetic tests offered systematically to the entire population or to certain groups of individuals in the population without there being a suspicion that the individual may have the characteristics being sought;j.genetic in vitro diagnostic medical devices means ready-to-use products for the determination of characteristics of human genetic material;k.dna profile means information specific to an individual which is obtained from the non-coding sequences of their dna using molecular genetic techniques;l.genetic data means information about the genetic material of a person that is obtained from a genetic test, including their dna profile;m.sample means biological material collected for a genetic test;n.person concerned means a person whose genetic material is tested or for whom a dna profile is created and from whom corresponding samples or genetic data exist; in the context of prenatal testing: the pregnant woman.chapter 2: general principles of genetic testing art. 4 non-discrimination no one may be discriminated against on grounds of his or her genetic material.art. 5 consent 1 genetic and prenatal testing, including screening, may not be performed unless the person concerned has been provided with adequate information about the testing and has given his or her voluntary consent. this shall not apply to exceptions stipulated in a federal law.2 if the person concerned is incapable of judgement, that person's legal representative shall provide consent on his or her behalf. in the medical context the limitations of article 10 paragraph 2 must be observed.3 consent may be withdrawn at any time.art. 6 right not to know every person has the right to refuse to receive information about his or her genetic status subject to article 18 paragraph 2.art. 7 protection of genetic data the processing of genetic data is subject to:a.professional secrecy as stipulated in articles 321 and 321a of the swiss criminal code5; andb.federal and cantonal data protection regulations. 5 sr 311.0art. 8 authorisation to perform genetic testing 1 any person who wishes to perform cytogenetic or molecular genetic tests requires authorisation from the competent federal authority.2 the federal council:a.nominates the competent federal authority;b.regulates the requirements and the procedure for granting the authorisation;c.defines the duties of the holder of the authorisation;d.regulates oversight and, in particular, makes provision for unannounced inspections;e.determines the fees.3 the federal council may, having consulted the expert commission for human genetic testing (art. 35):a.require authorisation to be obtained for other genetic tests or prenatal risk assessment if these have to fulfil the same requirements in terms of quality assurance and interpretation of their results as cytogenetic and molecular genetic tests;b.exempt from the requirement for authorisation genetic tests which do not need to fulfil any special requirements in terms of performance and interpretation of their results.4 dna profiles within the meaning of this act may only be created by laboratories recognised by the federal government. the federal council regulates the requirements and the procedure for recognising such laboratories and for oversight.art. 9 genetic in vitro diagnostic medical devices 1 it is forbidden to supply genetic in vitro diagnostic medical devices to individuals for a purpose which cannot be considered part of those individuals' professional or commercial activities.2 the federal council may, having consulted the expert commission for human genetic testing, make provision for exceptions to this prohibition provided the products are used under medical supervision and misinterpretation of the test result is not possible.chapter 3: genetic testing in a medical context art. 10 genetic testing of individuals 1 genetic tests may only be performed on individuals if they serve a medical purpose and the right to self-determination according to article 18 is ensured.2 a genetic test may only performed on a person incapable of judgement if the test is necessary to protect that person's health. exceptionally, a test of this kind is permissible if there is no other way of identifying a severe hereditary disorder in the family or a corresponding predisposition and the burden on the person concerned is minimal.art. 11 prenatal tests it is forbidden to perform prenatal tests whose purpose is:a.to determine characteristics of the embryo or foetus which do not directly impair its health; or b.to determine the sex of the embryo or foetus for a purpose other than diagnostic.art. 12 screening 1 screening may only be performed if the programme has been authorised by the competent federal authority.2 authorisation can be granted if:a.early treatment or prophylaxis is possible;b.the test method has been shown to produce reliable results; andc.appropriate genetic counselling is provided.3 before the competent federal authority issues the authorisation, it consults the expert commission for human genetic testing and, where necessary, the swiss national advisory commission on biomedical ethics.4 the federal council may make provision for further conditions. it designates the competent federal authority and regulates the procedure for issuing authorisations, oversight and fees.art. 13 right to prescribe genetic tests 1 genetic tests may only be prescribed by medical doctors who are authorised to practice their profession independently or under the supervision of such.2 presymptomatic and prenatal genetic tests and tests for the purpose of family planning may only be prescribed by doctors who have received appropriate post-graduate training or who, during their post-graduate training, work under the supervision of doctors who have received appropriate post-graduate training.3 the doctor who prescribes a genetic test under the terms of paragraph 2 ensures that the person concerned receives genetic counselling.art. 14 genetic counselling in general 1 presymptomatic and prenatal genetic tests and tests for the purpose of family planning must be preceded and followed by non-directive genetic counselling provided by a qualified person. the counselling session must be documented. 2 counselling must address only the individual and family situation of the person concerned; it must not take public interest into consideration. it must take into account the possible psychological and social impact of the test results on the person concerned and his or her family.3 the person concerned or, if he or she is not capable of judgement, his or her legal representative must be informed specifically of:a.the purpose, nature and significance of the test and of any complementary measures;b.any risks which may be associated with the test and the frequency and nature of the disorder being diagnosed;c.the possibility of an unexpected test result;d.the possible physical and psychological burden;e.third-party payment options for the cost of the test and of subsequent measures;f.support available in connection with the test result;g.the severity of the anomalies which may be detected and the possible therapeutic and prophylactic measures.4 a sufficient period of time for reflection must be allowed between the counselling session and the test.5 in screening testing the counselling must be adapted to the circumstances.art. 15 genetic counselling for prenatal genetic tests 1 the pregnant woman must be informed expressly about her right to self-determination both before and after a prenatal genetic test.2 the woman must be made aware if there is a high probability that the proposed test will not lead to any therapeutic or prophylactic options; she must also be informed of the opportunity to contact an information and counselling centre for prenatal testing.3 if a severe, incurable disorder is detected, the woman must also be informed about alternatives to termination of the pregnancy and made aware of the existence of associations of parents of disabled children and self-help groups.4 the woman's husband or partner should be involved in the genetic counselling if possible.art. 16 information in connection with prenatal risk assessment before a laboratory test which provides information about the risk of the embryo or foetus having a genetic anomaly, and before investigations of the embryo or foetus using imaging techniques, the pregnant woman must be informed of the following:a.the purpose and significance of the test;b.the possibility of unexpected test results;c.the possible complementary tests and interventions; andd.information and counselling centres as defined in article 17.art. 17 information and counselling centres for prenatal testing 1 the cantons shall ensure that there are independent information and counselling centres for prenatal testing, with personnel with the required competency.2 they may set up centres of this kind jointly or delegate their tasks to the recognised pregnancy advisory centres (federal act of 9 october 19816 on pregnancy advisory centres).3 the centres provide general information and counselling on prenatal testing and, if requested to do so, put clients in touch with associations of parents of disabled children or self-help groups. 6 sr 857.5art. 18 right to self-determination 1 having been provided with adequate information, the person concerned is free to decide:a.whether to undergo a genetic or prenatal test and, where appropriate, a subsequent test;b.whether to know the result of the test; andc.what conclusions he or she wishes to draw from the test result.2 the doctor must immediately inform the person concerned of the test result if there is an immediate physical danger to the person, to the embryo or to the foetus, which could be averted.3 consent for presymptomatic or prenatal genetic testing and for tests for the purpose of family planning must be obtained in writing, with the exception of screening tests.4 if the person concerned is incapable of judgement, his or her legal representative shall decide.art. 19 disclosure of genetic data 1 the doctor may disclose genetic test results only to the person concerned or, if he or she is incapable of judgement, to his or her legal representative.2 if the person concerned gives his or her express consent, the doctor may disclose the test result to the person's family members, spouse or partner.3 if consent is denied, the doctor may apply to the competent cantonal authority as stipulated in article 321 number 2 of the swiss criminal code7 to be released from his or her duty of professional secrecy, should the protection of the overriding interests of the family members, spouse or partner require that they receive this information. the authority may request an opinion from the expert commission for human genetic testing.7 sr 311.0art. 20 further use of biological material 1 a sample may only be used for further purposes to which the person concerned has consented.2 and 3 .88 repealed by annex no 3 of the human research act of 30 sept. 2011, with effect from 1 jan. 2014 (as 2013 3215; bbl 2009 8045).chapter 4: genetic testing in the context of employment art. 21 principle at hiring and during a professional relationship, the employer and his or her medical consultant may not:a.require presymptomatic genetic tests to be performed;b.require the results of prior presymptomatic genetic tests to be disclosed nor make use of such results;c.require genetic tests to be performed with the intention of detecting personal characteristics of the employee which do not relate to his or her health.art. 22 exceptions for presymptomatic genetic tests to prevent occupational diseases and accidents at hiring and during a professional relationship, the occupational health or designated doctor may prescribe a presymptomatic genetic test if the following conditions are met:a.suva has ruled that the post is subject to occupational health monitoring, or other federal regulations require the employee to undergo a medical examination to ascertain his or her suitability for the job because there is a danger of an occupational disease or severe environmental contamination occurring or there is a serious risk of accident or health hazards for third parties. b.workplace-related measures within the meaning of article 82 of the federal act of 20 march 19819 on accident insurance or other legal provisions are not sufficient to preclude these risks.c.available scientific knowledge has established a causal relationship between a specific genetic predisposition of the person carrying out the job and occupational disease, danger of environmental contamination or a risk of accident or health hazards to third parties.d.the expert commission for human genetic testing has confirmed the causal relationship and has deemed the type of test to be reliable in identifying the relevant genetic predisposition.e.the person concerned has given his or her written consent to the test.9 sr 832.20art. 23 performance of the test 1 the test can only address the genetic predisposition relevant to the particular post. attempting to acquire other genetic data is forbidden.2 genetic counselling as stipulated in article 14 must be provided before and after the test.3 the sample must be destroyed on completion of the test.art. 24 disclosure of the test result and assumption of the costs 1 the doctor transmits the result of the test to the person concerned. the employer is only informed whether the person concerned can or cannot be considered for the intended activity.2 if the occupational health examination is mandated by suva, this body pays for the test; in other cases the employer bears the costs.art. 25 regulatory intervention if the executive bodies designated by the employment act of 13 march 196410 or the federal act of 20 march 198111 on accident insurance observe violations of articles 21-24, they are bound by virtue of their office to intervene.10 sr 822.1111 sr 832.20chapter 5: genetic testing in the context of insurance art. 26 prohibition of testing insurance providers may not require either presymptomatic or prenatal genetic tests prior to providing insurance.art. 27 prohibition of further enquiries 1 insurance providers may neither require the disclosure of, nor utilize, results of prior presymptomatic or prenatal genetic tests or tests for family planning purposes, from applicants for the following:a.insurance which is subject either in part or as a whole to the terms of the federal act of 6 october 200012 on general aspects of social insurance law;b.mandatory occupational insurance or voluntary occupational insurance that goes beyond the scope of the mandatory insurance;c.insurance relating to the obligation to continue paying the individual's salary in case of illness or maternity;d.life insurance with an insured sum up to a maximum of chf 400,000;e.voluntary invalidity insurance with an annuity not exceeding chf 40,000.2 if an individual takes out several life or invalidity insurance policies, the maximum amount stipulated in para. 1 d or e is valid for the sum of the policies. the applicant must provide the insurance provider with the relevant information.12 sr 830.1art. 28 permissible further enquiries about results of prior presymptomatic genetic tests 1 before a private insurance policy not covered by article 27 is taken out, insurance providers may only require the applicant to disclose the results of prior presymptomatic genetic tests to the designated doctor if:a.the test in question provides reliable results both technically and in medical practice; andb.the scientific value of the test for the calculation of premiums has been demonstrated.2 the designated doctor may inform the insurance provider only of the risk group to which the applicant must be assigned.3 the designated doctor may only retain the results of the test if they are relevant for the conclusion of the contract.4 the test results must be used solely for the purpose for which they were obtained from the applicant.chapter 6: genetic testing in the context of liability art. 29 prohibition of presymptomatic genetic testing 1 performing presymptomatic genetic tests for the purpose of calculating claims or determining compensation is forbidden, except in cases involving a genetic anomaly acquired during the embryonic phase and for which compensation or restitution is being claimed.2 requesting or utilizing the results of prior presymptomatic or prenatal genetic tests or tests for family planning purposes, for the purpose of calculating claims or determining compensation, is forbidden.art. 30 detection of diseases genetic tests to diagnose a disease with the aim of calculating claims or determining compensation may only be performed with the written consent of the person concerned or by order of the court.chapter 7: dna profiling to determine filiation or identity art. 31 principle 1 when creating dna profiles to determine filiation or for identification purposes it is not permitted to seek information concerning health or other personal characteristics, with the exception of the sex of the person concerned.2 the sample must be taken by the laboratory which will perform the dna profiling or by a doctor mandated by the laboratory. the person concerned must provide proof of his or her identity.3 the samples may not be used for other purposes.art. 32 civil proceedings 1 in civil proceedings, dna profiling of parties or third parties may only be performed by order of the court or with the written consent of the person concerned.2 the laboratory must retain the samples obtained in the course of the proceedings. the court which ordered the test ensures that the samples are destroyed immediately after the implementation of the final judgment, unless a person concerned has requested in writing that his or her samples be retained for a further period.art. 33 administrative proceedings 1 if in administrative proceedings there are justified doubts about the filiation or the identity of a person which cannot be dispelled in any other way, the competent authority may make the granting of authorisation or benefits conditional to dna profiling.2 dna profiling may only be performed with the written consent of the persons concerned.3 the samples must be retained by the laboratory. the authority ensures that the samples are destroyed immediately after the implementation of the decision.art. 34 determination of origin outside administrative proceedings 1 outside the context of administrative proceedings, dna profiling to determine filiation may be performed only with the written consent of the persons concerned; a child incapable of judgement and whose filiation with a certain person must be determined, may not be represented by that person.2 the laboratory that performs the dna profiling must, before undertaking the test, inform the persons concerned in writing about the provisions of the civil code13 concerning the determination of filiation and draw their attention to the possible psychological and social impact of the test.3 the person concerned or, if he or she is incapable of judgement, his or her legal representative, shall decide whether his or her sample shall be retained or destroyed.4 prenatal dna profiling to establish paternity may not be prescribed by a doctor unless the pregnant woman has previously had a thorough discussion addressing in particular, her reasons for wanting to perform the test, the risks associated with obtaining the sample, the psychological, social and legal aspects associated with the pregnancy, any subsequent measures that may be taken following the result and the possibility of obtaining support. the counselling session must be documented.13 sr 210chapter 8: expert commission for human genetic testing art. 35 1 the federal council shall appoint an expert commission for human genetic testing.2 the expert commission shall have the following tasks in particular:a.to develop standards for the quality control of genetic tests with respect to the granting of authorisations (art. 8 para. 2) and to submit recommendations to the federal council on whether certain genetic tests should be exempted from or subjected to the requirement for authorisation (article 8 para. 3);b.at the request of the competent federal authority, to comment on requests for authorisation and to participate in inspections (art. 8 para. 1 and 2);c.to make recommendations on whether certain genetic in vitro diagnostic medical devices should be exempted from the prohibition stipulated in article 9 paragraph 1;d.to advise on screening programmes (art. 12);e.where necessary, to make recommendations on post-graduate training as stipulated in article 13 paragraph 2; f.to make recommendations on genetic counselling (art. 14 and 15) and information relating to prenatal risk assessment (art. 16);g.to advise, on request from the competent cantonal authority, on applications for release from the duty of professional secrecy (art. 19 para. 3);h.to provide confirmations as stipulated in article 22 letter d;i.to make recommendations on dna profiling;j.to follow the scientific and practical development of genetic testing, to make recommendations and to highlight gaps in the legislation in this field.3 the commission shall fulfil its tasks independently.chapter 9: criminal provisions art. 36 genetic tests performed without consent any person who wilfully prescribes or performs a genetic test without obtaining the consent of the person being tested, as required by this act, shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.1414 amended by art. 333 of the swiss criminal code (sr 311.0) in its version in the federal act of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459).art. 37 genetic testing without authorisation any person who wilfully performs a genetic test on a third party without the authorisation stipulated in article 8 shall be liable to a fine.1515 amended by art. 333 of the swiss criminal code (sr 311.0) in its version in the federal act of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459).art. 38 supply of genetic in vitro diagnostic medical devices 1 any person who, in contravention of article 9 paragraph 1, wilfully supplies genetic in vitro diagnostic medical devices to individuals for a purpose which cannot be considered part of those individuals' professional or commercial activities shall be liable to a fine. 162 if the act is committed for commercial gain, the penalty shall be a custodial sentence not exceeding three years or to a monetary penalty.1716 amended by art. 333 of the swiss criminal code (sr 311.0) in its version in the federal act of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459).17 amended by art. 333 of the swiss criminal code (sr 311.0) in its version in the federal act of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459).art. 39 abuse in the context of employment any person who, in contravention of article 21 and in the context of employment, wilfully:a.requires a presymptomatic genetic test or a genetic test to determine personal characteristics which are not related to health; orb.requires the results of prior presymptomatic genetic tests to be disclosed or asks about them during an employment-related medical examination or makes use of such results.shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.1818 amended by art. 333 of the swiss criminal code (sr 311.0) in its version in the federal act of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459).art. 40 abuse in the context of insurance any person who, in the context of insurance, wilfully:a.in contravention of article 26, requires presymptomatic or prenatal genetic tests to be performed; orb.in contravention of article 27, requires the disclosure of the results of prior presymptomatic or prenatal genetic tests or tests for family planning purposes, or asks about these in the context of a medical risk assessment, or makes use of such results.shall be liable to a custodial sentence not exceeding three years or to a monetary penalty. 1919 amended by art. 333 of the swiss criminal code (sr 311.0) in its version in the federal act of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459).art. 41 competent authority and administrative criminal law 1 the cantons shall be responsible for the prosecution and assessment of criminal acts under the terms of this act.2 articles 6 and 7 (offences committed within a company) and 15 (forgery, obtaining a false certificate by fraud) of the federal act of 22 march 197420 on administrative criminal law apply.20 sr 313.0chapter 10: final provisions art. 42 authorisation to perform genetic testing 1 any person who requires an authorisation as stipulated in article 8 must submit the request to the competent federal authority within three months of this act coming into force.2 any person who does not submit the request within the deadline must cease his or her activity.art. 43 screening screening programmes which have already been implemented by the time this act comes into force do not require authorisation.art. 44 referendum and commencement 1 this act is subject to optional referendum.2 the federal council shall determine its commencement date.commencement date: 1 april 20072121 federal council decree of 14 february 2007 (as 2007 649)

810.30 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton research involving human beings(human research act, hra)of 30 september 2011 (status as of 26 may 2021)the federal assembly of the swiss confederation,on the basis of article 118b paragraph 1 of the federal constitution1,and having considered the dispatch of the federal council dated 21 october 20092,decrees:1 sr 1012 bbl 2009 8045chapter 1 general provisions section 1 purpose, scope and definitions art. 1 purpose 1 the purpose of this act is to protect the dignity, privacy and health of human beings involved in research.2 it is also designed to:a. create favourable conditions for research involving human beings;b. help to ensure the quality of research involving human beings;c. ensure the transparency of research involving human beings.art. 2 scope 1 this act applies to research concerning human diseases and concerning the structure and function of the human body, which involves:a. persons;b. deceased persons;c. embryos and foetuses;d. biological material;e. health-related personal data.2 it does not apply to research which involves:a. ivf embryos in accordance with the stem cell research act of 19 december 20033;b. anonymised biological material;c. anonymously collected or anonymised health-related data.3 sr 810.31art. 3 definitions in this act:a. research means method-driven search for generalisable knowledge;b. research concerning diseases means research on the causes, prevention, diagnosis, treatment and epidemiology of impairments of physical and mental health in human beings;c. research concerning the structure and function of the human body means basic research, in particular on human anatomy, physiology and genetics, and non-disease-related research concerning interventions and impacts on the human body;d. research project with an expected direct benefit means a research project whose results can be expected to improve the health of the participants;e. biological material means bodily substances derived from living persons;f. health-related personal data means information concerning the health or disease of a specific or identifiable person, including genetic data;g. genetic data means information on a person's genes, obtained by genetic testing;h. coded biological material and coded health-related personal data means biological material and data linked to a specific person via a code;i. anonymised biological material and anonymised health-related data means biological material and health-related data which cannot (without disproportionate effort) be traced to a specific person;j. child means a legal minor under 14 years of age;k. adolescent means a legal minor aged 14 years or more;l.4 .4 repealed by annex of the fa of 22 march 2019, with effect from 26 may 2021 (as 2020 2961; bbl 2019 1).section 2 principles art. 4 primacy of individual interests the interests, health and welfare of the individual human being shall prevail over the interests of science and society.art. 5 scientifically relevant topic research involving human beings may only be carried out if it addresses a topic of scientific relevance concerning:the understanding of human diseases;the structure and function of the human body; orpublic health.art. 6 non-discrimination 1 nobody is to be subjected to discrimination in connection with research.2 with regard to the selection of participants in particular, no group of persons shall be disproportionately included in or excluded from research without good reason.art. 7 consent 1 research involving human beings may only be carried out if, in accordance with the provisions of this act, the persons concerned have given their informed consent or, after being duly informed, have not exercised their right to dissent.2 the persons concerned may withhold or revoke their consent at any time, without stating their reasons.art. 8 right to receive information 1 the persons concerned are entitled to be informed of results relating to their health. the information is to be communicated in an appropriate manner. the persons concerned may choose to forgo such information.2 they are entitled to be informed about all the personal data held in relation to them.art. 95 prohibition of commercialisation 1 it is prohibited to offer, grant, demand or accept payment or any other non-cash advantage in exchange for the human body or parts thereof as such.2 it is also prohibited to use the human body or parts thereof if they have been subject to a prohibited act as specified in paragraph 1.5 amended by annex no 2 of the fd of 19 june 2020 on the approval of the council of europe convention against trafficking in human organs and on its implementation, in force since 1 feb. 2021 (as 2020 6567; bbl 2019 5971).art. 10 scientific requirements 1 research involving human beings may only be carried out if:a. the recognised regulations concerning scientific integrity are complied with, in particular with regard to the handling of conflicts of interest;b. scientific quality requirements are met;c. the recognised international good practice guidelines for research involving human beings are complied with; andd. the persons responsible have appropriate professional qualifications.2 the federal council shall specify which national and international regulations must be complied with.chapter 2 general requirements for research involving persons section 1 protection of participants art. 11 subsidiarity 1 a research project involving persons may only be carried out if equivalent findings cannot be obtained by other means.2 a research project involving particularly vulnerable persons may only be carried out if equivalent findings cannot be obtained by other means.art. 12 risks and burdens 1 in every research project, the risks and burdens for the participants must be minimised as far as possible.2 the likely risks and burdens for the participants must not be disproportionate to the expected benefits of the research project.art. 13 placebo in research projects with an expected direct benefit, the use of a placebo or nontreatment is only permissible if no additional risk of serious or irreversible harm is to be expected for the persons concerned and:no standard treatment is available; orthe use of a placebo is required for compelling, scientifically sound methodological reasons, in order to establish the efficacy or safety of a treatment method.art. 14 non-remunerative participation 1 no person may receive payment or any other non-cash advantage for participation in a research project with an expected direct benefit. participation in a research project with no expected direct benefit may be appropriately remunerated.2 no person may demand or accept payment or any other non-cash advantage from another in return for the latter's participation in a research project.art. 15 safety and protective measures 1 anyone who conducts a research project must, before it begins, take all the measures required to protect the participants.2 if, during the research project, circumstances arise which could jeopardise the safety or health of the participants or lead to a disproportionate relationship between the risks and burdens and the benefits, all the measures required to ensure protection are to be taken without delay.section 2 information and consent art. 16 informed consent 1 persons may only be involved in a research project if they have given their informed consent. consent must be given in writing; the federal council may specify exemptions.2 the persons concerned must receive comprehensible oral and written information on:a. the nature, purpose and duration of, and procedure for, the research project;b. the foreseeable risks and burdens;c. the expected benefits of the research project, in particular for themselves or for other people;d. the measures taken to protect the personal data collected;e. their rights.3 before a decision on consent is made by the persons concerned, they must be allowed an appropriate period for reflection.4 the federal council may specify further elements of the information to be provided.art. 17 consent to further use for research if the intention exists to make further use for research of biological material sampled or health-related personal data collected, the consent of the persons concerned must be obtained at the time of such sampling or collection, or they must be informed of their right to dissent.art. 18 incomplete information 1 in exceptional cases, the persons concerned may be given incomplete information regarding individual aspects of a research project before it begins:a. insofar as this is essential for methodological reasons; andb. if the research project entails no more than minimal risks and burdens.2 the participants must subsequently be duly informed as soon as possible.3 once they have been informed in accordance with paragraph 2, they may give or withhold their consent to the use of their biological material or their data. only when such consent has been given is the biological material or data to be used for the research project.section 3 liability and coverage art. 19 liability 1 any person who carries out a research project involving persons shall be liable for damage suffered by them in connection with the project. the federal council may specify exemptions from liability.2 compensation claims prescribe in accordance with article 60 of the swiss code of obligations.6 the federal council may specify a longer prescriptive period for particular research areas.7 3 the provisions of the code of obligations on tort are otherwise applicable; in the exercise of official duties, the government liability act of 14 march 19588, or cantonal government liability law, is applicable.6 sr 2207 amended by annex no 17 of the fa of 15 june 2018 (revision of the law on prescription), in force since 1 jan. 2020 (as 2018 5343; bbl 2014 235).8 sr 170.32art. 20 coverage 1 liability must be appropriately covered through insurance or in some other manner. the federal government and its public-law institutions and corporations are exempt from the liability coverage requirements.2 the federal council may:a. specify requirements for insurance and other forms of coverage;b. exempt research areas or classes of damage from the liability coverage requirements.3 for the protection of the injured party, it may:a. grant this party a direct claim against the party providing liability coverage;b. restrict the cancellation rights and objections of the party providing liability coverage, while granting appropriate rights of recourse.chapter 3 additional requirements for research involving particularly vulnerable persons section 1 research involving children, adolescents and adults lacking capacity art. 21 involvement of persons lacking capacity in the consent procedure 1 children, adolescents and adults lacking capacity must be involved as far as possible in the consent procedure.2 increasing weight must be accorded to the views of children and adolescents lacking capacity the older and more mature they are.art. 22 research projects involving children 1 a research project with an expected direct benefit may only be carried out in children who are capable of judgement if:a. the child has given informed consent; andb. the legal representative has given informed consent in writing.2 a research project with no expected direct benefit may only be carried out in children who are capable of judgement if, in addition to paragraph 1:a. it entails no more than minimal risks and burdens; andb. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the same disease or disorder, or in the same situation.3 a research project with an expected direct benefit may only be carried out in children who lack capacity if:a. the legal representative has given informed consent in writing; andb. the child does not visibly express opposition to the research intervention either verbally or by his or her behaviour.4 a research project with no expected direct benefit may only be carried out in children who lack capacity if the requirements specified in paragraphs 2 and 3 are met.art. 23 research projects involving adolescents 1 a research project with or without an expected direct benefit may only be carried out in adolescents who are capable of judgement if:a. the adolescent has given informed consent in writing; andb. the legal representative has given informed consent in writing if the research project entails more than minimal risks and burdens.2 a research project with an expected direct benefit may only be carried out in adolescents who lack capacity if:a. the legal representative has given informed consent in writing; andb. the adolescent does not visibly express opposition to the research intervention either verbally or by his or her behaviour.3 a research project with no expected direct benefit may only be carried out in adolescents who lack capacity if, in addition to the requirements specified in paragraph 2:a. it entails no more than minimal risks and burdens; andb. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the same disease or disorder, or in the same situation.art. 24 research projects involving adults lacking capacity 1 a research project with an expected direct benefit may only be carried out in adults who lack capacity if:a. this is permitted by the consent of the person concerned, granted while in a state of capacity and duly documented;b. informed consent has been given in writing by the legal representative, a designated trusted person or the next of kin, if no documented consent is available; andc. the person concerned does not visibly express opposition to the research intervention either verbally or by his or her behaviour.2 a research project with no expected direct benefit may only to be carried out in adults who lack capacity if, in addition to the requirements specified in paragraph 1:a. it entails no more than minimal risks and burdens; andb. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the same disease or disorder, or in the same situation.section 2 research involving pregnant women and embryos and foetuses in vivo art. 25 prohibited research projects research projects designed to modify properties of an embryo or foetus for nondisease-related reasons are prohibited.art. 26 research projects involving pregnant women and embryos and foetuses in vivo 1 a research project with an expected direct benefit for a pregnant woman or for an embryo or foetus may only be carried out if the foreseeable risks and burdens, both for the pregnant woman and for the embryo or foetus, are not disproportionate to the expected benefits.2 a research project with no expected direct benefit for the pregnant woman or for the embryo or foetus may only be carried out if:a. it entails no more than minimal risks and burdens for the embryo or foetus; andb. it can be expected to yield substantial findings which could in the long term be beneficial for pregnant women or for embryos or foetuses.art. 27 research projects concerning methods of induced abortion 1 a pregnant woman may only be asked whether she wishes to participate in a research project concerning methods of induced abortion after she has decided to undergo an abortion.2 article 26 does not apply.section 3 research involving prisoners art. 28 research projects involving prisoners 1 for research projects with an expected direct benefit which involve prisoners, the general requirements for research involving persons apply; however, article 11 paragraph 2 does not apply.2 a research project with no expected direct benefit which involves prisoners may only be carried out if it entails no more than minimal risks and burdens.art. 29 prohibition of a relaxation of conditions participation in a research project must not be associated with relaxing the conditions of imprisonment.section 4 research in emergency situations art. 30 research projects in emergency situations 1 a research project with an expected direct benefit may be carried out in emergency situations if:a. the necessary measures have been taken so that the wishes of the person concerned can be determined as soon as possible;b. the person concerned does not visibly express opposition to the research intervention through either verbally or by his or her behaviour; andc. a physician who is not participating in the research project is called in to safeguard the interests of the person concerned before he or she is involved in the project; in exceptional cases, where there are good reasons for doing so, the physician may be called in at a later stage.2 a research project with no expected direct benefit may be carried out in emergency situations if, in addition to the requirements specified in paragraph 1:a. it entails no more than minimal risks and burdens; andb. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the same disease or disorder, or in the same situation.art. 31 post hoc or proxy consent 1 the person concerned must be duly informed about the research project as soon as this becomes possible. he or she may subsequently give or withhold consent.2 if the person concerned refuses to give post hoc consent, the biological material and data may no longer be used for the research project.3 the federal council shall specify the procedure for the procurement of post hoc or proxy consent, in particular with regard to the involvement of children, adolescents and adults lacking capacity.chapter 4 further use of biological material and health-related personal data for research art. 32 further use of biological material and genetic data 1 further use may be made of biological material and genetic data in uncoded form for a research project if informed consent has been given by the person concerned, or by the legal representative or next of kin. for consent, articles 16 and 22-24 apply mutatis mutandis.2 further use may be made of biological material and genetic data in coded form for research purposes if informed consent has been given by the person concerned, or by the legal representative or next of kin. for consent, articles 16 and 22-24 apply mutatis mutandis.3 biological material and genetic data may be anonymised for research purposes if the person concerned or the legal representative or next of kin have been informed in advance and have not dissented to anonymisation. for dissent, articles 22-24 apply mutatis mutandis.art. 33 further use of non-genetic health-related personal data 1 further use may be made of non-genetic health-related personal data in uncoded form for research purposes if informed consent has been given by the person concerned, or by the legal representative or next of kin. for consent, articles 16 and 22-24 apply mutatis mutandis.2 further use may be made of non-genetic health-related personal data in coded form for research purposes if the person concerned or the legal representative or next of kin have been informed in advance and have not dissented. for dissent, articles 22-24 apply mutatis mutandis.art. 34 absence of informed consent if the requirements for informed consent specified in articles 32 and 33 are not met, further use may be made of biological material or health-related personal data for research purposes in exceptional cases if:a. it is impossible or disproportionately difficult to obtain consent or to provide information on the right to dissent, or this would impose an undue burden on the person concerned;b. no documented refusal is available; andc. the interests of research outweigh the interests of the person concerned in deciding on the further use of his or her biological material and data.art. 35 anonymisation and coding the federal council shall specify the requirements for correct and secure anonymisation and coding and also the conditions for breaking the code.chapter 5 research involving deceased persons art. 36 consent 1 research may be carried out in deceased persons if, before their death, the persons concerned consented to the use of their body for research purposes.2 if no documented consent or refusal of the deceased person is available, the body or parts thereof may be used for research purposes if consent is given by the next of kin or by a trusted person designated during the lifetime of the deceased person.3 the consent of the next of kin or the trusted person is governed by article 8 of the transplantation act of 8 october 20049.4 in the case of deceased persons whose death occurred more than 70 years previously, research may be carried out without consent being given as specified in paragraph 2. if such research is opposed by the next of kin, it may not be carried out.9 sr 810.21art. 37 additional requirements 1 a research project may be carried out in deceased persons when their death has been determined.2 a research project may be carried out in deceased persons undergoing artificial respiration if, in addition to the requirement specified in paragraph 1, equivalent findings cannot be obtained with deceased persons not undergoing artificial respiration. the federal council may specify further conditions.3 anyone who carries out a research project in accordance with paragraph 2 must not have been involved in the determination of death or be authorised to issue instructions to the persons involved in this procedure.art. 38 research in connection with an autopsy or transplantation small quantities of bodily substances removed in the course of an autopsy or transplantation may be anonymised for research purposes without consent, in the absence of a documented refusal of the deceased person.chapter 6 research involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths art. 39 requirements for research in embryos and foetuses from induced abortions 1 a pregnant woman may only be asked whether she wishes to make her embryo or foetus available for research purposes after she has decided to undergo an abortion. for consent, articles 16 and 22-24 apply mutatis mutandis.2 the time and method of induced abortion must be chosen without regard to the research project.3 embryos and foetuses from induced abortions may be used for a research project when death has been determined.4 anyone who carries out a research project in accordance with paragraph 3 must not be involved in the abortion or be authorised to issue instructions to the persons involved in this procedure.art. 40 requirements for research in embryos and foetuses from spontaneous abortions including stillbirths 1 embryos and foetuses from spontaneous abortions including stillbirths may only be used for research purposes with the consent of the couple concerned. for consent, article 16 applies mutatis mutandis.2 embryos and foetuses from spontaneous abortions may be used for a research project when death has been determined.chapter 7 transfer, export and storage art. 41 transfer for purposes other than research biological material or health-related personal data which has been sampled or collected or of which further use has been made for research purposes may only be passed on for purposes other than research if:a. a legal basis exists for such a transfer; orb. in the particular case, informed consent to the transfer has been given by the person concerned.art. 42 export 1 biological material or genetic data may be exported for research purposes if informed consent has been given by the person concerned. for consent, articles 16 and 22-24 and 32 apply mutatis mutandis.2 non-genetic health-related personal data may be disclosed abroad for research purposes if the requirements specified in article 6 of the federal act of 19 june 199210 on data protection are met.10 sr 235.1art. 43 storage 1 anyone who stores biological material or health-related personal data for research purposes must take appropriate technical and organisational measures to prevent unauthorised use thereof, and fulfil the operational and professional requirements.2 the federal council shall specify the requirements for storage.art. 44 deceased persons, embryos and foetuses including stillbirths articles 41-43 apply mutatis mutandis to deceased persons, to embryos and foetuses including stillbirths and parts thereof, and to data collected in this connection.chapter 8 authorisation, notifications and procedure art. 45 mandatory authorisation 1 authorisation from the responsible ethics committee is required for:a. conducting a research project; orb. making further use of biological material or health-related personal data for research purposes in cases where consent has not been obtained or information on the right to dissent has not been provided (art. 34).2 authorisation is granted if the ethical, legal and scientific requirements of this act are met. the decision must be available within two months of submission of the application. the federal council may:a. specify shorter, risk-adapted maximum limits for processing periods;b. adjust the processing periods, if this is required by recognised international regulations.113 the federal council may make changes to research projects subject to authorisation. in doing so, it shall have regard to recognised international regulations.11 amended by annex of the fa of 22 march 2019, in force since 26 may 2021 (as 2020 2961; bbl 2019 1).art. 46 notification and information requirements 1 the federal council may specify notification or information requirements, in particular with regard to:a. the completion or discontinuation of a research project;b. adverse events observed in connection with a research project;c. the occurrence of circumstances during the conduct of a research project which could affect the safety or health of the participants.2 in doing so, it shall have regard to recognised international regulations.art. 47 responsible ethics committee 1 the responsible ethics committee is that of the canton in whose territory the research is conducted.2 if a research project is carried out according to a standard protocol, but in different cantons (multicentre research project), authorisation is required from the ethics committee which is responsible at the site of activity of the project coordinator (the lead committee).3 in order to assess whether the professional and operational requirements are fulfilled in other cantons, the lead committee shall seek the opinion of the ethics committees concerned. it shall be bound by their opinion.4 paragraphs 2 and 3 apply mutatis mutandis to authorisation for the use in accordance with article 34 of biological material and health-related personal data of which further use is made or which are collected according to a standard protocol, but in different cantons.art. 48 official measures 1 if the safety or health of the persons concerned is at risk, the ethics committee may revoke or suspend its authorisation or make the continuation of the research project subject to additional conditions.2 the ethics committee may request information or documentation from the holder of the authorisation. this must be provided or made available free of charge.3 the competent federal and cantonal authorities retain the right to take measures.4 the authorities and ethics committees shall keep each other informed and coordinate their measures.art. 49 procedure 1 the documents for the authorisation and notification procedures, and for reporting and supervision, shall be submitted to the cantonal information system referred to in article 56a.121bis the federal council shall specify requirements for the procedure so as to ensure consistent enforcement and the implementation of national and international regulations. it may stipulate that the submission of applications, correspondence and the publication of decisions must be effected electronically.132 in particular for research projects involving biological material and genetic data in accordance with article 32, or non-genetic health-related personal data in accordance with article 33, it may specify less stringent procedural requirements.3 cantonal procedural law otherwise applies.12 amended by annex of the fa of 22 march 2019, in force since 26 may 2021 (as 2020 2961; bbl 2019 1).13 inserted by annex of the fa of 22 march 2019, in force since 26 may 2021 (as 2020 2961; bbl 2019 1).art. 50 right of appeal 1 the procedure for appeals against ethics committee decisions is governed by cantonal procedural law and the general provisions concerning the administration of federal justice.2 the appealing party may not file an appeal based on substantive inappropriateness.chapter 9 research ethics committees art. 51 duties 1 within the framework of their responsibilities under chapter 8, ethics committees shall assess whether research projects and the conduct thereof comply with the ethical, legal and scientific requirements of this act. in particular, they shall assess whether the protection of the persons concerned is guaranteed.2 they may advise researchers in particular on ethical questions and, if so requested by the researchers, comment on research projects not subject to this act, and specifically projects carried out abroad.art. 52 independence 1 ethics committees shall exercise their duties in a professionally independent manner, without being subject to instructions from the supervisory authority in this regard.2 the members of ethics committees shall disclose their interests. each ethics committee shall maintain a publicly accessible register of interests.3 members who are interested parties shall not participate in the assessment and decision procedures.art. 53 composition 1 ethics committees must be composed in such a way that they have the professional skills and experience required to discharge their duties. the members must include:a. experts in various disciplines, in particular medicine, ethics and law; andb. at least one person representing patients.142 ethics committees may call in external specialists to serve as experts.3 the federal council shall enact additional regulations concerning the composition of ethics committees and the requirements to be fulfilled by their members. in doing so, it shall have regard to recognised international regulations.14 amended by annex of the fa of 22 march 2019, in force since 26 may 2021 (as 2020 2961; bbl 2019 1).art. 54 organisation and financing 1 each canton shall designate the ethics committee responsible for its territory and appoint the members thereof. it shall oversee the activities of the ethics committee.2 each canton has at most one ethics committee. several cantons may appoint a joint ethics committee or agree that one canton's ethics committee is also to be responsible for other cantons.3 the federal council may issue guidelines concerning the minimum number of research projects to be assessed by an ethics committee per year. it shall first consult the cantons.4 each ethics committee shall have a scientific secretariat. details of the organisation and working methods are to be publicly accessible in by-laws.5 the canton shall assure the financing of the ethics committee. it may make provision for the charging of fees.art. 55 coordination and information 1 the federal office of public health (foph) is responsible for coordination between ethics committees and with other supervisory authorities. it may delegate this responsibility to third parties.2 ethics committees shall report annually to the foph on their activities, in particular on the type and number of research projects assessed and on the processing periods.3 the foph shall publish a list of ethics committees and inform the public regularly about their activities.4 in consultation with the ethics committees and other supervisory authorities concerned, it may issue recommendations for appropriate harmonisation of procedures and of assessment practice.chapter 10 transparency and data protection art. 56 registration 1 authorised clinical trials must be recorded in a public registry. the federal council shall define the clinical trials in more detail and may specify exemptions from mandatory registration; in doing so, it shall be guided by recognised international regulations.152 it shall designate the registry, provide information on access thereto and specify the content of registration, as well as notification requirements and the notification procedure. in doing so, it shall have regard to recognised international regulations and if possible take existing registries into consideration.3 it may:a. entrust public- or private-law organisations with the establishment and management of the registry;b.16 specify that the results of registered research projects must be published on a recognised platform.15 second sentence amended by annex of the fa of 22 march 2019, in force since 26 may 2021 (as 2020 2961; bbl 2019 1).16 amended by annex of the fa of 22 march 2019, in force since 26 may 2021 (as 2020 2961; bbl 2019 1).art. 56a17 cantonal information system 1 the cantons shall operate a shared information system for the conduct of authorisation and notification procedures, the transmission of reports and the supervision of research projects.2 the system shall contain data, including personal data on administrative or criminal proceedings and sanctions or on health, which is necessary for the conduct of authorisation and notification procedures and for reporting and supervision in accordance with this act.3 the cantons shall ensure that the information system is compatible with the medical devices information system of the swiss agency for therapeutic products and with the european database on medical devices (eudamed).4 the federal council may specify that:a. the data referred to in paragraph 2 concerning clinical trials with medical devices is to be automatically aligned with the medical devices information system of the swiss agency for therapeutic products or with eudamed;b. any data referred to in paragraph 2 which is not sensitive is to be published with due protection of professional confidentiality and trade secrets.17 inserted by annex of the fa of 22 march 2019, in force since 26 may 2021 (as 2020 2961; bbl 2019 1).art. 57 duty of confidentiality persons responsible for the enforcement of this act have a duty to maintain confidentiality.art. 58 processing of personal data in discharging their duties, ethics committees and the other enforcement bodies are entitled to process personal data. sensitive personal data may be processed, insofar as this is necessary.art. 59 disclosure of data 1 where no conflicting private interest of overriding importance exists, data may be disclosed to:a. the federal and cantonal agencies responsible for enforcement of this act, and to public- or private-law organisations and persons if they require the data to fulfil the duties assigned to them under this act;b. criminal investigation authorities if the data is required to prosecute or prevent a felony or an offence under this act.2 where no conflicting private interest of overriding importance exists, data may, in individual cases, following a written request, be disclosed to:a. civil courts if the data is required to judge a court case;b. criminal courts and criminal investigation authorities if the data is required to investigate a felony or misdemeanour.3 data which is of general interest and relates to the application of this act may be published. the data subjects must not be identifiable.4 in other cases, data may be disclosed to third parties as follows:a. data not relating to specific persons, provided that there is an overriding interest in this data being made available;b. personal data, provided that the data subject has given written consent in each case.5 only the data which is required for the purpose in question may be disclosed.6 the federal council shall regulate the details of the disclosure of data and the notification of the persons concerned.art. 60 transmission of data to foreign authorities and international organisations 1 confidential data may only be transmitted to foreign authorities and institutions or to international organisations if:a. this is required by agreements under international law or resolutions passed by international organisations;b. this is necessary to avert an imminent danger to life or health; orc. this would enable serious offences under this act to be exposed.2 the federal council shall regulate responsibilities and the procedures for exchanging data with foreign authorities and institutions and with international organisations.art. 61 evaluation 1 the foph is responsible for assessing the effectiveness of this act.2 the federal department of home affairs shall report to the federal council on the results of the evaluation and submit proposals for further action.chapter 11 criminal provisions art. 62 misdemeanours 1 unless a more serious offence has been committed under the criminal code18, any person who wilfully:a. conducts a research project without the authorisation of an ethics committee or deviating from an authorised protocol (art. 45) and thereby endangers the health of the participants;b. conducts a research project as defined in chapter 2, 3, 5 or 6 without obtaining the consent required under this act (arts. 16, 17, 18 para. 3, art. 22 paras. 1, 3 let. a and 4, arts. 23, 24, 26, 28, 30, 36 paras. 1 and 2, 39 para. 1, 40);c.19 offers, grants, demands or accepts payment or any other non-cash advantage in exchange for the human body or parts thereof as such;cbis.20 uses the human body or parts thereof if they have been subject to a prohibited act as specified in letter c;d. conducts a research project designed to modify properties of the embryo or foetus for non-disease-related reasons (art. 25);e. uses embryos or foetuses from induced or spontaneous abortions for a research project before death has been determined (art. 39 para. 3, art. 40 para. 2)shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.2 if the act is committed for commercial gain, the penalty shall be a custodial sentence not exceeding three years; this shall be combined with a monetary penalty.3 if the act is committed through negligence, the penalty shall be a monetary penalty not exceeding 180 daily penalty units.18 sr 311.019 amended by annex no 2 of the fd of 19 june 2020 on the approval of the council of europe convention against trafficking in human organs and on its implementation, in force since 1 feb. 2021 (as 2020 6567; bbl 2019 5971).20 inserted by annex no 2 of the fd of 19 june 2020 on the approval of the council of europe convention against trafficking in human organs and on its implementation, in force since 1 feb. 2021 (as 2020 6567; bbl 2019 5971).art. 63 contraventions 1 any person who wilfully or negligently:a. commits an offence as specified in article 62 paragraph 1 letter a without the participants' health being endangered;b. makes a payment or provides any other non-cash advantage to a person for participation in a research project with an expected direct benefit, or demands or accepts payment or any other non-cash advantage from a person for participation in a research project (art. 14);c. makes further use of biological material or health-related personal data without the informed consent required under this act (arts. 32, 33), in cases where the conditions specified in article 34 are not met and appropriate authorisation has not been obtained from the responsible ethics committee;d. transfers biological material or health-related personal data for non-research-related purposes in the absence of a legal basis or without the requisite consent (art. 41)shall be liable to a fine.2 a contravention and the penalty for a contravention become time-barred after five years.art. 64 jurisdiction and administrative criminal law 1 the cantons have jurisdiction for the prosecution and judgment of offences.2 articles 6, 7 (offences committed within a business) and 15 (forgery of documents, obtaining a false certificate by fraud) of the federal act of 22 march 197421 on administrative criminal law apply.3 the competent authorities shall inform the foph of all judgments passed in accordance with article 62 paragraph 1 letters b-cbis or article 63 paragraph 1 letter c on account of an offence involving the human body or parts thereof.2221 sr 313.022 inserted by annex no 2 of the fd of 19 june 2020 on the approval of the council of europe convention against trafficking in human organs and on its implementation, in force since 1 feb. 2021 (as 2020 6567; bbl 2019 5971).chapter 12 final provisions art. 65 implementing provisions 1 the federal council shall enact the implementing provisions.2 in doing so, it shall consider the different extents to which individual research areas and methods involve risks to dignity and privacy, in particular when specifying:the scientific requirements (art. 10);b. any exemptions from liability (art. 19) and liability coverage requirements (art. 20);c. the requirements for insurance and other forms of coverage (art. 20);d. the procedural requirements (art. 49).art. 66 amendment of current legislation current legislation shall be amended as specified in the annex.art. 67 transitional provisions 1 authorisations granted by cantonal ethics committees for the conduct of research projects remain valid for the term of the authorisation.2 if no authorisation, as defined in paragraph 1, has been granted for a research project which is already under way when this act comes into effect, an application for authorisation in accordance with article 45 paragraph 1 letter a shall be submitted to the responsible ethics committee within six months after the commencement of this act.3 authorisations for the waiver of professional confidentiality in medical research remain valid for the term of the authorisation. if the authorisation has been granted for an unlimited term, an application for authorisation in accordance with article 45 paragraph 1 shall be submitted to the responsible ethics committee within a year of the commencement of this act.4 the federal council shall regulate the registration under article 56 of research projects which are in progress when this act comes into force.art. 68 referendum and commencement 1 this act is subject to an optional referendum.2 the federal council shall determine the commencement date.commencement date: 1 january 20142323 fcd of 20 sept. 2013.annex (art. 66)amendment of current legislation the federal acts below are amended as follows:.2424 the amendments may be consulted under as 2013 3215.

810.301english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon human research with the exception of clinical trials(human research ordinance, hro)of 20 september 2013 (status as of 26 may 2021)the swiss federal council,on the basis of the human research act of 30 september 20111 (hra),ordains:1 sr 810.30chapter 1 general provisions art. 1 purpose this ordinance regulates:a. the requirements for the conduct of human research projects with the exception of clinical trials; andb. the authorisation and notification procedures for research projects as specified in letter a.art. 2 applicable provisions the provisions concerning scientific integrity and scientific quality set out in articles 3 and 4 of the ordinance of 20 september 20132 on clinical trials (clino) apply mutatis mutandis.2 sr 810.305art. 3 responsibilities of project leader and sponsor 1 the project leader is responsible for the conduct of the research project in switzerland and for protection of the participants at the research site.2 the project leader is also responsible for organising the research project, and in particular for the initiation, management and financing of the project in switzerland, provided that no other person or institution headquartered or represented in switzerland takes responsibility for this (sponsor).art. 4 professional qualifications 1 the project leader responsible for a research project must:a. be entitled to practise independently the profession specifically qualifying him or her to conduct the research project in question;b. have the training and experience required to conduct the research project in question;c. be conversant with the legal requirements for research projects or be able to ensure compliance by calling in appropriate expertise.2 the other persons conducting the research project must have the professional knowledge and experience appropriate to the activities in question.art. 5 storage of health-related personal data and biological material 1 any person who stores health-related personal data for research must take appropriate operational and organisational measures to protect it, and in particular:a. restrict the handling of the health-related personal data to those persons who require this data to fulfil their duties;b. prevent unauthorised or accidental disclosure, alteration, deletion and copying of the health-related personal data;c. document all processing operations which are essential to ensure traceability.2 any person who stores biological material for research must, in particular:a. comply with the principles set out in paragraph 1 mutatis mutandis;b. ensure that the technical requirements are met for appropriate storage of the biological material;c. make available the resources required for storage.chapter 2 research involving measures for sampling of biological material or collection of health-related personal data from persons section 1 general provisions art. 6 research project for the purposes of this chapter, a research project is any project in which biological material is sampled or health-related personal data is collected from a person in order to:a. answer a scientific question; orb. make further use for research purposes of the biological material or the health-related personal data.art. 7 categorisation 1 a research project comes under category a if the planned measures for sampling biological material or collecting personal data entail only minimal risks and burdens.2 a research project comes under category b if the planned measures entail more than only minimal risks and burdens.3 sampling biological material or collecting health-related personal data entails minimal risks and burdens if the measures, in terms of intensity and quality, and taking into account the vulnerability of the participants and the specific circumstances, have only a slight and temporary impact on the participants' health. in particular, minimal risks and burdens may be associated with:a. surveys and observations;b. peripheral venous or capillary blood sampling and skin punch biopsies of limited extent;c. removing or collecting bodily substances without invasive interventions (in particular, saliva, urine and stool samples);d. taking swabs;e. magnetic resonance imaging scans without a contrast medium, ultrasound examinations or electrograms;f.3 examinations using medical devices in accordance with article 3 of the medical devices ordinance of 1 july 20204 that bear a conformity marking and are used without a contrast medium, and examinations using authorised medicinal products capable of emitting ionising radiation, provided that the effective dose is below 5 msv per research project and per participant.3 amended by annex 2 no 1 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).4 sr 812.213art. 8 information 1 in addition to the points specified in article 16 paragraph 2 hra, the persons concerned must receive information on:a. the effort involved and the obligations arising from participation; b. their right to withhold or to revoke their consent without giving reasons;c. the consequences of revoking consent to further use of the biological material and personal data collected up to this point;d. their right to receive information at any time in response to further questions;e. their right to be informed of results concerning their health, and their right to forgo such information or to designate a person who is to take this decision for them;f. the measures envisaged to cover any damage arising from the research project, including the procedure in the event of a claim;g. the main sources of financing for the research project;h. other points relevant to their decision on participation.2 if the intention exists to make further use for research of the biological material sampled or the health-related personal data collected, the persons concerned must also receive information on the points specified in articles 2832.3 the information may be provided in stages. it may be additionally presented in a non-textual form.4 appropriate measures must be taken to ensure that the persons concerned have understood the essential elements of the information provided.art. 9 exceptions to written form 1 information and consent may be provided and documented in a nonwritten form if:a. the research project in question comes under category a, as defined in this ordinance, and involves adults with capacity;b. provision of written information and consent would be disproportionate, given the project design; andc. reference is made to the departure from written form in the application to the responsible research ethics committee (ethics committee).2 in individual cases, information may be provided and consent granted in a nonwritten form if:a. the person concerned, for physical or cognitive reasons, cannot read or cannot write; andb. the project leader furnishes proof of the provision of information and consent, specifically by means of written confirmation by witnesses, or by a recording of verbal consent.3 in individual cases, the requirement to provide information in written form may be waived if:a. this could only be implemented with disproportionate effort, given the language skills of the person concerned; andb. an independent qualified translator is called in to provide oral information and gives written confirmation thereof.art. 10 consequences of revocation of consent 1 if consent is revoked, the biological material and healthrelated personal data of the person concerned must be anonymised after data evaluation has been completed.2 anonymisation of the biological material and personal data may be dispensed with if:a. the person concerned expressly renounces this right when revoking consent; orb. it is established at the beginning of the research project that anonymisation is not possible and the person concerned, having been adequately informed of this fact, consented to participate.3 persons revoking consent must be offered any follow-up care required to protect their health.art. 11 research projects in emergency situations for research projects in emergency situations, articles 15-17 clino5 apply mutatis mutandis.5 sr 810.305art. 12 exemptions from liability any person who proves that:a. the damage is only slight and temporary; andb. the extent of the damage is no greater than would be expected in the current state of scientific knowledgeshall be exempt from liability under article 19 paragraph 1 hra.art. 13 coverage 1 category a research projects are exempt from the liability coverage requirements specified in article 20 hra.2 for category b research projects, the policy value shall be set in accordance with annex 1.3 the liability coverage must cover damage occurring up to 10 years after the completion of the research project.4 in addition, article 11, article 13 paragraph 1 and article 14 clino6 apply mutatis mutandis.6 sr 810.305section 2 authorisation procedure art. 14 application 1 the project leader shall submit the application documents specified in annex 2 to the responsible ethics committee for review.2 the ethics committee may request additional information.3 the sponsor may submit the application instead of the project leader. in this case, the sponsor assumes the obligations of the project leader as specified in articles 17-23. the application documents must be co-signed by the project leader.art. 15 review areas the responsible ethics committee shall review:a. the completeness of the application;b. the categorisation requested;c. the research project with regard to:1. scientific quality, in the case of a research project as specified in article 6 letter a,2. the ratio between the likely risks and burdens and the expected benefits (art. 12 para. 2 hra),3. the measures taken to minimise risks and burdens, and for the protection and follow-up of participants (art. 15 hra), including precautionary measures in the handling of personal data,4. the need to involve persons, and in particular persons who are particularly vulnerable (art. 11 hra),5. the criteria for the selection of participants,6. the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection,7. the appropriateness of the remuneration for participants and compliance with the prohibition of commercialisation (art. 9 hra),8. compliance with scientific integrity requirements;d. the completeness of the documentation for recruitment, information and consent, and its comprehensibility, especially with regard to the possible involvement of particularly vulnerable persons;e. for category b research projects: the guaranteeing of the right to compensation in the event of damage (art. 20 hra);f. for investigations involving radiation sources7: additionally, compliance with radiological protection legislation and the dose estimation, in cases where an opinion does not have to be sought from the federal office of public health (foph) in accordance with article 19 paragraph 2;g. the professional qualifications of the project leader and the other researchers;h. compliance with the requirements concerning the storage of biological material or health-related personal data specified in article 5;i. the suitability of the infrastructure at the research site;j. the financing of the research project and the agreements between the sponsor, third parties and the project leader concerning the allocation of tasks, remuneration and publication;k. other areas, where this is necessary to assess the protection of participants.7 term in accordance with annex 11 no 5 of the radiation protection ordinance of 26 apr. 2017, in force since 1 jan. 2018 (as 2017 4261). this modification has been made throughout the text.art. 16 procedure and deadlines 1 the ethics committee shall acknowledge receipt of the application within 7 days and notify the project leader of any formal deficiencies in the application documents.2 it shall reach a decision within 30 days after acknowledgement of receipt of the formally correct application documents.3 if the ethics committee requests additional information in accordance with article 14 paragraph 2, the clock shall be stopped until this information has been received.art. 17 multicentre research projects 1 the project leader shall submit the application for a multicentre research project to the lead committee in accordance with article 47 paragraph 2 hra.2 the lead committee shall acknowledge receipt of the application within 7 days and at the same time notify the project leader whether the application documents submitted are formally in order.3 at the request of the lead committee, the project leader shall submit the required number of copies of the application documents specified in annex 2 to the ethics committees responsible at the other research sites (ethics committees concerned). these shall review the local conditions and inform the lead committee of their assessment within 15 days.4 the lead committee shall reach a decision within 45 days of acknowledging receipt of the formally correct application. it shall inform the ethics committees concerned of its decision.art. 18 changes 1 significant changes to an authorised research project must be authorised by the ethics committee before being implemented. exempt from this requirement are measures which have to be taken immediately in order to protect the participants.2 the project leader shall submit to the ethics committee any application documents specified in annex 2 which are affected by the change. at the same time, the project leader shall provide information on the reasons for the change.3 the following are considered to be significant changes:a. changes affecting the participants' safety and health, or their rights and obligations;b. in the case of a category b research project, changes to the protocol which concern the goal or the central topic of the research project;c. a change of research site or conducting the research project at an additional site; ord. a change of project leader or sponsor.4 the ethics committee shall reach a decision on significant changes within 30 days. article 16 applies mutatis mutandis.5 for the authorisation procedure in the case of significant changes to authorised multicentre research projects, article 17 applies mutatis mutandis.art. 19 procedure for investigations involving radiation sources 1 in the case of investigations involving radiation sources, the project leader shall additionally submit to the responsible ethics committee the documents specified in annex 2 number 2. subject to the provisions of the following paragraphs, the authorisation procedure is governed by articles 14-18.2 the project leader shall additionally submit to the foph the application documents specified in annex 2 number 3, informing the ethics committee at the same time if the effective dose per person, taking the uncertainty factor into account, is more than 5 msv per year and:a. a radiopharmaceutical is used which is not authorised in switzerland;b. a radiopharmaceutical is used which is authorised in switzerland, and the intervention in question is not a routine nuclear medicine examination; orc. some other radioactive source8 is used.3 the foph shall deliver an opinion for the ethics committee on compliance with radiological protection legislation and on the dose estimation.4 the ethics committee shall grant authorisation if:a. the requirements covered by article 15 are met; andb. the foph has raised no objections to the research project.5 it shall reach a decision in this case within 45 days after acknowledgement of receipt of the formally correct application documents. it shall inform the foph of its decision.8 term in accordance with annex 11 no 5 of the radiation protection ordinance of 26 apr. 2017, in force since 1 jan. 2018 (as 2017 4261). this modification has been made throughout the text.section 3 notifications and reporting art. 20 notification of safety and protective measures if immediate safety and protective measures have to be taken during the conduct of a research project, the project leader shall notify the ethics committee of these measures, and of the circumstances necessitating them, within 7 days.art. 21 serious events 1 if, in the course of a research project, serious events occur in participants, the research project must be interrupted.2 a serious event is defined as any adverse event where it cannot be excluded that the event is attributable to the sampling of biological material or the collection of health-related personal data, and which:a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay;b. results in permanent or significant incapacity or disability; orc. is life-threatening or results in death.3 if necessary in order to guarantee participants' safety and health, further events are to be designated as serious in the protocol or at the request of the responsible ethics committee.4 the project leader shall notify the ethics committee of a serious event within 7 days. in addition, the project leader shall report to the committee on the connection between the event and the collection of health-related personal data or the sampling of biological material. at the same time, he or she shall submit proposals concerning the next steps to be taken.5 if a serious event occurs in connection with an investigation involving a radiation source on which the foph has delivered an opinion in accordance with article 19, this must be additionally reported to the foph within 7 days.6 the ethics committee shall reach a decision on the continuation of the research project within 30 days after receipt of the report.art. 22 notification upon completion or discontinuation of a research project the project leader shall notify the ethics committee of the discontinuation or completion of a research project within 90 days.art. 239 assessment, notification and reporting on the use of radiation sources 1 in the case of investigations using radiation sources, the project leader shall assess compliance with the dose guidance value under article 45 of the radiological protection ordinance of 26 april 201710.2 he or she shall give notify the competent ethics committee if the permitted dose guidance value within seven working days of the information coming to light.3 the competent ethics committee may obtain technical advice from the foph in order to assess the dose calculation or the dose estimate and to decide what further measures are required. 4 within a year of completing or discontinuing a research project which included investigations involving radioactive sources, the project leader shall submit to the foph a final report including all information of relevance for radiological protection, and in particular a retrospective dose estimation by the participants.5 routine nuclear medicine examinations involving authorised radiopharmaceuticals are exempt from the reporting requirement under paragraph 4.6 within the framework of the opinion delivered in accordance with article 19, or on request, the foph may specify further exemptions from the reporting requirements.9 amended by annex 11 no 5 of the radiation protection ordinance of 26 apr. 2017, in force since 1 jan. 2018 (as 2017 4261).10 sr 814.501chapter 3 further use of biological material and health-related personal data for research section 1 general provisions art. 24 further use further use of biological material and health-related personal data is defined as any handling, for research purposes, of biological material already sampled or data already collected, and in particular:a. procuring, bringing together or collecting biological material or healthrelated personal data;b. registration or cataloguing of biological material or health-related personal data;c. storage or inclusion in biobanks or databases;d. making accessible or available or transferring biological material or healthrelated personal data.art. 25 anonymisation 1 for the anonymisation of biological material and health-related personal data, all items which, when combined, would enable the data subject to be identified without disproportionate effort, must be irreversibly masked or deleted.2 in particular, the name, address, date of birth and unique identification numbers must be masked or deleted.art. 26 coding 1 biological material and health-related personal data are considered to be correctly coded in accordance with article 32 paragraph 2 and article 33 paragraph 2 hra if, from the perspective of a person who lacks access to the key, they are to be characterised as anonymised.2 the key must be stored separately from the material or data collection and in accordance with the principles of article 5 paragraph 1, by a person to be designated in the application who is not involved in the research project.art. 27 conditions for breaking the code for coded biological material and coded health-related personal data, the code may only be broken if:a. breaking the code is necessary to avert an immediate risk to the health of the person concerned;b. a legal basis exists for breaking the code; orc. breaking the code is necessary to guarantee the rights of the person concerned, and in particular the right to revoke consent.section 2 informed consent and information art. 28 informed consent for further use of biological material and genetic personal data in uncoded form for a research project 1 the persons concerned must receive written and oral information on:a. the nature, purpose and duration of, and procedure for, the research project;b. their right to withhold or to revoke their consent at any time without giving reasons;c. the consequences of revocation of consent for the biological material and personal data used up to this point;d. their right to receive information at any time in response to further questions relating to the research project;e. their right to be informed of results concerning their health, and their right to forgo such information or to designate a person who is to take this decision for them;f. measures to protect the biological material and the personal data;g. the main sources of financing for the research project;h. other points relevant to their decision.2 the information may be additionally presented in a non-textual form.3 consent must be given in writing.4 the exceptions to written form are governed by article 9 mutatis mutandis.art. 29 informed consent for further use of biological material and genetic personal data in coded form for research purposes 1 the persons concerned must receive written or oral information on:a. the proposed further use of the coded biological material and coded genetic personal data for research purposes;b. their right to withhold or to revoke their consent at any time without giving reasons;c. measures to protect the biological material and personal data, and in particular management of the key;d. the possibility of the biological material and the genetic personal data being passed on to third parties for research purposes.2 consent must be given in writing; the exceptions are governed by article 9 mutatis mutandis.art. 30 information on the proposed anonymisation of biological material and genetic personal data for research purposes the persons concerned must receive written or oral information on:a. the proposed anonymisation of the biological material and genetic personal data for research purposes;b. their right to dissent;c. the consequences of anonymisation with regard to results concerning their health;d. the possibility of the biological material and the data being passed on to third parties for research purposes.art. 31 informed consent for further use of non-genetic health-related personal data in uncoded form for research purposes 1 the persons concerned must receive written or oral information on:a. the proposed further use of the non-genetic health-related personal data for research purposes;b. their right to withhold or to revoke their consent at any time without giving reasons;c. their right to be informed of results concerning their health, and their right to forgo such information;d. measures to protect the personal data;e. the possibility of the personal data being passed on to third parties for research purposes.2 consent must be given in writing; the exceptions are governed by article 9 mutatis mutandis.art. 32 information on the proposed further use of non-genetic health-related personal data in coded form for research purposes the persons concerned must receive written or oral information on:a. the proposed further use of the non-genetic health-related personal data in coded form for research purposes;b. their right to dissent;c. measures to protect the personal data, and in particular management of the key;d. the possibility of the personal data being passed on to third parties for research purposes.section 3 authorisation procedure and notification requirements for research projects involving biological material and health-related personal data art. 33 research project for the purposes of this section, a research project is any project in which further use is made of biological material already sampled or health-related personal data already collected in order to answer a scientific question.art. 34 review areas 1 the ethics committee shall review:a. the completeness of the application;b. the fulfilment of the conditions specified in articles 32 and 33 hra;c. for research projects involving biological material and health-related personal data in coded form: correct and secure coding;d. compliance with the requirements for the storage of biological material or health-related personal data;e. the professional qualifications of the project leader and the other persons involved in the research project;f. other areas, where this is necessary to assess the protection of the persons concerned.2 in this process, it shall take into account existing authorisations from ethics committees with regard to the biological material or the health-related personal data.art. 35 applicable provisions the following provisions apply mutatis mutandis:a. for the submission of the application: article 14;b. for the procedure and deadlines: article 16;c. for multicentre research projects: article 17.art. 36 notification requirements 1 the project leader shall notify the ethics committee of a change of project leader in advance.2 the project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.section 4 authorisation procedure and notification requirements for further use of biological material and health-related personal data for research in the absence of informed consent in accordance with article 34 hra art. 37 review areas the ethics committee shall review:a. the completeness of the application;b. the reasons, as specified in article 34 letters a and b hra;c. the interests of the proposed research which outweigh the interests of the person concerned in deciding on the further use of his or her biological material and health-related personal data;d. the group of persons entitled to pass on the biological material and the personal data;e. compliance with the requirements concerning the storage of biological material or health-related personal data and the group of persons with access rights;f. the professional qualifications of the persons entitled to receive the biological material and the personal data;g. other areas, where this is necessary to assess the protection of the persons concerned.art. 38 applicable provisions the following provisions apply mutatis mutandis:a. for the submission of the application: article 14;b. for the procedure and deadlines: article 16;c. for further use or collection according to a standard protocol, but in different cantons: the procedure specified in article 17.art. 39 authorisation the authorisation shall include at least the following information:a. the purpose for which further use may be made of the biological material and the health-related personal data;b. the designation of the biological material and health-related personal data covered by the authorisation;c. the group of persons entitled to pass on the biological material and the health-related personal data;d. the group of persons entitled to receive the biological material and the personal data.art. 40 notifications 1 the project leader must notify the ethics committee in advance of any changes to the information given in the authorisation.2 the project leader must notify the ethics committee of the completion or discontinuation of the collection process within 90 days.chapter 4 research involving deceased persons art. 41 review areas the ethics committee shall review:a. the completeness of the application;b. the scientific quality;c. compliance with the requirements for consent (art. 36 hra);d. for research projects involving deceased persons undergoing artificial respiration: the need to involve them in the research project (art. 37 para. 2 hra) and compliance with the requirement for independence of the persons involved in the determination of their death (art. 37 para. 3 hra);e. compliance with the requirements for the storage of biological material or health-related personal data;f. compliance with the prohibition of commercialisation (art. 9 hra);g. the professional qualifications of the project leader and the other researchers.art. 42 applicable provisions the following provisions apply mutatis mutandis:a. for the submission of the application: article 14;b. for the procedure and deadlines: article 16;c. for multicentre research projects: the procedure specified in article 17.art. 43 notifications 1 the project leader must notify the ethics committee in advance of the following changes to the research project:a. change of project leader;b. for research projects involving deceased persons undergoing artificial respiration: significant changes to the protocol.2 the project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.chapter 5 research involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths art. 44 informed consent 1 for research projects involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths, the pregnant woman or the couple concerned must receive written and oral information on:a. the use of the embryo or foetus for research purposes;b. their right to withhold or to revoke their consent at any time without giving reasons;c. measures to protect the biological material and the personal data;d. the handling of the embryo or foetus after completion of the research.2 the information may be additionally presented in a non-textual form.3 consent must be given in writing. the consequences of revocation of consent are governed by article 10.4 the exceptions to written form are governed by article 9 mutatis mutandis.art. 45 review areas the ethics committee shall review:a. the completeness of the application;b. the scientific quality;c. compliance with the requirements for informed consent;d. for research projects involving embryos and foetuses from induced abortions: compliance with the requirements specified in article 39 paragraphs 1, 2 and 4 hra;e. compliance with the prohibition of commercialisation (art. 9 hra);f. compliance with the requirements concerning the storage of biological material or health-related personal data;g. the professional qualifications of the project leader and the other researchers;h. other areas, where this is necessary to assess the protection of the pregnant woman or the couple concerned.art. 46 applicable provisions the following provisions apply mutatis mutandis:a. for the submission of the application: article 14;b. for the procedure and deadlines: article 16;c. for multicentre research projects: the procedure specified in article 17;d. for notification requirements: article 36.chapter 6 final provisions art. 47 updating of annexes the federal department of home affairs may update the annexes in accordance with international or technical developments. it shall undertake updates which may give rise to technical barriers to trade in consultation with the federal department of economic affairs, education and research.art. 48 transitional provisions 1 research projects as defined in chapter 2 which were granted authorisation before 1 january 2014 are considered to be category b research projects.2 on request, the authority which authorised the research project before 1 january 2014 may assign the research project to category a. in this case, the liability, coverage and notification requirements are governed by the new law.3 the ethics committee shall make the decision specified in paragraph 2 according to the simplified procedure specified in article 6 of the hra organisation ordinance of 20 september 201311.4 the provisions of this ordinance are applicable:a. to the assessment of significant changes to research projects as specified in chapter 2;b. to notifications concerning research projects as specified in chapters 3-5.5 the responsible ethics committee shall make a decision on applications concerning research projects not subject to authorisation under existing law, submitted in accordance with article 67 paragraph 2 hra, within six months after acknowledgement of receipt of the formally correct application documents.11 sr 810.308art. 49 commencement this ordinance comes into force on 1 january 2014.annex 1 (art. 13)policy values for liability coverage for category b research projects involving persons, the policy value shall be at least:a. per person: 250 000 swiss francs;b. for damage to property: 20 000 swiss francs;c. for the entire research project: 3 million swiss francs.annex 2 (art. 14, 17-19)application documents to be submitted to the responsible ethics committee for the procedure 1 application documents for research projects involving the sampling of biological material or the collection of health-related personal data from persons 1.1 basic form, including a summary of the protocol in the national language of the research site and reasons for the requested categorisation;1.2 protocol;1.3 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;1.4 other documents issued to participants;1.5 information on the type and amount of remuneration for participants;1.6 for category b research projects: certificate of insurance or other proof of coverage for possible damage;1.7 information on the secure handling of biological material and personal data, and in particular on the storage thereof;1.8 the project leader's cv, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project, indicating their responsibilities and relevant professional knowledge;1.9 information on the suitability and availability of infrastructure at the research site;1.10 agreements between the project leader and the sponsor or third parties, in particular with regard to the financing of the research project, remuneration of the project leader and publication.2 additional application documents for research projects which include investigations involving radiation sources 2.1 details of all relevant radiological protection aspects, and in particular a calculation or estimate of the effective dose, organ doses and any tumour doses;2.2 the licences required under article 28 of the radiological protection act of 22 march 199112.12 sr 814.503 additional application documents for research projects which include investigations involving radioactive sources and require an opinion from the foph in accordance with article 19 paragraph 2 3.1 information on the properties of the radiopharmaceutical, and in particular on pharmacokinetics, quality, stability, radiochemical purity and radionuclide purity;3.2 for authorised radiopharmaceuticals: the prescribing information;3.3 for non-authorised radiopharmaceuticals: information on the manufacturing and quality control processes for the radiopharmaceutical, the names of the persons responsible for these processes and details of their professional qualifications;3.4 the names of the persons responsible for the use of the radiopharmaceutical in humans and details of their professional qualifications;3.5 information specified in the foph form for research projects involving radiopharmaceuticals or radiolabelled compounds13.13 this form can be obtained [in french/german] from the federal office of public health, radiological protection division, ch-3003 bern; it can also be accessed online at: www.bag.admin.ch > themen > strahlung, radioaktivitt und schall.4 application documents for research projects involving further use of biological material or health-related personal data 4.1 basic form, including a summary of the scientific question in the national language of the research site;4.2 description of the scientific question;4.3 proof of the origin of the biological material and health-related personal data, and of compliance with the requirements concerning informed consent and information on the right to dissent specified in articles 32 and 33 hra;4.4 for further use of biological material and health-related personal data in coded form: proof of secure and correct coding;4.5 proof of secure handling of biological material and personal data, and in particular the storage thereof;4.6 the project leader's cv, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project, indicating their responsibilities and relevant professional knowledge;4.7 information on the infrastructure available at the research site;4.8 any authorisations granted by ethics committees in switzerland for the sampling of biological material or the collection of health-related personal data.5 application documents for further use of biological material or health-related personal data in the absence of informed consent in accordance with article 34 hra 5.1 basic form, including a summary of the project in the national language of the research site;5.2 planned procedure;5.3 description of the proposed research purposes for which further use is to made of the biological material or health-related personal data, including an explanation of how the research interests outweigh the interests of the persons concerned;5.4 designation of the biological material or health-related personal data of which further use is to be made;5.5 designation of the group of persons who are to be entitled to pass on the biological material or the health-related personal data;5.6 designation of the persons who are to be entitled to receive the biological material or the health-related personal data;5.7 designation of the persons responsible for protection of the data disclosed;5.8 designation of the group of persons who are to have access rights for the biological material or the health-related personal data;5.9 proof of secure handling of biological material and personal data, and in particular the storage thereof;5.10 information on the duration of storage;5.11 the project leader's cv, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project, indicating their responsibilities and relevant professional knowledge;5.12 information on the infrastructure available at the research site.6 application documents for research projects involving deceased persons 6.1 basic form, including a summary of the protocol in the national language of the research site;6.2 protocol;6.3 proof of compliance with the requirements for consent specified in article 36 hra;6.4 proof of compliance with the requirement for prior determination of death specified in article 37 paragraph 1 hra;6.5 for research projects involving deceased persons undergoing artificial respiration: statement of the reasons why such persons need to be involved in the research project, and proof of the independence of the persons determining death;6.6 documents concerning any remuneration;6.7 proof of secure handling of biological material and personal data, and in particular the storage thereof;6.8 the project leader's cv, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project, indicating their responsibilities and relevant professional knowledge;6.9 information on the infrastructure available at the research site;6.10 agreements between the project leader and third parties, in particular with regard to the financing of the research project, remuneration of the project leader and publication.7 application documents for research projects involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths 7.1 basic form, including a summary of the protocol in the national language of the research site;7.2 protocol;7.3 recruitment documents, including the wording of any advertisements, and the information sheet and informed consent form;7.4 description of measures to ensure compliance with the requirements for consent specified in article 39 paragraph 1 or article 40 paragraph 1 hra;7.5 description of measures to ensure compliance with the requirement for prior determination of death specified in article 39 paragraph 3 or article 40 paragraph 2 hra;7.6 for research projects involving embryos and foetuses from induced abortions: proof of compliance with the requirements specified in article 39 paragraphs 2 and 4 hra;7.7 documents concerning any remuneration;7.8 proof of secure handling of biological material and personal data, and in particular the storage thereof;7.9 the project leader's cv, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project, indicating their responsibilities and relevant professional knowledge;7.10 information on the infrastructure available at the research site;7.11 agreements between the project leader and third parties, in particular with regard to the financing of the research project, remuneration of the project leader and publication.8 application documents for the ethics committees concerned in multicentre research projects 8.1 basic form, including a summary of the research project in the national language of the research site;8.2 protocol;8.3 for research projects involving persons or research projects involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths: information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements, used at the research site in question;8.4 for research projects involving deceased persons: proof of compliance with the requirements for consent specified in article 36 hra and proof of compliance with the requirement for prior determination of death specified in article 37 paragraph 1 hra at the research site in question;8.5 the cv of the person responsible at the research site in question, including evidence of his or her knowledge and experience, and a list of the other persons involved in the research project at the site concerned, indicating their responsibilities and relevant professional knowledge;8.6 proof of the suitability and availability of the infrastructure at the research site in question;8.7 agreements between the sponsor and the person responsible at the research site in question, in particular with regard to his or her remuneration;8.8 for category b research projects involving persons: certificate of insurance or other proof of coverage for possible damage at the research site in question, including any agreements on this matter between the sponsor and the person responsible at the research site.

810.305english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon clinical trials with the exception of clinical trials of medical devices1(clinical trials ordinance, clino)of 20 september 2013 (status as of 26 may 2021)1 amended by annex 2 no 2 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).the swiss federal council,on the basis of the human research act of 30 september 20112 (hra), of article 36 paragraphs 1, 3 and 4 of the transplantation act of 8 october 20043 (transplantation act),and of article 54 paragraphs 3, 6 and 7 of the therapeutic products act of 15 december 20004 (tpa),ordains:2 sr 810.303 sr 810.214 sr 812.21chapter 1 general provisions section 1 purpose and definitions art. 1 purpose 1 this ordinance regulates:a.5 the requirements for the conduct of clinical trials as defined in article 3 letter l hra:1.6 clinical trials with medicinal products, including combinations under article 2 paragraph 1 letters f and g of the medical devices ordinance of 1 july 2020 (meddo)7, or transplant products,2. clinical trials with in vitro diagnostic medical devices or products under article 2a paragraph 2 tpa8,3. clinical trials of transplantation,4. clinical trials that are not clinical trials under numbers 1 to 3;b. the authorisation and notification procedures for clinical trials;c. the duties and responsibilities of research ethics committees (ethics committees), the swiss agency for therapeutic products (the agency) and the federal office of public health (the foph) in connection with the authorisation and notification procedures;d. the registration of clinical trials and public access to the registry.2 the following apply:a. for clinical trials with medical devices under the meddo: the ordinance of 1 july 20209 on clinical trials with medical devices;b. for clinical trials of xenotransplantation: the xenotransplantation ordinance of 16 march 200710 applies.115 amended by annex 2 no 2 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).6 amended by annex no 2 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).7 sr 812.2138 term in accordance with annex no 2 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281). this change has been made throughout the text.9 sr 812.213.310 sr 810.21311 amended by annex 2 no 2 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).art. 212 definitions in this ordinance:a. clinical trial means a research project involving individuals that prospectively assigns them to undergo a health-related intervention in order to study its effects on health or on the structure and function of the human body;b. health-related intervention means a preventive, diagnostic, therapeutic, palliative or rehabilitative measure investigated in a clinical trial;c. minimal risks and burdens means risks and burdens, which, in terms of intensity and quality, and taking into account the vulnerability of the participants and the specific circumstances, will have only a slight and temporary impact on the participants' health; in particular, minimal risks and burdens may be associated with:1. surveys and observations,2. peripheral venous or capillary blood sampling and skin punch biopsies of limited extent,3. removing or collecting bodily substances without invasive interventions, in particular, saliva, urine and stool samples,4. taking swabs,5. magnetic resonance imaging scans without a contrast medium, ultrasound examinations or electrograms,6. examinations using medical devices under article 3 meddo13 bearing conformity markings without a contrast medium, or using authorised medicinal products capable of emitting ionising radiation, provided that the effective dose is below 5 msv per research project and per person concerned;d. sponsor means a person or institution headquartered or represented in switzerland that takes responsibility for organising a clinical trial, and in particular for the initiation, management and financing of the trial in switzerland;e. investigator means a person responsible in switzerland for the conduct of a clinical trial and for the protection of the participants at the trial site; an investigator who takes responsibility for organising a clinical trial in switzerland is also a sponsor.12 amended by annex 2 no 2 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).13 sr 812.213section 2 principles art. 3 scientific integrity 1 the sponsor and the investigator, and the other persons involved in the clinical trial, shall maintain scientific integrity. in particular, it is prohibited:a. to falsify, fabricate or suppress research results;b. to fail to disclose conflicts of interest at the planning stage, in the authorisation procedure, or when conducting or publishing research;c. to impede or prevent research activities without good reason;d. to prevent or sanction the exposure of scientific misconduct.2 the applicable guidelines are the principles and procedures for integrity in scientific research issued by the swiss academies of arts and sciences, as specified in annex 1 number 1. in justified cases, other recognised scientific integrity guidelines of equivalent standing may be used.art. 4 scientific quality the sponsor and the investigator of a clinical trial shall ensure scientific quality. in particular:a. they shall define a research question based on the current state of scientific knowledge;b. they shall use an appropriate scientific methodology; andc. they shall ensure the availability of the resources required for the clinical trial and provide the necessary infrastructure.art. 5 rules of good clinical practice 1 clinical trials must be conducted in accordance with the rules of good clinical practice, as specified in annex 1 number 2.2 a clinical trial covered by chapter 4 may be conducted in accordance with other rules which are recognised in the specialty in question, provided that the protection of participants and data quality and security are guaranteed.3 the measures and precautions required in accordance with the rules of good clinical practice must be adapted to the extent of the risks to which participants are exposed. depending on the extent of these risks, there may be certain deviations from the rules of good clinical practice. any deviations must be recorded in the protocol. the protection of the participants and data quality and security must be guaranteed in all cases.art. 6 professional qualifications 1 the clinical trial investigator must:a. be adequately trained in good clinical practice and have the professional knowledge and experience required for the clinical trial; andb. be conversant with the legal requirements for clinical trials or be able to ensure compliance by calling in appropriate expertise.2 in addition, the investigator in a clinical trial of medicinal products or transplantation must be entitled to practise the medical profession independently.3 for clinical trials of in vitro diagnostic medical devices14 and products under article 2a paragraph 2 tpa and for clinical trials covered by chapter 4, a person without medical qualifications may also serve as an investigator, provided that this person is entitled to practise independently the profession specifically qualifying him or her to conduct the clinical trial.4 the other persons conducting the clinical trial must have the professional knowledge and experience appropriate to the activities in question.14 term in accordance with annex 2 no 2 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033). this change has been made throughout the text.section 3 information, consent and revocation art. 7 information 1 in addition to the points specified in article 16 paragraph 2 hra, the persons concerned must receive information on:a. possible alternatives to the intervention under investigation, if the clinical trial is expected to offer a direct benefit;b. the effort involved and the obligations arising from participation;c. their right to withhold or to revoke their consent without giving reasons and without suffering any disadvantages in relation to their medical treatment;d. the consequences of revocation of consent for their subsequent medical treatment, and for further use of the personal data and biological material collected up to this point;e. their right to receive information at any time in response to further questions relating to the clinical trial;f. their right to be informed of results concerning their health, and their right to forgo such information or to designate a person who is to take this decision for them;g. the measures envisaged to cover any damage arising from the clinical trial, including the procedure in the event of a claim;h. the sponsor and the main sources of financing for the clinical trial;i. other points relevant to their decision on participation.2 if the intention exists to make further use for research of biological material sampled or health-related personal data collected in the clinical trial, the persons concerned must also receive information on the points specified in articles 28-32 of the human research ordinance of 20 september 201315.3 the information may be provided in stages. it may be additionally presented in a non-textual form.4 appropriate measures must be taken to ensure that the persons concerned have understood the essential elements of the information provided.15 sr 810.301art. 8 exceptions to written form 1 in individual cases, information may be provided and consent given in a nonwritten form if:a. the person concerned, for physical or cognitive reasons, cannot read or cannot write; andb. the investigator furnishes proof of the provision of information and consent, specifically by means of written confirmation by witnesses, or by a recording of verbal consent.2 in individual cases, the requirement to provide information in written form may be waived if:a. this could only be implemented with disproportionate effort, given the language skills of the person concerned; andb. an independent qualified translator is called in to provide oral information and gives written confirmation thereof.art. 9 consequences of revocation of consent 1 if consent is revoked, the biological material and healthrelated personal data of the person concerned must be anonymised after data evaluation has been completed.2 anonymisation of the biological material and personal data may be dispensed with if:a. the person concerned expressly renounces this right when revoking consent; orb. it is established at the beginning of the clinical trial that anonymisation is not possible and the person concerned, having been adequately informed of this fact, consented to participate.3 persons revoking consent must be offered any follow-up care required to protect their health.section 4 liability and coverage art. 10 exemptions from liability 1 exempt from liability in relation to clinical trials under article 19 paragraph 1 hra shall be any person who proves that the damage is attributable to:a. the administration of an authorised medicinal product used in accordance with the prescribing information;b. the administration of an authorised medicinal product, if this is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria;c. the employment of an in vitro diagnostic medical device and product under article 2a paragraph 2 tpa bearing a conformity marking and used in accordance with the instructions;d. the use of some other health-related intervention which is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria.2 also exempt from liability under article 19 paragraph 1 hra shall be any person who proves that the extent of the damage is no greater than would be expected in the current state of scientific knowledge and:a. comparable damage could also have occurred if the injured party had undergone standard therapy for the disease; orb. in the case of acutely life-threatening diseases for which no standard therapy exists.art. 11 extension of the limitation period the limitation period for compensation claims in respect of damage:a. attributable to the use of ionising radiation is governed by article 40 of the radiological protection act of 22 march 199116;b. attributable to the use of genetically modified organisms is governed by article 32 of the gene technology act of 21 march 200317.16 sr 814.5017 sr 814.91art. 12 exemptions from liability coverage requirements exempt from liability coverage requirements are:a. damage exempt from liability in accordance with article 10;b. category a clinical trials (art. 19 para. 1, art. 20 para. 1, art. 49 para. 1 and art. 61 para. 1) involving measures for sampling of biological material or collection of health-related personal data which entail only minimal risks and burdens.art. 13 requirements for liability coverage 1 the liability coverage requirements can be fulfilled:a. by taking out insurance; orb. by providing security of equivalent value.2 the policy value shall be set in accordance with annex 2.3 the liability coverage must cover damage occurring up to ten years after the completion of the clinical trial.art. 14 protection of the injured party 1 cancellation of the insurance policy by the insurance company is not permissible after the occurrence of the insured event.2 within the framework of the insurance coverage, the injured party or legal successor has a direct claim against the insurance company. objections cannot be raised on the basis of the insurance policy or the insurance policies act of 2 april 190818.3 if the insurance company is subject to action under paragraph 2, it shall have a right of recourse against the insured party.4 paragraphs 1-3 apply mutatis mutandis if security of equivalent value is provided in accordance with article 13 paragraph 1 letter b.18 sr 221.229.1section 5 clinical trials in emergency situations art. 15 post hoc consent 1 the sponsor and the investigator must, when planning or conducting a clinical trial in an emergency situation, take any measures necessary to ensure that:a. the consent of the person concerned can be obtained post hoc as soon as possible;b. in the case of a clinical trial involving children or adolescents, the consent of the legal representative can be obtained as soon as possible, if this is required in accordance with articles 22 and 23 hra;c. in the case of a clinical trial involving adults permanently lacking capacity, the consent of the person authorised to act as a representative can be obtained as soon as possible, if no statement of wishes formulated in a state of capacity is available.2 the procedure for obtaining post hoc consent must be defined in the protocol.art. 16 death of the person 1 if a person who was included in a clinical trial in an emergency situation dies before it has been possible to obtain consent or refusal in accordance with article 15, the biological material and the health-related personal data collected may only be used if this person has consented, in an advance directive or otherwise, to the use of such material and health-related data for research purposes.2 in the absence of a statement of wishes as specified in paragraph 1, use is permissible if consent is given by the next of kin or a designated trusted person. consent is governed by article 8 of the transplantation act.art. 17 handling of biological material and health-related personal data 1 the biological material sampled and the health-related personal data collected during a clinical trial in an emergency situation may only be evaluated when consent has been obtained in accordance with article 15 or 16.2 in exceptional cases, the biological material and the health-related personal data may be evaluated before consent has been obtained if:a. the biological material is only utilisable for a limited period; orb. this is necessary for the sake of the participants' safety and health.3 if consent to participate in a clinical trial in an emergency situation is withheld post hoc, the biological material and the health-related personal data must be destroyed.4 if the validity of the clinical trial or its results is compromised in essential respects by the destruction of the biological material and the health-related personal data, the use thereof in the clinical trial is permissible in spite of refusal of consent. the biological material and the health-related personal data must be anonymised without delay. the right to dissent of the person concerned is reserved.5 if it is foreseeable that material or data may be evaluated before consent has been obtained, in accordance with paragraph 2, or used in spite of refusal of consent, in accordance with paragraph 4, this must be stated in the protocol.section 6 storage of health-related personal data and biological material art. 18 1 any person who stores health-related personal data in connection with a clinical trial must take appropriate operational and organisational measures to protect it, and in particular:a. restrict the handling of the health-related personal data to those persons who require this data to fulfil their duties;b. prevent unauthorised or accidental disclosure, alteration, deletion and copying of the health-related personal data;c. document all processing operations which are essential to ensure traceability.2 any person who stores biological material in connection with a clinical trial must, in particular:a. comply with the principles set out in paragraph 1 mutatis mutandis;b. ensure that the technical requirements are met for appropriate storage of the biological material;c. make available the resources required for storage.chapter 2 authorisation and notification procedures for clinical trials of medicinal products, in vitro diagnostic medical devices19 or products under article 2a paragraph 2 tpa and transplant products 19 term in accordance with annex 2 no 2 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033). this change has been made throughout the textsection 1 general provisions art. 19 categorisation of clinical trials of medicinal products 1 clinical trials of medicinal products come under category a if the medicinal product is authorised in switzerland and its use:a. is in accordance with the prescribing information;b. is in an indication or dosage different from that specified in the prescribing information, but in accordance with the following criteria:1. the indication is within the same disease group of the international classification of diseases (icd), as specified in annex 1 number 3,2. the disease in question is self-limiting and the dosage of the medicinal product is lower than that specified in the prescribing information; orc. is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria.2 clinical trials of medicinal products come under category b if the medicinal product:a. is authorised in switzerland; andb. is not used as specified in paragraph 1.3 they come under category c if the medicinal product is not authorised in switzerland.4 in justified cases, a clinical trial of a medicinal product authorised in switzerland may be assigned to a different category if this is possible or necessary with regard to medicinal product safety or protection of the participants' safety and health.art. 20 categorisation of clinical trials of in vitro diagnostic medical devices and products under article 2a paragraph 2 tpa 1 clinical trials of in vitro diagnostic medical devices and products under article 2a paragraph 2 tpa come under category a if:a. the in vitro diagnostic medical device and product under article 2a paragraph 2 tpa bears a conformity marking; andb. it is used in accordance with the instructions.2 they come under category c if:a. the in vitro diagnostic medical device and product under article 2a paragraph 2 tpa does not have a conformity marking;b. it is not used in accordance with the intended purposes recognised in the conformity assessment and specified in the instructions; orc. use of the in vitro diagnostic medical device and product under article 2a paragraph 2 tpa is prohibited in switzerland.art. 21 clinical trials of transplant products for clinical trials of transplant products, the provisions of this ordinance concerning clinical trials of medicinal products apply mutatis mutandis.art. 22 clinical trials of gene therapy and clinical trials of genetically modified or pathogenic organisms 1 for the purposes of this ordinance, clinical trials of gene therapy are trials in which genetic information is introduced into somatic cells (somatic gene therapy).2 for the purposes of this ordinance, clinical trials of genetically modified organisms are trials of medicinal products containing genetically modified organisms as defined in the release ordinance of 10 september 200820, and in particular replication-competent viruses.3 for the purposes of this ordinance, clinical trials of pathogenic organisms are trials of medicinal products containing pathogenic organisms as defined in the release ordinance.4 for clinical trials of gene therapy and for clinical trials of genetically modified or pathogenic organisms, the provisions of this ordinance concerning clinical trials of medicinal products apply mutatis mutandis.20 sr 814.911art. 23 coordination and information in authorisation procedures 1 the investigator and the sponsor may simultaneously submit applications to the responsible ethics committee and to the agency.2 the responsible ethics committee and the agency shall inform each other about matters relating to the review areas specified in article 25 and in article 32, and shall coordinate their assessments.section 2 procedure for the responsible ethics committee art. 24 application 1 the investigator shall submit to the responsible ethics committee the application documents specified in annex 3 for review.2 the ethics committee may request additional information.3 the sponsor may submit the application instead of the investigator. in this case, the sponsor assumes the obligations of the investigator as specified in articles 28 and 29 and also the notification and reporting obligations vis--vis the responsible ethics committee. the application documents must be co-signed by the investigator.art. 25 review areas the responsible ethics committee shall review:a. the completeness of the application;b. the categorisation requested;c. the information intended for registration in accordance with article 64;d. the protocol with regard to:1. the scientific relevance of the topic (art. 5 hra), the suitability of the chosen scientific methodology and compliance with good clinical practice,2. the ratio between the likely risks and burdens and the expected benefits (art. 12 para. 2 hra),3. the measures taken to minimise risks and burdens, and for the protection and follow-up of participants (art. 15 hra), including precautionary measures in the handling of personal data,4. the need to involve persons, and in particular persons who are particularly vulnerable (art. 11 hra),5. the criteria for the selection of participants,6. the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection,7. the appropriateness of the remuneration for participants,8. compliance with scientific integrity requirements;e. the completeness of the documentation for recruitment, information and consent, and its comprehensibility, especially with regard to the possible involvement of particularly vulnerable persons;f. the guaranteeing of the right to compensation in the event of damage (art. 20 hra);g. the adequacy of the knowledge and experience of the investigator and of the other persons conducting the clinical trial, in relation to the discipline concerned and the conduct of a clinical trial;h. the suitability of the infrastructure at the trial site;i. the financing of the clinical trial and the agreements between the sponsor, third parties and the investigator concerning the allocation of tasks, remuneration and publication;j. for category a clinical trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo capable of emitting ionising radiation: additionally, compliance with radiological protection legislation and the dose estimation;k. for investigations involving radiation sources21: additionally, compliance with radiological protection legislation and the dose estimation, in cases where an opinion does not have to be sought from the foph in accordance with article 28;l. other areas, where this is necessary to assess the protection of participants.21 german text amended by annex 11 no 6 of the radiological protection ordinance of 26 apr. 2017, in force since 1 jan. 2018 (as 2017 4261). this amendment is not relevant to the english text.art. 26 procedure and deadlines 1 the ethics committee shall acknowledge receipt of the application within 7 days and notify the investigator of any formal deficiencies in the application documents.2 it shall reach a decision within 30 days of acknowledgement of receipt of the formally correct application documents.3 if the ethics committee requests additional information in accordance with article 24 paragraph 2, the clock shall be stopped until this information has been received.4 it shall inform the agency of its decision in the case of category b and c clinical trials.art. 27 multicentre clinical trials 1 the coordinating investigator shall submit the application for multicentre clinical trials to the lead committee in accordance with article 47 paragraph 2 hra. the sponsor may submit the application instead of the coordinating investigator; article 24 paragraph 3 applies mutatis mutandis.2 the coordinating investigator is the person responsible in switzerland for coordination of the investigators responsible at the individual trial sites.3 the lead committee shall acknowledge receipt of the application within 7 days and at the same time notify the coordinating investigator whether the application documents are formally in order.4 at the request of the lead committee, the coordinating investigator shall submit the required number of copies of the application documents specified in annex 3 to the ethics committees responsible at the other trial sites (ethics committees concerned). these shall review the local conditions and inform the lead committee of their assessment within 15 days.5 the lead committee shall reach a decision within 45 days of acknowledgement of receipt of the formally correct application. it shall inform the ethics committees concerned of its decision and the agency in the case of category b and c clinical trials.art. 28 procedure for investigations involving radiation sources 1 in the case of investigations involving radiation sources, the investigator shall additionally submit to the responsible ethics committee the documents specified in annex 3 number 5. subject to the provisions of the following paragraphs, the authorisation procedure is governed by articles 24-27 and 29.2 the investigator shall additionally submit to the foph the application documents specified in annex 3 number 6, informing the ethics committee at the same time, if the effective dose per person, taking the uncertainty factor into account, is more than 5 msv per year and:a. a radiopharmaceutical is used which is not authorised in switzerland;b. a radiopharmaceutical is used which is authorised in switzerland, and the intervention in question is not a routine nuclear medicine examination; orc. some other radioactive source22 is used.3 the foph shall deliver an opinion for the ethics committee on compliance with radiological protection legislation and on the dose estimation.4 the ethics committee shall grant authorisation if:a. the requirements covered by article 25 are met; andb. the foph has raised no objections to the clinical trial.5 it shall reach a decision within 45 days of acknowledgement of receipt of the formally correct application documents. it shall inform the foph of its decision.22 term in accordance with annex 11 no 6 of the radiological protection ordinance of 26 april 2017, in force since 1 jan. 2018 (as 2017 4261).art. 29 changes 1 significant changes to an authorised clinical trial must be authorised by the ethics committee before being implemented. exempt from this requirement are measures which have to be taken immediately in order to protect the participants.2 the investigator shall submit to the ethics committee any application documents specified in annex 3 which are affected by the change. at the same time, the investigator shall provide information on the reasons for the change.3 the following are considered to be significant changes:a. changes affecting the participants' safety and health, or their rights and obligations;b. changes to the protocol, and in particular changes based on new scientific knowledge which concern the trial design, the method of investigation, the endpoints or the form of statistical analysis;c. a change of trial site, or conducting the clinical trial at an additional site; ord. a change of sponsor, coordinating investigator or investigator responsible at a trial site.4 the ethics committee shall reach a decision on significant changes within 30 days. article 26 applies mutatis mutandis.5 if a site at which a clinical trial is to be additionally conducted does not lie within the responsibility of the ethics committee which granted authorisation, the procedure is governed by article 27 mutatis mutandis.6 other changes must be notified to the ethics committee in the annual safety report specified in article 43.section 3 procedure for the swiss agency for medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo art. 3023 exemption from mandatory authorisation category a clinical trials are exempted from the requirement for authorisation from the agency as specified in article 54 paragraph 1 tpa.23 amended by annex no 2 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).art. 31 application 1 the sponsor shall submit to the agency the application documents specified in annex 4 for review.2 the agency may request additional information.art. 32 review areas 1 for clinical trials of medicinal products, the agency shall review:a. the completeness of the application;b. the safety of the medicinal product, and in particular the preclinical and clinical pharmacology, toxicology, formulation and pharmacokinetics, and the proposed dosage and indication;c. the risk assessment and risk management based on the medicinal product safety data;d. the quality of the medicinal product and compliance with good manufacturing practice (gmp);e. other areas, where this is necessary to assess the safety or quality of the medicinal product.2 for category b clinical trials of medicinal products capable of emitting ionising radiation, it shall additionally review compliance with radiological protection legislation and the dose estimation.3 for clinical trials of medical devices, it shall review:a. the completeness of the application;b. the requirements specified in article 54 paragraph 4 letter b tpa.art. 33 procedure and deadlines 1 the agency shall acknowledge receipt of the application within 7 days and notify the sponsor of any formal deficiencies in the application documents.2 it shall reach a decision within 30 days of acknowledgement of receipt of the formally correct application documents.3 if a medicinal product, in vitro diagnostic medical device or combinations under article 2 letters f-h meddo is to be used in persons for the first time or manufactured in a new process, this deadline may be extended by a maximum of 30 days. the agency shall inform the sponsor of the extended deadline.4 if the agency requests additional information in accordance with article 31 paragraph 2, the clock shall be stopped until this information has been received.5 the agency shall inform the responsible ethics committee and other competent cantonal authorities of its decision.art. 34 changes 1 significant changes to an authorised clinical trial must be authorised by the agency before being implemented. exempt from this requirement are measures which have to be taken immediately in order to protect the participants.2 the sponsor must submit to the agency any application documents specified in annex 4 which are affected by the change. at the same time, the sponsor shall provide information on the reasons for the change.3 the following are considered to be significant changes:a. changes to the medicinal product, in vitro diagnostic medical device or combinations under article 2 letters f-h meddo, or to its administration or use;b. changes based on new preclinical or clinical data which may affect product safety; orc. changes concerning the production of the medicinal product, in vitro diagnostic medical device or combinations under article 2 letters f-h meddo which may affect product safety.4 the agency shall reach a decision within 30 days after receipt of the complete application documents affected by the change. article 33 applies mutatis mutandis.5 other changes which affect the documents submitted to the agency must be notified to the agency as quickly as possible.section 4 special provisions for clinical trials of gene therapy, for clinical trials of genetically modified or pathogenic organisms, and for clinical trials involving ionising radiation art. 35 clinical trials of gene therapy and clinical trials of genetically modified or pathogenic organisms 1 for category b and c clinical trials of gene therapy and for clinical trials of genetically modified or pathogenic organisms as defined in article 22, the documents specified in annex 4 number 4 must be submitted to the agency.2 before granting authorisation, the agency shall seek opinions from the swiss expert committee for biosafety (secb), the federal office for the environment (foen) and the foph.3 in addition to the areas specified in article 32, it shall review whether the quality and biological safety of the product are guaranteed with regard to the participants and to human health and the environment.4 it shall grant authorisation if:a. the secb has confirmed the quality and biological safety of the product with regard to the participants and to human health and the environment; andb. no objections to the clinical trial have been raised by the foph or by the foen, based on the assessment of the environmental data.5 the agency shall grant authorisation within 60 days of acknowledgement of receipt of the formally correct application documents. the agency shall inform the competent federal and cantonal authorities of its decision.6 authorisations shall remain valid for the duration of the clinical trial, but for no longer than five years after they are granted.7 the agency, the foph and the foen shall jointly issue guidelines on assessment of risks to human health and the environment.art. 36 clinical trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo capable of emitting ionising radiation 1 for category b and c clinical trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo capable of emitting ionising radiation, the documents specified in annex 4 number 5 must additionally be submitted to the agency.2 in the case of category c clinical trials, the agency shall seek an opinion from the foph before granting authorisation. the foph shall review compliance with radiological protection legislation and the dose estimation.3 the agency shall grant authorisation if:a. the requirements covered by article 32 are met; andb. the foph has raised no objections to the clinical trial.4 the agency shall reach a decision on category c clinical trials within 60 days of acknowledgement of receipt of the formally correct application documents. it shall inform the foph of its decision.5 in the case of category c clinical trials, it shall transmit to the foph directly after receipt:a. the final report specified in article 38 paragraph 3 including all information of relevance for radiological protection, and in particular a retrospective participant dose estimation, unless stipulations to the contrary have been made by the foph;b. the reports specified in article 41 paragraph 2 and article 42 paragraph 1.section 5 notifications and reporting art. 37 notification of safety and protective measures 1 if immediate safety and protective measures have to be taken during the conduct of a clinical trial, the investigator shall notify the ethics committee of these measures, and of the circumstances necessitating them, within 7 days.2 in the case of clinical trials of medical devices, this notification shall be made within 2 days.3 for category b and c clinical trials, the notifications specified in paragraphs 1 and 2 shall be made to the agency. this obligation rests on the sponsor.art. 38 notification and reporting upon completion, discontinuation or interruption of a clinical trial 1 the investigator shall notify the ethics committee of the completion of the clinical trial in switzerland within 90 days. completion of a clinical trial is marked by the last participant's final follow-up visit, in the absence of provisions to the contrary in the protocol.2 the investigator shall notify the ethics committee of the discontinuation or interruption of the clinical trial within 15 days. in the notification, the reasons for the discontinuation or interruption shall be stated.3 the investigator shall submit a final report to the ethics committee within a year after completion or discontinuation of the clinical trial, unless a longer period is specified in the protocol.4 if a multicentre clinical trial is discontinued or interrupted at one of the trial sites, the coordinating investigator shall also notify the responsible ethics committee concerned in accordance with paragraph 2.5 for category b and c clinical trials, the notifications and reports specified in paragraphs 1-3 shall be made to the agency. these obligations rest on the sponsor.art. 39 documentation of adverse events (ae) in clinical trials of medicinal products 1 if, in the course of a category c clinical trial of medicinal products, adverse events which are not to be classified as serious occur in participants, they must be documented by the investigator in a standardised manner.2 adverse events occurring in the course of a category b clinical trial must be documented in a standardised manner, if this is envisaged in the protocol or was requested by the authorities responsible for authorisation.3 for category a clinical trials, there is no obligation to document adverse events.4 the definition of adverse events is governed by the rules of good clinical practice as specified in annex 1 number 2.art. 40 serious adverse events (sae) in clinical trials of medicinal products 1 if, in the course of a clinical trial, serious adverse events occur in participants, the investigator must document these in a standardised manner and notify the sponsor within 24 hours after they become known. events which are not to be reported according to the protocol are exempted.2 in the absence of provisions to the contrary in the protocol, the investigator shall notify the responsible ethics committee of a fatal serious adverse event occurring at a trial site in switzerland within 7 days.3 in the case of a multicentre clinical trial, the coordinating investigator shall also report events as specified in paragraph 2 to the responsible ethics committee concerned within the same period.4 the definition of serious adverse events is governed by the rules of good clinical practice as specified in annex 1 number 2.art. 41 suspected unexpected serious adverse reactions (susar) in clinical trials of medicinal products 1 if, in the course of a clinical trial, a suspected unexpected serious adverse reaction occurs in participants, the investigator must document this in a standardised manner and notify the sponsor within 24 hours after it becomes known.2 the investigator shall notify the responsible ethics committee of a fatal suspected unexpected serious adverse reaction occurring in switzerland within 7 days, and of any other suspected unexpected serious adverse reaction within 15 days.3 if, in the case of a multicentre clinical trial, a suspected unexpected serious adverse reaction occurs at one of the trial sites, the coordinating investigator shall also notify the responsible ethics committee concerned in accordance with paragraph 2, within the same period.4 for category b and c clinical trials, the notifications specified in paragraph 2 shall also be made to the agency. this obligation rests on the sponsor. for category a clinical trials, the sponsor is subject to the notification requirements specified in article 59 paragraphs 1 and 2 tpa.5 the definition of a suspected unexpected serious adverse reaction is governed by the rules of good clinical practice as specified in annex 1 number 2.art. 4224 serious adverse events (sae) and deficiencies in clinical trials of in vitro diagnostic medical devices 1 the investigator shall, within 7 days, notify the responsible ethics committee of the following:a. serious adverse events which occur in participants in switzerland in the course of a category c clinical trial of in vitro diagnostic medical devices and where it cannot be excluded that the events are attributable:1. to the in vitro diagnostic medical device under investigation, or2. to an intervention undertaken in the clinical trial;b. deficiencies in the in vitro diagnostic medical device under investigation that could have led to serious adverse events if suitable action had not been taken, intervention had not been made, or circumstances had been less fortunate.2 if, in the case of a multicentre clinical trial at one of the trial sites, serious adverse events or deficiencies occur deficiencies in the in vitro diagnostic medical device under investigation, the coordinating investigator shall also notify the responsible ethics committee concerned.3 for a category c clinical trial, the notifications specified in paragraph 1 shall also be made to the agency. this obligation rests on the sponsor. in addition, the sponsor shall notify the agency of any events occurring or deficiencies in the in vitro diagnostic medical device under investigation observed abroad. in the case of a category a clinical trial, the sponsor is subject to the notification requirements specified in article 15 paragraph 1 of the medical devices ordinance of 17 october 200125.4 the definition of serious adverse events and deficiencies an in vitro diagnostic medical devices is governed by the rules of good clinical practice as specified in annex 1 number 2.24 amended by annex 2 no 2 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).25 [as 2001 3487, 2010 1215]art. 43 reporting on the safety of participants 1 once a year, the investigator shall present to the responsible ethics committee a list of events and deficiencies in the in vitro diagnostic medical device under investigation and adverse reactions as specified in articles 40-42 and, on this basis, shall submit a report on their severity and causal relationship to the intervention, and on the safety of participants (annual safety report, asr).262 in the case of clinical trials also conducted abroad according to the same protocol, the events and deficiencies in the in vitro diagnostic medical device under investigation and adverse reactions occurring abroad must also be included in the list and the report.273 for category b and c clinical trials, reports as specified in paragraphs 1 and 2 must also be submitted to the agency. this obligation rests on the sponsor.26 amended by annex 2 no 2 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).27 amended by annex 2 no 2 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).art. 4428 assessment, notification and reporting on the use of radiation sources 1 in clinical trials involving medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo capable of emitting ionising radiation, and in investigations using radiation sources, the investigator shall assess compliance with the dose guidance value in accordance with article 45 of the radiological protection ordinance of 26 april 201729.2 if the permitted dose guidance value is exceeded at any time, the investigator shall notify the responsible ethics committee within seven working days of it becoming known.3 in the case of category b and c clinical trials with medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo that emit ionising radiation, notification in accordance with paragraph 2 must also be given to the agency. this obligation rests on the sponsor.4 the responsible ethics committee and the agency may obtain specialist advice from the foph in order to assess the dose calculation or the dose estimation and to decide what further measures are required.5 within a year of the completion or discontinuation of a clinical trial which included investigations involving radioactive sources, the investigator shall submit to the foph a final report including all information of relevance for radiological protection, and in particular a retrospective participant dose estimation.6 the reporting requirements in accordance with paragraph 5 do not apply in the case of routine nuclear medicine examinations involving authorised radiopharmaceuticals.7 within the framework of the opinion delivered in accordance with article 28, or on request, the foph may specify further exemptions from the reporting requirements in accordance with paragraph 5.28 amended by annex 11 no 6 of the radiological protection ordinance of 26 apr. 2017, in force since 1 jan. 2018 (as 2017 4261).29 sr 814.501art. 45 data retention requirements 1 the sponsor must retain all data relating to the clinical trial until the expiry date of the last batch supplied of the medicinal product investigated or of the last in vitro diagnostic medical device manufactured, but at least for ten years after the completion or discontinuation of the clinical trial.302 the investigator must retain all documents required for the identification and follow-up of participants, and all other original data, for at least ten years after the completion or discontinuation of the clinical trial.313 for clinical trials of transplant products and for clinical trials of blood and blood products, the retention requirements are governed by article 40 paragraph 1 tpa.30 amended by annex 2 no 2 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).31 amended by annex 2 no 2 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).section 6 inspections and official measures art. 46 agency inspections 1 the agency is entitled to inspect all clinical trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo and transplant products.2 if the agency carries out inspections, it shall inform in advance the responsible ethics committee and other competent cantonal and federal authorities. they may participate in the inspection.3 the agency's powers are governed by article 62 of the medicinal products authorisation ordinance of 14 november 201832.4 the agency may additionally carry out inspections abroad at the sponsor's expense, if this is necessary to assess the clinical trial conducted in switzerland. the sponsor must be informed in advance.5 the agency shall inform the responsible ethics committee and other competent cantonal and federal authorities of the results of the inspection.32 sr 812.212.1. the reference has been amended on 1 jan. 2019 pursuant to art. 12 para. 2 of the publications act of 18 june 2004 (sr 170.512).art. 47 official measures of the agency the agency may revoke or suspend the authorisation granted or make the continuation of the clinical trial subject to additional conditions, in particular if:a. the safety or health of participants is at risk, particularly as a result of inadequate product safety or manufacturing defects;b. the quality of the data collected is poor;c. the clinical trial is not conducted in accordance with the application documents approved by the agency or by the ethics committee;d. the authorisation and notification requirements have not been complied with.art. 48 coordination and information 1 the responsible ethics committee, the agency and the other competent cantonal authorities shall coordinate in advance the official measures to be taken.2 the right is reserved to take measures which have to be ordered without delay in order to protect the safety or health of the persons concerned. the ethics committees and the other competent federal and cantonal authorities shall immediately inform each other about such measures.chapter 3 authorisation and notification procedures for clinical trials of the transplantation of human organs, tissues and cells section 1 general provisions art. 49 categorisation 1 a clinical trial of the transplantation of human organs, tissues and cells comes under category a if the transplantation to be investigated is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria.2 a clinical trial of the transplantation of human organs, tissues and cells comes under category c if the transplantation to be investigated is not recognised as standard as specified in paragraph 1.3 clinical trials of the transplantation of embryonic and foetal tissues and cells come under category c.art. 50 information and coordination in authorisation procedures 1 the investigator and the sponsor may simultaneously submit applications to the responsible ethics committee and to the foph.2 the responsible ethics committee and the foph shall inform each other about matters relating to the review areas specified both in article 25 and in article 53, and shall coordinate their assessments.section 2 procedure for the responsible ethics committee art. 51 for the procedure for the authorisation of clinical trials of transplantation by the responsible ethics committee, articles 24-29 apply mutatis mutandis.section 3 procedure for the foph art. 52 exemption from mandatory authorisation category a clinical trials are exempted from the requirement for authorisation from the foph specified in article 36 paragraph 1 of the transplantation act.art. 53 review areas for clinical trials of transplantation, the foph shall review:a. the completeness of the application;b. the origin of the organs, tissues or cells used in the clinical trial;c. compliance with the requirements of the transplantation legislation, particularly with regard to the duties of care in the handling of organs, tissues and cells, and the allocation of organs;d. the availability of the authorisations required in accordance with the transplantation act;e. other areas, where this is necessary to assess the safety and quality of the organs, tissues or cells used.art. 54 authorisation procedure 1 the sponsor shall submit to the foph the application documents specified in annex 4 for review.2 the foph may request additional information.3 for the procedure and deadlines, article 33 applies mutatis mutandis.art. 55 changes 1 significant changes to an authorised clinical trial must be authorised by the foph before being implemented. exempt from this requirement are measures which have to be taken immediately in order to protect the participants.2 the sponsor must submit to the foph any application documents specified in annex 4 which are affected by the change. at the same time, the sponsor shall provide information on the reasons for the change.3 the following are considered to be significant changes:a. new scientific knowledge, based in particular on new preclinical or clinical data, which affects the assessment of the safety of the organs, tissues or cells used; orb. changes relating to the origin, the tests to be performed or the storage of the organs, tissues or cells used.4 also considered significant in the case of clinical trials of the transplantation of embryonic or foetal tissues and cells are changes which may affect the safety of the participants.5 the foph shall reach a decision within 30 days of receipt of the complete set of application documents affected by the change. article 33 applies mutatis mutandis.6 other changes which affect documents submitted to the foph must be notified to the foph as quickly as possible.art. 56 special provisions for clinical trials of the transplantation of embryonic or foetal tissues and cells 1 the foph shall grant authorisation if, in addition to article 53, the requirements specified in article 34 of the transplantation ordinance of 16 march 200733 are met.2 it shall grant authorisation within 60 days or, in the case of significant changes, within 30 days after receipt of the complete application documents.3 for clinical trials of the transplantation of embryonic or foetal tissues and cells, articles 35, 36 and 38 of the transplantation ordinance additionally apply.33 sr 810.211section 4 notifications and reporting art. 57 1 for notifications and reporting in the case of clinical trials of transplantation, articles 37-41, 43 and 44 apply mutatis mutandis.342 the obligations which must be fulfilled under these provisions vis--vis the agency are to be fulfilled, for clinical trials of transplantation, vis--vis the foph.3 for clinical trials of transplantation, the duties of the sponsor and the investigator concerning documentation, traceability and retention of records are governed by articles 34 and 35 of the transplantation act.34 correction of 27 dec. 2013 (as 2013 5579).section 5 inspections and official measures art. 58 foph inspections 1 the foph may carry out inspections at any time and inspect all documents and data relating to a clinical trial of transplantation. it may request the cantonal authorities or third parties to carry out inspections.2 other powers and duties of cooperation are governed by article 63 paragraphs 2 and 3 and article 64 of the transplantation act.art. 59 official measures 1 the foph may revoke or suspend the authorisation granted or make the continuation of the clinical trial subject to additional conditions, particularly if:a. it has reason to assume that the requirements are no longer met, the documents specified in article 54 have been changed without due notification having been made, or the trial is not being conducted in accordance with these documents;b. such measures are necessitated by new information concerning safety or the scientific basis.2 for the coordination of measures and the exchange of information between the foph, the responsible ethics committee and other competent cantonal authorities, article 48 applies mutatis mutandis.chapter 4 other clinical trials section 1 general provisions art. 60 scope this chapter applies to clinical trials which are neither trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo or transplant products nor trials of transplantation.art. 61 categorisation 1 a clinical trial comes under category a if the health-related intervention investigated:a. entails only minimal risks and burdens; orb. is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria.2 a clinical trial comes under category b if the health-related intervention investigated:a. entails more than minimal risks and burdens; andb. is not recognised as standard as specified in paragraph 1 letter b.section 2 authorisation and notification procedures for the responsible ethics committee art. 62 applicable provisions the provisions which apply mutatis mutandis are:a. for the authorisation procedure for clinical trials, articles 24-29;b. for the notification of safety and protective measures, article 37 paragraph 1;c. for notification and reporting upon completion, discontinuation or interruption of a clinical trial, article 38 paragraphs 1-4;d. for reporting on the safety of participants, article 43 paragraphs 1 and 2;e. for data retention requirements, article 45 paragraph 2.art. 63 documentation and notification of serious adverse events 1 if, in the course of a clinical trial, serious adverse events occur in participants in switzerland, and it cannot be excluded that the events are attributable to the intervention under investigation, the investigator must document them in a standardised manner. in addition, the investigator shall report these events:a. to the sponsor within 24 hours after they become known; andb. to the responsible ethics committee within 15 days.2 a serious adverse event is defined as any event which:a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay;b. results in permanent or significant incapacity or disability;c. is life-threatening or results in death; ord. causes a congenital anomaly or birth defect.3 if necessary in order to guarantee participants' safety and health, further adverse events which must be documented or reported are to be designated in the protocol or at the request of the responsible ethics committee.4 if, in the case of a multicentre clinical trial, serious adverse events occur at one of the trial sites, the coordinating investigator shall also report the events as specified in paragraphs 1 and 3 to the responsible ethics committee concerned, within the same period.3535 correction of 27 dec. 2013 (as 2013 5579).chapter 5 registration art. 64 approved registries and data to be entered 1 for an authorised clinical trial, the sponsor must register the data specified in annex 5 number 1:a. in a primary registry36 recognised by the world health organization (who); orb. in the registry of the u.s. national library of medicine37.2 the sponsor shall additionally enter the data specified in annex 5 number 2 in the supplementary federal database, using a swiss national language.3 the data must be entered in the form authorised by the responsible ethics committee.36 the registries can be consulted at: www.who.int > programmes and projects > clinical trials - international registry platform.37 the registry can be consulted at: www.clinicaltrials.govart. 65 time of registration 1 the registration specified in article 64 must be performed before the clinical trial is conducted, subject to the provisions of paragraph 2.2 clinical trials in which the medicinal product under investigation is being administered to adult persons for the first time (phase i clinical trials) must be registered no later than one year after the completion of the clinical trial.3 the sponsor must update the data entered in accordance with the requirements of the registry in question, as specified in article 64 paragraph 1, but at least once a year.art. 66 responsibility the sponsor is responsible for the accuracy and completeness of the data entered.art. 67 portal 1 public access to information on clinical trials conducted in switzerland shall be guaranteed by a portal providing access to one or more registries.2 the portal shall enable in particular:a. linking of data in the supplementary federal database to data in the approved registry, as specified in article 64 paragraph 1;b. searching for clinical trials by keywords.3 the operation of the portal and of the supplementary federal database shall be guaranteed by the coordination office specified in article 10 of the hra organisation ordinance of 20 september 201338.38 sr 810.308chapter 6 final provisions art. 68 updating of annexes the federal department of home affairs may update annexes 1-5 in accordance with international or technical developments. it shall undertake updates which may give rise to technical barriers to trade in consultation with the federal department of economic affairs, education and research.art. 69 repeal of other legislation the following ordinances shall be repealed:1. ordinance of 14 june 199339 on the waiver of professional confidentiality in medical research;2. ordinance of 17 october 200140 on clinical trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo;3. hiv studies ordinance of 30 june 199341.39 [as 1993 1983]40 [as 2001 3511, 2004 4037 no i 6, 2007 5651 no ii 3, 2010 1215 annex 7 4043, 2012 2777 annex 5 no 4]41 [as 1993 2294]art. 70 amendment of other legislation the amendment of other legislation is regulated in annex 6.art. 71 transitional provisions for clinical trials authorised under existing law 1 clinical trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo and transplant products and trials of transplantation which were authorised before 1 january 2014 are considered to be category c clinical trials.2 other authorised clinical trials are considered to be category b clinical trials.3 on request, the authority which authorised the clinical trial before 1 january 2014 may assign the clinical trial to a different category. in this case, the liability, coverage, notification, reporting and documentation requirements are governed by the new law.4 the responsible ethics committee shall make the decision specified in paragraph 3 according to the simplified procedure specified in article 6 of the hra organisation ordinance of 20 september 201342.5 the assessment of significant changes is governed by the new law.42 sr 810.308art. 72 transitional provision for clinical trials not subject to authorisation under existing law the responsible ethics committee shall make a decision on applications concerning clinical trials not subject to authorisation under existing law, submitted in accordance with article 67 paragraph 2 hra, within six months after acknowledgement of receipt of the formally correct application documents.art. 73 transitional provision concerning mandatory registration the sponsor of an authorised clinical trial which is not completed within a year after the commencement of the hra must, within six months, enter the data specified in annex 5 number 1 in a registry, as specified in article 64 paragraph 1.art. 74 commencement this ordinance comes into force on 1 january 2014.annex 143 43 revised by no i of the fdha ordinance of 24 march 2017 (as 2017 2439) and annex no 1 of the o of 25 oct. 2017, in force since 26 nov. 2017 (as 2017 5935). (art. 3, 5, 19, 39-42)rules and classifications 1 guidelines on scientific integrity the applicable guidelines are the principles and procedures for integrity in scientific research issued by the swiss academies of arts and sciences, in the version dated 28 february 200844.44 these guidelines can be obtained against payment or consulted free of charge at the federal office of public health, ch-3003 bern; they can also be accessed online at: www.akademien-schweiz.ch > publications > guidelines and recommendations.2 rules of good clinical practice the applicable rules of good clinical practice are:1. for clinical trials of medicinal products and transplant products: the guideline for good clinical practice issued by the international conference on harmonisation, in the version dated 9 november 201645 (ich guideline);2. for clinical trials of medical devices: annexes viii and x to directive 93/42/eec46 and annexes 6 and 7 to directive 90/385/eec47 and the requirements specified in en iso 14155:201148. the definition of serious adverse events in accordance with article 42 is based on the guidelines on in vitro diagnostic medical devices and products under article 2a paragraph 2 tpa (meddev 2.7/3) of may 201549;3. for clinical trials as specified in chapters 3 and 4 of this ordinance: the ich guideline mutatis mutandis.45 this guideline can be obtained against payment or consulted free of charge at the federal office of public health, ch-3003 bern; it can also be accessed online at: www.ich.org > work products > efficacy guidelines.46 council directive 93/42/eec of 14 june 1993 concerning medical devices, oj l 169, 12.7.1993, p. 1; last amended by directive 2007/47/ec, oj l 247, 21.9.2007, p. 21.47 council directive 90/385/eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices, oj l 189, 20.7.1990, p. 17; last amended by directive 2007/47/ec, oj l 247, 21.9.2007, p. 21.48 this standard can be consulted free of charge at the federal office of public health, ch3003 bern and at the swiss agency for therapeutic products, ch-3003 bern. it can also be purchased from the swiss association for standardisation, sulzerallee 70, 8404 winterthur; www.snv.ch.49 these guidelines can be consulted free of charge at the federal office of public health, ch-3003 bern, or accessed online at: www.ec.europa.eu/growth/ > sectors > medical devices > guidance.3 international classification of diseases the applicable classification is the 2010 version of the international classification of diseases issued by the world health organization (who) (icd-10)50; the relevant disease groups are those identified by three-character codes.50 the classification can be obtained against payment or consulted free of charge at the federal office of public health, ch-3003 bern; it can also be accessed online at: www.who.int > health topics > classifications of disease.annex 2 (art. 13)policy values for liability coverage 1. for category a clinical trials where any measures for the collection of health-related personal data or the sampling of biological material entail more than only minimal risks and burdens, the policy value shall be at least:a. per person: 250 000 swiss francs;b for damage to property: 20 000 swiss francs;c. for the entire clinical trial: 3 million swiss francs.2. for other clinical trials, the policy value shall be at least:a. per person: 1 million swiss francs;b. for damage to property: 50 000 swiss francs;c. for the entire clinical trial: 10 million swiss francs.annex 3 (art. 24, 27-29)application documents to be submitted to the responsible ethics committee for the procedure for clinical trials 1 application documents for category a clinical trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo and transplant products 1.1 basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;1.2 protocol;1.3 case report form (crf);1.4 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;1.5 other documents issued to participants;1.6 information on the type and amount of remuneration for participants;1.7 for clinical trials of medicinal products: the prescribing information;1.8 for clinical trials of in vitro diagnostic medical devices and products under article 2a paragraph 2 tpa: the conformity marking, including the intended use and instructions;1.9 for clinical trials not using proprietary products: proof of compliance with good manufacturing practice and correct labelling of the medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo;1.10 the investigator's cv, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating their responsibilities and relevant professional knowledge;1.11 information on the suitability and availability of infrastructure at the trial site;1.12 information on the secure handling of personal data;1.13 agreements between the sponsor, or third parties acting on the sponsor's behalf, and the investigator, in particular with regard to the financing of the clinical trial, remuneration of the investigator and publication;1.14 certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party acting on the sponsor's behalf, and the investigator;1.15 any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.2 application documents for category b and c clinical trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo and transplant products 2.1 basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;2.2 protocol;2.3 case report form (crf);2.4 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;2.5 other documents issued to participants;2.6 information on the type and amount of remuneration for participants;2.751 for category b clinical trials of medicinal products: the prescribing information and the investigator's brochure (ib), giving details of how the use of the product differs from the dosage/indication specified in the prescribing information;2.8 for category c clinical trials of medicinal products: the investigator's brochure (ib);2.9 for category c clinical trials of medical devices with no assessment of conformity: the documents specified in annex 4 number 3.4 letter a;2.10 for category c clinical trials of medical devices bearing a conformity marking which are not used in accordance with the intended purpose or the instructions: the documents specified in annex 4 number 3.5 letters a-d;2.11 the investigator's cv, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating their responsibilities and relevant professional knowledge;2.12 information on the suitability and availability of infrastructure at the trial site;2.13 information on the secure handling of personal data;2.14 agreements between the sponsor, or third parties acting on the sponsor's behalf, and the investigator, in particular with regard to the financing of the clinical trial, remuneration of the investigator and publication;2.15 certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party acting on the sponsor's behalf, and the investigator;2.16 for clinical trials of gene therapy: the information specified in annex 4 number 4;2.17 any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.51 correction of 27 dec. 2013 (as 2013 5579).3 application documents for clinical trials of transplantation and for clinical trials not involving medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo 3.1 basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;3.2 protocol;3.3 case report form (crf);3.4 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;3.5 other documents issued to participants;3.6 information on the type and amount of remuneration for participants;3.7 for clinical trials of transplantation of human organs, tissues and cells: information on donor information and consent;3.8 for category a clinical trials of transplantation of human organs, tissues and cells: in addition to the information specified in number 3.7, information on:a. the origin and quality of the organs, tissues or cells used, and in particular on the tests performed in this connection,b. compliance with duties of care, particularly with regard to the assessment of fitness to donate and mandatory testing, and the subsequent handling of organs, tissue and cells,c. authorisation, if handling of the organs, tissues or cells used is subject to authorisation under the transplantation act;3.9 the investigator's cv, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating their responsibilities and relevant professional knowledge;3.10 information on the suitability and availability of infrastructure at the trial site;3.11 information on the secure handling of personal data;3.12 agreements between the sponsor, or third parties acting on the sponsor's behalf, and the investigator, in particular with regard to the financing of the clinical trial, remuneration of the investigator and publication;3.13 certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party acting on the sponsor's behalf, and the investigator;3.14 for clinical trials of transplantation of genetically modified human organs, tissues and cells: the information specified in annex 4 number 6.7;3.15 any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.4 application documents for the ethics committees concerned in multicentre clinical trials 4.1 basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;4.2 protocol;4.3 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements, used at the site in question;4.4 the cv of the investigator responsible at the site in question, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial at the site in question, indicating their responsibilities and relevant professional knowledge;4.5 information on the suitability and availability of infrastructure at the trial site in question;4.6 agreements between the sponsor, or third parties acting on the sponsor's behalf, and the coordinating investigator and other investigators at the other sites, in particular with regard to the remuneration of the investigator at the site in question;4.7 certificate of insurance or other proof of coverage for possible damage occurring at the trial site in question, including agreements on this matter between the sponsor, or a third party acting on the sponsor's behalf, and the investigator.5 additional application documents for category a clinical trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo capable of emitting ionising radiation, and for investigations involving radiation sources 5.1 details of all relevant radiological protection aspects, and in particular a calculation or estimate of the effective dose, organ doses and any tumour doses;5.2 the licences required under article 28 of the radiological protection act of 22 march 199152.52 sr 814.506 additional application documents for clinical trials which include investigations involving radiation sources and require an opinion from the foph in accordance with article 28 paragraph 2 6.1 information on the properties of the radiopharmaceutical, and in particular on pharmacokinetics, quality, stability, radiochemical purity and radionuclide purity;6.2 for authorised radiopharmaceuticals: the prescribing information;6.3 for non-authorised radiopharmaceuticals: information on the manufacturing and quality control processes for the radiopharmaceutical, the names of the persons responsible for these processes and details of their professional qualifications;6.4 the names of the persons responsible for the use of the radiopharmaceutical in humans and details of their professional qualifications;6.5 information specified in the foph form for clinical trials of radiopharmaceuticals or radiolabelled compounds53.53 this form can be obtained [in french/german] from the federal office of public health, radiological protection division, ch-3003 bern; it can also be accessed online at: www.bag.admin.ch > themen > strahlung, radioaktivitt und schall.annex 4 (art. 31, 34-36, 54, 55)application documents to be submitted to the swiss agency for therapeutic products or to the foph for the procedure for clinical trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo and transplant products, clinical trials of gene therapy and of genetically modified or pathogenic organisms, and clinical trials of transplantation 1 application documents for category b clinical trials of medicinal products and transplant products 1.1 basic form;1.2 protocol;1.3 prescribing information for the medicinal product or transplant product;1.4 documents on the quality of the medicinal product, only concerning any changes in the composition and manufacturing thereof;1.5 investigator's brochure (ib), only concerning changes in the administration of the medicinal product;1.6 proof of compliance with good manufacturing practice (gmp);1.7 proof of compliance with correct labelling;1.8 any decisions of foreign drug regulatory authorities concerning the clinical trial, including any conditions imposed and the reasons given;1.9 information on any applications currently being reviewed by an ethics committee in switzerland, and on any decisions of ethics committees in switzerland.2 application documents for category c clinical trials of medicinal products and transplant products 2.1 basic form;2.2 protocol;2.3 documents on the quality of the medicinal product or transplant product;2.4 investigator's brochure (ib), including information on risk assessment; if the medicinal product under investigation is authorised for the proposed use in a country with a comparable drug regulation system, the relevant prescribing information may be submitted; for clinical trials in which the medicinal product or transplant product under investigation is being used in persons for the first time: in addition, the study reports cited in the ib;2.5 for trials of transplant products or gene therapy: documents on preclinical and toxicology studies;2.6 proof of compliance with good manufacturing practice (gmp);2.7 proof of compliance with correct labelling;2.8 any decisions of foreign drug regulatory authorities concerning the clinical trial, including any conditions imposed and the reasons given;2.9 information on any applications currently being reviewed by an ethics committee in switzerland, and on any decisions of ethics committees in switzerland.3 application documents for category c clinical trials of medical devices 3.1 basic form;3.2 protocol;3.3 case report form (crf);3.4 for clinical trials of a medical device with no conformity marking: the relevant documentation, comprising:a. investigator's brochure (ib), with a compilation of current clinical and non-clinical information on the product under investigation and its components,b. list of the applicable standards for medical devices and description of all deviations,c. documentation of and reasons for any deviations from the standard iso 14155,d. manufacturer's statement or release in accordance with annex viii to directive 93/42/eec54 or annex 6 to directive 90/385/eec55,e. confirmation that documentation is being kept available as specified in annex viii to directive 93/42/eec or annex 6 to directive 90/385/eec,f. if the sponsor of the clinical trial and the manufacturer of the product are not identical: agreement on risk management between the sponsor and manufacturer;3.5 for clinical trials of a medical device bearing a conformity marking which is not used in accordance with the intended purpose or the instructions: the relevant documentation, comprising:a. information on the conformity of the medical device,b. product information on the medical device,c. risk analysis for the new use and safety measures derived therefrom,d. other elements of the ib concerning the new use,e. list of the applicable standards for medical devices, description of deviations from these standards associated with the new use,f. documentation of and reasons for any deviations from the standard iso 14155;3.6 information sheet and informed consent form;3.7 any decisions of foreign medical device regulatory authorities concerning the clinical trial, including any conditions imposed and the reasons given;3.8 information on any applications currently being reviewed by an ethics committee in switzerland, and on any decisions of ethics committees in switzerland.54 council directive 93/42/eec of 14 june 1993 concerning medical devices, oj l 169, 12.7.1993, p. 1; last amended by directive 2007/47/ec, oj l 247, 21.9.2007, p. 21.55 council directive 90/385/eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices, oj l 189, 20.7.1990, p. 17; last amended by directive 2007/47/ec, oj l 247, 21.9.2007, p. 21.4 additional application documents for category b and c clinical trials of gene therapy and of genetically modified or pathogenic organisms 4.1 information on the risks of the investigational product containing genetically modified or pathogenic organisms;4.2 risk assessment of the conduct of the clinical trial with regard to the protection of human health and the environment;4.3 a description of the safety measures required for the protection of human and animal health and the environment, and in particular to prevent the release of microorganisms into the environment during and after transplantation, and during transport, storage and disposal.5 additional application documents for clinical trials of medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo capable of emitting ionising radiation 5.1 details of all relevant radiological protection aspects, and in particular a calculation or estimate of the effective dose, organ doses and any tumour doses;5.2 the licences required under article 28 of the radiological protection act of 22 march 199156;5.3 for medicinal products, in vitro diagnostic medical devices or combinations under article 2 letters f-h meddo containing radioactive sources57:a. information on the properties of the radiopharmaceutical, and in particular on pharmacokinetics, quality, stability, radiochemical purity and radionuclide purity,b. for authorised radiopharmaceuticals: the prescribing information,c. for non-authorised radiopharmaceuticals: information on the manufacturing and quality control processes for the radiopharmaceutical, the names of the persons responsible for these processes and details of their professional qualifications,d. the names of the persons responsible for the use of the radiopharmaceutical in humans and details of their professional qualifications,e. information specified in the foph form for clinical trials of radiopharmaceuticals or radiolabelled compounds58.56 sr 814.5057 german text amended by annex 11 no 6 of the radiological protection ordinance of 26 apr. 2017, in force since 1 jan. 2018 (as 2017 4261).58 this form can be obtained [in french/german] from the federal office of public health, radiological protection division, ch-3003 bern; it can also be accessed online at: www.bag.admin.ch > themen > strahlung, radioaktivitt und schall.6 application documents for category c clinical trials of transplantation of human organs, tissues and cells 6.1 basic form;6.2 protocol;6.3 proof of the origin of the organs, tissues or cells used;6.4 documents on the quality of the organs, tissues or cells used, and in particular on the tests performed;6.5 proof of compliance with duties of care, particularly with regard to the assessment of fitness to donate and mandatory testing, and the procedure in the event of reactive test results;6.6 proof of compliance with correct labelling;6.7 authorisation, if handling of the organs, tissues or cells used is subject to authorisation;6.8 any decisions of foreign regulatory authorities concerning the clinical trial, including any conditions imposed and the reasons given;6.9 information on any applications currently being reviewed by an ethics committee in switzerland, and on any decisions of ethics committees in switzerland.annex 5 (art. 64)content of registration 1 data to be entered in a registry the data specified in version 1.2.1 of the who trial registration data set59 must be entered in a registry as specified in article 64 paragraph 1.59 the trial registration data set can be consulted free of charge at the federal office of public health, ch-3003 bern: www.bag.admin.ch. it can also be accessed online at: www.who.int > programmes and projects > clinical trials - international registry platform > registry network.2 data to be entered in the supplementary database in the supplementary database specified in article 64 paragraph 2, the following data must be entered in a swiss national language:a. the name of the registry specified in article 64 paragraph 1 in which the data was entered, together with the time of registration and the identification number issued by the registry;b. the title of the clinical trial and a summary of the study protocol in layfriendly language;c. the health-related intervention being studied;d. the disease or condition being studied;e. eligibility and exclusion criteria;f. trial sites.annex 6 (art. 70)amendment of other legislation the following ordinances shall be amended as follows:.6060 the amendments may be consulted under as 2013 3407.

810.306english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinance on clinical trials with medical devices(clino-md)of 1 july 2020 (status as of 26 may 2021)the swiss federal council,based on the human research act of 30 september 20111 (hra)and on articles 54 paragraphs 3, 6 and 8, 54b paragraphs 2 and 3 and 82 of the therapeutic products act of 15 december 20002 (tpa),ordains:1 sr 810.302 sr 812.21chapter 1 general provisions section 1 subject matter, definitions and applicable provisions art. 1 subject matter 1 this ordinance shall regulate:a. the requirements pertaining to clinical trials with medical devices and other devices in accordance with article 1 of the medical devices ordinance of 1 july 2020 (meddo)3;b. the approval and reporting procedures for clinical trials involving the devices in accordance with letter a;c. the duties and responsibilities of research ethics committees (ethics committees), the swiss agency for therapeutic products (swissmedic) and the federal office of public health (foph) in connection with the approval and reporting procedures;d. the registration of clinical trials involving devices in accordance with letter a;e. public access to information concerning clinical trials.2 in this ordinance, the term devices is used to designate all products defined in paragraph 1 letter a.3 sr 812.213art. 2 definitions the following definitions shall apply in this ordinance:a. clinical trial means the systematic investigation of a device involving one or more persons for the purpose of assessing the safety or performance of the device;b. conformity-related clinical trial means a clinical trial conducted to demonstrate the conformity of the device being investigated;c. contracting state means any state that is bound to mutually recognise conformity assessments and conformity procedures for devices by an agreement with switzerland under international law based on equivalent legislation;d. sponsor means any individual or institution or organisation that takes responsibility for the initiation of a clinical trial - specifically its instigation, management and financing - in switzerland;e. investigator means any individual responsible for the conduct of a clinical trial and for the protection of the participants at a clinical trial site; any participant who assumes responsibility for initiating a clinical trial in switzerland is simultaneously the trial's sponsor.art. 3 applicable provisions 1 the following provisions of the ordinance of 20 september 20134 on clinical trials in human research (clino) apply to clinical trials with devices:a. for scientific integrity and scientific quality: articles 3 and 4 clino;b. for participant information, consent and withdrawal of consent: articles 7-9 clino;c. for liability and indemnification: article 10 paragraphs 1 letter c and 2 and article 11-14 clino;d. for the conduct of clinical trials in emergency situations: articles 15-17 clino;e. for the storage of personal health data and biological material: article 18 clino;f. for inspections and administrative measures: article 46 paragraphs 1, 2, 4 and 5 and article 47 and 48 clino.2 the powers exercised by swissmedic and the duty to cooperate and provide information incumbent on the sponsor and investigator in the event of inspections and administrative measures are governed mutatis mutandis by articles 77 and 78 meddo5.3 clinical trials with in vitro diagnostic devices, devices as specified in art. 2a paragraph 2 tpa or combinations as specified in article 2 paragraph 1 letters f and g meddo are subject to clino.64 sr 810.3055 sr 812.2136 amended by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).section 2 general obligations of the sponsor and investigator and professional qualifications art. 4 general obligations of the sponsor and investigator 1 the sponsor and investigator must conduct clinical trials in accordance with article 72 and chapters i and iii of annex xv to regulation (eu) 2017/7457 on medical devices (eu-mdr).2 compliance with the requirements of paragraph 1, specified in greater detail by designated technical standards8 or common specifications in accordance with article 9 paragraph 1 eu-mdr, is presumed if the clinical trial is conducted in accordance with those standards or specifications. article 6 paragraph 5 meddo9 applies mutatis mutandis.3 if the sponsor is not domiciled in switzerland and does not have a place of business there, it must designate an agent that is domiciled or has a place of business in switzerland as an address for correspondence. this agent must ensure compliance with the sponsor's obligations.7 regulation (eu) no 2017/745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 2001/83/ec, regulation (ec) no 178/2002 and regulation (ec) no 1223/2009 and repealing council directives 90/385/eec and 93/42/eec, oj l 117 of 5.5. 2017, p. 1; last amended by regulation (eu) 2002/561, oj l 130 of 24.4.2020, p. 18.8 the electrical standards can be obtained from the industry association electrosuisse, luppmenstrasse 1, 8320 fehraltorf, www.electrosuisse.ch, and the other standards from the swiss association for standardization (snv), sulzerallee 70, 8404 winterthur, www.snv.ch9 sr 812.213art. 5 professional qualifications 1 clinical trial investigators must:a. be entitled to practise independently as a doctor or in another profession that specifically qualifies them to conduct the clinical trial;b. demonstrate adequate knowledge of the internationally recognised requirements for the conduct of clinical trials and the specialist knowledge and experience required for the clinical trial; andc. possess knowledge of the legal requirements governing clinical trials or be able to guarantee the availability of such knowledge by recruiting appropriate expertise.2 the remaining people conducting the clinical trial must possess the training or experience in the specialist field that is required to conduct clinical trials.chapter 2 approval and reporting procedures section 1 general provisions art. 6 categorisation of clinical trials 1 clinical trials fall into category a if: a. the device to be investigated carries a conformity marking in accordance with article 13 meddo10; b. the device to be investigated is used in accordance with the instructions for use; andc. it is not prohibited to make the device to be investigated available on the market, put it into service or use it in switzerland.2 category a clinical trials are divided into sub-categories as follows:a. if the participants do not undergo additional invasive or stressful procedures compared with the procedures applied when the device is used under normal conditions: sub-category a1;b. if the participants undergo additional invasive or stressful procedures compared with the procedures applied when the device is used under normal conditions: sub-category a2.3 clinical trials fall into category c if:a. the device carries a conformity marking in accordance with article 13 meddo but is not used in accordance with the instructions for use (sub-category c1);b. the device does not carry a conformity marking in accordance with article 13 meddo (sub-category c2); orc. it is prohibited to make the device available on the market, put it into service or use it in switzerland (sub-category c3).10 sr 812.213art. 7 exemption from mandatory approval category a clinical trials are exempt from the requirement to obtain approval from swissmedic set out in article 54 paragraph 1 tpa.art. 8 data processing in electronic systems and information sharing 1-5 .116 the medical devices information system in accordance with article 62c tpa and the information system operated by the cantons in accordance with article 56a hra may contain information on administrative or criminal proceedings or sanctions concerning the sponsor, investigator or manufacturer that swissmedic and the competent ethics committee require in order to fulfil their duties under this ordinance.7 swissmedic shall, upon request, forward the highly sensitive data in accordance with paragraph 6 to the ethics committees.11 to come into force in due course (art. 50 para. 2).art. 9 information and coordination for approval procedures the competent ethics committee and swissmedic shall provide information to each other on the following aspects and coordinate their assessments:a. categorisation of the clinical trial in accordance with article 6;b. aspects concerning the review areas in accordance with article 11 and article 17;c. the conduct of the procedures set out in articles 12 and 19 and in chapter 3.section 2 procedures to be performed by the competent ethics committee art. 10 application 1 the sponsor shall submit the application documents specified in annex 1.122 the ethics committee may demand additional information.3 the investigator may submit the application in place of the sponsor. in this case, it assumes the duties of the sponsor as set out in articles 14 and 15 and the duty to notify and report to the competent ethics committee. the sponsor must co-sign the application documents.12 amended by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).art. 11 review areas the areas to be reviewed by the ethics committee are governed by article 25 clino13.13 sr 810.305art. 12 procedures and time limits 1 the ethics committee shall confirm receipt of the application to the sponsor within 10 days and notify the sponsor of any formal shortcomings in the application documents. it shall give the applicant 10 days to rectify the shortcomings and inform the applicant that it will not admit the application if the shortcomings are not rectified within the deadline.2 it shall make its decision within 40 days of confirming receipt of the formally correct application documents. 3 if the ethics committee demands additional information in accordance with article 10 paragraph 2, the 40-day period shall be paused until the information is received.art. 13 multi-centre clinical trials 1 the sponsor shall submit its application for a multi-centre clinical trial in accordance with article 47 paragraph 2 hra to the ethics committee responsible for the coordinating investigator. the coordinating investigator may submit the application in place of the sponsor. article 10 paragraph 3 applies mutatis mutandis.2 the coordinating investigator is the person with responsibility in switzerland for coordinating the investigators responsible for the various trial sites.3 the lead committee shall confirm receipt of the application to the sponsor within 10 days and notify it of any formal shortcomings in the application documents. it shall give the applicant 10 days to rectify the shortcomings and inform the applicant that it will not admit the application if the shortcomings are not rectified within the deadline. upon application, the lead committee may extend these deadlines by a period of five days in each case.4 it shall notify the ethics committees responsible for the trial sites (participating ethics committees) that it has received the application. these shall review the local conditions and notify the lead committee of their evaluation within 15 days.5 the lead committee shall make its decision within 40 days of confirming receipt of the formally correct application documents.art. 14 procedure for investigations involving radiation sources 1 for investigations involving radiation sources, the sponsor shall submit the additional application documents specified in annex 1 number 4. the approval procedure shall be governed by articles 10-13 and 15, subject to the paragraphs below.142 the sponsor shall submit the additional application documents specified in annex 1 number 5 if the effective dose, taking account of the uncertainty factor, exceeds 5msv per person and year and:15a. the trial involves a radiopharmaceutical that is not authorised in switzerland;b. the trial involves a radiopharmaceutical that is authorised in switzerland but does not involve a routine nuclear medical investigation; orc. the trial involves a different radioactive source.3 the ethics committee shall forward the application documents to the foph in accordance with annex 1 number 5.4 the foph shall send the ethics committee its comments on compliance with radiological protection legislation and on the estimated dose. it may grant exemptions to the reporting obligation in accordance with article 39 paragraph 5.5 the ethics committee shall approve the trial if:a. the requirements set out in article 11 are fulfilled; andb. the foph has not submitted any objections to the clinical trial within a reasonable period.6 it shall notify the foph of its decision.14 amended by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).15 amended by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).art. 15 amendments 1 all amendments to an approved clinical trial that could have a significant impact on the safety, health or rights of participants and on the robustness or reliability of the clinical data obtained (substantial amendments) must be approved by the ethics committee prior to their adoption. this obligation does not extend to measures that have to be taken immediately to protect trial participants.2 the sponsor shall submit any application documents specified in article 10 paragraph 1 that are affected by the amendment. amendments must be clearly marked. the sponsor shall submit information on the nature of and reasons for the amendment at the same time.3 the ethics committee shall issue its decision on substantial amendments within 30 days. article 12 applies mutatis mutandis. 4 where a further clinical trial site is to be added and that site lies outside the competence of the ethics committee that approved the clinical trial, the procedure set out in article 13 applies mutatis mutandis.5 other amendments must be reported to the ethics committee with the annual safety report as specified in article 35.6 for clinical trials in sub-category a2, the sponsor shall also notify the contracting states in which the clinical trial is being conducted or is due to be conducted of the nature of and reasons for the amendments; it shall attach the documents as specified in annex 1 which are affected by the amendments.section 3 approval procedures to be performed by swissmedic art. 16 application 1 the sponsor shall submit the application documents specified in annex 1 number 2.2 swissmedic may demand additional information.3 if the sponsor withdraws its application for conformity-related clinical trials in sub-categories c1 and c2 before swissmedic has made a decision, it shall inform the contracting states in which the clinical trial is being conducted or is due to be conducted.art. 17 review areas 1 for clinical trials, swissmedic shall verify:a. whether the application is complete;b. whether the requirements of article 54 paragraph 4 letter b tpa are fulfilled.2 it shall conduct a simplified review if the sponsor demonstrates the following in its application:a. the clinical trial falls into sub-category c1 or c2 and involves a non-invasive device classified as class i or iia under article 15 meddo16;b. use of the device to be investigated entails at most minimal risk for the trial participants;c. the investigator has signed a written agreement with the sponsor requiring the investigator to notify the sponsor without delay of serious adverse events or any other incident as specified in article 32;d. the sponsor operates a risk management and safety monitoring system.3 swissmedic shall restrict its simplified review to determining whether the application is complete and the evidence required under paragraph 2 has been provided.16 sr 812.213art. 18 clinical trials with devices capable of emitting ionising radiation 1 the additional application documents specified in annex 1 numbers 4 and 5 must be submitted for category c clinical trials.172 swissmedic shall invite the foph to submit its comments before it approves trials. the foph shall review compliance with radiological protection legislation and the estimated dose.3 swissmedic shall approve the trial if:a. the requirements set out in article 17 are fulfilled; andb. the foph has not submitted any objections to the clinical trial within an appropriate period.4 it shall notify the foph of its decision.17 amended by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).art. 19 procedures and time limits 1 swissmedic shall confirm receipt of the application to the sponsor within 10 days and notify it of any formal shortcomings in the application documents. it shall give the applicant 10 days to rectify the shortcomings and inform the applicant that it will not admit the application if the shortcomings are not rectified within the deadline. upon application, swissmedic may extend the deadline for rectifying the shortcomings by 20 days.2 it shall make its decision within 45 days of confirming receipt of the formally correct application documents. it may only approve a clinical trial if the competent ethics committee has approved it beforehand.3 swissmedic shall also inform the contracting states if it rejects the application.4 if a device is being used in humans for the first time or manufactured using a new process, swissmedic may extend the period specified in paragraph 2 by no more than 20 days. it shall notify the sponsor of the extension.5 if swissmedic demands additional information as specified in article 16 paragraph 2, the 45-day period shall be paused until the information is received.art. 20 amendments 1 substantial amendments to an approved clinical trial, in accordance with article 15 paragraph 1, must be submitted to swissmedic for approval prior to their adoption. this obligation does not extend to measures that have to be taken immediately to protect trial participants. 2 the sponsor shall submit to swissmedic the application documents as specified in article 16 paragraph 1 that are affected by the amendment. it shall submit information on the nature of and reasons for the amendment at the same time.3 swissmedic shall make its decision within 38 days of receiving all the application documents affected by the amendment. article 19 applies mutatis mutandis. this period may be extended by seven days.4 other amendments applicable to the application documents submitted to swissmedic must be notified to swissmedic as quickly as possible.4bis for conformity-related clinical trials in sub-categories c1 and c2 that are also being conducted or are also due to be conducted in eu or eea states, the sponsor shall notify swissmedic of the nature of and reasons for substantial amendments to the clinical trial in eu or eea states that affect the protocol, investigational device or instructions for use for the investigational device.185 the sponsor of a conformity-related clinical trial in sub-categories c1 and c2 shall also notify the contracting states in which the clinical trial is being conducted or is due to be conducted of the nature of and reasons for the amendments; it shall attach the documents as specified in annex 1 which are affected by the amendments.18 inserted by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).chapter 3 coordinated assessment procedure art. 21-3119 19 to come into force in due course (art. 50 para. 2).chapter 4 documentation, notifications and reporting section 1 documentation and reporting of incidents and of safety and protection measures art. 32 documentation of adverse events 1 the sponsor must document the following adverse events that occur during a clinical trial in a standardised form:a. adverse events of all types designated in the protocol as crucial to assessing the results of the clinical trial;b. all serious adverse events:c. any device deficiency that could have resulted in serious adverse events under less propitious circumstances or if appropriate action or an intervention had not taken place;d. all new findings relating to a documented incident as specified in letters a-c. 2 the sponsor shall provide swissmedic and the competent ethics committee with the documentation specified in paragraph 1 upon request.3 the definitions of adverse events and device deficiencies are those in article 2 numbers 57-59 eu-mdr20.20 see the footnote to art. 4 para. 1.art. 33 reporting of serious adverse events21 1 for category c clinical trials, the sponsor shall notify swissmedic and the competent ethics committee without delay of:a. each serious adverse event that has a causal relationship with the investigational device, the comparator device or a test procedure or where a causal relationship appears entirely possible;b. any device deficiency that could have resulted in serious adverse events under less propitious circumstances or if appropriate action or an intervention had not taken place;c. all new findings relating to a reported incident as specified in letters a and b.1bis for conformity-related clinical trials in sub-categories c1 and c2 that are also being conducted abroad, the sponsor shall also notify swissmedic and the competent ethics committee without delay of all incidents, device deficiencies and findings as specified in paragraph 1 which arise from the conduct of the clinical trial abroad.222 to ensure reporting is not delayed, the sponsor may provisionally submit an incomplete report. 3 for conformity-related clinical trials in sub-categories c1 and c2, the sponsor shall also provide reports in accordance with paragraph 1 to those contracting states in which the clinical trial is being conducted or is due to be conducted4 for category a clinical trials, the sponsor shall report:a. to the competent ethics committee: without delay any serious adverse event for which a causal relationship between the event and the test procedure used in the clinical trial has been ascertained; paragraph 2 is applicable;b. to swissmedic and the competent ethics committee: the reports as specified in articles 87-90 eu-mdr23.21 amended by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).22 inserted by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).23 see the footnote to art. 4 para. 1.art. 34 reporting of safety and protective measures 1 if safety and protective measures have to be implemented without delay during the course of a clinical trial, the sponsor shall report these measures and the circumstances that necessitated them to the ethics committee within two days.1bis for clinical trials that are also being conducted or are also due to be conducted in eu or eea states, the sponsor shall also notify the ethics committee within two days of all prescribed or voluntary safety and protective measures that are being implemented in eu or eea states and the circumstances that necessitated them.242 the sponsor must report any clinical trial that is terminated or interrupted for reasons of safety in accordance with article 36 paragraph 4.3 for category c clinical trials, reporting under paragraphs 1 and 1bis must also be submitted to swissmedic.254 for conformity-related clinical trials in sub-categories c1 and c2, the sponsor shall also provide reports under paragraph 1 to the contracting states in which the clinical trial is being conducted or is due to be conducted24 inserted by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).25 amended by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).section 2 reporting on the safety of participants and reporting at the conclusion, termination or interruption of a clinical trial art. 35 annual reporting on the safety of participants 1 once a year, the sponsor shall submit to the competent ethics committee a list of the serious adverse events and device deficiencies in accordance with article 33 and provide it with a report on their severity, causal relationship with the device and the intervention, as well as on the safety of the participants (annual safety report, asr).2 for category c clinical trials that are also being conducted abroad, the list and report must also include adverse events and device deficiencies that occurred abroad.2bis for category c clinical trials that are also being conducted in, or are also due to be conducted in, eu or eea states, the report in accordance with paragraph 2 must include the status of the clinical trial in the states in question.2626 inserted by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).art. 36 reporting the conclusion, termination and interruption of a clinical trial 1 the sponsor shall report the conclusion of the clinical trial in switzerland to the ethics committee within 15 days.2 unless otherwise specified in the protocol, the conclusion of the clinical trial is deemed to be the final visit by the final participant.3 the sponsor shall report the termination or interruption of the clinical trial to the ethics committee within 15 days. the report must set out the reasons for the termination or interruption.4 if the trial is terminated or interrupted for reasons of safety, the following shall apply:a. the report must be submitted within 24 hours.b. the report must also be submitted to those contracting states in which the clinical trial is being conducted or is due to be conducted.4bis for clinical trials that are also being conducted in eu or eea states, the sponsor must also report any termination or interruption of the trial in eu or eea states to the ethics committee within 24 hours if the termination or interruption was for reasons of safety.275 if a multi-centre clinical trial is terminated or interrupted at one of the trial sites, the sponsor must also perform the reporting according to paragraph 3 and 4 to the other participating ethics committees.27 inserted by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).art. 37 final report 1 the sponsor shall submit to the ethics committee a final report in accordance with section 2.8 of chapter i and section 7 of chapter iii of annex xv to eu-mdr28:a. within one year of the clinical trial being concluded;b. within three months of the clinical trial being terminated or interrupted.2 if scientific reasons prevent compliance with the reporting deadline specified in paragraph 1 letter a, the sponsor must submit the report as soon as it is available. the protocol must specify when the final report will be submitted and provide reasons.3 a summary in lay language must be included with the final report.28 see the footnote to art. 4 para. 1.art. 38 notification and reporting to swissmedic for category c clinical trials, the notifications and reports specified in articles 35-37 must also be submitted to swissmedic.section 3 reporting in connection with the use of radiation sources and document retention art. 39 verification, notification and reporting in connection with the use of radiation sources 1 for clinical trials with devices capable of emitting ionising radiation and investigations with radiation sources, the sponsor shall verify compliance with the dose constraint specified in article 45 rpo29.2 should the dose constraint be exceeded at any time, the sponsor shall notify the fact to the competent ethics committee within 7 days of becoming aware of it.3 for category c trials with devices that emit ionising radiation, the notification in accordance with paragraph 2 must also be sent to swissmedic.4 the competent ethics committee and swissmedic may consult the foph for expert advice on assessing the calculated or estimated dose and on determining further measures.5 for clinical trials in accordance with paragraph 1, the sponsor shall document in the final report all relevant radiological protection information, particularly an estimation of the dose the participants were exposed to; this shall not apply in the case of an exemption from the reporting obligation as specified in article 14 paragraph 4.6 the competent ethics committee shall forward the final report to the foph.29 sr 814.501art. 40 document retention requirements 1 the sponsor must retain all data concerning the clinical trial until the expiry date of the last series of devices used in the trial, but for a minimum of ten years following the conclusion or termination of the clinical trial. the retention period for implantable devices is at least 15 years.2 the investigator must retain all documents required to identify and provide post-trial care to participants, as well as all other original data, for at least ten years after the conclusion or termination of the clinical trial. the retention period for implantable devices is at least 15 years.chapter 5 transparency art. 41 and 4230 30 to come into force in due course (art. 50 para. 2).chapter 6 final provisions art. 43 updating of the annexes the federal department of home affairs may update annex 1 in line with international or technical developments. where updates may pose technical barriers to trade, it shall effect such updates by mutual agreement with the federal department of economic affairs, education and research.art. 44 amendment of other legislation the amendment of other legislation is regulated in annex 2.art. 45 information on directly applicable legal acts of the european commission swissmedic shall provide on its website information on legal acts of the european commission that, under the terms of this ordinance, are directly applicable in switzerland in the version binding upon the member states of the european union.art. 46 harmonisation of enforcement 1 swissmedic and the ethics committees may prescribe electronic forms and technical procedures for inputting and transmitting documents and for sharing information in the electronic systems in accordance with article 8.2 for the purposes of enforcing this ordinance, particularly the provision of electronic forms and aids to enforcement, swissmedic and the ethics committees shall comply with the implementing acts adopted by the european commission under articles 70, 78 and 81 eu-mdr31, specifically in reference to:a. harmonised electronic forms for applications for clinical trials and their assessment, procedures to be performed by ethics committees and swissmedic and for the coordinated assessment procedure;b. harmonised electronic forms for substantial amendments;c. harmonised electronic forms for reporting serious adverse events and device deficiencies;d. the exchange of information between the member states and switzerland in the course of communication of intended measures, the termination of a clinical trial for reasons of safety, the withdrawal of an application and refusal to authorise a clinical trial;e. time limits for reporting serious adverse events and device deficiencies that are notifiable by virtue of their gravity;f. the requirements of chapter ii of annex xv to eu-mdr;g. the coordinated assessment procedure.31 see the footnote to art. 4 para. 1.art. 47 cooperation with the european commission and authorities of the contracting states 1 where provided for by international agreements, swissmedic shall cooperate with the european commission and the authorities of the contracting states.2 in doing so, swissmedic shall involve the ethics committees in appropriate fashion where their area of responsibility is affected.art. 48 transitional provisions for clinical trials approved under previous legislation and involving medical devices 1 approvals for clinical trials of devices issued by the competent ethics committee and swissmedic prior to the entry into force of this ordinance shall remain valid until their expiry date.2 the results of clinical trials of devices that are still in progress when this ordinance enters into force have to be published in a recognised register in accordance with article 64 paragraph 1 clino32 within the time limit specified in article 42.3 where clinical trials in accordance with paragraph 1 undergo substantial amendments, the sponsor must apply for categorisation under article 6 at the same time.32 sr 810.305art. 49 transitional provisions 1 until article 8 paragraphs 1, 4 and 5 of this ordinance comes into force (art. 50 para. 2), sponsors shall use the following information systems to input and transmit applications, notifications, reports and other information required under this ordinance:a. the cantons' information system in accordance with article 56a hra for documents and information intended for the competent ethics committee;b. the medical devices information system in accordance with article 62c tpa for documents and information intended for swissmedic.2 until article 8 paragraphs 2 and 3 of this ordinance comes into force (art. 50 para. 2):a. swissmedic shall use the medical devices information system in accordance with article 62c tpa to input and transmit decisions and to exchange information with applicants;b. the competent ethics committee shall use the cantons' information system in accordance with article 56a hra for the purposes described in letter a.3 until articles 41 and 42 of this ordinance come into force (art. 50 para. 2), sponsors must register clinical trials in accordance with articles 64, 65 paragraphs 1 and 3 and 66 and 67 clino33. they must also publish the results of such clinical trials in a recognised register in accordance with article 64 paragraph 1 clino within the following time limits:a.34 for concluded category c clinical trials: at the latest before the device is placed on the market or one year after submitting the final report in accordance with article 37 if the device has not been placed on the market by this point in time;b. for concluded category a clinical trials and if a trial is terminated or interrupted: immediately after submitting the final report in accordance with article 37.33 sr 810.30534 amended by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).art. 50 commencement 1 subject to the exceptions in paragraph 2, this ordinance comes into force on 26 may 2021.2 articles 8 paragraph 1-5, 21-31, 41 and 42 come into force at a later date.annex 135 35 revised by annex no 1 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).(art. 10 para. 1, 14, 15 para. 6, 16 para. 1, 18 para. 1, 20 para. 5, 23 para. 2)application documents for the approval procedure for clinical trials 1 application documents for category a clinical trials 1.1 the application documents specified in chapter ii of annex xv to eu-mdr36, taking account of the amendments to this annex adopted by the european commission by means of delegated acts on the basis of article 70 eu-mdr, must be submitted with the following specification:a. with reference to chapter ii sections 1.1 and 3.1.2 of annex xv to eu-mdr (identification of the sponsor): name, address and contact details of the sponsor and, where the sponsor is not domiciled in switzerland and does not have a place of business there, its agent in switzerland;b. the following information in addition to that required by chapter ii section 3.1 of annex xv to eu-mdr for multi-centre clinical trials in switzerland: name, address and contact details of the coordinating investigator in switzerland.1.1bis for clinical trials that are also being conducted or are also due to be conducted in eu or eea states, any opinions of the relevant foreign ethics committee on the clinical trial must be submitted, including any conditions and the reasons for these conditions.1.2 the following information specified in chapter ii of annex xv to eu-mdr does not have to be submitted:a. the information in section 1.16;b. the information in sections 2.3-2.8;c. the information in section 4.2.1.3 swissmedic shall provide on its website information on the delegated acts under section 1.1 that, under the terms of this ordinance, are directly applicable in switzerland in the version binding upon the member states of the eu (art. 45).36 see the footnote to art. 4 para. 1.2 application documents for category c clinical trials 2.1 the application documents specified in chapter ii of annex xv to eu-mdr, taking account of the amendments to this annex adopted by the european commission by means of delegated acts on the basis of article 70 eu-mdr, must be submitted with the following specifications for sections 1.1 and 3.1.2 (identification of the sponsor): name, address and contact details of the sponsor and, if the sponsor is not domiciled in switzerland and does not have a place of business there, its agent in switzerland.2.1bis for clinical trials that are also being conducted or are also due to be conducted in eu or eea states, any decisions or opinions of the relevant foreign medical devices supervisory authority and ethics committee on the clinical trial must be submitted, including any conditions and the reasons for these conditions.2.2 if the clinical trial is a multi-centre trial in switzerland, the name, address and contact details of the coordinating investigator in switzerland must be provided in addition to the information required under chapter ii section 3.1.3 of annex xv to eu-mdr.2.3 the following information specified in chapter ii of annex xv to eu-mdr does not have to be submitted:a. the information in section 1.16;b. the information in section 4.2.2.4 swissmedic shall provide on its website information on the delegated acts under section 2.1 that, under the terms of this ordinance, are directly applicable in switzerland in the version binding upon the member states of the eu (art. 45).3 application documents for clinical trials in sub-categories c1 and c2 in the coordinated procedure 3.1 general partfor the general part, the application documents specified in chapter ii of annex xv to eu-mdr, with the exception of the national part in accordance with article 23 paragraph 2, taking account of the amendments to this annex adopted by the european commission by means of delegated acts on the basis of article 70 eu-mdr, must be submitted with the following specifications for sections 1.1 and 3.1.2 (identification of the sponsor): name, address and contact details of the sponsor and, where the sponsor is not domiciled in switzerland, its agent in switzerland.3.2 national partfor the national part, the application documents specified in chapter ii sections 1.13, 3.1.3 and 4.2-4.4 of annex xv to eu-mdr, taking account of the amendments to this annex adopted by the european commission by means of delegated acts on the basis of article 70 eu-mdr, must be submitted with the following specification for section 3.1.2: for multi-centre trials in switzerland: name, address and contact details of the coordinating investigator in switzerland.3.3 swissmedic shall provide on its website information on the delegated acts under section 3.1 and 3.2 that, under the terms of this ordinance, are directly applicable in switzerland in the version binding upon the member states of the eu (art. 45).4 additional application documents for clinical trials with devices capable of emitting ionising radiation and for investigations involving radiation sources (art. 14 para. 1) for clinical trials with devices capable of emitting ionising radiation and for investigations involving radiation sources (art. 14 para. 1), the following additional information and documents must be submitted:a. information on significant radiation protection aspects, particularly a calculation or estimation of the effective dose-equivalent, the doses absorbed by the organs and, if applicable, the doses absorbed by the tumours;b. the necessary permits in accordance with article 28 of the radiological protection act of 22 march 199137.37 sr 814.505 additional application documents for category c clinical trials with devices capable of emitting ionising radiation and for clinical trials involving investigations with radiation sources and requiring the comments of the foph in accordance with article 14 paragraph 2 for category c clinical trials with devices capable of emitting ionising radiation (art. 18) and investigations involving radiation sources that require the comments of the foph in accordance with article 14 paragraph 2, the following information must be submitted in addition to the information listed under number 4:a. if applicable, information on the properties, specifically the pharmacokinetics, quality, stability, radiochemical purity and radionuclide purity;b. for authorised radiopharmaceuticals: the information for healthcare professionals;c. for non-authorised radiopharmaceuticals: information on the manufacturing process and quality control of the radiopharmaceutical, the names of the people responsible for both and their professional qualifications;d. the names of the people responsible for the use of the radiopharmaceutical on humans and their professional qualifications;e. information required by the foph form for clinical trials with radiopharmaceuticals or radiolabelled substances38.38 this form can be obtained from foph, radiation protection division, 3003 bern or on the internet at www.bag.admin.ch > healthy living > environment & health > radiation, radioactivity & sound.annex 2 (art. 44)amendments to other legislation the following are amended as follows:.3939 the amendments can be consulted at as 2020 3033.

810.308 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinance on organisational aspectsof the human research act(hra organisation ordinance, orgo-hra)of 20 september 2013 (status as of 26 may 2021)the swiss federal council,on the basis of articles 49 paragraphs 1 and 2, 53 paragraph 3, 59 paragraph 6, 60 paragraph 2 and 65 of the human research act of 30 september 20111 (hra),ordains:1 sr 810.30chapter 1 research ethics committee art. 1 composition 1 the research ethics committee (ethics committee) shall be composed at least of persons possessing expertise in the following disciplines:a. medicine;b. psychology;c. nursing;d. pharmaceutics or pharmaceutical medicine;e. biology;f. biostatistics;g. ethics; andh. law, including data protection.2 it shall be of balanced composition as regards gender and professional groups.3 the ethics committee must be able to draw on knowledge of local conditions in the various areas of responsibility.4 if the ethics committee lacks the expertise required for the assessment of a research project, it must call in external specialists.art. 2 requirements for members 1 members of the ethics committee must, on commencing their service, attend a course on the duties of the ethics committee and the fundamentals of the assessment of research projects, and must regularly undergo further training in this area.2 the members specified in article 1 paragraph 1 letters a-c must have experience in the conduct of research projects.art. 3 scientific secretariat 1 persons working for the scientific secretariat must have:a. a degree in medicine, pharmaceutics, natural sciences, psychology or law;b. adequate training in good clinical practice;c. a knowledge of scientific methods for human research projects; andd. a knowledge of the legal requirements governing human research.2 the scientific secretariat shall be staffed at a level that is sufficient:a. to ensure its availability for the committee and for applicants; andb. to guarantee that procedural deadlines are met.art. 4 withdrawal from participation 1 members of the ethics committee shall withdraw from participation in cases where:a. they are personally involved, or otherwise have a personal interest, in the research project;b. persons reporting to them, to whom they report, or with whom they have close personal ties, are involved in the research project; orc. they are an interested party for other reasons.2 members who are interested parties must not participate in deliberations or in decision-making on the matter in question.art. 5 regular procedure 1 the ethics committee shall make decisions under the regular procedure with the participation of at least seven members. the composition of this group shall be such as to guarantee an expert and interdisciplinary assessment of the application.2 decisions shall be taken after oral deliberations. in justified exceptional cases, it is permissible for proceedings to be conducted in writing; a member may at any time request oral deliberations.3 decisions of the ethics committee shall be made by majority vote. in the event of a tie, the chair or vice-chair shall have a casting vote.4 the provisions of articles 6 and 7 are reserved.art. 6 simplified procedure 1 the ethics committee shall make decisions with the participation of three members on:a.2 category a clinical trials, as specified in article 19 paragraph 1, article 20 paragraph 1, article 49 paragraph 1 and article 61 paragraph 1 of the ordinance of 20 september 20133 on clinical trials (clino), provided that the trial does not raise any particular ethical, scientific or legal issues;abis.4 clinical trials of devices in subcategory a1 as referred to in article 6 paragraph 1 of the ordinance of 1 july 20205 on clinical trials with medical devices, provided the trial does not raise any particular specific ethical, scientific or legal issues;b. category a research projects involving persons, as specified in article 7 paragraph 1 of the human research ordinance of 20 september 20136;c. the further use for research of biological material or health-related personal data in the absence of informed consent, in accordance with article 34 hra, provided that this does not raise any particular ethical, scientific or legal issues;d. research projects involving deceased persons, with the exception of research projects involving deceased persons undergoing artificial respiration, as specified in article 37 paragraph 2 hra;e. significant changes to authorised research projects, if they raise particular ethical, scientific or legal issues.2 the group of three must comprise members from different disciplines specified in article 1.73 the conduct of proceedings in writing is permissible if no members request oral deliberations.4 the regular procedure shall be adopted if:a. unanimous agreement is not reached; orb. a request to this effect is made by a member of the group of three.2 amended by annex no 3 of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).3 sr 810.3054 inserted by annex 2 no 3 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).5 sr 812.213.36 sr 810.3017 amended by annex 2 no 3 of the o of 1 july 2020 on clinical trials with medical devices, in force since 26 may 2021 (as 2020 3033).art. 7 decisions to be made by the chair 1 the chair or vice-chair of the ethics committee shall make decisions on:a. research projects involving existing biological material or existing health-related personal data, with the exception of further use in accordance with article 34 hra;b. significant changes to authorised research projects which do not raise any particular ethical, scientific or legal issues;c. whether the requirements concerning local conditions in multicentre research projects are met;d. refusal to consider incomplete applications;e. the cancellation of applications which are no longer relevant or have been withdrawn;f. the fulfilment of conditions imposed;g. the ordering of official measures as specified in article 48 hra.2 he or she may at any time order the adoption of the simplified or regular procedure.art. 8 obligation to retain documents and right of inspection 1 application documents submitted to the ethics committee, minutes of meetings and correspondence must be retained for ten years after the completion or discontinuation of a research project.2 the cantonal supervisory authority may inspect these documents.art. 9 notification requirements the cantonal supervisory authority shall notify the coordination office as specified in article 10 of the responsible ethics committee.chapter 2 coordination office art. 10 1 the federal office of public health (foph) shall manage the coordination office as specified in article 55 hra.2 in particular, the coordination office has the following duties:a. it ensures regular exchanges between the supervisory authorities concerned.b. it ensures regular exchanges with research representatives and institutions.c. in cooperation with the ethics committees and, where appropriate, other supervisory authorities concerned, it issues recommendations on authorisation and notification procedures and on specific aspects of decision-making practice.d. it participates in the design and implementation of basic and further training for members of ethics committees.e. it provides information for the public, preparing in particular a summary of the annual reports submitted by ethics committees and a statistical overview of the research projects authorised.3 it may, within the framework of the operation of the portal and the supplementary federal database in accordance with article 67 clino8, enable the electronic exchange of documents relating to the authorisation and notification procedures between applicants and authorisation authorities.4 it shall issue guidelines on the content of the reports to be submitted by ethics committees in accordance with article 55 paragraph 2 hra.8 sr 810.305chapter 3 data protection art. 11 disclosure of personal data 1 before the enforcement body discloses personal data to the authorities responsible in accordance with article 59 paragraphs 1 and 2 hra, it shall solicit comments from the data subject, providing information at the same time on:a. the purpose of the disclosure of data;b. the nature of the data to be disclosed; andc. the data recipient.2 the obligations specified in paragraph 1 do not apply if:a. the data subject has already been adequately informed;b. the disclosure of data is evident from the circumstances of the particular case;c. there is an immediate risk of legal claims or important third-party interests being prejudiced, or the fulfilment of legal duties being prevented; ord. the data subject cannot be traced.3 if data is to be published under article 59 paragraph 3 hra, all items which, when combined, would enable the data subject to be identified without disproportionate effort, must be masked or deleted. these include in particular the name, address, date of birth and unique identification numbers.art. 12 exchange of data with foreign authorities and institutions 1 the following are empowered to exchange confidential data with foreign authorities and institutions or international organisations:a. the responsible ethics committee;b. the cantonal supervisory authority;c. the swiss agency for therapeutic products (agency); andd. the foph.2 if the confidential data includes personal data, this may only be transmitted to foreign authorities and institutions or to international organisations if the privacy of the data subject is not seriously endangered thereby, in particular due to the absence of legislation that guarantees adequate protection.3 in the absence of legislation that guarantees adequate protection, personal data may only be transmitted abroad if:a. disclosure is required in order to protect the life or the physical integrity of the data subject;b. disclosure is essential in order to avert an imminent danger to public health;c. sufficient safeguards, in particular contractual clauses, ensure an adequate level of protection abroad; ord. the data subject has consented in the particular case.chapter 4 commencement art. 13 this ordinance shall come into force on 1 january 2014.

810.311 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon research involving embryonic stem cells(stem cell research ordinance, scro)of 2 february 2005 (status as of 1 april 2012)the swiss federal council,on the basis of article 17 of the stem cell research actof 19 december 20031 (the act),ordains:1 sr 810.31 section 1: informed consent of the couple concerned art. 1 determination of the surplus status of an embryo if an embryo cannot be used to establish a pregnancy, the physician treating a couple in connection with an assisted reproduction procedure shall inform the couple:a.that it is a surplus embryo;b.why the embryo has become surplus; andc.that the surplus embryo will be destroyed unless it is used, subject to the conditions specified in the act, for the derivation of stem cells with a view to the conduct of a research project (stem cell derivation) or for a research project aimed at improving derivation methods.art. 2 information to be provided for the couple concerned prior to consent 1 if a licence has been obtained for stem cell derivation or for a research project aimed at improving derivation methods, the physician shall verbally inform the couple concerned, in a comprehensible manner:a.about the nature, purpose and expected starting date of the intended research project;b.about the couple's rights under article 5 paragraph 3 of the act and under paragraphs 3 and 4 of this article;c.about the non-commercialism specified in article 4 of the act;d.about the measures provided for in article 27 to protect the couple's personal data;e.that third parties may acquire rights to stem cells or products derived therefrom, for example in accordance with the patent act of 25 june 19542, without any entitlements accruing to the couple as a result;f.that it is possible for stem cells or products derived therefrom to be used in clinical research and practice, without any entitlements accruing to the couple as a result;g.that, under article 9 paragraph 1 letter c of the act, the stem cells derived may be passed on for other research projects; andh.about the content of the written consent, as specified in article 3.2 the physician shall provide the couple with an information sheet and an informed consent form made available by the person responsible for the research project (project manager).3 the couple have the right to put questions, or have questions put, to the project manager.4 the couple must be allowed an appropriate period for reflection on the decision concerning consent.2 sr 232.14art. 3 content of informed consent form by signing the informed consent form, the couple concerned certify that they have received the information specified in article 2 and that they consent to the use of the surplus embryo for stem cell derivation or for a research project aimed at improving derivation methods.art. 4 consequences of refusal or revocation of consent if consent is refused or revoked by the couple concerned, or by the woman or the man, this may not prejudice the couple in relation to any subsequent treatment in the assisted reproduction procedure.section 2: licence for the derivation of embryonic stem cells art. 5 application when a licence is sought for stem cell derivation with a view to conducting a research project (art. 7 of the act), the following documents must be submitted to the federal office of public health (federal office) for review:a.complete documentation of the stem cell derivation project, including evidence of the suitability of the laboratory facilities;b.complete documentation for the research project involving embryonic stem cells, as submitted to the competent ethics committee in accordance with article 17;c.the approval of the research project granted by the competent ethics committee;d.a statement, based on an extract from the registry specified in article 18 of the act, of the reasons why the embryonic stem cells available in this country are not suitable for the research project;e.information on the number of surplus embryos expected to be required.art. 6 review of the application 1 the federal office determines whether:a.the documents are complete;b.the licence conditions specified in the act are met.2 it may request additional documents from the project manager.art. 7 review period 1 the federal office shall reach a decision within 60 days.2 if the federal office requests additional documents from the project manager, the review period begins as soon as the documents have arrived; it shall notify the project manager of the beginning of the period.section 3: licence for research projects aimed at improving derivation methods art. 8 application when a licence is sought for a research project aimed at improving derivation methods (art. 8 of the act), the following documents must be submitted to the federal office for review:a.complete documentation for the research project, including evidence of the suitability of the laboratory facilities;b.an account of the extent to which the research project is expected to yield important findings for the improvement of derivation methods;c.a statement of the reasons why equivalent findings could not also be obtained in a different way, in particular through experiments involving animal embryos;d.information on the number of surplus embryos expected to be required;e.the information sheet and informed consent form.art. 9 review of the application 1 the federal office determines whether:a.the documents are complete;b.the information sheet and the informed consent form are complete and comprehensible;c.the licence conditions specified in the act are met.2 it may request additional documents from the project manager.art. 10 review period 1 the federal office shall reach a decision within 60 days.2 if the federal office requests additional documents from the project manager, the review period begins as soon as the documents have arrived; it shall notify the project manager of the beginning of the period.section 4: licence for the storage of surplus embryos art. 11 application when a licence is sought for the storage of surplus embryos (art. 10 of the act), the following documents must be submitted to the federal office for review:a.the licence granted under article 7 or 8 of the act;b.a statement of the reasons why storage of the surplus embryos is essential;c.evidence of the qualifications of the staff;d.evidence of the suitability of the laboratory facilities.art. 12 review of the application the federal office determines whether:a.the documents are complete;b.the licence conditions specified in the act are met.section 5: licence for the import of embryonic stem cells art. 13 application when a licence is sought for the import of embryonic stem cells (art. 15 of the act), the following documents must be submitted to the federal office for review:a.complete documentation for the research project involving embryonic stem cells, as submitted to the competent ethics committee in accordance with article 17;b.the approval of the research project granted by the competent ethics committee;c.details of the number of embryonic stem cells or stem cell lines required and a characterisation thereof, as specified in article 29 paragraph 1 letter b;d.evidence provided by the authority designated as competent under national legislation in the country concerned or recognised by that country to the effect that:1.the stem cells have been derived from surplus embryos,2.the couple concerned have freely given informed consent to the use of the embryo for research purposes, and3.the couple concerned are receiving no payment in return.art. 14 review of the application the federal office determines whether:a.the documents are complete;b.the licence conditions specified in the act are met.section 6: licence for the export of embryonic stem cells art. 15 application when a licence is sought for the export of embryonic stem cells (art. 15 of the act), the following documents must be submitted to the federal office for review:a.the title, objective and place of execution of the research project involving embryonic stem cells;b.the name and address of the project manager;c.the number of embryonic stem cells or stem cell lines to be exported and a characterisation thereof, as specified in article 29 paragraph 1 letter b;d.evidence provided by the authority designated as competent under national legislation in the country concerned or recognised by that country, to the effect that:1.the project is designed to yield important findings with regard to the detection, treatment or prevention of serious human diseases or concerning human developmental biology, and2.the project has received ethical approval from an authority independent of the project manager.art. 16 review of the application the federal office determines whether:a.the documents are complete;b.the licence conditions specified in the act are met.section 7: assessment by the competent ethics committee and authorisation of the research project art. 17 application when an assessment is sought of a research project involving embryonic stem cells (art. 11 of the act), the following documents must be submitted to the competent ethics committee for review:a.complete documentation for the research project;b.a statement of the reasons why equivalent findings could not also be obtained in a different way;c.the information sheet and the informed consent form, if embryonic stem cells have to be derived for the research project.art. 18 review of the application 1 the ethics committee determines whether:a.the documents are complete;b.the conditions specified in the act for the conduct of a research project with embryonic stem cells are met.2 if the research project is to be conducted at several centres, it suffices if an assessment is given according to the standard procedure by the ethics committee that is competent at the first centre; decisions may be reached by the other ethics committees concerned according to a simplified procedure. the project manager must submit the approval granted by the ethics committee competent at the first centre.3 for the evaluation of the research project, the ethics committee may consult experts and request additional documents from the project manager.art. 19 assessment period 1 the ethics committee shall issue its assessment within 30 days.2 if the ethics committee consults experts or requests additional documents from the project manager, the assessment period begins as soon as the experts' comments or the documents have arrived; the ethics committee shall notify the project manager of the beginning of the period.art. 20 authorisation of the research project 1 prior to the initiation of the research project, the project manager shall notify the federal office thereof and submit:a.the title of the research project, if the federal office has the project documents at its disposal in connection with the licensing procedure under article 5 or 13;b.the complete documentation for the research project, as submitted to the competent ethics committee in accordance with article 17, together with this committee's approval, if embryonic stem cells available in this country are to be used for the project.2 the federal office may request additional documents from the project manager.3 within 15 days of receipt of the notification or the necessary documents, the federal office shall assign a reference number to the research project, provided that it has no objections. it shall inform the project manager of the number.4 after the communication of the reference number, the research project may be initiated.art. 21 re-evaluation and withdrawal of approval 1 the ethics committee may re-evaluate a research project and if appropriate withdraw its approval, if this is necessitated by new scientific findings and a resultant change in the ethical assessment.2 it shall notify the project manager and the federal office immediately of the withdrawal of its approval.3 it shall inform the federal office immediately of any irregularities in the conduct of the research project.section 8: changes to the project art. 22 1 any person who derives embryonic stem cells, carries out a research project aimed at improving derivation methods, stores surplus embryos, or imports or exports embryonic stem cells must notify the federal office of any significant planned changes to the project concerned.2 any person who carries out a research project involving embryonic stem cells must notify the ethics committee and the federal office of any significant planned changes to the research protocol.3 the federal office, or the ethics committee and the federal office, shall issue a response within 30 days of receipt of such notification.4 a project of the type specified in paragraph 1 may only be continued with the proposed changes if the federal office grants a new licence.5 a research project of the type specified in paragraph 2 may only be continued in accordance with the modified research protocol if the ethics committee renews its approval and the federal office renews its authorisation of the project.section 9: notification and reporting duties art. 23 notification after discontinuation or completion of the project 1 any person who derives embryonic stem cells or carries out a research project aimed at improving derivation methods must notify the federal office of the discontinuation or completion of stem cell derivation or the research project within 15 days.2 any person who carries out a research project involving embryonic stem cells must notify the federal office and the ethics committee of the discontinuation or completion of the project within 15 days.3 if a project is discontinued, the reasons must be indicated in the notification.art. 24 final report 1 any person who derives embryonic stem cells or carries out a research project aimed at improving derivation methods must submit a report to the federal office within six months of the discontinuation or completion of stem cell derivation or the research project.2 any person who carries out a research project involving embryonic stem cells must submit a report to the federal office and the ethics committee within six months of the discontinuation or completion of the research project.3 the federal office may specify a shorter period if there is good cause for doing so; in response to a justified request from the project manager, it may in exceptional cases extend the period.art. 25 content of the final report 1 the final report must document the course and results of the embryonic stem cell derivation, or of the research project aimed at improving derivation methods or involving embryonic stem cells.2 the final report on embryonic stem cell derivation must also include the following details:a.the number of embryos used; andb.the number of embryonic stem cells derived, or the number of stem cell lines and a characterisation thereof, as specified in article 29 paragraph 1 letter b.3 the final report on a research project aimed at improving derivation methods must also include the following details:a.the number of embryos used;b.the number of embryonic stem cells derived, or the number of stem cell lines and a characterisation thereof, as specified in article 29 paragraph 1 letter b, if stem cells are derived in connection with the project; andc.a summary of the positive and the negative results.4 the final report on a research project involving embryonic stem cells must also include a summary of the positive and the negative results.art. 26 storage of embryonic stem cells any person who stores embryonic stem cells must notify the federal office annually, as at 1 july, of the total numbers of deposits and withdrawals, and of the number of stem cell lines stored and the characterisation thereof, as specified in article 29 paragraph 1 letter b.section 10: data protection art. 27 1 no data permitting identification of the couple concerned may be communicated to the persons involved in stem cell derivation or in research projects.2 the clinic performing the ivf procedure shall anonymise the data concerning the surplus embryo by the assignment of a code before passing on the embryo for stem cell derivation or for a research project aimed at improving derivation methods.3 it shall retain the data of the couple concerned, the information sheet, the original signed consent form and the code key for ten (10) years. the data security measures must conform to the current technical standards.section 11: public registry art. 28 purpose of the registry the registry specified in article 18 of the act is intended in particular:a.to enable embryonic stem cells to be passed on for research projects carried out in this country, as specified in article 9 paragraph 1 letter c of the act;b.to permit assessment of whether embryonic stem cells suitable for a research project are available in this country;c.to provide an overview of ongoing and completed research projects in this country.art. 29 content of the registry 1 any person who derives embryonic stem cells, carries out a research project aimed at improving derivation methods, or involving embryonic stem cells, or imports embryonic stem cells must submit the following information to the federal office:a.a description of the project in which the stem cells are derived or used, including the following details:1.title of the project,2.objective of the project,3.name and address of the project manager,4.starting date and expected duration of the project;b.a characterisation of the embryonic stem cells derived or used in the project, and of the stem cell lines used; stem cell lines are pluripotent cells derived from cells of an early embryo, which can be cultured in vitro and reproduced over generations, exhibiting a stable genotype and phenotype.2 the federal office shall include in the registry the information required by paragraph 1 letter a when a licence is granted under articles 5, 8 or 13, or when a notification is received under article 20.3 it shall publish in the registry the summaries specified in article 25 paragraphs 3 letter c and 4.4 it may request clarification of the information submitted.section 12: charges art. 30 calculation of charges 1 the charges are calculated according to the rates given in article 31. within the framework of these rates, the charges are set on the basis of the time required, taking account of the necessary expertise.2 for services not explicitly mentioned in article 31, the level of the charge is based on the time required. the hourly rate, according to the expertise required and the functional level of the personnel involved, ranges from 90 to 200 swiss francs.art. 31 rates of charges the federal office levies the following charges in particular:swiss francsa.3licence for derivation of embryonic stem cells from surplus embryos: grant, renewal, suspension, revocation500 - 10 000b.4licence for a research project aimed at improving derivation methods: grant, renewal, suspension,revocation500 - 10 000c.5licence for the storage of surplus embryos: grant, renewal, suspension, revocation250 - 5 000d.6licence for the import or export of embryonic stem cells: grant, renewal, suspension, revocation500 - 10 000e.inspection (excluding preparation and report) per day1 000 - 20 000f.certificates, reports200 - 2 0003 amended by no i of the ordinance of 2 march 2012, in force since 1 april 2012 (as 2012 1201).4 amended by no i of the ordinance of 2 march 2012, in force since 1 april 2012 (as 2012 1201).5 amended by no i of the ordinance of 2 march 2012, in force since 1 april 2012 (as 2012 1201).6 amended by no i of the ordinance of 2 march 2012, in force since 1 april 2012 (as 2012 1201).art. 32 surcharge the federal office may levy a surcharge of up to 50 per cent of the charge if the service:a.is provided, on request, urgently or outside normal working hours;b.is exceptionally time-consuming or involves particular difficulties.art. 33 expenses in addition to the charges levied, expenses relating to the individual service are invoiced. the following items are deemed to be expenses:a.fees for committee members, experts and representatives;b.costs occasioned by the collection of evidence, scientific studies, special investigations or the procurement of documents;c.travel and transport costs;d.costs of tests at internal or external laboratories;e.costs of work carried out by third parties on behalf of the federal office.section 13: forms art. 34 the federal office may prescribe forms:a.for the licensing procedures under articles 5, 8, 11, 13 and 15;b.for the fulfilment of notification and reporting duties under articles 20, 23 and 24;c.for the information to be collected for the public registry.section 14: commencement art. 35 this ordinance comes into force on 1 march 2005.

812.121english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton narcotics and psychotropic substances(narcotics act, narca)1of 3 october 1951 (status as of 15 may 2021)1 title amended by no i of the fa of 24 march 1995, in force since 1 july 1996 (as 1996 1677; bbl 1994 iii 1273).the federal assembly of the swiss confederation,on the basis of articles 118 and 123 of the federal constitution2,3 and having considered the federal council dispatch dated 9 april 19514,decrees:2 sr 1013 amended by no 7 of the fa of 19 march 2010 on the implementation of council framework decision 2008/977/ji on the protection of personal data processed in the framework of police and judicial cooperation in criminal matters, in force since 1 dec. 2010 (as 2010 3387; bbl 2009 6749).4 bbl 1951 i 829chapter 15 general provisions 5 structure of enactment and the numbering of the introductory articles and sections in accordance with no i of the fa of 20 march 1975, in force since 1 aug. 1975 (as 1975 1220; bbl 1973 i 1348). art. 16 aim this act is intended to:a. prevent the unauthorised consumption of narcotics and psychotropic substances, in particular by encouraging abstinence;b. regulate the availability of narcotics and psychotropic substances for medical and scientific purposes;c. protect persons against the negative health-related and social consequences of mental and behavioural disorders associated with dependence;d. protect public order, safety and security the risks posed by narcotics and psychotropic substances;e. combat criminal acts closely connected with narcotics and psychotropic substances.6 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 1a7 four-pillar policy 1 the confederation and the cantons shall introduce measures in the following four areas (the four-pillar policy):a. prevention;b. therapy and reintegration;c. harm reduction and survival support;d. control and law enforcement.2 in doing so, the confederation and the cantons shall take account of the concerns of protecting public health and minors.7 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 1b8 relationship with the therapeutic products act narcotics used as therapeutic substances are governed by the provisions of the therapeutic products act of 15 december 20009. the provisions of this act apply, insofar as the therapeutic products act contains no rule or a less stringent rule.8 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).9 sr 812.21art. 210 definitions in this act:a. narcotics means substances and preparations that cause dependence that have the effects associated with morphine, cocaine or cannabis, and substances and preparations produced on their basis of or that have a similar effect to the same;b. psychotropic substances means substances and preparations that cause dependence that contain amphetamines, barbiturates, benzodiazepines or hallucinogens such as lysergide or mescaline or that have a similar effect to the same;c. substances means raw materials such as plants or fungi or parts thereof, and chemically produced compounds;d. preparations means ready-to-use narcotics and psychotropic substances;e. precursors means substances that do not cause dependence, but which may be transformed into narcotics or psychotropic substances;f. auxiliary chemicals means substances that assist in the production of narcotics and psychotropic substances.10 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 2a11 list the federal department of home affairs shall maintain a list of narcotics, psychotropic substances precursors and auxiliary chemicals. it shall generally base this list on the recommendations of the relevant international organisations.11 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 2b12 rule for psychotropic substances unless this act provides otherwise, the provisions on narcotics also apply to psychotropic substances.12 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 3 simplified control measures13 1 the federal council may make precursors and auxiliary chemicals subject to the narcotics controls set out in chapters 2 and 3. it may require a licence or other less stringent monitoring measures, such as customer identification, accounting obligations and duties to provide information. in doing so, it shall generally follow the recommendations of the relevant international organisations.142 the federal council may partially or - in certain concentrations or quantities - entirely exempt narcotics from the control measures if the relevant international organisations (united nations, world health organisation) decide on or recommend the exemption based on an agreement ratified by switzerland.153 .164 when implementing paragraph 1, in particular for duties to provide information or advice, the federal council may call on the assistance of private organisations.1713 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).14 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).15 amended by no i of the fa of 20 march 1975, in force since 1 aug. 1975 (as 1975 1220; bbl 1973 i 1348).16 inserted by no i of the fa of 18 dec. 1968 (as 1970 9; bbl 1968 i 737). repealed by no i of the fa of 20 march 2008, with effect from 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).17 inserted by no i of the fa of 24 march 1995, in force since 1 july 1996 (as 1996 1677; bbl 1994 iii 1273).art. 3a18 18 inserted by no i of the fa of 24 march 1995 (as 1996 1677; bbl 1994 iii 1273). repealed by no i of the fa of 20 march 2008, with effect from 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).chapter 1a19 prevention, therapy and harm reduction 19 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645). section 1 prevention art. 3b division of tasks between confederation and cantons 1 the cantons shall promote education and advice on the prevention of disorders associated with addiction and their negative health-related and social consequences. in doing so, they shall pay special attention to the protection of children and adolescents. they shall introduce adequate general conditions and create the required facilities or support private institutions that meet the quality requirements.2 the confederation shall conduct national programmes on prevention and in particular encourage the early recognition of disorders associated with addiction; in doing so, it shall prioritise the concerns relating to the protection of children and adolescents. it shall raise public awareness of the problems of addiction.art. 3c power to report 1 public offices and specialists in the education, social work, health, justice and police sectors may report cases of existent or anticipated disorders associated with addiction, in particular in cases involving children and adolescents, to the relevant treatment or social assistance agencies, if:a. they have identified the same in the course of their official or professional activities;b. the persons concerned, their dependants or the general public are placed at risk; andc. they regard a supervision measure as appropriate.2 if a report relates to a child or an adolescent under 18, his or her legal representative must also be informed, unless there is good cause for not doing so.3 the cantons shall designate professionally qualified public or private treatment or social assistance agencies that are responsible for supervising reported persons, in particular children or adolescents at risk.4 the staff of the relevant treatment or social assistance agencies are subject to official and professional secrecy in accordance with articles 320 and 321 of the criminal code20.215 public offices and specialists under paragraph 1 who learn that a person under their supervision has breached article 19a are not obliged to file a criminal complaint.20 sr 311.021 corrected by the drafting committee on 20 feb. 2013, published on 4 april 2013 (as 2013 973).section 2 therapy and reintegration art. 3d supervision and treatment 1 the cantons shall ensure the supervision of persons with disorders associated with addiction who require the medical or psycho-social treatment or welfare measures.2 the treatment is carried out with the aim of guaranteeing the therapeutic and social integration von persons with disorders associated with addiction, improving their physical and psychological health and creating conditions in which they can live a drug-free life.3 the cantons shall also support the professional and social reintegration of such persons.4 they shall create the facilities required for treatment and the reintegration or support private institutions that meet the quality requirements.5 the federal council shall issue recommendations on the principles for funding addiction therapies and reintegration measures.art. 3e22 narcotics-based treatment 1 a licence is required for prescribing, dispensing and administering narcotics in order to treat persons dependent on narcotics. the licence is issued by the cantons.2 the federal council may lay down general conditions.3 heroin-based treatment requires a federal licence. the federal council shall issue special provisions. it shall in particular ensure that:a. heroin is only prescribed to persons dependent on narcotics who have failed to respond to other forms of treatment or whose state of health precludes other forms of treatment;b. heroin is only prescribed by specialist physicians in appropriate facilities;c. the conduct of and progress with heroin-based treatment is reviewed periodically.22 in force since 1 jan. 2010.art. 3f23 data processing 1 the authorities and institutions responsible for the implementation of this act are entitled to process personal data, and in particular sensitive personal data and personality profiles in order to review the requirements for and the progress with the treatment of persons dependent on narcotics.2 they shall guarantee the protection of data in accordance with paragraph 1 through technical and organisational measures.3 the federal council shall regulate the details, in particular:a. the authorities and institutions responsible for the data processing;b. the data to be processed;c. the data flows;d. the rights of access.23 in force since 1 jan. 2010.section 3 harm reduction and survival support art. 3g duties of the cantons in order to prevent or reduce health-related and social harm among persons with disorders associated with addiction, the cantons shall introduce harm reduction and survival support measures. they shall create the required facilities or support private institutions that meet the quality requirements.art. 3h risk to traffic if an official agency fears that a person poses a risk to road, shipping or civil aviation traffic due to a disorder associated with addiction, it must notify the competent authority.section 4 coordination, research, training and quality assurance art. 3i services provided by the confederation 1 the confederation shall support the cantons and private organisations in relation to prevention, therapy and harm reduction by providing services; it shall support them in particular:a. with coordination, including planning and managing the service offered;b. with the implementation of quality measures and proven intervention models.2 it shall inform them of new scientific findings.3 it may take its own additional measures to reduce addiction problems or entrust their implementation to private organisations.art. 3j promotion of research the confederation may in terms of the federal research act of 7 october 198324 support scientific research in the following fields in particular:a. the mode of action of substances that induce addiction;b. the causes and effects of disorders associated with addiction;c. preventive and therapeutic measures;d. the prevention or reduction of disorders associated with addiction;e. the effectiveness of reintegration measures.24 [as 1984 28, 1992 1027 art. 19, 1993 901 annex no 4 2080 annex no 9, 1996 99, 2000 1858, 2003 4265, 2004 4261, 2006 2197 annex no 39, 2008 433, 2010 651, 2011 4497 no i 1, 2012 3655 no i 13, 2013 2639. as 2013 4425 art. 57 para. 1]. see now the fa of 14 dec. 2012 on the promotion of research and innovation (sr 420.1).art. 3k basic and advanced training the confederation shall support basic and advanced training in the fields of prevention, therapy and reintegration, and in harm reduction and survival support.art. 3l recommendations on quality assurance in consultation with the cantons, the confederation shall develop recommendations on quality assurance in the fields of the prevention, therapy and reintegration, and of harm reduction and survival support.chapter 2 manufacturing, dispensing, obtaining and using narcotics section 1 production and sales businesses art. 4 licence for production and trade25 1 businesses and persons that cultivate, produce, process or trade in narcotics require a licence from the swiss agency for therapeutic products (the agency). article 8 is reserved.262 the federal council shall regulate the requirements for the grant, expiry or withdrawal of the licence, and its form, content and term of validity.25 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).26 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 5 import, export and transit27 1 any import or export of narcotics subject to control requires a licence from the agency.28 this shall be granted in accordance with the international agreement. an export licence may also be granted even if it is not required under this act and the international agreements but requested by the country of destination.291bis the federal council may issue special provisions on the import or export of narcotics by travellers suffering from medical conditions. the agency may process sensitive personal data connected with the import or export of narcotics by travellers suffering from medical conditions, provided this is required by international agreements.302 the supervision of the transit of narcotics shall be carried out by the customs administration in consultation with the agency.27 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).28 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).29 amended by no i of the fa of 20 march 1975, in force since 1 aug. 1975 (as 1975 1220; bbl 1973 i 1348).30 inserted by art. 3 no 9 of the fd of 17 dec. 2004 on the adoption and implementation of the bilateral agreements between switzerland and the eu on the association to schengen and dublin, in force since 12 dec. 2008 (as 2008 447 5405 art. 1 let. f; bbl 2004 5965).art. 6 restrictions under international agreements31 1 the federal council may prohibit licence holders from cultivating, manufacturing, importing or exporting, or stockpiling on the basis of international agreements.322 it may delegate the power to issue such rulings to the federal department of home affairs while retaining its oversight.31 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).32 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 733 raw materials and products with narcotic-type effects 1 raw materials and products suspected of having similar effects to the substances and preparations in accordance with article 2 may only be cultivated, produced, imported or exported, stored, used or placed on the market with a licence issued by the federal department of home affairs and in accordance with its conditions.2 the agency shall establish whether raw materials and products are substances or preparations in accordance with article 2. if this is the case, a licence under articles 4 and 5 is required.3 the federal department of home affairs shall maintain a list of these substances and preparations.33 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 8 prohibited narcotics34 1 the following narcotics may not be cultivated, imported, produced or placed on the market:35a. opium for smoking and the residues created in its production or use;b. diacetylmorphine and its salts;c. hallucinogens such as lysergide (lsd 25);d.36 narcotics containing an effective concentration of cannabinoids.372 .383 the federal council may prohibit the import, production and placing on the market of further narcotics if international agreements prohibit their production or the most important producer countries cease their production.394 any stocks of prohibited narcotics must be transformed under the supervision of the relevant cantonal authority in to a legally-permitted substance or, if this is not possible, destroyed.5 the federal office of public health may issue exceptional licences for cultivating, importing, producing and placing on the market the narcotics mentioned in paragraphs 1 and 3, where this is not prohibited by an international agreement and these narcotics are needed for scientific research, the development of medicinal products or for restricted medical use.406 for the cultivation of a narcotic mentioned in paragraphs 1 and 3 that is an active ingredient in an authorised medicinal product, an exceptional licence is required from the federal office of public health.417 for the import, production and placing on the market of a narcotic mentioned in paragraphs 1 and 3 that is an active ingredient in an authorised medicinal product, a licence is required from the agency in accordance with article 4.428 the federal office of public health may grant exceptional licences, provided the substances mentioned in the paragraphs 1 and 3 are used in control measures.4334 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).35 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).36 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).37 amended by no i of the fa of 20 march 1975, in force since 1 aug. 1975 (as 1975 1220; bbl 1973 i 1348).38 repealed by no i of the fa of 20 march 1975, with effect from 1 aug 1975 (as 1975 1220; bbl 1973 i 1348).39 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).40 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).41 inserted by no i of the fd on the medical prescription of heroin of 9 oct. 1998 (as 1998 2293; bbl 1998 1607). amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).42 inserted by no i of the fd on the medical prescription of heroin of 9 oct. 1998 (as 1998 2293; bbl 1998 1607). amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).43 inserted by no i of the fd on the medical prescription of heroin of 9 oct. 1998 (as 1998 2293; bbl 1998 1607). amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 8a44 pilot trials 1 after consulting the cantons and communes concerned, the federal office of public health may authorise scientific pilot trials involving narcotics containing an effective concentration of cannabinoids:a. that are limited in terms of location, time and subject matter;b. that allow findings to made on the impact of new regulations on the use of these narcotics for non-medical purposes and on the health of participants;c. that are conducted so as to ensure the protection of health and of minors, and the protection of public order and public safety; andd. in which, if possible, cannabis products are used that are of swiss origin and that comply with the rules of swiss organic farming.2 the federal council shall regulate the requirements for conducting the pilot trials. in doing so, it may derogate from articles 8 paragraphs 1 letter d and 5, 11, 13, 19 paragraph 1 letter f and 20 paragraph 1 letters d and e.3 narcotics containing an effective concentration of cannabinoids that are supplied in the course of the pilot trials are exempt from tobacco tax under article 4 of the tobacco tax act of 21 march 196945.44 inserted by no i of the fd on the medical prescription of heroin of 9 oct. 1998 (as 1998 2293; bbl 1998 1607). amended by no i of the fa of 25 sept. 2020, in force from 15 may 2021 to 14 may 2031 (as 2021 216; bbl 2019 2529).45 sr 641.31section 2 medical professionals art. 9 1 medical professionals as defined in the therapeutic products legislation46, who carry out their professional activities independently in accordance with the medical professions act of 23 june 200647 either as a private business or in the service of the cantons or communes and who have the relevant cantonal authorisation, and managers of public or hospital pharmacies may acquire, store, use and dispense narcotics without licences; the foregoing does not apply to exceptional licences under article 8. cantonal provisions on direct dispensing by physicians, dentists and veterinary surgeons are reserved.482 authorisation under paragraph 1 is also granted to medical professionals and students of medical professions at university level who are authorised by the relevant cantonal authority to represent a medical professional in a medical profession at university level.492a .503 .514 the cantons may limit the authorisation granted to dentists to specific narcotics.5 the conditions that apply to foreign sanatoriums in switzerland shall be regulated by the cantons shall in consultation with the agency.46 medicinal products licensing ordinance of 14 nov. 2014 (sr 812.212.1). the reference was adapted in application of art. 12 para. 2 of the publications act of 18 june 2004 (sr 170.512) on 1. jan. 2019.47 sr 811.1148 amended by no ii 1 of the fa of 20 march 2015, in force since 1 jan. 2018 (as 2015 5081, 2017 2703; bbl 2013 6205).49 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).50 inserted by no i of the fa of 18 dec. 1968 (as 1970 9 13; bbl 1968 i 737). repealed by no i of the fa of 20 march 2008, with effect from 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).51 repealed by no ii 1 of the fa of 20 march 2015, with effect from 1 jan. 2018 (as 2015 5081, 2017 2703; bbl 2013 6205).art. 10 1 physicians and veterinary surgeons who carry out their professional activities independently in accordance with the medical professions act of 23 june 200652 are authorised to prescribe narcotics.532 foreign physicians and veterinary surgeons entitled to practise their professions in the swiss border areas under international agreements may use and prescribe the narcotics required for doing so; the related prescriptions must be executed by a pharmacy in the relevant border area.3 the federal council shall determine the additional requirements under which a prescription for narcotics issued by a foreign physician or veterinary surgeon in switzerland may be executed.52 sr 811.1153 amended by annex no 5 of the healthcare occupations act of 30 sept. 2016, in force since 1 feb. 2020 (as 2020 57; bbl 2015 8715).art. 11 1 physicians and veterinary surgeons are obliged to use, dispense and prescribe narcotics only in the quantities necessary according to the recognised rules of medical science.1bis physicians and veterinary surgeons who dispense narcotics authorised as medicinal products for indications other than those for which they were authorised must report this within 30 days to the relevant cantonal authorities. they must provide all the information requested by the relevant cantonal authorities on the nature and purpose of the treatment.542 paragraphs 1 and 1bis also apply to the use and dispensing of narcotics by dentists.5554 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).55 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 12 1 the cantons may revoke authorisation in accordance with article 9 for a limited period or permanently if the authorised medical professional56 is narcotics dependent or has committed an offence under articles 19-22.572 the order applies throughout the confederation.3 article 54 of the criminal code58 remains reserved.56 term: medicinal products licensing ordinance of 14 nov. 2018 (sr 812.212.1). the reference was adapted in application of art. 12 para. 2 of the publications act of 18 june 2004 (sr 170.512) on 1. jan. 2019.57 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).58 sr 311.0art. 13 in pharmacies, narcotics may only be dispensed to the public on the basis of a prescription from a physician or veterinary surgeon.section 3 hospitals and institutions art. 14 1 hospitals may be granted a licence by the relevant cantonal authority to acquire, store and use narcotics according to their operational requirements, provided a person specified in article 9 is responsible for their storage and use.2 institutions involved in scientific research may be granted a licence by the relevant cantonal authority to cultivate, acquire, store and use narcotics to the extent required for their own needs.593 article 8 is reserved.6059 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).60 inserted by no i of the fa of 20 march 1975, in force since 1 aug. 1975 (as 1975 1220; bbl 1973 i 1348).section 3a61 organisations and authorities 61 inserted by no i of the fa of 18 dec. 1968 (as 1970 9; bbl 1968 i 737). amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645). art. 14a 1 the federal council may license national or international organisations such as those of the red cross, the united nations, its special organisations and national institutions, and authorities such as the customs and border guard agencies to acquire, import, store, use, prescribe, dispense or export narcotics in the course of their activities.1bis the cantons may grant a licence cantonal authorities and communal authorities, in particular the police, in accordance with paragraph 1.2 the federal council and the cantons may revoke the licence they have granted for a limited period or permanently where special circumstances so require.section 4 .62 62 repealed by no i of the fa of 20 march 2008, with effect from 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645). art. 1563 63 repealed by no i of the fa of 20 march 2008, with effect from 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 15a-15c64 64 inserted by no i of the fa of 20 march 1975 (as 1975 1220; bbl 1973 i 1348). repealed by no i of the fa of 20 march 2008, with effect from 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).chapter 3 control art. 1665 for each supply of narcotics, a delivery note must be issued and handed to the recipient with the product. the supply must be reported to the agency separately. exempted from the foregoing is dispensing by authorised medical professionals66 for the treatment of persons and animals and to physicians in the same cantonal territory who do not dispense directly.65 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).66 term: medicinal products licensing ordinance of 14 nov. 2018 (sr 812.212.1). the reference was adapted in application of art. 12 para. 2 of the publications act of 18 june 2004 (sr 170.512) on 1. jan. 2019.art. 17 1 businesses, persons and institutions who hold a licence under articles 4 and 14 paragraph 2 are obliged to keep constant records of all dealing with narcotics.672 the businesses and persons mentioned in article 4 must report to the agency68 at the end of each year on their dealing with narcotics and the stocks that they hold.693 businesses and persons licensed to cultivate, produce and process narcotics must also report to the agency annually on the extent the area under cultivation and the type and quantity of narcotics obtained, produced and processed.704 the persons authorised under article 9 to acquire, use or dispense narcotics or the persons responsible for them under article 14 paragraph 1 must justify the use of the narcotics.5 the federal council shall issue provisions on safeguarding, labelling and promoting narcotics, as well as the information given on package inserts.7167 amended by no i of the fa of 18 dec. 1968, in force since 1 jan. 1970 (as 1970 9 13; bbl 1968 i 737).68 revised by the federal assembly drafting committee (art. 33 parlpa; as 1974 1051).69 amended by annex no ii 3 of the therapeutic products act of 15 dec. 2000, in force since 1 jan. 2002 (as 2001 2790; bbl 1999 3453).70 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).71 inserted by no i of the fa of 18 dec. 1968, in force since 1 jan. 1970 (as 1970 9 13; bbl 1968 i 737).art. 18 1 the businesses, persons, facilities and institutions subject to official control must make their areas under cultivation, production, sales and storerooms accessible to the control agencies, together with their stocks of narcotics and all related receipts. they must provide information whenever requested to do so by the authorities.722 the public officials of the confederation and the cantons who are delegated the task of controlling dealings in narcotics must treat the information obtained in doing so as confidential. the duty of confidentiality as defined in article 320 of the criminal code73 is unlimited in time.72 amended by no i of the fa of 18 dec. 1968, in force since 1 jan. 1970 (as 1970 9 13; bbl 1968 i 737).73 sr 311.0chapter 3a74 data protection under the schengen association agreements 74 inserted by art. 3 no 9 of the fd of 17 dec. 2004 on the adoption and implementation of the bilateral agreements between switzerland and the eu on the association to schengen and dublin, in force since 12 dec. 2008 (as 2008 447 5405 art. 1 let. f; bbl 2004 5965).art. 18a disclosure of personal data to a state bound by one of the schengen association agreements the disclosure of personal data to the relevant authorities of states bound by one of the schengen association agreements75 is equivalent to the disclosure of personal data between federal bodies.75 agreement of 26 oct. 2004 between the swiss confederation, the european union and the european community on the swiss confederation's association with the implementation, application and development of the schengen acquis (sr 0.362.31); agreement of 28 april 2005 between the swiss confederation and the kingdom of denmark on the implementation, application and development of those parts of the schengen acquis that are based on the provisions of title iv of the treaty establishing the european community (sr 0.362.33); agreement of 17 dec. 2004 between the swiss confederation, republic of iceland and the kingdom of norway on the implementation, application and development of the schengen acquis and on the criteria and procedure for determining the state responsible for examining an application for asylum lodged in switzerland, iceland or norway (sr 0.362.32); protocol of 28 feb. 2008 between the swiss confederation, the european union, the european community and the principality of liechtenstein on the accession of the principality of liechtenstein to the agreement between the swiss confederation that european union and the european community on the association of the swiss confederation with the implementation, application and development of the schengen acquis (sr 0.362.311).art. 18b76 76 repealed by no 7 of the fa of 19 march 2010 on the implementation of council framework decision 2008/977/ji on the protection of personal data processed in the framework of police and judicial cooperation in criminal matters, with effect from 1 dec. 2010 (as 2010 3387; bbl 2009 6749).art. 18c right to information the right to information is governed by the federal or cantonal data protection provisions.77 the proprietor of the data collection shall also provide information on the details available on the origin of the data.77 amended by no 7 of the fa of 19 march 2010 on the implementation of council framework decision 2008/977/ji on the protection of personal data processed in the framework of police and judicial cooperation in criminal matters, in force since 1 dec. 2010 (as 2010 3387; bbl 2009 6749).art. 18d and 18e78 78 repealed by no 7 of the fa of 19 march 2010 on the implementation of council framework decision 2008/977/ji on the protection of personal data processed in the framework of police and judicial cooperation in criminal matters, with effect from 1 dec. 2010 (as 2010 3387; bbl 2009 6749).chapter 4 criminal provisions section 1 offences79 79 inserted by no i of the fa of 28 sept. 2012, in force since 1 oct. 2013 (as 2013 1451; bbl 2011 8195 8221). art. 1980 1 any person who without authorisation:a. cultivates, produces or otherwise produces narcotic substances;b. stores, sends, transports, imports, exports or carries in transit narcotic substances,c. sells or prescribes narcotic substances, or otherwise procures for such substances for another or places such substances on the market;d. possesses, keeps, buys, acquires or otherwise obtains narcotic substances;e. finances the unlawful trade in narcotic substances or arranges its financing;f. publicly encourages the consumption of narcotic substances or publicly announces the opportunity to acquire or consume narcotic substances;g. makes preparations for any of the acts mentioned in letters a-f,is liable to a custodial sentence not exceeding three years or to a monetary penalty.2 the offender is liable to a custodial sentence of not less than one year, which may be combined with a monetary penalty, if he or she:a. knows or must assume that the offence relates to a quantity of narcotic substances that could directly or indirectly endanger the health of a large number of people;b. acts as a member of a group that has been formed in order to trade unlawfully in narcotic substances;c. achieves a high turnover or substantial profit through commercial trading;d. offers, provides or otherwise makes available narcotic substances in educational institutions attended primarily by young persons or in the immediate vicinity of such institutions.3 the court may at its discretion mitigate the penalty in the following cases:a. an offence under paragraph 1 letter g;b. an offence under paragraph 2, where the offender is dependent on narcotic substances and the offence was intended to finance his or her own consumption of narcotic substances.4 the offender also commits an offence under the provisions of paragraphs 1 and 2 if he or she committed the offence abroad but is apprehended in switzerland and is not extradited, provided the act is also an offence at the place of commission. if the law at the place of commission is more lenient, it shall be applied. article 6 of the criminal code81 applies.80 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).81 sr 311.0art. 19bis 82 any person who offers, supplies or in any other way makes accessible narcotics to a person under 18 without medical grounds for doing so is liable to a custodial sentence not exceeding three years or a monetary penalty.82 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 19a83 1. any person who wilfully consumes without authorisation narcotics or any person who commits an offence in terms of article 19 for his or her own consumption is liable to a fine84.2. in minor cases, no proceedings may be taken or the penalty may be waived. an official caution may be issued.3. if the offender is or makes himself or herself subject to medically supervised care due to consumption of narcotics, prosecution may be waived. criminal proceedings shall be conducted if the offender withdraws from care or treatment.4. if the offender is dependent on narcotics, the court may order him or her to be admitted to a hospital. article 44 of the criminal code85 applies mutatis mutandis.83 inserted by no i of the fa of 20 march 1975, in force since 1 aug. 1975 (as 1975 1220; bbl 1973 i 1348).84 term in accordance with annex no 3 of the fa of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979). this amendment has been made throughout the text.85 sr 311.0. now art. 60 and 63.art. 19b86 1 any person who prepares a negligible quantity of a narcotic for his or her own consumption or supplies a person over the age of 18 free of charge for the purpose of consuming the narcotic together at the same time does not commit an offence.2 10 grams of a narcotic containing an effective concentration of cannabinoids constitutes a negligible quantity.8786 inserted by no i of the fa of 20 march 1975 (as 1975 1220; bbl 1973 i 1348). amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).87 inserted by no i of the fa of 28 sept. 2012, in force since 1 oct. 2013 (as 2013 1451; bbl 2011 8195 8221).art. 19c88 any person who wilfully incites or attempts to incite another to consume narcotics without authorisation is liable to a fine.88 inserted by no i of the fa of 20 march 1975, in force since 1 aug. 1975 (as 1975 1220; bbl 1973 i 1348).art. 2089 1 any person who:a. makes an application containing false information in order to obtain an import, transit or export licence for him or herself or for another;b. without a licence diverts narcotics or substances in accordance with article 3 paragraph 1 for which he or she holds a swiss export licence to a different destination in switzerland or abroad;c. without a licence cultivates, produces, imports or exports, stores or places on the market substances and preparations in accordance with article 7;d. as a medical professional90 uses or dispenses narcotics other than in accordance with articles 11 or 13;e. as a physician or veterinary surgeon prescribes narcotics other than in accordance with article 11;is liable to a custodial sentence not exceeding three years or to monetary penalty.2 the offender is liable to a custodial sentence of no less than one year if he or she achieves a large turnover or substantial profit through commercial trading. the custodial sentence may be combined with a monetary penalty.89 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).90 term: medicinal products licensing ordinance of 14 nov. 2018 (sr 812.212.1). the reference was adapted in application of art. 12 para. 2 of the publications act of 18 june 2004 (sr 170.512) on 1. jan. 2019.art. 2191 1 any person who wilfully:a. fails to file reports under articles 11 paragraph 1bis, 16 and 17 paragraph 1, issue the required delivery notes or make narcotics controls or provides false information therein or omits to enter information that he or she should have included;b. uses delivery notes or narcotics controls that contain false or incomplete information;is liable to a custodial sentence not exceeding three years or monetary penalty.2 the offender is liable to a fine if he or she acts through negligence.91 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 2292 any person who wilfully or negligently:a. fails to fulfil his or her duties of care as a person authorised to deal with narcotics;b. breaches the provisions on narcotics advertising and information;c. breaches storage and retention obligations;d. breaches an implementation regulation issued by the federal council or the relevant department, the contravention of which is declared a criminal offence, or an order issued to him containing a reference to the penalty under this article;is liable to a fine.92 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 2393 1 if a public official responsible for implementing this act wilfully commits an offence under articles 19-22, the penalty shall be increased appropriately.2 a public official responsible for combating unauthorised dealings in narcotics who accepts an offer of narcotics in order to assist with investigations does not commit an offence, even if he or she does not disclose his or her identity and function.9493 amended by no i of the fa of 20 march 1975, in force since 1 aug. 1975 (as 1975 1220; bbl 1973 i 1348).94 amended by art. 24 no 2 of the fa of 20 june 2003 on covert investigations, in force since 1 jan. 2005 (as 2004 1409; bbl 1998 4241).art. 2495 1 unlawful assets located in switzerland shall be forfeited to the state even if the offence is committed abroad. where there is no place of jurisdiction under article 32 of the criminal procedure code of 5 october 200796 (cpc), the canton in which the assets are located is responsible for arranging their forfeiture.972 the relevant authorities shall confiscate the narcotics obtained in implementing this act and arrange for their disposal or destruction.9895 amended by no i of the fa of 20 march 1975, in force since 1 aug. 1975 (as 1975 1220; bbl 1973 i 1348).96 sr 312.097 second sentence amended by annex 1 no ii 27 of the criminal procedure code of 5 oct. 2007, in force since 1 jan. 2011 (as 2010 1881; bbl 2006 1085).98 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 2599 99 repealed by no i of the fa of 20 march 1975, with effect from 1 aug. 1975 (as 1975 1220; bbl 1973 1348).art. 26 the general provisions of the criminal code100 apply unless this act itself contains provisions.100 sr 311.0art. 27101 1 the special provisions of the criminal code102 and the provisions of the foodstuffs act of 20 june 2014103 are reserved.1042 in the event of the unauthorised import, export or transit of narcotics in accordance with article 19, the criminal provisions of the customs act of 18 march 2005105 and the ordinance of 29 march 2000106 to the federal act on value added tax do not apply.101 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).102 sr 311.0103 sr 817.0104 amended by annex no ii 4 of the foodstuffs act of 20 june 2014, in force since 1 may 2017 (as 2017 249; bbl 2011 5571).105 sr 631.0106 [as 2000 1347, 2001 3294 no ii 4, 2004 5387, 2006 2353 4705 no ii 45, 2007 1469 annex 4 no 24 6657 annex no 9. as 2009 6743 art. 163]. see now: the value added tax ordinance of 27 nov. 2009 (sr 641.201).section 2 prosecution107 107 inserted by no i of the fa of 28 sept. 2012 (as 2013 1451; bbl 2011 8195 8221). amended by annex no ii 3 of the fixed penalties act of 18 march 2016, in force since 1 jan. 2020 (as 2017 6559, 2019 527; bbl 2015 959). art. 28108 1 prosecution is the responsibility of the cantons.2 articles 6 and 7 of the federal act of 22 march 1974109 on administrative criminal law also apply to prosecution by cantonal authorities.3 notice of convictions, penalty orders and decisions not to proceed in cases under article 19 paragraph 2 must be given in full written form to the federal office of police immediately after they are issued where the indictment demanded an unsuspended custodial sentence.108 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).109 sr 313.0art. 28a110 offences under articles 20-22 that are established by the relevant federal authority in the area subject to federal law enforcement shall be prosecuted and judged by that authority. the procedure is governed by the federal act of 22 march 1974111 on administrative criminal law.110 inserted by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).111 sr 313.0art. 28b-28l112 112 inserted by no i of the fa of 28 sept. 2012 (as 2013 1451; bbl 2011 8195 8221). repealed by annex no ii 3 of the fixed penalties act of 18 march 2016, with effect from 1 jan. 2020 (as 2017 6559, 2019 527; bbl 2015 959).chapter 5113 tasks of the cantons and the confederation 113 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645). section 1 tasks of the confederation art. 29 1 the confederation exercises oversight over the implementation of the act.2 it conducts controls at the border (import, transit and export) and in customs warehouses and bonded warehouses.3 the confederation and the cantons work together to fulfil their tasks under this act and shall coordinate their measures. they may call on the assistance of other organisations concerned.4 the federal council shall appoint a specialist committee114 to advise it on the issue of addiction.114 the name of the committee was amended on 1 feb. 2019 in application of art. 20 para. 2 of the publications act of 7 oct. 2015 (sr 170.512.1).art. 29a 1 the federal office of public health shall arrange for the scientific evaluation of the measures under this act. it may give the data obtained under article 3f in anonymised form to the federal statistical office for evaluation and publication.2 on completion of important evaluations, the federal department of home affairs shall submit a report to the federal council and the relevant committees of the federal assembly on the results and shall submit proposals for further action.3 the federal office of public health shall maintain a documentation, information and coordination office.4 the agency shall submit reports in accordance with the international agreements.art. 29b 1 in relation to combating unauthorised dealing in narcotics, the federal office of police acts as a national analysis, coordination and investigation agency in accordance with the federal act of 7 october 1994115 on the central offices of the federal criminal police.2 it has the following tasks:a. it assists the authorities of other states to combat unauthorised dealing in narcotics within the framework of existing mutual assistance regulations and legal practices.b. it compiles documents that may assist in preventing offences against this act and facilitate the prosecution of offenders.c. it liaises with:1. corresponding services in the federal administration (federal office of public health, directorate general of customs);2.116 swiss post;3. the special tasks service (fdjp);4. the cantonal police authorities;5. the central agencies in other countries;6. the international criminal police organisation interpol.3 customs and border guard authorities shall report offences against this act to the federal office of police so that the information can be passed on to foreign and international authorities; they shall also inform the cantons.4 taking evidence in connection with international mutual assistance in criminal cases relating to narcotics is governed by the relevant provisions of the criminal procedure code of 5 october 2007117.115 sr 360116 amended by annex no ii 5 of the postal services act of 17 dec. 2010, in force since 1 oct. 2012 (as 2012 4993; bbl 2009 5181).117 sr 312.0art. 29c 1 the federal council shall designate a national reference laboratory; this shall conduct research, provide information and coordinate in analytical, pharmaceutical and clinical-pharmacological matters involving narcotics and substances under articles 2, 3 paragraph 1 and 7 paragraph 3.2 the federal council shall designate a national monitoring agency to monitor the problems of addiction. this agency shall collect, analyse and interpret statistical data. it shall work with the cantons and the international organisations.3 the confederation may delegate to third parties specific tasks of research, information and coordination and of monitoring the problems of addiction under paragraphs 1 and 2.section 2 tasks of the cantons art. 29d 1 the cantons shall issue the required regulations for implementing the federal law and designate the relevant authorities and offices responsible for:a. the tasks and powers in relation to prevention, therapy, reintegration, harm reduction and survival support (chapter 1a), in particular to receive reports on persons with existing or imminent disorders associated with addiction (art. 3c);b. granting licences (art. 3e, 14 and 14a para. 1bis);c. accepting reports on narcotics dispensed or prescribed for conditions other than those permitted (art. 11 para. 1bis);d. controls (art. 16-18);e. prosecution (art. 28) and for revoking authorisation to deal in narcotics (art. 12);f. the supervision of the authorities and agencies mentioned in letters a-e and of authorised licensed treatment and social assistance agencies.2 the cantons have the power to charge fees for licences that they grant (art. 3e, 14 and 14a para. 1bis) and for special rulings and controls.3 the cantons shall notify the federal department of home affairs of their implementing regulations.art. 29e 1 the cantonal governments shall report to the federal council regularly on the implementation of this act and the observations made in doing so, and shall provide the required data (art. 29c para. 2).2 the cantons must notify the federal office of police promptly in accordance with the provisions of the federal act of 7 october 1994118 on the central offices of the federal criminal police of any prosecutions initiated due to offences against this act. the relevant information shall be transmitted electronically or entered directly in the data processing systems of the federal office of police. the federal council shall regulate the details.118 sr 360chapter 6 final provisions art. 30119 1 the federal council shall issue the required implementing provisions.2 it shall specify the fees that the agency charges for licences, controls and services. it may delegate his power to the agency.3 it shall specify in specific cases the powers, the detailed requirements for their exercise and the methods for the required controls when granting licences to organisations, institutions and authorities as defined in article 14a. it may if necessary issue alternative regulations to the act when regulating the controls.119 amended by no i of the fa of 20 march 2008, in force since 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 31-34120 120 repealed by no i of the fa of 20 march 2008, with effect from 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 35121 121 repealed by no i of the fa of 20 march 1975, with effect from 1 aug. 1975 (as 1975 1220; bbl 1973 i 1348).art. 36122 122 repealed by no i of the fa of 20 march 2008, with effect from 1 july 2011 (as 2009 2623, 2011 2559; bbl 2006 8573 8645).art. 37 1 the federal council shall specify the date on which this act takes effect.2 on this date, the federal act of 2 october 1924123 concerning narcotics and provisions of federal and cantonal acts and ordinances that conflict with this act shall be repealed.commencement date: 1 june 1952124123 [bs 4 434]124 fcd of 4 march 1952.

812.212.1english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon licensing in the medicinal products sector(medicinal products licensing ordinance, mplo)of 14 november 2018 (status as of 1 january 2020)the swiss federal council,having regard to the therapeutic products act of 15 december 20001 (tpa),ordains:1 sr 812.21chapter 1 subject matter and definitions art. 1 object and definition of terms 1 this ordinance regulates:a.the manufacture of medicinal products;b.wholesale trading in medicinal products;c.the import, export and transit trade in medicinal products;d.trading in medicinal products in foreign countries from switzerland;e.the extracting of blood for transfusions or for the manufacture of medicinal products together with other essential elements of transfusion safety in handling blood and labile blood products;f.brokerage or agency activities in connection with medicinal products;g.temporary licences to use medicinal products in accordance with article 9b paragraph 1 tpa.2 with the exception of articles 27, 28 and 47, this ordinance applies by analogy to the handling of transplant products as described in article 2 paragraph 1 letter c of the transplantation ordinance of 16 march 20072.3 articles 29-38 do not apply to transplant products described in article 2 paragraph 1 letter c number 2 of the transplantation ordinance of 16 march 2007.2 sr 810.211art. 2 definitions in this ordinance:a.active pharmaceutical ingredients means substances or mixtures to which the effect of a ready-to-use medicinal product is attributed and which are used in ready-to-use medicinal products;b.immunological medicinal products means medicinal products administered to create active or passive immunity or help diagnose immunity status, in particular vaccines, toxins and sera, and medicinal products intended to identify or cause a particular acquired modification of the immune response to an allergising substance, such as allergens;c.ready-to-use medicinal product means a medicinal product that has been released technically on the basis of the entire manufacturing process and is available in a form and presentation enabling it to be used as intended;d.blood means human blood;e.labile blood products means products that are extracted from donated blood, either directly or in one or a small number of manufacturing steps, and which quickly change without any external influence, in particular cell preparations and plasma;f.medicated feedingstuffs means ready-to-use veterinary medicinal products comprising a mixture of premixed medicinal products and feedstuffs or drinking water;g.premixed medicinal products means veterinary medicinal products, comprising active ingredients and excipients intended for mixing with animal feedstuffs or drinking water or for direct administration to a category of animals;h.batch means a homogeneous and defined quantity of raw materials, medicinal products or packaging material prepared in one manufacturing operation or in a series of manufacturing operations;i.system to ensure the pharmaceutical quality of medicinal products means the whole range of measures taken to ensure that medicinal products have the necessary quality for their intended use;j.medical personnel means doctors, dentists, veterinary surgeons and pharmacists;k.facilities means individual parts or groups of buildings or systems, in one or more locations, and vehicles and other resources involved in the manufacturing, testing, import and export of medicinal products, in wholesale trading or trading abroad with medicinal products, or in brokerage or agency activities related to medicinal products;l.wholesale trade means all activities relating to the paid or unpaid transferring or provision of medicinal products - from acquisition, stockage, storage, offering and advertising to the supply of medicinal products - to persons authorised to trade in them, process them, dispense them or use them in a professional capacity;m.import means all the activities listed under letter l relating to the transport of medicinal products into switzerland;n.export means all the activities listed under letter l relating to the transport of medicinal products out of switzerland;o.technical release means the decision taken on completion of manufacture or of a step in the manufacturing process confirming that the batch in question conforms to the requirements of internal or external clients in terms of composition, manufacturing procedure, specifications and quality and was manufactured in compliance with the rules of good manufacturing practice (gmp) as shown in annex 1 or 2.chapter 2 establishment licences section 1 manufacturing licence art. 3 conditions for granting a licence 1 any person applying to the swiss agency for therapeutic products (swissmedic) for a manufacturing licence must prove that:a.a system to ensure the pharmaceutical quality of medicinal products is in operation and that the company management and staff in the individual departments concerned take an active part in such a system;b.each department has a sufficient number of qualified and competent staff members to enable it to achieve its quality targets;c.a responsible person as described in articles 5 and 6 is available;d.the facilities are organised in an appropriate way;e.the facilities are designed, structured, maintained and modernised regularly to guarantee the safe manufacture of medicinal products and the premises and equipment that can influence the quality of the medicinal products are qualified for their purpose;f.a documentation system is available to provide the working instructions, process descriptions and protocols of the relevant manufacturing procedures;g.the manufacturing, testing and cleaning procedures are validated;h.quality control is separate from manufacture;i.the obligations described in articles 4 and 7 and in relation to the manufacture of labile blood products and the obligations in articles 28-38 are met.2 the work of all persons occupying key positions in the company must be set out in job descriptions and their hierarchical positions set out in organisational charts.3 swissmedic may specify further technical requirements and details.art. 4 responsibility and good manufacturing practice 1 holders of a licence under article 3 are responsible for the processing and working procedures they carry out.2 medicinal product manufacture must be carried out in accordance with the rules of good manufacturing practice described in annex 1 or 2.3 in the manufacture of complementary medicinal products, the gmp rules must be followed by analogy and the specific regulations for the therapies concerned which are laid down in the pharmacopoeias recognised by swissmedic must be adhered to.art. 5 technical supervision of the facilities 1 the responsible person is responsible for the direct technical supervision of the facilities and in particular ensures that the medicinal products are handled appropriately.2 they are responsible for the quality of the manufactured medicinal products and ensure that the legal provisions applicable to therapeutic products are observed.3 they are authorised to issue instructions within their sphere of activity.4 they and the company management jointly ensure their deputisation by adequately qualified specialists.5 if the facilities cease operations, or if operations can be expected to cease imminently, the responsible person must report this situation to swissmedic without delay.6 they may not sit on one of the facilities' supervisory committees and must decide on the release or rejection of batches independently of the company's management. swissmedic may grant a licence to small facilities without such segregation if they cannot implement the segregation because of their size.7 if the size and nature of the facilities permit this activity to be performed on a part-time basis, responsibilities must be set out in writing and the minimum number of hours during which the person must be present in the facility must be determined.art. 6 individual requirements that the responsible person must fulfil 1 the responsible person must have the necessary technical knowledge and be trustworthy. they must also fulfil the following professional requirements:a.for the manufacture of ready-to-use medicinal products or intermediate products, the responsible person must be a qualified pharmacist with professional experience;b.for the manufacture of labile blood products or immunological medicinal products the responsible person must have a university degree in medicine or a life science and have the necessary professional experience;c.for the manufacture of active pharmaceutical ingredients or medicated feedingstuffs, the responsible person must have a university degree in a life science and the necessary professional experience;d.for the manufacture of radiopharmaceuticals, the responsible person must have a certificate issued by the european association of nuclear medicine for radiopharmacy and have the necessary experience.2 if a person can prove sufficient knowledge and experience, swissmedic may also recognise other professional qualifications for this job.3 swissmedic may specify further details to article 5 and this article, in particular the minimum number of hours during which the responsible person must be present in the facility and the requirements that they must fulfil in terms of training and experience.art. 7 technical release 1 the responsible person decides on the technical release of a product batch.2 they issue a batch certificate confirming that the batch in question conforms to the requirements of internal or external clients in terms of composition, manufacturing procedure, specifications and quality and was manufactured in compliance with the gmp rules in accordance with annex 1 or 2.art. 8 cantonal manufacturing licence 1 hospital pharmacists and persons in possession of a cantonal licence in accordance with article 30 tpa who prepare medicinal products in accordance with article 9 paragraph 2 letters a-cbis or paragraph 2bis tpa must carry out a risk assessment in accordance with annex 3. this provision does not apply to the cases set out in paragraph 6 below.2 the conduct of these risk assessments should be documented. this documentation should be presented to the cantonal supervisory authority on request.3 if the risk assessment produces a value below the threshold specified in annex 3, a cantonal manufacturing licence is required instead of a licence issued by swissmedic.4 the licence is granted if it can be ensured that the rules of good manufacturing practice for small quantities of medicinal products in accordance with annex 2 are observed.5 the cantons regulate the other conditions for the granting of the licence in accordance with paragraph 3 and periodically carry out facility checks.6 any person who manufactures radiopharmaceuticals requires a licence granted by swissmedic.art. 9 surveys of medicinal products prepared in accordance with article 9 paragraph 2 letters a-cbis tpa the cantons may conduct surveys among manufacturers concerning the medicinal products prepared in accordance with article 9 paragraph 2 letters a-cbis and paragraph 2bis tpa. the manufacturers are obliged to provide the necessary information to the cantons on request.art. 10 cantonally authorised medicinal products the preparation of medicinal products in accordance with article 9 paragraph 2 letter f tpa is exempt from licensing by swissmedic.section 2 licence for the import, wholesale trade and export of medicinal products art. 11 general preconditions 1 any person applying for a licence to import medicinal products must prove that:a.a system to ensure the pharmaceutical quality of medicinal products is in operation and that the company management and staff in the individual departments concerned take an active part in such a system;b.each department has a sufficient number of qualified and competent staff members to enable it to achieve its quality targets;c.the tasks of all persons occupying key positions in the company are set out in job descriptions and their hierarchical positions are set out in organisational charts;d.a responsible person in accordance with articles 17 and 18 is available;e.the facilities are organised in an appropriate way;f.the facilities are designed, structured, maintained and modernised regularly to guarantee the safe import of medicinal products;g.a documentation system is available that comprises the working instructions, process descriptions and protocols of the relevant import procedures;h.the requirements and obligations of articles 15 and 16 are fulfilled;i.the manufacturer of the medicinal products to be imported has a manufacturing licence issued by a country whose gmp control system is considered by swissmedic to be equivalent, or which states that the medicinal products are manufactured in compliance with the gmp rules valid in switzerland.2 any person who applies for a licence to trade wholesale in medicinal products or a licence to export medicinal products must fulfil the requirements stated in paragraph 1 letters a-h; letters f and g apply by analogy.3 swissmedic may specify further technical requirements and details.art. 12 additional preconditions 1 any person who applies for a licence to trade wholesale in medicinal products or a licence to import ready-to-use medicinal products, and who in addition wishes to release ready-to-use medicinal products onto the market in their capacity as holder of the marketing authorisation must fulfil the requirements stated in article 11 and also ensure that:a.an analysis sample sufficient for two complete release analyses is kept of each batch of a medicinal product released onto the market;b.an inspection sample is available for each batch of a medicinal product;c.general and batch-specific documentation of the manufacture of a medicinal product, including documentation of its technical release and testing, is available;d.a person is appointed for pharmacovigilance who has the appropriate specialist knowledge and is in charge of reporting adverse drug reactions in accordance with articles 61 and 65 of the therapeutic products ordinance of 21 september 20183 (tpo);e.the requirements described in article 13 have been fulfilled.2 the person described in paragraph 1 letter d need not be on the staff of the company; however, their responsibilities must in all cases be described in writing.3 any person who applies for a licence to trade wholesale in medicinal products or a licence to import or export medicinal products and who in addition, and in their capacity as customer, wishes to have medicinal products manufactured or tested by a third party, must fulfil the requirements described in article 11 and also ensure that:a.the contractor has the information and qualifications necessary to manufacture the medicinal product lawfully;b.each batch of a medicinal product fulfils the requirements established for composition, manufacturing procedure, specifications and quality and is manufactured in conformity with the gmp rules;c.general and batch-specific documentation on the manufacture of a medicinal product, including documentation of its technical release and testing, is available.4 swissmedic may specify further technical requirements and details.3 sr 812.212.21art. 13 market release 1 the responsible person employed by the holder of the marketing authorisation decides on the market release of a batch before it is placed on the market. 2 they check whether:a.a valid batch certificate issued by the manufacturer is available and whether the batch was manufactured in conformity with the gmp rules described in annex 1;b.the batch in question fulfils the requirements of the authorisation;c.the conditions described in articles 11 and 12 have been fulfilled; andd.the entire supply chain is in conformity with the authorisation and the gdp rules described in annex 4.3 swissmedic may specify additional checks.4 the responsible person confirms that the checks described in paragraphs 2 and 3 have been performed.art. 14 reanalysis if ready-to-use medicinal products are manufactured in a state with which switzerland has not signed an agreement on the mutual recognition of the gmp control procedures and there are justified doubts about the safety or quality of the batches to be imported, swissmedic may order that each batch undergo reanalysis in switzerland.art. 15 responsibility and good distribution practice 1 holders of a licence under article 11 bear responsibility for the activities they carry out.2 the import, export and wholesale trading of ready-to-use medicinal products must conform to the gdp rules described in annex 4. these rules also apply by analogy to veterinary medicinal products and non-ready-to-use medicinal products.art. 16 mandatory documentation licence holders must keep the following documents in particular in order to ensure traceability:a.the name of the medicinal product;b.the transaction date;c.the quantity;d.the batch number;e.the expiry date;f.the name and address of the supplier and the customer.art. 17 technical supervision of the facilities 1 the responsible person is responsible for the direct technical supervision of the facilities and in particular ensures that the medicinal products are handled appropriately. 2 they ensure that the import, export and wholesale trading in medicinal products are in conformity with the gdp rules described in annex 4 and ensure that the legal provisions applicable to therapeutic products are observed.3 they are authorised to issue instructions within their sphere of activity. 4 they and the company management jointly ensure their deputisation by adequately qualified specialists.5 if the facilities cease operations, or if operations can be expected to cease imminently, they must report this situation to swissmedic without delay.6 they may not sit on one of the facilities' supervisory committees and must decide on the release or rejection of batches independently of the company's management. swissmedic can grant a licence to small facilities without such segregation if they cannot implement the segregation because of their size.7 if the size and nature of the facilities permit this activity to be performed on a part-time basis, responsibilities must be specified in writing and the minimum number of hours during which the person must be present in the facility must be determined.art. 18 individual requirements that the responsible person must fulfil 1 the responsible person must have the necessary training, technical knowledge and experience, and be trustworthy.2 to obtain a licence in accordance with article 12 paragraphs 1 and 3, the responsible person must also fulfil the following requirements and tasks:4a.the responsible person must possess a degree in pharmacology and the necessary experience in the manufacture of ready-to-use medicinal products. if the person can prove sufficient knowledge and experience in the medicinal products sector, swissmedic may also recognise other professional qualifications for this job.b.in granting market release, the responsible person ensures that each batch is not placed on the swiss market until all the applicable conditions of articles 11-13 have been fulfilled and the entire supply chain is in conformity with the authorisation and the gdp rules. 3 swissmedic may specify further details to article 17 and this article, in particular the minimum number of hours during which the responsible person must be present in the facility and the requirements that they must fulfil in terms of training and experience.4 correction of 28 may 2019 (as 2019 1605).art. 19 import of non-authorised medicinal products for clinical trials 1 the import of medicinal products for use in a clinical trial in accordance with the protocol for that trial requires a licence issued by swissmedic. this licence also covers the individual import of immunological medicinal products and of blood and blood products.2 a licence is not required if the importing person or institution already holds a licence as described in article 11.art. 20 exemption from mandatory licensing 1 doctors and veterinary surgeons who practise their profession on both sides of the border in accordance with current international agreements may import and export ready-to-use medicinal products in small quantities without a licence insofar as this is indispensable for practising their profession.2 any person holding a cantonal licence to dispense medicines as a public pharmacy, hospital pharmacy or drugstore does not require an operating licence from swissmedic for the wholesale trade in medicines occasionally conducted with other holders of a cantonal dispensing licence in the canton in which they are established. if the medicines are sold to more than five customers a year or if distribution is transferred to a third party, an operating licence from swissmedic is required.3 for wholesale trade activities in accordance with paragraph 2, the gdp rules described in annex 4 apply mutatis mutandis.4 the cantonal authorities must be notified of wholesale trade activities in accordance with paragraph 2.section 3 licence for trading in foreign countries art. 21 preconditions 1 any person applying for a licence to trade in foreign countries must prove that:a.the facilities operate a system to ensure the pharmaceutical quality of medicinal products and that the company management and staff in the individual departments concerned take an active part in this system;b.a responsible person in accordance with article 23 is available;c.the facilities are organised in an appropriate way;d.a documentation system is available that comprises the working instructions, process descriptions and protocols of the relevant procedures involved in the activities;e.due diligence is exercised as described in article 22.2 swissmedic may specify further technical requirements and details.3 the licence does not entitle the holder to issue manufacturing orders.art. 22 due diligence 1 holders of a licence under article 21 are responsible for the correct conduct of trade with medicinal products and the traceability of the buying and selling of medicinal products.2 they ensure that supplier and customer are authorised to carry out the work procedures that they perform. they must be able to prove this.3 they obtain in particular the documents showing the quality of the medicinal product and those showing at least the transaction date, quantity, batch number, expiry date and exact name of the medicinal product and the name and address of the supplier and customer, and keep these documents.4 they ensure, including during transport, that the necessary storage conditions remain within the limits determined by the manufacturer or stated on the packaging. they must be able to prove this in writing.5 they must provide the customer on each delivery with details of the original manufacturer and the original batch number of the merchandise delivered.6 they must forward to the customer or the supplier all information provided by any supplier or customer that pertains to the quality and safety of the medicinal product or is relevant for the authorities.7 they must operate an effective procedure for the batch recall of medicinal products.art. 23 technical supervision and responsible person 1 responsible persons carry out the direct technical supervision of the facilities and, in particular, ensure orderly trading in medicinal products.2 they are authorised to issue instructions within their sphere of activity.3 they ensure their deputisation by adequately qualified specialists.4 if the facilities cease operations, or if operations can be expected to cease imminently, they must report this situation to swissmedic without delay. 5 they must have the necessary training, expertise and experience, and be trustworthy. 6 they decide independently of the company's management and may not sit on any of the facilities' supervisory committees. swissmedic may grant a licence to small facilities without such segregation if they cannot implement the segregation because of their size.7 if the size and nature of the facilities permit this activity to be performed on a part-time basis, responsibilities must be specified in writing and the minimum number of hours that the responsible person must be present in the facility must be determined.8 swissmedic may specify further details, in particular the minimum number of hours that the responsible person must be present in the facility and the requirements that they must fulfil in terms of training and experience.section 4 licence to perform brokerage or agency activities art. 24 preconditions 1 any person applying for a licence to perform brokerage or agency activities must prove that:a.the facilities operate a functioning quality assurance system and that the company management and staff in the individual departments concerned take an active part in this system;b.a responsible person in accordance with article 26 is available;c.the facilities are organised in an appropriate way;d.a documentation system is available that comprises the working instructions, process descriptions and protocols of the relevant procedures;e.due diligence is exercised as described in article 25.2 swissmedic may specify further technical requirements and details.3 the licence does not entitle the holder to issue manufacturing orders.art. 25 due diligence 1 holders of a licence in accordance with article 24 must ensure that the supplier and the customer are authorised to carry out the work processes that they perform. they must be able to prove this.2 they must ensure that the medicinal products have not originated from illegal trading and are not intended for unlawful purposes.3 they must forward to the customer or the supplier all information provided by any supplier or customer regarding the quality and safety of the medicinal product or that is relevant for the authorities, in particular information about medicinal product recalls.4 the agents must additionally retain copies of the paperwork documenting the business transaction. art. 26 technical supervision and responsible person 1 responsible persons carry out the direct technical supervision of the facilities and in particular ensure compliance with due diligence within the facilities.2 they are authorised to issue instructions within their sphere of activity.3 they ensure their deputisation by adequately qualified specialists.4 if the facility ceases operations, or if operations can be expected to cease imminently, they must report this situation to swissmedic without delay.5 they must have the necessary training, expertise and experience, and be trustworthy.6 they decide independently of the company's management and may not sit on any of the facilities' supervisory committees. swissmedic may grant a licence to small facilities without such segregation if they cannot implement the segregation because of their size.7 if the size and nature of the facilities permit this activity to be performed on a part-time basis, responsibilities must be specified in writing and the minimum number of hours during which the responsible person must be present in the facility must be determined.8 swissmedic may specify further details, in particular the minimum number of hours during which the responsible person must be present in the facility and the requirements that they must fulfil in terms of training and experience.section 5 special provisions for blood and blood products art. 27 conditions for granting a licence for the collection of blood 1 any person applying for a licence to collect blood for transfusion or the manufacture of medicinal products in accordance with article 34 tpa must prove that:a.the conditions described in article 3 have been fulfilled;b.the responsible person fulfils the conditions of articles 5 and 6 and has a university degree in medicine or a life science and the scientific and medical experience needed to collect blood;c.blood is collected in compliance with the gmp rules described in annex 1;d.due diligence is exercised as described in articles 28-38.2 swissmedic may specify further technical requirements and details.art. 28 responsible person for haemovigilance 1 the holder of a licence for activities with blood or labile blood products must appoint a person responsible for haemovigilance.2 the responsible person must be a doctor and have the appropriate technical knowledge.3 this person has an obligation to report adverse drug reactions in accordance with articles 61 and 65 tpo5.4 swissmedic may also recognise persons with other professional qualifications as responsible persons, provided they possess sufficient knowledge and experience.5 while responsible persons do not need to be employees of the company, their responsibilities must in all cases be defined in writing.5 sr 812.212.21art. 29 donor suitability 1 the suitability of blood donors must be evaluated by a qualified physician with experience in transfusion medicine or by a person trained in this assessment who is working under the supervision of a qualified physician.2 the donors must be provided with comprehensive information about donating blood and the risks of infection with major pathogens must be explained before the blood donation so that they can decide not to donate blood if the blood they donate could represent a risk of infection for third parties.3 otherwise, the information provided in the context of a donation is guided by annex 5 number 3.4 persons in the following categories are not permitted to donate blood:a.those who have been diagnosed with hiv;b.those who are suffering from aids or who have symptoms indicative of an aids-related illness;c.those whose behaviour carries the risk of infection with hiv;d.intimate partners of persons described under letters a-c;e.those who carry a specific risk of prion infection;f.those who have received transplant material of animal origin.5 otherwise, donor suitability is evaluated in accordance with annex 5 number 1.art. 30 compulsory testing 1 a sample of every collected blood donation used for transfusion or to manufacture labile blood products must be tested in accordance with the testing requirements listed in annex 5 number 2.2 the tests must be performed using appropriate methods or procedures that are validated in accordance with the state-of-the-art scientific and technical knowledge and are suitable for testing donated blood and plasma.3 before blood or erythrocyte preparations are transfused, their compatibility with the recipient's blood must be established using appropriate methods.art. 31 appropriate tests and test procedures 1 if the tests are carried out abroad, it must be proven that they comply with the state-of-the-art scientific and technological knowledge.2 swissmedic may specify technical requirements and particulars in relation to the tests and test procedures.3 when tests are being carried out on blood or labile blood products intended for transfusion or to manufacture medicinal products, the rules of good practice must be adhered to in accordance with annex 1 of the ordinance of 29 april 20156 on microbiological laboratories.6 sr 818.101.32art. 32 procedure in the event of a positive test result 1 if the test is repeatedly reactive, the blood donation may not be used for transfusion or to manufacture blood products.2 if further confirmation tests on blood intended for autologous transfusion give a negative result or if the results of tests carried out in accordance with annex 5, number 2.2 letter d deviate from the norm, the treating physician decides whether to carry out the transfusion.art. 33 donor counselling 1 the donor may only be informed of a positive test result if the test has been confirmed using an appropriate method.2 where a donor is informed of a positive test result, they must also be offered counselling and assistance.3 the donor may refuse to be informed of a test result.art. 34 labelling 1 blood and labile blood products and the corresponding blood samples must be labelled in accordance with the rules of gmp and good practice in accordance with annex 1 of the ordinance of 29 april 20157 on microbiological laboratories.2 in the case of autologous transfusion, the label must also bear the name of the donor and the label must be signed by the autologous donor immediately before blood collection.3 autologous donations must be kept separate from homologous donations.7 sr 818.101.32art. 35 records and traceability 1 holders of a licence for handling blood and labile blood products must maintain records of all safety-relevant activities, in particular in relation to the collection of blood, and the manufacture, release, distribution, destruction and recall of blood or labile blood products.2 they must ensure that blood or labile blood products can be traced back to the donor. for this purpose, each blood donation must be given a donor number that makes it possible at any time to clearly identify the donation, the donor's medical history, every blood product made from his donation and all documents related to these products.3 whenever blood is donated, the following information must be recorded in detail:a.the date and identification of the donation and the donor;b.information on the decision on donor suitability and, if relevant, the reason for excluding a donor;c.the test results and their interpretation.4 each protocol must be signed by a person who is authorised to do so by the quality management system.art. 36 archiving and transmitting data 1 if the holder of a licence to handle blood and labile blood products ceases this activity prior to expiry of the archiving obligation in accordance with article 40 tpa, the archives must be handed over to swissmedic, or to the blood transfusion service of the swiss red cross if it is one of its establishments.2 swissmedic or the blood transfusion service of the swiss red cross destroys the archives on expiry of the archiving obligation.art. 37 protective measures 1 holders of a licence to handle blood or labile blood products must immediately take the necessary protective measures if they notice that:a.at the time of donation the donor did not fulfil the criteria required to be considered a suitable donor;b.the tests for transmittable diseases have not been carried out in accordance with the regulations;c.the donor has undergone seroconversion or has contracted a blood-borne infection;d.the recipient of a donation develops a post-transfusion infection which could be traced back to the donor;e.serious defects in relation to the gmp rules described in annex 1 have occurred during the blood collection process or the manufacturing of labile blood products.2 the measures that will be taken if the situations described in paragraph 1 letters b-e occur must be reported to swissmedic.3 measures taken in the event of occurrences described in paragraph 1 letters c and d may involve investigations into previous donations or other donors.4 institutions which use blood and labile blood products in patients must inform the manufacturers on request of the relevant information about use of the labile blood product and about the conclusion of the tracing procedure if investigations as described in paragraph 3 are carried out.art. 38 additional safety measures 1 blood and labile blood products may only be used for homologous transfusions if the leucocytes have been depleted in a validated state-of-the-art scientific or technical procedure.2 plasma may only be used for homologous transfusions if, in addition to the safety measure described in paragraph 1 and the tests described in article 30:a.it has been stored for four months and on expiry of the deadline a new test on the donor produced a negative result; orb.it has undergone a procedure to inactivate or eliminate viruses.3 platelet concentrates may only be used in switzerland if appropriate measures are taken to mitigate the risk of bacterial contamination.4 unused autologous donations must not be used for homologous transfusions or to manufacture blood products.chapter 3 licensing procedure art. 39 granting the licence 1 the licence is granted if:a.the application is complete; b.the applicant fulfils all relevant conditions at all facilities for the activities applied for.2 swissmedic shall suspend the substantive assessment of the application if criminal proceedings are pending against a responsible person in accordance with articles 5, 6, 17, 18, 23 or 26, as a result of which swissmedic concludes that the conditions for adequate technical supervision are no longer fulfilled.3 if a responsible person is under investigation for infringing the tpa or the narcotics act of 3 october 19518 in criminal proceedings, swissmedic may suspend the corresponding licence.4 it may demand an extract from the criminal records relating to the responsible person's.5 the applicant is granted a single licence for all activities in the application in accordance with the tpa and this ordinance.8 sr 812.121art. 40 content of the licence the licence specifies the name of the responsible person, the licensed activities and the site of the facilities. it may not be transferred to other persons or to other sites.art. 41 amendments 1 holders of a licence must apply to swissmedic with the necessary documentation for any amendments to the content of the licence.2 they must report the essential details of all major changes to facilities, equipment or procedures used in the manufacture, testing or import and export of medicinal products, for wholesale trading or in trading abroad with medicinal products or for brokerage or agency activities in connection with medicinal products and which could influence quality.3 swissmedic shall respond to applications under paragraph 1 and make any objections to amendments as in paragraph 2 within a period of 30 days.art. 42 periodic review 1 fulfilment of all the conditions for retaining the licence is reviewed periodically by inspection.2 if the conditions are no longer fulfilled or if their fulfilment cannot be examined, specifically because the licensed activities have not been performed for more than twelve months, swissmedic may revoke the licence either wholly or in part.art. 43 detailed specifications swissmedic may specify the terms of the licensing procedure in greater detail.chapter 4 special provisions for import, export, transit and trading abroad art. 44 import of individual batches of immunological medicinal products that are authorised or not subject to authorisation or of blood and blood products 1 any person who imports the following medicinal products that are authorised or not subject to authorisation or blood and blood products into switzerland requires a licence for each shipment:a.immunological medicinal products;b.blood and blood products.2 a licence is not required for the import of individual batches of: a.allergens;b.blood that is authorised or not subject to authorisation and blood products of this kind if these medicinal products:1.are imported in medical emergencies or for autologous transfusion,2.are not intended for use in humans, or3.have an official batch release from one of the control authorities belonging to the official control authority batch release network (ocabr network);c.immunological medicinal products that are authorised or not subject to authorisation provided an official batch release from one of the control authorities belonging to the ocabr network is available for the batch to be imported.3 in the interest of protecting health, swissmedic may impose temporary or permanent mandatory licensing on the import of individual batches of immunological medicinal products or of blood and blood products that are authorised or not subject to authorisation even if an official batch release as described in paragraph 2 letter b number 3 is available.art. 45 conditions for granting a licence any person applying for a licence in accordance with article 44 paragraph 1 must prove that:a.they have a licence to import medicinal products;b.if these are ready-to-use medicinal products destined for the swiss market, they have the corresponding authorisation;c.they ensure the safe and lawful import of the medicinal products and accept responsibility for this;d.the manufacturing and import of the medicinal products and wholesale trading in medicinal products are in conformity with the gmp rules described in annex 1 and the gdp rules described in annex 4;e.in the case of blood and blood products for use in humans, in addition to letters a-d:1.no pathogens or indication of the presence of pathogens can be detected,2.each individual blood donation is analysed using tests that correspond to state-of-the-art scientific and technical knowledge,3.blood and plasma are only imported unmixed, unless swissmedic has exceptionally granted a licence to import mixed products,4.the requirements in accordance with article 27 paragraph 1 letter c and articles 34, 35 and 37 are adhered to.art. 46 procedure 1 the application for a licence to import individual batches must be submitted to swissmedic together with the necessary documentation.2 the licence is valid for one month.3 the applicant must ensure that the licence is presented to the customs office at the time when the medicinal products are imported.4 on customs clearance, the customs office shall discharge the licence and forward it to swissmedic.5 in the absence of a licence to import individual batches in accordance with article 44 paragraph 1, medicinal products are refused entry at the border and reported to swissmedic.art. 47 individual batch import of immunological medicinal products for veterinary use 1 the application to import individual batches of immunological medicinal products for veterinary use must be submitted to the federal food safety and veterinary office in accordance with article 46 paragraph 1. a licence is not required to import individual batches of allergens.2 the applicant must ensure that the licence is presented to the customs office at the time when the medicinal products are imported.3 on customs clearance, the customs office discharges the licence and forwards it to the institute for virology and immunology of the federal food safety and veterinary office.art. 48 import of non-authorised ready-to-use medicinal products by individuals individuals may import ready-to-use medicinal products that are not authorised in switzerland in quantities needed for their personal use. this does not apply to:a.medicinal products which contain genetically modified organisms,b.immunological medicinal products for use in livestock;c.vaccines, toxins and sera for veterinary usage;d.transplant products within the meaning of the transplantation ordinance of 16 march 20079 which have been genetically modified.9 sr 810.211art. 49 import of non-authorised ready-to-use medicinal products by professionals 1 a medical professional who has a cantonal dispensing licence may import small quantities of a ready-to-use human medicinal product that is not authorised in switzerland provided:a.the medicinal product is intended for a specific patient or for emergencies; b.the medicinal product has been authorised by a country with a comparable regulatory system; andc.for the medicinal product concerned:1.no alternatively usable medicinal product is authorised in switzerland,2.an alternatively usable medicinal product is authorised in switzerland, but is not available on the swiss market, or3.it is not appropriate to switch the medication to a medicinal product authorised and available in switzerland. 2 treating physicians with a cantonal professional licence may import small quantities of ready-to-use human medicinal products that are not authorised in switzerland if: a.they have performed a risk analysis to confirm the appropriateness of the usage and notified the competent cantonal authorities of their conclusions before the medicinal products are imported; andb.the medicinal product:1.fulfils the conditions described in paragraph 1 letters a and c, and2.has been authorised by a country with a comparable regulatory system for use in a clinical trial.3 pharmacists with pharmaceutical responsibility in a hospital pharmacy may import small quantities of ready-to-use human medicinal products to supply their own customers if the conditions in paragraph 1 letters b and c or the conditions in paragraph 1 letter c and 2 letters a and b are fulfilled.4 medical professionals as described in article 25 paragraph 1 letters b and c tpa who have a cantonal professional licence may import small quantities of non-prescription ready-to-use human medicinal products that are not authorised in switzerland under the terms of their dispensing licence provided the conditions in paragraph 1 are fulfilled. 5 prior to import, importing persons must check in each case whether the relevant requirements in paragraphs 1-4 are met and ensure that the medicinal products are transported in conformity with the gdp rules described in annex 4.6 they must keep a record of the check described in paragraph 5 and of the time when the check was carried out and the import took place, and the nature, number and intended use of the imported human medicinal products.7 the import of medicinal products for animals by medical professionals is subject to article 7 of the veterinary medicinal products ordinance of 18 august 200410.10 sr 812.212.27art. 50 medicinal products that can be used for capital punishment 1 any person who exports medicinal products that can be used for capital punishment requires a licence from swissmedic for each transaction.2 any person who trades abroad in such medicinal products requires a licence from swissmedic for each transaction.3 a licence as described in paragraphs 1 and 2 may be granted provided the applicant: a.confirms to swissmedic that, following investigations, there is no evidence that the medicinal products in question will be used for capital punishment; andb.submits a declaration by the customer stating that the medicinal products will not be used by the customer or by third parties for capital punishment.4 swissmedic publishes a list of medicinal products that can be used for capital punishment it takes into account valid eu law, in particular the delegated acts and implementing acts adopted by the european commission on the basis of council regulation (ec) no. 1236/200511.11 council regulation (ec) no 1236/2005 of 27 june 2005 concerning trade in certain goods which could be used for capital punishment, torture or other cruel, inhuman or degrading treatment or punishment; oj l 200 of 30.07.2005 p. 1.art. 51 transit the transit of medicinal products which are dangerous to health is not permitted.chapter 5 temporary licences to use medicinal products in accordance with art. 9b para. 1 tpa art. 52 preconditions 1 a temporary licence to use medicinal products in accordance with article 9b paragraph 1 tpa may be granted to the sponsor of a clinical trial approved in switzerland if the sponsor:a.confirms that the medicinal product is identical to the medicinal product used in at least one clinical trial approved in switzerland;b.justifies every deviation from the most recently approved protocol and specifies the conditions under which the medicinal product will be used;c.justifies the non-inclusion of patients in the clinical trial;d.states the reasons why use is likely to be of major therapeutic benefit;e.proves that there is no alternative and equivalent medicinal product authorised in switzerland;f.proposes and justifies a period of validity for the licence;g.states and justifies the treatment centres and the proposed number of patients;h.submits a draft of the information provided for patients; andi.has obtained a preliminary opinion on letters b-h from the ethics committee which approved the reference trial or, in the case of a multicentre clinical trial, from the lead ethics committee.2 if the application concerns the use of a medicinal product which has been tested in patients with good results in a clinical trial, it must be used in accordance with the protocol for that clinical trial. the conditions set out in paragraph 1 letters a and d-i must be fulfilled.3 this licence also covers the import of the medicinal products concerned, including the individual import of immunological medicinal products, blood and blood products.art. 53 procedure for granting and extending a licence 1 the application is submitted to swissmedic with the documents listed in annex 6.2 swissmedic may request additional information.3 it informs the ethics committee about its decision and, where appropriate, any subsequent decisions.art. 54 preconditions 1 the sponsor notifies swissmedic of all major changes affecting the medicinal product or its usage by analogy with article 34 paragraph 3 of the ordinance of 20 september 201312 on clinical trials.2 the sponsor notifies swissmedic of all adverse reactions and events in accordance with article 59 tpa.3 the sponsor sends swissmedic a safety report once a year.12 sr 810.305art. 55 withdrawal of the licence 1 swissmedic may withdraw the licence in the interest of protecting patients' health.2 the announcement of a final swissmedic decision rejecting the application for a licence to place the medicinal product on the market leads to withdrawal of the licence.3 if swissmedic authorises the marketing of the medicinal product, the temporary licence to use the product ends when the medicinal product is actually supplied. the sponsor informs swissmedic of the time at which the medicinal product is actually supplied.chapter 6 implementation section 1 inspections art. 56 requirements pertaining to inspectorates inspectorates that conduct inspections by virtue of this ordinance must have a quality management system that complies with internationally recognised standards and must be accredited.art. 57 requirements pertaining to inspectors 1 inspectors must have an appropriate university degree in the relevant field or a comparable qualification, together with experience and regular training.2 they must be independent of the companies that they are in charge of inspecting. if this is not the case, they must recuse themselves.article 58 recognition of inspectorates 1 swissmedic checks and supervises whether the cantonal inspectorates mandated to carry out inspections in accordance with article 60 tpa fulfil the requirements described in articles 56 and 57.2 it recognises the inspectorates that fulfil these requirements. art. 59 cantonal obligation to notify the cantons must notify swissmedic of any changes within their inspectorates.art. 60 ordering and conduct of inspections 1 the competent authority may at any time order inspections in switzerland or carry them out themselves whenever they consider this necessary.2 swissmedic may inspect manufacturers of medicinal product abroad and facilities abroad that engage in wholesale trading in medicinal products, at the importing company's expense. it informs this company in advance.3 in those states with which switzerland has signed an agreement for the mutual recognition of gmp systems, swissmedic only carries out inspections in justified exceptional cases and after consultation with the competent healthcare authorities in that state.art. 61 issuing certificates at the request of facilities inspected in switzerland or abroad in accordance with article 60, swissmedic may confirm by means of a certificate that the facilities are in conformity with the standards of good practice recognised in switzerland.art. 62 powers of the inspectors the inspectors may:a.demand a current description of the facilities in the form of a site master file from the company to be inspected;b.enter any part of a company's facilities with or without prior notification and, if required, take photographs;c.make copies of documents, including data saved on electronic data storage media or in part of a computer system;d.take samples of medicinal products, raw materials, intermediate products, packaging material or materials used in the manufacturing process; ande.take all necessary immediate measures.art. 63 guidelines on the swiss inspection system after consultation with the inspectors appointed by the cantons, swissmedic issues guidelines to guarantee uniform inspection procedures throughout switzerland.section 2 collaboration between swissmedic and other authorities art. 64 collaboration between swissmedic and the cantons 1 swissmedic and the cantonal authorities collaborate in their control work and may in particular exchange confidential information.2 they notify each other about:a.the granting, amendment, suspension or withdrawal of a licence;b.measures taken;c.inspections.3 the cantonal authorities provide swissmedic with any information brought to their attention that indicates quality or safety defects.4 swissmedic may assist the cantonal inspectorates in training their inspectors.art. 65 collaboration with the customs authorities 1 customs clearance for imports, exports and goods in transit is governed by customs legislation.2 the customs authorities provide swissmedic with information on the import, export and transit of medicinal products.3 swissmedic may require the customs authorities to detain medicinal products for further inspection and take samples.section 3 data protection and informing the general public art. 66 processing personal data the organs responsible for enforcement are authorised to process the personal data that they require for performing all the tasks assigned to them by this ordinance. these data include:a.health data recorded in connection with the official market surveillance of blood and blood products (art. 39, 58 and 59 tpa);b.data on administrative and criminal proceedings and sanctions that are relevant to the assessment of licence applications, specifically in assessing whether a responsible person is appropriate for this task.art. 67 operating information systems 1 swissmedic is responsible for the secure operation of its information systems and the lawfulness of its data processing.2 it issues a processing policy for each information system. in this policy, it establishes the technical and organisational measures used to ensure the security and protection of the processed data.3 if it transfers activities to third parties, it ensures compliance with data security requirements by means of a contract.art. 68 access rights 1 employees of swissmedic have online access to the information systems to the extent necessary for them to perform their tasks.2 access to the information systems may be logged. such logs are kept for no longer than two years.art. 69 archiving and deletion of data swissmedic retains personal data in its information systems for no longer than ten years. the data are deleted as soon as they are no longer required to perform a task. art. 70 informing the public about licences swissmedic regularly publishes lists with the information specified in annex 7.chapter 7 final provisions art. 71 amendments to the annexes 1 the federal department of home affairs may adapt the annexes to this ordinance to take account of international or technical developments.2 amendments that could constitute technical barriers to trade are made in agreement with the federal department of economic affairs, education and research.art. 72 repeal and amendment of other legislation the repeal and amendment of other legislation are covered in annex 8.art. 73 transitional provisions 1 licences granted under the previous law retain their validity no longer than the date on which they expire. the application to renew a licence must be submitted spontaneously to swissmedic with the necessary documentation at least six months before expiry of the licence. amendments to such licences must be requested as part of a renewal application.2 applications for brokerage and agency licences must be submitted to swissmedic no later than 30 june 2019. activities may be continued until swissmedic reaches a decision.3 applications for licences that were submitted before 1 january 2019 will be assessed and granted in accordance with previous law.art. 74 commencement 1 this ordinance comes into force on 1 january 2019 subject to paragraph 2.2 article 20 paragraphs 2-4 come into force on 1 january 2020.annex 113 13 revised in accordance with the correction of 16 july 2019 (as 2019 2195).(art. 4 para. 2, 7 para. 2, 13 para. 2 let. a, 27 para. 1 let. c, 37 para. 1 let. e, 45 let. d)international rules of good manufacturing practice 1. the following guidelines apply as rules of good manufacturing practice (gmp):a.commission directive 2003/94/ec of 8 october 200314 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use;b.commission directive 91/412/eec of 23 july 199115 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products;c.guide to good manufacturing practice for medicinal products for human use and medicinal products for veterinary use of the european commission (eudralex, volume 4)16; d.principles and guidelines for good manufacturing practice in accordance with the convention for the mutual recognition of inspections in respect of the manufacture of pharmaceutical products of 8 october 197017.2. special provisions for medicated feedingstuffs: council directive 90/167/eec of 26 march 199018 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the community.3. special provisions for blood and blood products: the guidelines for good practice described in the annex to recommendation r (95) 15 of the council of europe of 12 october 199519 on the preparation, use and quality assurance of blood components.14 oj l 262 of 14.10.2003, p. 22.15 oj l 228 of 17.8.1991, p. 70. 16 the text of the guidelines can be obtained from the swiss association for standardisation, sulzerallee 70, 8404 winterthur; www.snv.ch or downloaded from: https://ec.europa.eu/health/documents/eudralex/vol-4_en. 17 sr 0.812.101 the text of these principles and guidelines can be obtained from the pic/s-secretariat, case postale 5695, ch-1211 geneva 11, or downloaded from www.picscheme.org.18 oj l 92 of 7.4.1990, p. 42. 19 the text of this recommendation can be obtained from the council of europe, f-67075 strasbourg (www.coe.int) or downloaded from www.edqm.eu/en/blood-transfusion-guide.annex 220 20 revised in accordance with the correction of 16 july 2019 (as 2019 2195).(art. 4 para. 2, 8 para. 4)rules of good manufacturing practice for medicinal products in small quantities the provisions of chapters 20.1 and 20.2 of the pharmacopoea helvetica21 (ph. helv.) apply as rules of good manufacturing practice for small quantities of medicinal products.21 the pharmacopoea helvetica is published by swissmedic and can be obtained from fobl, distribution of federal publications, 3003 bern, www.bundespublikationen.admin.ch, at the conditions shown in feeo-fedpubs (sr 172.041.11).annex 3 (art. 8 para. 1-3)risk assessment for the preparation of medicinal products specified in article 9 paragraph 2 letters a-cbis tpa 1 calculation of the risk factor the risk factor should always be calculated for a particular medicinal product. if the multiplication of the factors in number 2 produces a figure below 100, a cantonal manufacturing licence is required instead of a swissmedic licence.2 criteria factor1. administration route:a.parenteral administration5b.ophthalmological administration in surgery or for traumatic injuries4c.inhaled administration4d.enteral or topical administration with requirements for sterility4e.enteral administration3f.ophthalmological administration in the uninjured eye1g.topical administration12. annual production quantity:a.liquid dosage forms in standard pack units or application units in litres1.more than 2,00052.1000-200043.500-99934.100-49925.less than 1001b.solid dosage forms, number of units1.more than 120,00052.60,000-120,00043.30,000-59,99934.6,000-29,99925.less than 60001c.semi-solid dosage forms (suppositories), number of units1.more than 40,00052.20,000-40,00043.10,000-19,99934.2000-999925.less than 20001d.semi-solid dosage forms (ointments, creams, etc.) in grams1.more than 200,00052.100,000-200,00043.50,000-99,99934.10,000-49,99925.less than 10,0001e.eye drops in litres1.more than 20052.100-20043.50-9934.10-4925.less than 1013. inherent risks of the active ingredient:a.high risk5b.medium risk3c.low risk1the following criteria at least are assessed in classifying the risk of an active ingredient: carcinogenicity, mutagenicity, environmental toxicity, allergy risk, therapeutic range, dosage unit, stability (light, oxygen, temperature, ph changes), pharmaceutical quality, pharmacopoeial conformity.4. manufacturing process:a.aseptic manufacture5b.manufacture with terminal sterilisation4c.dissolving and mixing3d.diluting2e.filling of non-sterile dosage forms15. quantitative ratios: contract manufactured medicinal products - medicinal products manufactured for dispensing to own customers:a.exclusively contract manufacture5b.mainly contract manufacture (ratio: around 2:1)4c.balanced (ratio: around 1:1)3d.mainly for own customers (ratio: around 1:2)2e.exclusively for own customers0.2annex 422 22 revised in accordance with the correction of 16 july 2019 (as 2019 2195).(art. 13 para. 2 let. d, 15 para. 2, 17 para. 2, 45 let. d)international rules of good distribution practice the following guidelines apply as rules of good distribution practice (gdp):a.european commission guidelines of 5 november 201323 on good distribution practice of medicinal products for human use;b.special provisions for active pharmaceutical ingredients: guide to good manufacturing practice for medicinal products for human use and medicinal products for veterinary use of the european commission (eudralex, volume 4) part ii24; c.special provisions for medicated feedingstuffs: council directive 90/167/ eec25 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the community.23 communication of the european commission, oj c 343 of 23.11.2013, p. 1.24 this text is only available in english. it can be found at: https://ec.europa.eu/health/documents/eudralex/vol-4_en25 oj l 92 of 7.4.1990, p. 42.annex 5 (art. 29 para. 3 and 5, 30 para. 1, 32 para. 2)donor suitability, test procedures and information about donating blood 1 evaluation of donor suitability recommendation r (95) of the council of europe of 12 october 199526 (incl. appendices) on the preparation, use and quality assurance of blood components.26 the text of this recommendation can be obtained from the council of europe, f-67075 strasbourg (www.coe.int) or downloaded from www.edqm.eu/en/blood-transfusion-guide. 2 test procedure requirements 2.1 an unmixed sample from each blood donation must be tested for hiv 1 and 2, the hepatitis b virus (hbv), the hepatitis c virus (hcv) and treponema pallidum. 2.2 testing must include the determination of:a.hiv 1 and 2 antibodies (anti-hiv 1+2 antibodies);b.hepatitis b virus surface antigen (hbsag) or antibodies against the hepatitis b virus core antigen (anti-hbc antibodies);c.hepatitis c antibodies (anti-hcv antibodies);d.treponema pallidum antibodies;e.hi virus (hiv 1): using an appropriate nucleic acid amplification technique;f.hepatitis b virus (hbv): using an appropriate nucleic acid amplification technique;g.hepatitis c virus (hcv): using an appropriate nucleic acid amplification technique.2.3 testing of autologous blood donations need only comprise the tests listed in number 2.2 letters a-d. 2.4 for plasma intended for fractionation, at least the tests listed in number 2.2 letters a-c must be performed.2.5 the abo blood group and the rhesus d antigen expression must be determined for each blood donation, except for plasma intended for fractionation. 2.6 additional tests may be required for specific components, donors or epidemiological situations.3 regulations concerning information 3.1 the information that must be given to potential donors of blood and labile blood products is specified in recommendation r (95) of the council of europe of 12 october 1995 (incl. appendices) on the preparation, use and quality assurance of blood components.3.2 the information that must be obtained from donors for every donation must contain the following details in particular:a.the personal details of the donor that permit unique identification with no danger of a mix-up, and contact details (donor identification);b.the donor's state of health and previous diseases, in particular the factors that can help to identify and exclude persons whose donation could pose a risk to themselves or a risk of transmitting a disease to others;c.the donor's signature on the donor questionnaire;d.the signature of the person specified in number 3.3.3.3 the donor's state of health and previous diseases must be recorded by a qualified healthcare professional by means of a questionnaire and a personal interview.3.4 in signing the questionnaire, the donor confirms that he or she:a.has read and understood the information provided;b.has had the opportunity to ask questions;c.has received satisfactory answers to any questions asked;d.having been informed about the process, has consented to the donation being continued;e.in the case of an autologous blood donation, has been informed that the donated blood or blood components may not be sufficient for the planned transfusion; and f.has provided all information to the best of their knowledge and in good faith.annex 6 (art. 53 para. 1)documentation required for a temporary licence to use medicinal products in accordance with article 9b paragraph 1 tpa 1.application for a temporary licence for use, including a reference to one or more clinical trials approved by the competent ethics committee and swissmedic.2.description of the project, including justification of use outside the context of clinical trials, with a benefit-risk assessment for the patients and reference to the investigator's brochure (ib). 3.updated reference ib, including risk assessment data.4.confirmation by the sponsor that the medicinal product is identical to the product used in the reference clinical trial.5.information provided to the patients, specifically concerning the special status of the medicinal product.6.if relevant, decisions on compassionate use by the european medicines agency or by a country with a comparable regulatory system (art. 13 tpa), including any conditions imposed and their justification.7.agreement between the sponsor and the treating physician defining their respective responsibilities.8.preliminary ethics committee decision.annex 7 (art. 70)provision of information about licences to the public the lists contain the following information:a.name and address of the licence holder;b.facility sites;c.licensed activities;d.date of last inspection;e.list of inspected non-ready-to-use medicinal products (active ingredients);f.status of gmp compliance;g.gmp certificate number;h.date of issue of the gmp certificate;i.any comments.annex 8 (art. 72)repeal and amendment of other legislation ithe medicinal products licensing ordinance of 17 october 200127 is repealed.iithe ordinances listed below are amended as follows:. 2827 [as 2001 3399, 2004 4037 no i 2, 2006 2945, 2007 1469 annex 4 no 40 1847 annex 3 no 2 1961 annex 7 no 1 5651 no ii 2, 2010 4031, 2015 1497 art. 27 no 2 1901 no ii, 2016 1171 no i 3, 2017 2785 5935 annex no 2, 2018 3577 annex 6 no ii 3]28 the amendments can be consulted under as 2018 5029.

812.213english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.medical devices ordinance(meddo)of 1 july 2020 (status as of 26 may 2021) the swiss federal council,based on the therapeutic products act of 15 december 20001 (tpa), article 21 number 2 of the electricity act of 24 june 19022, article 5 of the federal act of 17 june 2011 on metrology3, article 4 paragraph 1 of the federal act of 12 june 20094 on product safety, article 37 of the radiological protection act of 22 march 19915 andin implementation the federal act of 6 october 19956 on technical barriers to trade,ordains:1 sr 812.212 sr 734.03 sr 941.204 sr 930.115 sr 814.506 sr 946.51chapter 1 general provisions section 1 scope and exceptions art. 1 scope 1 this ordinance applies to:a. medical devices and the associated accessories, as defined in article 3;b. groups of products without an intended medical purpose in accordance with annex 1.2 in this ordinance, the term devices is used to designate the products defined in paragraph 1.3 this ordinance also applies to:a. devices which, when placed on the market or put into service, incorporate as an integral part a medicinal product that has an action ancillary to that of the device;b. devices intended to deliver a medicinal product;c. devices manufactured:1. from tissue or cells of animal origin or their derivatives which are non-viable or have been rendered non-viable,2. from derivatives of tissue or cells of human origin that are non-viable or have been rendered non-viable;d. devices which, when placed on the market or put into service, incorporate as an integral part non-viable tissue or non-viable cells of human origin or their derivatives that have an action ancillary to that of the device;e. devices that incorporate as an integral part an in vitro diagnostic medical device; such constituent parts shall be subject to the provisions for in vitro medical devices.art. 2 exceptions 1 this ordinance does not apply to:a. human blood, blood products, plasma or blood cells of human origin, or devices which, when placed on the market or put into service, incorporate such blood products, plasma or cells with the exception of the devices specified in article 1 paragraph 3 letter a;b. vital organs, tissues or cells and transplant products of human origin;c. vital organs, tissues or cells and transplant products of animal origin;d. any items other than those listed in letters a-c that are composed of or contain viable biological substances or viable organisms, including living micro-organisms, bacteria, fungi or viruses, in order to achieve or support the intended purpose of the device;e. in vitro diagnostic medical devices; these are subject to articles 105 and 107;f. non-separable combinations of a medicinal product and device intended to deliver a medicinal product that are intended solely for use in this combination and are not reusable;g. combinations which, when placed on the market or put into service, incorporate as an integral part a medicinal product in addition to the device, where the medicinal product assumes a primary function in such combinations;h. combinations which, when placed on the market or put into service, incorporate as an integral part non-viable tissue or non-viable cells of human origin or their derivatives in addition to the device, where such tissue, cells or derivatives assume a primary function in the device;i. medical devices intended solely for use in animals or veterinary diagnostics.2 in the cases specified in paragraph 1 letters f-h, the part of the combination that fulfils the role of device must satisfy the general safety and performance requirements set out in article 6.section 2 definitions and references to european legislation art. 3 medical device and accessories 1 medical devices are instruments, apparatus, appliances, software, implants, reagents, materials or other objects:a. that are intended by their manufacturer for use in human beings;b. that do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which action can be assisted by such means; andc. that serve to fulfil one or more of the following specific medical purposes either alone or in combination:1. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,2. diagnosis, monitoring, treatment, alleviation or compensation of injuries or handicaps,3. investigation, replacement or modification of the anatomy or of a physiological or pathological process or condition,4. acquisition of information by means of in vitro investigation of samples obtained from the human body, including donated organs, blood or tissue.2 medical devices also include:a. contraceptive or fertility-enhancing products;b. items intended specifically to clean, disinfect or sterilise the devices listed in article 1, paragraph 1 and in paragraph 1 of this article.3 medical device accessory means any article that is not a medical device in its own right, but which is intended by its manufacturer to be used together with one or more particular medical devices and:a. which makes it possible to use the medical device or devices in accordance with its or their intended purpose; orb. which specifically and directly supports the medical function of the medical device or devices in line with its or their intended purpose.art. 4 further definitions 1 in this ordinance:a. making available on the market means any supply of a device, other than an investigational device, for distribution, consumption or use on the swiss market in the course of a commercial activity, whether in return for payment or free of charge;b. placing on the market means the first making available of a device, other than an investigational device, on the swiss market;c. putting into service means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the swiss market for the first time for its intended purpose;d. maintenance means measures such as mechanical maintenance, software updates, inspection, repair, preparation for first use and reprocessing for reuse or measures to keep a device in functional condition or restore it to functional condition;e. reprocessing means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, particularly packing, transport and storage, as well as testing and restoring the technical and functional safety of the used device;f. manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark; this definition is subject to the clarifying explanations and exceptions in article 16 paragraphs 1 and 2 of regulation (eu) 2017/7457 on medical devices (eu-mdr);g. authorised representative means any natural or legal person domiciled in switzerland who has received and accepted a written mandate from a manufacturer located in another country to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this ordinance;h. importer means any natural or legal person established within switzerland that places a device from a foreign country on the swiss market;i. distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the swiss market, up until the point of putting into service;j. economic operator means the manufacturer, authorised representative, importer, distributor or natural or legal person as specified in article 22 paragraphs 1 and 3 eu-mdr;k. healthcare facility means any organisation whose primary purpose is to provide care or treatment for patients or to promote public health;l. hospital means any healthcare institution in which inpatient treatments for illnesses, inpatient medical rehabilitation and inpatient medical measures for cosmetic purposes are provided by medical or nursing interventions;m. contracting state means any state that is bound to mutually recognise conformity assessments and conformity procedures for devices by an agreement with switzerland under international law based on equivalent legislation.2 the definitions set out in article 2 numbers 3-26, 31, 37, 38, 40-44, 46, 48, 51-53, 57-69 and 71 eu-mdr, taking account of the amendments to the definitions in article 2 numbers 18-21 eu-mdr, effected by the european commission by means of delegated acts8.7 regulation (eu) 2017/745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 2001/83/ec, regulation (ec) no 178/2002 and regulation (ec) no 1223/2009 and repealing council directives 90/385/eec and 93/42/eec, oj l117 of 5.5. 2017, p. 1; last amended by regulation (eu) 202/561, oj l 130 of 24.4.2020, p. 18.8 see annex 4.art. 5 references to european legislation 1 the equivalent terms specified in annex 2 and as used in eu-mdr9 and this ordinance shall apply.2 where this ordinance makes reference to provisions of eu-mdr that in turn refer to other provisions of eu-mdr or other eu acts of law, those provisions shall also apply. the interpretation in the footnote to article 4 paragraph 1 letter f is authoritative for references to eu-mdr, while the interpretations of the relevant eu act set out in annex 3 number 1 apply to references to other eu acts. this provision excludes onward references to the eu acts listed in annex 3 number 2; here the swiss terms listed in the annex shall apply.9 see the footnote to art. 4 para. 1 let. f.chapter 2 making available on the market and putting into service section 1 requirements art. 6 general safety and performance requirements 1 a device may be placed on the market or put into service only if it complies with this ordinance when duly supplied and properly installed, maintained and used in accordance with its intended purpose.2 devices must conform to the general safety and performance requirements set out in annex i to eu-mdr10, taking account of their intended purpose.3 appropriate evidence that the part of the combination that is deemed to be a device under the cases set out in article 2 letters f-h fulfils the product requirements must be presented to the competent authority on demand.4 compliance with the essential requirements of this ordinance, as covered by designated technical standards11, common specifications or prescriptions of the pharmacopoeia12, is presumed if the device is in conformity with these standards, specifications or prescriptions.5 the presumption made in paragraph 4 also applies to compliance with the system or process requirements that economic operators must comply with under this ordinance, including requirements associated with quality management systems, risk management, post-market surveillance systems, clinical trials, clinical evaluation or post-market clinical follow-up.6 compliance with the common specifications in paragraph 4 is required unless the manufacturer can provide appropriate proof that the solutions it has chosen guarantee equivalent conformity with the safety and performance requirements. the above is subject to article 8 paragraph 1.10 see the footnote to art. 4 para. 1 let. f.11 the electrical standards can be obtained from the industry association electrosuisse, luppmenstrasse 1, 8320 fehraltorf, www.electrosuisse.ch; the remaining standards can be obtained from the swiss association for standardization (snv), sulzerallee 70, 8404 winterthur, www.snv.ch.12 sr 812.211art. 7 distance sales 1 devices marketed by means of information society services - specifically an online service - that fulfil the conditions set out in paragraph 4 must comply with this ordinance.2 similarly, devices that are not placed on the market but are used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services or by other means of communication must also comply with this ordinance.3 upon request by the swiss agency for therapeutic products (swissmedic), any natural or legal person offering a device in accordance with paragraph 2 or providing a service must be able make available a copy of the declaration of conformity.4 a device is deemed to be supplied via an information society service if that service:a. is provided by distance selling, specifically without the contracting parties being physically present at the same time;b. is provided electronically; andc. is provided at the individual request of the recipient or the recipient's representative.5 to protect public health, swissmedic may require a provider of information society services to discontinue its activities in switzerland.art. 8 specific requirements 1 devices without an intended medical purpose in accordance with article 1 paragraph 1 letter b must comply with the common specifications stipulated by swissmedic.2 devices that have both a medical and non-medical intended purpose must fulfil both the requirements for devices with a medical intended purpose and the requirements for devices without an intended medical purpose.3 devices that are also machines within the meaning of article 1 of the machine ordinance of 2 april 200813 must satisfy the pertinent general safety and health protection requirements of the machine ordinance where these requirements are more specific than those of chapter ii of annex i to eu-mdr14.13 sr 819.1414 see the footnote to art. 4 para. 1 let. f.art. 9 devices manufactured and used in healthcare institutions 1 devices manufactured and used solely within healthcare institutions are deemed to have been put into service. such devices are subject to the pertinent general safety and performance requirements of annex i to eu-mdr15 but not to any of the other requirements set out in this ordinance, provided the requirements of article 5 paragraph 5 letters a-h eu-mdr are fulfilled.2 paragraph 1 does not apply to devices manufactured on an industrial scale.15 see the footnote to art. 4 para. 1 let. f.art. 10 custom-made devices 1 custom-made devices are subject to the requirements of annex xiii to eu-mdr16. the declaration according to section 1 of annex xiii to eu-mdr must be enclosed when the devices are placed on the market.2 in addition to the procedure under paragraph 1, manufacturers of class iii implantable custom-made devices must also conduct a conformity assessment procedure as specified in chapter i of annex ix to eu-mdr. alternatively, they may opt for a conformity assessment in accordance with part a of annex xi to eu-mdr.3 manufacturers must create and update the documentation specified in section 2 of annex xiii to eu-mdr and ensure it can be made available to the competent authorities.16 see the footnote to art. 4 para. 1 let. f.art. 11 systems and procedure packs 1 the requirements of articles 22 and 29 paragraph 2 eu-mdr apply to the placing on the market of systems and procedure packs17.2 any natural or legal person who sterilises systems or procedure packs for placing on the market must apply a conformity assessment procedure for the sterilisation process and involve in that procedure a conformity assessment body that is designated under this ordinance or recognised under an international agreement (designated body). the modalities for doing so are governed by article 22 paragraph 3 eu-mdr.3 any natural or legal person who places the following systems or procedure packs on the market must fulfil the obligations of a manufacturer under articles 46-50 and conduct the pertinent conformity assessment procedure under article 23: systems or procedure packs that:a. contain devices that do not carry a conformity marking;b. consist of a combination of devices that is not compatible with their original intended purpose; orc. have not been sterilised in accordance with the manufacturer's instructions.17 see the footnote to art. 4 para. 1 let. f.art. 12 parts and components 1 any natural or legal person who makes available on the market an item intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose shall ensure that the item does not adversely affect the safety and performance of the device. supporting evidence must be kept available for the competent authority.2 an item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this ordinance.art. 13 conformity marking and identification number 1 devices placed on the market in switzerland or made available on the swiss market must bear a conformity marking in accordance with annex 5. the conformity marking presented in annex v to eu-mdr18 is also a permissible conformity marking.2 the following must not bear a conformity marking:a. custom-made devices;b. devices exclusively for demonstration and exhibition purposes;c. systems and procedure packs;d. investigational devices, subject to the provisions of article 6 of the ordinance of 1 july 202019 on clinical trials with medical devices;e. devices manufactured and used in healthcare institutions.3 where devices' conformity has to be assessed by a designated body, the identification number of this body must be appended to the conformity marking.18 see the footnote to art. 4 para. 1 let. f.19 sr 812.213.3art. 14 location of conformity marking and identification number 1 the conformity marking and, where necessary, associated identification number must appear on the device itself or on its sterile packaging.2 where this is not possible or practicable owing to the composition of the device, the conformity marking and, where necessary, identification number must be displayed on the packaging.3 the conformity marking must also appear on the instructions for use and trade packaging.4 the requirements of article 20 paragraphs 3-6 eu-mdr20 and the general principles of regulation (ec) no. 765/200821 must also be observed when affixing the conformity marking.20 see the footnote to art. 4 para. 1 let. f.21 regulation (ec) no. 765/2008 of the european parliament and of the council of 9 july 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing regulation (eec) no 339/93, version according to oj l 218 of 13.8.2008, p. 30.section 2 classification, labelling and device identification art. 15 classification 1 devices shall be divided into classes i, iia, iib and iii, taking into account the intended purpose of the devices and their inherent risks. this classification must comply with the provisions of annex viii to eu-mdr22.2 the procedure for resolving disputes between the manufacturer and a designated body as regards the classification of a device is governed by article 51 paragraph 2 eu-mdr.22 see the footnote to art. 4 para. 1 let. f.art. 16 product information 1 product information comprises the labelling and instructions for use. it is governed by chapter iii of annex i to eu-mdr23.2 it must be written in all three official languages of switzerland. symbols established by means of technical standards may be used to replace written statements.3 the product information may be provided in fewer than the three official languages of switzerland or in english, provided that:a. the device is supplied exclusively to professionals or is a custom-made device or a medical device manufactured and used in a healthcare institution;b. it is certain that the user meets the necessary professional and linguistic requirements and qualifications, and is in agreement;c. the protection of patients, users and third parties is ensured; andd. the efficacy and performance of the medical device are not placed at risk.4 if requested, additional information must be provided to users in one of the official languages of switzerland.5 if a product cannot be, or cannot yet be, placed on the market as a medical device but may be confused with such a device, the claims relating to the said product must indicate clearly and legibly that it is not a medical device and is not suitable for medical purposes.6 devices intended solely for demonstration and exhibition purposes must be specifically labelled as such. the information must be clearly visible and comprehensible.7 misleading or contradictory information on a device's intended purpose, safety and performance is forbidden.23 see the footnote to art. 4 para. 1 let. f.art. 17 unambiguous product identification 1 any manufacturer or natural or legal person who assembles systems and procedure packs in accordance with article 22 paragraphs 1 and 3 eu-mdr24 shall assign the product, system or procedure pack, with the exception of custom-made devices, and all superordinate packaging layers a unique device identifier (udi25) prior to placing it on the market.262 it must state the udi on the labelling of the device, system or procedure pack and all superordinate packaging layers. transport containers are not regarded as a superordinate packaging layer.273 it shall maintain a list of all the udis it has assigned. this list is part of the technical documentation specified in annex ii to eu-mdr. it must be kept up-to-date at all times.284 the obligations and modalities associated with product identification and registration are governed by articles 27 and 29 and annex vi to eu-mdr, taking account of the amendments to this annex made by the european commission by means of delegated acts29.5 .3024 see the footnote to art. 4 para. 1 let. f.25 stands for unique device identification26 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).27 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).28 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).29 see annex 4.30 to enter into force in due course (art. 110 para. 2).section 3 reporting obligations and information art. 18 obligation to report the use of devices manufactured in healthcare institutions 1 healthcare institutions that manufacture and use devices as specified in article 9 shall provide the following information to swissmedic prior to putting the devices into service:a. their name and address;b. the name and intended purpose of the device;c. the risk class of the device in accordance with article 15 paragraph 1.2 any other relevant information about these devices must be submitted to swissmedic at swissmedic's request. the declaration required under article 5 paragraph 5 letter e eu-mdr31 must be made publicly available.3 changes to the information required in paragraph 1 must be reported to swissmedic within 30 days.4 depending on the risk inherent in a device and its use, swissmedic may exempt devices manufactured and used in accordance with article 9 from the reporting obligation.31 see the footnote to art. 4 para. 1 let. f.art. 19 reporting obligation for natural and legal persons who make custom-made devices available on the market 1 any natural or legal person who makes custom-made devices available on the swiss market must provide the following information to swissmedic before making the devices available:a. the name and address of the manufacturer and all manufacturing sites;b. the name and address of the authorised representative if applicable;c. the codes required to identify the relevant product categories, as specified by the european commission by means of implementing acts32.2 changes to this information must be reported to swissmedic within 30 days of the changes taking effect.3 depending on the risk inherent in a device and its use, swissmedic may exempt custom-made devices from the reporting obligation under paragraph 1.32 see annex 4.art. 20 information on implantable devices 1 for implantable products, the manufacturer must provide, in addition to the product information required under article 16, the information required under article 18 paragraph 1 eu-mdr33, including the implantation certificate. the exemptions specified under article 18 paragraph 3 eu-mdr apply, taking account of the amendments adopted by the european commission by means of delegated acts34.2 the implantation certificate must be written in all three official languages of switzerland.3 healthcare institutions must enter the details of the implant recipient in the implantation certificate and give the certificate to the recipient. they provide the essential information needed by the recipient in a quickly accessible form.33 see the footnote to art. 4 para. 1 let. f.34 see annex 4.chapter 3 conformity assessment, certificate and declaration section 1 conformity assessment art. 21 principle 1 any natural or legal person who is domiciled in switzerland and makes devices available on the market in switzerland or in a contracting state must, upon request, provide the authorities responsible for controls as part of market monitoring with the declaration of conformity.2 any natural or legal person who is domiciled in switzerland and places a device on the market in switzerland or in a contracting state or puts a device into service in switzerland or in a contracting state without placing it on the market must carry out and be able to produce documentary evidence of an evaluation of the device's conformity with the general safety and performance requirements.3 the demonstration of compliance with the general safety and performance requirements must also include a clinical evaluation in accordance with article 61 eu-mdr35.35 see the footnote to art. 4 para. 1 let. f.art. 22 exemptions 1 in response to a justified application, swissmedic may authorise the placing on the market and putting into service of a specific device the use of which is in the interests of public health or patient safety or health even though:a. the relevant conformity assessment procedure according to article 23 has not been carried out; orb. the language requirements in article 16 paragraph 2 have not been met.2 individual devices that have not undergone the relevant conformity assessment procedure may be placed on the market and used without authorisation from swissmedic provided:a. they serve to avert life-threatening conditions or to resolve the permanent impairment of a bodily function;b. no conforming device is available for this specific indication;c. they are used exclusively by healthcare professionals on individual persons;d. the healthcare professional using the device has informed the individual concerned about the non-conformity of the medical device and the related risks; ande. the individual concerned has consented to the use of the device.3 for devices placed on the market exclusively within the armed forces or within the framework of their specific tasks, the federal department of home affairs (fdha) may, in agreement with the federal department of defence, civil protection and sports, grant exemptions.art. 23 procedure the conformity assessment procedure is governed by articles 52 and 54 and by annexes ix-xi to eu-mdr36, taking account of the amendments to article 52, paragraph 4, sub-paragraph 2 eu-mdr adopted by the european commission by delegated act37.36 see the footnote to art. 4 para. 1 let. f.37 see annex 4.art. 24 involvement of a designated body 1 when a designated body is involved, all the information necessary for the conformity assessment must be made available to it.2 manufacturers must not apply to more than one designated body in switzerland or a contracting state to conduct a conformity assessment procedure for the same product.3 any natural or legal person who applies to a designated body must inform that body whether an application to a different designated body in switzerland or a contracting state has been withdrawn before a decision was issued or rejected by a different designated body in switzerland or a contracting state.4 if a manufacturer withdraws its application to have a conformity assessment procedure conducted before the designated body has issued its decision on the assessment, the designated body in question will notify swissmedic and the other designated bodies.5 the information required in paragraph 4 must be supplied exclusively via eudamed.6 where a manufacturer voluntarily changes designated body, it must comply with the requirements of article 58 eu-mdr38.38 see the footnote to art. 4 para. 1 let. f.section 2 certificate of conformity art. 25 issuing and content 1 the designated bodies issue certificates of conformity in accordance with annexes ix-xi to eu-mdr39 (certificates).2 the certificates must be issued in one of the three official languages of switzerland or in english.3 they must, as a minimum, include the information required in annex xii to eu-mdr, taking account of the amendments to this annex adopted by the european commission by means of delegated acts40.4 certificates issued by bodies designated under eu law and domiciled in an eu or eea state but not recognised by an international agreement are deemed equivalent to certificates issued by swiss bodies if it can be credibly demonstrated that:a. the conformity assessment procedures used meet swiss requirements; andb. the certificates were issued by a body with an equivalent qualification to that required in switzerland.4139 see the footnote to art. 4 para. 1 let. f.40 see annex 4.41 inserted by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281)art. 26 validity 1 certificates are valid for a maximum of five years. the expiry date must appear on the certificate.2 at the manufacturer's request, the validity of the certificate can be extended by a maximum of five years following a new assessment carried out in accordance with the relevant conformity assessment procedure. certificates can be extended more than once.3 any addendum to a certificate is valid for the same period as the certificate to which it belongs.art. 27 suspension, restriction and revocation 1 if a designated body finds that a manufacturer no longer fulfils the requirements of this ordinance, it shall impose on that manufacturer a suitable deadline for restoring compliance.2 if this deadline passes without the manufacturer taking suitable corrective action, the designated body shall suspend, revoke or restrict the certificate in question.3 a certificate that has been amended, suspended or revoked by a designated body must no longer be used in its original form.art. 28 documentation requirements 1 the designated body will provide swissmedic and the other designated bodies with:42a. all information on certificates it has issued and any amendments or addenda to such certificates;b. information on suspended, reactivated or revoked certificates;c. information on certificates it has rejected;d. information on restrictions imposed on certificates.2 it will also provide swissmedic with information on whether or not a conformity assessment procedure should be applied in accordance with article 54 paragraph 1 eu-mdr43. notifications of certificates for devices that have undergone a procedure of this type must include the documents specified in article 55 paragraph 1 eu-mdr.4442 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).43 see the footnote to art. 4 para. 1 let. f.44 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).section 3 declaration of conformity art. 29 1 if the applicable conformity assessment procedure has demonstrated that the requirements of this ordinance have been fulfilled, the manufacturer of devices that are not custom-made or investigational issues a declaration of conformity. this declaration shall be subject to ongoing updating.2 the declaration of conformity must include the information required in annex iv to eu-mdr45, taking account of the amendments to this annex adopted by the european commission by means of delegated acts46. it must be written in one of the three official languages of switzerland or english or translated into one of these languages.3 if a device also requires a manufacturer's declaration of conformity for aspects not covered by this ordinance but nevertheless required by other legislation in order to demonstrate compliance with that legislation, one single declaration of conformity will be issued.4 by issuing the declaration of conformity, the manufacturer assumes responsibility for ensuring that the device complies with the requirements of this ordinance as well as with any other legislation to which the device is subject.45 see the footnote to art. 4 para. 1 let. f.46 see annex 4.chapter 4 requirements applicable to tissues and cells of human origin that are incorporated into or used in the production of devices art. 30 establishment licence 1 an establishment licence issued by swissmedic is required by any natural or legal person who:a. removes tissue or cells from humans for the purpose of devitalising the tissue or cells and using them to manufacture devices or supplying them for use in device manufacture;b. stores tissue or cells removed for the purposes in letter a;c. imports or exports tissue or cells removed for the purposes in letter a.2 a licence shall be issued if:a. the requirements in terms of professional qualifications and operational infrastructure are fulfilled;b. a quality assurance system that complies with current scientific and technological standards is in place;c. the facility has a responsible person with the necessary specialist knowledge, experience and directive authority in their area of responsibility and who is responsible for quality;d. the obligations specified in articles 31 and 32 are fulfilled.3 swissmedic shall verify that the conditions for issuing an establishment licence are fulfilled in the course of an inspection.4 articles 39-43 of the medicinal products licensing ordinance of 14 november 201847 (mplo) also apply.47 sr 812.212.1art. 31 collection, donation and testing 1 the requirements of articles 3, 4, 6-15 and 30-33 of the transplantation act of 8 october 200448 and of articles 2-12 of the transplantation ordinance of 16 march 200749 apply mutatis mutandis to collection, donation and testing.2 holders of an establishment licence issued under article 30 must verify the suitability of donors.48 sr 810.2149 sr 810.211art. 32 duty to keep records and traceability 1 it must be possible to trace all tissue and cells harvested from humans for the purpose of devitalisation and use in devices from the donor to the recipient and vice versa. art. 35, paragraphs 1 and 2, mplo50 also apply.2 moreover, the provisions of articles 34 and 35 of the transplantation act of 8 october 200451 apply mutatis mutandis to traceability.50 sr 812.212.151 sr 810.21chapter 5 designated bodies section 1 designation art. 33 requirements and application 1 swissmedic will only designate conformity assessment bodies that have completed an assessment procedure in accordance with article 34 and which satisfy the requirements set out in annex vii to eu-mdr52.2 applications for designation must be submitted to swissmedic. they must in particular include:a. details of the activities and the types of product for which designation is sought;b. proof that the requirements of annex vii to eu-mdr are met.3 swissmedic shall verify whether the application for designation is complete within thirty days, and request the applicant to submit any information that may be missing.4 it shall review the application and accompanying documents and issue a preliminary assessment report.52 see the footnote to art. 4 para. 1 let. f.art. 34 assessment 1 swissmedic shall conduct an on-site assessment of the conformity assessment body and, if relevant, of all sub-contractors and subsidiaries.2 if swissmedic identifies non-compliances in the course of its assessment, it shall draw up a list of non-compliances for the applicant. swissmedic shall set the conformity assessment body a deadline by which the latter must submit to swissmedic a corrective action plan to remedy the non-compliances and a plan setting out preventive measures.3 the plans must indicate the root cause of the identified non-compliances and must include a timeframe for implementing the measures.4 swissmedic will decide whether the proposed action is suitable and whether the timeframe for implementation is appropriate.art. 35 assessment report 1 if swissmedic approves the plans required under article 34 paragraph 2, it shall prepare an assessment report.2 this shall comprise the following:a. the result of the assessment;b. confirmation that suitable corrective and preventive measures have been planned and where necessary implemented;c. the scope of the designation.art. 36 issue and extension of designation 1 swissmedic shall grant the designation if the conformity assessment body meets the requirements.2 the extension of designations is subject to the requirements and procedures laid out in articles 33-35.art. 37 sub-contractors and subsidiaries 1 designated bodies that delegate part of the work to sub-contractors or to a subsidiary bear full responsibility for the work carried out on their behalf by the sub-contractor or by the subsidiary.2 they must ensure that the sub-contractor or the subsidiary meets the applicable requirements of annex vii to eu-mdr53.3 they must notify swissmedic if they delegate work under the terms of paragraph 1. they must be able to demonstrate to swissmedic that the sub-contractor or the subsidiary is capable of carrying out the tasks assigned to it.4 work may only be delegated if the designated body has notified the natural or legal person who requested the conformity assessment accordingly.5 the designated bodies must publish a list of their subsidiaries.53 see the footnote to art. 4 para. 1 let. f.art. 38 duty of cooperation and notification requirement 1 the designated bodies, including their subsidiaries and sub-contractors, are required to keep available for swissmedic at all times all data that is necessary for assessment, designation, monitoring and re-assessment, including the documents required to assess the qualifications of sub-contractors or subsidiaries. the data must be kept up-to-date at all times.2 the designated bodies shall notify swissmedic within 15 days of any change that affects their ability to meet the requirements of annex vii to eu-mdr54 or to carry out conformity assessments.54 see the footnote to art. 4 para. 1 let. f.art. 39 tariffs the designated bodies shall issue lists of the standard tariffs charged for their activities and make these lists publicly accessible.section 2 cessation of conformity assessment activities art. 40 1 if a designated body ceases to carry out its conformity assessment activities, it shall notify swissmedic and the manufacturers concerned as soon as possible. in the case of planned cessation of activities, notice must be given one year before the activities cease. swissmedic will revoke the designation from the date on which the activities cease.2 the certificates will remain valid for a maximum of nine months following cessation of activities, provided another designated body assumes responsibility for certifying the products concerned and confirms this in writing.3 the designated body assuming responsibility in accordance with paragraph 2 shall conduct a full assessment of the products concerned before the nine-month period expires and before issuing new certificates for the products.section 3 suspension, restriction or revocation of designation art. 41 principle 1 designation shall be suspended, restricted or revoked if the designated body:a. no longer or only partly meets the requirements; orb. fails to carry out corrective action ordered by swissmedic.2 suspensions will be imposed for a maximum of twelve months. they may be extended by a maximum of a further twelve months.3 if designation is suspended, restricted or revoked, the designated body must inform all affected manufacturers accordingly within ten days.art. 42 unduly issued certificates 1 in the event of its designation being restricted, suspended or revoked, the designated body will suspend or withdraw any certificates which were unduly issued.2 if the designated body fails to fulfil this requirement, swissmedic will instruct it to suspend or revoke the certificates and set an appropriate deadline for doing so.art. 43 validity of certificates in the event of suspension or restriction of designation 1 if swissmedic suspends or restricts the designation of a designated body, the certificates concerned remain valid provided swissmedic:a. confirms within a month that no safety issue exists in connection with the products concerned; andb. outlines a timeline and measures to remedy the suspension or restriction.2 the certificates also remain valid if swissmedic:a. confirms that, during the suspension or restriction, no certificates relevant to the suspension will be issued, amended or re-issued; andb. states that the designated body is able to continue to monitor and retain responsibility for existing certificates during the suspension or restriction.3 the designated body shall notify the manufacturers concerned or the persons or entities placing the devices concerned on the market.4 should swissmedic ascertain that the designated body is unable to continue to oversee existing certificates, these certificates will retain their validity if the manufacturer of the product in question confirms to swissmedic or, if it is domiciled in a contracting state, to the competent authority there, in writing and within three months of designation being suspended or restricted that:a. another qualified designated body is temporarily assuming the oversight duties; andb. this designated body will be responsible for the certificates during the period of suspension or restriction.art. 44 validity of certificates in the event of designation being revoked 1 if swissmedic revokes the designation of a designated body, the certificates affected remain valid for nine months provided:a. swissmedic or, if the manufacturer is domiciled in a contracting state, the competent authority there confirms that the products in question present no safety issues;b. another designated body confirms in writing that it is assuming immediate responsibility for the certificates for these products and can complete the assessment of the products within twelve months of designation being revoked.2 swissmedic may, within the limits of its competence, extend the provisional validity of the certificates for further periods of three months, which altogether must not exceed twelve months.section 4 monitoring and re-assessment of designated bodies art. 45 1 swissmedic shall monitor the designated bodies and their subsidiaries and sub-contractors and carry out re-assessments. in the course of monitoring and re-assessing designated bodies and reviewing their assessments, swissmedic shall take account of the requirements and procedures set out in articles 44 and 45 eu-mdr55.2 it will verify whether designated bodies still satisfy the requirements of article 36 paragraph 1 and annex vii to eu-mdr three years after designation, and then every four years, in the course of a full re-assessment. this provision is subject to changes in assessment intervals resulting from delegated acts56 issued by the european commission.3 swissmedic will carry out an on-the-spot assessment at least once a year to ascertain whether the designated bodies and, if applicable, their subsidiaries and sub-contractors are fulfilling the requirements and obligations of annex vii to eu-mdr.4 for this purpose, it may at any time:a. carry out on-site assessments with or without advance notice;b. carry out audits of the employees of the designated body and its subsidiaries or sub-contractors or observe audits that the designated body carries out on manufacturers' premises.55 see the footnote to art. 4 para. 1 let. f.56 see annex 4.chapter 6 requirements for economic operators section 1 manufacturers art. 46 conformity marking and clinical evaluation 1 manufacturers guarantee that their products have been designed and manufactured in accordance with the requirements of this ordinance when they place them on the market or put them into service.2 they must print the conformity marking on their products.3 they must conduct a clinical evaluation in accordance with article 61 eu-mdr57 taking account of the amendments to this article adopted by the european commission by means of delegated acts58 and in accordance with annex xiv to eu-mdr. they must update this clinical evaluation in line with the results of post-market clinical follow-up.57 see the footnote to art. 4 para. 1 let. f.58 see annex 4.art. 47 technical documentation 1 manufacturers must list in the technical documentation the information required in annexes ii and iii to eu-mdr59, taking account of the amendments to these annexes made by the european commission by means of delegated acts60.2 manufacturers must submit either the complete technical documentation or a summary of this documentation when requested to do so by the competent authority.59 see the footnote to art. 4 para. 1 let. f.60 see annex 4.art. 48 document retention requirements 1 manufacturers must ensure that the following are available to the competent authority for at least ten years after the final product covered by the declaration of conformity has been placed on the market:a. complete technical documentation;b. declaration of conformity;c. a copy of the certificates issued, including any amendments and addenda.2 the document retention period for implantable products shall be at least 15 years from the date the last product was placed on the market.art. 49 person responsible for regulatory compliance 1 manufacturers must have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.2 proof that the person responsible for regulatory compliance possesses the requisite expertise, the responsibilities of this person, exceptions and further modalities are governed by article 15 eu-mdr61.3 the person responsible for regulatory compliance must have a deputy. if a number of persons are jointly responsible for regulatory compliance, their respective areas of responsibility shall be stipulated in writing.4 the person responsible for regulatory compliance must suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of their duties, regardless of whether or not they are employees of the organisation.61 see the footnote to art. 4 para. 1 let. f.art. 50 further obligations the further obligations incumbent on manufacturers, particularly the requirements to be fulfilled by their quality and risk management systems, are governed by article 10 eu-mdr62.62 see the footnote to art. 4 para. 1 let. f.section 2 authorised representative art. 51 obligations 1 where the manufacturer of a device is not domiciled in switzerland, the device may only be placed on the market if the manufacturer designates an authorised representative domiciled in switzerland by means of a written mandate.2 the authorised representative is responsible for the formal and safety-related aspects of placing the device on the market.3 the authorised representative's rights and obligations and the scope of its mandate are governed by article 11 eu-mdr63.3bis the manufacturer and authorised representative may contractually agree that instead of the authorised representative keeping available a copy of the technical documentation, the manufacturer shall, on request, submit the documentation straight to swissmedic. the authorised representative must ensure that the documentation is submitted within seven days.644 changes in authorised representative are governed by article 12 eu-mdr.5 paragraphs 1-4 also apply to natural or legal persons who assemble systems and procedure packs in accordance with article 22 paragraphs 1 and 3 eu-mdr and who are not domiciled in switzerland.6563 see the footnote to art. 4 para. 1 let. f.64 inserted by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281)65 inserted by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281)art. 52 person responsible for regulatory compliance 1 authorised representatives must ensure that they have permanently and continuously at their disposal at least one person who possesses the requisite expertise as regards the requirements for medical devices under this ordinance and who is responsible for regulatory compliance.2 in other respects, article 49 paragraphs 2-4 shall apply.section 3 importers art. 53 1 importers may only place on the market devices that comply with this ordinance. before placing devices on the market, they shall verify that:a. the device carries the conformity marking;b. the declaration of conformity has been drawn up;c. the manufacturer is identified and has designated an authorised representative in accordance with article 51;d. the product is labelled in accordance with this ordinance and accompanied by instructions for use;e. the manufacturer has assigned a udi where applicable.2 importers must print their name, place of business and contact address on the product, the product packaging or a document enclosed with the product.3 where an importer considers or has reason to believe that a device is not in conformity with the requirements of this ordinance, it must not place the device on the market until it has been brought into conformity.4 the further obligations of importers prior to and after placing a device on the market are governed by articles 13 and 16 paragraphs 3 and 4 eu-mdr66. in particular, importers must comply with the following obligations:a. storage, transport and quality management system;b. cooperation with the manufacturer, authorised representative, designated body and competent authorities;c. the provision of information to the manufacturer, authorised representative, designated body and competent authorities.66 see the footnote to art. 4 para. 1 let. f.section 4 distributors art. 54 1 when making a device available on the market, distributors must, in the context of their activities, act with due care in relation to the requirements applicable. before making a device available on the market, distributors must verify that:a. the device carries the conformity marking;b. the declaration of conformity has been drawn up;c. the device is accompanied by product information;d. where devices have been imported the importer has provided the information required in article 53 paragraph 2;e. the manufacturer has assigned a udi where applicable.2 with the exception of paragraph 1 letter d, random sampling may be used for the purposes of verification.3 where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this ordinance, it must not make the device available on the market until it has been brought into conformity.4 the further obligations of distributors prior to and after making a device available on the market are governed by articles 14 and 16 paragraphs 3 and 4 eu-mdr67. in particular, distributors must fulfil the following obligations:a. storage, transport and quality management system;b. cooperation with the manufacturer, authorised representative, importer and competent authorities;c. the provision of information to the manufacturer, authorised representative, importer and competent authorities.67 see the footnote to art. 4 para. 1 let. f.section 568 registration of economic operators 68 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281). art. 55 1 manufacturers or their authorised representatives and importers must register the information required by part a of annex vi to eu-mdr69 with swissmedic within three months of placing a device on the market for the first time. 2 the economic operator in question must report any changes to the information to swissmedic within one week.3 further obligations and registration modalities are governed by articles 30 paragraph 3 and 31 eu-mdr.4 swissmedic will verify the information provided by the economic operators and assign them a unique identification number.5 any natural or legal person placing systems and procedure packs on the market for the first time under article 11 must register their name and the address at which they can be contacted with swissmedic within three months of placing the system or procedure pack on the market. where an authorised representative is required under article 51 paragraph 5, the name and address of the authorised representative must also be registered with swissmedic.69 see the footnote to art. 4 para. 1 let. f.chapter 7 device surveillance section 1 post-market surveillance art. 56 system 1 for each device, manufacturers must plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. this system forms an integral part of the manufacturer's quality management system.2 the system must be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.3 the modalities of the system, particularly the resulting actions, updates and amendments to technical documentation, are governed by article 83 paragraph 3 eu-mdr70.70 see the footnote to art. 4 para. 1 let. f.art. 57 incidents and actions 1 should it become evident in the course of post-market surveillance that preventive and/or corrective action is necessary, manufacturers must take suitable steps, notifying the competent authorities and, if applicable, the designated body.2 if a manufacturer becomes aware of a serious incident in connection with a device that has been made available on the market, or takes action to prevent or minimise the risk of such an incident for medical or technical reasons (field safety corrective actions), it must report the fact in accordance with article 66.art. 58 plan the post-market surveillance plan must satisfy the requirements of section 1 of annex iii to eu-mdr71. with the exception of custom-made devices, the plan is part of the technical documentation specified in annex ii to eu-mdr.71 see the footnote to art. 4 para. 1 let. f.art. 59 report 1 manufacturers of class i devices must draw up a report on post-market surveillance.2 this report must contain:a. a summary of the results and conclusions of the analyses of the data gathered as a result of the plan specified in article 58;b. a rationale and description of any preventive and corrective actions taken.3 the report forms part of the post-market surveillance technical documentation specified in annex iii to eu-mdr72.4 the manufacturer must update the report when necessary and make it available to the competent authority upon request.72 see the footnote to art. 4 para. 1 let. f.section 2 safety report art. 60 obligation 1 manufacturers of class iia, class iib and class iii devices shall prepare a safety report for each device and where relevant for each category or group of devices.2 manufacturers of class iia devices shall update the safety report when necessary and at least every two years. manufacturers of class iib and class iii devices must update this report at least annually.art. 61 content 1 the safety report must contain:a. a summary of the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan as specified in article 58;b. a rationale and description of any preventive and corrective actions taken.2 throughout the lifetime of the device concerned, the safety report must set out:a. the conclusions of the benefit-risk determination;b. the key results of post-market clinical follow-up;c. the total sales volume of the device;d. an estimate of the size of the population using the device;e. characteristics of the population in letter d;f. the frequency of device usage, where practicable.3 the safety report forms part of the technical documentation specified in annexes ii and iii to eu-mdr73. for custom-made devices, the report forms part of the documentation specified in section 2 of annex xiii to eu-mdr.73 see the footnote to art. 4 para. 1 let. f.art. 6274 review 1 manufacturers will make their safety reports available to the designated body involved in the conformity assessment.2 the designated body will review the safety report for class iii devices or implantable devices and record the outcome of its review with details of any action taken.3 manufacturers or their authorised representatives will, upon request, make the safety report and the outcome of the designated body's review, with details of any action taken, available to the competent authority.74 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).section 3 summary of safety and clinical performance art. 63 1 for class iii devices and for implantable devices, other than custom-made or investigational devices, the manufacturer must draw up a summary of safety and clinical performance.2 the summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient.3 the minimum content of the summary is governed by article 32, paragraph 32 eu-mdr75.4 the draft summary of safety and clinical performance must be submitted to the designated body involved in the conformity assessment pursuant to article 24 for validation by that body.5 the manufacturer will publish the summary after it has been validated.766 the manufacturer must mention on the label or instructions for use where the summary is available.75 see the footnote to art. 4 para. 1 let. f.76 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).section 4 traceability and recording of product identification art. 64 traceability 1 distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.2 the duty of disclosure under article 47c tpa continues for at least 10 years, or for at least 15 years for implantable products, after the last product covered by the conformity assessment was placed on the market.art. 65 recording the udi 1 economic operators shall store and keep, preferably by electronic means, the udi of the class iii implantable devices which they have supplied or with which they have been supplied.2 swissmedic may extend this obligation to other devices, or categories or groups of devices.section 5 vigilance art. 66 reporting obligation 1 manufacturers of devices made available in switzerland or natural or legal persons who assemble systems or procedure packs in accordance with article 22 paragraphs 1 and 3 eu-mdr77 must report to swissmedic:a. any serious incidents involving the device in question that have occurred in switzerland, as soon as they become aware of them;b. any field safety corrective actions undertaken in switzerland.782 exemptions from this reporting obligation, modalities, periodic summary reports, trend reporting and analyses of serious incidents and field safety corrective action are governed by articles 27 paragraph 5 and 87-89 eu-mdr.2bis where an authorised representative is required pursuant to article 51, this representative is responsible for the reporting obligation in paragraph 1. furthermore, the authorised representative must submit the trend reports pursuant to paragraph 2 on incidents in switzerland and abroad to swissmedic without being requested to do so. final reports prepared in accordance with article 89 paragraph 5 eu-mdr should be submitted to swissmedic. the transfer of these obligations from the manufacturer or from the natural or legal person assembling systems or procedure packs under article 22 paragraphs 1 and 3 eu-mdr to the authorised representative must be agreed in writing in the mandate.793 .804 any professional who becomes aware of an incident when using devices must report this to the supplier and swissmedic. the report may be submitted by a professional association. the timelines for doing so are as set out in article 87 eu-mdr.5 reports must be submitted to swissmedic electronically and in machine-readable format. swissmedic publishes information on electronic submission and the forms to be used with content specifications.77 see the footnote to art. 4 para. 1 let. f.78 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).79 inserted by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281)80 repealed by no i of the o of 19 may 2021, with effect from 26 may 2021 (as 2021 281).art. 67 reporting systems in hospitals 1 hospitals must set up an internal reporting system within the framework of an established quality management system for the purpose of reporting under article 66 paragraph 4.2 they must designate a suitable competent person (vigilance contact person) with a medical or technical qualification to assume responsibility for reporting to swissmedic. they must supply this person's contact details to swissmedic.3 records and all documents created under the vigilance quality management system must be retained for at least 15 years.chapter 8 conduct in relation to devices art. 68 supply devices are supplied in accordance with their intended purpose and the information provided by the manufacturer.art. 69 advertising 1 claims for products must only contain statements that correspond to the product information.2 misleading statements, particularly concerning the intended purpose, safety and performance of a device, are prohibited.3 devices intended solely for use by professionals must not be advertised to the public.art. 70 use by professionals 1 any professional who uses a device from a foreign country without placing it on the market is responsible for the conformity of that device.2 device groups intended for use by professionals and which could harm the health of humans in the case of improper use are listed in annex 6.3 the groups of devices in annex 6 may only be used in accordance with the professional and operating requirements stated therein.art. 71 maintenance 1 any person using devices in a professional capacity must ensure that the devices are maintained and tested in accordance with the regulations.2 maintenance must be carried out in accordance with the principles of a quality management system, is to be organised appropriately, and must be guided in particular by:a. the manufacturer's instructions;b. the particular risk associated with the device and its use.3 for devices with a measurement function, test procedures may be required in accordance with the measuring instruments ordinance of 15 february 200681.4 swissmedic can issue and publish requirements for maintenance measures. these requirements will be deemed to constitute the current scientific and technological standards.81 sr 941.210art. 72 reprocessing 1 any person using in a professional capacity a device intended for repeated use must ensure on each occasion and prior to use that its functionality has been tested and that it has been processed in accordance with current scientific and technological standards and taking account of the instructions of the manufacturer and the requirements of hygiene.2 reprocessing must employ suitable procedures that have been validated in accordance with current scientific and technological standards and whose efficacy has been demonstrated and can be reliably traced and reproduced within a quality management system.3 any natural or legal person who processes devices for third parties must:a. declare that the processed device:1. has been processed in accordance with the manufacturer's instructions, or2. has been processed using a procedure specific to the processor that is equally safe and effective as the procedure specified by the manufacturer and has been demonstrated to be equally safe and effective by means of a risk analysis and validation process;b. operate a quality management system that is both suitable and certified to nationally or internationally recognised standards;c. provide proof that reprocessing takes place in suitable premises, in accordance with the recognised rules of science and technology and in compliance with hygiene requirements.d. document that the device has been processed in accordance with letter a.4 the declaration required under paragraph 3 letter a must identify the device and state the name and address of the establishment that processed it.art. 73 single-use devices and their reprocessing 1 reprocessing and further use of single-use devices is forbidden.2 single-use devices reprocessed in a foreign country under article 17 paragraph 3 eu-mdr82 must neither be used nor made available on the market.82 see the footnote to art. 4 para. 1 let. f.art. 74 cyber security 1 healthcare institutions must put in place all technical and organisational resources required by the state of the art to ensure that network-compatible products are protected against electronic attack and unauthorised access.2 hospitals must identify, evaluate and document the measures taken under paragraph 1 in accordance with the principles of a risk management system. this system forms an integral part of the hospitals' quality management system.chapter 9 market surveillance art. 75 principle 1 inspections under the auspices of market surveillance will cover devices made available on the market, conformity assessment procedures, device surveillance, device handling and economic operators' fulfilment of their obligations. they will also cover devices made available in contracting states by natural or legal persons domiciled in switzerland, the conformity assessment procedures and surveillance activities for such devices and the natural or legal persons' fulfilment of their obligations.2 the market surveillance activities undertaken by swissmedic and the cantons are governed by articles 93-95, 97 and 98 eu-mdr83. articles 97 paragraph 3 and 98 paragraphs 3 and 4 eu-mdr are excluded.3 the cantons will draw up annual plans for their market surveillance activities under paragraph 2. they will provide swissmedic with an annual summary of the results of their surveillance activities. swissmedic can determine both the content of the summary and the form in which it is made available.4 in case of an actual necessity for the protection of public health, swissmedic will decree the measures under article 66 tpa in a general ruling.83 see the footnote to art. 4 para. 1 let. f.art. 76 responsibilities 1 swissmedic is responsible for monitoring:a. devices and device conformity;b. vigilance;c. maintenance and reprocessing of devices:1. in hospitals,2. that are intended for use in hospitals.2 certain aspects of the monitoring activities set out in paragraph 1 remain the responsibility of other federal offices or institutions.3 the cantons are responsible for monitoring:a. the retail trade and dispensing points;b. the manual production of custom-made devices, of systems and of procedure packs;c. maintenance and reprocessing of devices by the professionals using them and in healthcare institutions with the exception of hospitals.art. 77 powers 1 for the purposes of verifying conformity, the authorities responsible for monitoring under article 76 may, without providing compensation:a. demand the proof and information required;b. take samples;c. have the samples tested or submitted to laboratory examination;d. enter and inspect, during normal working hours and with advance notice or, if necessary, unannounced, the business premises and facilities of natural or legal persons who have an obligation to provide information;e. consult documents and demand that they, or additional information, be provided in one of the official languages of switzerland or in english.2 if a manufacturer or a natural or legal person who assembles systems or procedure packs under article 22 paragraphs 1 and 3 eu-mdr84 fails to fulfil their obligations under article 66, swissmedic may impose appropriate measures to protect health, up to and including prohibiting the making available on the market or the putting into service of the devices in question.8584 see the footnote to art. 4 para. 1 let. f.85 inserted by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281)art. 78 duty to cooperate and provide information economic operators that place a device on the market in switzerland or in a contracting state, and economic operators, professionals and healthcare institutions that make a device available or put it into service in switzerland or a contracting state have a duty to cooperate on matters of enforcement. in particular, they must provide, free of charge, all necessary information and all necessary proof and documentation to the enforcement bodies.chapter 10 data processing section 1 data processing in general art. 79 processing of personal data swissmedic and third parties contracted by swissmedic are empowered to process the personal data that they need to perform the tasks mandated to them by this ordinance. specifically, this includes:a. health data acquired in the course of market surveillance and vigilance;b. data documenting the reliability and professional qualifications of vigilance contact persons (art. 67 para. 2) or the individuals responsible for compliance with the regulations (art. 49 and 52).art. 80 operation of information systems 1 it is swissmedic's responsibility to ensure that its information systems operate securely and that data is processed in accordance with legal requirements.2 it will draw up a set of processing rules for each information system. these will specify the technical and organisational measures to be taken to ensure that the data is protected and secure.art. 81 access rights 1 the following persons and agencies will be given online access to information systems provided this is necessary for the fulfilment of their respective tasks:a. swissmedic staff employed in vigilance and market surveillance and third parties mandated to perform tasks in this area;b. swissmedic staff employed in administrative penal law;c. swissmedic administrators and mandated third parties.2 a log of persons and bodies granted access to the information systems will be kept. the data in this log will be stored for two years.art. 82 data archiving and deletion personal data will be stored for a period of ten years from the final entry. on the expiry of this period, it will be destroyed.section 2 medical devices information system art. 83 responsible authority swissmedic is responsible for the medical devices information system required under article 62c tpa (medical devices information system).art. 84 data protection and security 1 swissmedic shall draw up processing rules in accordance with article 21 of the ordinance of 14 june 199386 to the federal act on data protection (ofadp).2 articles 20 and 21 ofadp apply to data security.3 data processing must be automatically logged.86 sr 235.11art. 85 content of the medical devices information system 1 this medical devices information system contains the following data:a. device data;b. data on economic operators;c. data on the designated bodies and certificates issued by them;d. data on clinical trials;e. vigilance data;f. market surveillance data;g. data that can be used to manage and adapt the medical devices information system (system data);h. authentication data, assigned user roles and basic settings for using the medical devices information system (user data).2 the medical devices information system only contains personal data where such data is required to record and process information.art. 86 data exchange with other information systems the medical devices information system can draw the data specified in article 85 from eudamed and from cantonal electronic systems; it can also submit data to eudamed and cantonal systems.art. 87 access rights swissmedic has access to all data recorded in and processed by the medical devices information system.art. 88 data subjects' rights and data rectification 1 data subjects' rights, particularly the right to information, rectification and deletion of data, are governed by data protection legislation.2 swissmedic will ensure that data that is incorrect or has been processed unlawfully is corrected in or deleted from the medical devices information system. correction and deletion will take place as quickly as possible, but no later than 60 days of the data subject making their request.art. 89 data archiving the personal data specified in article 85 paragraph 2 must be stored in such a way that it is only possible to identify data subjects for a period of ten years after the last device covered by the declaration of conformity was placed on the market. for implantable devices, this period is extended to 15 years.art. 90 publication of data swissmedic may publish the following in the medical devices information system:a. product data, as specified in accordance part b of annex vi to eu-mdr87;b. information on economic operators and devices, as specified in part a of annex vi to eu-mdr;c. the general information specified in article 35 paragraph 7 eu-mdr governing the assessment, designation and notification of conformity assessment bodies and for the monitoring of designated bodies, and on changes that have a significant impact on such tasks;d. summaries of the annual report on monitoring and on-site assessment activities drawn up in accordance with article 44 paragraph 12 eu-mdr;e. summaries of safety and clinical performance in accordance with article 63;f. information on certificates issued under articles 28 and 42-44;g. field safety notices for users or customers issued in the course of field safety corrective actions in accordance with article 89 paragraph 8 eu-mdr;h. summaries of the reports on swissmedic's activities in monitoring market surveillance;i. scientific opinions in accordance with article 106 paragraph 12 eu-mdr;j. information on market monitoring activities, particularly recalls, on non-conforming devices and preventive health protection measures.87 see the footnote to art. 4 para. 1 let. f.art. 91 subsequent use of data non-personal data can be used for the independent assessment of long-term device safety or performance or of the traceability of implantable products.art. 92 applicability of the data protection act all data processing activities carried out in the medical devices information system must comply with the federal act of 19 june 199288 on data protection.88 sr 235.1chapter 11 final provisions section 1 enforcement art. 93 amendment of annexes 1 the fdha can amend annexes 1-3 to this ordinance in line with international and technical progress.2 where amendments may pose technical barriers to trade, it will effect them by mutual agreement with the federal department of economic affairs, education and research.art. 94 information on directly applicable legal acts of the european commission swissmedic will provide on its website information on legal acts of the european commission that, according to this ordinance, are directly applicable in switzerland in the version binding upon the member states of the eu and as listed in annex 4.art. 95 harmonisation of enforcement 1 when implementing this ordinance, swissmedic will respect the implementing acts adopted by the european commission on the basis of eu-mdr89.2 regulations (eu) no 207/201290 and no 722/201291 will remain in force until such time as they are repealed in the eu by implementing acts adopted by the european commission on the basis of eu-mdr.89 see the footnote to art. 4 para. 1 let. f.90 commission regulation (eu) no 207/2012 of 9 march 2012 on electronic instructions for use of medical devices, version according to oj l 72 of 10.3.2012, p. 28.91 commission regulation (eu) no 722/2012 of 8 august 2012 concerning particular requirements as regards the requirements laid down in council directives 90/385/eec and 93/42/eec with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin, version according to oj l 212 of 9.8.2012, p. 3.art. 96 cooperation with the european commission and authorities of the contracting states 1 where provided for by international agreements, swissmedic, the designated bodies and economic operators will cooperate with the european commission and the authorities of the contracting states.2 swissmedic can appoint experts who are qualified to evaluate conformity assessment bodies in the field of medical devices.3 the agency may appoint experts to participate in expert groups of the european commission and the authorities of the contracting states.art. 97 collaboration with the customs authorities 1 the customs authorities provide swissmedic with information on the import, export and transit of devices.2 swissmedic can mandate the customs authorities to detain devices for further inspection and to obtain samples.art. 98 expert laboratories in switzerland 1 laboratories that wish to be designated an expert laboratory by the european commission in accordance with article 106 paragraph 7 eu-mdr92 may apply to swissmedic for designation.2 they must demonstrate to swissmedic in particular that they:a. meet the criteria set out in article 106 paragraph 8 eu-mdr; andb. are able to assume the tasks under article 106 paragraph 10 eu-mdr, taking account of the amendments to this provision adopted by the european commission by means of delegated acts93, in accordance with the requirements in each case.3 they must operate in one of the following fields:a. physico-chemical characterisation;b. microbiological, mechanical, electrical, electronic or non-clinical biological and toxicological testing or biocompatibility testing.4 if the requirements are met, swissmedic will propose to the eu commission that the laboratory be designated an expert laboratory.92 see the footnote to art. 4 para. 1 let. f.93 see annex 4.section 2 repeal of other legislation and transitional provisions art. 99 repeal of other legislation the following ordinances are repealed:1. the medical devices ordinance of 17 october 200194;2. ordinance of 22 june 200695 on the list of prescription medical devices.94 [as 2001 3487; 2004 4037 no i 5, ii para. 2; 2008 4377 annex 5 no 2; 2010 1215, 2749 no i 7; 2015 999; 2017 5935; 2019 999 art. 28 para. 2; 2020 2975]95 [as 2006 3679]art. 100 validity of certificates issued under the old legislation 1 certificates issued under the old legislation prior to 25 may 2017 will retain their validity until the expiry date stated therein, but no longer than 26 may 2022.2 certificates issued under the old legislation since 25 may 2017 will retain their validity until the expiry date stipulated in them, but no longer than 26 may 2024.art. 101 placing on the market of products that comply with the old legislation 1 provided they continue to comply with the old legislation from 26 may 2021 and have not undergone any significant changes in their design or intended purpose, the following medical devices may be placed on the market or put into service until 26 may 2024:a. devices classified as class i under the old legislation for which a declaration of conformity was issued before 26 may 2021 and for which the conformity assessment procedure under this ordinance necessitates the involvement of a designated body;b. devices with a certificate valid under article 100.2 the post-market surveillance and market monitoring of these devices, vigilance, and registration of economic operators and of the devices themselves are subject to the provisions of this ordinance.3 devices legally placed on the market prior to 26 may 2021 under the old legislation and devices placed on the market from 26 may 2021 under paragraph 1 can continue to be placed on the market or put into service until 26 may 2025. the above is subject to article 103.art. 102 exemptions for non-compliant medical devices exemptions issued by swissmedic under article 9 paragraph 4 of the medical devices ordinance of 17 october 200196 shall retain their validity.96 see the footnote to art. 99 no 1.art. 103 devices incorporating devitalised tissue or cells of human origin 1 devices incorporating devitalised tissue or cells of human origin or their derivatives as specified in article 1 paragraph 3 letter c no. 2 and d that were lawfully placed on the market or put into service prior to 26 may 2021 may still be placed on the market or put into service until 26 may 2025. art. 101 paragraph 2 applies mutatis mutandis.2 until such time as a corresponding special ordinance is issued, devices covered by article 2a paragraph 2 tpa are subject to the medical devices ordinance of 17 october 200197. devices covered by article 2a paragraph 2 tpa that were lawfully placed on the market prior to 26 may 2021 may still be placed on the market or put into service until such time as a corresponding special ordinance is issued.97 see the footnote to art. 99 no 1.art. 104 affixing the udi the udi required by article 17 paragraph 2 must be affixed:a. for implantable and class iii devices: from 26 may 2021;b. for class iia and iib devices: from 26 may 2023;c. for class i devices: from 26 may 2025;d. for reusable devices where the udi has to be affixed to the product itself: two years after the dates given in letters a-c for the relevant product class.art. 104a98 appointment of authorised representatives 1 if the manufacturer is domiciled in an eu or eea state, or if the manufacturer has designated an authorised representative domiciled in an eu or eea state, that manufacturer must designate an authorised representative in accordance with article 51 paragraph 1 within the following time periods:a. for class iii devices, class iib implantable devices and active implantable devices: by 31 december 2021;b. for non-implantable class iib devices and class iia devices: by 31 march 2022;c. for class i devices: by 31 july 2022.2 for systems and procedure packs, an authorised representative in accordance with article 51 paragraph 5 must be appointed by 31 july 2022.98 inserted by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281)art. 104b99 registration by economic operators economic operators that have placed devices on the market prior to 26 may 2021 in accordance with article 22a of the medical devices ordinance of 17 october 2001100 must register the information required under article 55 paragraphs 1 and 5 by 26 november 2021.99 inserted by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281)100 see the footnote to art. 99 no 1.art. 105101 in vitro diagnostic medical devices 1 until such time as a corresponding special ordinance is issued, in vitro diagnostic medical devices are subject to the medical devices ordinance of 17 october 2001102, subject to paragraphs 2 and 3.2 in vitro diagnostic medical devices must not carry the name and address of the natural or legal person who first places them on the swiss market on their labelling, outer packaging or instructions for use if they carry the name and address of the natural or legal person who places them on the market in an eu or eea state.3 in vitro diagnostic medical devices that have been notified to the competent authority of an eu or eea state in accordance with article 6 paragraph 2 of the medical devices ordinance of 17 october 2001 do not have to be additionally notified to swissmedic.101 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).102 see the footnote to art. 99 no 1.art. 106 devices without an intended medical purpose unless swissmedic has designated common specifications in accordance with article 8 paragraph 1 for devices without an intended medical purpose in accordance with annex 1, these devices are subject to the old legislation.art. 107 conformity assessment bodies 1 conformity assessment body designations issued under section 4 of the medical devices ordinance of 17 october 2001103 will become void.2 the conformity assessment body that issued the certificates under the old legislation will remain responsible for adequately monitoring these devices. it will be subject to supervision by swissmedic.3 conformity assessment body designations issued under section 4a of the medical devices ordinance of 17 october 2001 will retain their validity.4 until a special ordinance for in vitro diagnostic medical devices enters into force, the conformity assessment bodies for these devices will continue to be designated in accordance with section 4 and 4a of the medical devices ordinance of 17 october 2001.103 see the footnote to art. 99 no 1.art. 108104 reporting devices, systems and procedure packs 1 until article 17 paragraph 5 comes into force, the following reporting obligations will continue to apply to natural or legal persons domiciled in switzerland:a. for manufacturers and natural or legal persons who assemble systems or procedure packs under article 22 paragraphs 1 and 3 eu-mdr105: the reporting obligations set out in article 6 paragraphs 1 and 4 of the medical devices ordinance of 17 october 2001106:b. for natural or legal persons who place medical devices on the market under article 2 paragraph 1 of the medical devices ordinance of 17 october 2001: the reporting obligations set out in article 6 paragraphs 3 and 4 of the medical devices ordinance of 17 october 2001.2 .107104 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).105 see the footnote to art. 4 para. 1 let. f.106 see the footnote to art. 99 no 1.107 to enter into force in due course (art. 110 para. 2).art. 109108 108 repealed by no i of the o of 19 may 2021, with effect from 26 may 2021 (as 2021 281).art. 110 commencement 1 subject to the exceptions in paragraph 2, this ordinance comes into force on 26 may 2021.2 articles 17 paragraph 5 and 108 paragraph 2 will come into force at a later date.109109 amended by no i of the o of 19 may 2021, in force since 26 may 2021 (as 2021 281).annex 1 (art. 1 para. 1 letter b)product groups without an intended medical purpose 1. contact lenses or other items intended to be introduced into or onto the eye.2. products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of products used in tattooing or body piercing.3. substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.4. equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.5. high intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.6. equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.annex 2 (art. 5 para. 1)equivalent terms the terms listed below and used in eu-mdr110 and this ordinance are equivalent as follows:euswitzerlanda. english termsunionswitzerlandmember stateswitzerlandthird countryother state union marketswiss marketunion legislation /union harmonisation legislationlegislationharmonised standarddesignated standard state of the artscientific and technological standardseu declaration of conformitydeclaration of conformityofficial journal of the european unionfederal gazette (bundesblatt)established outside / within the uniondomiciled in / outside switzerlandauthoritycompetent authority under swiss lawhealthcare professionalprofessionalsuspensionsuspensionwithdrawalrevocationtransplantsorgansb. german termsunionschweizmitgliedstaatschweizdrittstaat / drittlandanderer staat unionsmarktschweizer marktrechtsvorschriften der union /harmonisierungsrechtssvorschriften der unionrechtsvorschriftenharmonisierte normbezeichnete norm stand der technikstand von wissenschaft und technikeu-konformittserklrungkonformittserklrungamtsblatt der europischen unionbundesblattausserhalb / in der union ansssigsitz ausserhalb / in der schweizbehrdenach schweizerischem recht zustndige behrdeangehrige der gesundheitsberufefachpersonenaussetzungsuspendierungzurckziehungwiderruftransplantateorganeunionsuissec. french termstat membresuissetat tiers / pays tiersautre tat march de l'unionmarch suisselgislation (actes lgislatifs) de l'union /lgislation d'harmonisation de l'unionlgislationsnorme harmonisenorme dsigne tat de l'arttat de la science et de la technique dclaration de conformit uedclaration de conformitinvestigation cliniqueessai cliniquedispositif faisant l'objet d'une investigationdispositif faisant l'objet d'un essai cliniquejournal officiel de l'union europennefeuille fdralesitu hors de l'union / tabli dans l'unionsis l'tranger / en suissenotice d'utilisationmode d'emploiconditionnementemballagenotification des incidents gravesdclaration des incidents gravesautoritsautorits comptentes en vertu du droit suisseprofessionnels de la santprofessionnelsretraitrvocationd. italian termsunionesvizzerastato membrosvizzerapaese terzoaltro statomercato dell'unionemercato svizzerolegislativo dell'unione /normativa di armonizzazione dell'unionelegislazioninorma armonizzatanorma designatastato dell'artestato della scienza e della tecnicadichiarazione di conformit uedichiarazione di conformitmarcatura ce di conformitmarchio di conformitgazzetta ufficiale dell'unione europeafoglio federaleavente sede fuori dall'unione,/ stabilito nell'unioneavente sede all'estero/ in svizzeraautoritautorit competente secondo il diritto svizzerooperatori sanitarispecialisticontrollatasociet controllataritirorevocaimmissione sul mercatoimmissione in commerciosegnalazione di incidenti gravinotifica di incidenti graviindagini clinichesperimentazioni clinichedispositivo oggetto di indaginedispositivo oggetto di sperimentazione clinicaconfezionamentoimballaggio110 see the footnote to art. 4 para. 1 let. f.annex 3 (art. 5 para. 2)applicable law 1 eu law where this ordinance makes reference to provisions of eu-mdr111 that in turn make reference to eu law, the versions below are applicable:1.1 regulation (ec) 1272/2008 of the european parliament and of the council of 16 december 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67/548/eec and 1999/45/ec, and amending regulation (ec) no 1907/2006, (oj l 353 of 31.12.2080, p. 1).1.2 commission regulation (eu) no 207/2012 of 9 march 2012 on electronic instructions for use of medical devices (oj l 72 of 10.3.2012, p. 28).1.3 commission regulation (eu) no 722/2012 of 8 august 2012 concerning particular requirements as regards the requirements laid down in council directives 90/385/eec and 93/42/eec with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin(oj l 212 of 9.8.2012, p. 3).111 see the footnote to art. 4 para. 1 let. f.2 swiss law where this ordinance makes reference to provisions of eu-mdr112 that in turn make reference to eu law, the swiss law below is applicable in place of the eu law:eu lawswiss legislation1. directive 2001/83/ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use, oj l 311 of 28.1.2001, p. 67. therapeutic products actof 15 december 20001132. regulation (ec) no 726/2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency, oj l 136 of 30.4.2004, p. 1.therapeutic products actof 15 december 20003. regulation (ec) no 1394/2007 of the european parliament and of the council of 13 november 2007 on advanced therapy medicinal products and amending directive 2001/83/ec and regulation (ec) no 726/2004, oj l 324 of 10.12.2017, p. 121. therapeutic products actof 15 december 20004. regulation (eu) 2017/746 of the european parliament and of the council of 5 april 2017 on in vitro diagnostic medical devices and repealing directive 98/79/ec and commission decision 2010/227/eu, oj l 117 of 5.5.2017, p. 176.therapeutic products actof 15 december 2000 5. council directive 85/374/eec of 25 july 1985 on the approximation of the laws, regulations and administrative provisions of the member states concerning liability for defective products, oj l 210 of 7.8.1985, p. 29. product liability actof 18 june 19931146. directive 2014/30/eu of the european parliament and of the council of 26 february 2014 on the harmonisation of the laws of the member states relating to electromagnetic compatibility, oj l 96 of 29.3.2001, p. 79.ordinance of25 november 2015115on electromagneticcompatibility7. directive 2006/42/ec of the european parliament and of the council of 17 may 2006 on machinery, and amending directive 95/16/ec, oj l 157 of 09.06.2006, p. 24.machine ordinanceof 2 april 20081168. regulation (ec) no 1223/2009 of the european parliament and of the council of 30 november 2009 on cosmetic products, oj l 324 of 22.12.2009, p. 59.fdha ordinanceof 16 december 2016117on cosmetics9. directive 2004/23/ec of the european parliament and of the council of 31 march 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, oj l 102 of 7.4.2004, p. 48.therapeutic products actof 15 december 2000and transplantation actof 8 october 200411810. directive 2002/98/ec of the european parliament and of the council of 27 january 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending directive 2001/83/ec, oj l 33 of 8.2.2003, p. 30.therapeutic products act of 15 december 2000 and transplantation actof 8 october 200411. regulation (ec) no 178/2002 of the european parliament and of the council of 28 january 2002 laying down the general principles and requirements of food law, establishing the european food safety authority and laying down procedures in matters of food safetyoj l 31 of 1.2.2002, p. 1.foodstuffs actof 20 june 201411912. regulation (eu) no 1025/2012 of the european parliament and of the council of 25 october 2012 on european standardisation, amending council directives 89/686/eec and 93/15/eec and directives 94/9/ec, 94/25/ec, 95/16/ec, 97/23/ec, 98/34/ec, 2004/22/ec, 2007/23/ec, 2009/23/ec and 2009/105/ec of the european parliament and of the council and repealing council decision 87/95/eec and decision no 1673/2006/ec of the european parliament and of the council, oj l 316 of 14.11.2021, p. 12.therapeutic products act of 15 december 2000 and federal act of 6 october 1995120on technical barriers to trade 13. regulation (ec) no 45/2001 of the european parliament and of the council of 18 december 2000on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data, oj l 8 of 12.1.2001, p. 1.federal act of 19 june 1992121on data protection14. regulation (ec) no. 765/2008 of the european parliament and of the council of 9 july 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing regulation (eec) no 339/93, oj l 218 of 13.8.2008, p. 30.federal act of 6 october 1995on technical barriers to tradeand product safety actof 12 june 200912215. regulation (ec) no 1907/2006 of the european parliament and of the council of 18 december 2006 concerning the registration, evaluation, authorisation and restriction of chemicals (reach), establishing a european chemicals agency, amending directive 1999/45/ec and repealing council regulation (eec) no 793/93 and commission regulation (ec) no 1488/94 as well as council directive 76/769/eec and commission directives 91/155/eec, 93/67/eec, 93/105/ec and 2000/21/ec, oj l 396, 30.12.2006, p. 1.chemicals act of15 december 200012316. regulation (eu) no 528/2012 of the european parliament and of the council of 22 may 2012 concerning the making available on the market and use of biocidal products, oj l 167 of 27.6.2012, p. 1.ordinance on biocidal productsof 18 may 200512417. council directive 80/181/eec of 20 december 1979 on the approximation of the laws of the member states relating to units of measurement and on the repeal of directive 71/354/eec, oj l 39 of 15.2.1980, p. 40.metrology act of 17 june 201112518. council directive 2013/59/euratom of 5 december 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing directives 89/618/euratom, 90/641/euratom, 96/29/euratom, 97/43/euratom and 2003/122/euratom, oj l 13 of 17.1.2014, p. 1.radiological protection actof 22 march 199112619. directive 2004/10/ec of the european parliament and of the council of 11 february 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances, oj l 50 of 20.2.2004, p. 44.ordinance of 18 may 2005127on good laboratory practice20. council directive 90/385/eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices, oj l 189 of 20.7.1990, p. 17.medical devices ordinanceof 17 october 200121. council directive 93/42/eec of 14 june 1993 concerning medical devices, oj l 169 of 12.7.1993, p. 1.medical devices ordinanceof 17 october 2001112 see the footnote to art. 4 para. 1 let. f.113 sr 812.21114 sr 221.112.944115 sr 734.5116 sr 819.14117 sr 817.023.31118 sr 810.21119 sr 817.0120 sr 946.51121 sr 235.1122 sr 930.11123 sr 813.1124 sr 813.12125 sr 941.20126 sr 814.50127 sr 813.112.1annex 4128 128 revised by rectification of 4 may 2021 (as 2021 260).(art. 4 para. 2, 17 para. 4, 19 para. 1 let. c, 20 para. 1, 23, 25 para. 3, 29 para. 2, 45 para. 2, 46 para. 3, 47 para. 1 and 98 para. 2 let. b)delegated acts of the european commission based on eu-mdr129 129 see the footnote to art. 4 para. 1 let. f.for the purposes of implementing this ordinance, the legal acts adopted on the basis of the provisions of eu-mdr set out below will apply in switzerland in the binding version applicable to the eu member states:subject matterpassed by the european commission based on the eu-mdrart. 4 para. 2 meddo delegated act in accordance with art. 3 eu-mdrart. 17 para. 4 meddodelegated act in accordance with art. 27 para. 10 eu-mdrart. 19, para. 1 let. c meddoimplementing act in accordance with article 42 paragraph 13eu-mdr art. 20 para. 1 meddodelegated act in accordance with art. 18 para. 3 eu-mdrart. 23 meddo delegated act in accordance with art. 52 para. 5 eu-mdr art. 25 para. 3 meddo delegated act in accordance with art. 56 para. 6 eu-mdrart. 29 para. 2 meddo delegated act in accordance with art. 19 para. 4 eu-mdrart. 45 para. 2 meddodelegated act in accordance with art. 44 para. 11 eu-mdrart. 46 para. 3 meddo delegated act in accordance with art. 61 para. 8 eu-mdr art. 47 para. 1 meddo delegated act in accordance with art. 10 para. 4 eu-mdrart. 98 para. 2 letter b meddodelegated act in accordance with art. 106 para. 15 eu-mdrannex 5 (art. 13 para. 1)conformity marking the conformity marking is as follows:where a designated body has to be involved, its identification number is to be placed beside its conformity marking.annex 6 (art. 70, paras 2 and 3)product groups intended for use by professionals, qualifications and circumstances of use 1. product groups devices for injection intended to remain in the human body for longer than 30 days (long-term injectable devices) must only be used by a doctor or by a professional with the qualifications set out in number 2 under the direct supervision of a doctor, who will be deemed accountable.2. qualifications long-term injectable devices may be used by qualified healthcare professionals with appropriate training in the injection of long-term implantable devices.

812.214.31 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinance on integrity and transparency in relation to therapeutic products(tpito)of 10 april 2019 (status as of 1 january 2020)the swiss federal council,on the basis of articles 4 paragraph 2, 55 paragraph 3 and 56 paragraphs 2 and 3 of the therapeutic products act of 15 december 20001 (tpa),ordains:1 sr 812.21section 1 general provisions art. 1 subject matter this ordinance regulates the details on the requirement for integrity and the duty of transparency in articles 55 and 56 tpa.art. 2 definitions in this ordinance:a. professionals means persons who prescribe prescription-only medicinal products, dispense the same, use them independently on professional basis, or purchase them or jointly decide on their purchase for these purposes;b. organisations means private or public legal entities and companies and sole proprietorships that employ professionals.section 2 integrity art. 3 advantages of modest value 1 advantages of modest value under article 55 paragraph 2 letter a tpa that are permitted are advantages given to professionals that have a maximum total value of 300 francs per professional per year that are of relevance to medical or pharmaceutical practice.2 an advantage is of relevance to medical or pharmaceutical practice if it is directly connected with the practice of the profession by the professional or of direct benefit to the professional's customers.3 competition winnings and prizes are only permitted if:a. they constitute an advantage of modest value and of relevance to medical or pharmaceutical practice;b. the competition is directed exclusively towards the addressees of specialist advertising as defined in article 3 of the medicinal products advertising ordinance of 17 october 20012 (mpao); andc. participation in the competition is not conditional on purchasing prescription-only medicinal products.2 sr 812.212.5art. 4 support for research, teaching and infrastructure contributions that are permitted as support given to organisations for research, teaching and infrastructure in accordance with article 55 paragraph 2 letter b tpa are contributions that:a. are not offered, promised or given to professional in person but to the organisation that employs the professional;b. are based on a written agreement which clearly states their intended purpose;c. are used exclusively for that intended purpose;d. are not subject to conditions or requirements that relate to the prescription, dispensing, use or purchase of certain prescription-only medicinal products;e. are credited to a specific account held by the organisation to which professionals do not have sole access; andf. are shown in the organisation's accounts.art. 5 support for the continuing education and training and continuing professional development of professionals 1 contributions that are permitted as support for the continuing education and training and continuing professional development of professionals in accordance with article 55 paragraph 2 letter b tpa are contributions that meet the requirements of article 4 letters a-f.2 the organisation must decide independently on the form and choice of the continuing education and training and continuing professional development events and on the professionals who participate.art. 6 support for participating in events for the continuing education and training and continuing professional development of professionals 1 contributions are permitted as support for participating in events for the continuing education and training and continuing professional development of professionals in accordance with article 55 paragraph 2 letter b tpa provided they are agreed in writing and the professionals participating or the organisations that employ them make an appropriate contribution to the costs of the event (the personal contribution to the costs).2 the personal contribution per person attending a continuing professional development event amounts to at least one third, and per person attending a continuing education and training event to at least one fifth of the following costs:a. registration fees;b. travel costs to and from the event;c. accommodation and meals; andd. costs of activities that are not required in order to participate in the event (fringe events) and that are clearly of subordinate importance.3 a personal contribution to the costs is not required if:a. the participating professional provides a service in return of equivalent value in accordance with article 7 at the event;b. the participating professional is not required to make an overnight stay at the location of the event and the event lasts for no more than half a working day, not including any meal served following the professional part of the event.4 the following are not permitted:a. the full or partial refund of the personal contribution to the costs;b. any payment in respect of indirect participation costs such as lost working hours or lost income;c. any payment of the costs of fringe events that are not clearly of subordinate importance to the professional part of the event;d. any payment of the costs of travelling, accommodation, meals or fringe events for persons accompanying the participating professional, even if the accompanying persons are themselves professionals.art. 7 compensation for services of equivalent value 1 compensation for services of equivalent value provided by a professional or organisation in accordance with article 55 paragraph 2 letter c tpa is compensation that:a. is based on a written agreement which sets out the nature and extent of the service and the compensation; andb. is commensurate with the service provided.2 in the context of a specialist discussion, the requirement in paragraph 1 letter a does not apply to the payment of the cost of meals up to a maximum of 100 francs.3 no compensation shall be due for services that a professional or organisation:a. provides for themselves;b. provides in fulfilment of statutory obligations; orc. is otherwise remunerated for.4 compensation under paragraph 1 is in particular permitted for:a. costs assumed in connection with the purchase of prescription-only medicinal products, such as the payment of transport costs, storage costs or the assumption of storage risks;b. teaching, expert and advisory activities or the conduct of scientific studies and clinical trials;c. reports on practical experiences that are published in a scientifically recognised specialist medium;d. participation in advisory bodies, workshops or market research projects, provided they have no promotional purpose.art. 8 discounts 1 a discount corresponds to the difference between the standard price of a product and the price effectively paid in a transaction. for medicinal products on the list of pharmaceutical specialities, a discount is deemed to have been granted in particular where the price effectively paid is less than the ex factory price.2 the delivery of a larger quantity than ordered and invoiced is not permitted.art. 9 free samples free samples as defined in article 10 mpao3 may not be sold by professionals who receive them.3 sr 812.212.5section 3 transparency art. 10 1 all discounts and refunds that are given on the purchase of therapeutic products to persons or organisations that prescribe, dispense or use medicinal products or purchase the same for that purpose must be disclosed to the federal office of public health on request.2 the duty of transparency in accordance with article 56 tpa does not apply to the purchase of over-the-counter medicinal products (distribution category e) and conventional medicinal products falling within class i in accordance with annex ix of council directive 93/42/eec4 concerning medical devices.4 council directive 93/42/eec of 14 june 1993 concerning medical devices, oj l 169 of 12.7.1993, s. 1; last amended by directive 2007/47/ec, oj l 247 of 21.9.2007, p. 21.section 4 controls art. 11 any person who produces or sells medicines subject to the provisions on integrity and transparency must:a. designate a person to deliver all the required documents and information to the federal office of public health on request;b. retain all the agreements entered into with professionals and organisations in terms of this ordinance for ten years after their final use;c. maintain a list of all professionals and organisations that have received due advantages in accordance with this ordinance.section 5 final provisions art. 12 amendment of other legislation the amendment of other legislation is regulated in the annex.art. 13 commencement this ordinance comes into force on 1 january 2020.annex (art. 12)amendment of other legislation the ordinances below are amended as follows:.55 the amendments can be consulted under as 2019 1395.

813.1 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal act on protection against dangerous substances and preparations(chemicals act, chema)of 15 december 2000 (status as of 1 january 2017)the federal assembly of the swiss confederation,based on articles 95 paragraph 1, 110 paragraph 1 letter a and 118 paragraph 2 letter a of the federal constitution1,and having considered the dispatch of the federal council dated 24 november 19992,ordains:1 sr 1012 bbl 2000 687chapter 1 general provisions and principles section 1 general provisions art. 1 purpose this act is intended to protect the lives and health of human beings against harmful effects arising from substances and preparations.art. 2 scope 1 this act applies to the handling of substances and preparations.2 the handling of microorganisms is deemed equivalent to the handling of substances and preparations in so far as they are used in biocidal products or plant protection products.3 the federal assembly may by means of an ordinance extend the scope of this act or of individual provisions to include:a.organisms that have, or may have, dangerous properties within the meaning of this act;b.the protection of the lives and health of farm and household animals.4 the federal council shall provide for exemptions from the scope or from individual provisions of this act in cases where:a.lives and health are adequately protected by other federal legislation against harmful effects arising from substances and preparations;b.substances and preparations are intended solely for through transit or export;c.general defence or the tasks of the police and customs authorities necessitate such exemptions.art. 3 dangerous substances and preparations 1 substances and preparations are deemed dangerous if they are capable of presenting a hazard to life or health as a result of physico-chemical or toxic effects.2 the federal council shall specify the properties deemed dangerous and define categories of danger.art. 4 definitions 1 in this act:a.substances means chemical elements and their compounds in the natural state or obtained by any production process. a distinction is drawn between existing and new substances:1.substances shall be deemed to be existing substances if they are designated as such by the federal council,2.all other substances shall be deemed new;b.active substances means substances and microorganisms including viruses which on account of their action are designed to be used as biocidal products or plant protection products;c.preparations means mixtures or solutions composed of two or more substances;d.biocidal products means active substances and preparations that are not plant protection products and which are designed to:1.deter, render harmless, destroy or otherwise control harmful organisms, or 2.prevent damage from being caused by harmful organisms;e.plant protection products means active substances and preparations that are designed to:1.protect plants and plant products against harmful organisms or prevent the action of such organisms,2.influence the life processes of plants other than as a nutrient,3.preserve plant products,4.destroy unwanted plants or parts of plants, or5.control the undesired growth of plants;f.manufacturer means any natural or legal person who, by way of profession or trade, produces or extracts substances or preparations, or imports them for professional or commercial purposes;g.notifier means any natural or legal person who notifies new substances to the notification authority, submits documentation on existing substances under review, or requests authorisation for active substances or preparations;h.notification authority means the federal authority that receives in particular notifications of new substances, documentation on existing substances under review, or requests for authorisation for active substances and preparations, as well as other submissions, coordinates the procedures and issues the necessary rulings;i.placing on the market means providing for or supplying to third parties and importing for professional or commercial purposes;j.handling means any activity in connection with substances or preparations, in particular, production, import, export, placing on the market, storage, keeping, transport, use or disposal.2 the federal council may define more precisely the terms specified in paragraph 1, as well as other terms used in this act, draw further distinctions, and, in the light of new scientific and technological knowledge and in line with international developments, make adjustments and grant exemptions.section 2 principles for the handling of substances and preparations art. 5 self-regulation 1 any manufacturer who places substances or preparations on the market shall be responsible for ensuring that they do not endanger life or health. in particular, the manufacturer shall:a.assess and classify substances and preparations according to their properties;b.package and label them in accordance with the type of hazard concerned.2 the federal council shall issue regulations on the nature, extent and review of self-regulation. in particular, it shall specify:a.test methods, the principles of good laboratory practice (glp) and the criteria for assessment and classification;b.packaging and labelling requirements.art. 6 placing on the market having completed the appropriate self-regulation procedures, the manufacturer shall be entitled to place substances and preparations on the market without the prior consent of the authorities. the following exceptions apply:a.notification is required for placing new substances on the market as such or as a constituent of a preparation (art. 9);b.authorisation is required for placing biocidal products or plant protection products on the market (art. 10 and 11).art. 7 obligation to inform purchasers 1 any person who places substances or preparations on the market must inform purchasers about properties and hazards relevant to health, and about the appropriate precautions and protective measures.2 the federal council shall issue regulations concerning the nature, content and scope of such information, in particular the distribution and content of a safety data sheet.art. 8 duty of care any person involved in the handling of substances or preparations must pay due regard to their dangerous properties and take any measures necessary to protect life and health. in particular, due consideration must be given to the relevant information provided by the manufacturer.chapter 2 notification of and authorisation for specific substances and preparations art. 9 notification of new substances 1 the notification authority shall review and assess the documents submitted in conjunction with the federal authorities responsible for the technical matters in question (assessment authorities) and shall inform the notifier of the outcome within a period specified by the federal council.2 a substance for which notification has been submitted may be placed on the market if the notification authority has accepted the notification or if it has not requested any further documents or information concerning the notification within the above-mentioned period.3 the federal council shall issue regulations on the requirements and the procedure for the notification of new substances. it shall specify any exemptions from mandatory notification, taking into account in particular the intended use, the type of substance or preparation and the quantities that are to be produced or placed on the market.art. 10 authorisation for biocidal products 1 the notification authority shall review and assess the documents submitted in conjunction with the assessment authorities and shall issue its decision - taking the risk assessment into consideration (art. 16) - within a period specified by the federal council.2 authorisation shall be granted for a biocidal product in particular if, when used as intended:a.it is sufficiently effective;b.it does not have any unacceptable adverse effects on the health of humans or of farm or household animals.3 authorisation may be withheld or revoked if the health risks give rise to concern and if another active substance is available for which authorisation has been granted for biocidal products of the same type, which is associated with a considerably lower health risk and which does not entail any significant economic or practical disadvantages for users.4 the federal council shall specify the types of authorisation and the authorisation procedures, as well as any exemptions from mandatory authorisation for biocidal products. authorisation shall be granted for limited periods.art. 11 authorisation for plant protection products 1 authorisation shall be granted for a plant protection product in particular if, when used as intended, it does not have any unacceptable adverse effects on the health of humans or of farm or household animals.2 in other respects, the types of authorisation and the authorisation procedures, as well as any exemptions from mandatory authorisation for plant protection products, shall be determined by the relevant agricultural legislation. when issuing the appropriate implementing regulations, the federal council shall give due consideration to the protection of health within the meaning of this act.art. 12 obligation to request information in advance before notifiers conduct the animal experiments required for notification or authorisation, they must enquire at the notification authority as to whether the substance or preparation concerned has already been notified or authorisation has already been granted.art. 13 second notification and second authorisation 1 notification or authorisation in accordance with articles 9-11 shall also be required in cases where substances or preparations subject to mandatory notification or authorisation have already been notified by another notifier or authorisation has already been granted to another notifier.2 the federal council shall establish a special procedure for second notification or authorisation and, giving due consideration to the interests of the original notifier, shall specify the conditions under which:a.the second notifier may refer to notification documents already submitted;b.the original notifier, in the interests of animal welfare, has to accept the use of its notification documents.art. 14 use of documents subject to the provisions of article 13 paragraph 2, the federal authorities involved in the notification or authorisation procedure shall not be entitled to use information or documents provided by a notifier for the benefit of a different notifier without the former's consent. the federal council shall specify the period of protection and determine any exemptions, giving due consideration to the confidentiality of the information concerned.art. 15 review of existing substances 1 the federal council shall issue regulations concerning the review and assessment of individual existing substances.2 the notification authority may request manufacturers to carry out investigations or tests or to provide documents relating to existing substances that:a.in view of the quantities produced or placed on the market or in view of their dangerous character may pose a particular risk to life or health; or b.are being reviewed in connection with international efforts and programmes.art. 16 risk assessment 1 the notification authority, in conjunction with the assessment authorities, shall identify possible hazards presented by substances or preparations (risk assessment). for this purpose, the notifier may be requested to provide additional information and, if necessary, to carry out further tests.2 a risk assessment shall be required for:a.new substances (art. 9);b.substances and preparations subject to mandatory authorisation (art. 10 and 11);c.existing substances under review in accordance with article 15 paragraph 2 letter b.3 on the basis of the risk assessment, having first consulted the notifier, the notification authority may recommend or order that the notifier should take measures to reduce the risks.4 if no measures can be taken to reduce the risks or if the risks cannot be adequately reduced by such measures, the authorities responsible shall take appropriate steps to amend the relevant legal regulations.5 risk assessments shall be reviewed and, if necessary, revised in the light of new findings. in addition, reviews shall be carried out periodically in the case of biocidal products and plant protection products.art. 17 supplementary information the notifier must inform the notification authority without delay and if necessary submit new documents if new findings emerge relating to the substance or preparation concerned or if significant changes occur with regard to essential points such as properties, intended use, or the quantities produced or placed on the market.chapter 3 special provisions concerning the handling of substances and preparations art. 18 reporting the details of substances and preparations 1 in cases where dangerous substances or preparations not subject to a mandatory notification or authorisation procedure are placed on the market, the manufacturer shall inform the notification authority of the following:a.the name and address of the manufacturer;b.the essential details concerning the identity of the product;c.the classification and labelling;d.the substances relevant to the classification.2 in the case of certain substances and preparations, the federal council may waive, in part or in full, the requirement to provide such information, particularly if:a.on account of their properties or the intended use, information on the substances or preparations concerned is of little importance for the identification of risks or for prevention;b.they are supplied exclusively to professional or commercial users; orc.they are supplied in small amounts to a restricted circle of users.3 it may, if this is important for the identification of risks or for prevention:a.stipulate that additional details be reported for certain substances and preparations, specifically concerning their composition;b.extend the scope of mandatory reporting to include preparations that are not dangerous but contain dangerous substances.art. 19 regulations concerning substances 1 the federal council may issue special regulations:a.for certain substances and preparations that may endanger life or health;b.for articles containing substances or preparations as specified under letter a that may endanger life or health when they are used as intended or in a foreseeable way.2 it may:a.impose restrictions on the way in which they are handled, and in particular produced, placed on the market and used;b.impose restrictions on the intended use for which a substance or preparation is placed on the market, and on the quality and form thereof;c.prohibit any handling if life and health cannot otherwise be protected;d.attach special conditions to exports;e.require articles to be labelled if certain substances are contained in or may be released from them;f.require certain poisonous plants and animals to be labelled as such if they are placed on the market;g.specify the classification and labelling of individual dangerous substances and set threshold concentrations for the classification and labelling of preparations that contain these substances.art. 20 advertising 1 the promotion and offering for sale of dangerous substances and preparations, and of preparations containing dangerous substances, must not give rise to misapprehensions regarding the hazards or encourage inappropriate handling. in the case of biocidal products, no misleading claims may be made regarding efficacy.2 the federal council shall issue regulations on how reference is to be made to the hazards in such promotion and offering for sale.art. 21 keeping, storage dangerous substances and preparations shall be kept and stored securely according to the type of hazard involved. in particular, they must:a.be protected against hazardous external influences;b.be inaccessible to unauthorised parties;c.be kept or stored in such a way as to prevent any risk of confusion, specifically with foodstuffs, or of their being used by mistake.art. 22 obligation to return and to accept returns 1 any person who supplies dangerous substances or preparations shall be obliged to accept them when returned by non-commercial users for appropriate disposal. small quantities shall be returnable free of charge.2 in the case of particularly dangerous substances and preparations, the federal council may stipulate that they are to be returned by the owner for disposal.art. 23 theft, loss, inadvertent placing on the market the federal council shall issue regulations concerning the measures that are to be taken when dangerous substances or preparations have been stolen, lost, or placed on the market by mistake.art. 24 regulations concerning personal and technical qualifications 1 the federal council shall specify the personal and technical qualifications required by persons wishing to handle substances and preparations with particularly dangerous properties or in specific categories of danger or carrying special risks. it shall establish a licensing requirement if this is necessary to protect life and health.2 it shall specify how the necessary expertise may be acquired.art. 25 measures required in commercial and educational establishments 1 any person who is involved in the handling of substances and preparations by way of profession or trade shall be obliged to take such measures to protect the life and health of employees as are necessary in the light of experience, practicable according to the state of technological development and appropriate to the circumstances of the establishment concerned. subject to the provisions of articles 42 and 45, the present provision shall be implemented in accordance with the labour law of 13 march 19643 and the federal law of 20 march 19814 on accident insurance.2 in commercial and educational establishments where dangerous substances or preparations are handled by way of profession or trade, a person is to be designated who is responsible for questions of appropriate handling and who can provide the enforcement authorities with the necessary information (art. 42 para. 2). this person shall be required to have the necessary technical qualifications and operational authority. the cantonal authority responsible for enforcement shall be notified of the name of the person designated.3 sr 822.114 sr 832.20chapter 4 documentation and information art. 26 documentation 1 the notification authority shall be responsible for the management of cross-sectoral documentation on substances and preparations. to this end, it shall maintain a product register.2 the assessment authorities shall be responsible for obtaining the documentation required to fulfil their tasks.art. 27 product register 1 the product register shall contain the information on substances and preparations that:a.has been acquired or compiled by the notification authority and the assessment authorities in the course of the notification or authorisation procedure as specified in chapter 2;b.has been reported by the manufacturer in accordance with article 18.2 the federal council shall regulate the processing of data contained in the product register, particularly its use and disclosure, giving due consideration to the interests of the manufacturer; it shall specify the type of information that may be disclosed to enforcement authorities implementing regulations on substances and preparations on the basis of other legal instruments.art. 28 information 1 the federal government shall inform the public and authorities about the risks and hazards involved in handling substances and preparations and shall recommend measures to reduce the risks.2 it shall issue technical guidelines and publish the lists of substances and preparations that are required for the application of this act.3 the cantons shall provide information within their areas of responsibility.art. 29 information on indoor air the federal government shall provide information on hazards arising from indoor pollutants. it may in particular issue recommendations on the limitation or prevention of exposures hazardous to health and on the improvement of indoor air quality.art. 30 poisons information centre 1 the federal council shall establish a poisons information centre and ensure that it is financially compensated for carrying out the tasks assigned to it.2 the information centre shall provide information on the prevention and treatment of poisoning and shall recommend appropriate measures; to this end, it shall collect and process the necessary information, including details of cases of poisoning.3 it shall have unrestricted access to the data in the product register (art. 27) and shall be entitled to request the manufacturer directly to provide any additional information on substances and preparations that may be required for the fulfilment of its tasks.4 the federal council shall take appropriate measures to ensure that the data made available in accordance with paragraph 3 is treated confidentially and that commercial and industrial secrets are protected. it shall specify in particular the conditions under which and the extent to which the information centre may, for medical purposes of a preventive or curative nature, disclose details of the composition and properties of substances and preparations.chapter 5 enforcement section 1 cantons art. 31 enforcement 1 in so far as the federal government is not responsible, this act shall be enforced by the cantons. they shall ensure that the authorities responsible for enforcing this act coordinate their activities with the enforcement authorities responsible for workplace safety and for environmental protection.2 they shall implement decisions issued by the federal authorities, when requested to do so by the latter.art. 32 cantonal regulations the cantons shall issue the organisational regulations for enforcement and shall notify the federal government thereof.section 2 federal government art. 33 supervision 1 the federal government shall supervise the enforcement of this act.2 it shall coordinate cantonal enforcement measures in so far as uniform enforcement is deemed desirable. to this end, it may in particular:a.impose a duty on the cantons to inform the federal government about enforcement measures;b.prescribe measures to ensure uniform enforcement by the cantons;c.in exceptional circumstances, order the cantons to take specific enforcement measures;d.5support continuing education and training for the enforcement authorities. 5 the amendment in accordance with the federal act of 20 june 2014 on continuing education and training, in force since 1 jan. 2017 relates only to the french and italian texts (as 2016 689; bbl 2013 3729).art. 34 enforcement powers of federal government 1 the federal government shall enforce:a.article 5 paragraph 1 letter a (assessment and classification of substances and preparations) and the requirements based on article 5 paragraph 2 letter a;b.article 7 (manufacturer's obligation to inform purchasers);c.articles 9-17 (notification of and authorisation for specific substances and preparations);d.article 18 (reporting of details of substances and preparations);e.article 19 paragraph 2 letter d (exports);f.articles 26-30 (documentation and information), with the exception of article 28 paragraph 3.2 it may delegate responsibility to the cantons for individual parts of the tasks specified in paragraph 1 or request their participation in specific parts of tasks.3 the federal government is responsible for enforcement with regard to the following matters:a.installations, activities, substances and preparations required for the purposes of national defence;b.imports, through transit or exports.art. 35 coordination 1 the federal council shall determine which assessment authorities are to be involved in the procedures and reviews specified in chapter 2.2 if under different items of legislation substances or preparations must be notified to or authorisation granted by more than one federal authority, it shall designate a joint notification authority.3 the federal council shall regulate the cooperation between the federal authorities involved.art. 36 delegation of enforcement tasks the federal council may delegate enforcement tasks to public or private organisations and persons.art. 37 scientific requirements, research 1 the federal government shall ensure that the scientific requirements necessary for the application of this act are fulfilled.2 it may carry out surveys itself or in cooperation with the cantons, or with appropriate institutions or experts.3 within the framework of international cooperation, it may finance investigations of substances and preparations in whole or in part.4 it shall promote scientific teaching and research in the field of dangerous properties of substances and preparations.art. 38 federal council implementing provisions the federal council shall issue the implementing provisions. where possible, it shall combine these with the implementing provisions for other federal acts if the latter include provisions relating to substances and preparations.art. 39 adoption of internationally harmonised regulations and standards 1 when issuing its provisions, the federal council shall give due consideration to internationally harmonised guidelines and recommendations, and internationally harmonised technical regulations and standards.2 it may declare certain internationally harmonised technical regulations and standards to be applicable in connection with this act. it may authorise the relevant federal office to make subsequent adjustments to technical details of minor importance in the regulations and standards that have been declared applicable.3 in exceptional cases, it may decide that the regulations and standards declared applicable are to be published in a special form and that translation into the official languages is not required.art. 40 international cooperation 1 by way of amendment to the provisions of article 18 of the federal act of 6 october 19956 on technical barriers to trade (tba), the federal council may approve the recognition in particular of tests, inspections or assessments carried out abroad and of foreign reports or certificates.2 within the scope of the authority granted by this act, it may conclude international agreements over and above the provisions of article 14 paragraph 1 tba.3 the federal authorities shall cooperate with foreign authorities and institutions, and with international organisations.6 sr 946.51art. 41 safeguard clause if the notification authority has good reason to believe that substances or preparations represent a health hazard, although they comply with the requirements of this act, in particular if their classification, packaging or labelling is no longer appropriate, it may, having first consulted the manufacturer, provisionally reclassify the substances or preparations, prohibit their placing on the market or make them subject to special conditions. in such cases, the measures required to amend the regulations concerned shall be taken without delay.section 3 special regulations on enforcement art. 42 powers of enforcement authorities 1 in order to monitor compliance with the provisions of this act, the enforcement authorities shall be authorised to test substances, preparations and articles as specified in article 19 paragraph 1 letter b and to examine procedures for the handling thereof.2 for this purpose, they shall be authorised to request that any persons involved in the handling of such substances, preparations or articles should, free of charge:a.provide the necessary information;b.carry out or submit to investigations;c.grant access to production and storage facilities;d.permit sampling or provide samples on request.3 they shall be authorised, at the expense of the person responsible, to take any measures necessary to remedy irregularities with regard to such substances, preparations or articles. in particular, they shall be authorised to:a.prohibit any further handling of such substances, preparations or articles;b.order them to be recalled or returned;c.order them to be rendered harmless or destroyed;d.order their seizure.art. 43 secrecy any person carrying out tasks in accordance with this act is bound to maintain secrecy.art. 44 confidentiality of information 1 information shall be treated as confidential if its disclosure would be detrimental to an interest deemed worthy of protection. in particular, one such interest is that of manufacturers in the preservation of their commercial and industrial secrets.2 the federal council shall define the types of information for which preservation of secrecy cannot be asserted to be an interest deemed worthy of protection.art. 45 data exchange among enforcement authorities 1 if several different federal authorities are involved in enforcement, they shall be responsible for ensuring that data is exchanged in so far as this is necessary for the fulfilment of their tasks.2 the federal council may approve the exchange of data with additional authorities or with public or private organisations and persons if this is necessary for the enforcement of this act.3 the federal authorities shall disclose to the relevant cantonal enforcement authorities any data required for the fulfilment of their enforcement tasks.4 the cantonal enforcement authorities shall communicate to the relevant federal authorities any data that they have collected in accordance with this act.5 for the purposes of data exchange, automated recall procedures may be established. in this case, the federal council, giving due consideration to the interests of the parties concerned deemed worthy of protection, shall determine who is permitted to call up data, what data may be called up, and for what purposes.art. 46 data exchange with foreign countries and with international organisations 1 the federal council shall establish responsibilities and procedures for the exchange of data with foreign authorities and institutions and with international organisations.2 confidential information may only be disclosed to foreign authorities and institutions or to international organisations if:a.this is required by international agreements or the resolutions of international organisations; orb.it is imperative in order to avert an imminent hazard to life or health.art. 47 fees the federal council shall set the fees to be levied for enforcement by the federal authorities. it may grant exemptions from the liability to pay fees.chapter 67 . 7 repealed by annex no. 90 of the federal administrative court act of 17 june 2005, with effect from 1 jan. 2007 (as 2006 2197 1069; bbl 2004 4202). art. 48 chapter 7 criminal provisions8 8 from 1 jan. 2007, the penalties and prescriptive periods below must be interpreted or recalculated in application of art. 333 para. 2-6 of the criminal code (sr 311.0) in the version of the federal act of 13 dec. 2002 (as 2006 3459). art. 49 misdemeanours 1 a penalty of imprisonment or a fine of up to 200,000 swiss francs shall be imposed on manufacturers who wilfully:a.place substances or preparations on the market for a use that poses an immediate threat to life or health, if they are aware or should be aware of this fact (art. 5 para. 1);b.fail to correctly classify, package or label substances or preparations (art. 5 para. 1), fail to produce a safety data sheet, or include inaccurate or incomplete information in such a sheet (art. 7);c.place substances or preparations on the market:1.without having notified them (art. 6 and art. 13 para. 1),2.before the notification has been accepted or the specified period has elapsed (art. 9 para. 2),3.without authorisation having been granted (art. 6 and art. 13 para. 1);d.withhold information on substances or preparations from, or give false information to, the authorities responsible (art. 9 para. 3, art. 10 para. 4, art. 11 para. 2, art. 15 para. 2, art. 16 para. 1, art. 17, art. 30 para. 3 and art. 42 para. 2);e.infringe regulations concerning substances (art. 19 para. 2 let. a-c, e and g);f.contravene measures ordered pursuant to the safeguard clause (art. 41).2 the penalty shall be imprisonment of up to five years or a fine of up to 500,000 swiss francs if human life is severely endangered as a result of the offences specified in paragraph 1.3 a penalty of imprisonment or a fine shall be imposed on anyone who wilfully:a.places dangerous substances or preparations on the market without duly informing the purchaser about the properties thereof or the appropriate precautions and protective measures, or without supplying the purchaser with a safety data sheet (art. 7);b.breaches the duty of care in the handling of dangerous substances and thereby knowingly endangers human life or health (art. 8, art. 21, art. 23 and art. 25 para. 1);c.contravenes the obligation to request information in advance (art. 12);d.infringes regulations concerning substances (art. 19 para. 2 let. a and c);e.infringes regulations concerning exports (art. 19 para. 2 let. d);f.handles substances or preparations without due authorisation (art. 24 para. 1);g.supplies dangerous substances or preparations to unauthorised parties (art. 19 para. 2 let. a and art. 24 para. 1);h.breaches the duty of secrecy (art. 30 para. 4, art. 43 and art. 44);i.contravenes measures ordered pursuant to the safeguard clause (art. 41).4 the penalty shall be imprisonment of up to five years or a fine of up to 100,000 swiss francs if human life is severely endangered as a result of the offences specified in paragraph 3.5 in cases of negligence, the penalty shall be imprisonment of up to one year or a fine of up to 100,000 swiss francs for offences specified in paragraph 1 and imprisonment of up to six months or a fine for offences specified in paragraph 3.art. 50 contraventions 1 a penalty of detention or a fine of up to 20,000 swiss francs shall be imposed to any person who wilfully:a.infringes the provisions concerning self-regulation (art. 5);b.breaches the duty of care in the handling of substances or preparations (art. 8, art. 21, art. 23 and art. 25 para. 1);c.fails to report details of substances or preparations or gives false information (art. 18);d.contravenes the labelling requirements for poisonous plants and animals (art. 19 para. 2 let. f);e.infringes the regulations concerning advertising (art. 20);f.refuses to accept the return of dangerous substances or preparations (art. 22 para. 1);g.breaches the duty to provide information to the cantonal enforcement authorities (art. 25 para. 2);h.breaches the duty to provide information or misinforms the enforcement authorities (art. 42 para. 2);i. contravenes an injunction issued with specific reference to the sanctions of the present article.2 in cases of negligence, the penalty shall be a fine.3 in cases where infringements of implementing regulations do not constitute an offence under paragraph 1 or article 49, the federal council may impose sanctions of detention or a fine of up to 20,000 swiss francs for wilful acts, or a fine in cases of negligence.4 attempt and aiding and abetting are also offences.5 in particularly minor cases, prosecution and penalties may be waived.6 the right to prosecute contraventions prescribes after two years, and penalties for contraventions after five years.art. 51 offences in commercial establishments articles 6 and 7 of the federal act of 22 march 19749 on administrative criminal law apply to offences under this act.9 sr 313.0art. 52 criminal prosecution and complaints 1 the cantons shall be responsible for the prosecution and adjudication of offences.2 if there are adequate grounds to suspect that an offence has been committed within the area of federal enforcement, the federal agency responsible shall report this to the cantonal authority. in particularly minor cases, a complaint may be dispensed with.chapter 8 final provisions art. 53 repeal and amendment of existing legislation the repeal and amendment of existing legislation is regulated in the annex.art. 54 transitional provisions 1 data collected under existing legislation by the toxicology documentation office (art. 18 of the toxic substances act of 21 march 196910), in particular that included in the list of toxic substances (art. 4 of the toxic substances act), may be included in the product register (art. 27) and continue to be used, in so far as it is relevant to the enforcement of this act.2 after the commencement of this act, substances and preparations that are packaged and labelled in accordance with existing legislation may still be placed on the domestic market by the manufacturer for one year and may be supplied to final users for two years. for these substances and preparations, the preparation and supply of safety data sheets shall be governed by existing law.3 for substances and preparations subject to mandatory notification or authorisation that are already on the market when this act comes into force, the federal council shall specify a facilitated notification or authorisation procedure. at the same time, for such cases, it shall grant an appropriate extension of the periods specified in paragraph 2.4 authorisation procedures for substances and preparations which are pending when this act comes into force shall be pursued and concluded by the federal authority that is responsible under this act in accordance with the provisions of this act.5 the federal council shall determine to what extent and for how long persons licensed to deal with toxic substances under existing law are entitled to handle dangerous substances and preparations.10 [as 1972 430 1977 2249 no. i 541, 1982 1676 annex no. 10, 1984 1122 art. 66 no. 4, 1985 660 no. i 41, 1991 362 no. ii 403, 1997 1155 annex no. 4, 1998 3033 annex no. 7.]art. 55 referendum and commencement 1 this act shall be subject to an optional referendum.2 the federal council shall set the commencement date.commencement date: 1 august 200511art. 19 para. 2 let. a and d, 34 para. 1 let. e, 38, 49 para. 3 let. e and annex no. ii 2 (art. 39 para. 1bis of the environmental protection act): 1 january 20051211 ordinance of 18 may 2005 (as 2005 2293).12 federal council decree of 10 nov. 2004annex repeal and amendment of current legislation ithe toxic substances act of 21 march 196913 is repealed.iithe federal acts listed below are amended as follows:.1413 [as 1972 430, 1977 2249 no. i 541, 1982 1676 annex no. 10, 1984 1122 art. 66 no. 4, 1985 660 no. i 41, 1991 362 no. ii 403, 1997 1155 annex no. 4, 1998 3033 annex no. 7]14 the amendments may be consulted under as 2004 4763.

813.112.1 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinance on good laboratory practice (oglp)of 18 may 2005 (status as of 1 december 2012)the federal councilbased on article 5 paragraph 2 letter a of the chemicals act of 15 december 2000 (chema)1,article 26 paragraph 3, article 38 paragraph 3 and article 39 paragraph 1 of the environmental protection act of 7 october 19832 (epa) and article 11 paragraph 2 letter a of the federal act of 15 december 20003 on therapeutic products (tpa) decrees:1 sr 813.12 sr 814.013 sr 812.21section 1 general provisions art. 1 objective and purpose 1 this ordinance lays down the principles of good laboratory practice (glp) as the quality standard for studies, and regulates compliance monitoring.2 the ordinance aims to:a.ensure that test data are reproducible;b.promote international acceptance of tests conducted in switzerland in order to avoid duplicate testing.art. 2 scope the ordinance applies to non-clinical studies of substances, preparations and articles (test items) that:a.serve to obtain data on the properties of a test item and its safety with respect to human health and the environment; andb.provide data to be submitted to the authorities in view of a registering or licensing procedure.art. 3 definitions 1 in this ordinance:a.good laboratory practice (glp) means a quality system concerned with the organisational process and the conditions under which studies are planned, performed, monitored, recorded, archived and reported.b.4areas of expertise means studies conducted in the following categories: 1.physical-chemical testing,2.toxicity studies, 3.mutagenicity studies, 4.environmental toxicity studies on aquatic and terrestrial organisms, 5.studies on behaviour in water, soil and air; bioaccumulation6.residue studies, 7.studies on effects on mesocosms and natural ecosystems, 8.analytical and clinical chemistry testing, 9.other studies, specify;c.study audit means an audit of a study to verify that its data, records, reports and other elements comply with glp principles;d.test facility means the persons, premises and operational unit(s) that are necessary for conducting studies; for multi-site studies conducted at more than one site, the test facility comprises the site at which the study director is located and all individual test sites that individually or collectively may be considered as such. 2 further terms relevant to glp are defined in annex 1.4 amended by annex no 2 of the ordinance of 7 nov. 2012, in force since 1 dec. 2012 (as 2012 6103).section 2 glp principles and compliance monitoring art. 4 glp principles 1 the principles of glp are listed in annex 2.2 the federal office of public health (foph)5, the federal office for the environment (foen) and swissmedic (swiss agency for therapeutic products) may issue joint guidelines on the interpretation of glp principles. in doing so they must take account of internationally recognised regulations.5 the name of the administrative unit was amended in application of art. 16 para 3 of the publications ordinance of 17 nov. 2004 (sr 170.512.1). this amendment has been applied throughout the text.art. 5 application 1 establishments that wish to have their test facilities listed in the register (art. 14) must apply to the notification authority (art. 8).2 for each test facility, the application must include the following information:a.name and address of the test facility;b.site plans documenting the use of the individual premises;c.organisation charts documenting the name and position of the test facility management, the personnel in charge of quality assurance and the study directors;d.name and address of a contact person;e.standard operating procedures for quality assurance;f.a list of all standard operating procedures;g.the relevant areas of expertise; h.a list of all studies planned over the next six months with the relevant schedules;i.a list of all studies conducted over the last six months, or still being carried out, in the relevant areas of expertise.3 on request from the competent authority, the establishments must submit other information.4 if conditions in a test facility are substantially modified, the establishment must submit a new application without delay. in this case the list pursuant to paragraph 2 letter i must include all studies since the last inspection. in the event of any doubt, the establishment must refer without delay to the notification authority to determine whether the modification is substantial. the notification authority gives its decision in agreement with the competent authorities concerned.art. 6 inspections 1 after receiving an application, the competent authority shall inspect the test facilities on site. during this inspection, the authority checks in particular whether the procedures, operating procedures and data obtained respect the principles of glp.2 thereafter, the authority shall inspect the test facilities again every two to three years. prior to each inspection the authority shall request information pursuant to article 5 paragraph 2. the list pursuant to article 5 paragraph 2 letter i must include all studies conducted since the last inspection. the competent authority may request further data.3 if there is sufficient reason to assume that a test facility does not comply with the glp principles, the competent authority may conduct an inspection without delay.4 the competent authority shall produce a report on each inspection.art. 7 study audits 1 the competent authority shall conduct a study audit on its own initiative or at the request of another competent swiss or foreign authority if:a.there is sufficient reason to assume that a test facility did not comply with glp principles when conducting certain studies;b.the results of a particular study are of vital importance for assessing human or environmental safety.2 if after completion of the study audit the competent authority concludes that the audited study did not comply with glp principles, it may carry out an inspection.3 the competent authority may also carry out a study audit as part of an inspection.4 the competent authority shall produce a report on each inspection.art. 8 competent authorities 1 the notification authority in accordance with article 4 paragraph 1 letter h of the chema shall coordinate the conduct of inspections and of study audits and, in agreement with the competent authorities, produce decisions on conformity with the principles of glp.2 the following authorities are competent to carry out inspections and study audits:a.the foph and swissmedic for studies of toxicological properties;b.the foen for studies of ecotoxological properties or of environmental behaviour of the test items;c.the foph, the foen or swissmedic after mutual agreement for studies of all other properties.3 where necessary the authorities may delegate tasks to each other, or call in specialists. they may delegate all or part of the tasks and competences with which they are entrusted by virtue of this ordinance to appropriate public corporations or individuals. the foph and swissmedic may only delegate the conduct of inspections and study audits.art. 9 duties and powers of the authority 1 the authority shall carry out inspections and study audits according to the guidelines in sections a and b of annex i of european directive 2004/9/ec of the parliament and of the council of 11 february 20046.2 on request, the establishment must submit to the authorities all documents and all other evidence required to assess its compliance with glp principles.3 the authorities must be allowed to access the test facilities at all times.4 if an establishment with test facilities has been accredited by the swiss accreditation service pursuant to article 14 of the ordinance of 17 june 19967 on accreditation and identification, the authority shall take these results into account.6 directive 2004/9/ec of the european parliament and of the council of 11 feb. 2004 on the inspection and verification of good laboratory practice (glp); oj no. l 050 of 20 feb. 2004, pp. 28-43. the european community legislation mentioned in this ordinance can be ordered for a fee or consulted free of charge at the notification authority for chemical products, 3003 bern; it can also be consulted at www.cheminfo.ch.7 sr 946.512art. 10 reports on inspections and study audits 1 the competent authority shall provide the establishment with the draft of the inspection report and allow it an appropriate period in which to state its position thereon. on receipt of a response from the establishment or on expiry of the period, the authority shall pass the inspection report to the notification authority.2 the competent authority shall pass the report on the study audit to the notification authority.3 the notification authority shall decide:a.on the basis of the inspection report, whether the test facility is operating according to the glp principles;b.on the basis of the study audit report, whether the study was carried out according to the glp principles;4 the provisions on study audits also apply to studies audited during an inspection.art. 11 information the notification authority shall inform the competent authorities of planned inspections and study audits, and of decisions pursuant to article 10.art. 12 obligation to notify 1 an establishment must immediately notify the notification authority if:a.it changes its name or address;b.one of its test facilities changes its name or address;c.one of its test facilities is no longer willing to comply with glp principles.d.there are changes in responsibilities at the level of the management of the test facility or of the quality assurance unit.e.it intends to extend the area of expertise.section 3 documentation and conformity with glp principles art. 13 1 for any study that must be carried out according to the principles of glp, it is necessary in the procedure of notification or authorisation: to show that the study was carried out in a test facility registered, at the time when the study was carried out, in the swiss register of test facilities that comply with the principles of glp;to present a study report in which the study director confirms, in one of the swiss national languages or in english, that the study was carried out in compliance with the principles of glp.2 if the study was carried out in a country other than switzerland, in addition to the study report, an extract from the foreign register or a confirmation from the foreign authority must be submitted proving that the test facility was included in the official monitoring programme at the time the study was carried out. in the case of countries that are not members of the organisation for economic co-operation and development (oecd), the notification authority may request other documents that it considers necessary to evaluate compliance with the principles of glp.3 if justified by the circumstances, and in particular if the results of the study are very important, or if there is doubt whether the principles of glp have been respected, a federal executive authority may ask the notification authority to have a study audit carried out.section 4 other regulations art. 14 register and glp list 1 the notification authority shall maintain a register of all establishments with their inspected test facilities and their audited studies. 2 the notification authority shall enter the data in the register as soon as the formal decision has been made confirming conformity of the test facility with the principles of glp. 3 the notification authority shall provide the establishment with a confirmation stating, in one of the official swiss languages or in english, that its test facilities are listed in the register.4 the notification authority shall regularly publish, in an appropriate way, a list of the test facilities that work according to the principles of glp.5 if the principles of glp are no longer respected, the test facility shall be removed from the list mentioned in paragraph 4.art. 15 content of the register the register shall specify:a.the name and address of the establishment and of its test facilities;b.the type and date of inspection and the relevant areas of expertise;c.the date of the study audit and identification of the study;d.the decision relative to compliance with glp principles;e.the date of the decision or of the notification that the relevant test facility no longer complies with glp principles.art. 16 notification in cases of serious non-compliance with glp principles 1 if in the course of an inspection, the competent authority ascertains that a test facility fails to comply with glp principles to the extent that the reliability of study results is no longer guaranteed, and that in consequence these results may generate erroneous conclusions relating to human and environmental safety, it must immediately inform the notification authority.2 the notification authority must inform the federal executive authorities responsible for evaluating notifications or authorisations for substances and preparations.art. 17 confidentiality of data 1 the competent authorities may transmit confidential data only to:a.each other;b.the federal executive authorities pursuant to article 16 paragraph 2;c.foreign glp authorities, if this is provided for by agreements under international law or by federal legislation.2 under no circumstances are the entries in the register pursuant to article 15 confidential.art. 18 dealings with foreign authorities 1 depending on the area of competence (art. 8), the foph, the foen and swissmedic shall represent switzerland on glp-related issues in dealings with authorities and institutions abroad, and with international organisations.2 the foen shall co-ordinate dealings with the organisation for economic co-operation and development (oecd) at national level. each year it shall supply the oecd and the oecd member states with a list of inspected establishments with their test facilities and conducted study audits, and notify them of establishments that are guilty of serious non-compliance with glp principles.section 5 final provisions art. 19 transitional provisions 1 decisions made and confirmations delivered before this ordinance comes into force remain valid until they are replaced by documents after the next inspection.2 requests made according to the previous legislation and still being processed by the glp authorities shall be passed on to the notification authority when this ordinance comes into force.art. 20 commencement this ordinance comes into force on 1 august 2005. annex 1 (art.3, para 2)terms relating to glp 1 terms concerning the organisation of a test facility 1.1 test site means the location(s) at which one or more phases of a study is conducted.1.2 test facility management means the person(s) who has the authority and formal responsibility for the organisation and functioning of the test facility according to these principles of good laboratory practice.1.3 test site management (if appointed) means the person(s) responsible for ensuring that the phase(s) of the study, for which he is responsible, are conducted according to these principles of good laboratory practice.1.4 study director means the individual responsible for the overall conduct of the non-clinical health and environmental safety study.1.5 principal investigator means an individual who, for a multi-site study, acts on behalf of the study director and has defined responsibility for delegated phases of the study. the study director's responsibility for the overall conduct of the study cannot be delegated to the principal investigator(s); this includes approval of the study plan and its amendments, approval of the final report, and ensuring that all applicable principles of good laboratory practice are followed.1.6 quality assurance programme means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these principles of good laboratory practice.1.7 standard operating procedures (sops) means documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines.1.8 master schedule means a compilation of information to assist in the assessment of workload and for the tracking of studies at a test facility.2 terms concerning studies 2.1 short-term study means a study of short duration with widely used, routine techniques.2.2 study plan means a document which defines the objectives and experimental design for the conduct of the study, and includes any amendments.2.3 study plan amendment means an intended change to the study plan after the study initiation date.2.4 study plan deviation means an unintended departure from the study plan after the study initiation date.2.5 test system means any biological, chemical or physical system or a combination thereof used in a study.2.6 raw data means all original test facility records and documentation, or verified copies thereof, which are the result of the original observations and activities in a study. raw data also may include, for example, photographs, microfilm or microfiche copies, computer readable media, dictated observations, recorded data from automated instruments, or any other data storage medium that has been recognised as capable of providing secure storage of information for a time period as stated in annex 2, number 10.2.7 specimen means any material derived from a test system for examination, analysis, or retention.2.8 experimental starting date means the date on which the first study specific data are collected.2.9 experimental completion date means the last date on which data are collected from the study.2.10 study initiation date means the date the study director signs the study plan.2.11 study completion date means the date the study director signs the final report.3 terms concerning the test item 3.1 test item means an article that is the subject of a study.3.2 reference item (control item) means any article used to provide a basis for comparison with the test item.3.3 batch means a specific quantity or lot of a test item or reference item produced during a defined cycle of manufacture in such a way that it could be expected to be of a uniform character and should be designated as such.3.4 vehicle means any agent which serves as a carrier used to mix, disperse, or solubilise the test item or reference item to facilitate the administration/application to the test system.annex 28 8 revised in accordance with annex no 2 of the ordinance of 7 nov. 2012, in force since 1 dec. 2012 (as 2012 6103).(art. 4, para 1)glp principles 1 test facility organisation and personnel 1.1 test facility management's responsibilities 1 each test facility management should ensure that these principles of good laboratory practice are complied with, in its test facility.2 as a minimum it should:a.ensure that a statement exists which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by these principles of good laboratory practice;b.ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study;c.ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual;d.ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions;e.ensure that appropriate and technically valid standard operating procedures are established and followed, and approve all original and revised standard operating procedures;f.ensure that there is a quality assurance programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with these principles of good laboratory practice;g.ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the study director before the study is initiated. replacement of a study director should be done according to established procedures, and should be documented.h.ensure, in the event of a multi-site study, that, if needed, a principal investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. replacement of a principal investigator should be done according to established procedures, and should be documented.i.ensure documented approval of the study plan by the study director;j.ensure that the study director has made the approved study plan available to the quality assurance personnel;k.ensure the maintenance of an historical file of all standard operating procedures;l.ensure that an individual is identified as responsible for the management of the archive(s);m.ensure the maintenance of a master schedule;n.ensure that test facility supplies meet requirements appropriate to their use in a study;o.ensure for a multi-site study that clear lines of communication exist between the study director, principal investigator(s), the quality assurance programme(s) and study personnel;p.ensure that test and reference items are appropriately characterised;q.establish procedures to ensure that computerised systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with these principles of good laboratory practice.3 when a phase(s) of a study is conducted at a test site, test site management (if appointed) will have the responsibilities as defined above with the following exceptions: point 1.1, paragraph 2, letters g., i., j. and o.1.2 study director's responsibilities 1 the study director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report.2 these responsibilities should include, but not be limited to, the following functions. the study director should:a.approve the study plan and any amendments to the study plan by dated signature;b.ensure that the quality assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the quality assurance personnel as required during the conduct of the study;c.ensure that study plans and amendments and standard operating procedures are available to study personnel;d.ensure that the study plan and the final report for a multi-site study identify and define the role of any principal investigator(s) and any test facilities and test sites involved in the conduct of the study;e.ensure that the procedures specified in the study plan are followed, and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from standard operating procedures during the conduct of the study;f.ensure that all raw data generated are fully documented and recorded;g.ensure that computerised systems used in the study have been validated;h.sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these principles of good laboratory practice;i.ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.1.3 principal investigator's responsibilities the principal investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable principles of good laboratory practice.1.4 study personnel's responsibilities 1 all personnel involved in the conduct of the study must be knowledgeable in those parts of the principles of good laboratory practice which are applicable to their involvement in the study.2 study personnel will have access to the study plan and appropriate standard operating procedures applicable to their involvement in the study. it is their responsibility to comply with the instructions given in these documents. any deviation from these instructions should be documented and communicated directly to the study director, and/or if appropriate, the principal investigator(s).3 all study personnel are responsible for recording raw data promptly and accurately and in compliance with these principles of good laboratory practice, and are responsible for the quality of their data.4 study personnel should exercise health precautions to minimise risk to themselves and to ensure the integrity of the study. they should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.2 quality assurance programme 2.1 general 1 the test facility should have a documented quality assurance programme to assure that studies performed are in compliance with these principles of good laboratory practice.2 the quality assurance programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures.3 this/these individual/s should not be involved in the conduct of the study being assured.2.2 responsibilities of the quality assurance personnel the responsibilities of the quality assurance personnel include, but are not limited to, the following functions. they should:a.maintain copies of all approved study plans and standard operating procedures in use in the test facility and have access to an up-to-date copy of the master schedule;b.verify that the study plan contains the information required for compliance with these principles of good laboratory practice. this verification should be documented;c.conduct inspections to determine if all studies are conducted in accordance with these principles of good laboratory practice. inspections should also determine that study plans and standard operating procedures have been made available to study personnel and are being followed. inspections can be of three types as specified by quality assurance programme standard operating procedures:1.study-based inspections,2.facility-based inspections,3.process-based inspections.records of such inspections should be retained.d.inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies;e.promptly report any inspection results in writing to management and to the study director, and to the principal investigator(s) and the respective management, when applicable;f.prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the study director and principal investigator(s), if applicable. this statement would also serve to confirm that the final report reflects the raw data.3 facilities 3.1 general 1 the test facility should be of suitable size, construction and location to meet the requirements of the study and to minimise disturbance that would interfere with the validity of the study.2 the design of the test facility should provide an adequate degree of separation of the different activities to assure the proper conduct of each study.3.2 test system facilities 1 the test facility should have a sufficient number of rooms or areas to assure the isolation of test systems and the isolation of individual projects, involving substances or organisms known to be or suspected of being biohazardous.2 suitable rooms or areas should be available for the diagnosis, treatment and control of diseases, in order to ensure that there is no unacceptable degree of deterioration of test systems.3 there should be storage rooms or areas as needed for supplies and equipment. storage rooms or areas should be separated from rooms or areas housing the test systems and should provide adequate protection against infestation, contamination, and/or deterioration.3.3 facilities for handling test and reference items 1 to prevent contamination or mix-ups, there should be separate rooms or areas for receipt and storage of the test and reference items, and mixing of the test items with a vehicle.2 storage rooms or areas for the test items should be separate from rooms or areas containing the test systems. they should be adequate to preserve identity, concentration, purity, and stability, and ensure safe storage for hazardous substances.3.4 archive facilities archive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens. archive design and archive conditions should protect contents from untimely deterioration.3.5 waste disposal handling and disposal of wastes should be carried out in such a way as not to jeopardise the integrity of studies. this includes provision for appropriate collection, storage and disposal facilities, and decontamination and transportation procedures.4 apparatus, material, and reagents 1 apparatus, including validated computerised systems, used for the generation, storage and retrieval of data, and for controlling environmental factors relevant to the study should be suitably located and of appropriate design and adequate capacity.2 apparatus used in a study should be periodically inspected, cleaned, maintained, and calibrated according to standard operating procedures. records of these activities should be maintained. calibration should, where appropriate, be traceable to national or international standards of measurement.3 apparatus and materials used in a study should not interfere adversely with the test systems.4 chemicals, reagents, and solutions should be labelled to indicate identity (with concentration if appropriate), expiry date and specific storage instructions. information concerning source, preparation date and stability should be available. the expiry date may be extended on the basis of documented evaluation or analysis.5 test systems 5.1 physical/chemical 1 apparatus used for the generation of physical/chemical data should be suitably located and of appropriate design and adequate capacity.2 the integrity of the physical/chemical test systems should be ensured.5.2 biological 1 proper conditions should be established and maintained for the storage, housing, handling and care of biological test systems, in order to ensure the quality of the data.2 newly received animal and plant test systems should be isolated until their health status has been evaluated. if any unusual mortality or morbidity occurs, this lot should not be used in studies and, when appropriate, should be humanely destroyed. at the experimental starting date of a study, test systems should be free of any disease or condition that might interfere with the purpose or conduct of the study. test systems that become diseased or injured during the course of a study should be isolated and treated, if necessary to maintain the integrity of the study. any diagnosis and treatment of any disease before or during a study should be recorded.3 records of source, date of arrival, and arrival condition of test systems should be maintained.4 biological test systems should be acclimatised to the test environment for an adequate period before the first administration/application of the test or reference item.5 all information needed to properly identify the test systems should appear on their housing or containers. individual test systems that are to be removed from their housing or containers during the conduct of the study should bear appropriate identification, wherever possible.6 during use, housing or containers for test systems should be cleaned and sanitised at appropriate intervals. any material that comes into contact with the test system should be free of contaminants at levels that would interfere with the study. bedding for animals should be changed as required by sound husbandry practice. use of pest control agents should be documented.7 test systems used in field studies should be located so as to avoid interference in the study from spray drift and from past usage of pesticides.6 test and reference items 6.1 receipt, handling, sampling and storage 1 records including test item and reference item characterisation, date of receipt, expiry date, quantities received and used in studies should be maintained.2 handling, sampling, and storage procedures should be identified in order that the homogeneity and stability are assured to the degree possible and contamination or mix-up are precluded.3 storage container(s) should carry identification information, expiry date, and specific storage instructions.6.2 characterisation 1 each test and reference item should be appropriately identified (e.g. code, chemical abstracts service registry number [cas number], name, biological parameters).2 for each study, the identity, including batch number, purity, composition, concentrations, or other characteristics to appropriately define each batch of the test or reference items should be known.3 in cases where the test item is supplied by the sponsor, there should be a mechanism, developed in co-operation between the sponsor and the test facility, to verify the identity of the test item subject to the study.4 the stability of test and reference items under storage and test conditions should be known for all studies.5 if the test item is administered or applied in a vehicle, the homogeneity, concentration and stability of the test item in that vehicle should be determined. for test items used in field studies (e.g. tank mixes) these may be determined through separate laboratory experiments.6 a sample for analytical purposes from each batch of test item should be retained for all studies except short-term studies.7 standard operating procedures 1 a test facility should have written standard operating procedures approved by test facility management that are intended to ensure the quality and integrity of the data generated by that test facility. revisions to standard operating procedures should be approved by test facility management.2 each separate test facility unit or area should have immediately available current standard operating procedures relevant to the activities being performed therein. published text, books, analytical methods, articles and manuals may be used as supplements to these standard operating procedures.3 deviations from standard operating procedures related to the study should be documented and should be acknowledged by the study director and the principal investigator(s), as applicable.4 standard operating procedures should be available for, but not be limited to, the following categories of test facility activities. the details given under each heading are to be considered as illustrative examples.a.test and reference items: receipt, identification, labelling, handling, sampling and storage.b.apparatus, materials and reagents1.apparatus: use, maintenance, cleaning and calibration,2.computerised systems: validation, operation, maintenance, security, change control and back-up.3.materials, reagents and solutions: preparation and labelling.c.record keeping, reporting, storage, and retrieval: coding of studies, data collection, preparation of reports, indexing systems, handling of data, including the use of computerised systems.d.test system (where appropriate):1.room preparation and environmental room conditions for the test system.2.procedures for receipt, transfer, proper placement, characterisation, identification and care of the test system.3.test system preparation, observations and examinations, before, during and at the conclusion of the study.4.handling of test system individuals found moribund or dead during the study.5.collection, identification and handling of specimens including necropsy and histopathology.6.siting and placement of test systems in test plots.e.quality assurance procedures: operation of quality assurance personnel in planning, scheduling, performing, documenting and reporting inspections.8 performance of the study 8.1 study plan 1 for each study, a written plan should exist prior to the initiation of the study. the study plan should be approved by dated signature of the study director and verified for glp compliance by quality assurance personnel as specified at point 2.2 letter b. the study plan should also be approved by the test facility management.2 study plan amendments and deviations should be treated as follows:a.amendments to the study plan should be justified and approved by dated signature of the study director and maintained with the study plan.b.deviations from the study plan should be described, explained, acknowledged and dated in a timely fashion by the study director and/or principal investigator(s) and maintained with the study raw data.3 for short-term studies, a general study plan accompanied by a study specific supplement may be used.8.2 content of the study plan the study plan should contain, but not be limited to the following information:a.identification of the study, the test item and reference item1.a descriptive title;2.a statement which reveals the nature and purpose of the study;3.identification of the test item by code or name (iupac; cas number, biological parameters, etc.);4.the reference item to be used.b.information concerning the sponsor and the test facility1.name and address of the sponsor;2.name and address of any test facilities and test sites involved;3.name and address of the study director;4.name and address of the principal investigator(s), and the phase(s) of the study delegated by the study director and under the responsibility of the principal investigator(s).c.dates1.the date of approval of the study plan by signature of the study director. the date of approval of the study plan by signature of the test facility management.2.the proposed experimental starting and completion dates.d.test methods: reference to the oecd test guideline or other test guideline or method to be used.e.issues (where applicable):1.justification for selection of the test system;2.characterisation of the test system, such as the species, strain, substrain, source of supply, number, body weight range, sex, age and other pertinent information;3.method of administration and the reason for its choice;4.dose levels and/or concentration(s), frequency, and duration of administration/application;5.detailed information on the experimental design, including a description of the chronological procedure of the study, all methods, materials and conditions, type and frequency of analysis, measurements, observations and examinations to be performed, and statistical methods to be used (if any).f.records: a list of records to be retained.8.3 conduct of the study 1 a unique identification should be given to each study. all items concerning this study should carry this identification. specimens from the study should be identified to confirm their origin. such identification should enable traceability, as appropriate for the specimen and study.2 the study should be conducted in accordance with the study plan.3 all data generated during the conduct of the study should be recorded directly, promptly, accurately, and legibly by the individual entering the data. these entries should be signed or initialled and dated.4 any change in the raw data should be made so as not to obscure the previous entry, should indicate the reason for change and should be dated and signed or initialled by the individual making the change.5data generated as a direct computer input should be identified at the time of data input by the individual(s) responsible for direct data entries. computerised system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data. it should be possible to associate all changes to data with the persons having made those changes, for example, by use of timed and dated (electronic) signatures. reason for changes should be given.9 reporting of study results 9.1 general 1 a final report should be prepared for each study. in the case of short term studies, a standardised final report accompanied by a study specific extension may be prepared.2 reports of principal investigators or scientists involved in the study should be signed and dated by them.3 the final report should be signed and dated by the study director to indicate acceptance of responsibility for the validity of the data. the extent of compliance with these principles of good laboratory practice should be indicated.4 corrections and additions to a final report should be in the form of amendments. amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the study director.5 reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition or amendment to the final report.9.2 content of the final report the final report should include, but not be limited to, the following information:a.identification of the study, the test item and reference item1.a descriptive title;2.identification of the test item by code or name (e.g., iupac, cas number, biological parameters, etc.);3.identification of the reference item by name;4.characterisation of the test item including purity, stability and homogeneity.b.information concerning the sponsor and the test facility1.name and address of the sponsor;2.name and address of any test facilities and test sites involved;3.name and address of the study director;4.name and address of the principal investigator(s) and the phase(s) of the study delegated, if applicable5.name and address of scientists having contributed reports to the final report; c.dates: experimental starting and completion dates.d.statement: a quality assurance statement listing the types of inspections made and their dates, including the phase(s) inspected, and the dates any inspection results were reported to management and to the study director and principal investigator(s), if applicable. this statement would also serve to confirm that the final report reflects the raw data.e.description of materials and test methods:1.description of methods and materials used;2.reference to oecd test guideline or other test guideline or method.f.results:1.a summary of results;2.all information and data required by the study plan;3.a presentation of the results, including calculations and determinations of statistical significance; 4.an evaluation and discussion of the results and, where appropriate, conclusions.g.storage: the location(s) where the study plan, samples of test and reference items, specimens, raw data and the final report are to be stored.10 storage and retention of records and materials 1 the following should be retained in the archives for at least ten years after study completion:a.the study plan, raw data, samples of test and reference items, specimens, and the final report of each study;b.records of all inspections performed by the quality assurance programme, as well as master schedules;c.records of qualifications, training, experience and job descriptions of personnel;d.records and reports of the maintenance and calibration of apparatus;e.validation documentation for computerised systems;f.the historical file of all standard operating procedures;g.environmental monitoring records.2 in the absence of a required retention period, the final disposal of any study materials should be documented. when samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation.3 material retained in the archives should be indexed so as to facilitate orderly storage and retrieval.4 only personnel authorised by management should have access to the archives. movement of material in and out of the archives should be properly recorded.5 if a test facility or an archive contracting facility goes out of business and has no legal successor, the archive should be transferred to the archives of the sponsor(s) of the study(s).

814.012english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon protection against major accidents(major accidents ordinance, mao)of 27 february 1991 (status as of 1 august 2019)the swiss federal council,on the basis of articles 10 paragraph 4 and 39 paragraph 1 of the federal actof 7 october 19831 on the protection of the environment (epa)and article 47 paragraph 1 of the waters protection act of 24 january 19912,3ordains:1 sr 814.012 sr 814.203 amended by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).section 1 general provisions art. 1 purpose and scope 1 the purpose of this ordinance is to protect the public and the environment against serious harm or damage resulting from major accidents.2 it applies to:a.4establishments where the threshold quantities for substances, preparations or special wastes specified in annex 1.1 are exceeded;b.5establishments where an activity involving genetically modified or pathogenic organisms or alien microorganisms subject to compulsory containment is carried out which is to be assigned to class 3 or class 4 in accordance with the containment ordinance of 9 may 20126;c.7railway installations in accordance with annex 1.2a;d.transit roads, as defined in the ordinance of 6 june 19838 on transit roads, where dangerous goods are transported or transhipped in accordance with the ordinance of 17 april 19859 on the carriage of dangerous goods by road (sdr) or the relevant international agreements;e.the rhine, where dangerous goods are transported or transhipped in accordance with the ordinance of 29 april 197010 on the carriage of dangerous goods on the rhine (adnr);f.11pipeline installations as defined in the pipelines ordinance of 26 june 201912 which meet the criteria specified in annex 1.3.2bis the enforcement authority may exempt establishments under paragraph 2 letter b from the scope of this ordinance that:a.only carry out class 3 activities with organisms in accordance with annex 1.4 which, due to their properties, cannot spread uncontrollably among the public and in the environment; and b.due to their hazard potential, cannot seriously harm the public or the environment.133 in individual cases, the enforcement authority may make the following establishments, transport routes or pipeline installations subject to this ordinance if, on account of their hazard potential, they could cause serious harm to the public or damage to the environment:14a.15establishments handling substances, preparations or special wastes;b.16establishments where an activity involving genetically modified or pathogenic organisms or alien microorganisms subject to compulsory containment is carried out which is to be assigned to class 2 in accordance with the containment ordinance, in consultation with the swiss expert committee for biosafety;c.transport routes outside establishments, where dangerous goods are transported or transhipped in accordance with paragraph 2;d.17pipeline installations as defined in the pipelines ordinance which do not meet the criteria specified in annex 1.3.184 this ordinance does not apply to installations and forms of transport which are subject to legislation on nuclear energy and radiological protection, insofar as the associated radiation could cause harm to the public or damage to the environment.195 the provisions of article 10 epa are directly applicable to establishments or transport routes which, in the case of exceptional events, could cause serious harm to the public or damage to the environment not arising from substances, preparations, special wastes or dangerous goods, or from genetically modified or pathogenic organisms or alien organisms subject to compulsory containment.204 amended by no ii 8 of the o of 18 may 2005 on the repeal and amendment of ordinances in connection with the commencement of the chemicals act, in force since 1 aug. 2005 (as 2005 2695).5 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).6 sr 814.9127 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).8 [as 1983 678. as 1992 341 art. 7]. now: transit roads ordinance of 18 dec. 1991 (sr 741.272).9 [as 1985 620, 1989 2482, 1994 3006, 1995 4425 annex 1 no ii 11 4866, 1997 422 no ii, 1998 1796 art. 1 no 18 and art. 6, 1999 751 no ii, 2002 419 1183. as 2002 4212 art. 29 para. 1]. now: the o of 29 nov. 2002 (sr 741.621).10 [as 1971 1957, 1977 768, 1983 486, 1987 1454, 1990 1356]. now: o of 3 march 2010 (sr 747.224.141).11 inserted by no i of the o of 13 feb. 2013 (as 2013 749). amended by annex no 2 of the pipelines ordinance of 26 june 2019, in force since 1 aug. 2019 (as 2019 2205).12 sr 746.1113 inserted by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).14 amended by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).15 amended by no ii 8 of the o of 18 may 2005 on the repeal and amendment of ordinances in connection with the commencement of the chemicals act, in force since 1 aug. 2005 (as 2005 2695).16 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).17 inserted by no i of the o of 13 feb. 2013 (as 2013 749). amended by annex no 2 of the pipelines ordinance of 26 june 2019, in force since 1 aug. 2019 (as 2019 2205).18 amended by annex 5 no 2 of the containment o of 25 aug. 1999, in force since 1 nov. 1999 (as 1999 2783).19 amended by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).20 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).art. 2 definitions 1 an establishment comprises installations as defined in article 7 paragraph 7 epa which have closely related operations and are in close proximity to each other (operating area).2 .213 the hazard potential is the sum of the effects which could arise from the quantities and properties of the substances, preparations, special wastes, organisms or dangerous goods in question.22 4 a major accident is an exceptional event occurring in an establishment, on a transport route or in a pipeline installation which has significant effects:23a.outside the operating area;b.on or near the transport route;c.24near the pipeline installation.5 the risk is determined by the extent of the possible harm to the public or damage to the environment resulting from major accidents and the likelihood of their occurrence.21 repealed by no i of the o of 29 april 2015, with effect from 1 june 2015 (as 2015 1337)22 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).23 amended by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).24 inserted by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).section 2 principles of prevention art. 3 safety measures25 1 the person responsible for an establishment, a transport route or a pipeline installation shall take all appropriate measures to reduce risk that are available in accordance with the state of the art of safety technology, supplemented by personal experience, and which are economically viable. these shall include measures to reduce the hazard potential, to prevent major accidents and to limit the effects thereof.262 when measures are selected, account shall be taken of operational and local factors which could cause major accidents, as well as actions of unauthorised persons.3 when measures are implemented, account shall be taken in particular of the principles laid down in annex 2, and in particular the measures in accordance with annexes 2.2-2.5.2725 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).26 amended by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).27 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).art. 428 28 repealed by no i of the o of 29 april 2015, with effect from 1 june 2015 (as 2015 1337)art. 5 summary report 1 the person responsible for an establishment must submit a summary report to the enforcement authority. it shall include:a.a concise description of the establishment, together with a general plan and information on the surrounding area;b.29a list of the maximum quantities of the substances, preparations or special wastes present in the establishment which exceed the threshold quantities specified in annex 1.1, together with the applicable threshold quantities;c.30the risk report specified in article 8 of the containment ordinance of 9 may 201231;d.documents drawn up in the preparation of any property and corporate liability insurance policies;e.details of safety measures;f.an estimate of the extent of possible harm to the public or damage to the environment resulting from major accidents.2 the person responsible for a transport route shall submit a summary report to the enforcement authority. it shall include:a.a concise description of the structural and technical design of the transport route, together with a general plan and information on the surrounding area;b.data on the volume and structure of traffic on the transport route and accident statistics;c.details of safety measures;d.an estimate of the likelihood of a major accident causing serious harm to the public or damage to the environment.3 the person responsible for a pipeline installation shall submit a summary report to the enforcement authority. it shall include:a.a concise description of the structural and technical design of the pipeline installation, together with a general plan and information on the surrounding area;b.data on the type, composition and physical state of the substances and preparations transported, together with the approved operating pressure and accident statistics;c.details of safety measures;d.an estimate of the likelihood of a major accident causing serious harm to the public or damage to the environment.324 .335 the enforcement authority shall exempt the person responsible for a through road from the duty to submit a summary report if, based on the information available, it is able, without a summary report, to assess as valid the assumption that the likelihood of major accidents causing serious harm is sufficiently low.3429 amended by no ii 8 of the o of 18 may 2005 on the repeal and amendment of ordinances in connection with the commencement of the chemicals act, in force since 1 aug. 2005 (as 2005 2695).30 amended by annex 5 no 7 of the containment o of 9 may 2012, in force since 1 june 2012 (as 2012 2777).31 sr 814.91232 amended by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).33 inserted by no i of the o of 13 feb. 2013 (as 2013 749). repealed by no i of the o of 29 april 2015, with effect from 1 june 2015 (as 2015 1337)34 inserted by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).art. 6 assessment of the summary report, risk report 1 the enforcement authority shall verify that the summary report is complete and correct.2 in particular, it shall verify:a.in the case of establishments, whether the estimate of the extent of possible harm or damage (art. 5 para. 1 let. f) is plausible;b.in the case of transport routes, whether the estimate of the likelihood of a major accident causing serious harm or damage (art. 5 para. 2 let. d) is plausible;c.35in the case of pipeline installations, whether the estimate of the likelihood of a major accident causing serious harm or damage (art. 5 para. 3 let. d) is plausible.3 following an on-site inspection, where appropriate, it shall assess the validity of the assumption that:a.in the case of establishments, serious harm to the public or damage to the environment arising from major accidents is not to be expected;b.in the case of transport routes, the likelihood of occurrence of a major accident causing serious harm or damage is sufficiently low;c.36in the case of pipeline installations, the likelihood of occurrence of a major accident causing serious harm or damage is sufficiently low.3bis the enforcement authority shall set out the results of its assessment in writing.374 if the assumption in accordance with paragraph 3 is not valid, it shall order the person responsible to prepare and submit to it a risk report in accordance with annex 4.3835 inserted by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).36 inserted by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).37 inserted by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).38 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).art. 7 assessment of the risk report 1 the enforcement authority shall review the risk report and assess whether the risk is acceptable. it shall set out its assessment in writing.392 when evaluating the acceptability of the risk, it shall take account of local risk factors and pay particular attention to the fact that the likelihood of occurrence of a major accident must be all the lower:a.40the more the need to protect the public or the environment against serious harm or damage arising from major accidents outweighs private and public interests in the operation of an establishment, a transport route or a pipeline installation;b.the greater the extent of the possible harm to the public or damage to the environment.39 amended by no i. of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).40 amended by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).art. 8 additional safety measures 1 if the risk is unacceptable, the enforcement authority shall order such additional measures as may be required. if necessary, these may include restrictions or prohibitions on operations and traffic.2 in the case of measures for which a different public body is responsible, the enforcement authority shall submit appropriate requests to the competent authority. if necessary, the federal council shall coordinate the adoption of measures.art. 8a41 change in circumstances 1 if the person responsible has prepared a summary report, but not a risk report and if the circumstances change significantly thereafter or relevant new findings become available, they must amend the summary report and resubmit it to the enforcement authority.2 if the person responsible has prepared a risk report and the circumstances change significantly thereafter or relevant new findings become available, they must: a.amend the risk report and resubmit it to the enforcement authority;b.amend the summary report instead of the risk report and resubmit it to the enforcement authority if:1.serious harm to the public or to the environment from major accidents need no longer be expected,2.in the case of transport routes and pipeline installations, the probability of a major accident causing serious harm is sufficiently low.41 inserted by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).art. 8b42 inspections 1 in order to verify if the person responsible is fulfilling their duties under this ordinance, the enforcement authority shall conduct regular on-site inspections. it shall set out its assessment in writing.2 the enforcement authority shall decide on the frequency of inspection based on the hazard potential, the type and complexity of the establishment, transport route or pipeline installation and the results of earlier inspections.42 inserted by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).art. 9 and 1043 43 repealed by no i of the o of 29 april 2015, with effect from 1 june 2015 (as 2015 1337)section 3 response to major accidents art. 11 1 the person responsible shall make every effort to respond to major accidents.2 in particular, he shall:a.immediately tackle major accidents and notify the point of contact;b.immediately secure the accident site and prevent further effects;c.remedy any effects as soon as possible.3 he shall submit a report to the enforcement authority within three months after the accident. the report shall include:a.a description of the course and effects of the major accident, and of the response provided;b.information on the effectiveness of the safety measures;c.an assessment of the accident.4 if the person responsible is unable to draw up the report within the period specified, he must submit an application for an extension to the enforcement authority, stating the reasons, together with an interim report on the state of the investigations.section 3a coordination with spatial planning activities44 44 inserted by no i of the o of 21 sept. 2018, in force since 1 nov. 2018 (as 2018 3505). art. 11a45 .46 1 the cantons shall take major accident prevention into account in structure and land use plans and in their other spatial planning activities.472 for establishments, transport routes and pipeline installations, the enforcement authority shall designate the adjoining area in which the construction of buildings and installations may lead to a significant increase in the risk.3 before the competent authority makes a decision on a change to a structure or land use plan in an area as specified in paragraph 2, it shall obtain an expert opinion from the enforcement authority for risk assessment purposes.45 inserted by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).46 repealed by no i of the o of 21 sept. 2018, with effect from 1 nov. 2018 (as 2018 3505).47 amended by no i of the o of 21 sept. 2018, in force since 1 nov. 2018 (as 2018 3505).section 448 responsibilities of the cantons 48 originally before art. 11a. art. 12 point of contact 1 the cantons shall designate a point of contact, which is responsible for receiving notifications of major accidents at any time and immediately alerting the emergency services.2 the cantons shall also ensure that a central office is designated, which immediately forwards notifications of major accidents to the national emergency operations centre (neoc) emergency desk (asn).4949 amended by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).art. 1350 information and alerts 1 the cantons shall inform the public of: a.the geographical location of establishments and transport routes;b.the adjoining areas in accordance with article 11a paragraph 2.2 the cantons shall ensure that, in the event of a major accident, the population affected is informed in good time and, if necessary, alerted and advised how to act.3 they shall also ensure that neighbouring cantons and states are informed in good time and, if necessary, alerted, if major accidents could have significant effects beyond cantonal or national borders.50 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).art. 14 coordination of emergency services the cantons shall coordinate the emergency services with the responsible persons' emergency plans.art. 1551 coordination of inspections as far as possible, the cantons shall coordinate the inspections of establishments and transport routes which they are required to carry out under this and other legislation.51 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).art. 16 provision of information to the foen52 1 the cantons shall periodically provide the federal office for the environment (foen) with information in the form of an overview of the hazard potentials and risks within their territory (risk register), together with the measures implemented.532 to this end, the competent federal and cantonal authorities shall make the necessary information available on request.3 the above is subject to legal requirements concerning secrecy.52 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).53 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).section 5 responsibilities of the confederation art. 17 data collection by the foen54 1 the competent federal and cantonal authorities shall forward to the foen on request any information collected in accordance with this ordinance.2 the foen shall ensure that the data is processed and made available to the competent authorities, insofar as this is necessary for the implementation of this ordinance.3 the above is subject to legal requirements concerning secrecy.54 expression in accordance with no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337). this amendment has been made throughout the text.art. 18 and 1955 55 repealed by no i of the o of 29 april 2015, with effect from 1 june 2015 (as 2015 1337)art. 2056 information 1 the competent federal authorities shall inform the public of:a.the geographical location of establishments, transport routes and pipeline installations;b.the adjoining areas in accordance with article 11a paragraph 2.2 in the event of major accidents which could have significant effects beyond national borders, the competent federal authorities shall inform the relevant swiss missions abroad and the foreign authorities concerned.56 amended by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).art. 2157 57 repealed by no i of the o of 29 april 2015, with effect from 1 june 2015 (as 2015 1337)art. 22 guidelines the foen shall, as required, publish guidelines which explain the essential provisions of the ordinance; these include, in particular, the provisions concerning the scope of the ordinance, safety measures, the preparation of the summary report and risk report, and the review and assessment thereof.section 6 final provisions art. 2358 enforcement 1 the cantons shall enforce this ordinance unless responsibility for enforcement is assigned to the confederation.2 when applying other federal acts or international agreements or resolutions relating to matters regulated by this ordinance, federal authorities shall also be responsible for enforcing this ordinance. participation of the foen and the cantons is governed by article 41 paragraphs 2 and 4 epa; these provisions are subject to legal requirements concerning secrecy.3 the foen shall specify the minimal geodata models and presentation models for official geodata in accordance with this ordinance for which it is designated as the competent federal authority in annex 1 of the ordinance of 21 may 200859 on geoinformation.6058 amended by no ii 8 of the o of 2 feb. 2000 to the federal act on the coordination and simplification of decision-making procedures, with effect from 1 march 2000 (as 2000 703).59 sr 510.62060 inserted by annex 2 no 5 of the o of 21 may 2008 on geoinformation, in force since 1 july 2008 (as 2008 2809).art. 23a61 amendment of annexes 1 detec may, having consulted the persons concerned and insofar as is required by the state of the art in safety technology, the hazard potential and the volume of hazardous goods, amend annexes 1.1 no 3 and 1.2a of this ordinance.2 detec may, in agreement with the federal department of economic affairs, education and research and the federal department of home affairs and having consulted the swiss expert committee for biosafety, amend the list in annex 1.4 if new findings as to the properties of certain organisms so require.61 inserted by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).art. 24 amendment of existing legislation .6262 the amendments may be consulted under as 1991 748.art. 2563 63 repealed by no i of the o of 29 april 2015, with effect from 1 june 2015 (as 2015 1337)art. 25a64 transitional provisions relating to the amendment of 13 february 2013 1 the person responsible for a pipeline installation shall submit the summary report (art. 5 para. 3) to the enforcement authority no later than 5 years after this amendment to the ordinance comes into force.2 the enforcement authority shall waive the requirement to provide information in accordance with paragraph 1 in cases where it already has the necessary information.64 inserted by no i of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).art. 25b65 transitional provisions relating to the amendment of 29 april 2015 persons responsible for establishments that fall within the scope of this ordinance for the first time following the amendment of 29 april 2015 must submit the summary report to the enforcement authority at the latest three years after the said amendment to the ordinance comes into force.65 inserted by no i of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).art. 26 commencement this ordinance comes into force on 1 april 1991.annex 1 scope and summary report annex 1.166 66 amended by no ii para. 2 of the o of 29 april 2015 (as 2015 1337). revised by no ii para. 1 of the o of 21 sept. 2018, in force since 1 nov. 2018 (as 2018 3505).(art. 1 and 5)threshold quantities for substances, preparations or special wastes 1 . 2 determination of threshold quantities 21 substances or preparations 1 for substances or preparations listed in the table under number 3, the threshold quantities specified therein apply.2 for other substances or preparations, the person responsible shall determine the threshold quantity using the criteria specified in number 4 in accordance with annex i of regulation (ec) no 1272/200867 and the criteria specified in number 5 for highly active substances and preparations. the lowest threshold quantity determined in this way is decisive.3 the person responsible need not determine the threshold quantity for a criterion or area if he can argue convincingly that the costs of acquiring the data would be disproportionate.67 regulation (ec) no 1272/2008 of 16 dec. 2008 of the european parliament and of the council on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67/548/eec and 1999/45/ec, and amending regulation (ec) no 1907/2006, oj l 353 of 31.12.2008, s. 1; last amended by regulation (eu) no 2016/1179, oj. l 195 of 20.7.2016, p. 11.22 special wastes the federal department of the environment, transport, energy and communications (detec) shall specify the threshold quantities for special wastes designated as such in the waste list issued in accordance with article 2 of the ordinance of 22 june 200568 on movements of waste. in doing so, it shall take account of their:a.health risks;b.physical risks;c.environmental risks;d.other risks.68 sr 814.6103 substances and preparations with specified threshold quantities nosubstance namecas no1tq (kg)21acetylene74-86-25 00024-aminodiphenyl and its salts 35003ammonium nitrate fertiliser with a nitrogen content 25 %20 0004ammonium nitrate fertiliser with a nitrogen content 25 % and a verifiable negative detonation and smoulder test200 0005arsenic(iii) oxide, arsenic(iii) acid and their salts1327-53-31006arsenic(v) oxide, arsenic(v) acid and/or their salts1303-28-21 0007benzidine and its salts 35008gasoline (regular, super)200 0009chlorine7782-50-520010chromium (vi) and its salts200111,2-dibromo-3-chlorpropane396-12-8500121,2-dibromethane3106-93-450013diethyl sulfate364-67-550014dimethylcarbamoyl chloride 379-44-7500151,2-dimethylhydrazine3540-73-850016ethanol motor fuels4200 00017heating oil, diesel500 00018hexamethylphosphoric triamide 3680-31-950019hydrazine3302-01-250020kerosene200 00021methyl isocyanate624-83-9150222-naphthylamine and its salts 350023nickel compounds in inhalable powder form1 000244-nitrodiphenyl392-93-3500251,3-propane sultone 31120-71-450026sulphur dichloride10545-99-01 00027hydrogen1333-74-05 0001substance identifier in the chemical abstract system2tq (kg)=threshold quantity in kg3carcinogens or preparations that contain these carcinogens in concentrations of over 5 per cent by weight4ethanol fuels with various percentages of ethanol in gasoline4 criteria for determining threshold quantities 41 health risks criteriavalues for criteriatq1 = 200 kgtq1 = 2000 kgtq1 = 20 000 kgtq1 = 200 000 kgclassification/labelling2h330h3003, h310, h331, h370h3013, h3023, h311, h 312, h3144, h 332, h3711tq (kg) = threshold quantity in kg2chemicals ordinance, sr 813.113if the substance or preparation is verifiably not toxic through inhalation nor dermally, for clp categories 1+2 (h300), a threshold quantity of 20 000 kg applies and for clp categories 3+4 (h301/h302), a threshold quantity of 200 000 kg applies.4corrosive substances and preparations (h314) that are also categorised and labelled as gases under pressure (h280/ h281) and/or as oxidising gases, liquids or solids (h270/h 271/h272) have a threshold quantity of 2000 kg, unless they have a lower threshold quantity due to other criteria.42 physical risks criteriavalues for criteriatq1 = 200 kgtq1 = 2000 kgtq1 = 20 000 kgtq1 = 50 000 kgclassification/labelling2h2003, h2013, h2023, h2033, h240, h241h220, h221, h224, h225, h226, h242, h250, h251, h252, h260, h261, h270, h271, h272h2224, h2234, h2281tq (kg) = threshold quantity in kg2chemicals ordinance, sr 813.113the threshold quantity relates to the net quantity of the active explosive substance.4to determine whether a threshold quantity has been exceeded, the stored quantities of flammable aerosol dispensers in the relevant clp categories must be added together on the basis of their net mass.43 environmental risks criteriavalues for criteriatq1 = 200 kgtq1 = 2000 kgtq1 = 20 000 kgtq1 = 200 000 kgclassification/labelling2h400, h410h4111tq (kg) = threshold quantity in kg2chemicals ordinance, sr 813.1144 other risks criteriavalues for criteriatq1 = 200 kgtq1 = 2000 kgtq1 = 20 000 kgtq1 = 200 000 kgclassification/labelling2euh032euh014, euh029, euh0311tq (kg) = threshold quantity in kg2chemicals ordinance, sr 813.115 highly active substances (has) criteria1values for criteriatq2= 20 kga.workplace inhalation threshold in the air3<10 g/m3b.effect dose (ed50)4 10 mgc.cmr substances with major accident potentialcategories 1a and 1b1the listed criteria apply, and the order of the criteria (letters) denotes their priority, i.e. if there is a value under criteria a, criteria b and c are no longer relevant.if a person responsible for a substance/preparation that meets one of the criteria concludes based on their self-assessment that harm to the public in the event of exposure on one occasion may be excluded or that the more serious effect of the substance/ preparation is not relevant to major accidents, the substance/ preparation is not deemed to be an has in terms of the major accidents ordinance. in order to assess whether an effect is relevant to major accidents, the definition of temporary emergency exposure limits (teel-2) applies. the major accidents ordinance does not apply to establishments that handle has only in the form of finished products that are intended for their own use or for supply to professional or commercial users or the general public.2tq (kg) = threshold quantity in kg3mak, tlv, oel, ioel, etc.4corresponds to the effect dose ed50 of 0.17 mg/kg at a body weight of 60 kg. the effect dose relates to the worst effect of the substance/preparation according to the self-assessment by the person responsible.annex 1.269 69 repealed by annex 5 no 2 of the containment o of 25 aug. 1999, with effect from 1 nov. 1999 (as 1999 2783).(art. 1 and 5)annex 1.2a70 70 inserted by no ii para. 1 of the o of 29 april 2015 (as 2015 1337). amended by no ii para. 2 of the o of 21 sept. 2018, in force since 1 nov. 2018 (as 2018 3505).(art. 1)scope for railway installations 1 track sections the major accidents ordinance applies to the track sections between the following operating points (with the exception of sections on foreign territory). the operating points are based on official geodata identifier 98.1 under the ordinance of 21 may 200871 on geoinformation (geoio).kilometre linefrom operating pointto operating pointusual name of the kilometre line on which the operating points lie100lsstdglausanne - simplon tunnel i - iselle109brtustdg(109)simplon tunnel ii131pdsmthles paluds - st-gingolph (frontire)150lssjlausanne - geneva airport151sjlpfrgeneva st-jean - la plaine-frontire152sjgepbst-jean - geneva-eaux-vives - annemasse154fubijonfuret - jonction160renoltserenens vd ouest - lausanne-triage sect.161ltflonalausanne-triage f - lonay a (bif)162ltplonblausanne-triage p1 - lonay b164lecrdenalcheires - denges a166renoltrenens vd ouest - lausanne-triage est169ltsebylausanne-triage sect. - bussigny170lteltslausanne-triage (est - sud)200renodaibrenens vd ouest - vallorbe206renobye(206)renens vd ouest - bussigny est210daibbidaillens - biel/bienne260zolnbiaezollikofen nord - biel/bienne aebistr.265bimabiobiel mett abzweigung - biel/bienne ost266madbirwmadretsch - biel/bienne rb west290wkdthegbern wylerfeld - thun291lguswkdlchligut - wankdorf299thabthscthun abzweigung - thun gb - thun schadau300spnibrlospiez - kandersteg - brig302mgtnmgtn(302)zweiter mittalgrabentunnel310thegspnithun - spiez - interlaken ost330wenestgewengi-ey - ltschberg - st.german (ost)331ferdstge(331)wengi-ey - ltschberg - st.german (west)332frsfrnpfrutigen - frutigen nordportal (ost)400lgutrtrwlchligut - wanzwil - rothrist west410olbiolten - solothurn - biel/bienne450olslgusolten sd - bern451abortr(451)aarburg-oftringen - rothrist gleis 1453bfgrtr(453)rothrist ost - rothrist gleis 4455 uhdbaespunterhalden be - aespli456ohbdaespoberhard be - aespli457 ohbdmathardfeld (spw) - mattstetten459 ruttlgut(459)rtti - lchligut500murbgbasel sbb - olten - lucerne510bsfrbswmulhouse-ville - basel sbb511bsobsnkbasel sbb - basel gb - basel rb514bswbsosncf verbindungslinie5188519315badmllheim (baden) - basel bad bhf520gelnbadgellert - basel bad db521bsnkmuumfahrung sd: basel sbb rb i - muttenz522gelnbsnkumfahrung nord: gellert - pratteln523badbskebasel bad rb - kleinhnigen hafen525bsnkbsaubasel sbb rb - basel auhafen531olnoloolten verbindungslinie540olwoesolten - wschnau594rysppozzgbt west595ryspgidigbt ost600imwchieimmensee - bellinzona - chiasso601ryaberna(601)ryncht - erstfeld nord gleis links604bruaskn(604)brunnen - sisikon (gleis links)605skgruo(605)sisikon - gruonbach (gleis links)606alsaalme(606)al sasso - al motto (binario sinistro)607 mcenribn(607)mt. ceneri - rivera (binario destro)608masnlgn(608)massagno - lugano (binario destro)630giuscdogiubiasco - locarno631cdopinccadenazzo - pino confine638basmchsmbalerna sm - chiasso smistamento639chiechsmmonte olimpino ii - chiasso smistamento640bgrubrugg - rupperswil641ruoru(641)rupperswil ost - rupperswil gleis rechts647bghdknbrugg - hendschiken nord648bgsbgnbrugg sd - brugg nord (vl)649aawoet(649)aarau - wschnau tunnel alt650klwwwoeskillwangen west - lenzburg - dniken ost653gexoimwgexi ost - rotkreuz - immensee west691rblklwwrbl kopf zurich - killwangen west692rblzrbldrbl nord693rbldrblerbl mitte698klwwhblo(698)killwangen west -411- heitersbergl. ost699sdoefg(699)neuer bzbergtunnel700bgprobrugg - pratteln ost701eglstsoeglisau - koblenz - stein sckingen ost703zseogmtzh oerlikon nord - wettingen - gruemet704wuerklwwwrenlos - killwangen west (rbl)706zseoopszurich seebach - glattbrugg sd710zasobgzurich hb - brugg ag711zasnzasszh hardbrcke - kollermhle715zasohrdzurich altstetten ost - zurich hard718zauzasszh aussersihl - zh altstetten sd720zauzbzh langstrasse - thalwil - ziegelbrcke721twtws(721)thalwil - thalwil sd722zaunidszh langstrasse - nidelbad - litti723nidstwnonidelbad sd - thalwil nord725nidbnidonidelbad - nidelbad ost751huerwnozh langstr. - wallisellen - winterthur752zoenhuerzurich oerlikon nord - hrlistein (abzw)757kldorfkloten - dorfnest (berwerfung)760zhdbbuezurich hardbrcke - blach762nhshwinterthur nord - schaffhausen rb ost763bad8519316basel bad bhf - waldshut - schaffhausen764sheulgschaffhausen - singen - konstanz770buenhblach - eglisau - neuhausen824rhkghrromanshorn - konstanz830wilwfwil - weinfelden840wfrhwinterthur nord - romanshorn850gsswnost.gallen - winterthur nord880truehagsargans ost - st.gallen881sasltruesargans schl. west - schleife - trbbach890sasozbsargans ost - ziegelbrcke900sasochwsargans ost - chur west (gleisende)71 sr 510.6202 freight installations the major accidents ordinance applies to the following freight installations:-basel sbb rb (bsrb)-zurich rb limmattal (rbl)-lausanne-triage (lt)-chiasso smistamento (chsm)-geneva-la-prailleannex 1.372 72 inserted by no ii of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).(art. 1)criteria for pipeline installations 1 pipeline installations for the transport of gaseous thermal and motor fuels fall within the scope of this ordinance if they meet the following criteria:a.the approved operating pressure is greater than 5 bar and less than or equal to 25 bar and the product of the approved operating pressure in pascals (pa) and the external diameter in metres is greater than 500,000 pa m (500 bar cm) (pressure is to be taken to mean positive pressure); orb.the approved operating pressure is greater than 25 bar and the product of the approved operating pressure in pascals (pa) and the external diameter in metres is greater than 1,000,000 pa m (1,000 bar cm) (pressure is to be taken to mean positive pressure).2 pipeline installations for the transport of liquid thermal and motor fuels fall within the scope of this ordinance if, with an approved operating pressure of greater than 5 bar, the product of the approved operating pressure in pascals (pa) and the external diameter in metres is greater than 200,000 pa m (200 bar cm) (pressure is to be taken to mean positive pressure).annex 1.473 73 inserted by no ii para. 1 of the o of 29 april 2015 (as 2015 1337). amended by no ii para. 2 of the o of 21 sept. 2018, in force since 1 nov. 2018 (as 2018 3505).(art. 1 para. 2bis)list of organisms which, due to their properties, cannot spread uncontrollably among the public and in the environment deutscher namenom franaisnome italianoenglish nameremarksstliche pferdeenzephalomyelitisvirus de l'encphalite quine de l'estvirus dell'encefalite equina dell'esteastern equine encephalitis virusonly if not working with insect vectorshepatitis b virusvirus de l'hpatite bvirus dell'epatite bhepatitis b virushepatitis c virusvirus de l'hpatite cvirus dell'epatite chepatitis c virushepatitis d virus virus de l'hpatite dvirus dell'epatite dhepatitis d virushepatitis e virus virus de l'hpatite evirus dell'epatite ehepatitis e virushepatitis g virus virus de l'hpatite gvirus dell'epatite ghepatitis g virushumane immundefizienzvirus virus de l'immunodficience humaine virus dell'immunodeficienza umanahuman immunodeficiency virusgelbfieber-virusvirus de la fivre jaunevirus della febbre giallayellow fever virusonly if not working with insect vectorstrypanosomentrypanosomatrypanosomatrypanosomaif working with insect vectorsplasmodienplasmodiumplasmodiumplasmodiumif working with insect vectorshumanes t-lymphotropes virus 1 and 2virus t-lymphotropique humain 1 et 2virus t-linfotropico dell'uomo 1 e 2human t-lymphotropic virus 1 and 2frhsommer-meningoenzephalitis (fsme)virus de la mningo-encphalite tiques, (vmet)virus meningoencefalite da zecche (fsme)tick-borne encephalitis virus (tbe)only if not working with insect vectorsbovine spongiforme enzephalopathie (bse)encphalopathie spongiforme bovine (esb)encefalopatia spongiforme bovina (bse)bovine spongiform encephalopathy (bse)transmissible spongiforme enzephalopathie (tse)encphalopathies spongiformes transmissibles (est) encefalopatie spongiformi trasmissibili (tse)transmissible spongiform encephalopathies (tses)louping ill viruslouping ill viruslouping ill viruslouping ill virusonly if not working with insect vectorsannex 274 74 amended by no ii para 2 of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).safety measures annex 2.1 (art. 3)procedure for establishments, transport routes and pipeline installations when adopting safety measures, the person responsible for an establishment, transport route or pipeline installation must:a.select a suitable site or a suitable route and ensure that appropriate safety distances are maintained;b.establish the organisational requirements;c.arrange for the training of staff and the provision of information to third parties;d.establish the procedures for determining and evaluating major accident scenarios;e.establish the procedures for planning and implementing measures;f.arrange for the monitoring, servicing and review of the safety-critical components;g.establish the procedures for emergency planning;h.arrange for the systematic review of the organisational requirements and procedures and deal with change management (inside and outside the installations);i.document the significant results under letters b-h.annex 2.2 (art. 3)measures for establishments handling substances, preparations or special wastes when adopting general safety measures, the person responsible for an establishment handling substances, preparations or special wastes must:a.as far as possible, replace dangerous substances or preparations with less dangerous ones, or limit the quantities thereof and as far as possible, avoid hazardous processes, methods or operating procedures;b.design load-bearing structures in such a way that no additional serious effects arise as a result of the stresses to be expected in the event of a major accident;c.install adequate warning and alarm systems;d.install suitable and reliable measurement or control systems, which, insofar as required for safety reasons, are multiple, of different types and operate independently of each other;e.install the necessary safety equipment and take the necessary structural, technical and organisational protective measures;f.monitor equipment and the operation of safety-critical components and carry out regular maintenance and inspections and document the checks;g.store substances, preparations or special wastes in an orderly manner, taking account of their properties, and keep up-to-date records of their quantities and location;h.deploy a sufficient number of suitably qualified staff, inform them about high-risk methods and processes used in the establishment, train them to prevent, limit and respond to major accidents, and ensure that the level of expertise is maintained in the event of staff changes;i.document any significant operational failures, their causes and the measures adopted, and retain the documents for a sufficient length of time;j.control access to the establishment;k.provide sufficient own resources for responding to major accidents, draw up an emergency plan for major accidents and discuss it with the emergency services, and carry out periodic exercises on the basis of this plan.annex 2.3 (art. 3)measures for establishments handling microorganisms when adopting general safety measures, the person responsible for an establishment where an activity involving genetically modified or pathogenic alien organisms or alien organisms subject to compulsory containment is carried out must:a.as far as possible, replace dangerous organisms with less dangerous ones;b.install suitable and reliable measurement or control systems, which, insofar as required for safety reasons, are multiple, of different types and operate independently of each other;c.install the necessary safety equipment and take the necessary structural, technical and organisational protective measures;d.monitor equipment and the operation of safety-critical components and carry out regular maintenance and inspections and document the checkse.install adequate warning and alarm systems;f.store organisms or special wastes in an orderly manner, taking account of their properties, and keep up-to-date records of their quantities and location;g.deploy a sufficient number of suitably qualified staff, inform them about high-risk methods and processes used in the establishment, train them to prevent, limit and respond to major accidents, and ensure that the level of expertise is maintained in the event of staff changes;h.document any significant operational failures, their causes and the measures adopted, and retain the documents for a sufficient length of time; i.provide sufficient own resources for responding to major accidents, draw up an emergency plan for major accidents and discuss it with the emergency services, and carry out periodic exercises on the basis of this plan.annex 2.4 (art. 3)measures for transport routes when adopting general safety measures, the person responsible for a transport route must:a.design the transport route in such a way that no additional serious effects arise as a result of the stresses to be expected in the event of a major accident;b.install the necessary safety equipment and take the necessary structural, technical and organisational protective measures;c.install adequate warning and alarm systems;d.monitor equipment and the operation of safety-critical elements of the transport route and carry out regular servicing;e.take the necessary traffic management or control measures for the transport of dangerous goods;f.collect, assess and pass on to the staff concerned any information available on the transport of dangerous goods;g.in cooperation with the emergency services, draw up an emergency plan for major accidents and carry out periodic exercises on the basis of this plan.annex 2.5 (art. 3)measures for pipeline installations when adopting general safety measures, the person responsible for a pipeline installation must:a.taking the surrounding area into account, install the necessary safety equipment and take the necessary structural, technical and organisational protective measures;b.collect, assess and pass on to interested third parties (e.g. staff, emergency services and land owners) any information available on the hazards posed by the thermal and motor fuels transported.annex 375 75 repealed by no ii para. 3 of the o of 29 april 2015, with effect from 1 june 2015 (as 2015 1337)annex 4 risk report annex 4.176 76 revised in accordance with no ii 8 of the o of 18 may 2005 on the repeal and amendment of ordinances in connection with the commencement of the chemicals act, in force since 1 aug. 2005 (as 2005 2695).(art. 6)establishments handling substances, preparations or special wastes 1 principles 1 the risk report must contain all the information required by the enforcement authority in order to verify and assess, in accordance with article 7, the risk posed by the establishment to the public or the environment. this includes, in particular, all the information listed in numbers 2-5.2 in justified cases, certain items of information may be omitted or replaced by others which are equally valid or more appropriate.3 the scope and degree of detail of the information given for each item will depend on the specific circumstances; in particular, consideration is to be given to the type of establishment, the hazard potential, the surrounding area and the safety measures.4 documentation used for the risk report, particularly test results, empirical data, literature references, results of calculations and detailed analyses, are to be kept at the disposal of the enforcement authority.2 basic data 21 establishment and surrounding area -description of the establishment, together with a site plan, including any licences, planning approvals or concessions,-characterisation of the establishment (main activities, organisational structure, number of staff, etc.),-details of the surrounding area, together with a general plan,-division of the establishment into study units and the reasons for this division.22 list of substances, preparations or special wastes present in each study unit -designation (chemical name, cas number, trade name, etc.),-maximum quantity,-location,-details of physical and chemical properties.23 description of installations in each study unit -structure of buildings,-methods and processes,-storage,-incoming and outgoing shipments,-provision of supplies and disposal,-installation-specific major accidents.24 safety measures in each study unit -regulations applied and experience,-measures taken to reduce the hazard potential,-measures taken to prevent major accidents,-measures taken to limit the effects of major accidents.3 analysis for each study unit 31 methods -description of the methods used.32 hazard potentials -overview and characterisation of the main hazard potentials.33 main major accident scenarios 331 release process -possible causes,-description of significant release processes,-estimate of the likelihood of occurrence, given the safety measures in place.332 effects of release -description of effects, based on dispersion considerations,-estimate of the likelihood of occurrence, given the safety measures in place.333 consequences for the public and the environment -description of the extent of possible harm to the public or damage to the environment,-estimate of the likelihood of occurrence, given the safety measures in place.4 conclusions -account of the risk for each study unit, given the safety measures in place,-estimate of the risk posed by the establishment as a whole.5 summary of the risk report -characterisation of the establishment and of the main hazard potentials,-description of the safety measures,-description of the main major accident scenarios,-estimate of the risk posed by the establishment as a whole.annex 4.277 77 revised by annex 5 no 2 of the containment o of 25 aug. 1999 (as 1999 2783), annex 5 no 7 of the containment o of 9 may 2012 (as 2012 2777) and no ii para. 2 of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337).(art. 6)establishments handling organisms 1 principles 1 the risk report must contain all the information required by the enforcement authority in order to verify and assess, in accordance with article 7, the risk posed by the establishment to the public or the environment. this includes, in particular, all the information listed in numbers 2-5.2 in justified cases, certain items of information may be omitted or replaced by others which are equally valid or more appropriate.3 the scope and degree of detail of the information given for each item will depend on the specific circumstances; in particular, consideration is to be given to the nature of the establishment, the hazard potential, the surrounding area and the safety measures. items marked with an asterisk (*) are generally only applicable to production facilities.4 documentation used for the risk report, particularly test results, empirical data, literature references, results of calculations and detailed analyses, are to be kept at the disposal of the enforcement authority.2 basic data 21 establishment and surrounding area -description of the establishment, together with a site plan, including any permits or planning approvals,-characterisation of the establishment,-names of the persons responsible,-information on the surrounding area, together with a general plan.22 activities involving organisms -risk assessment in accordance with article 8 of the containment ordinance of 9 may 201278; in particular, the identity and characteristics of the organisms and the nature and scale of the activity,-the purpose of the contained use,-the culture volumes,*the nature of the intended product and of any by-products which are or may be produced in the course of the activity.78 sr 814.91223 installation -description of the sections of the installation,*the maximum number of persons working in the installation and of persons working directly with the microorganisms.24 waste, wastewater and exhaust air -types and quantities of waste and wastewater arising from the use of organisms,-ultimate form and destination of inactivated wastes.25 safety measures -class of the activity in accordance with the containment ordinance -measures specified in the containment ordinance,-measures taken to prevent major accidents,-measures taken to limit the effects of major accidents.3 analysis 31 methods -description of the methods used.32 hazard potentials -overview and characterisation of the main hazard potentials.33 main major accident scenarios -possible causes of major accidents,-description of significant release events and their effects, based on dispersal considerations,-description of the extent of possible harm to the public or damage to the environment,-estimate of the likelihood of occurrence, given the safety measures in place.4 conclusions -account of the risk, given the safety measures in place,-estimate of the risk posed by the establishment.5 summary of the risk report -characterisation of the establishment and of the main hazard potentials,-description of the safety measures,-description of the main major accident scenarios,-estimate of the risk posed by the establishment.annex 4.3 (art. 6)transport routes 1 principles 1 the risk report must contain all the information required by the enforcement authority in order to verify and assess, in accordance with article 7, the risk posed by the transport route to the public or the environment. this includes, in particular, all the information listed in numbers 2-5.2 in justified cases, certain items of information may be omitted or replaced by others which are equally valid or more appropriate.3 the scope and degree of detail of the information given for each item will depend on the specific circumstances; in particular, consideration is to be given to the specific features and location of the transport route, the surrounding area, the volume and structure of traffic, accident statistics and safety measures.4 documentation used for the risk report, particularly test results, empirical data, literature references, results of calculations and detailed analyses, are to be kept at the disposal of the enforcement authority.2 basic data 21 transport route and surrounding area -description of the transport route, together with a site plan,-information on the structure of the transport route and technical and organisational data,-information on safety equipment,-information on the surrounding area, including a general plan.22 volume and structure of traffic and accident statistics -traffic data, such as the total volume of traffic and the proportion of heavy goods traffic,-data on the volume of dangerous goods traffic as a proportion of total heavy goods traffic,-data on the accident rate, accident black spots and general accident statistics.23 safety measures -regulations applied and experience,-measures taken to reduce the hazard potential,-measures taken to prevent major accidents,-measures taken to limit the effects of major accidents.3 analysis 31 methods -description of the methods used,-description of the survey method used to determine the proportion of dangerous goods traffic.32 hazard potentials -overview and characterisation of the main hazard potentials.33 main major accident scenarios -possible causes of major accidents,-description of significant release events and their effects, based on dispersion considerations,-description of the extent of possible harm to the public or damage to the environment,-estimate of the likelihood of occurrence, given the safety measures in place.4 conclusions -account of the risk, given the safety measures in place,-estimate of the risk posed by the transport route.5 summary of the risk report -characterisation of the transport route and of the main hazard potentials,-description of the safety measures,-description of the main major accident scenarios,-estimate of the risk posed by the transport route.annex 4.479 79 inserted by no ii of the o of 13 feb. 2013, in force since 1 april 2013 (as 2013 749).(art. 6)pipeline installations 1 principles 1 the risk report must contain all the information required by the enforcement authority in order to verify and assess, in accordance with article 7, the risk posed by the pipeline installation to the public or the environment. this includes, in particular, all the information listed in numbers 2-5.2 in justified cases, certain items of information may be omitted or replaced by others which are equally valid or more appropriate.3 the scope and degree of detail of the information given for each item will depend on the specific circumstances; in particular, consideration is to be given to the specific type of pipeline installation, its hazard potential and the surrounding area, as well as to safety measures.4 documentation used for the risk report, particularly test results, empirical data, literature references, results of calculations and detailed analyses, are to be kept at the disposal of the enforcement authority.2 basic data 21 pipeline installation and surrounding area -description of the pipeline installation, together with a route/site plan,-information on the structure of the pipeline installation and technical and organisational data,-information on safety equipment,-information on the surrounding area, including a general plan.22 safety measures -technical standards,-measures taken to reduce the hazard potential,-measures taken to prevent major accidents,-measures taken to limit the effects of major accidents.3 analysis 31 methods -description of the methods used.32 hazard potentials -overview and characterisation of the main hazard potentials.33 main major accident scenarios -possible causes of major accidents,-description of significant release events and their effects, based on dispersion considerations,-description of the extent of possible harm to the public or damage to the environment,-estimate of the likelihood of occurrence, given the safety measures in place.4 conclusions -account of the risk, given the safety measures in place,-estimate of the risk posed by the pipeline installation.5 summary of the risk report -characterisation of the pipeline installation and of the main hazard potentials,-description of the safety measures,-description of the main major accident scenarios,-estimate of the risk posed by the pipeline installation.

814.017 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon the register relating to pollutant release and the transfer of waste and of pollutants in waste water(prtro)of 15 december 2006 (status as at 23 january 2007)the swiss federal council,based on article 46 paragraph 2 of the federal act of 7 october 19831 on the protection of the environment (epa), ordains:1 sr 814.01section 1 general provisions art. 1 aim and scope of application 1 this ordinance is intended to guarantee public access to information on pollutant release and the transfer of waste and of pollutants in waste water by means of a register.2 it applies to facilities with installations in accordance with annex 1.art. 2 definitions in this ordinance:prtr means pollutant release and transfer register (register relating to pollutant release and the transfer of waste and of pollutants in waste water);installation in accordance with annex 1 also includes two or more installations of the same type in a single facility that together exceed the capacity threshold for that type of installation;facility means one or more installations in close proximity to each other that are operated by the same owner or operator as a single operational unit;owner or operator means the owner of a facility or person who actually operates a facility;pollutant means a substance or group of substances in accordance with annex 2;release means the introduction of pollutants into the air, the water or the land either deliberately or accidentally, directly or through sewer systems without final waste-water treatment, in particular by spillage, emission, discharge, injection, disposal or dumping;transfer means the deliberate or inadvertent movement beyond the boundaries of the facility:1.of waste destined for recovery or disposal, or2.of pollutants in waste water destined for waste-water treatment;waste water means water altered by industrial, commercial, agricultural or other use;hazardous waste means waste in terms of article 2 paragraph 2 letter a of the ordinance of 22 june 2005 on the movement of waste2.2 sr 814.610section 2 duties of the facility owner or operator art. 3 duty of care the owner or operator of a facility with installations in accordance with annex 1 must ensure that its information made available to the general public in the register is complete, based on standard definitions and comprehensible.art. 4 reporting requirement 1 the owner or operator of a facility with installations in accordance with annex 1 shall submit to the federal office for the environment (the foen) every year by 1 july the information referred to in article 5 paragraph 1 if that facility in the previous calendar year:a.released a larger quantity of a pollutant into the air, water or land than the quantity stipulated in the form of a threshold value in annex 2 ;b.transferred more than two tonnes of hazardous waste;c.transferred more than 2000 tonnes of other waste; ord.transferred a larger quantity of a pollutant in waste water than the quantity stipulated in the form of a threshold value for water in annex 2.art. 5 content of the report 1 the report must contain:the name, address and geographical coordinates of the facility and the installations in terms of annex 1;the name and address of the owner or operator;c.the quantity of the pollutant that the facility released in the previous calendar year into the air, water, or land including its number (annex 2 first column);d.the quantity of the hazardous waste that was transferred in the previous calendar year. an indication must be given, using the letter "r" or "d", of whether the waste was destined for recovery or disposal respectively in terms of annex 3; for the transborder transfer of hazardous waste, the name and address of the waste recovery or waste disposal facility as well as the address of the location of recovery or disposal must be provided;e.the quantity of other waste that was transferred in the previous calendar year. an indication must be given, using the letter "r" or "d", of whether the waste was destined for recovery or disposal respectively in terms of annex 3.f.the quantity of each pollutant that was transferred in waste water in the previous calendar year including its number (annex 2 first column); andg.the method used for determining the information in letters c - f, with an indication of whether the information is based on measurements, calculations or estimates.2 the method used for determining the information on the release or the transfer must be selected in such a way that the best available information is obtained; if possible, an internationally recognised method should be selected.3 the information must be entered directly into the confidential register provided by the foen; by way of exception, the data may be submitted to the foen in another way. the foen decides on the format of the data.4 anyone who has already submitted information in accordance with article 5 paragraph 1 to the confederation in compliance with other regulations may authorise the confederation to enter that information in the register in accordance with paragraph 3. the foen may request information from other federal agencies that has been obtained in compliance with other regulations and that is suitable for transfer to the register and it shall maintain a list of such information. art. 6 retention obligation 1 the owners or operators of facilities with installations in accordance with annex 1 must retain the collections of data from which the information submitted is derived for a period of five years following the report of the information. these collections must also contain details of the methods of recording the data.2 the collections must be made available to the authorities on request.section 3 duties of the authorities art. 7 maintaining the prtr 1 the foen shall maintain a prtr.2 the prtr shall contain:a.the non-confidential information in accordance with article 5 paragraph 1;information on pollutant release from diffuse sources;electronic links to existing national environmental databases;electronic links to the prtrs of the contracting parties to the protocol and, where possible, of other countries.3 the foen shall update the register:annually with the non-confidential information for the previous calendar year in accordance with paragraph 2 letter a;periodically with information on releases of pollutants from diffuse sources in accordance with paragraph 2 letter b.art. 8 information to the general public 1 the foen shall make the prtr available for inspection by the general public at the latest nine months after expiry of the reporting date in terms of article 4.2 access, in particular via the internet, to information contained in the prtr shall be guaranteed for a minimum of ten years from the date of its electronic publication, in particular on the internet.3 the foen shall ensure that the information contained in the prtr for each calendar year can be searched electronically in accordance with following criteria:a.name of facility and its geographical coordinates;b.installations in accordance with annex 1;c.owner or operator;d.pollutant or waste;e.environmental media into which the pollutant is released;f.recovery or disposal operation in accordance with annex 3;g.name and address of the waste recovery or waste disposal facility as well as the address of the location of recovery or disposal in cases of transborder transfer of hazardous waste.4 it shall ensure that a search can be made for the diffuse sources contained in the register.art. 9 confidentiality 1 information in accordance with article 5 paragraph 1 is deemed to be public if its disclosure is not contrary to any overriding private or public interests that are worthy of protection.2 private or public interests that are worthy of protection are the interests listed in article 7 of the freedom of information act of 17 december 20043.3 anyone who submits documents to the foen must:a.indicate any information that should be treated as confidential; andb.provide reasons why the interest claimed takes precedence over the interest in publication.4 the foen shall assess whether the interest claimed should take precedence. if its assessment is not consistent with the application made by the facility owner or operator, it must inform the facility owner or operator of this by means of a formal decision after giving the owner or operator the opportunity to state his position.5 if information is treated as confidential, notice must be given in the register of the type of information and the reason for its confidentiality.3 sr 152.3art. 10 verification of data 1 the cantons have access to the information held in the confidential register (art. 5 para. 3) on facilities with installations in accordance with annex 1 located on their territory.2 they must verify whether:a.the owner or operator has complied with the reporting requirement; andb.the reported information is complete, based on standard definitions and comprehensible.3 if they ascertain that the requirements of this ordinance have not been fulfilled, they shall notify the foen within 3 months of the expiry of the reporting date under article 4 paragraph 1. the foen must order the required measures.art. 11 advice to the general public and cooperation with the cantons 1 the foen shall inform the general public on a regular basis about the prtr, and provide advice on its use and purpose.2 it shall ensure a regular exchange of information with the cantons and shall cooperate with the cantons in the further development of the prtr.section 4 final provisions art. 12 amendment of current law .44 amendments may be consulted under as 2007 141.art. 13 transitional provisions 1 the report in terms of article 5 paragraph 1 must be submitted for the first reporting year by 1 july 2008.2 if the owners or operators of facilities with installations in accordance with annex 1 report data that relates to the period before the commencement of this ordinance, this data will be processed in accordance with article 9.art. 14 commencement this ordinance comes into force on 1 march 2007.annex 1 (art. 1 para. 2)installations no. installations1. energy sectora.mineral oil and gas refineriesb.installations for gasification and liquefactionc.thermal power stations and other combustion installations with a heat input of more than 50 megawatts (mw)d.coke ovense.coal rolling mills with a capacity of more than 1 t per hourf.installations for the production of coal products and solid smokeless fuel2. production and processing of metalsa.metal ore (including sulphide ore) roasting or sintering installations b.installations for the production of pig iron or steel (primary or secondary melting) including continuous casting with a capacity of more than 2.5 t per hourc.installations for the processing of ferrous metals: 1.hot-rolling mills with a capacity of more than 20 t crude steel per hour2.smitheries with hammers with a energy of more than 50 kilojoules per hammer where the calorific power exceeds 20 mw3.application of protective fused metallic coats with an input of more than 2 t of crude steel per hourd.ferrous metal foundries with a production capacity of more than 20 t per daye.installations1.for the production of non-ferrous crude metals from ore, concentrates or secondary raw materials by metallurgical, chemical or electrolytic processes2.for the smelting, including the alloying, of non-ferrous metals, including recovered products (refining, foundry casting, etc.) with a melting capacity of more than 4 t per day for lead and cadmium or more than 20 t per day for all other metalsf.installations for the surface treatment of metals and plastic materials using an electrolytic or chemical process, where the volume of the treatment vats exceeds 30 m3. mineral industrya.underground mining and related operationsb.opencast mining where the surface of the area being mined exceeds 25 hac.installations for the production of1.cement clinker in rotary kilns with a production capacity of more than 500 t per day2.lime in rotary kilns with a production capacity exceeding 50 t per day3.cement clinker or lime in other furnaces with a production capacity exceeding 50 t per dayd.installations for the production of asbestos and the manufacture of asbestos-based productse.installations for the manufacture of glass, including installations for the manufacture of glass fibres with a melting capacity of more than 20 t per dayf.installations for melting mineral substances including the production of mineral fibres with a melting capacity of more than 20 t per dayg.installations for the manufacture of ceramic products by firing, and in particular roofing tiles, bricks, refractory bricks, tiles, stoneware or porcelain with a production capacity of more than 75 t per day or of a kiln capacity of more than 4 m and of a setting density per kiln of over 300 kg/m4. chemicals industrya.chemicals installations for the production on an industrial scale of basic organic chemicals such as1.simple hydrocarbons (linear or cyclic, saturated or unsaturated, aliphatic or aromatic)2.oxygen-containing hydrocarbons, such as alcohols, aldehydes, ketones, carboxylic acids, esters, acetates, ethers, peroxides, epoxy resins3.sulphurous hydrocarbons4.nitrogenous hydrocarbons, such as amines, amides, nitrous compounds, nitro compounds or nitrate compounds, nitriles, cyanates, isocyanates5.phosphorous-containing hydrocarbons6.halogenic hydrocarbons7.organometallic hydrocarbons8.basic plastic materials (polymers, synthetic fibres, cellulose-based fibres)9.synthetic rubbers10.dyes and pigments11.surface-active agents and surfactantsb.chemical installations for the production on an industrial scale of basic inorganic chemicals such as1.gases, such as ammonia, chlorine or hydrogen chloride, fluorine or hydrogen fluoride, carbon oxides, sulphur compounds, nitrogen oxides, hydrogen, sulphur dioxide, carbonyl chloride2.acids, such as chromic acid, hydrofluoric acid, phosphoric acid, nitric acid, hydrochloric acid, sulphuric acid, oleum, sulphurous acids3.bases, such as ammonium hydroxide, potassium hydroxide, sodium hydroxide4.salts, such as ammonium chloride, potassium chlorate, potassium carbonate, sodium carbonate, perborate, silver nitrate5.non-metals, metal oxides or other inorganic compounds such as calcium carbide, silicon, silicon carbidec.chemical installations for the production on an industrial scale of phosphorus-, nitrogen- or potassium-based fertilisers (simple or compound fertilisers)d.chemical installations for the production on an industrial scale of basic plant health products and of biocidese.installations using a chemical or biological process for the production on an industrial scale of basic pharmaceutical products f.installations for the production on an industrial scale of explosives and pyrotechnic products5. waste and waste water managementa.installations for the incineration, pyrolysis, recovery, chemical treatment, or landfilling of hazardous waste receiving 10 tonnes or more per dayb.installations for the incineration of municipal waste with a capacity of more than 3 t per hourc.installations for the disposal of non-hazardous waste with a capacity of more than 50 t per dayd.landfills, excluding landfills of inert waste receiving more than 10 tonnes per day or with a total capacity of more than 25 000 tonnese.installations for the disposal or recycling of animal carcasses and animal waste with a total capcity of more than 10 t per dayf.municipal waste-water treatment plants with a capacity of more than 100 000 population equivalentsg.independently operated industrial waste-water treatment plants that serve one or more activities described in this annex and have a capacity of more than 10 000 m3 per day6. paper and wood production and processinga.industrial installations for the production of pulp from timber or similar fibrous materialsb.industrial installations for the production of paper and board and other primary wood products (such as chipboard, fibreboard and plywood) with a production capacity of more than 20 t per dayc.industrial installations for the preservation of wood and wood products with chemicals with a production capacity of more than 50 m per day7. intensive livestock production and acquaculturea.installations for the intensive rearing of poultry or pigs1.with more than 40 000 places for poultry2.with more than 2000 places for production pigs (over 30 kg)3.with more than 750 places for sowsb.intensive acquaculture with more than 1000 t fish and shellfish per annum8. animal and vegetable products from the food and beverage sectora.slaughterhouses with a carcass production capacity of more than 50 t per dayb.treatment and processing installations for the production of food and beverage products from:1.animal raw materials (other than milk) with a finished product production capacity of more than 75 t per day2.vegetable raw materials with a finished product production capacity of more than 300 t per day (average value on a quarterly basis)c.installations for the treatment and processing of milk with a capacity to receive more than 200 t per day (average value on an annual basis)9. other activitiesa.installations for the pre-treatment (such as washing, bleaching, or mercerisation) or dyeing of fibres or textiles with a treatment capacity of more than 10 t per dayb.installations for the tanning of hides or skins with a treatment capacity of more than 12 t of finished product per dayc.installations for the surface treatment of substances, objects or products using organic solvents, in particular for dressing, printing, coating, degreasing, waterproofing, sizing, painting, cleaning or impregnating with a consumption capacity of more than 150 kg per hour or of more than 200 t per annumd.installations for the production of carbon (hard-burnt coal) or electrographite by means of incineration or graphitisatione.installations for the building of and painting or removal of paint from ships with a capacity for ships over 100 m longannex 2 (art. 4 para. 1 let. a and d)pollutants notea dash (-) indicates that there is no reporting obligation in respect of the parameter or medium in question.no.cas numberpollutantthreshold value to airto waterto land kg/yearkg/yearkg/year 174-82-8methane (ch4)100 000-- 2630-08-0carbon monoxide (co)500 000-- 3124-38-9carbon dioxide (co2)100 million.-- 4hydro-fluorocarbons (hfcs)100-- 510024-97-2nitrous oxide (n2o)10 000-- 67664-41-7ammonia (nh3)10 000-- 7non-methane volatile organic compounds (nmvoc)100 000-- 8nitrogen oxides (nox/no2)100 000-- 9perfluorocarbons (pfcs)100--102551-62-4sulphur hexafluoride (sf6)50--11sulphur oxides (sox/so2)150 000--12total nitrogen -50 00050 00013total phosphorus-5 0005 00014hydrochlorofluorocarbons (hcfcs)1--15chlorofluorocarbons (cfcs)1--16halons1--177440-38-2arsenic and compounds (as as)2055187440-43-9cadmium and compounds (as cd)1055197440-47-3chromium and compounds (as cr)1005050207440-50-8copper and compounds (as cu)1005050217439-97-6mercury and compounds (as hg)1011227440-02-0nickel and compounds (as ni)502020237439-92-1lead and compounds (as pb)2002020247440-66-6zinc and compounds (as zn)2001001002515972-60-8alachlor-1126309-00-2aldrin111271912-24-9atrazine-112857-74-9chlordane11129143-50-0chlordecone11130470-90-6chlorfenvinphos-113185535-84-8chloro-alkanes, c10-c13-11322921-88-2chlorpyrifos-113350-29-3ddt11134107-06-21,2-dichloroethane (edc)1 00010103575-09-2dichloromethane (dcm)1 00010103660-57-1dieldrin11137330-54-1diuron-1138115-29-7endosulfan-113972-20-8endrin11140halogenated organic compounds (as aox)-1 0001 0004176-44-8heptachlor11142118-74-1hexachlorobenzene (hcb)10114387-68-3hexachlorobutadiene (hcbd)-1144608-73-11,2,3,4,5,6-hexachlorocyclohexane (hch)10114558-89-9lindane111462385-85-5mirex11147pcdd +pcdf (dioxins +furans) (as teq)0.0010.0010.00148608-93-5pentachlorobenzene1114987-86-5pentachlorophenol (pcp)1011501336-36-3polychlorinated biphenyls (pcbs)0.10.10.151122-34-9simazine-1152127-18-4tetrachloroethylene (per)2 000--5356-23-5tetrachloromethane (tcm)100--5412002-48-1trichlorobenzenes (tcbs) 10--5571-55-61,1,1-trichloroethane100--5679-34-51,1,2,2-tetrachloroethane50--5779-01-6trichloroethylene2 000--5867-66-3trichloromethane500--598001-35-2toxaphene1116075-01-4vinyl chloride1 000101061120-12-7anthracene50116271-43-2benzene1 000200 (as btex)*200 (as btex)*63brominated diphenylethers (pbdes)-1164nonylphenol ethoxylates (np/npes) and related substances-1165100-41-4ethyl benzene-200 (as btex)*200 (as btex)*6675-21-8ethylene oxide1 00010106734123-59-6isoproturon-116891-20-3naphthalene100101069organotin compounds (as total sn)-505070117-81-7di-(2-ethyl hexyl)phthalate (dehp)101171108-95-2phenols (as total c)-202072polycyclic aromatic hydrocarbons (pahs)**505573108-88-3toluene-200 (as btex)*200 (as btex)*74tributyltin and compounds-1175triphenyltin and compounds-1176total organic carbon (toc) (as total c or cod/3)-50 000-771582-09-8trifluralin-11781330-20-7xylenes-200 (as btex)*200 (as btex)*79chlorides (as total cl)-2 million.2 million.80chlorine and inorganic compounds (as hcl)10 000--811332-21-4asbestos11182cyanides (as total cn)-505083fluorides (as total f)-2 0002 00084fluorine and inorganic compounds (as hf)5 000--8574-90-8hydrogen cyanide (hcn) 200--86particulate matter (pm10)50 000--single pollutants are to be reported if the threshold for btex (the sum parameter of benzene, toluene, ethyl benzene, xylene) is exceeded.**polycyclic aromatic hydrocarbons (pahs) are to be measured as benzo(a)pyrene (50-32-8), benzo(b)fluoranthene (205-99-2), benzo(k)fluoranthene (207-08-9), indeno(1,2,3-cd)pyrene (193-39-5) (derived from the protocol on persistent organic pollutants to the convention on long-range transboundary air pollution)annex 3 (art. 5 para. 1 let. d and e)disposal and recovery operations 1. disposal operations ("d") -deposit into or onto land (e.g. landfill)-land treatment (e.g. biodegredation of liquid or sludgy discards in soils)-specially engineered landfill (e.g. placement into lined discrete cells which are capped and isolated from one another and the environment)-biological treatment not specified elsewhere in this annex which results in final compounds or mixtures that are discarded by means of any of the operations specified in this part-physico-chemical treatment not specified elsewhere in this annex which results in final compounds or mixtures that are discarded by means of any of the operations specified in this part (e.g. evaporation, drying, calcination, neutralisation, precipitation)-incineration on land-permanent storage (e. g. placement of containers in a mine)-blending or mixing prior to submission to any of the operations specified in this part-repackaging prior to submission to any of the operations specified in this part-storage pending any of the operations specified in this part2. recovery operations ("r") -use as a fuel (other than in direct incineration) or other means to generate energy-solvent reclamation/regeneration -recycling/reclamation of organic substances that are not used as solvents -recycling/reclamation of metals and metal compounds-recycling/reclamation of other inorganic materials-regeneration of acids or bases-recovery of components used for pollution abatement-recovery of components from catalysts-used oil re-refining or other reuses of previously used oil-land treatment resulting in benefit to agriculture or ecological improvement-uses of residual materials obtained from any of the recovery operations specified above in this part-exchange of wastes for submission to any of the recovery operations specified above in this part-accumulation of material intended for any operation specified in this part

814.201english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.waters protection ordinance(wpo)of 28 october 1998 (status as of 1 january 2021) the swiss federal council,based on articles 9, 14 paragraph 7, 16, 19 paragraph 1, 27 paragraph 2, 36a paragraph 2, 46 paragraph 2, 47 paragraph 1 and 57 paragraph 4 of the waters protection act of 24 january 19911 (wpa),2ordains:1 sr 814.202 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).chapter 1 general provisions art. 1 purpose and principle 1 this ordinance shall facilitate the protection of surface and underground waters from harmful effects and enable their sustainable use.2 for this purpose, all measures taken under this ordinance must take account of the ecological goals for waters (annex 1).art. 2 scope 1 this ordinance regulates:a.ecological goals for waters;b.requirements on water quality;c.disposal of waste water;d.disposal of sewage sludge;e.requirements for animal husbandry farms;f.protection of waters in terms of area planning;g.maintenance of appropriate residual flow;h.3prevention and remediation of other harmful effects on waters;i.granting of federal contributions.2 the ordinance applies to radioactive substances, insofar as such substances have biological effects resulting from their chemical characteristics. insofar as these substances have biological effects resulting from radiation, the legislation on radiation protection and nuclear energy applies.3 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).chapter 2 disposal of waste water section 1 differentiation between polluted and non-polluted waste water art. 3 1 the authorities shall assess whether waste water entering a body of water by way of discharge or infiltration is considered to be polluted or non-polluted, taking account of:a.the type, the amount, the characteristics and the temporal occurrence of potential water pollutants substances in the waste water;b.the condition of the receiving waters.2 during infiltration of waste water, they shall also take account of whether: a.waste water can be polluted because of existing soil pollution or the unsaturated subsoil;b.4waste water is sufficiently purified in the soil or in the unsaturated subsoil;c.guide values under the ordinance of 1 july 19985 on the pollution of soil (soilpo) can be maintained in the long term, excepting infiltration into a plant intended for this purpose, or onto roads next to embankments or grass verges.3 precipitation water running off built-up or sealed surfaces is as a rule considered to be non-polluted waste water if it: a.originates from roof surfaces;b.6originates from roads, paths and areas on which no substantial amounts of potential water pollutants are unloaded, processed and stored and if they are sufficiently purified by infiltration into the ground. in assessing whether amounts of substances are substantial, the risk of accidents must be taken into consideration;c.7originates from track installations where there is a long-term guarantee that pesticides will not be used or if pesticides have been sufficiently retained and degraded by a biologically active layer of soil.4 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).5 sr 814.126 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).7 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).section 2 drainage planning art. 4 regional drainage planning 1 the cantons shall ensure that a regional drainage plan (rdp) is drawn up to guarantee appropriate waters protection in a limited, hydrologically-related area in which waters protection measures of the communes must be coordinated.2 the rdp determines in particular:a.the locations of waste water treatment plants and areas which are to be joined to them;b.which and to what extent surface waters are suitable for the discharge of waste water, particularly that arising from precipitation;c.the waste water treatment plants for which requirements in respect of discharge of waste water must be stricter or supplemented.3 in drawing up the rdp, the authorities shall take account of spatial requirements of waters, flood protection and measures for waters protection other than waste water treatment.4 the rdp is mandatory for planning and establishing of waters protection measures in communes.5 it shall be accessible to the public.art. 5 communal drainage planning 1 the cantons shall ensure that general drainage plans (gdp) are drawn up which guarantee adequate waters protection in communes and effective drainage of housing areas.2 the gdp shall specify as a minimum:a.waste water treatment areas that must be served by public sewers;b.areas in which precipitation water running off built-up or sealed surfaces must be disposed of separately from other waste water;c.areas in which non-polluted waste water must be allowed to infiltrate;d.areas in which non-polluted waste water must be discharged into surface waters;e.measures by which non-polluted waste water with permanent flow must be kept away from waste water treatment plants;f.the locations where waste water treatment plants must be set up, and with which treatment system and with what capacity; g.areas in which systems other than waste water treatment plants must be used, and how, in these areas, waste water is to be disposed of.3 the gdp shall be adjusted if necessary:a.to take account of developments in housing areas;b.if a rdp is drawn up or changed.4 it shall be accessible to the public.section 3 discharge of polluted waste water art. 6 discharge into waters 1 the authorities shall authorise the discharge of polluted waste water into surface waters, drainage areas, underground rivers and streams if the requirements on discharge into waters according to annex 3 are complied with.2 they shall set additional or stricter requirements, if:a.the waters concerned by the discharge of waste water do not fulfil water quality requirements according to annex 2 or if this is necessary to comply with international agreements or decisions; andb.on the basis of investigation (art. 47) it is certain that deficient water quality is largely due to discharge of waste water, and procedures necessary to comply are not disproportionate for the waste water treatment plant.3 they may set additional or stricter requirements if the water quality according to annex 2 is not sufficient for a specific use of the body of water concerned.4 they may apply less stringent requirements if:a.by reducing the amounts of waste water discharged, fewer potential water pollutants are discharged even though the concentrations allowed are higher; orb.the environment as a whole is less impaired by the discharge of non-recyclable substances in industrial waste water than by another method of disposal; requirements on water quality according to annex 2 and international agreements or decisions must be complied with.art. 7 discharge into public sewers 1 the authorities shall authorise discharge of waste water from industry according to annex 3.2 or of other waste water according to annex 3.3 into public sewers if the requirements of the relevant annex are complied with.2 they shall set additional or stricter requirements if by discharge of waste water:a.operation of public sewers may be restrict or disrupted; b.in the case of waste water from the central waste water treatment plant, the requirements on discharge into a body of water are not met or may only be met by disproportionate measures, or could restrict or disrupt the operation of the plant in another way; orc.8.d.the operation of the plant in which sludge is incinerated may restricted or disrupted.3 they may apply less stringent requirements if:a.by reducing the amounts of waste water discharged, fewer potential water pollutants are discharged even though the concentrations allowed are higher; orb.the environment as a whole will be less impaired by the discharge of non-recyclable substances in industrial waste water than by another disposal method, and in the case of waste water from the central waste water treatment plant, requirements on discharge into a body of water are met; orc.this is appropriate for the operation of the waste water treatment plant.8 repealed by no i of the o of 4 nov. 2015, with effect from 1 jan. 2016 (as 2015 4791).art. 8 infiltration 1 the infiltration of polluted waste water is prohibited.2 the authorities may authorise the infiltration of communal waste water or of other polluted waste water of comparable composition, if:a.the waste water has been treated and meets the requirements for discharge into waters;b.in the case of the groundwater concerned, water quality requirements according to annex 2 are met after infiltration of the waste water;c.infiltration ensues at an installation intended for the purpose, the directives of the soilpo9 are not exceeded even in the long term, or in the absence of directives soil fertility is also guaranteed in the long term; andd.requirements valid for waste water treatment plants which discharge waste water into a body of water are met (arts. 13-17).9 sr 814.12art. 9 waste water of specific origin 1 polluted waste water occurring outside public sewers for which neither discharge into waters, nor infiltration, nor use combined with farm manure (art. 12 para. 4 wpa) is permitted must be collected in a cesspit which is regularly emptied with its contents being transferred to a central waste water treatment plant or facility for special treatment. 2 waste water from processing farm manure, hydroponics and other horticultural methods must be used in an environmentally compatible manner and reused agriculturally or horticulturally according to the state of the art.3 waste water from mobile sanitation facilities must be collected and may be discharged into public sewers only by using equipment intended for this purpose. excluded from this are sanitation facilities in:a.railway carriages with their own waste water treatment facilities;b.railway carriages for long-distance traffic which were commissioned before 1 january 1 1997;c.railway carriages for regional or urban traffic which were commissioned before 1 january 2000.art. 10 prohibition of waste disposal with waste water it is prohibited:a.to dispose of solid and liquid wastes with waste water unless this is expedient for treatment of waste water;b.to discharge substances in a way which is contrary to instructions on the manufacturer's label or in the directions for use.section 4 construction and operation of waste water treatment plants art. 11 separation of waste water in buildings during construction or substantial building alterations, the persons responsible for the buildings must ensure that precipitation water and permanent flows of non-polluted waste water are channelled off separately from polluted waste water prior to reaching the outside of the building. art. 12 connection to sewers 1 the discharge of polluted waste water into public sewers outside building zones (art. 11 para. 2 let. c wpa) is:a.expedient if the connection may be constructed properly and with standard building expenditure;b.reasonable if the costs of the connection do not substantially exceed those for comparable connections within the building zone.2 the authorities may only authorise new discharges of permanent flows of non-polluted waste water into a central waste water treatment plant (art. 12 para. 3 wpa) if local conditions do not permit infiltration or discharge into a body of water3 in order for a farm to qualify for exemption from the bond to be connected to the public sewers (art 12 para. 4 wpa), its cattle and pig stock must comprise at least eight livestock units.art. 13 expert operation 1 persons responsible for waste water treatment plants must:a.maintain the facilities in working order;b.identify cases of divergence from normal operation, clarify the causes and immediately rectify these;c.during operation take all reasonable measures to contribute to reducing the amount of substances discharged.2 persons responsible for enterprises discharging industrial waste water into public sewers as well as persons responsible for waste water treatment plants discharging waste water into the public sewers or into a body of water must ensure that:a.those responsible for the operation are named;b.operating staff possess the necessary expert knowledge; andc.that amounts and concentrations of substances discharged are determined if the authorisation contains numerical requirements.3 under paragraph 2, the authorities may require that owners:a.determine the amounts and concentrations of substances discharged which would influence the quality of the polluted water and of the receiving waters by virtue of their properties, quantity and period of discharge, even if the authorisation contains no numerical requirements;b.conserve certain waste water test results for an appropriate period;c.determine the effects of waste water discharge or infiltration on water quality if there is a risk that the water quality requirements under annex 2 are not complied with. 4 the amounts and concentrations of substances discharged may be determined arithmetically on the basis of substance flows.art. 14 operational reports 1 persons responsible for enterprises that discharge industrial waste water into public sewers and persons responsible for waste water treatment plants who discharge waste water into public sewers or into a body of water must report to and as instructed by the authorities:a.the amount of waste water discharged;b.the amounts and concentrations of substances discharged which they must determine according to article 13.2 persons responsible for central waste water treatment plants must also report: a.important operating data such as degree of effectiveness, quantity and characteristics of sludge, type of sludge disposal, energy consumption and operating costs;b.conditions in the catchment area of the plant, such as connection rate and the percentage of non-polluted waste water with permanent flow.art. 15 supervision by the authorities 1 the authorities shall examine periodically whether:a.enterprises which discharge industrial waste water into public sewers, and waste water treatment plants which discharge waste water into public sewers or into a body of water are complying with the requirements set out in the authorisation;b.these requirements continue to guarantee adequate waters protection.2 for this purpose, they shall take account of the results of the assessments made by the person responsible.3 they shall adjust the authorisations if necessary and order the required measures. in doing so, they shall take account of the urgency of the required measures, as well as the obligations resulting from international agreements or decisions.art. 16 measures with reference to exceptional events 1 the persons responsible for waste water treatment plants that discharge waste water into a body of water and persons responsible for enterprises who discharge industrial waste water into a waste water treatment plant must take appropriate and economically acceptable measures to reduce the risk of pollution of a body of water arising from exceptional events.2 if in spite of these measures the risk is unacceptable, the authorities shall order the necessary additional measures.3 regulations in the major accidents ordinance of 27 february 199110 and the ordinance of 20 november 199111 on the guarantee of drinking water supplies in emergencies that go further are reserved.10 sr 814.01211 sr 531.32art. 17 reporting on exceptional events 1 persons responsible for waste water treatment plants that discharge waste water into a body of water must ensure that any event which is exceptional is reported immediately to the authorities, if such an event or events could lead to a situation in which it is no longer possible to guarantee compliance with the regulations on the discharge of waste water into a body of water or the intended use or disposal of sludge.2 persons responsible for enterprises that discharge industrial waste water must ensure that exceptional events are immediately reported to the owner of the waste water treatment plant if these could lead to a situation in which the normal, orderly operation of the water or waste water treatment plant is restricted or disrupted.3 the authorities shall ensure that the communities and individuals affected by an exceptional event are informed about possible harmful effects on waters in due time. if substantial effects may be expected beyond cantonal or national boundaries, they shall also ensure that the federal alarm centre, as well as the neighbouring cantons and states are notified.4 .125 reporting and information obligations arising from the major accidents ordinance are reserved.12 repealed by no i of the o of 4 nov. 2015, with effect from 1 jan. 2016 (as 2015 4791).chapter 3 disposal of sludge art. 18 sludge disposal plan 1 the cantons shall draw up a sludge disposal plan and bring it into line with the new requirements within the deadlines imposed by experts.2 the disposal plan sets the following as a minimum:a.how sludge from the central waste water treatment plants should be disposed of;b.which procedures, including construction and modification of installations used for disposal of sludge, are required at what time.3 the sludge disposal plan shall be accessible to the public.art. 19 storage facilities 1 persons responsible for waste water treatment plants shall ensure that they can store the sludge until environmentally compatible disposal is guaranteed.2 if sludge from a waste water treatment plant cannot be disposed of in an environmentally compatible manner at any time, the plant must have a storage capacities of at least two months.133 .1413 amended by annex no 1 of the o of 26 march 2003, in force since 1 oct. 2006 (as 2003 940). 14 repealed by annex no 1 of the o of 26 march 2003, with effect from 1 oct. 2006 (as 2003 940).art. 20 inspection and obligation to report 1 persons responsible for waste water treatment plants must ensure that the quality of sludge is inspected within the deadlines imposed by experts.2 .153 .1615 repealed by no i of the o of 18 oct. 2006, with effect from 1 jan. 2007 (as 2006 4291).16 repealed by no i of the o of 4 nov. 2015, with effect from 1 jan. 2016 (as 2015 4791).art. 21 supply 1 persons responsible for central waste water treatment plants must keep a record of recipients of sludge, the amount supplied, type of disposal declared and time of supply and retain this information for at least ten years and make it available to the authorities on request.2 .173 .184 they may only dispose of sludge other than as planned in the cantonal sludge disposal plan with the agreement of cantonal authorities. if sludge is to be disposed of in another canton, the cantonal authorities shall consult the authorities of the receiving canton in advance.17 repealed by no i of the o of 4 nov. 2015, with effect from 1 jan. 2016 (as 2015 4791).18 repealed by annex 3 no ii 4 of the o of 22 june 2005 on movements of waste, with effect from 1 jan. 2006 (as 2005 4199).chapter 4 requirements for animal husbandry farms art. 22 animal husbandry farms the following are deemed to be animal husbandry farms (art. 14 wpa):a.farms and farming co-operatives that keep livestock;b.other enterprises involved in commercial animal husbandry; enterprises which keep zoo and circus animals or individual draft or riding animals or pets are excepted.art. 23 livestock units (lu) the calculation for converting the number of livestock on any enterprise into lu (art. 14 para. 4 wpa) is based on the quantity of manure produced by them annually. for one lu, this quantity is taken as containing a total of 105 kg of nitrogen and 15 kg of phosphorus. art. 24 normal local farming area 1 the normal local farming area (art. 14 para. 4 wpa) is the agricultural land located within 6 km by road from the livestock buildings in which the farm manure is produced.192 in order to take account of local farming conditions, the cantonal authorities may reduce or extend this limit by a maximum of 2 km.19 amended by annex 9 no 2 of the direct payments ordinance of 23 oct. 2013, in force since 1 jan. 2014 (as 2013 4145).art. 25 exceptions to the requirements relating to agricultural land 1 farms that keep poultry or horses and farms serving the public interest need not have their own or leased agricultural land on which at least half of the farm manure accumulating in the enterprise can be used if it is guaranteed that the farm manure will be used by an organisation or another farm.202 .213 farms serving the public interest (art. 14 para. 7 let. b wpa) are:a.farms that serve experimental, research or development purposes (research institutes, university farms, performance testing institutions, insemination stations, etc.);b.22pig farms that cover at least 25 per cent of the energy needs of pigs with food by-products that come from milk processing;c.23pig farms that cover at least 40 per cent of the energy needs of pigs with food by-products that do not come from milk processing;d. 24pig breeding enterprises that cover at least 40 per cent of the energy needs of pigs with food by-products that come both from milk processing and not from milk processing.4 in mixed animal husbandry farms, the exception under paragraph 1 applies only to that part of the animal husbandry that fulfils conditions for granting an exception.255 the cantonal authorities shall in each case grant an exception under paragraph 1 for a duration of five years at most.2620 amended by annex 9 no 2 of the direct payments ordinance of 23 oct. 2013, in force since 1 jan. 2014 (as 2013 4145).21 repealed by annex 9 no 2 of the direct payments ordinance of 23 oct. 2013, with effect from 1 jan. 2014 (as 2013 4145).22 amended by no ii of the o of 27 oct. 2010, in force since 1 jan. 2011 (as 2010 5881). see also the transitional provision of this modification at the end of the text.23 amended by no iii of the o of 25 may 2011, in force since 1 july 2011 (as 2011 2407).24 inserted by no iii of the o of 25 may 2011, in force since 1 july 2011 (as 2011 2407). see also the transitional provision of this modification at the end of the text.25 amended by annex 9 no 2 of the direct payments ordinance of 23 oct. 2013, in force since 1 jan. 2014 (as 2013 4145).26 amended by annex 9 no 2 of the direct payments ordinance of 23 oct. 2013, in force since 1 jan. 2014 (as 2013 4145).art. 26 and 2727 27 repealed by annex 9 no 2 of the direct payments ordinance of 23 oct. 2013, with effect from 1 jan. 2014 (as 2013 4145).art. 28 inspection of storage facilities for farm manure and liquid digestate28 1 the cantonal authorities shall ensure that storage facilities for farm manure and liquid digestate are regularly inspected; the frequency of the inspections shall correspond to the risk of pollution to the waters.292 the following shall be inspected:a.whether the prescribed storage capacity is available;b.whether the storage facilities (including pipes) leak;c.whether facilities are in working order;d.whether the facilities are operated in accordance with the regulations.28 amended by annex 9 no 2 of the direct payments ordinance of 23 oct. 2013, in force since 1 jan. 2014 (as 2013 4145).29 amended by annex 9 no 2 of the direct payments ordinance of 23 oct. 2013, in force since 1 jan. 2014 (as 2013 4145).chapter 5 protection for waters in terms of area planning art. 29 designation of water protection areas and determination of groundwater protection zones and areas 1 when dividing their territory into water protection areas (art. 19 wpa), the cantons shall indicate those at particular risk and the other areas. those described in annex 4 number 11 as at particular risk include:a.water protection area au for the protection of exploitable underground waters;b.water protection area ao for the protection of water quality of surface waters if this is required to guarantee a specific use of a body of water;c.the area of contribution zu intended for the protection of water quality at existing and planned groundwater wells serving the public interest if the water is polluted by substances which are not sufficiently degraded or retained, or if there is a genuine risk of pollution by such substances;d.30the area of contribution zo intended for the protection of water quality of surface waters if water is polluted by run-off of pesticides or nutrients.2 they shall designate groundwater protection zones (art. 20 wpa) described in annex 4 number 12 in order to protect groundwater wells and groundwater recharge installations serving the public interest. they may designate groundwater protection zones even for planned wells and recharge installations serving the public interest, the locations of which and amount of withdrawals from which are established.3 they shall designate the groundwater protection areas described in annex 4 number 13 (art. 21 wpa) in order to protect the underground waters planned for use.4 they shall base their decisions on the designation of water protection areas and groundwater protection zones and areas on existing hydro-geological findings. if these are not sufficient, they shall ensure that the required hydro-geological investigations are conducted.30 amended by no ii 9 of the o of 18 may 2005 on the repeal and amendment of ordinances in connection with the commencement of the chemicals act, in force since 1 aug. 2005 (as 2005 2695).art. 30 water protection maps 1 the cantons shall draw up waters protection maps and adjust these as necessary. the waters protection maps shall indicate as a minimum:a.water protection areas;b.groundwater protection zones;c.groundwater protection areas; d.groundwater outflow points, wells and recharge installations that are of significance for water supply.2 the waters protection maps shall be accessible to the public. the cantons shall provide the federal office for the environment (foen) and neighbouring cantons concerned with the waters protection maps and their annual modifications in digital form.3131 amended by no i of the o of 4 nov. 2015, in force since 1 jan. 2016 (as 2015 4791).art. 31 protection measures 1 any person who constructs or alters installations or carries out activities which represent a risk to waters in areas particularly at risk (art. 29 para. 1) as well as in groundwater protection zones and areas must take all measures expedient for the protection of the waters according to the circumstances and in particular must:a.take the measures required under annex 4 number 2;b.set up the necessary monitoring, alarm and stand-by arrangements.2 the authorities shall ensure that: a.for existing installations in areas under paragraph 1, where there is a genuine risk of pollution of the waters, measures to protect waters, especially those under annex 4 number 2, are taken, according to circumstances;b.existing installations in groundwater protection zones s1 and s2 that endanger a groundwater well or a recharge installation are removed within an appropriate period of time, and that until removal of these installations other measures for protecting the drinking water are taken, in particular disinfection or filtration.art. 32 authorisations for installations and activities in areas particularly at risk 1 .322 in the areas particularly at risk (art. 29) an authorisation is especially required for:33a.underground buildings;b.installations which damage protective layers or aquicludes;c.using the groundwater (including use for heating or cooling purposes);d.permanent drainage and irrigation;e.exposure of the groundwater table;f.drillings;g.34storage installations for liquid manure and liquid digestate;h.35storage installations for liquids that may pollute waters already in small quantities and with a usable volume of more than 2000 l per storage tank;i.36storage installations for liquids that may pollute waters in groundwater protection zones and areas with a usable volume of more than 450 l;j.37transhipment areas for liquids which may pollute waters.3 if authorisation is required, the applicant must prove that the requirements for protection of waters are fulfilled and provide the documents necessary for this (if necessary hydro-geological investigations).4 the authorities shall grant an authorisation if adequate protection of waters can be guaranteed subject to conditions and requirements. it shall also lay down requirements for decommissioning the installations.32 repealed by no i of the o of 18 oct. 2006, with effect from 1 jan. 2007 (as 2006 4291).33 amended by no i of the o of 18 oct. 2006, in force since 1 jan. 2007 (as 2006 4291).34 inserted by no i of the o of 18 oct. 2006 (as 2006 4291). amended by annex 9 no 2 of the direct payments ordinance of 23 oct. 2013, in force since 1 jan. 2014 (as 2013 4145).35 inserted by no i of the o of 18 oct. 2006, in force since 1 jan. 2007 (as 2006 4291).36 inserted by no i of the o of 18 oct. 2006, in force since 1 jan. 2007 (as 2006 4291).37 inserted by no i of the o of 18 oct. 2006, in force since 1 jan. 2007 (as 2006 4291).art. 32a38 inspection of storage installations for liquids which may pollute waters 1 the persons responsible for storage installations for liquids that may pollute waters that require authorisation must arrange for an external visual inspection to be conducted every ten years in order to check for defects.392 an internal visual inspection must be conducted every ten years for:a.storage tanks with more than 250 000 l usable volume that do not have a protective construction or a double-walled floor;b.single-walled underground storage tanks.3 the persons responsible must arrange for the inspection of the proper functioning of the leak detection system in storage installations for liquids which may pollute waters every two years in the case of double-walled containers and pipes and every year in the case of single-walled containers and pipes.38 inserted by no i of the o of 18 oct. 2006, in force since 1 jan. 2007 (as 2006 4291).39 amended by no i of the o of 4 nov. 2015, in force since 1 jan. 2016 (as 2015 4791).chapter 6 maintaining appropriate rates of residual water flow art. 33 water withdrawals from watercourses 1 for withdrawals from watercourses (art. 29 wpa) which comprise stretches with permanent flow and others without permanent flow, a permit is required if the site of the water withdrawal shows permanent flow. the conditions for granting the permit must be fulfilled only in the stretches with a permanent flow (art. 30 wpa).2 if the waters at the site of water withdrawal shows no permanent flow, the authorities shall ensure that the required measures under federal act of 1 july 196640 on the protection of nature and cultural heritage and the federal act of 21 july 199141 on fish and fisheries are taken.40 sr 45141 sr 923.0art. 33a42 ecological potential when determining the ecological potential of a body of water, consideration shall be given to the following:a.the ecological importance of the body of water in its current state;b.the potential ecological importance of the body of water in a state in which the man-made harm is eliminated to the extent possible at a reasonable cost.42 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).art. 34 protection and utilisation plan 1 the authorities shall file the application for the approval of a protection and utilisation plan (art. 32 let. c wpa) with the foen43.2 the application shall contain:a.the protection and utilisation plan decided on;b. the justification why the measures planned represent sufficient compensation for a lower minimum residual flow;c. information on how the planned measures should be made binding on all concerned for the duration of the license.3 compensatory measures in the context of the protection and utilisation plan are deemed appropriate if they serve to protect waters or the habitats depending on it. measures that would be necessary in any case, according to federal regulations on environmental protection, are not taken into consideration.43 term in accordance with no i 13 of the o of 7 nov. 2007 on the new system of fiscal equalisation and the division of tasks between the confederation and the cantons, in force since 1 jan. 2008 (as 2007 5823). this amendment has been made throughout the text.art. 35 residual flow report 1 for water withdrawals which are subject to an environmental impact assessment (eia), the residual flow report is part of the environmental impact report (art. 33 para. 4 wpa).2 for water withdrawals on which the federal government must be consulted and which are not subject to an eia, the authorities shall ensure that the opinion of the cantonal expert body on the residual water report or on an amended draft thereof is made available to the foen. the foen may limit itself to making a summary review of the documents.4444 amended by no i 1 of the o of 29 june 2011 on the amendment of ordinances in the environment sector, in force since 1 aug. 2011 (as 2011 3379).art. 36 inventory of existing water withdrawals 1 for water withdrawals serving installations using water power, the inventory shall include (art. 82 para. 1 wpa) as a minimum:a.a description of the water withdrawal and restitution (names, co-ordinates, height above sea level and, where appropriate, names of power stations and dams);b.the beginning and duration of the right of use granted, its extent, in particular the amount of water extractable in m3/s as well as the name of the person entitled to extract (the user);c.the removable amount of water in m3/s;d.the residual flow maintained previously with details of the location or the water endowment flow in l/s;e.other obligations to transfer water imposed on the user;f.the participation of the user in maintaining and correcting the waters;g.further conditions or installations in the interests of waters protection and fisheries;h.the q347 flow rate, the flow regime of the watercourse upstream of the water withdrawal point and the amount withdrawn every month in m3/s, expressed as the average over several years, to the extent that this data is available at the time the inventory is drawn up;i.whether the water is withdrawn from a watercourse flowing through landscapes or habitats which are listed in the national or cantonal inventories.2 for withdrawals using fixed non-hydropower equipment which may be authorised under article 30 letter a wpa, the inventory shall as a minimum state the purpose of the withdrawal and the information in paragraph 1, letters a, b, d, h, and i.3 for withdrawals using fixed non-hydropower equipment which may be authorised under article 30 letters b or c wpa, the inventory shall state the information in paragraph 1 letters a and b.art. 37 list of water withdrawals not listed in the inventory the cantons shall draw up a list of withdrawals for the use of water power from watercourses without permanent flow.art. 38 remediation report 1 for every withdrawal of water listed in the inventory under article 36 paragraphs 1 and 2, the remediation report (art. 82 para. 2 wpa) shall indicate whether the watercourse requires remediation; if this is the case, the report indicates the reasons for such remediation, its extent and the period of time forecast to implement it.2 for every water withdrawal, the report contains in particular:a.the description of the water withdrawal and return (names, co-ordinates, height above sea level and, where appropriate, names of any power stations or dams);b.the rate of q347 flow;c.data relating to the flow regime of the watercourse upstream of the water withdrawal point and in the stretch of residual water flow;d.the amount withdrawn every month in m3/s expressed as the average over several years.3 for water withdrawals where remediation is necessary, the report shall also contain information on:a.remediation measures which may be imposed without infringing rights of use which justify a claim for compensation by the user (art. 80 para. 1 wpa);b.more extensive remediation measures which are necessary because of overriding public interests (art. 80 para. 2 wpa); for watercourses flowing through landscapes or habitats which are listed in national or cantonal inventories, the report shall name the special requirements for the watercourse arising from the protection targets defined in the inventory;c.type of remediation measures (higher levels of water endowment, structural, operational and other measures);d.the expected schedule for completion of the remediation measures.art. 39 information obligation 1 the user must provide the authorities with the information required to draw up the inventory and the remediation report.2 the authorities may require the user to carry out flow measurements.art. 40 submission, updating and accessibility of inventories, lists and remediation reports 1 the cantons shall submit the inventories, lists and remediation reports to the foen.2 they shall update the inventories and lists.3 they shall ensure that the inventories, lists and remediation reports are made accessible to the public after consulting those concerned. business secrecy shall be preserved.art. 41 water withdrawals under licences already granted articles 36-40 apply by analogy to planned water withdrawals for which a licence was granted before the entry into force of the waters protection act (art. 83 wpa).chapter 7 prevention and remediation of other harmful effects on waters45 45 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).section 146 space provided for waters and rehabilitation of watercourses 46 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955). see also the transitional provision of this modification at the end of the text.art. 41a space provided for watercourses 1 in biotopes of a national importance, in cantonal nature conservation areas, in mire landscapes of exceptional beauty and national importance, in water bird and migratory bird reserves of international or national importance and, in the case of waters-related protection targets, in landscapes of national importance and cantonal landscape conservation areas the width of the space provided for waters must amount to at least:a.for watercourses with a channel bed of less than 1 m natural width: 11 m;b.for watercourses with a channel bed of 1-5 m natural width: 6 times the width of the channel bed plus 5 m;c.for watercourses with a channel bed of more than 5 m natural width: the width of the channel bed plus 30 m.2 in other areas, the width of the space provided for waters must amount to at least:a.for watercourses with a channel bed of less than 2 m natural width: 11 m;b.for watercourses with a channel bed of 2-15 m natural width: 2.5 times the width of the channel bed plus 7 m.3 the width of the space provided for waters calculated in accordance with paragraphs 1 and 2 must be increased where this is required to guarantee:a.protection against flooding;b.the space required for rehabilitation;c.the protection targets for watercourses under paragraph 1 and other overriding interests of nature and landscape conservation;d.a use of the waters.4 provided protection against flooding is guaranteed, the width of the space provided for waters may be adapted:a.to the structural conditions in densely built-up areas;b.to the topographic conditions on stretches of waters:1.in which the waters largely fill the valley floor, and2.that have slopes on both sides that are too steep to permit farming activities.475 in the absence of any overriding interests to the contrary, determining the space provided for waters may be dispensed with if the waters:a.are located in forest or in areas, that are not designed mountain- or valley areas in accordance with the agriculture legislation in the arable land register; b.are culverted;c.are artificially laid out; ord.48are very small.47 amended by no i of the o of 22 march 2017, in force since 1 may 2017 (as 2017 2585).48 inserted by no i of the o of 22 march 2017, in force since 1 may 2017 (as 2017 2585).art. 41b space provided for standing waters 1 the width of the space provided for waters must amount to at least 15 m measured from the shoreline.2 the width of the space provided for waters calculated in accordance with paragraphs 1 must be increased where this is required to guarantee:a.protection against flooding;b.the space required for rehabilitation;c.overriding interests of the nature- and landscape conservation;d.the use of the waters.3 the width of the space provided for waters may be adapted to the structural conditions in densely built-up areas provided protection against flooding is guaranteed.4 in the absence of any overriding interests to the contrary, determining the space provided for waters may be dispensed with if the waters:a.are located in forest or in areas, that are not designed mountain- or valley areas in accordance with the agriculture legislation in the arable land register; b.have a surface area of less than 0.5 ha; orc.are artificially laid out.art. 41c extensive structuring and management of the space provided for waters 1 in the space provided for waters, only fixed installations serving the public interest such as footpaths and hiking trails, run-of-river power plants or bridges may be built. the authority may authorise the following installations provided there are no overriding interests to the contrary:in densely built-up areas, installations that meet zoning requirements;abis.49installations that meet zoning requirements outside densely built-up areas on individual plots of ground that have not been built on within a series of several plots of ground that have been built on;b.agricultural and forestry tracked and gravel paths with a distance of at least 3m from the shoreline of the waters if topographically limited spatial conditions pertain;c.fixed parts of installations that aid water withdrawal or discharge;d.50small installations that serve the use of the waters.512 the continued existence of installations and permanent crops in terms of article 22 paragraph 1 letters a-c, e and g-i of the agricultural terms ordinance of 7 december 199852 in the space provided for waters that are lawfully constructed and useable as intended is in principle protected.533 no fertilisers and plant health products may be used in the space provided for waters. individual treatments of problem plants are permitted outside a 3-metre wide strip along the bank where these cannot be controlled mechanically at a reasonable cost.4 the space provided for waters may be used for agricultural purposes if it is used in accordance with the requirements of the direct payments ordinance of 23 october 201354 as straw fields, hedgerows, field or riparian woodland, riparian meadow along watercourses, extensively used meadow, extensively used pasture ground or wooded pasture ground. these requirements also apply to the use of areas outside the agricultural land in use.554bis if in the case of roads and paths with a base layer or railway lines that run alongside waters the space provided for waters on the land side extends only a few metres beyond the transport infrastructure, the authority may authorise exceptions from the management restrictions in paragraphs 3 and 4 for the part on the land side provided no fertilisers or plant health products can enter the water.565 measures against natural erosion of the banks of a watercourse are permitted only if required for protection against flooding or to prevent an unreasonable loss of agricultural land.6 the following do not apply:a.paragraphs 1-5 to that part of the space provided for waters that exclusively serves to guarantee the use of the waters;b.paragraphs 3 and 4 to the space provided for culverted waters.49 inserted by no i of the o of 22 march 2017, in force since 1 may 2017 (as 2017 2585).50 inserted by no i of the o of 22 march 2017, in force since 1 may 2017 (as 2017 2585).51 amended by no i of the o of 4 nov. 2015, in force since 1 jan. 2016 (as 2015 4791).52 sr 910.9153 amended by no i of the o of 4 nov. 2015, in force since 1 jan. 2016 (as 2015 4791).54 sr 910.1355 amended by annex 9 no 2 of the direct payments ordinance of 23 oct. 2013, in force since 1 jan. 2014 (as 2013 4145).56 inserted by no i of the o of 22 march 2017, in force since 1 may 2017 (as 2017 2585).art. 41cbis 57 farming land with the quality of crop rotation areas in the space provided for waters 1 arable farming land with the quality of crop rotation areas in the space provided for waters must be shown separately by the cantons when making the inventory of crop rotation areas in accordance with article 28 of the spatial planning ordinance of 28 june 200058. it may continue to be included in the cantonal minimum of crop rotation areas. if a related federal decree is issued (art. 5 wpa), these areas may be intensively farmed in emergency situations.2 alternative land must be provided in accordance with the sectoral plan for crop rotation areas (art. 29 of the spatial planning ordinance of 28 june 2000) in compensation for arable farming land with the quality of crop rotation areas in the space provided for waters that is required to implement structural flood protection or rehabilitation measures.57 inserted by no i of the o of 4 nov. 2015 (as 2015 4791). amended by no i of the o of 22 march 2017, in force since 1 may 2017 (as 2017 2585).58 sr 700.1art. 41d planning of rehabilitation projects 1 the cantons shall devise the principles required to plan the rehabilitation of watercourses. the principles shall include information on the following in particular:a.the ecomorphological condition of the waters;b.the installations in the space provided for waters;c.the ecological potential and the agricultural importance of the waters.2 they shall set out in a plan for a period of 20 years the stretches of water to be rehabilitated, the form of the rehabilitation measures and the deadlines by which the measures must be implemented, and shall coordinate the plan with the neighbouring cantons to the extent that this is required. rehabilitation projects shall primarily be planned where their benefits:a.are substantial for nature and the landscape;b.are substantial compared with the probable cost;c.may be increased through coordination with other measures to protect natural habitats or to prevent flooding.3 they shall adopt the plans under paragraph 2 for watercourses by 31 december 2014 and for standing waters by 31 december 2022. they shall submit the plans to the foen one year before their adoption so that the foen may comment thereon.594 they shall renew the plans under paragraph 2 every 12 years for a period of 20 years and shall submit these plans to the foen one year before their adoption so that the foen may comment thereon.59 amended by no i 4 of the o of 28 jan. 2015 on amendments to ordinance law on the environment, in particular in relation to the programme agreements for the programme period 2016-2019, in force since 1 jan. 2016 (as 2015 427).section 260 hydropeaking 60 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955). art. 41e serious harm due to hydropeaking there is serious harm to indigenous flora and fauna and to their habitats due to hydropeaking where:a.the flow rate for upsurge is at least 1.5 times greater than for downsurge; andb.the site-specific quantity, composition and diversity of the plant and animal communities are changed to their detriment, in particular because regularly and in an unnatural manner fish are run ashore, fish spawning grounds are destroyed, aquatic animals are washed away, turbidity arises or the water temperature is altered in an unlawful manner.art. 41f planning remediation measures for hydropeaking 1 the cantons shall submit to the foen a plan for measures to remediate hydropower plants that cause hydropeaking in accordance with the procedure described in annex 4a number 2.2 the persons responsible for hydropower plants must grant access to the authority responsible for the plan and provide the required information, in particular on:a.the coordinates and the designation the individual parts of the plant;b.the flow rates of the watercourse concerned with measured values at intervals of no more than 15 minutes (hydrograph) over a period covering the past five years; if these measured values are not available, the hydrograph may be calculated using data relating to hydro-electric power production at the plant and the water flow;c.the measures carried out and planned to reduce the effects of hydropeaking;d.the available results of the study on the effects of hydropeaking;e.the planned structural and operational changes at the plant.art. 41g remediation measures for hydropeaking 1 based on the measures plan, the cantonal authority shall order the remediation of hydropeaking and require the persons responsible for hydropower plants to examine various types of remediation measure in order to implement the plan.2 before it decides on the remediation project, it shall consult the foen. with a view to an application under article 30 paragraph 1 of the energy ordinance of 1 november 201761 (eno), the foen shall verify whether the criteria of annex 3 number 2 eno are met.623 the persons responsible for hydropower plants shall verify the effectiveness of the measures taken as required by the authority.61 sr 730.0162 second sentence amended by annex 7 no ii 2 of the energy ordinance of 1 nov. 2017, in force since 1 jan. 2018 (as 2017 6889).section 3 flushing out and emptying of impoundments63 63 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955). art. 42 .64 1 before an authority authorises the flushing out or emptying of an impoundment, it shall ensure that sediments are removed other than by washing away if this is environmentally compatible and economically acceptable.2 when washing away sediments the authorities shall ensure that communities of plants, animals and micro-organisms are harmed as little as possible, in particular by laying down:a.time and type of flushing out or emptying;b.the maximum concentration of suspended matter in the water which must be respected during the flushing out or emptying;c.to what extent washing away must be carried out so that during the flushing out or emptying, fine matter deposited in watercourses is removed.3 paragraphs 1 and 2 do not apply to the abrupt lowering of the water level following an exceptional event (art. 40 para. 3 wpa).64 repealed by no i of the o of 4 may 2011, with effect from 1 june 2011 (as 2011 1955).section 4 bed load budget65 65 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955). art. 42a66 serious harm due to change in the bed load budget a change in the bed load budget causes serious harm to the indigenous flora and fauna and their habitats if installations such as hydropower plants, gravel excavation sites, bed load traps or river control structures alter the morphological structures or the morphological dynamics of the waters to their detriment.66 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).art. 42b67 planning the measures to remediate the bed load budget 1 the cantons shall submit a plan to the foen of their measures to remediate the bed load budget in accordance with the procedure described in annex 4a number 3.2 the persons responsible for installations must allow access to the authority responsible for the plan and provide the required information, in particular on:a.the details and the designation of the installations and in the case of hydropower plants the individual parts of the installation;b.how the bed load is dealt with;c.the measures carried out and the planned in order to improve the bed load budget;d.the available results of the study of the bed load budget;e.the planned structural and operational changes to the installation.67 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).art. 42c68 measures to remediate the bed load budget 1 in the case of installations which according to the plan require measures to remediate the bed load budget, the cantons shall prepare a study on the nature and extent of the required measures.2 based on the study, the cantonal authority shall in accordance with paragraph 1 order the remediation measures. in the case of hydropower plants, the bed load must wherever possible be made to pass through the installation.3 before it decides on the remediation project in the case of hydropower plants, it shall consult the foen. the foen shall examine with a view to an application under article 30 paragraph 1 eno69 whether the criteria of annex 3 number 2 eno are met.704 the persons responsible for hydropower plants shall verify the effectiveness of the measures taken in accordance with instructions from the cantonal authority.68 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).69 sr 730.0170 second sentence amended by annex 7 no ii 2 of the energy ordinance of 1 nov. 2017, in force since 1 jan. 2018 (as 2017 6889).art. 43 extraction of gravel, sand and other materials from watercourses 1 in order that the bed load budget in a watercourse is not unfavourably influenced by extraction of gravel, sand or other materials (art. 44 para. 2 let. c wpa), the authorities must ensure that:a.the quantity of bed load extracted from the watercourse does not exceed the natural supply;b.the extraction does not in the long term lead to a subsidence of the bottom outside the extraction perimeter;c.the extraction does not render impossible the maintenance and re-establishment of inventoried floodplains;d.the extraction does not lead to a substantial change in the particle size distribution of the bottom material outside the extraction perimeter.2 extraction according to paragraph 1 should not lead to turbidity that may impair fishing waters.section 5 drainage water from underground buildings71 71 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955). art. 44 .72 1 drainage water from underground buildings must be contained and channelled off in such a way that it cannot be polluted by such construction operations, in particular by exceptional events. this does not apply to small amounts of drainage water if retention measures prevent the pollution of the receiving waters.2 for the discharge of drainage water from underground buildings into watercourses, the following applies:a.the spillway construction must be such as to ensure homogeneous and rapid mixing of the water;b.the temperature of the receiving waters must not be raised over its near as possible natural state by more than 3 c; if the stretch belongs to a trout zone, the temperature must not be raised by more than 1.5 c; c.the discharge must not result in the water temperature exceeding 25 c.3 depending on local circumstances the authorities shall specify:a.requirements for discharge into lakes and infiltration;b.additional requirements for discharge into watercourses if necessary.72 repealed by no i of the o of 4 may 2011, with effect from 1 june 2011 (as 2011 1955).chapter 8 enforcement art. 4573 enforcement by cantonal and federal authorities 1 the cantons shall enforce this ordinance unless it delegates enforcement to the confederation.2 if the federal authorities apply other federal laws, or international treaties or decisions that relate to the subject matter of this ordinance, they shall also enforce this ordinance. the cooperation of the foen and the cantonal authorities is governed by article 48 paragraph 1 wpa; statutory duties of secrecy are reserved.3 at the request of the cantons, the federal authorities shall take account of their provisions and measures, unless fulfilment of the tasks of the federal authority is thereby rendered impossible or made disproportionately difficult.4 if the federal authorities enact administrative ordinances such as guidelines or instructions that concern waters protection, they shall consult the foen.5 the federal department of the environment, transport, energy and communications (the department) may, if required, amend the lists of parameters and the numerical requirements for water quality in accordance with annex 2 number 11 paragraph 3, number 12 paragraph 5 and number 22 paragraph 2.7473 amended by no ii 12 of the o of 2 feb. 2000 to the federal act on the coordination and simplification of decision-making procedures, in force since 1 march 2000 (as 2000 703).74 inserted by no i of the o of 4 nov. 2015, in force since 1 jan. 2016 (as 2015 4791).art. 46 co-ordination75 1 where required, the cantons shall coordinate measures under this ordinance with each other and with measures in other sectors. they shall also ensure the coordination of the measures with those of neighbouring cantons.761bis they shall take account of plans under this ordinance when drawing up structure and land use plans.772 in drawing up the supply plan for drinking water, they include both groundwater resources already used and those intended for exploitation and ensure that water withdrawals are co-ordinated so that no excessive withdrawals take place and the groundwater resources are used economically. 3 in granting authorisations for discharges and infiltration under articles 6-8 the authorities shall take account of both the requirements of the environmental protection act of 7 october 198378 on public protection from odour emissions as well as the requirements of the employment act of 13 march 196479 and the accident insurance act of 20 march 198180 on protection of the health of staff at waste water treatment plants. 75 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).76 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).77 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).78 sr 814.0179 sr 822.1180 sr 832.20art. 47 procedures for polluted waters 1 if the authorities establish that a body of water does not fulfil the requirements of annex 2 on water quality or that the specific use of the body of water cannot be guaranteed they shall:a.determine and assess the type and extent of the pollution;b.determine the causes of the pollution;c.assess the effectiveness of possible measures;d.ensure that the required measures are undertaken based on the relevant regulations.2 if several sources of pollution are involved, the measures to be taken by those responsible must be coordinated.art. 48 investigations and assessments 1 investigations and assessments are subject to the recognised state of the art; in particular, the relevant standards of the european committee for standardisation (cen)81 or other standards that provide equivalent results apply. 2 insofar as this ordinance contains no regulations on the type and frequency of sampling or the assessment of compliance with requirements, the authorities shall specify such regulations on a case-by-case basis. 81 standards may be viewed free of charge or obtained for a fee from the swiss association for standardisation (snv), sulzerallee 70, 8404 winterthur; www.snv.ch.art. 49 information 1 the foen shall provide information on the state of waters and waters protection, provided this is in the interest of switzerland as a whole. in particular it shall publish reports on the state of waters protection in switzerland. the cantonal authorities shall provide the necessary information.2 the cantonal authorities shall provide information on the state of waters and waters protection in their canton. at the same time they shall also provide information on the measures taken and their impact and on bathing sites where the requirements for bathing are not met (annex 2 no 11 para. 1 let. e).8282 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).art. 49a83 geoinformation the foen shall provide specifications for the minimum geodata models and presentation models for the official geodata under this ordinance for which it is designated federal specialist authority in annex 1 to the geoinformation ordinance of 21 may 200884.83 inserted by annex 2 no 7 of the o of 21 may 2008 on geoinformation, in force since 1 july 2008 (as 2008 2809).84 sr 510.620art. 5085 85 repealed by no iii 2 of the o of 12 aug. 2015, with effect from 1 oct. 2015 (as 2015 2903).art. 51 international decisions, recommendations and commissions86 1 the department is authorised to approve decisions and recommendations that are based on the following international agreements, with the agreement of the federal department of economic affairs, education and research:87a.convention of 22 september 199288 for the protection of the marine environment of the north-east atlantic (ospar convention);b.convention of 29 april 196389 on the international commission for protection of the rhine against pollution;c.convention of 3 december 197690 on the protection of the rhine against chemical pollution.2 the foen shall supply the approved decisions and recommendations to third parties on request.3 the department shall elect members of the swiss delegations to the inter-state commissions for protection of waters.9186 amended by no ii 12 of the o of 2 feb. 2000 to the federal act on the coordination and simplification of decision-making procedures, in force since 1 march 2000 (as 2000 703).87 amended by no i of the o of 4 nov. 2015, in force since 1 jan. 2016 (as 2015 4791).88 sr 0.814.29389 [as 1965 388, 1979 93. as 2003 1934 art. 19 no 2, 3]. today: convention of 12 april 1999 on the international commission for protection of the rhine against pollution (sr 0.814.284).90 [as 1979 97, 1983 323, 1989 161. as 2003 1934 art. 19 no 2].91 inserted by fig. ii 12 of the o of 2 feb. 2000 to the federal act on the coordination and simplification of decision-making procedures, in force since 1 march 2000 (as 2000 703).chapter 8a92 federal waste water charge 92 inserted by no i of the o of 4 nov. 2015, in force since 1 jan. 2016 (as 2015 4791).art. 51a charge rate the level of the charge in accordance with article 60b wpa amounts to 9 francs per resident per annum. the charge is based on the number of residents that are connected to the waste water treatment plant on 1 january of the calendar year in which the charge is collected.art. 51b data provided by the cantons the cantons must:a.notify the foen each year by 31 march of the number of residents that are connected to each waste water treatment plant on their territory as of 1 january of the calendar year in question;b.submit to the foen by 31 october of each calendar year the final accounts with requests for compensatory payments under article 60b paragraph 2 wpa that are received by 30 september of the same calendar year.art. 51c collection of the charge 1 the foen shall invoice the charge to the subjects liable to pay by 1 june in the calendar year concerned. it shall issue a ruling on the charge in the event of any dispute over the invoice. 2 at the request of the canton, the foen may invoice the canton for the charge if the canton confirms that it collects the charge from the waste water treatment plants on its territory on the same terms as those of the foen. this request must be submitted to the foen by 31 march.3 payment must be made within 60 days of the due date. the charge becomes due on receipt of the invoice or, if the invoice is disputed, on the ruling on the charge taking full legal effect in accordance with paragraph 1. in the event of late payment, interest of 5 per cent becomes due.9393 amended by no i of the o of 22 march 2017, in force since 1 may 2017 (as 2017 2585).art. 51d time limit 1 the right to collect the charge lapses ten years from the end of the calendar year in which it arises. 2 the time limitation period is interrupted and restarted:a.if the subject liable to the charge acknowledges the right to collect it;b.by any official act by which the right to collect the charge is enforced against the subject liable to pay it.3 the right to collect the charge expires in every case 15 years from the end of the calendar year in which it arises.chapter 9 granting of federal subsidies section 194 measures 94 amended by no i 13 of the o of 7 nov. 2007 on the new system of fiscal equalisation and the division of tasks between the confederation and cantons, in force since 1 jan. 2008 (as 2007 5823). art. 52 nitrogen removal at waste water treatment plants95 1 the level of the global compensatory payments made to installations and equipment for nitrogen removal (art. 61 para. 1 wpa) is governed by the number of tonnes of nitrogen removed each year.2 insofar as it is necessary to comply with international agreements or decisions of international organisations, the extent and complexity of the measures may also be taken into account.3 the level of the global compensatory payments shall be agreed between the foen and the canton concerned.95 amended by no i of the o of 4 nov. 2015, in force since 1 jan. 2016 (as 2015 4791).art. 52a96 elimination of organic trace substances at waste water plants 1 compensatory payments in respect of measures to eliminate organic trace substances under article 61a paragraph 1 wpa shall be made to the cantons on a case-by-case basis.2 if the measure giving rise to the compensatory payment is not implemented within five years of payment being assured, the assurance is no longer valid.3 if sewers are constructed instead of installations and equipment to eliminate organic trace substances, the maximum costs attributable are those that could have arisen in the event of measures being taken at the waste water treatment plant itself.4 before the authority decides on the measure, it shall consult the foen.96 inserted by no i of the o of 4 nov. 2015, in force since 1 jan. 2016 (as 2015 4791).art. 53 waste disposal installations compensatory payments made in respect of waste disposal installations eligible for subsidies (art. 62 paras 1 and 2 wpa) shall be made on a case by case basis for planning, initial establishment and extension.art. 54 measures in agriculture 1 the level of the global compensatory payments made in respect of measures in agriculture (art. 62a wpa) is governed by the properties and the number of kilograms of the substances that are prevented from washing away or leaching each year.2 for measures that result in changes in farm structures, the level is also governed by the attributable costs.3 the level of the global compensatory payments shall be agreed between the federal office for agriculture (foag) and the canton concerned.art. 54a97 planning of rehabilitation measures 1 the level of the global compensatory payments made for planning measures to rehabilitate waters (art. 62b para. 1 wpa) is governed by the length the bodies of water to which the plan relates.2 the level of the global compensatory payments shall be agreed between the foen and the canton concerned.97 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).art. 54b98 implementation of rehabilitation measures 1 the level of the global compensatory payments for measures to rehabilitate waters (art. 62b para. 1 wpa) is governed by:a.the length of the stretch of water that is to be rehabilitated or is opened by the removal of obstructions;b.the width of the channel bed of the watercourse;c.the width of the space provided for the waters that are to be rehabilitated;d.the benefits of rehabilitation for nature and the landscape in comparison with the probable costs;e.the benefits of rehabilitation for recreation;f.the quality of the measures.2 the level of the global compensatory payments shall be agreed between the foen and the canton concerned.3 compensatory payments may be made individually if the measures:a.cost more than five million francs;b.have a supracantonal impact or concern border waters;c.affect protected zones or properties listed in national inventories;d.require a complex or special expert assessment due to the possible alternatives or for other reasons; ore.were unforeseeable.4 the contribution to the attributable costs of the measures under paragraph 3 shall amount to between 35 and 80 per cent and is governed by the criteria listed in paragraph 1.5 compensatory payments for rehabilitation shall only be granted if the canton concerned has drawn up a rehabilitation plan that meets the requirements of article 41d.6 no compensatory payments shall be granted under article 62b paragraph 1 wpa for measures required under article 4 of the federal act of 21 june 199199 on hydraulic engineering.98 inserted by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955). see also the transitional provision relating to this amendment at the end of the text.99 sr 721.100art. 55 initial procurement studies 1 compensatory payments for ascertaining the causes of inadequate water quality in an important body of water with a view to carrying out remediation measures (art. 64 para. 1 wpa) will be paid on a case-by-case basis insofar as the projects concern the state of the body of water and its tributaries.2 the compensatory payments for the provision of fundamentals amount to 30 per cent of the attributable costs and those for the inventories on water supply installations and groundwater resources (art. 64 para. 3 wpa) 40 per cent of the attributable costs.art. 56 training of specialists and provision of information to the public 1 financial assistance for the training of specialists (art. 64 para. 2 wpa) amounts to:a.a maximum of 25 per cent of the costs;b.a maximum of 40 per cent of the costs in the case of projects that are particularly expensive given the number of probable participants.2 financial assistance for the provision of information to the public (art. 64 para. 2 wpa) may be granted to projects if:a.they are of significance for switzerland as a whole; andb.provided the information documents are made available for distribution throughout switzerland.3 the financial assistance for the provision of information to the public amounts to:a.a maximum of 40 per cent the costs for the preparation of documents;b.a maximum of 20 per cent the costs for the conduct of information campaigns.4 the foen shall grant financial assistance for the training of specialists and for the provision of information to the public on a case-by-case basis.art. 57 risk guarantee 1 a risk guarantee for promising new forms of installations and equipment (art. 64a wpa), that perform a public service may be granted provided company guarantees are not available.2 the risk guarantee applies to the costs incurred in rectifying defects or if necessary for the reconstruction of the installations and equipment in the first five years after beginning operations must, provided they are not made necessary through the fault of the person responsible for the installation or equipment.3 the risk guarantee amounts to at least 20 but no more than 60 per cent of the costs in accordance with paragraph 2.4 for the procedure, articles 61c and 61d apply by analogy.art. 58100 attributable costs 1 attributable costs are those costs that are genuinely incurred and are directly connected with implementing projects giving rise to entitlement to subsidy. these include the cost of pilot projects, and in the case of the rehabilitation of bodies of water, the cost of acquiring the required land.2 costs that are not attributable are in particular fees and taxes.100 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).section 2101 procedure for granting global compensatory payments 101 amended by no i 13 of the o of 7 nov. 2007 on the new system of fiscal equalisation and the division of tasks between the confederation and cantons, in force since 1 jan. 2008 (as 2007 5823). art. 59 application 1 the canton shall submit the application for global compensatory payments to the competent federal office (art. 60 para. 1).2 the application must include information on:a.the programme goals to be achieved and in the case of compensatory payments for measures in agriculture information on the goals to be achieved in the canton as a whole;b.the measures probably required to achieve the goals and how they are to be implemented;c.the effectiveness of the measures.art. 60 programme agreement 1 the following authorities are responsible for concluding the programme agreement:a.102the foen for compensatory payments to waste water treatment plants and for the planning and conduct of measures to rehabilitate waters;b.the foag for compensatory payments for measures in agriculture.2 the programme agreement shall be concluded for a specific territory. the subject matter of the programme agreement shall in particular be:a.the strategic programme goals that must be jointly achieved;b.the obligations of the canton;c.the federal subsidy to be provided;d.controlling.3 the duration of the programme agreement amounts in the case of compensatory payments to:a.measures in agriculture: normally 6 years;b.other measures: 4 years.1034 the competent federal office shall issue guidelines on the procedure in the case of programme agreements and on the information and documents on the subject matter of the programme agreement.102 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).103 amended by no i of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).art. 61 payment global compensatory payments are paid out in instalments.art. 61a reporting and controls 1 the canton shall report annually to the competent federal office on the use of the global compensatory payments.2 the competent federal office shall verify by random sample:a.the implementation of individual measures in accordance with the programme goals;b.the use of the subsidies paid out.art. 61b inadequate fulfilment and misuse of subsidies 1 the competent federal office shall withhold all or part of the instalment payments during the programme if the canton:a.fails to fulfil its reporting duty (art. 61a para. 1);b.fails to meet its obligations to a substantial extent through its own fault.2 if on conclusion of the programme it emerges that the canton has failed to meet its obligations, the competent federal office shall require the canton to rectify the situation; it shall set the canton an appropriate deadline for doing so.3 if installations or equipment for which compensatory payments have been made are used for a purpose other than that intended, the competent federal office may require the canton to stop or remedy the misuse within a reasonable period.4 if the defects are not rectified or if the misuse does not stop or is not remedied, the payments may be reclaimed in accordance with articles 28 and 29 of the subsidies act of 5 october 1990104.104 sr 616.1section 3105 procedure for granting compensatory payments or financial assistance in specific cases 105 inserted by no i 13 of the o of 7 nov. 2007 on the new system of fiscal equalisation and the division of tasks between the confederation and cantons, in force since 1 jan. 2008 (as 2007 5823).art. 61c application 1 the application for financial assistance or compensatory payments in specific cases is submitted to the foen.2 it shall issue guidelines on the information and documents to be included in the application.art. 61d granting and payment of subsidies 1 the foen shall specify the subsidies in a ruling or enter into an agreement with the recipient of the subsidies for this purpose.2 it shall pay out the subsidies according to how the project is progressing.art. 61e inadequate fulfilment and misuse of subsidies 1 if the recipient of a promised compensatory payment or financial assistance despite being warned fails to carry out a measure not or does so inadequately, the compensatory payment or financial assistance shall not be paid out or shall be reduced.2 if compensatory payments or financial assistance have been paid out and the recipient despite being warned fails to carry out a measure not or does so inadequately, the payments may be reclaimed in accordance with articles 28 and 29 of the subsidies act106.3 if installations or equipment for which compensatory payments or financial assistance have been paid out are used for a purpose other than that intended, the foen may require the canton to stop or remedy the misuse within a reasonable period.4 if the misuse is not stopped or remedied, the payments may be reclaimed in accordance with article 29 of the subsidies act.106 sr 616.1art. 61f reporting and controls reporting and controls in relation to compensatory payments and financial assistance in specific cases are governed by analogy by article 61a.chapter 10 commencement art. 62 this ordinance comes into force on 1 january 1999.transitional provision to the amendment of 18 october 2006107 107 as 2006 4291installations and parts of installation that were constructed in accordance with the regulations before this amendment comes into force may continue to be operated if they are fit for operation and do not represent a specific risk to the waters; single wall underground storage tanks for liquids which may pollute water may continue to be used until 31 december 2014 at the latest.transitional provisions to the amendment of 4 may 2011108 108 as 2011 19551 the cantons shall specify the space provided for waters in accordance with articles 41a and 41b by 31 december 2018.2 until they have specified the space provided for waters, the regulations on installations in accordance with article 41c paragraphs 1 and 2 apply along waters with a margin on each side with a width in each case of:a.8 m plus the width of the existing channel bed in the case of watercourses with a channel bed of no more than 12 m width;b.20 m in the case of watercourses with an existing channel bed of more than 12 m width;c.20 m in the case of standing waters with a surface area of more than 0.5 ha.3 instead of the criteria under article 54b paragraph 1 letters a and b, the level of the compensatory payments for rehabilitation operations carried out before 31 december 2024 may be determined by the extent of the measures.1094 article 54b paragraph 5 does not apply to rehabilitation operations carried out before 31 december 2015.109 amended by no i 1 of the o of 17 april 2019 on amendments to ordinance law on the environment, in particular in relation to the programme agreements for the programme period 2020-2024, in force since 1 jan. 2020 (as 2019 1487).transitional provision to the amendment of 25 may 2011110 110 as 2011 2407the cantonal authority may grant an exception under article 25 paragraph 1 until 31 december 2015 at the latest to farms that no longer meet the requirements of article 25 paragraph 3 letters c and d, as a result of the ban on the feeding of slaughterhouse and butcher's by-products and left-over food, provided these farms prove that they have used slaughterhouse and butcher's by-products and left-over food as feed and cannot compensate for the loss of such feed by using other food by-products.transitional provision to the amendment of 4 november 2015111 111 as 2015 47911 the cantons shall ensure that the implementation of all the measures required to comply with the requirements of annex 3.1 clause 2 no 8 begin by 31 december 2035 at the latest. they shall fix the last possible date for implement the measures according to their urgency and in doing so take account of the following:a.the remediation and renewal cycles of the waste water treatment plants;b.the size of the waste water treatment plants;c.the volume of waste water in the receiving waters;d.the length of the flow section in waters that are affected by the discharge of waste water.2 for groundwater wells and groundwater recharge installations in highly heterogeneous karst and fissured rock aquifers, zones sh and sm in terms of annex 4 number 125 need not be designated if the groundwater protection zones and areas of contribution were designated under the previous law and have not been modified to a substantial extent.annex 1 (art. 1)ecological objectives for waters 1 surface waters 1 the communities of plants, animals and micro-organisms in surface waters and the surroundings influenced by them shall:a.be close to nature and appropriate to the location as well as reproducing and regulating themselves;b.show a diversity and frequency of species that are specific to unpolluted or slightly polluted waters of the type in question.2 the hydrodynamics (bed load transport rate, and flow regimes) and the morphology should be near-natural. in particular, they should guarantee unreservedly the self-cleaning processes, the natural exchange of substances between water and the channel bed as well as the interactions with the surroundings.3 the water quality shall be such that:a.the temperature conditions are near-natural;b.the water, suspended matter and sediments contain no persistent synthetic substances;c.other potential water pollutants which could enter the water as a result of human activities,-do not accumulate in the plants, animals, micro-organisms, suspended matter or sediments,-do not have any harmful effects on the communities of plants, animals and micro-organisms and on the use of the water,-do not cause an unnaturally high production of bio-mass,-do not harm the biological processes that fulfil the basic physiological needs of plant and animal life, such as the metabolic processes, the reproductive processes and the olfactory orientation of animals,-occur in the body of water in concentrations that are within the range of natural concentrations where they are already present naturally, -occur in the body of water only in near-zero concentrations where they are not naturally present.2 underground waters 1 the biotic community of underground waters shall:a.be close to nature and appropriate to the location;b.be specific to unpolluted or only slightly polluted waters.2 the aquifer (flow section, permeability), the upper and lower confining beds and the hydro-dynamism of the groundwater (groundwater levels, flow regime) should correspond to near natural conditions. in particular, the self-cleaning processes and the interactions between water and its surroundings should be guaranteed unreservedly.3 the groundwater quality shall be such that:a.the temperature conditions are near natural;b.the water contains no persistent synthetic substances;c.other potential water pollutants which could enter the water as a result of human activities:-do not accumulate in the biotic community or in the inert matter of the aquifer,-occur in concentrations that are within the range of natural concentrations where these are already present in natural state groundwater,-do not occur in groundwater where they are not present naturally-have no harmful effects on the use of the groundwater. annex 2112 112 revised by annex 2 no 4 of the plant protection products ordinance of 23 june 1999 (as 1999 2045), no ii 9 of the o of 18 may 2005 on the repeal and amendment of ordinances in connection with the commencement of the chemicals act (as 2005 2695), no iii of the o of 4 nov. 2015 (as 2015 4791), and the correction of 2 feb. 2016 (as 2016 473).(art. 6, 8, 13 and 47)requirements on water quality 1 surface waters 11 general requirements 1 the water quality must be such that:a.no visible colonies of bacteria, fungi or protozoa and no unnatural proliferation of algae or higher water plants are formed in any waters;b.fish-spawning grounds are preserved;c.after application of appropriate treatment, the water complies with requirements of the legislation on foodstuffs; d.groundwater is not contaminated by infiltration of water;e.the hygiene requirements for bathing are met at sites where bathing is expressly permitted by the authorities or where a large number of people normally bathe and the authorities do not advise against it;f.substances that enter waters as a result of human activities do not detrimentally affect the reproduction, development and health of sensitive plants, animals and microorganisms.2 after waste water has undergone homogeneous mixing with the body of water the mixture must not result in:a.the formation of mud;b.any turbidity, discoloration or foam, except in the event of heavy rainfall;c.any noticeable alteration in the odour of the water in comparison with its natural state;d.any lack of oxygen or unfavourable ph values.3 the following numerical requirements apply to every water flow after thorough mixing of the waste water discharged into the receiving waters; a reserve may be made for particular natural conditions such as water discharge from mires, rare high-water peaks or rare low-water events.noparameterrequirements1nitrate (no3- - n)for waters which serve as a source of drinking water:5,6 mg/l n (corresponds to 25 mg/l nitrate)2lead (pb)0.01 mg/l pb (total)10.001 mg/l pb (dissolved)3cadmium (cd)0,2 g/l cd (total)10.05 g/l cd (dissolved)4chromium (cr)0.005 mg/l cr (total)10.002 mg/l cr (iii und vi)5copper (cu)0.005 mg/l cu (total)10.002 mg/l cu (dissolved)6nickel (ni)0.01 mg/l ni (total)10.005 mg/l ni (dissolved)7mercury (hg)0.03 g/l hg (total)10.01 g/l hg (dissolved)8zinc (zn)0.02 mg/l zn (total)10.005 mg/l zn (dissolved)9organic pesticides (biocidal and plant protection products)0.1 g/l per individual substance unless regulated otherwise below.1the dissolved concentration is determinant. if the value specified for the total concentration is respected, it may be assumed that the value for the dissolved concentration is also respected.12 additional requirements for watercourses 1 the water quality must be such that:a.no visible iron sulphide patches form in the channel bed, unless due to particular natural conditions;b.nitrite and ammonia concentrations do not interfere with the reproduction development and health of sensitive organisms, such as salmonidae.2 the oxygen content on the channel bed must not be adversely affected by:a.increased oxygen consumption due to an unnatural excess of oxidisable substances;b.a reduced permeability of the bottom resulting from unnaturally high sedimentation of fine particles (clogging) or artificial sealing.3 the hydrodynamics, morphology and temperature conditions of the water must not be so changed by water withdrawals, water discharges and building activities that its self-purification capacity is reduced or the water quality in the body of water is made insufficient to sustain communities specific to it.4 the introduction or the withdrawal of heat must not alter the temperature in a watercourse by more than 3 c above or below the temperature in its as near natural as possible state, or, in trout water stretches, by more than 1.5 c; furthermore, the water temperature must not exceed 25c. these requirements apply after thorough mixing.5 the following numerical requirements apply to every water flow after thorough mixing of the waste water discharged into the receiving waters; a reserve may be made for particular natural conditions such as water discharge from mires, rare high-water peaks or rare low-water events.no.parameterrequirements1biochemical oxygen demand (bod5)2 to 4 mg/l o2the lower value applies to waters which are naturally only slightly polluted.2dissolved organic carbon (doc)1 to mg/l cthe lower value applies to waters which are naturally only slightly polluted.3ammonium (sum of nh4+ n and nh3 - n)at temperatures:- above 10 c: 0.2 mg/l n- below 10 c: 0.4 mg/l n13 additional requirements for standing waters 1 the morphology and functions of the upper layers of sediments which are essential for providing the water quality required to preserve the communities of plants, animals and micro-organisms must not be durably altered by changes made to the terrain (e.g. dredging, movement of excavated material within the expanse of water, levelling or backfilling of banks, reinforcement of banks or creation of dikes).2 the nutrient content should allow at most an average production of biomass; subject to particular natural circumstances.3 for lakes, moreover, the following applies:a.the regulation of the lake waters, the discharge and extraction of water, the use of water for cooling and for the extraction of heat, should not alter the natural regime of temperatures or the distribution of nutrients within the expanse of water, nor should it disrupt conditions for living and reproduction of organisms, particularly in the riparian zone;b.the oxygen content of the water should at no time and at no lake depth amount to less than 4 mg/l o2; in addition, it must be sufficient for sensitive animals such as worms to be able to inhabit the lake bottom throughout the year and in numbers as close as possible to natural abundance, subject to particular natural conditions.2 underground waters 21 general requirements 1 the concentration of substances in the groundwater for which requirements are specified in no 22 should not continually increase. 2 the quality of the groundwater must be such that it does not pollute surface water after exfiltration.3 the introduction or withdrawal of heat must not alter the temperature of the groundwater by more than 3 c above or below the temperature in its natural state; this does not apply to very local changes in temperature.4 infiltration of waste water into underground waters must not result in:a.any disturbing change in the odour of the water;b.any lack of oxygen or unfavourable ph values;c.any turbidity or discoloration, except in the case of consolidated rock groundwater.5 infiltration installations, withdrawals of water and other interventions connected with construction work must not, insofar as possible, damage the protective upper confining bed, or alter the hydrodynamics in such a way as to have detrimental effects on the quality of water.22 additional requirements for groundwater which is used for drinking water or is intended as such 1 the water quality must be such that after the use of basic water conditioning, it complies with the requirements of the foodstuffs legislation.2 the following numerical requirements apply, subject to the particular natural circumstances. for substances originating from polluted sites, these requirements do not apply in the downstream area where the greater part of these substances is degraded or retained. no.parameterrequirement1dissolved organic carbon (doc)2 mg/l c2ammonium (sum of nh4+ n and nh3 n)in oxic conditions: 0.08 mg/l n (corresponds to 0.1 mg/l ammonium)in anoxic conditions: 0.4 mg/l n (corresponds to 0.5 mg/l ammonium)3nitrate (no3- - n)5.6 mg/l n (corresponds to 25 mg/l nitrate)4sulphate (so42 - )40 mg/l so42 -5chloride (cl -)40 mg/l cl -6aliphatic hydrocarbons0.001 mg/l per single substance7monocyclic aromatic hydrocarbons 0.001 mg/l per single substance8polycyclic aromatic hydrocarbons (pah)0.1 g/l per single substance9volatile organic halogens (vox)0.001 mg/l per single substance10adsorbable organic halogens (aox)0.01 mg/l x11organic pesticides (biocidal products and plant protection products )0.1 g/l per single substance. annex 3 requirements for the discharge of polluted waste water annex 3.1113 113 revised by no i of the o of 31 oct. 2001 (as 2001 3168), no iii of the o of 4 nov. 2015 (as 2015 4791) and no i of the o of 17 april 2019, in force since 1 jan. 2021 (as 2019 1489). see also the transitional provision to the amendment of 4 nov. 2015 above. the correction of 7 feb. 2017 relates to the italian text only (as 2017 509).(art. 6 para. 1)discharge of communal waste water into waters 1 definition and principles 1 communal waste water includes:a.domestic waste water (waste water from households and similar waste water);b.precipitation water running off built-up or sealed surfaces and discharged along with domestic waste water.2 the following requirements apply to communal waste water from waste water treatment plants treating in excess of 200-population equivalent (pe114). they apply at the site of discharge and for the standard operation of the plant, subject to exceptional situations such as unusually heavy rainfall.3 for communal waste water from waste water treatment plants with 200 pe or fewer and for waste water from overflows from combined systems, the authorities determine the requirements from case to case taking local conditions into consideration. 4 if the waste water from a central waste water treatment plant also contains industrial waste water (annex 3.2) or other polluted waste water (annex 3.3), the authorities shall specify the requirements for discharge into waters in their authorisation, if necessary in derogation from the requirements listed in nos 2 and 3, in such a way that no more potential water pollutants are discharged with the waste water than would be the case if the different waste waters were treated separately in compliance with the requirements of the corresponding annexes.114 one pe corresponds to one organic biodegradable load with a biochemical oxygen demand in 5 days of 60 g of oxygen per day. 2 general requirements no.parameterrequirements1total suspended solidsfor waste water from plants of less than 10 000 pe the following requirements apply:-discharge concentration: 20 mg/lfor waste water from plants from 10 000 pe the following applies:-discharge concentration: 15 mg/l 2chemical oxygen demand (cod)for waste water from plants of less than 10 000 pe the following requirements apply:-discharge concentration: 60 mg/l o2 and-removal efficiency, with respect to raw waste water: 80%for waste water from plants of 10.000 pe or over the following requirements apply:-discharge concentration: 45 mg/l o2 and-removal efficiency, with respect to raw waste water: 85%3dissolved organic carbon (doc)for waste water from plants of 2000 pe or over the following requirements apply:- discharge concentration: 10 mg/l and- removal efficiency: 85%, expressed asif the value is not complied with, the authorities shall assess the substances, determine their origin and if necessary specify the required procedures in accordance with annexes 3.2 and 3.3.4transparency (snellen method)30 cm5ammonium (sum of nh4+ n and nh3 - n)if the ammonium concentrations in the waste water are potentially detrimental to the water quality of a watercourse, the following requirements apply if the waste water temperature is higher than 10 c;-discharge concentration: 2 mg/l n and-removal efficiency: 90 %, expressed asin these cases nitrification must be carried out throughout the year: remark: kjeldahl nitrogen is the sum of the nitrogen inform the ammonium, ammonia and organic nitrogen.6nitrite (no2- - n)0.3 mg/l n (guide value)7adsorbable organic halogen (aox)0.08 mg/l x.if the value is not complied with, the authorities shall assess the substances, determine their origin and if necessary specify the required procedures in accordance with annexes 3.2 and 3.3.8organic substances that can pollute waters even in low concentrations (organic trace substances)the removal efficiency with respect to raw waste water and measured using selected substances must amount to 80 % for waste water from:-plants with 80 000 or more connected residents;-plants with 24 000 or more connected residents in the catchment area of lakes; the canton may authorise exceptions if the benefit of removal for the environment and for the drinking water supply is negligible;-plants with 8000 or more connected residents that discharge into a watercourse containing more than 10 % waste water untreated for organic trace substances; the canton shall identify the plants that must take measures as part of a plan for the catchment area; -other plants with 8000 or more connected residents if removal is required due to special hydrogeological conditions;-.115the department shall specify the substances to be used to measure the removal efficiency in an ordinance, and how efficiency is calculated.9biochemical oxygen demand (bod5, with nitrification inhibition)for waste water from plants with less than 10 000 pe for which the bod5 concentrations in the waste water have a detrimental effect on the water quality of a watercourses the following applies:-discharge concentration: 20 mg/l o2and-removal efficiency with respect to raw waste water: 90 %for waste water from plants from 10 000 pe for which the bod5 concentrations in the waste water have a detrimental effect on the water quality of a watercourses the following applies:-discharge concentration: 15 mg/l o2and-removal efficiency with respect to raw waste water: 90 %115 comes into force on 1 jan. 2028 (as 2019 1489).3 additional requirements for discharge into sensitive waters no.parameterrequirements1total phosphorus(after conversion to dissolved orthophosphate)for waste water from plants-in the catchment area of lakes,-situated on watercourses downstream of lakes, if this is required for the protection of the watercourse, and -of 10.000 pe or over, situated on watercourses in the catchment area of the rhine downstream of lakes,the following requirements apply:-discharge concentration: 0.8 mg/l p and-removal efficiency, with respect to raw waste water: 80%2total nitrogenin plants for which no discharge concentration and no removal efficiency for total nitrogen is specified, must be operated in such a way that during waste water purification and sludge treatment as much nitrogen as possible is eliminated. all structural modifications which are possible at no great cost must be undertaken; this applies particularly to plants that already carry out nitrification.prior to 28 february 2002, cantons in the catchment area of the rhine shall work out a plan on how to reduce discharges of nitrogen by 2600 tonnes compared to 1995 with effect from the year 2005 onwards. plants that are earmarked in this plan for nitrogen elimination must be operational by 2005 at the latest.4 frequency of sampling and admissible divergences 41 frequency of sampling 1 the requirements under nos 2 and 3 refer to an examination period of one year and to continuous sampling, conducted at regular intervals on different days of the week. with regard to organic trace substances, the samples must be taken over 48 hours and with regard to other parameters over 24 hours.2 the number of samples per year depends on the size of the plant:a.plants of less 2000 pethe cantonal authorities shall specify the minimum number of samples to be analysed on a case by case basis.b.plants of 2000 pe or overin the first year after the commissioning or extension of the plant at least twelve samples. in the following years at least four samples if the waste water complied with the requirements in the first year. if the waste water does not comply with the requirements in any year, a further twelve samples at least must be analysed the following year. with regard to organic trace substances, at least eight samples must be analysed instead of at least twelve.c.plants of 10 000 pe and overat least twelve samples per year.with regard to organic trace substances, from the second year after the commissioning or extension of the plant at least six samples must be analysed if the waste water complied with the requirements in the first year; if the waste water does not comply with the requirements in any year, a further twelve samples at least must be analysed the following year.d.plants of 50 000 pe and overat least 24 samples per year.with regard to organic trace substances, from the second year after the commissioning or extension of the plant at least twelve samples must be analysed if the waste water complied with the requirements in the first year; if the waste water does not comply with the requirements in any year, a further 24 samples at least must be analysed the following year.42 admissible non-compliant samples 1 the maximum number of non-compliant samples admissible depends on the total number of samples as indicated in the table below.2 the following values must never be exceeded:-total suspended solids 50 mg/l-chemical oxygen demand (bod5) 120 mg/l-dissolved organic carbon (doc) 20 mg/l-biochemical oxygen demand (bod5) 40 mg/l3 the following annual averages must not be exceeded:-phosphorus in plants of 10 000 pe and over0.8 mg/l ptable: admissible number of non-compliant samplesnumber of samples per yearadmissible number of noncompliant samplesnumber of samples per yearadmissible number of noncompliant samples 4- 7 1172-18714 8- 16 2188-20315 17- 28 3204-21916 29- 40 4220-23517 41- 53 5236-25118 54- 67 6252-26819 68- 81 7269-28420 82- 95 8285-30021 96-110 9301-31722111-12510318-33423126-14011335-35024141-15512351-36525156-17113annex 3.2116 116 revised by no i of the o of 22 oct. 2003, in force since 1 jan. 2004 (as 2003 4043).(art. 6 para. 1 and 7 para. 1)discharge of industrial waste water into waters or into public sewer systems 1 definition and principles 1 industrial waste water includes:a.waste water from industrial plants;b.comparable waste water, such as that from laboratories and hospitals.2 any person who discharges industrial waste water must, during production processes and waste water treatment take the require stat-of-the-art measures to avoid polluting waters. in particular, he or she must ensure that:a.as little waste water is generated and as few potential water pollutants are discharged as is technically and operationally feasible and economically acceptable;b.unpolluted waste water and cooling water are separated from polluted waste water;c.polluted waste water is neither diluted nor mixed with other waste water in order to comply with the requirements; dilution or mixing is permitted if this is appropriate for the treatment of the waste water and as a result no more potential water pollutants are discharged than would be the case if the waste waters were treated separately.3 at the site of discharge, when discharging waste water into waters or public sewers they must comply with:a.the general requirements in accordance with no 2; andb.the special requirements for specific substances in accordance with no 3 for waste water from certain industrial sectors. 4 if the person responsible for the concern can prove that he or she has taken the required state-of-the-art measures mentioned in paragraph 2, and that compliance with the general requirements specified in no 2 would be disproportionate, the authorities shall specify less stringent values.5 if the required state-of-the-art measures mentioned in paragraph 2 make it possible to comply with more stringent requirements than those specified in nos 2 and 3, the authorities shall apply more stringent values based on the information received from the person responsible for the concern and after having heard this person.6 if nos 2 and 3 contain no requirements for specific potential water pollutants, the authorities shall specify the necessary requirements based on the state of the art in the authorisation. in so doing they shall take account of international or national standards, directives published by the foen or standards drawn up by the industrial sector concerned in collaboration the foen.7 if industrial waste water also containing communal waste water (annex 3.1) or other polluted waste water (annex 3.3) is discharged into a body of water, the authorities shall specify the requirements in the authorisation in such a way that no more potential water pollutants are discharged with the waste water than would be the case if the different waste waters were treated separately in compliance with the requirements of the corresponding annexes.2 general requirements no.parametercolumn 1: requirements for discharge into waterscolumn 2: requirements for discharge into public sewers1ph6.5 to 9.06.5 to 9.0; divergences are admissible if there is sufficient mixing with other waste waters in the sewers.2temperatureat most 30 c. the authorities may allow minor short-term excesses in summertime.at most 60 c. the temperature in the sewer system must not exceed 40 c after mixing.3transparency (snellen method)30 cm -4total suspended solids20 mg/l -5arsenic (as)0.1 mg/l as (total)0.1 mg/l as (total) 6lead (pb)0.5 mg/l pb (total)0.5 mg/l pb (total) 7cadmium (cd)0.1 mg/l cd (total)0.1 mg/l cd (total) 8chromium (cr)2 mg/l cr (total); 0.1 mg/l cr-vi2 mg/l cr (total) 9cobalt (co)0.5 mg/l co (total)0.5 mg/l co (total) 10copper (cu)0.5 mg/l cu (total)1 mg/l cu (total) 11molybdenum (mo)-1 mg/l mo (total) 12nickel (ni)2 mg/l ni (total)2 mg/l ni (total) 13zinc (zn)2 mg/l zn (total)2 mg/l zn (total) 14cyanide (cn-)0.1 mg/l cn- (free and easily releasable cyanide)0.5 mg/l cn- (free and easily releasable cyanide)15total hydrocarbons10 mg/l 20 mg/l 16volatile chlorinated hydrocarbons(vocl) or volatile organic halogens (vox)0.1 mg/l clor0.1 mg/l x 0.1 mg/l clor0.1 mg/l x 3 special requirements for specific substances from certain industrial sectors in addition to the following requirements, the internationally agreed decisions and recommendations approved by the federal council or the department in under article 51 apply to the whole of switzerland.11731 foodstuff processing no.sector/processcolumn 1: requirements for discharge into waterscolumn 2: requirements for discharge into public sewers-milk processing-fruit and vegetable processing-manufacture and bottling of soft drinks-potato processing-meat processing-breweries-manufacture of alcohol and alcoholic drinks-manufacture of fodder from plant products-manufacture of leather glue, gelatine and bone glue-malt factories-fish processingrequirements for communal waste water in accordance with annex 3.1 apply.excepted are the requirements for total phosphorus in cases in where phosphorus must be added in the waste water treatment plant for the biological treatment step.in fat and oil processing plants, separators must be fitted if necessary.32 secondary iron and steel industry no.sector/processparameter/requirements for discharge into waters and public sewers1continuous casting process water: -at least 95 per cent recirculationtotal suspended solids:-10 g/t processed steel ( daily average)oil:-5 g/t processed steel (daily average)2cold rollingtotal suspended solids:-10 g/t processed steel (daily average)oil:-5 g/t processed steel (daily average)3hot rollingprocess water:-at least 95 per cent recirculationtotal suspended solids:-50 g/t processed steel (daily average)oil:-10 g/t processed steel (daily average)4pickling plantscadmium (cd):-0.2 mg/l cd (daily average) or chromium (cr):-0.1 mg/l cr-vi (daily average)-1 mg/l cr (total) (daily average)nickel (ni):-1 mg/l ni (daily average)zinc (zn):-2 mg/l zn (daily average)acid regeneration:-acid regeneration for reduction of nitrate discharge from pickling plants using more than 20 tonnes of nitric acid per year, or other equivalent measuresfor plants that were commissioned before 1 january 1993, the authorities shall specify the requirements on a case-by-case basis.33 surface treatment / electroplating no.sector/ processparameter / requirements for discharge into waters and public sewers1use of 1,2-dichloroethane to degrease metals1,2-dichloroethane:-0.1 mg/l (monthly average)-0.2 mg/l (daily average)2use of trichloroethene to degrease metals trichloroethene:-0.1 mg/l (monthly average)-0.2 mg/l (daily average)3use of tetrachloroethene to degrease metalstetrachloroethene:-0.1 mg/l (monthly average)-0.2 mg/l (daily average)4surface treatmentvolatile organic halogens (vox):-0.1 mg/l vox (daily average)cyanide (cn-):-0.2 mg/l cn- (unbound) (daily average)mercury (hg):-0.05 mg/l hg (daily average) or -0.03 kg hg per tonne of mercury used (daily average)cadmium (cd):-0.2 mg/l cd (daily average) or-0.3 kg cd per tonne of cadmium used (daily average)chromium (cr):-0.1 mg/l cr-vi (daily average)-0.5 mg/l cr (total) (daily average)alead (pb):-0.5 mg/l pb (daily average)acopper (cu):-0.5 mg/l cu (daily average)anickel (ni):-0.5 mg/l ni (daily average)azinc (zn):-0.5 mg/l zn (daily average); in justified cases the authorities may admit up to 2 mg/l zn (daily average)silver (ag):-0.1 mg/l ag (daily average)tin (sn):-2 mg/l sn (daily average).afor surface treatment plants discharging small quantities of metals (defined as: sum of total chromium, lead, copper, nickel and zinc less than 200 g/day), the authorities may admit up to 2 mg/l (monthly average).34 chemical industry no.sector/processparameter/requirements on discharge into waters and public sewers1manufacture of chlorine by chlorine-alkali electrolysismercury (hg):use of mercury-free processes.for existing plants applies:-0.5 g hg per tonne of chlorine production capacity in monthly average-2.0 g hg per tonne of chlorine production capacity (daily average)2production of cadmium pigmentscadmium (cd):-0.2 mg/l cd (monthly average)-0.4 mg/l cd (daily average)35 manufacture of paper, cardboard and pulp no.sector/processparameter/requirements on discharge into watersparameter/requirements on discharge into public sewers1production of paper or cardboardtotal suspended solids:-1 kg per tonne production of paper or cardboard (daily average) or 50 mg/l (daily average) chemical oxygen demand (cod)/dissolved organic carbon (doc):-according to type of paper: 2,5-5 kg cod per tonne production of paper or cardboard (daily average) or 1,5-2,5 kg doc per tonne production of paper or cardboard (daily average)biochemical oxygen demand (bod5):-according to type of paper: 0.5-1 kg per tonne production of paper or cardboard (daily average); in justified cases the authorities may instead of the above-mentioned requirement admit a value of 25 mg/l bod5 (daily average). the authorities set the requirements from case to caseno.sector/processparameter/requirements on discharge into waters2production of sulphite pulp (bod5):-5 kg per tonne production of air dry pulp (monthly average)chemical oxygen demand (cod):-35 kg per tonne production of air dry pulp (monthly average)-70 kg per tonne production of air dry pulp (monthly average) for plants which were commissioned before 1.1.1997if the correlation between the cod and the total organic carbons (toc) is given and proved, monitoring may be carried out on the toc instead of on the cod.total suspended solids:-4.5 kg per tonne production of air dry pulp (monthly average)8.0 kg per tonne production of air dry pulp (monthly average) from 1.1.2000 for plants which were commissioned before 1.1.1997 and did not increase their production capacity after 1.1.1997 by more than 50 per cent.adsorbable organic halogens (aox), for plants which do not produce exclusively chlorine-free bleached pulp:-0.5 kg per tonne production of bleached air dry pulp (monthly average)molecular chlorine ratio:-less than 0.05 to 0.1, according to type of pulp36 public utilities and waste disposal plants no.sector / processcolumn 1: requirements on discharge into waterscolumn 2: requirements on discharge into public sewers1filter water from water treatmenttotal suspended solids:-30 mg/l (daily average) (guide value)no special requirements 2waste incineration plantsantimony (sb):-0.1 mg/l sbaarsenic (as):-0.1 mg/l asalead (pb):-0.1 mg/l pbacadmium (cd):-0.05 mg/l cdachromium (total cr):-0.1 mg/l cracopper (cu):-0.1 mg/l (cu)anickel (ni):-0.1 mg/l niazinc (zn):-0.1 mg/l znamercury (hg):-0.001 mg/l hgadissolved organic carbon (doc):-10 mg/l docantimony (sb):-0.1 mg/l sbaarsenic (as):-0.1 mg/l asalead (pb):-0.1 mg/l pbacadmium (cd):-0.05 mg/l cdachromium (total cr):-0.1 mg/l cracopper (cu):-0.1 mg/l cuanickel (ni):-0.1 mg/l niazinc (zn):-0.1 mg/l znamercury (hg):-0.001 mg/l hgasulphate:if there is a risk of corrosion in the public sewers, the authorities shall specify a value for admissible sulphate concentrations in each individual case.3processing wastes containing mercurymercury (hg):-0.05 mg/l hg in monthly average-0.1 mg/l hg in daily averagemercury (hg):-0.05 mg/l hg in monthly average-0.1 mg/l hg in daily average4desilverisation of fixative bathssilver (ag):the authorities set the requirements from case to case.silver (ag):-5 mg/l ag5desilverisation of bleach- hardenerssilver (ag) and bleaching agents: the authorities shall apply the requirements in each individual case.silver (ag) and bleaching agents:-5 mg/l agpoorly biodegradable bleaching agents (especially fe-edta -complex and edta-surplus):-the authorities set the requirements from case to case.aguide value for requirements on discharge to be specified by the authorities on a case by case basis depending on the actual conditions.37 other sectors no.sector/ processcolumn: requirements on discharge into waterscolumn 2: requirements on discharge into public sewers1photographic processessilver (ag):the authorities set the requirements from case to case.silver (ag):50 mg/l ag in cases where annual consumption of fixative bath does not exceed 1000 l/a5 mg/l ag in cases where consumption of fixative bath is in excess of 1000 l/a2manufacture of primary batteries containing mercurymercury (hg):-0.05 mg/l hg (monthly average)-0.1 mg/l hg (daily average)-0.03 g/kg hg per kg of mercury used (monthly average)-0.06 g/kg hg per kg of mercury used (daily average)3manufacture of other primary batteries and secondary batteriescadmium (cd):-0.2 mg/l cd (monthly average)-0.4 mg/l cd (daily average)4processes requiring use of pathogenic micro-organisms -pathogenic microorganisms:inactivation5dental surgeries and clinicsamalgam:the authorities specify the requirements on a case to case basis. amalgam:treatment units in which amalgam is processed, shall be equipped with an amalgam separator with a removal efficiency of at least 95%.117 available from the federal office for the environment, 3003 bern.annex 3.3118 118 revised by no i of the o of 11 april 2018, in force since 1 june 2018 (as 2018 1685).(art. 6 para. 1 and 7 para. 1)discharge of other polluted waste water into waters or into public sewers 1 general requirements 1 for polluted waste water other than communal or industrial waste water, the authorities shall determine the requirements on discharge on the basis of the characteristics of the waste water, the state of the art and the condition of the body of waters concerned. in so doing they shall take account of international or national standards, directives published by the foen or standards worked out by the sector concerned in co-operation with the foen.2 precipitation water running off built-up or sealed surfaces and not mixed with other polluted waste water is also regarded as other polluted waste water.3 in order that the state of the art be maintained, polluted waste water from sectors, processes and plants, must comply at least with the requirements of no 2; numerical requirements apply at the site of discharge.2 special requirements 21 continuous cooling installations 1 plants with continuous cooling installations must be designed and operated according to the state of the art so that as little heat as possible is generated and the waste heat is recovered as far as possible.2 dissolved organic carbon in the cooling water (doc) may be increased by at most 5 mg/l doc. 3 if potential water pollutants are added to the cooling water (e.g. biocides), requirements for discharge of these substances shall be specified. 4 in addition, for discharge into watercourses and stretches of standing water on rivers, the following apply:a.the temperature of the cooling water may amount to a maximum of 30 c; in derogation, the authority may permit the temperature to amount to a maximum of 33 c if the temperature of the waters from which the withdrawal is made exceeds 20 c; if the water temperature exceeds 25 c, the authority may permit exceptions if the increase in the water temperature amounts to a maximum of 0.01 c per discharge or the discharge comes from an existing nuclear power plant;b.a watercourse must not warm up by more than 3 c above or below the temperature in its as near natural as possible state, or, in trout water stretches, by more than 1.5 c; furthermore, the water temperature must not exceed 25 c;c.the spillway construction must guarantee rapid mixing;d.the waters must be warmed up slowly enough to avoid any harmful effects on communities of plants, animals and micro-organisms.5 when discharging into lakes, additional requirements in accordance with paragraphs 1-3 of the discharge conditions shall be determined on a case by case basis according to local conditions, in particular concerning the temperature of the cooling water, the depth and type of discharge.6 when discharging into public sewers, in addition to the requirements in accordance with paragraphs 1-3, the temperature of the waste water discharged may not exceed 60 c and the temperature in the sewer systems may not exceed 40 c after mixing.22 closed-circuit cooling installations 1 when discharging mud-loaded water from closed-circuit cooling installations into a body of water the following values may not be exceeded:a.temperature: 30 c; b.total suspended solids: 40 mg/l; c.dissolved organic carbon (doc): 10 mg/l. 2 if potential water pollutants are added to the cooling water, requirements for such substances shall be specified.23 construction sites 1 waste water from construction sites may be discharged into a body of water or public sewers if it complies with the general requirements for industrial waste water in accordance with annex 3.2 number 2. 2 in addition, the following values may not be exceeded when discharging into a body of water:a.aox: 0.08 mg/l x;b.nitrite: 0.3 mg/l n.24 faade and tunnel cleaning 1 waste water from faade or tunnel cleaning may be discharged into a body of water only if it contains no detergent and has been sufficiently purified in a plant.2 it may be discharged into public sewers if it does not make the recovery of the sludge difficult and if the treatment efficiency of the plant is sufficient to eliminate potential water pollutants.25 landfills 1 landfill leachate may be discharged into waters if:a.it complies with the general requirements for industrial waste water in accordance with annex 3.2 number 2;b.the biochemical oxygen demand (bod5) does not exceed 20 mg/l o2; andc.dissolved organic carbon (doc) does not exceed 10 mg/l c.2 it may be discharged into a public sewer if it complies with the general requirements in accordance with annex 3.2 number 2.3 the authorities shall determine on a case by case basis whether the values specified in paragraphs 1 and 2 must be adapted and if additional requirements must be issued due to the composition of the leachate or the condition of the of waters in question.26 gravel conditioning 1 water from gravel washing may be discharged into a body of water if:a.it complies with the general requirements for industrial waste water in accordance with annex 3.2 number 2;b.the ph does not exceed 9.2 it shall not be discharged into a public sewer.27 fish farms 1 only feedstuff low in phosphorus may be used on fish farms.2 plants must be de-sludged according to directions of the authorities.3 water discharged from the plant may not contain more than 20 mg/l (guide value) of total suspended solids. 4 if therapeutic or other potential water pollutants are used, in particular in order to maintain the health of fish, the authorities shall specify the requirements for the protection of the body of water on a case by case basis.28 swimming pools water from swimming pools may be discharged into a body of water only if it does not contain more than 0.05 mg/l (guide value) of disinfectant (e.g. active chlorine).annex 4119 119 revised by annex 2 no 4 of plant protection products ordinance of 23 june 1999 (as 1999 2045), no ii 9 of the o of 18 may 2005 on the repeal and amendment of ordinances in connection with the commencement of the chemicals act (as 2005 2695), no ii of the o of 18 oct. 2006 (as 2006 4291), no ii para. 1 of the o of 4 may 2011 (as 2011 1955) and no iii of the o of 4 nov. 2015, in force since 1 jan. 2016 (as 2015 4791). see also the transitional provision to this amendment above.(art. 29 and 31)planning the protection of waters 1 description of water protection areas at particular risk and determination of groundwater protection zones and areas 11 particularly endangered water protection areas 111 water protection area au 1 the water protection area au comprises the exploitable underground waters as well as the marginal areas necessary for their protection.2 an underground body of water is exploitable or suitable for procurement of water if the water in its natural or enriched state:a.is available in sufficient quantity to be exploitable, demand not being taken into account; andb.complies with the requirements of the foodstuff legislation for drinking water, if necessary after basic treatment.112 water protection area ao the water protection area ao comprises the surface waters and their riparian zone, as far as these are required for guaranteeing special use.113 area of contribution zu the area of contribution zu comprises the region from which, at low water level, about 90 per cent of the groundwater originates that may be at most withdrawn at the groundwater well. if this area can be determined only with disproportionate expense, the area of contribution zu comprises the entire catchment area of the groundwater well.114 area of contribution zo the area of contribution zo comprises the catchment area from which the major part of the pollution of the surface waters originates.12 groundwater protection zones 121 general 1 groundwater protection zones consist of zones s1 and s2 and:a.in the case of unconsolidated sediment and weakly heterogeneous karst and fissured-rock aquifers: zone s3;b.in the case of strongly heterogeneous karst and fissured-rock aquifers: zones sh and sm; zone sm must not be designated in the case of karst and fissured rock groundwater if designation as an area of contribution zu can ensure equivalent protection.2 in the case of extraction wells, the dimensioning of groundwater protection zones is determined by the maximum quantity that could be extracted.122 zone s1 1 zone s1 is intended to prevent damage to and pollution of groundwater wells and recharge installations as well as their immediate surroundings.2 in the case of strongly heterogeneous karst and fissured-rock aquifers, it should also prevent the pollution of the immediate environment of geological structures where concentrated surface water enters the subsoil (sinkholes) and where there is a risk to sources of drinking water.3 it comprises the groundwater well or recharge installation and the immediate surroundings of the installations. in the case of karst or fissured rock groundwater, it also comprises the immediate environment of sinkholes where there is a risk to sources of drinking water.123 zone s2 1 zone s2 is intended to prevent:a.the groundwater being polluted by excavations and underground works near to groundwater wells or recharge installations; and b.the groundwater well inflow being obstructed by underground installations.2 in the case of unconsolidated sediment and weakly heterogeneous karst and fissured-rock aquifers, it should also prevent pathogens and substances that may pollute water from entering the groundwater well in such quantities that there is a risk to sources of drinking water.3 they shall be separated around groundwater wells or recharge installations and shall be dimensioned in such a way that:a.the distance from zone s1 to the outer border of zone s2 shall amount to at least 100 m in the upstream direction; it may be less if hydrogeological investigations prove that the groundwater well or recharge installation are equally well protected by intact and relatively impermeable cover layers; andb.in the case of unconsolidated sediment and weakly heterogeneous karst and fissured-rock aquifers the flow duration of the groundwater from the outer border of zone s2 to the groundwater well or the recharge installation will be at least ten days.124 zone s3 1 zone s3 is intended to guarantee that in the case of imminent dangers (e.g. accidents with substances which may pollute water) enough space and time is available for the necessary measures.2 the distance from the outer border of zone s2 to the outer border of zone s3 is as a rule at least as great as the distance from zone 1 to the outer border of zone s2.125 zones sh and sm 1 zones sh and sm are intended to prevent:a.groundwater from being polluted by the construction and operation of installations and output of substances; andb.the hydrodynamics of the groundwater being adversely affected by building activities.2 zone sh includes areas of high vulnerability in the catchment area of a groundwater well. 3 zone sm includes areas of at least moderate vulnerability in the catchment area of a groundwater well. 4 the vulnerability is determined on the basis of the properties of the covering (soil and protective layer) and of the karst or fissured rock system and the infiltration conditions.13 groundwater protection area groundwater protection areas are demarcated in such a way as to enable the locations of the groundwater wells and recharge installations to be determined appropriately and to demarcate the groundwater protection zones accordingly.2 measures for the protection of waters 21 protection of areas particularly at risk 211 water protection areas au and ao 1 in the water protection areas au and ao, no installations may be constructed that constitute a special risk to a body of water; in particular, the construction of storage tanks with more than 250 000 l usable volume and containing liquids that may pollute waters already in small quantities is not permitted. the authority may permit exceptions for good cause.2 in water protection area au,, no installations may be constructed which lie below the average groundwater level. the authorities may grant exemptions where the flow-through capacity of the groundwater is reduced by a maximum of 10 per cent when compared with its state when uninfluenced by the plant in question.3 for the excavation of gravel, sand and other material in water protection area au:a.a protective layer of material must be left that is at least 2 m above the highest maximum ten-year groundwater level; in the case of a recharge installation, the actual level of the water table applies if it is higher than the maximum ten-year high;b.the excavation area shall be limited in such a way that natural groundwater recharge is guaranteed;c.after excavation, the soil shall be restored so that it offers the same protection as in its original state.212 areas of contribution zu and zo if, due to soil use, waters are polluted in the areas of contribution zu and zo by runoff and leaching of substances such as plant protection products or fertilisers, the cantons shall specify the measures required for waters protection. for example: a.restrictions of use for plant protection products and fertilisers specified by the cantons in accordance with annexes 2.5 number 1.1 paragraph 4 and 2.6 number 3.3.1 paragraph 3 orrchem120;b.limiting the areas for production of large crops and vegetables;c.limiting crop selection and rotation as well as farming techniques;d.refraining from ploughing grasslands in autumn;e.refraining from converting pasture into arable land;f.maintaining permanent plant cover on the soil in all circumstances;g.only using mechanical aids, techniques, equipment and cultural methods that are particularly adapted.120 sr 814.8122 groundwater protection zones 221 zone s3 1 in zone s3, the following are not permitted:a.industrial and commercial plants that place groundwater at risk;b.constructions that decrease the storage volume or the flow capacity of the aquifer; the authority may permit exceptions for good cause if a risk to drinking water sources can be excluded;c.infiltration of waste water, except for infiltration of non-polluted waste water from roof tops (art. 3 para. 3 letter a) through a biologically active soil;d.substantial reductions in the protective covering (soil and protective layer);e.pipelines which are subject to the pipelines act of 4 october 1963121; gas pipelines are exempt;f.circuits that remove heat from or add heat to the subsoil;g.underground storage tanks and pipes containing liquids which may pollute water;h.storage tanks containing liquids which may pollute water with more than 450 l of usable volume in each protective structure; exempted therefrom are free-standing storage tanks with heating oil or diesel that supply energy to buildings or facilities for no more than two years; the total usable volume may amount to a maximum of 30 m3 for each protective structure;i.operating plants containing liquids which may pollute water with more than 2000 l of usable volume; exempted therefrom are plants that are permitted in zone s3 under article 7 paragraph 2 of the low current installations ordinance of 30 march 1994122 or article 7 paragraph 2 of the heavy current installations ordinance of 30 march 1994123.2 the application of plant protection substances, wood protection substances, as well as fertilisers and similar products, is governed by annexes 2.4 numbers 1, 2.5 and 2.6 orrchem.121 sr 746.1122 sr 734.1123 sr 734.2221bis zone sm 1 the following are not permitted in zone sm:a.industrial and commercial plants that place groundwater at risk;b.building activities that have detrimental effects on the hydrodynamics of the groundwater;c.infiltration of waste water, with the exception of the infiltration of non-polluted waste water (art. 3 para. 3) through a biologically active layer of soil and of polluted communal waste water from small treatment plants in compliance with the requirements of article 8 paragraph 2, if the cost of discharging the communal waste water from the protection zone would disproportionate and a risk to drinking water sources can be excluded;d.substantial reductions in the protective covering (soil and protective layer);e.pipelines subject to the pipelines act of 4 october 1963124; exempted therefrom are gas pipelines;f.circuits that remove heat from or add heat to the subsoil;g.underground storage tanks and pipes containing liquids which may pollute water;h.storage tanks containing liquids which may pollute water with more than 450 l of usable volume in each protective structure; exempted therefrom are free-standing storage tanks with heating oil or diesel that supply energy to buildings or facilities for no more than two years; the total usable volume may amount to a maximum of 30 m3 for each protective structure;i.operating plants containing liquids which may pollute water with more than 2000 l of usable volume; exempted therefrom are plants that are permitted in zone s3 under article 7 paragraph 2 of the low current installations ordinance of 30 march 1994125 or article 7 paragraph 2 of the heavy current installations ordinance of 30 march 1994126.2 the application of plant protection substances, wood protection substances, as well as fertilisers and similar products, is governed by annexes 2.4 numbers 1, 2.5 and 2.6 orrchem.124 sr 746.1125 sr 734.1126 sr 734.2221ter zone sh 1 in zone sh, the requirements of number 221bis apply; in addition, the following are not permitted:a.plants and activities that place groundwater at risk;b.the infiltration of waste water, with the exception of the infiltration of non-polluted waste water (art. 3 para. 3) through a biologically active layer of soil.2 for the application of wood protection substances, plant protection substances and fertilisers, annexes 2.4 numbers 1, 2.5 and 2.6 orrchem apply.222 zone s2 1 in zone s2, requirements in accordance with no 221 apply; in addition subject to paragraphs 2 and 3, the following are not permitted:a.the construction of installations; the authorities may permit exceptions for good cause, provided there is no risk to the exploitation of drinking water;b.excavations that cause detrimental change to the protective covering (soil and protective layer);c.infiltration of waste water;d.other activities that place groundwater at risk.2 for the application of wood protection substances, plant protection substances and fertilisers, annexes 2.4 numbers 1, 2.5 and 2.6 orrchem apply.223 zone s1 in zone s1, the only construction work and other activities permitted are those connected with the supply of drinking water, except for the cutting of grass which is then left on site.23 groundwater protection areas 1 construction work and other activities carried on in groundwater protection areas must comply with requirements set out in no 222 paragraph 1.2 if the position and the extent of the future outer protection zone (zone s3) are known, the corresponding areas must comply with the requirements set out in no 221 paragraph 1.annex 4a127 127 inserted by no ii para. 2 of the o of 4 may 2011, in force since 1 june 2011 (as 2011 1955).(art. 41f and 42b)planning remediation measures for hydropeaking and bed load budget 1 definition there are special conditions in particular if:a.two or more installations cause serious harm in the same catchment area; andb.the degree of harm caused by each individual installation cannot yet be assessed.2 planning stages for the remediation of hydropeaking 1 the cantons shall submit an interim report to the foen by 30 june 2013. the report shall contain:a.for each catchment area, a list of the existing hydropower plants that may cause flow fluctuations (pumped-storage power plants and run-of-river power plants);b.information as to which hydropower plants on which stretches of water are seriously harming the indigenous flora and fauna and their habitats due to hydropeaking;c.an assessment of the ecological potential of the seriously harmed stretches of water and of the degree of harm;d.for each hydropower plant that is seriously harming indigenous flora and fauna and their habitats due to hydropeaking: possible remediation measures, their assessment and a list of the measures to be taken and information on the coordination of these measures in the catchment area;e.for hydropower plants for which no decision can yet be made on the remediation measures to be taken under letter d due to special circumstances: a deadline by which the information under letter d must be submitted to the foen.2 they must submit the agreed plan to the foen by 31 december 2014. it shall contain:a.a list of the hydropower plants whose responsible person must take measures to remediate serious harm to the indigenous flora and fauna and their habitats due to hydropeaking, with information on the remediation measures to be taken and the deadlines by which these must be planned and implemented. the deadlines are governed by the urgency of the need for remediation;b.information on how the remediation measures in the catchment area of the body of water concerned will be coordinated with other measures to protect natural habitats and against flooding;c.for hydropower plants for which no decision can yet be made on the remediation measures due to special circumstances: a deadline by which the canton shall specify whether and if applicable which remediation measures must be planned and implemented and by when.3 planning stages in the case of the remediation of the bed load budget 1 the cantons shall submit and interim report to the foen by 31 december 2013. it shall contain:a.a list of stretches of water where the indigenous flora and fauna and their habitats, the groundwater regimen or flood protection are seriously harmed by a change in the bed load budget;b.an assessment of the ecological potential of the seriously harmed stretches of water and of the degree of the harm;c.a list of all hydropower plants on the seriously harmed stretches of water as well as other installations causing serious harm to the stretches of water under letter a;d.a list of the installations whose responsible person must probably take remediation measures, with information on the feasibility of the remediation measures and on the coordination of these measures in the catchment area.2 they shall submit the agreed plan to the foen by 31 december 2014. it shall contain:a.a list of the installations whose responsible person must take measures to remediate serious harm to the indigenous flora and fauna and their habitats, the groundwater regimen or flood protection due to a change in the bed load budget and the deadlines by which the measures must be planned and be implemented. the deadlines are governed by the urgency of the need for remediation;b.information on how other measures to protect natural habitats and against flooding shall be taken into account in the remediation of the bed load budget;c.for installations for which no decision can yet be made on the remediation measures due to special circumstances: a deadline by which the canton shall specify whether and if applicable by when remediation measures must be planned and implemented.annex 5 (art. 62)repeal and amendment of previous law 1. the following are repealed: a.general water protection ordinance of 19 june 1972128;b.ordinance of 8 december 1975129 on waste water discharge;c.ordinance of 22 october 1981130 on zone surveys for protection of bodies of water;d.regulations of 9 august 1972131 of the federal water protection commission.128 [as 1972 967, 1980 48, 1986 1254 no ii 2, 1991 370 annex no 6, 1993 3022 no i, ii]129 [as 1975 2403, 1989 2048, 1993 3022 no iv 5]130 [as 1981 1738]131 [as 1972 1708]2.-5. .132132 the amendments may be consulted under as 1998 2863.

814.41english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.noise abatement ordinance(nao)of 15 december 1986 (status as of 1 july 2021)the swiss federal council,on the basis of articles 5, 12 paragraph 2, 13 paragraph 1, 16 paragraph 2, 19, 21 paragraph 2, 23, 39 paragraph 1, 40 and 45 of the federal act of 7 october 19831 on the protection of the environment (the act),ordains:1 sr 814.01chapter 1 general provisions art. 1 aim and scope 1 this ordinance is intended to protect against harmful and disturbing noise.2 it regulates:a. the limitation of exterior noise emissions caused by the operation of new and existing installations in accordance with article 7 of the act;b. the designation and development of building zones in areas exposed to noise;c. the issuing of planning permission for buildings with rooms sensitive to noise and lying in areas exposed to noise;d. the soundproofing against exterior and interior noise of new buildings with rooms sensitive to noise;e. the soundproofing against exterior noise of existing buildings with rooms sensitive to noise;f. the determination of the exposure to exterior noise and its rating based on exposure limit values.3 it does not regulate:a. protection against noise originating from an industrial site as long as this only affects industrial buildings and dwellings within the site;b. protection against infra- and ultrasound.4.22 repealed by no i of the o of 12 april 2000, with effect from 1 may 2000 (as 2000 1388).art. 2 definitions 1 stationary installations are buildings, transport facilities, building facilities and other immobile equipment that generate exterior noise during operation. these include in particular roads, railway installations, aerodromes, industrial, commercial and agricultural installations, firing ranges and permanent military firing ranges and training grounds.2 new stationary installations also include stationary installations and buildings whose use has been completely altered.3 emission limitation measures are technical, structural or functional modifications to installations, or measures to redirect, restrict or calm the flow of traffic, or structural measures along the emission path. the purpose of the measures is to prevent or reduce the generation or propagation of exterior noise.4 improvements are emission limitation measures for existing stationary installations.5 exposure limit values include impact thresholds, planning values and alarm values. these are set according to the noise characteristics, the time of day and the sensitivity to noise of the buildings and areas to be protected.6 rooms sensitive to noise are:a. rooms in dwellings with the exception of kitchens without dining facilities, washrooms and storerooms;b. rooms in industrial buildings that are regularly occupied by persons for sustained periods of time, with the exception of those for farm animals and those with high levels of industrial noise.chapter 2 vehicles, mobile appliances and machines section 1 emission limitation measures from vehicles art. 3 1 noise emitted from motorised vehicles, aircraft, water craft and railways must be reduced as far as possible by technical and operational means, and to the extent that this is economically acceptable.2 emission limitation measures are governed by the legislation on road traffic, civil aviation, inland navigation or the railways, provided the vehicle concerned is covered by one of these categories of legislation. 3 emission limitation measures for other vehicles is governed by the provisions on mobile appliances and machines.section 2 emission limitation measures for mobile appliances and machines art. 4 principles 1 the emissions of exterior noise from mobile appliances and machines must be reduced to the extent that:a. this is technically and operationally feasible and economically acceptable; and thatb. the well-being of the affected population is not seriously impaired.2 the enforcement authorities shall order operational and structural measures, or those for proper maintenance.3 where it is not possible to avoid exposure to highly disturbing noise due to the operation of military equipment, machines and weapons, the enforcement authorities shall relax the requirements.4 the emissions of appliances and machines that are used to operate a stationary installation are limited according to the provisions on stationary installations.art. 53 conformity assessment and marking of equipment and machines 1 equipment and machines may be placed on the market only following a conformity assessment and the appropriate marking.2 the federal department of the environment, transport, energy and communications (detec) shall specify:4a. the types of equipment and machines subject to the conformity assessment and marking;b. the requirements for preventive emission limitation measures and marking, taking into account internationally recognised standards;c. the documents to be submitted for the purpose of the conformity assessment;d. the test, measurement and calculation procedures;e. the subsequent controls;f. the recognition of foreign test results and labelling.3 amended by no i of the o of 23 aug. 2006, in force since 1 nov. 2006 (as 2006 3693).4 amended by no i of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223).art. 6 regulations on noise from building sites the federal office for the environment5 shall issue regulations covering structural and operational measures to control noise from building sites.5 the name of the administrative unit has been changed in application of art. 16 para. 3 of the publication ordinance of 17 nov. 2004 (as 2004 4937). this change has been made throughout the text.chapter 3 new and modified stationary installations art. 7 emission limitation measures for new stationary installations 1 noise emissions from new stationary installations shall be limited as directed by the enforcement authorities insofar as:a. this is technically and operationally feasible and economically acceptable; andb. the noise exposure level resulting from the installation alone does not exceed the planning values.2 the enforcement authorities shall relax the requirements in cases where compliance with the planning values would place a disproportionate burden on the installation and there is an overriding public interest, particularly regarding questions of spatial planning. the impact thresholds must not, however, be exceeded.66 amended by no i of the o of 16 june 1997, in force since 1 aug. 1997 (as 1997 1588).art. 8 emission limitation measures for modified stationary installations 1 where a stationary installation that already exists when this ordinance comes into force is modified, the noise emissions from the new or modified parts of the installation must be limited as directed by the enforcement authorities as far as this is technically and operationally feasible and economically acceptable.72 if the installation is significantly modified, the noise emissions from the installation as a whole must be limited at least to the extent that the impact thresholds are not exceeded.3 conversions, extensions and operational changes carried out by the person responsible for the installation constitute significant modifications to stationary installations if it is anticipated that the noise exposure level will rise perceptibly as a result either of the installation itself or of the increased demand on existing transport facilities. the rebuilding of an installation constitutes a significant modification irrespective of the circumstances.4 if a new stationary installation is modified, article 7 applies.87 amended by no i of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223).8 amended by no i of the o of 16 june 1997, in force since 1 aug. 1997 (as 1997 1588).art. 9 increased demand on transport facilities the operation of new or significantly modified stationary installations must not lead to a situation in which:a. owing to the increased demand made on a transport facility, the impact thresholds are exceeded; orb. owing to the increased demand made on a transport facility in need of remediation, the noise exposure level rises perceptibly.art. 10 soundproofing measures in existing buildings 1 if the requirements specified in articles 7 paragraph 2 and 8 paragraph 2 or in article 9 are not fulfilled by new or significantly modified public or licensed stationary installations, the enforcement authorities shall require the owners of existing buildings exposed to noise to soundproof the windows of rooms sensitive to noise in accordance with annex 1.2 with the approval of the enforcement authorities, building owners may carry out other structural soundproofing measures provided these reduce the noise within the rooms to the same extent.3 soundproofing measures need not be taken if:a. no perceptible reduction of the noise level in the building is to be expected;b. they conflict with the overriding interest of preserving local character or monuments;c. the building is due to be demolished within three years of putting the new or modified installation into service, or the rooms concerned will be converted to purposes not sensitive to noise within this period.art. 11 costs 1 the person responsible for the new or significantly modified installation bears the costs of limiting the emission it causes.2 if the building owner is required to take soundproofing measures according to article 10 paragraph 1, the person responsible for the installation also bears the customary local costs proven to be due for: a. engineering and supervision of works;b. soundproofing of the windows in accordance with annex 1 and the resulting necessary adaptations;c. the financing if the person responsible has failed to contribute despite being requested to do so by the building owner;d. any fees due.3 if the building owner is required to take soundproofing measures according to article 10 paragraph 2, the person responsible for the installation bears the customary local costs proven to be due insofar as these do not exceed those under paragraph 2. the building owner bears the remaining costs.4 where the need for emission limitation measures or soundproofing measures arises as a result of noise from several installations, the costs are divided among the installations in proportion to their contribution to the noise exposure level.5 the building owner bears the costs for maintenance and renewal of the soundproofing measures.art. 12 inspection the enforcement authorities shall inspect the new or modified installation within one year of its being put into service to check whether the emission limitation and soundproofing measures ordered have been taken. in the event of any doubt, they carry out tests to assess the effectiveness of the measures.chapter 4 existing stationary installations section 1 improvements and soundproofing measures art. 13 improvements 1 in the case of stationary installations that contribute significantly to the impact thresholds being exceeded, the enforcement authorities shall order the necessary improvement measures, after hearing the persons responsible for the installations.2 the installations shall be improved to the extent that:a. is technically and operationally feasible and economically acceptable; andb. the impact thresholds are no longer exceeded.3 unless there are overriding interests, the enforcement authorities give priority to measures which prevent or reduce noise generation in preference to those which simply prevent or reduce noise propagation.4 improvements need not be carried out if:a. the impact thresholds are exceeded only in building zones that have not yet been developed;b. due to the cantonal building and planning legislation, planning, design or structural measures taken at the site exposed to the noise will satisfy the impact thresholds before the time limit specified in article 17.art. 14 relaxation of the requirements for improvements 1 the enforcement authorities shall relax the requirements in cases where:a. improvements would result in unreasonable operational limitations or costs;b. overriding interests, namely those of the preservation of local character, nature and landscape protection, traffic and operational safety, or national security, conflict with the improvement objective.2 unlicensed private installations must not, however, exceed the alarm values.art. 15 soundproofing measures for existing buildings 1 if, as a result of relaxing the requirements, the alarm values for public or licensed stationary installations cannot be complied with, the enforcement authorities shall require the owners of existing buildings exposed to noise to soundproof the windows of rooms sensitive to noise in accordance with annex 1.2 with the approval of the enforcement authorities, building owners may take other soundproofing measures in the building provided these reduce the noise within the rooms to the same extent.3 soundproofing measures need not be taken if:a. no perceptible reduction of noise in the building is to be expected;b. they conflict with the overriding interest of preserving local character or monuments;c. the building is due to be demolished within three years of the soundproofing measures being ordered, or the rooms will be converted to purposes not sensitive to noise within this period.art. 16 costs 1 the person responsible for the installation bears the costs of its improvement.2 the person responsible for a public or licensed installation also bears the costs of soundproofing measures for existing buildings under article 11, unless an exemption has been granted under article 20 paragraph 2 of the act.3 where improvements or soundproofing measures are required as a result of noise from several installations, the costs are divided among the installations in proportion to their contribution to the noise exposure level.4 the building owner bears the costs of maintenance and renewal of the soundproofing measures.art. 17 time limits 1 the enforcement authorities set the time limits for implementing improvements and soundproofing measures according to their urgency. 2 in assessing urgency, the following factors are decisive:a. the extent to which the impact thresholds are exceeded;b. the number of persons affected by the noise;c. the cost-benefit relationship.3 the improvements and soundproofing measures must be completed within 15 years of this ordinance coming into force.4 the time limit (para. 3) for improvements and soundproofing measures on roads are extended:for national roads until 31 march 2015;for trunk roads according to article 12 of the federal act of 22 march 19859 on the application of the earmarked mineral oil tax (minoa), and for other roads until 31 march 201810.5 the time limits specified in the federal act of 24 march 200011 on railways noise abatement apply to the completion of improvements and soundproofing measures on railway installations.126 the improvements and soundproofing measures must be completed: at military aerodromes by 31 july 2020; at civil aerodromes that are used by heavy aircraft by 31 may 2016;at civil shooting ranges that require compulsory improvements as a result of the amendment of 23 august 200613 of annex 7: by 1 november 2016;at military firing ranges and training grounds: by 31 july 2025.149 sr 725.116.210 inserted by no i of the o of 1 sept. 2004, in force since 1 oct. 2004 (as 2004 4167).11 sr 742.14412 inserted by no i of the o of 1 sept. 2004, in force since 1 oct. 2004 (as 2004 4167).13 as 2006 369314 inserted by no i of the o of 23 aug. 2006 (as 2006 3693). amended by no i of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223).art. 18 inspection within one year of completion, the enforcement authorities shall inspect the improvements and soundproofing measures to check compliance with the measures ordered. in case of doubt, they carry out tests to assess the effectiveness of the measures.art. 1915 15 repealed by no i of the o of 1 sept. 2004, with effect from 1 oct. 2004 (as 2004 4167).art. 2016 periodical surveys 1 the federal office for the environment shall enquire regularly of the enforcement authorities as to the status of the improvements and the noise protection measures, in particular concerning roads, railway installations, aerodromes, shooting ranges and military shooting ranges and training areas.2 for roads, the enforcement authorities must provide the following documents in particular by 31 march each year:a summary of:1. the roads or sections of road requiring improvements,2. the time frame within which these roads and sections of road will be improved,3. the total costs of these improvements and noise protection measures, and 4. the number of persons exposed to noise levels above the impact thresholds and alarm values;b. a report on:1. the improvements made to roads and sections of road, and the soundproofing measures implemented in the previous year, and2. the effectiveness and the costs of these improvements and noise protection measures.3 for national roads, it shall obtain the information under paragraph 2 from the federal roads office. for trunk roads and other roads it shall obtain this information from the cantons. the information must be submitted in accordance with the requirements of the federal office for the environment.4 the federal office for the environment shall assess the information in particular in relation to the progress made with improvements and the costs and effectiveness of the measures. it shall inform the enforcement authorities of the results and publishes them.16 amended by no i 14 of the o of 7 nov. 2007 on the new system of fiscal equalisation and division of tasks between the confederation and the cantons, in force since 1 jan. 2008 (as 2007 5823).section 217 federal subsidies for improvements and soundproofing measures on existing trunk roads and other roads 17 amended by no i 14 of the o of 7 nov. 2007 on the new system of fiscal equalisation and division of tasks between the confederation and the cantons, in force since 1 jan. 2008 (as 2007 5823).art. 21 eligibility for subsidies 1 the confederation shall grant subsidies for improvements and soundproofing measures on existing infrastructure for:18trunk roads according to article 12 minoa19;other roads.2 the subsidies granted under paragraph 1 letter a form part of the global payments according to article 13 minoa. the payments under paragraph 1 letter b are granted globally for the road sections defined with the cantons in programme agreements.3 .2018 amended by no i of the o of 21 feb. 2018, in force since 1 april 2018 (as 2018 965).19 sr 725.116.220 inserted by no i of the o of 21 feb. 2018 (as 2018 965). repealed by no i of the o of 12 may 2021, with effect from 1 july 2021 (as 2021 293).art. 22 application 1 the canton submits the application for subsidies for improvements and soundproofing measures for roads according to article 21 paragraph 1 letter b to the federal office for the environment. 2 the application must in particular contain information on:the roads or road sections to be improved during the period covered by the programme agreement;the improvements and soundproofing measures planned and their cost;the efficiency of the measures.art. 23 programme agreement 1 the federal office for the environment concludes the programme agreement with the cantonal authorities responsible.2 the programme agreement covers in particular:a. the roads or road sections to be improved;b. the amount paid by the confederation;c. the control procedures.3 the programme agreement applies for four years; in justified cases a longer or shorter period may be agreed.214 the federal office for the environment issues directives on the procedure followed for programme agreements and on the information and documentation relating to the subjects of the programme agreement.21 amended by no i of the o of 21 feb. 2018, in force since 1 april 2018 (as 2018 965).art. 24 determination of the subsidy 1 the amount of the subsidy for improvements is determined by:a. the number of people who are protected by these measures; and b. the reduction in noise pollution.2 for soundproofing measures on existing buildings, chf 400 is allocated per soundproof window or other equally effective structural noise protection measure.3 the amount of the subsidy is negotiated between the confederation and the canton.art. 24a and 24b repealedart. 25 payment global subsidies are paid out in instalments.art. 26 reports and controls 1 the canton shall report annually to the competent federal office on the use of the subsidies.2 the federal office for the environment shall verify by random sample:implementation of individual measures in accordance with the programme goals;use of the payments made.art. 27 inadequate fulfilment and misuse of subsidies 1 the federal office for the environment shall withhold all or part of the instalment payments during the programme if the canton:fails to fulfil its reporting duty (art. 26 para. 1);fails to meet its obligations to a substantial extent through its own fault.2 if on conclusion of the programme it emerges that the canton has failed to meet its obligations, the competent federal office shall require the canton to rectify the situation; it shall set the canton an appropriate deadline for doing so.3 if installations for which subsidies have been made are used for a purpose other than that intended, the federal office for the environment may require the canton to cease or make good the misuse within a reasonable period.4 if the defects are not rectified or the misuse does not stop or is not remedied, the subsidies may be reclaimed in accordance with articles 28 and 29 of the subsidies act of 5 october 199022.22 sr 616.1art. 28 repealedchapter 5 requirements for building zones and planning permission in areas exposed to noise art. 29 designation of new building zones and new zones with higher noise abatement requirements 1 new building zones for buildings with rooms sensitive to noise and new no-build zones with higher noise abatement requirements shall be designated only in areas in which noise exposure does not exceed the planning values or in which these values can be complied with by planning, design or structural measures.2.23 23 repealed by no i of the o of 16 june 1997, with effect from 1 aug. 1997 (as 1997 1588).art. 3024 development of building zones building zones for buildings with rooms sensitive to noise that have not yet been developed when the act comes into force may only be developed to the extent that the planning values are complied with or can be complied with by a change in the type of use, or by planning, design or structural measures. the enforcement authorities may grant exceptions for small sections of building zones.24 amended by no i of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223).art. 31 planning permission in areas subject to noise 1 if the impact thresholds are exceeded, new buildings and significant modifications to buildings with rooms sensitive to noise may only be authorised if the values can be complied with:by locating the rooms sensitive to noise on the side of the building away from the source of the noise; orby structural or design measures which shield the building against noise.252 if the impact thresholds cannot be complied with by measures under paragraph 1, planning permission may be granted only if there is an overriding interest in constructing the building and the cantonal authorities agree.3 the landowners bear the costs of the measures.25 amended by no i of the o of 16 june 1997, in force since 1 aug. 1997 (as 1997 1588). art. 31a26 special provisions for airports used by large aircraft 1 in the case of airports that are used by large aircraft, the planning values and impact thresholds under annex 5 number 222 are complied with at night if:a. no flight operations are planned between 24 and 06 hours; b. rooms sensitive to noise are protected against exterior and interior noise as a minimum in accordance with the increased requirements for soundproofing under sia standard 181 of 1 june 200627 of the swiss society of engineers and architects; andc. the bedrooms:1. have a window that closes automatically between 22 and 24 hours and can be opened automatically at other times, and2. are designed to guarantee an appropriate indoor climate.2 when designating or developing building zones, the competent authority shall ensure that the requirements set out in paragraph 1 letters b and c are made binding on property owners.3 the federal office for the environment may issue recommendations on the enforcement of paragraph 1 letter c. in doing so, it shall take account of the relevant technical standards.26 inserted by no i of the o of 28 nov. 2014, in force since 2 feb. 2015 (as 2014 4501).27 the said standard may be inspected free of charge at the swiss society of engineers and architects (sia), selnaustrasse 16, 8027 zurich, or obtained for a free from www.sia.ch.chapter 6 soundproofing of new buildings art. 32 requirements 1 the project owner of a new building shall ensure that the soundproofing of the external building elements and partitions of rooms sensitive to noise, and of the stairs and building facilities complies with recognised codes of building practice. these are in particular, for noise from civil aerodromes that are used by heavy aircraft, the stricter requirements, and for noise from other stationary installations, the minimum requirements, of sia standard no 181 of the swiss society of engineers and architects.282 if the impact thresholds are exceeded but the requirements of article 31 paragraph 2 for granting planning permission are fulfilled, the enforcement authorities shall impose stricter requirements for the soundproofing of the external building elements appropriately.3 the requirements also apply to the external building elements, partitions, stairways and building facilities that are converted, replaced or newly installed. on request, the enforcement authorities grant relief if compliance with the requirements would involve unreasonable cost.28 sentence amended by no i of the o of 12 april 2000, in force since 1 may 2000 (as 2000 1388).art. 33 external building elements, partitions and building facilities 1 external building elements form the external boundary of a room (e.g. windows, external doors, external walls, roofs).2 partitions (e.g. internal walls, ceilings, doors) serve to separate individual units, such as dwellings, within the building.3 building facilities are fixed installations such as heating, ventilation, supply and disposal systems, lifts and washing machines.art. 34 application for planning permission 1 the project owner must specify in the application:a. the exterior noise pollution in the event that the impact thresholds are exceeded;b. the use to which the rooms are put;c. the external building elements and partitions of rooms sensitive to noise.2 for building projects in areas in which the impact thresholds are exceeded, the enforcement authorities may demand details of the soundproofing of the external building elements.art. 35 inspections after building works are completed, the enforcement authorities shall make random checks to verify whether the soundproofing measures comply with the requirements. in the event of any doubt, they must carry out a more detailed inspection.chapter 7 investigation, assessment and control of exposure to exterior noise due to stationary installations29 29 amended by no i of the o of 1 sept. 2004, in force since 1 oct. 2004 (as 2004 4167). section 1 investigation art. 3630 obligation to investigate 1 the enforcement authorities shall investigate the exposure to exterior noise due to stationary installations, or order its investigation if they have grounds to believe that the relevant exposure limit values are being exceeded or that this is to be expected.2 they shall take account of increases and reductions in noise exposure levels that are to be expected due to:the construction, alteration or improvement of stationary installations, in particular if the projects in question have already been approved or made available for public inspection at the time of the investigation; andthe construction, alteration or demolition of other structures if the projects have been made available for public inspection at the time of the investigation.3 .3130 amended by no i of the o of 1 sept. 2004, in force since 1 oct. 2004 (as 2004 4167).31 repealed by art. 15 of the o of 4 dec. 2015 on railway noise abatement measures, with effect from 1 jan. 2016 (as 2015 5691).art. 3732 noise pollution register 1 in the case of roads, railway installations, aerodromes and military firing ranges and training grounds, the enforcement authorities shall record in specific registers (noise pollution registers) the noise exposure levels measured in accordance with article 36.33 2 the noise pollution registers specify:the noise pollution measured;the calculation procedure used;the input data for the calculation;the classification of the areas exposed to noise in the land use plan;the sensitivity levels applicable;the installations and their owners;the number of persons who are affected by noise exposure levels above the applicable exposure limit values.3 the enforcement authorities are responsible for the supervision and revision of the registers.4 on request, they submit the noise pollution registers to the federal office for the environment. the office may issue recommendations on the standardised recording and presentation of the data.5 the federal office for civil aviation is responsible for measurement of noise exposure levels produced by basel mulhouse airport on swiss territory.6 any person may have access to the noise pollution register provided that confidentiality with respect to manufacturing and business secrets is ensured, and no conflict with other interests that override exists.32 amended by no i of the o of 1 sept. 2004, in force since 1 oct. 2004 (as 2004 4167).33 amended by no i of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223).art. 37a34 determination and control of noise exposure levels 1 the enforcement authorities state the permitted noise exposure level in their decision on the construction, alteration or improvement of an installation.2 if it is established or anticipated that the noise exposure levels due to an installation will deviate significantly and permanently from those quoted in the decision, the enforcement authorities shall take the necessary measures.3 the federal office for the environment may issue recommendations on the standardised recording and presentation of the noise exposure levels in these decisions.34 inserted by no i of the o of 12 april 2000 (as 2000 1388). amended by no i of the o of 1 sept. 2004, in force since 1 oct. 2004 (as 2004 4167).art. 38 method of determination 1 noise exposure levels are determined in the form of a rating sound level, lr, or a maximum sound level, lmax, on the basis of calculations or measurements.352 noise exposure levels due to aircraft shall principally be determined by calculation. the calculations are carried out using recognised state-of-the-art methods. the federal office for the environment shall recommend suitable calculation procedures.363 the requirements for calculation procedures and measuring instruments are given in annex 2.3735 amended by no i of the o of 1 sept. 2004, in force since 1 oct. 2004 (as 2004 4167 4313).36 inserted by no i of the o of 12 april 2000, in force since 1 may 2000 (as 2000 1388).37 originally para. 2.art. 39 point of determination 1 for buildings, noise exposure levels shall be determined at the centre of open windows in rooms sensitive to noise. noise exposure levels due to aircraft may also be determined in the vicinity of the building.382 in the non-developed sector of zones with higher noise abatement requirements, noise exposure levels shall be measured 1.5 m above the ground.3 in building zones that have not yet been developed, noise exposure levels shall be measured at points where the building and planning legislation allows the building of rooms sensitive to noise.38 the correction of 7 may 2019 concerns the french text only (as 2019 1337).section 2 rating art. 40 exposure limit values 1 the enforcement authorities shall rate the exposure to exterior noise due to stationary installations on the basis of the exposure limit values specified in annexes 3 ff.2 the exposure limit value, it is also considered exceeded if it is less than the sum of the levels of exposure to similar types of noise generated by several installations. this does not apply to the planning values for new stationary installations (art. 7 para. 1).3 in the absence of exposure limit values, the enforcement authorities shall rate the noise exposure levels in accordance with article 15 of the act. they shall also take account of articles 19 and 23 of the act.art. 41 validity of the exposure limit values 1 the exposure limit values apply to buildings with rooms sensitive to noise.2 they also apply:in yet undeveloped building zones in areas where the construction of buildings with rooms sensitive to noise is allowed under the building and planning legislation;in the non-developed areas of zones with higher noise abatement requirements.3 for areas and buildings in which, as a rule, people are present either only during the day or only at night, no exposure limit values apply at night or during the day.art. 42 special exposure limit values for rooms in industrial buildings 1 for rooms in industrial buildings (art. 2 para. 6 let. b) lying in areas of sensitivity levels i, ii or iii, the planning and impact thresholds shall be increased by 5 db(a).2 paragraph 1 does not apply to rooms in schools, institutions and homes. it applies to hotels and guesthouses only if these can be adequately ventilated when the windows are closed.art. 43 sensitivity levels 1 in land use zones according to articles 14 ff. of the spatial planning act of 22 june 197939, the following sensitivity levels apply:sensitivity level i in zones with higher noise abatement requirements, notably in leisure zones;sensitivity level ii in zones in which operations that emit noise are not permitted, notably in residential zones and zones for public buildings and installations;sensitivity level iii in zones in which operations emitting a certain level of noise are permitted, notably in residential and industrial zones (mixed zones) and agricultural zones;sensitivity level iv in zones in which operations emitting a high level of noise are permitted, notably in industrial zones.2 parts of land use zones rated as sensitivity levels i or ii may be assigned the next higher level if they are already exposed to noise.39 sr 700 art. 44 procedures 1 the cantons shall ensure that sensitivity levels are assigned to the land use zones in the building regulations or land use plans of the communes.2 the sensitivity levels are assigned at the time of designation or modification of the land use zones, or at the time of modification of the building regulations.403 prior to assignment, the cantons shall determine the sensitivity levels on a case by case basis in accordance with article 43.4 .4140 amended by no iv 31 of the o of 22 aug. 2007 on the formal revision of federal legislation, in force since 1 jan. 2008 (as 2007 4477).41 repealed by no 1 of the o of 27 june 1995, with effect from 1 aug. 1995 (as 1995 3694).chapter 8 final provisions section 1 enforcement art. 4542 responsibilities of the confederation and the cantons43 1 the cantons shall enforce this ordinance unless it delegates enforcement to the confederation.2 if the federal authorities apply other federal laws or international treaties or decisions that relate to the subject matter of this ordinance, they shall also enforce this ordinance. the cooperation of the federal office for the environment and the cantons is governed by article 41 paragraphs 2 and 4 of the act; statutory duties of secrecy are reserved.3 the following authorities are responsible for enforcing the provisions governing emission limitation measures (art. 4, 7-9 and 12), improvements (art. 13, 14, 16-18 and 20) and the determination and control of noise exposure levels (art. 36, 37, 37a and 40):for railway installations:detec, where the provisions relate to major railway projects under the annex to the railways act of 20 december 195744 and are implemented by means of a planning approval procedure,in other cases, the federal office of transport;for civil aerodromes:detec, where the provisions relate to buildings and installations under article 37 of the air navigation act of 21 december 194845 that are used for operation of an aerodrome and are implemented by means of a planning approval procedure,in other cases, the federal office of civil aviation;for national roads:detec, where the provisions are implemented by means of a planning approval procedure,in other cases the federal roads office;for national defence installations: the federal department of defence, civil protection and sport;for electrical installations:the swiss federal office of energy in cases where the federal inspectorate for heavy current installations (esti) has been unable to deal with objections from or resolve disputes with the federal authorities concerned, in accordance with article 16 paragraph 2 letter b of the electricity act of 24 june 190246,in other cases the esti;for cable railway installations according to article 2 of the cable railways act of 23 june 200647: the federal office of transport48.4 in cases where the responsibility for ordering emission limitation measures and improvements lies with the federal authorities, but that for noise protection lies with the cantonal authorities, the two authorities shall coordinate the necessary measures.5 for national roads, detec is also responsible for enforcing the provisions governing soundproofing measures (art. 10 and 15). it coordinates the enforcement of these provisions with the soundproofing measures that are arranged by the cantons.4942 amended by no ii 14 of the o of 2 feb. 2000 to the federal act on the coordination and simplification of decision-making procedures, in force since 1 march 2000 (as 2000 703).43 inserted by annex 2 no 9 of the o of 21 may 2008 on geoinformation, in force since 1 july 2008 (as 2008 2809).44 sr 742.10145 sr 748.046 sr 734.047 sr 743.0148 amended by no i of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223).49 inserted by no i of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223).art. 45a50 national noise pollution survey the federal office for the environment shall conduct a national survey of noise pollution. it shall publish a geo-referenced presentation of the noise pollution in particular for road, railway and aircraft noise and for noise from military firing ranges and training grounds. it shall updates this presentation at least every five years. 50 inserted by no i of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223).art. 4651 geoinformation the federal office for the environment shall provide specifications for the minimal geodata models and presentation models for official geodata under this ordinance, for which it is designated as the federal specialist authority in annex 1 to the geoinformation ordinance of 21 may 200852.51 amended by annex 2 no 9 of the o of 21 may 2008 on geoinformation, in force since 1 july 2008 (as 2008 2809).52 sr 510.620section 2 transitional provisions art. 4753 stationary installations and buildings 1 stationary installations are deemed to be new stationary installations if the decision authorising the start of building work has not yet taken full legal effect when this ordinance comes into force.2 for stationary installations that are to be modified, articles 8-12 apply only if the decision authorising the modification has not yet taken full legal effect when this ordinance comes into force.3 buildings are deemed to be new buildings if planning permission has not yet taken full legal effect when this ordinance comes into force. 4 for buildings that must be modified, articles 31 and 32 paragraph 3 apply only if planning permission has not yet taken full legal effect when this ordinance comes into force.53 amended by no i of the o of 23 aug. 2006, in force since 1 nov. 2006 (as 2006 3693).art. 4854 54 repealed by no i of the o of 30 june 2010, with effect from 1 aug. 2010 (as 2010 3223).art. 48a55 55 inserted by no i of the o of 1 sept. 2004 (as 2004 4167). repealed by no i of the o of 21 feb. 2018, with effect from 1 april 2018 (as 2018 965).art. 4956 56 repealed by no iv 31 of the o of 22 august 2007 on the formal revision of federal legislation, with effect from 1 jan. 2008 (as 2007 4477).section 3 commencement art. 50 this ordinance comes into force on 1 april 1987.annex 157 57 amended by no ii of the o of 23 aug. 2006, in force since 1 nov. 2006 (as 2006 3693)(art. 10 para. 1 and 15 para. 1)requirements for soundproofing of windows 1 the weighted sound reduction index for the building, including the spectrum-adjustment factor, r'w + (c or ctr), measured on site of the windows and related elements such as roller-shutter boxes and quiet ventilators must be at least equal to the following minimum values, depending on the relevant rating sound level lr:lr in db(a)r'w + (c or ctr) in dbdaynightup to 75up to 7032over 75over 70382 r'w is equal to at least 35 db and at most 41 db.3 for particularly large windows, the enforcement authorities shall impose appropriate requirements that are stricter than paragraphs 1 and 2.4 the weighted sound reduction index for buildings, r'w, and the spectrum-adjustment factor, c or ctr, are determined according to the recognised rules, in particular the iso 140 and iso 717 standards of the international standards organisation.5 the spectrum-adjustment factor ctr applies to predominantly low frequency noise, in particular from roads with a maximum speed of up to 80 km/h and from airfields. the spectrum-adjustment factor c applies to predominantly high frequency noise, in particular from roads with a maximum speed above 80 km/h and from railways.6 the enforcement authorities may order the installation of quiet ventilators in bedrooms.annex 258 58 amended by no ii para. 1 of the o of 23 aug. 2006 (as 2006 3693). revised in accordance with no ii para. 1 of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223).(art. 38 para. 3)requirements for the calculation procedures and measuring instruments 1 calculation procedures 1 the procedures used to calculate noise exposure levels must take account of:the emissions from the noise source of the installation;the distance between the exposure point and the noise source of the installation or the flight paths (attenuation due to propagation and dissipation);the influence of the ground on the propagation of the noise (ground effects);the influence of buildings and natural obstacles on the propagation of the noise (attenuation due to obstacles and reflection).2 the federal office for the environment (foen) recommends suitable state-of-the-art calculation procedures to the enforcement authorities.2 measuring instruments the requirements of the measuring instruments ordinance of 15 february 200659 and the corresponding implementing provisions of the federal justice and police department apply to the instruments used to measure noise exposure levels.59 sr 941.210annex 3 (art. 40 para. 1)exposure limit values for road traffic noise 1 scope the exposure limit values specified in number 2 apply to road traffic noise. this includes noise on roads from motor vehicles (motor vehicle noise) and railways (railway noise).2 exposure limit values sensitivity level (art. 43)planning valuelr in db(a)impact thresholdlr in db(a)alarm valuelr in db(a)daynightdaynightdaynighti504055456560ii554560507065iii605065557065iv6555706075703 determination of the rating sound level 31 principles 1 the rating sound level lr for road traffic noise is determined from the partial rating sound levels for motor vehicle noise (lr1) and railway noise (lr2) as follows:lr = 10 x log (100,1 x lr1 + 100,1 x lr2 )2 the partial rating sound level lr1 is the sum of the equivalent continuous aweighted sound level leq,m resulting from motor vehicles, and the level correction k1:lr1 = leq,m + k13 the partial rating sound level lr2 is the sum of the equivalent continuous aweighted sound level leq,b resulting from the railways, and the level correction k2:lr2 = leq,b + k24 the partial rating sound levels lr1 and lr2 are determined for average day and night traffic flows assuming a dry road surface.32 average day and night traffic 1 the average day and night traffic is defined as the annual average of the hourly traffic between 06 and 22 hours and between 22 and 06 hours.2 the hourly motor vehicle traffic during the day (nt) and at night (nn) are each divided into two partial traffic flows, nt1 and nt2, and nn1 and nn2, respectively.3 the partial traffic flows nt1 and nn1 for motor vehicle traffic include private cars, delivery vehicles, minibuses, motorcycles and trolley buses.4 the partial traffic flows nt2 and nn2 for motor vehicle traffic comprise lorries, articulated lorries, coaches, motorcycles and tractors.5 railway traffic comprises all scheduled and non-scheduled trains, including service journeys.33 determination of average day and night motor vehicle traffic 1 the average day and night traffic (nt, nn) and the partial traffic flows (nt1, nt2, nn1, nn2) are determined:from traffic surveys for existing roads;from forecasts of traffic volume for roads which are to be built or modified.2 where insufficient data is available from traffic surveys, or no detailed forecasts exist, the traffic flows nt, nn, nt1, nt2, nn1 and nn2 are calculated from the average daily traffic (adt; vehicles per 24 h) as follows:nt = 0.058 adt nn = 0.009 adtnt1 = 0.90 nt nn1 = 0.95 nnnt2 = 0.10 nt nn2 = 0.05 nn3 the adt is determined according to the recognised principles of traffic planning and traffic technology.34 determination of the average day and night traffic for railways the average day and night traffic for railways is determined:from the timetable and traffic data for existing railway installations;from traffic volume forecasts for railway installations which are to be built or modified.35 level corrections 1 the level correction k1 for motor vehicle noise is calculated as follows from the average day and night traffic:k1 = -5 for n < 31.6k1 = 10 log(n/100) for 31.6 n 100k1 = 0 for n > 100here, n stands for the hourly motor vehicle traffic nt or nn. 2 the k2 level correction for railway noise is equal to -5. for screeching railway noise that occurs frequently and is clearly audible, the k2 level correction is equal to 0.annex 4 (art. 40 para. 1)exposure limit values for railway noise 1 scope 1 the exposure limit values specified in number 2 apply to the noise from standard and narrow gauge railways.2 noise on roads arising from railways is considered equivalent to road traffic noise (annex 3 number 1).3 the noise from cable railways and railway workshops, energy installations and similar railway works, is considered equivalent to noise from industrial and commercial installations (annex 6 number 1).2 exposure limit values sensitivity level (art. 43)planning valuelr in db(a)impact thresholdlr in db(a)alarm valuelr in db(a)daynightdaynightdaynighti504055456560ii554560507065iii605065557065iv6555706075703 determination of the rating sound level 31 principles 1 the rating sound level lr for railway noise is determined from the partial rating sound levels for vehicle noise (lr1) and shunting noise (lr2) as follows:lr = 10 x log (100,1 x lr1 + 100,1 x lr2)2 the partial rating sound level lr1 is the sum of the equivalent continuous aweighted sound level leq,f resulting from vehicle operation, and the level correction k1:lr1 = leq,f + k13 the partial rating sound level lr2 is the sum of the equivalent continuous aweighted sound level leq,r resulting from shunting, and the level correction k2:lr2 = leq,r + k24 the partial rating sound levels lr1 and lr2 are determined for average day and night traffic flows.32 average day and night operations 1 average day and night operations are hauling and shunting operations from 06 to 22 hours and from 22 to 06 hours respectively, averaged over the year.2 vehicle operations comprise all scheduled and non-scheduled trains, including service journeys.3 shunting comprises all shunting movements and operations intended for the purpose of connecting and disconnecting trains.4 vehicle operations and shunting are determined:a. from the timetable and operating data for existing railway installations;b. from operational forecasts for railway installations which are to be built or modified.33 level corrections 1 the level correction k1 for transport noise is calculated as follows:k1 = -15 for n < 7.9k1 = 10 log (n/250) for 7.9 n 79k1 = 5 for n > 79here, n stands for the number of train journeys per day or night.2 the level correction k2 for shunting noise is based on the frequency and audibility of all pulsating, tonal and screeching types of noise, and is equal to:audibility of all types of noisefrequency of all types of noiseseldomoccasionalfrequentweak024clear246strong468annex 560 60 amended by no i of the o of 30 may 2001 (as 2001 1610). revised in accordance with no ii para. 1 of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223).(art. 40 para. 1)exposure limit values for noise from civil aerodromes 1 scope and definitions 1 the exposure limit values specified in number 2 apply to the noise from civil air transport at civil aerodromes.2 civil aerodromes means the national airports in basel, geneva and zurich, the other licensed aerodromes and the airfields.3 light aircraft means an aircraft having a maximum permissible take-off weight of 8618 kg or less.4 heavy aircraft means an aircraft having a maximum permissible take-off weight of over 8618 kg.5 the noise from repair workshops, maintenance works and similar operations at civil aerodromes is considered equivalent to the noise from industrial and commercial installations (annex 6 sec. 1).2 exposure limit values 21 exposure limit values for light aircraft traffic noise, expressed as lrk sensitivity level (art. 43)planning valueimpact thresholdalarm valuelrk in db(a)lrk in db(a)lrk in db(a)i505565ii556070iii606570iv65707522 exposure limit values for total traffic noise from light and heavy aircraft, expressed as lr for the total traffic noise from civil aerodromes used by heavy aircraft, the following exposure limit values apply in addition to the exposure limits expressed as lrk:221 daytime exposure limit values (06-22 hours), expressed as lrt sensitivity level(art. 43)planning valueimpact thresholdalarm valuelrt in db(a)lrt in db(a)lrt in db(a)i5355 60ii57 60 65iii606570iv657075222 night time exposure limit values for the first (22-23 hours), the second (23-24 hours) and the last night hour (05-06 hours), expressed as lrn sensitivity level(art. 43)planning valueimpact thresholdalarm valuelrn in db(a)lrn in db(a)lrn in db(a)i4345 55 ii47/50150/55160/651iii50 55 65iv55 60 701 the higher value applies for the first night hour (22-23 hours)23 exposure limit values expressed as max for civil aerodromes used exclusively by helicopters (heliports), the following exposure limit values, expressed as max, apply in addition to the exposure limits expressed as lrk:sensitivity level (art. 43)planning valueimpact thresholdalarm valuein db(a)in db(a)in db(a)i707585ii758090iii808590iv8590953 determination of the rating sound level lrk for light aircraft noise 31 principles 1 the rating sound level lrk for light aircraft noise is the sum of the equivalent continuous a-weighted sound level leqk and the level correction k:lrk = leqk + k2 the equivalent continuous sound level leqk is determined for the average number of hourly aircraft movements (number of movements n) for a day with average peak operations.3 aircraft movements are all landings and takeoffs of light aircraft. go-arounds count as two flight movements.32 number of aircraft movements n for existing civil aerodromes for existing civil aerodromes, the number of aircraft movements n is determined as follows:the six months with the greatest amount of traffic during the operating year are identified;for these six months, the average daily number of flight movements is determined separately for each of the seven days of the week. the average daily values for the two days of the week with the most traffic are designated as n1 and n2;n is determined by averaging n1 and n2 over the twelve daytime hours as follows:n = (n1 + n2)/2433 number of aircraft movements n for new civil aerodromes 1 for civil aerodromes which are to be built or modified, the number of flight movements n is determined from forecasts of traffic volume.2 if no detailed forecasts can be made, n is calculated from the forecasted annual number of aircraft movements n as follows:n = (n x 2,4)/(365 x 12)34 level corrections the level correction k is calculated from the annual number of aircraft movements n as follows:k = 0 for n < 15 000k = 10 x log (n/15 000) for n 15 0004 determination of the rating sound level lr for traffic at civil aerodromes used by heavy aircraft 41 principles 1 at civil aerodromes used by heavy aircraft, the rating sound level lr of total traffic is determined based on the relevant aircraft traffic, whereby separate calculations are made for daytime (06-22 hours), and for the first (22-23 hours), second (23-24 hours) and last (05-06 hours) night hours.2 at civil aerodromes used by heavy aircraft, the daytime rating sound level for total traffic lrt is calculated from the rating sound levels for light aircraft lrk and heavy aircraft lrg as follows:lrt = 10 x log (10 0,1 x lrk + 10 0,1 x lrg)3 for heavy aircraft noise, the daytime rating sound level is the sum of the equivalent continuous a-weighted sound level leqg arising from aircraft operations between 06 and 22 hours, averaged over one year:lrg = leqg 4 for heavy aircraft noise, the rating sound level lrn for the first, the second and the last night hour is the equivalent continuous a-weighted sound level leqn, each averaged over one hour, arising from aircraft operations during the periods 22-23, 23-24 hours and 05-06 hours, averaged over one year:lrn = leqn42 relevant aircraft traffic 1 the equivalent continuous sound levels leqg and leqn are determined from the operational data.2 for civil aerodromes that are to be built or modified, the relevant aircraft traffic is determined from forecasts of traffic volume.3 flights taking place after the second night hour (23-24 hours) and before the last night hour (05-06) are assigned to the second night hour (23-24 hours).5 determination of the average maximum noise level max for heliports 1 the average maximum noise level max for heliports is the energetic average of the maximum noise level of a representative number of passing flights or overflights.2 measurements of max are carried out with the instruments set on slow.annex 6 (art. 40 para. 1)exposure limit values for industrial and commercial noise 1 scope 1 the exposure limit values specified in number 2 apply to noise:from industrial, commercial and agricultural installations;from goods handling in industrial, commercial and agricultural installations and at railway stations, aerodromes, etc.;from traffic within the perimeter of industrial and commercial installations and farmyards;from multi-storey car parks and from larger off-road car parks;from heating, ventilation and air-conditioning installations.2 energy, waste processing and transport installations, aerial cableways and cable railways, ski lifts and racing tracks that are used regularly for sustained periods of time are considered equivalent to industrial and commercial installations.2 exposure limit values sensitivity level (art. 43)planning valuelr in db(a) impact thresholdlr in db(a)alarm valuelr in db(a)daynightdaynightdaynighti504055456560ii554560507065iii605065557065iv6555706075703 determination of the rating sound level 31 principles 1 the rating sound level lr for industrial, commercial and similar types of noise is determined from the partial rating sound levels lr,i for each noise phase as follows, whereby separate calculations are made for daytime (07 to 19 hours) and night-time (19 to 07 hours):2 the partial rating sound level lr,i is determined for the average daily duration of the noise phase i as follows:lr,i = leq,i + k1,i + k2,i + k3,i + 10 x log (ti/to)where:leq,i is the equivalent continuous a-weighted sound level during the noise phase i;k1,i is the level correction for the noise phase i;k2,i is the level correction for the noise phase i;k3,i is the level correction for the noise phase i;ti is the average daily duration of the noise phase i in minutes;to = 720 minutes.3 noise phases are time periods in which the exposure point is subject to uniform noise with respect to sound level, frequency and pulse content.32 average daily duration of noise phases 1 the average daily duration (ti) of the noise phase i is calculated from its annual duration (ti) and the annual number of working days (b) as follows:ti = ti/b2 for new or modified installations, the average daily duration of the noise phase i is determined from operational forecasts.33 level corrections 1 value of the level correction k1:a. for noise according to number 1 paragraph 1 letters a and b5b. for noise according to number 1 paragraph 1 letter c0c. for noise according to with number 1 paragraph 1 letter d0 by day5 at nightd. for noise according to number 1 paragraph 1 letter e5 by day10 at night.2 the level correction k2 takes account of the audibility of the tonality content of the noise at the point of exposure and is equal to:a. for non-audible tonality content 0b. for weakly audible tonality content 2c. for clearly audible tonality content 4d. for strongly audible tonality content 6.3 the level correction k3 takes account of the audibility of the pulse content of the noise at the point of exposure and is equal to:a. for non-audible pulse content 0b. for weakly audible pulse content 2c. for clearly audible pulse content 4d. for strongly audible pulse content 6.annex 761 61 amended by no i of the o of 23 aug. 2006 (as 2006 3693.). revised in accordance with no ii para. 1 of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223).(art. 40 para. 1)exposure limit values for noise from civil firing range installations 1 scope 1 the exposure limit values specified in number 2 apply to the noise from civil firing range installations at which only hand guns or small arms are used to fire at stationary or moving targets.2 the hand guns or small arms used at the firing range installations are allocated to the following weapons categories:assault rifles and portable firearms of comparable calibre;small arms with centre fire cartridges, in particular ordnance pistols;small arms with rim fire cartridges;portable firearms with rim fire cartridges;sporting guns with ball cartridges;shotguns;other firearms.3 firing range installations are public if they are used for shooting practice in accordance with articles 62 and 63 of the armed forces act of 3 february 199562.62 sr 510.102 exposure limit values sensitivity level(art. 43)planning valueimpact thresholdalarm valuelr in db(a)lr in db(a)lr in db(a)i505565ii556075iii606575iv657080for noise from public installations according to number 1 paragraph 363, at which, for weapons in categories a or b, the level correction ki < -15, no alarm values apply. for such installations, no soundproofing measures under article 15 are required. the level correction ki is calculated as specified in number 321.63 the reference was amended on 1 aug. 2010 pursuant to art. 12 para. 2 of the publications act of 18 june 2004 (sr 170.512).3 determination of rating sound level 31 principles 1 the rating sound level lr for the noise from firing range installations is the energetic sum of the partial rating sound level lri for the weapons categories:2 the partial rating sound level lri is the sum of the average single shot sound level li of a weapons category and the level correction ki:lri = li + ki3 the average single shot sound level li is the energetic average weighted according to the number of shots of the energetically averaged single shot sound level lj of a type of weapon or type of ammunition:4 the energetically averaged single shot sound level lj must be determined using the measurements of the a-weighted maximum sound level with the fast time constants.where:mj is the number of shots fired annually using a single type of weapon or a single type of ammunition of a weapons category, averaged over three years;mi is the number of shots fired annually using weapons of a single category, averaged over three years.32 level correction 321 calculation 1 the level correction ki is calculated as follows:ki = 10 x log (dwi + 3 x dsi) + 3 x log mi - 44where:dwi is the number of annual firing half-days falling on a weekday, averaged over three years, for each weapons category;dsi is the number of annual firing half-days falling on a sunday or a general public holiday, averaged over three years, for each weapons category.2 when determining the number of firing half-days and the number of shots, all exercises that take place regularly over a period of three years must be taken into account.322 determination of the number of firing half-days 1 any firing exercise taking place in the morning or in the afternoon and lasting more than two hours counts as a firing half-day. exercises lasting two hours or less count as half a firing half-day.2 for new or modified firing range installations, the number of firing half-days is determined on the basis of operational forecasts. for existing firing range installations, the number of firing half-days is determined by counting.323 determination of the number of shots 1 for existing firing range installations, the number of shots mi per weapons category is determined from the operational logs.2 if the operational logs of existing firing range installations are incomplete or if the firing range installations are new or have been modified, the number of shots m is determined from forecasts of future use.annex 864 64 inserted by no ii of the o of 27 june 1995 (as 1995 3694). revised in accordance with no ii para. 2 of the o of 12 april 2000 (as 2000 1388) and of the o of 23 aug. 2006, in force since 1 nov. 2006 (as 2006 3693).(art. 40 para. 1)exposure limit values for noise at military aerodromes 1 scope 1 the exposure limit values specified in number 2 apply to traffic noise from military aerodromes.2 civil regional airports and airfields used for military purposes also count as military aerodromes.3 helicopters are considered equivalent to propeller aircraft.4 noise from repair workshops, maintenance workshops and similar operations at military aerodromes is considered equivalent to the noise from industrial and commercial installations (annex 6 number 1).2 exposure limit values 21 exposure limit values expressed as lr sensitivity level(art. 43)planning valueimpact thresholdalarm valuelr in db (a)lr in db (a)lr in db (a)i505565ii606570iii606570iv65707522 exposure limit values expressed as lrz in addition to the exposure limit values expressed as lr, the exposure limit values specified in annex 5 and expressed as lr, referred to below as lrz, also apply to the noise from civilian traffic at military airfields.3 determination of the rating sound level 31 principles 1 the rating sound level lr for noise from military aerodromes is calculated from the rating sound levels lrm for military aircraft noise and lrz for civil aircraft noise, as follows:lr = 10 log (100,1lrm + 100,1lrz)2 the rating sound level lrz is determined in the same way as the corresponding lr for civil aerodromes specified in annex 5 numbers 3 and 4.3 the rating sound level lrm is determined from the partial rating sound levels lrj, for noise from jet aircraft, and lrp, for noise from propeller aircraft, as follows:lrm = 10 log (100,1lrj + 100,1lrp)4 the partial rating sound level lrj is the sum of the equivalent continuous a-weighted sound level leqj arising from the operation of jet aircraft, and the level corrections k0 and k1:lrj = leqj + k0 + k15 the partial rating sound level lrp is the sum of the equivalent continuous a-weighted sound level leqp arising from the operation of propeller aircraft, and the level corrections k0 and k2:lrp = leqp + k0 + k26 the equivalent continuous sound levels leqj and leqp are calculated for the average number of hourly flight movements for a day with an average level of traffic, whereby flight movements of jet aircraft and propeller aircraft are counted separately (number of flight movements nj and np).7 flight movements are all takeoffs and landings of jet and propeller aircraft. go-arounds count as two flight movements.32 numbers of flight movements nj and np for military aerodromes 1 for existing military aerodromes, the number of flight movements nj and np are determined as follows:a. the six months of the operating year with the greatest amount of traffic are identified, whereby flight movements of jet aircraft and propeller aircraft are counted separately;b. for these six months, the number of flight movements of jet aircraft mj and propeller aircraft mp are determined;c. the numbers of flight movements nj and np are calculated from mj and mp by averaging them over 130 days and twelve daytime hours:nj = mj/(12 x 130) np = mp/(12 x 130)2 for military aerodromes that are to be built or modified, the numbers of flight movements nj and np are determined from forecasts of traffic volume.33 level corrections 1 the level correction k0 is equal to -8.2 the level correction k1 is calculated from the annual number of flight movements of jet aircraft nj as follows:k1 = 0 for nj < 15 000k1 = 10 x log (nj/15 000) for nj 15 0003 the level correction k2 is calculated from the annual number of flight movements of propeller aircraft np as follows:k2 = 0 for np < 15 000k2 = 10 x log (np/15 000) for np 15 000annex 965 65 inserted by no ii para. 2 of the o of 30 june 2010, in force since 1 aug. 2010 (as 2010 3223). (art. 40 para. 1)exposure limit values for noise from military firing ranges and training grounds 1 scope 1 the exposure limit values specified in number 2 apply to the firing noise on military firing ranges and training grounds.2 in addition to the exposure limit values specified in number 2, the exposure limit values specified in annex 7 apply to the noise from civil firing on military firing ranges and training grounds, with the exception of firing by the police and border guards.3 noise from repair workshops, maintenance workshops and similar operations and noise from traffic on military firing ranges and training grounds is considered equivalent to the noise from industrial and commercial installations (annex 6 number 1).4 noise from helicopters on military firing ranges and training grounds is considered equivalent to the noise from heliports (annex 5 numbers 23 and 5).2 exposure limit values sensitivity level (art. 43)planning valueimpact thresholdalarm valuelr in db(a)lr in db(a)lr in db(a)i505565ii556070iii606570iv6570753 determination of the rating sound level 31 principles the rating sound level lr for the firing noise from military firing ranges and training grounds is calculated as follows from the sound levels lae1 and lae2 and the level corrections k1 and k2: lr =10 . log(100. 1.l ae1 +100. 1.(l ae2 +k1) ) - 10 . log(t) + k2where:lr rating sound level for noise from military firing ranges and training grounds;t rating time in seconds = 52 weeks 5 days 12 hours 60 minutes 60 seconds;lae1 sound exposure level of all the shooting events of a year which have taken place mondays to fridays between 07 and 19 hours;lae2 sound exposure level of all the shooting events of a year which have taken place outside of the lae1 timeframe;k1 5k2 1532 determination of shooting operations 1 for existing military firing ranges and training grounds, the number of shots is determined from surveys carried out over three years.2 if, for existing military firing ranges and training grounds, no data on the number of shots is available or if the installations are new or have been modified, the number of shots is determined from forecasts of future use.

814.50 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.radiological protection act(rpa)of 22 march 1991 (status as of 1 may 2017)the federal assembly of the swiss confederation,on the basis of articles 64, 74, 118, 122 und 123 of the federal constitution1,2and having considered the dispatch of the federal council dated 17 february 19883,decrees:1 sr 1012 amended by annex no ii 5 of the foodstuffs act of 20 june 2014, in force since 1 may 2017 (as 2017 249; bbl 2011 5571).3 bbl 1988 ii 181chapter 1 general provisions art. 1 purpose the purpose of this act is to protect people and the environment against dangers from ionizing radiation.art. 2 scope 1 the act applies to all activities, installations, events and situations that may involve an ionizing radiation hazard, and in particular to:a.the handling of radioactive substances and of installations, equipment and articles containing radioactive substances or capable of emitting ionizing radiation;b.events that may lead to an increase in environmental radioactivity.2 the term handling covers extraction, manufacturing, processing, distribution, installation, use, storage, transport, disposal, import, export and transit, and any other form of transfer to a third party.43 articles 28-38 are not applicable to activities requiring a licence under the nuclear energy act of 21 march 20035.64 the federal council may provide for exemptions from this act in the case of substances with low levels of radioactivity.4 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).5 sr 732.16 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).art. 3 additional provisions in addition to the provisions of this act, the following provisions are applicable:a.7for nuclear facilities, nuclear goods and radioactive waste, the nuclear energy act of 21 march 20038;b.for nuclear damage caused by nuclear facilities or the transport of nuclear materials, the nuclear energy liability act of 18 march 19839;c.for off-site transport of radioactive substances, the federal regulations on the transport of hazardous goods.7 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).8 sr 732.19 sr 732.44art. 4 costs-by-cause principle anyone who causes measures to be taken under this act shall bear the costs thereof.art. 5 research, development, training 1 the confederation shall promote scientific research on the effects of radiation and radiological protection, as well as training in the area of radiological protection.2 it may:a.promote development activities in these areas;b.train specialists;c.participate in enterprises devoted to research or training.art. 6 qualifications 1 only duly qualified persons shall be permitted to carry out activities that may involve an ionizing radiation hazard.2 the federal council shall specify the requirements for the qualifications of such persons.art. 7 commissions 1 the federal council shall establish the following advisory commissions:a.commission for radiological protection10;b.commission for abc-protection11.122 it shall define their responsibilities.10 the name of this administrative unit was amended by art. 16 para. 3 of the publications ordinance of 17 nov. 2004 (as 2004 4937), in force since 1 jan. 2015.11 the name of this administrative unit was amended by art. 16 para. 3 of the publications ordinance of 17 nov. 2004 (as 2004 4937), in force since 1 jan. 2015.12 amended by annex no ii 9 of the federal act of 22 march 2002 on the revision of organisational provisions of federal legislation, in force since 1 feb. 2003 (as 2003 187; bbl 2001 3845).chapter 2 protection of people and the environment section 1 principles of radiological protection art. 8 justification of radiation exposure an activity that involves the exposure of people or the environment to ionizing radiation (radiation exposure) may only be carried out if it can be justified in terms of the associated benefits and risks.art. 9 limitation of radiation exposure all measures dictated by experience and the current state of science and technology must be adopted in order to limit the radiation exposure of each individual person and of all parties concerned.art. 10 dose limits the federal council shall, in accordance with the current state of scientific knowledge, specify limits for radiation exposure (dose limits) for persons who may be exposed to an increased level of controllable radiation compared with the general population as a result of their work or other circumstances (exposed persons).section 2 protection of exposed persons art. 11 compliance with dose limits anyone who handles or is responsible for a source must take all measures necessary to ensure compliance with the dose limits.art. 12 determination of the radiation dose 1 in exposed persons the radiation dose must be determined by appropriate methods.2 the federal council shall regulate determination of the radiation dose. it shall define, in particular:a.those cases where radiation exposure is to be measured individually (personal dosimetry);b.the intervals at which the radiation dose is to be determined;c.the requirements for approval of personal dosimetry laboratories;d.the required retention period for the results of personal dosimetry.3 exposed persons are required to undergo any dosimetry prescribed. they shall be informed of the results.art. 13 medical measures for occupationally exposed persons 1 occupationally exposed workers covered by compulsory insurance are subject to the medical measures for the prevention of occupational diseases specified in articles 81-87 of the accident insurance act of 20 march 198113.2 the federal council may also specify medical measures for other occupationally exposed persons.3 occupationally exposed persons are required to undergo any medical examinations prescribed.13 sr 832.20art. 14 disclosure of medical data 1 the physician charged with the medical examination shall disclose to the supervisory authority any data necessary for medical surveillance and the compilation of statistics. the supervisory authority is not permitted either to use such data for other purposes or to pass it on to third parties.2 the federal council shall specify the data to be disclosed to the supervisory authority. it shall define the retention period.art. 15 medical applications 1 no dose limits are specified for patients exposed to radiation for diagnostic or therapeutic purposes.2 the radiation exposure of patients shall be at the discretion of the person responsible. however, such persons must comply with the principles of radiological protection specified in articles 8 and 9.3 the federal council shall issue provisions for the protection of patients.art. 16 responsibility within enterprises 1 the licence holder or the persons in charge of an enterprise are responsible for ensuring compliance with the radiological protection regulations. for this purpose, they are required to appoint an appropriate number of experts and to provide them with the necessary powers and resources.2 all persons working in an enterprise are required to support the management and the experts with regard to radiological protection measures.section 3 monitoring of the environment and protection of the public in the event of increased radioactivity art. 17 environmental monitoring 1 in the environment, there shall be regular monitoring of ionizing radiation and of levels of radioactivity, particularly in air, water, soil, foodstuffs and feedingstuffs.2 the federal council shall take the necessary measures; in particular, it shall designate the bodies and institutions responsible for monitoring.3 it shall ensure that the results of monitoring are published.art. 1814 off-site limits 1 for the purpose of environmental monitoring, the federal council shall specify off-site limits for radionuclides and for direct radiation.2 it shall specify the off-site limits so that, according to the standards of science and technology or based on experience, exposure to radiation below these limits does not endanger human beings, animals or plants, their communities or habitats.3 for radionuclides in foodstuffs, the maximum concentrations in terms of the foodstuffs legislation apply.14 amended by annex no ii 5 of the foodstuffs act of 20 june 2014, in force since 1 may 2017 (as 2017 249; bbl 2011 5571).art. 19 emergency response organization 1 the federal council shall establish an emergency response organization for incidents that could endanger the public as a result of increased radioactivity.2 the emergency response organization shall have, in particular, the following responsibilities:a.in the event of an incident, it shall forecast the dangers arising for the public;b.it shall monitor the extent and course of increased radioactivity and assess possible impacts on people and the environment;c.where there is an imminent danger, it shall order the necessary emergency measures and supervise their implementation.3 the details shall be elaborated by the federal council. it shall ensure that the emergency response organization:a.informs the competent federal and cantonal agencies of the extent of the danger and requests the necessary protective measures;b.informs the public.art. 20 measures in response to danger arising from increased radioactivity 1 in the event of danger arising from increased radioactivity, the federal council shall order the measures necessary:a.to protect the public;b.to secure supplies throughout the country;c.to maintain essential public services.2 it shall issue the regulations required in the event of danger arising from increased radioactivity. in particular, it shall specify:a.the radiation doses acceptable in exceptional situations;b.the duty of persons and undertakings to assume responsibility, within the scope of their usual occupational and entrepreneurial activities, for certain tasks that are indispensable for the protection of the public; the life and health of the persons deployed shall be protected;c.the equipment, training and insurance cover required for persons charged with special tasks.3 if the federal council and the emergency response organization are not in a position to order the necessary measures, the cantonal governments or, in urgent cases, the competent cantonal agencies or, if need be, the communal authorities shall take the necessary measures.art. 21 implementation of measures 1 unless the federal council assigns responsibility for implementation to the federal authorities, the cantons and communes shall be responsible for the preparation and execution of measures in accordance with article 20. the cantons shall collaborate with the emergency response organization.2 if the cantonal or communal bodies responsible for implementation are not in a position to fulfil their functions, the federal council may place them under the authority of the emergency response organization or instruct other cantons to put available resources at their disposal.3 the confederation, cantons and communes may also engage private organizations for the implementation of certain measures.art. 22 emergency protection 1 in cases where the release of dangerous amounts of radioactive substances into the environment cannot be ruled out, the enterprises concerned shall be required, as part of the licensing procedure:a.to establish, at their own expense, an alarm system for the population at risk or to contribute proportionally to the costs of a general alarm system;b.to participate in the preparation and implementation of emergency protection measures.2 the federal council shall define the responsibilities of the competent federal, cantonal and communal agencies.art. 23 international cooperation the federal council may conclude international agreements concerning:a.the mutual exchange of information on environmental radioactivity;b.immediate notification in the event of danger arising from radioactivity that could cross international borders;c.the harmonization of plans for measures to be taken in the event of crossborder radioactive contamination.art. 24 persistently increased environmental radioactivity if increased levels of radioactivity from natural or other sources are detected in the environment over a prolonged period, the federal council may order special measures to limit radiation exposure. it may involve the cantons for purposes of implementation.section 4 radioactive waste art. 25 definition and principles 1 radioactive waste means radioactive substances or radioactively contaminated materials which are not reused.2 radioactive substances are to be handled in such a way that as little radioactive waste as possible is generated.3 radioactive waste arising in switzerland must, as a general rule, be disposed of in this country. by way of exception, an export licence may be granted for the disposal of radioactive waste if:a.the recipient country has consented to the import of the radioactive waste for disposal in an international agreement;b.an appropriate nuclear facility meeting international standards of science and technology is available in the recipient country;c.transit has been approved by the transit countries;d.the sender has entered into a binding agreement with the recipient of the radioactive waste, with the approval of the authority designated by the federal council, to the effect that the sender will take back the waste if necessary 154 by way of exception, an import licence may be granted for radioactive waste that does not originate in switzerland but is to be disposed of in this country if:a.switzerland has consented to the import of the radioactive waste for disposal in an international agreement;b.an appropriate nuclear facility meeting international standards of science and technology is available in switzerland;c.transit has been approved by the transit countries;d.the recipient has entered into a binding agreement with the sender of the radioactive waste, with the approval of the country of origin, to the effect that the sender will take back the waste if necessary.1615 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).16 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).art. 26 handling of radioactive waste on-site and discharge to the environment 1 on-site, radioactive waste must be handled and stored in such a way as to minimize releases of radioactive substances to the environment.2 the federal council shall specify the conditions under which low-level radioactive waste may be discharged to the environment.3 radioactive waste that is not to be discharged to the environment must be suitably retained or securely contained, possibly in solidified form, collected and stored at a site approved by the supervisory authority while awaiting surrender or export.1717 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).art. 27 surrender18 1 anyone who produces radioactive waste not arising as a result of the use of nuclear energy is required to surrender it to a centre designated by the competent authority.2 the waste producer must bear the costs of disposal.193 the federal council shall regulate the treatment of waste on-site and its surrender.204 if immediate surrender or disposal is not possible, or not appropriate for reasons of radiological protection, the waste must be placed in supervised interim storage.2118 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).19 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).20 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).21 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).chapter 3 licences and supervision art. 28 mandatory licensing a licence is required by anyone who:a.handles radioactive substances or equipment and articles containing radioactive substances;b.manufactures, distributes, installs or uses installations and equipment capable of emitting ionizing radiation;c.administers ionizing radiation and radioactive substances to humans.art. 29 powers of the federal council the federal council may:a.subject other activities that may involve an ionizing radiation hazard to mandatory licensing;b.exempt activities specified in article 28 letters a or b from mandatory licensing if an ionizing radiation hazard can be ruled out;c.specify the conditions under which certain types of articles, installations and equipment containing radioactive substances or capable of emitting ionizing radiation may, after testing of the standard model, be granted general approval or approval restricted to certain applications.art. 3022 licensing authorities the federal council shall designate the licensing authorities.22 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).art. 31 conditions a licence shall be granted if:a.the applicant or an expert appointed by the applicant (art. 16) has the necessary qualifications;b.the enterprise has an appropriate number of experts at its disposal;c.the applicant and the experts ensure safe operation;d.the enterprise has adequate liability insurance;e.the installations and equipment are in accordance with the current state of science and technology with regard to radiological protection;f.radiological protection is assured in accordance with this act and the implementing provisions.art. 32 licence holder and content 1 the licence shall only be valid for the designated enterprise or the designated person.2 it shall contain a description of the licensed activity, including any requirements and stipulations, and give the names of the experts responsible for radiological protection. it shall be granted for a limited period.3 the licensing authority may transfer the licence to a new holder, provided the latter meets the conditions specified in article 31.art. 33 modification the licence shall be modified:a.at the holder's request, if the proposed modification meets the conditions for the granting of a licence;b.automatically, where this is necessitated by changes in the actual or legal conditions specified in article 31.art. 34 revocation and expiry 1 the licence shall be revoked:a.if the conditions for granting it are not met or are no longer met;b.if a stipulation associated with the licence or a measure ordered has not been complied with despite notice being given.2 the licence shall expire:a.if it is duly relinquished by the holder;b.at the end of the specified term;c.if the holder dies or, in the case of legal persons and registered companies, the entry in the commercial register is deleted;d.if the enterprise is discontinued or ownership is transferred.3 the licensing authority shall issue a decree declaring the licence to have expired, subject to the possibility of renewal or a transfer in accordance with article 32 paragraph 3.art. 35 duties of notification and provision of information 1 the licence holder must notify the supervisory authority:a.of any proposed modifications to the structure or operation of installations or equipment which could adversely affect operational safety;b.of any plans to use additional radioactive substances or to increase the activity of licensed radioactive substances.2 the licence holder and persons working for the enterprise must provide information to the supervisory authority and its agents, allow them to consult documents and grant access to the premises insofar as this is necessary for the fulfilment of supervisory responsibilities.3 if an inadmissible radiation exposure is suspected or known to have occurred, the licence holder or expert must notify the competent authorities immediately.art. 36 record-keeping requirements 1 anyone who handles radioactive substances or equipment and articles containing radioactive substances is required to keep records thereof.2 reports are to be submitted regularly to the supervisory authority.3 the federal council may waive the record-keeping requirements for low-level radioactive substances.art. 37 supervision 1 the federal council shall designate the supervisory authorities.2 the supervisory authority shall issue the necessary decrees. if necessary, it may take protective measures at the expense of the party responsible. in particular, it may order the discontinuation of operations or the seizure of dangerous substances, equipment or articles.3 it may engage third parties for the implementation of inspections. their responsibilities under criminal and property law are defined by the government liability act of 14 march 195823; with regard to duties of confidentiality and testimony, they are bound by the regulations applicable for federal officials.23 sr 170.32art. 38 removal of sources of risk 1 once a licence is revoked or has expired, the sources of risk must be removed by the former licence holder or the party responsible for them. in particular:a.radioactive substances are to be transferred to another licence holder or disposed of as radioactive waste;b.installations and equipment capable of emitting ionizing radiation are to be transferred to another licence holder or placed in a condition rendering unauthorised operation impossible.2 if necessary, the federal authorities shall take over or seize substances, installations, equipment and articles and shall remove the sources of risk at the licence holder's expense.3 the licensing authority shall determine whether premises with contaminated or activated areas and their surroundings may be used for other purposes.4 the licensing authority shall issue a decree declaring that the sources of risk have been duly removed.chapter 4 liability24 24 revised by the drafting commission of the federal assembly (art. 33 parlpa; as 1974 1051). art. 39 liability 1 anyone who operates equipment or carries out activities involving an ionizing radiation hazard shall be liable for any resultant damage unless it can be demonstrated that all due care was exercised to avoid the damage.2 where two or more persons are liable under paragraph 1, they shall be jointly and severally liable.3 the above is without prejudice to the nuclear energy liability act of 18 march 198325 with regard to nuclear damage caused by nuclear facilities or the transport of nuclear materials.25 sr 732.44art. 40 limitation of liability claims claims for compensation or redress arising from damage caused by ionizing radiation and not covered by the nuclear energy liability act of 18 march 198326 shall be time-barred three years after the injured party has become aware of the damage and of the identity of the liable party, and in any event 30 years after the cessation of the detrimental effects.26 sr 732.44chapter 5 proceedings, legal recourse and fees art. 41 proceedings and legal recourse proceedings and legal recourse shall be governed by the federal act of 20 december 196827 on administrative procedure and the federal act of 16 december 194328 on the organisation of federal justice.27 sr 172.02128 [bs 3 531; as 1948 485 art. 86, 1955 871 art. 118, 1959 902, 1969 737 art. 80 let. b 767, 1977 237 no ii 3 862 art. 52 no 2 1323 no iii, 1978 688 art. 88 no 3 1450, 1979 42, 1980 31 no iv 1718 art. 52 no 2 1819 art. 12 para. 1, 1982 1676 annex no 13, 1983 1886 art. 36 no 1, 1986 926 art. 59 no 1, 1987 226 no ii 1 1665 no ii, 1988 1776 annex no ii 1, 1989 504 art. 33 let. a, 1990 938 no iii para. 5, 1992 288, 1993 274 art. 75 no 1 1945 annex no 1, 1995 1227 annex no 3 4093 annex no 4, 1996 508 art. 36 750 art. 17 1445 annex no 2 1498 annex no 2, 1997 1155 annex no 6 2465 annex no 5, 1998 2847 annex no 3 3033 annex no 2, 1999 1118 annex no 1 3071 no i 2, 2000 273 annex no 6 416 no i 2 505 no i 1 2355 annex no 1 2719, 2001 114 no i 4 894 art. 40 no 3 1029 art. 11 para. 2, 2002 863 art. 35 1904 art. 36 no 1 2767 no ii 3988 annex no 1, 2003 2133 annex no 7 3543 annex no ii 4 let. a 4557 annex no ii 1, 2004 1985 annex no ii 1 4719 annex no ii 1, 2005 5685 annex no 7. as 2006 1205 art. 131 para. 1]. see now: the federal supreme court act of 17 june 2005 (sr 173.110).art. 42 fees the federal council shall set the fees for:a.the granting, transfer, modification and revocation of licences;b.the exercise of supervision and the performance of inspections;c.the collection, conditioning, storage and disposal of radioactive waste.chapter 6 criminal provisions art. 4329 unjustified radiation exposure of persons 1 any person who wilfully subjects someone to manifestly unjustified radiation exposure shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.302 any person who wilfully subjects another to manifestly unjustified radiation exposure with the intention of damaging that person's health shall be liable to a custodial sentence or to a monetary penalty.313 any person who negligently subjects another to manifestly unjustified radiation exposure shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.3229 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).30 amended by art. 333 of the criminal code (sr 311.0) in the amended version of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).31 amended by art. 333 of the criminal code (sr 311.0) in the amended version of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).32 amended by art. 333 of the criminal code (sr 311.0) in the amended version of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).art. 43a33 illegal handling of radioactive substances, unjustified radiation exposure of property 1 any person who wilfully:34a.stores, disposes of or discharges radioactive substances to the environment in contravention of the regulations;b.subjects property of considerable value to manifestly unjustified radiation exposure with the intention of impairing its utilityshall be liable to a custodial sentence not exceeding three years or to a monetary penalty.2 if the offender acted negligently, the penalty shall be a monetary penalty not exceeding 180 daily penalty units.3533 inserted by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).34 amended by art. 333 of the criminal code (sr 311.0) in the amended version of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).35 amended by art. 333 of the criminal code (sr 311.0) in the amended version of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).art. 44 contraventions 1 any person who wilfully or negligently:36a.37carries out acts requiring a licence without having a licence, obtains a licence illegally, or fails to comply with conditions or stipulations included in the licence;b.fails to take the measures required to comply with dose limits;c.fails to undergo prescribed dosimetry;d.fails to fulfil the duties of a licence holder or expert;e.fails to fulfil the duty to surrender radioactive waste or remove sources of risk;f.infringes an implementing regulation, infringement of which is declared to be punishable, or an order addressed to him or her with reference being made to the penalty provided for in this article.shall be liable to a fine.2 the federal council may provide for fines not exceeding 20,000 swiss francs for infringements of regulations issued to deal with danger arising from radioactivity.3836 amended by art. 333 of the criminal code (sr 311.0) in the amended version of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).37 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).38 amended by art. 333 of the criminal code (sr 311.0) in the amended version of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).art. 45 applicability of administrative criminal law 1 the special provisions of the federal act of 22 march 197439 (arts. 14-18) on administrative criminal law are applicable.2 articles 6 and 7 of the federal act on administrative criminal law apply to the contraventions specified in article 43.39 sr 313.0art. 46 proceedings and jurisdiction 1 the felonies and misdemeanours specified in articles 43 and 43a shall be subject to federal criminal jurisdiction.402 infringements under article 44 and article 45 paragraph 1 shall be prosecuted and adjudicated by the competent licensing or supervisory authority. proceedings shall be governed by the federal act of 22 march 197441 on administrative criminal law.40 amended by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).41 sr 313.0chapter 7 final provisions art. 47 enforcement 1 the federal council shall be responsible for enforcement and shall issue the implementing provisions.2 it may delegate to the competent department or subordinate bodies the task of issuing radiological protection regulations for activities requiring a licence under the nuclear energy act of 21 march 200342. it shall take account of the scope of such regulations.433 it may involve the cantons for purposes of enforcement.4442 sr 732.143 inserted by annex no ii 4 of the nuclear energy act of 21 march 2003, in force since 1 dec. 2005 (as 2004 4719; bbl 2001 2665).44 originally para. 2.art. 48 amendment of current legislation .4545 the amendment may be consulted under as 1994 1933.art. 49 transitional provision for liability claims that arose under current legislation but are not yet time-barred when this act commences, the limitation periods specified in article 40 apply.art. 50 referendum and commencement 1 this act is subject to an optional referendum.2 the federal council shall determine the commencement date.commencement date: 1 october 19944646 federal council decree of 22 june 1994.

814.680 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon the remediation of polluted sites(contaminated sites ordinance, cso)of 26 august 1998 (status as of 1 may 2017)the swiss federal council,based on article 32c paragraph 1 second sentence and article 39 paragraph 1 of the environmental protection act of 7 october 19831 (epa),ordains:1 sr 814.01section 1 general provisions art. 1 aim and subject matter 1 this ordinance is intended to ensure that polluted sites are remediated if they cause harmful effects or nuisances, or if there is a real danger that such effects may arise.2 it regulates the following procedures for treating polluted sites:a.their recording in a register;b.the assessment of the need for monitoring and remediation;c.the assessment of the objectives and urgency of remediation;d.the specification of the measures for investigation, monitoring and remediation.art. 2 definitions 1 polluted sites means sites whose pollution originates from waste, and that are restricted in area. they comprise:a.waste disposal sites, i.e. inoperative or operative landfills and other sites where waste has been deposited, except for sites at which only unpolluted excavation material, quarried material or spoil have been deposited;b.industrial sites, i.e. sites whose pollution originates from inoperative or operative installations or industrial operations in which environmentally hazardous substances have been used;c.accident sites, i.e. sites polluted as a result of extraordinary events, including industrial accidents.2 sites in need of remediation are polluted sites that cause harmful effects or nuisances or where there is a real danger that such effects may arise.3 contaminated sites are polluted sites in need of remediation.art. 3 construction and alteration of buildings and installations polluted sites may be modified by the construction or alteration of buildings and installations only if:a.they are not in need of remediation and the project does not make their remediation necessary; orb.their later remediation is not seriously hampered, or, insofar as they are modified by the project, they are remediated at the same time.art. 4 general requirements for measures investigation, monitoring and remediation measures under this ordinance must correspond to the state of the art and be documented by those responsible.section 2 register of polluted sites art. 5 creation of the register 1 the authorities shall identify the polluted sites by evaluating existing information such as maps, registers and reports. they may obtain information from the holders of the sites or from third parties.2 they shall give notice of the content of the proposed register entry to the holders and provide them with the opportunity to state their opinion and to provide clarification. at the request of the holders, the authorities shall issue a declaratory ruling.3 they shall enter in the register those sites that are established as polluted in accordance with paragraphs 1 and 2 or where there is a high probability that they are polluted. where possible, the entries shall contain the following information:a.location;b.type and quantity of waste delivered to the site;c.period of disposal of waste, period of operation, or time of accident;d.investigations and measures already taken for the protection of the environment;e.effects that have already been ascertained;f.endangered environmental areas;g.particular events such as waste incineration, landslides, floods, fires or major accidents.4 the authorities shall divide the polluted sites into the following categories based on the information contained in the register, particularly with regard to type and quantity of waste delivered to the site:a.sites from which no harmful effects or nuisances are to be expected; andb.sites requiring an investigation as to whether they are in need of monitoring or remediation.5 the authorities shall prepare a list of priorities for performing the investigations. in doing so, they shall pay due regard to the information contained in the register concerning the type and quantity of waste delivered to the polluted site, the likelihood of substances being released and the importance of the environmental areas affected.art. 6 keeping the register 1 the authorities shall add information on the following to the entry in the register:a.the need for monitoring and remediation; b.the objectives and urgency of remediation;c.the measures taken or ordered by them for the protection of the environment.2 they shall delete the site entry in the register if: a.the investigations show that the site is not polluted with environmentally hazardous substances; or b.the environmentally hazardous substances have been eliminated.art. 6a2 coordination with the structure and land use planning the authorities shall take account of the register in their structure and land use planning.2 inserted by annex 6 no 9 of the waste management ordinance of 4 dec. 2015, in force since 1 jan 2016 (as 2015 5699).section 3 need for monitoring and remediation art. 7 preliminary investigation 1 based on the list of priorities, the authorities shall require a preliminary investigation to be carried out within a reasonable period for sites in need of investigation. this shall normally consist of a historical and a technical investigation, so that the need for monitoring and remediation can be assessed (art. 8), and the environmental hazard evaluated (risk assessment).2 the historical investigation shall establish the possible causes of the pollution of the site, in particular:a.the events and the temporal and spatial history of developments at the site;b.the procedures used for handling environmentally hazardous substances at the site. 3 based on the historical investigation, a performance specification shall be prepared on the aim, extent and methods of the technical investigation. the performance specification shall be submitted to the authorities for comment.4 the technical investigation shall establish the type and quantity of substances at the site, the likelihood of their release and the importance of the environmental areas affected.art. 8 assessment of the need for monitoring and remediation 1 based on the preliminary investigation, the authorities shall assess whether the polluted site is in need of monitoring or remediation in accordance with articles 9 - 12. in doing so, they shall pay due regard to effects caused by other polluted sites or by third parties.2 they shall state in the register whether a polluted site is:a.in need of monitoring;b.in need of remediation (contaminated site);c.in need of neither monitoring nor remediation.art. 9 protection of groundwater 1 subject to paragraph 1bis, a polluted site is deemed to be in need of monitoring to protect the groundwater, if:a.any of the concentration values specified in annex 1 is exceeded in the eluate of the material at the site; orb.for groundwater water protection areas au, the concentration of substances originating from the site immediately downstream of the site exceeds 10% of one of the concentration values specified in annex 1; orc.for groundwater outside water protection areas au, the concentration of substances originating from the site immediately downstream of the site exceeds 40% of one of the concentration values specified in annex 1.31bis if after several years of monitoring a site, it is established that, considering the evolution of pollutant concentrations and the characteristics of the site, it is highly probable that the site will not need remediation under paragraph 2, the site is deemed no longer to be in need of monitoring.42 a polluted site is deemed to be in need of remediation to protect the groundwater, if:a.5potential water pollutants originating from the site are detected in groundwater catchments of public interest in concentrations that exceed the detection threshold;b.6for groundwater in water protection areas au7: the concentration of substances originating from the site immediately downstream of the site exceeds one-half the concentration value specified in annex 1;c.8for groundwater outside water protection area au s: the concentration of substances originating from the site immediately downstream of the site exceeds double the concentration value specified in annex 1; ord.it is in need of monitoring in accordance with paragraph 1 letter a, and, owing to insufficient retention capacity, or degradation of substances originating from the site, there is a real danger of groundwater pollution.3 amended by no i of the o of 9 may 2012, in force since 1 aug. 2012 (as 2012 2905).4 inserted by no i of the o of 9 may 2012, in force since 1 aug. 2012 (as 2012 2905).5 amended by no i of the o of 22 march 2017, in force since 1 may 2017 (as 2017 2589).6 amended by annex 5 no. 5 of the o on the protection of waters of 28 oct. 1998, in force since 1 jan. 1999 (as 1998 2863).7 amended by article 29 para. 1 let. a of the o on the protection of waters of 28 oct. 1998 (sr 814.201).8 amended by annex 5 no. 5 of the o on the protection of waters of 28 oct. 1998, in force since 1 jan. 1999 (as 1998 2863).art. 10 protection of surface waters 1 subject to paragraph 1bis, a polluted site is deemed to be in need of monitoring to protect the surface waters, if:9a.any of the concentration values specified in annex 1 is exceeded in the eluate of the material at the site which is susceptible of affecting surface waters; or b.in water that flows into surface waters, a concentration value specified in annex 1 is exceeded for substances originating from the site.1bis if after several years of monitoring a site, it is established that, considering the evolution of pollutant concentrations and the characteristics of the site, it is highly probable that the site will not need remediation under paragraph 2, the site is deemed no longer to be in need of monitoring.102 for the protection of surface waters, a polluted site is deemed to be in need of remediation if: a.in water that flows into surface waters, the concentration of substances originating from the site exceeds by tenfold a concentration value specified in annex 1; orb.it is in need of monitoring in accordance with paragraph 1 letter a, and owing to insufficient retention capacity, or degradation of substances originating at the site, there is a real danger of pollution of surface waters.9 amended by no i of the o of 9 may 2012, in force since 1 aug. 2012 (as 2012 2905).10 inserted by no i of the o of 9 may 2012, in force since 1 aug. 2012 (as 2012 2905).art. 1111 prevention of air pollution 1 for the protection of persons from air pollution, a polluted site is deemed to be in need of monitoring if its interstitial air exceeds a concentration value specified in annex 2, and the emission originating from the site reaches places that may regularly be frequented by persons for longer periods.2 for the protection of persons from air pollution, a polluted site is deemed to be in need of remediation if its interstitial air exceeds a concentration value specified in annex 2, and the emission originating from the site reaches places that may regularly be frequented by persons for longer periods.11 amended by no i of the o of 22 march 2017, in force since 1 may 2017 (as 2017 2589).art. 1212 prevention of pollution of the soil 1 soil that is a polluted site or part thereof is deemed to be in need of remediation if a substance in the soil exceeds a concentration value specified in annex 3. the foregoing also applies to soil that is already subject to a restriction of use.2 soil that is not in need of remediation in accordance with paragraph 1 despite being polluted sites or parts thereof, and the impacts of polluted sites on soil are assessed in accordance with the ordinance of 1 july 199813 on the pollution of soil.12 amended by annex no. ii 2 of the o of 26 sept. 2008 on the charge for the remediation of contaminated sites, in force since 1 jan. 2009 (as 2008 4771).13 sr 814.12art. 13 action of the authorities 1 for polluted sites in need of monitoring, the authorities shall require a monitoring plan to be drawn up and suitable measures to be taken to detect a real danger of harmful effects or nuisances before these become manifest. the monitoring measures shall be applied until there is no longer any need for monitoring in accordance with articles 9-12.142 for sites that are in need of remediation (contaminated sites), the authorities shall require that: a.a detailed investigation be carried out within a reasonable period;b.the site be monitored until completion of remediation.14 amended by no i of the o of 9 may 2012, in force since 1 aug. 2012 (as 2012 2905).section 4 objectives and urgency of remediation art. 14 detailed investigation 1 to specify the objectives and assess the urgency of remediation, the following detailed information shall be obtained and evaluated in a risk assessment:a.type, location, quantity and concentration of the environmentally hazardous substances at the polluted site;b.type, load and temporal development of the existing and possible impacts on the environment; c.location and importance of the environmental areas at risk.2 if the results of the detailed investigation deviate substantially from those of the preliminary investigation, the authorities shall reassess whether the site is in need of remediation in accordance with articles 9-12.art. 15 objectives and urgency of remediation 1 the objective of remediation is the elimination of impacts that led to the need for remediation in accordance with articles 9 - 12, or of the real danger of such effects.2 as regards remediation for the purpose of groundwater protection, deviation from the objective is made if:a.by this means the total environmental impact can be lessened;b.disproportionate costs would otherwise result; and c.15the exploitability of groundwater in water protection areas au is guaranteed, or if surface waters connected to groundwater outside water protection areas au fulfil the requirements of the waters protection legislation regarding water quality.3 as regards remediation for the purpose of surface waters protection, deviation from the objectives is made if:a.by this means the total environmental impact can be lessened;b.disproportionate costs would otherwise result; andc.the waters complies with the requirements of the waters protection legislation regarding water quality.4 remediation is deemed to be of particular urgency if an existing use is impaired or immediately endangered. 5 the authorities shall assess the objectives and the urgency of remediation on the basis of the detailed investigation.15 amended by annex 5 no. 5 of the o on the protection of waters of 28 oct. 1998, in force since 1 jan. 1999 (as 1998 2863).section 5 remediation art. 1616 remediation measures 1 the objective of remediation must be achieved by measures that:a.enable environmentally hazardous substances to be eliminated (decontamination); orb.enable the diffusion of environmentally hazardous substances to be prevented in the long term and monitored (securing).2 .1716 amended by annex no. ii 2 of the o of 26. sept. 2008 on the charge for the remediation of contaminated sites, in force since 1 jan. 2009 (as 2008 4771).17 repealed by no i of the o of 22 march 2017, with effect from 1 may 2017 (as 2017 2589).art. 17 remediation project the authorities shall require that for contaminated sites a remediation project be prepared within a time frame appropriate to the urgency of remediation. this shall describe in particular the following:a.the remediation measures including those for monitoring and for waste disposal, the effectiveness of the measures, the assessment of their results and the time expenditure;b.the impact of the proposed measures on the environment;c.the residual danger to the environment following remediation;d.the shares of the responsibility for the contaminated site in cases where the person required to carry out remediation measures demands a ruling on the allocation of costs (art. 32d para. 318 epa).18 now: para. 4.art. 18 specification of essential measures 1 the authorities shall assess the remediation project. in doing so, they shall pay particular regard to the following:a.the environmental impact of the measures;b.their long-term effectiveness;c.the danger to the environment caused by the contaminated site before and after remediation;d.in cases of incomplete decontamination, the extent to which the measures may be monitored, avenues for remedying the deficiencies and securing the necessary funding for the proposed measures;e.whether the requirements for deviation from the remediation objective in accordance with article 15 paragraphs 2 and 3 are satisfied.2 on the basis of this assessment, they shall issue a ruling containing in particular:a.the final objectives of the remediation;b.the remediation measures, the assessment of results and the time frame to be adhered to;c.further charges and conditions for the protection of the environment.art. 1919 evaluation of results persons required to carry out remediation measures must notify the authorities of the remediation measures carried out and demonstrate that the remediation objectives have been achieved. the authorities shall express an expert opinion in this regard.19 amended by annex no. ii 2 of the o of 26. sept. 2008 on the charge for the remediation of contaminated sites, in force since 1 jan. 2009 (as 2008 4771).section 6 obligation to carry out investigation, monitoring and remediation measures art. 20 1 the investigation, monitoring and remediation measures shall be carried out by the holder of the polluted site.2 if the authorities have reason to believe that the pollution of the site was caused by the action of third parties, the authorities may require them to carry out the preliminary investigation, the monitoring measures or the detailed investigation.3 if the pollution of the site was caused by the action of third parties, the authorities may require these with the approval of the holder to prepare the remediation project and perform the remediation measures.section 7 final provisions art. 2120 enforcement 1 the cantons shall enforce this ordinance unless it delegates enforcement to the confederation.21 the cantons shall submit the information required in article 5 paragraphs 3 and 5 and article 6 as well as the information on remediated sites required by article 17 to the foen by the end of each calendar year.221bis the foen shall evaluate the information and inform the public regularly on the progress with the remediation of contaminated sites.232 if federal authorities apply other federal acts or agreements or decisions under international law that relate to the subject matter of this ordinance, they shall also enforce this ordinance. the cooperation of the foen and of the cantons is governed by article 41 paragraphs 2 and 4 epa; statutory duties of secrecy are reserved. if the federal authorities dispense with issuing a ruling when specifying remediation measures (art. 23 para. 3), they shall consult the cantons concerned about the intended measures.243 the federal authorities shall determine the procedures for categorising polluted sites (art. 5 para. 4), preparing the list of priorities (art. 5 para. 5) and deleting entries in the register (art. 6 para. 2) after consultation with the foen.254 they shall inform the cantons concerned of the content of the register (art. 5 and 6) at regular intervals. these shall include a reference to the relevant polluted sites in their own register.20 amended by no. ii 16 of the o of 2 feb. 2000 relating to the federal act on the coordination and simplification of decision-making procedures, in force since 1 march 2000 (as 2000 703).21 amended by annex no ii 2 of the o of 26 sept. 2008 on the charge for the remediation of contaminated sites, in force since 1 jan. 2009 (as 2008 4771).22 second sentence amended by no i of the o of 22 march 2017, in force since 1 may 2017 (as 2017 2589).23 inserted by annex no. ii 2 of the o of 26. sept. 2008 on the charge for the remediation of contaminated sites, in force since 1 jan. 2009 (as 2008 4771).24 amended by no. i 2 of the o of 29 june 2011 on amendments of ordinances in the field of environment, in force since 1 aug. 2011 (as 2011 3379).25 amended by no. i 2 of the o of 29 june 2011 on amendments of ordinances in the field of environment, in force since 1 aug. 2011 (as 2011 3379).art. 2226 26 repealed by no. ii 16 of the o of 2 feb. 2000 to the federal act on the coordination and simplification of decision-making procedures, with effect from 1 march 2000 (as 2000 703).art. 23 collaboration with those concerned 1 in enforcing this ordinance, the authorities shall collaborate with those directly concerned. in particular, they shall examine whether voluntary measures provided for in sectoral agreements of the private sector are suitable for the enforcement of this ordinance.2 they shall endeavour to reach agreement with those directly concerned on the necessary assessments and measures in accordance with the requirements of this ordinance. to this end, they shall consult those directly concerned at the earliest possible time. 3 they may dispense with issuing rulings if carrying out the required investigation, monitoring and remediation measures is guaranteed by other means. art. 24 deviation from procedural regulations deviation from the procedures specified in this ordinance shall be permitted if:a.immediate measures for the protection of the environment are necessary;b.the need for monitoring or remediation can be assessed, or the required measures determined, on the basis of existing information;c.a polluted site is modified by the construction or alteration of a building or installation;d.voluntary measures by those directly concerned have an equivalent effect to those specified in the ordinance.art. 25 guidelines in preparing guidelines for implementing this ordinance, the federal agency shall collaborate with the cantons and the industrial organisations concerned.art. 25a27 geoinformation the federal office shall specify the minimum geodata models and representation models for geographical base data in accordance with this ordinance for which the federal office is designated as the specialist authority at federal level in annex 1 to the geoinformation ordinance of 21 may 200828.27 inserted by annex 2 no. 11 of the o of 21 may 2008 on geoinformation, in force since 1 july 2008 (as 2008 2809).28 sr 510.620art. 26 amendment of current legislation .2929 the amendment may be inspected in as 1998 2261.art. 27 transitional provision the register (art. 5) shall be prepared by 31 december 2003.art. 28 commencement this ordinance comes into force on 1 october 1998.annex 130 30 revised by annex no. ii 2 of the o of 26 sept. 2008 on the charge for the remediation of contaminated sites (as 2008 4771), no ii of the o of 9 may 2012 (as 2012 2905) and of 22 march 2017, in force since 1 may 2017 (as 2017 2589).(art. 9 and 10)concentration values for assessing the impact of polluted sites on ground and surface waters 1 in assessing the impact of polluted sites on waters, the concentration values in the following table apply. where no concentration values are given in the table for potential water pollutants which are polluting a site, the authority shall specify a value on a case by case basis with the consent of the foen and according to the provisions of the legislation on waters protection.2 where the assessment is based on the eluate of the material of the site, the following requirements apply to sampling, preparation of the eluates and their analysis:a.the number of samples and sampling points shall be chosen such that the samples are representative of the pollution of the site.b.the eluate shall be prepared on the basis of a test column. the elution liquid used shall be oxygen-free deionised water. this must normally flow upwards through the column at a defined rate. prior to analysis, the eluate may normally neither be centrifuged nor filtered in a microfilter.c.the eluate need only be analysed in respect of those substances that are expected to occur at the site based on the historical investigation. in cases where lumped parameters only are analysed, the lowest concentration value of the individual substances shall be taken as the assessment criterion.3 for sites with particularly heterogeneous pollution (e.g. waste disposal sites), if samples can be obtained from the seepage water, these may be regarded as equivalent to an eluate.4 in assessing the impact of volatile substances31, the seepage water shall be regarded as equivalent to an eluate. if it is not possible to take samples of the seepage water, pollutant concentrations shall be calculated based on measurements of interstitial air concentration.5 an eluate test in accordance with paragraph 2 may be dispensed with if the pollutant concentration in the eluate of the material is assessable (i.e. to be above or below the concentration values) on the basis of other information, for example composition and origin of the material at the site, lumped parameters or ecotoxicological investigations, or can be calculated from total content.6 the federal office shall issue guidelines on sampling, preparation of eluates and their analysis, and on assessment of the impact of volatile substances.substanceconcentration valueinorganic substancesantimony 0.01 mg sb/larsenic 0.05 mg as/llead 0.05 mg pb/lcadmium0.005 mg cd/lchromium (vi) 0.02 mg crvi/lcobalt 2 mg co/lcopper 1.5 mg cu/lnickel 0.7 mg ni/lmercury0.001 mg hg/lsilver 0.1 mg ag/lzinc 5 mg zn/ltin 20 mg sn/lammonium** 0.5 mg nh4+/lcyanide (free) 0.05 mg cn-/lfluoride 1.5 mg f-/lnitrite** 0.1 mg no2-/lorganic substancesaliphatic hydrocarbons:-total (c5-c10) 2 mg/l-methyl tert-butyl ether (mtbe) 0.2 mg/lamines-aniline 0.05 mg/l-4-aniline chloride 0.1 mg/lhalogenated hydrocarbons-1,2-dibromoethane (edb) 0.05 g/la-1,1-dichloroethane* 3 mg/l-1,2-dichloroethane (edc)*0.003 mg/l-1,1-dichloroethene* 0.03 mg/l-1,2-dichloroethene (cis and trans)* 0.05 mg/l-dichloromethane (methylene chloride, dcm)* 0.02 mg/l-1,2-dichloropropane*0.005 mg/l-1,1,2,2-tetrachloroethane0.001 mg/l-tetrachloroethene (perc) 0.04 mg/l-tetrachloromethane (carbon tetrachloride)*0.002 mg/l-1,1,1-trichloroethane* 2 mg/l-trichloroethene (tce)* 0.07 mg/l-trichloromethane (chloroform)* 0.04 mg/l-vinyl chloride* 0.5 g/l-chlorobenzene 0.7 mg/l-1,2-dichlorobenzene 3 mg/l-1,3-dichlorobenzene 3 mg/l-1,4-dichlorobenzene 0.01 mg/l-1,2,4-trichlorobenzene 0.4 mg/l-polychlorinated biphenyls (pcbs)b 0.1 g/lmonocyclic aromatic hydrocarbons (btex)-benzene* 0.01 mg/l-toluene 7 mg/l-ethylbenzene 3 mg/l-xylenes 10 mg/lnitro compounds-2,4-dinitrophenol 0.05 mg/l-dinitrotoluene 0.5 g/l-nitrobenzene 0.01 mg/l-4-nitrophenol 2 mg/lphenols-2-chlorophenol 0.2 mg/l-2,4-dichlorophenol 0.1 mg/l-2-methylphenol (o-cresol) 2 mg/l-3-methylphenol (m-cresol) 2 mg/l-4-methylphenol (p-cresol) 0.2 mg/l-pentachlorophenol (pcp)0.001 mg/l-phenol (c6h6o) 10 mg/lpolycyclic aromatic hydrocarbons (pak)-acenaphthene 2 mg/l-anthracene 10 mg/lc-benz[a]anthracene 0.5 g/l-benzo[b]fluoranthene 0.5 g/l-benzo[k]fluoranthene0.005 mg/l-benzo[a]pyrene 0.05 g/l-chrysene 0.05 mg/l-dibenz[a,h]anthracene 0.05 g/l-fluoranthene 1 mg/l3-fluorene 1 mg/l-indeno[1,2,3-cd]pyrene 0.5 g/l3-naphthalene 1 mg/l-pyrene 1 mg/l3adetection thresholdbpcb: the sum of the 6 congeners 28, 52, 101, 138, 153 and 180 multiplied by the factor 4.3 must not exceed the concentration value.cnot normally detectable in the eluate at these concentrations.*to be assessed according to paragraph 4.**applies to surface waters only31 indicated in the table by *.annex 2 (art. 11)concentration values for the assessment of interstitial air at polluted sites 1 in assessing the interstitial air of polluted sites, the concentration values in the following table apply. where no concentration values are given in the table for emissions occurring at the site, e.g. odours or particles, the site is deemed to be in need of remediation if the emissions may lead to excessive ambient concentrations in accordance with the ordinance of 16 december 198532 on air pollution control.2 for sampling and the performance of interstitial air analyses, the following apply:a.samples must be taken using ground gas detectors at a number of points representative of the pollution of the site. it shall be ensured that no extraneous air is included in the samples.b.the interstitial air need only be analysed in respect of those constituents that are expected to occur at the site based on the historical investigation. if the analysis is confined to lumped parameters, the lowest concentration value of the individual substances shall be taken as the assessment criterion.3 interstitial air samples may be dispensed with if it can be demonstrated by other means that the concentration values in the interstitial air cannot be exceeded, i.e. based on precise information concerning the composition and origin of the material at the site.4 the federal agency shall issue guidelines on sampling and on procedures for interstitial air analyses.substanceconcentration valueinorganic substancesmercury 0.005 ml/m3carbon dioxide 5000 ml/m3hydrogen sulphide 10 ml/m3organic substancespetrol (free of aromatics) 500 ml/m3light petrol (aromatic content 0-10 by vol.-%) 500 ml/m3methane10 000 ml/m3halogenated hydrocarbons-chlorobenzene 10 ml/m3-1,1-dichloroethane 100 ml/m3-1,2-dichloroethane (edc) 5 ml/m3-1,1-dichloroethene 2 ml/m3-1,2-dichloroethene (cis and trans) 200 ml/m3-dichloromethane 100 ml/m3-1,2-dichloropropane 75 ml/m3-1,1,2,2-tetrachloroethane 1 ml/m3-tetrachloroethene (perc) 50 ml/m3-tetrachloromethane (carbon tetrachloride) 5 ml/m3-1,1,1-trichloroethane 200 ml/m3-trichloroethene (tce) 50 ml/m3-trichloromethane 10 ml/m3-vinyl chloride 2 ml/m3monocyclic aromatic hydrocarbons (btex)-benzene 1 ml/m3-toluene 50 ml/m3-ethylbenzene 100 ml/m3-xylenes 100 ml/m3polycyclic aromatic hydrocarbons (pak)-benzo[a]pyrene0.0002 ml/m3-naphthalene 10 ml/m332 sr 814.318.142.1annex 333 33 inserted by annex no. ii 2 of the o of 26 sept. 2008 on the charge for the remediation of contaminated sites, in force since 1 jan. 2009 (as 2008 4771). revised by no ii of the o of 9 may 2012 (as 2012 2905) and no i of the o of 14 jan. 2015, in force since 1 march 2015 (as 2015 317).(art. 12 para. 1)concentration values for the assessment of the need for remediation of soil the concentration values in the table below apply in the assessment of the need for remediation of soil. where no concentration values are given in the table for potential soil pollutants which are polluting a site, the authority shall specify a value on a case by case basis with the consent of the foen and according to the provisions of the legislation on the protection of the environment.1 sites used for agricultural or horticultural purposes substanceconcentration valueinorganic substanceslead2000 mg pb/kgcadmium 30 mg cd/kgcopper1000 mg cu/kgzinc2000 mg zn/kgorganic substancespolychlorinated biphenyls (pcbs) 3 mg/kgpolycyclic aromatic hydrocarbons (pahs)* 100 mg/kgbenzo-a-pyrene 10 mg/kg*16 epa pahs: napthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benz[a]anthracene, chrysene, benzo[a]pyrene, benzo[b]fluoranthene, benzo[k]fluoranthene, dibenz[a,h]anthracene, benzo[g,h,i]perylene, indeno[1,2,3-c,d]pyrene2 sites in private gardens and allotments, children's playgrounds and other facilities where children play regularly substanceconcentration valueinorganic substancesantimony 50 mg sb/kgarsenic 50 mg as/kglead1000 mg pb/kgcadmium 20 mg cd/kgchromium (vi) 100 mg crvi/kgcopper1000 mg cu/kgnickel1000 mg ni/kgmercury 2 mg hg/kgsilver 500 mg ag/kgzinc2000 mg zn/kginorganic substancesvolatile chlorinated hydrocarbons* 1 mg/kgpolychlorinated biphenyls (pcbs)** 1 mg/kgaliphatic hydrocarbons c5-c10*** 5 mg/kgaliphatic hydrocarbons c11-c40 500 mg/kgmonocyclic aromatic hydrocarbons (btex)**** 500 mg/kgbenzene 1 mg/kgpolycyclic aromatic hydrocarbons (pahs)***** 100 mg/kgbenzo[a]pyrene 10 mg/kg*7 volatile chlorinated hydrocarbons: dichloromethane, trichloromethane, tetrachloromethane, cis-1,2-dichloroethylene, 1,1,1-trichloroethane, trichloroethylene (tce), tetrachlorethylene (perc)**6 pcb congeners 4.3: no. 28, 52, 101, 138, 153, 180***c5- to c10 hydrocarbons: area of the fid-chromatogram between n-pentane and ndecane, multiplied by the response factor of n-hexane, minus btex****6 btex: benzene, toluene, ethylbenzene, o-xylene, m-xylene, p-xylene*****16 epa pahs: napthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benz-a-anthracene, chrysene, benzo[a]pyrene, benzo[b]fluoranthene, benzo[k]fluoranthene, dibenz[a,h]anthracene, benzo[g,h,i]perylene, indeno[1,2,3-c,d]pyrene

814.681 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinance on the charge for the remediation of contaminated sites(ocrcs)of 26 september 2008 (status as of 1 january 2016) the swiss federal council,on the basis of article 32e paragraphs 1, 2 and 5 of the environmental protection act of 7 october 19831 (epa), and of article 57 paragraph 2 of the government and administration organisation act of 21 march 19972,ordains:1 sr 814.012 sr 172.010chapter 1 subject matter art. 1 this ordinance regulates:a.the levying of a charge for the deposit of waste in a landfill in switzerland and on the export of waste for deposit in a landfill abroad;b.the use of the income from the charge to provide payments for:1.the investigation, monitoring and remediation of polluted sites,2.the investigation of sites that are not found to be polluted.chapter 2 charge art. 2 obligation to pay the charge 1 the holders of landfills must pay a charge on the deposit of waste in a landfill in switzerland.2 any person who exports waste for deposit in a landfill must pay a charge. the obligation to pay the charge also applies to waste that is deposited in a landfill abroad following its export for recovery or treatment. the charge is not due if the waste deposited in the landfill is less than 15 per cent of the quantity of waste exported.3 .33 repealed by annex 6 no 10 of the waste management ordinance of 4 dec. 2015, with effect from 1 jan. 2016 (as 2015 5699).art. 3 charge rates 1 the charge rate for waste deposited in a landfill in switzerland is:a.in the case of type b landfills: chf 5 per tonne;b.in the case of type c, d and e landfills: chf 16 per tonne.42 the charge rate for waste deposited in a landfill abroad is:a.in the case of underground landfills: chf 22 per tonne;b.in the case of other landfills: as much as would be charged for the deposit of waste in a landfill in switzerland.3 .54 amended by annex 6 no 10 of the waste management ordinance of 4 dec. 2015, in force since 1 jan. 2016 (as 2015 5699).5 repealed by annex 6 no 10 of the waste management ordinance of 4 dec. 2015, with effect from 1 jan. 2016 (as 2015 5699).art. 4 origin of the right to claim the charge the charge shall become due at the time of deposit in a landfill in switzerland or at the time of export.art. 5 charge declaration 1 persons required to pay the charge must by the 28 february of each year submit a charge declaration to the federal office for the environment (foen) in respect of the charge due for the previous calendar year.2 the declaration must contain all the information required to determine the amount of the charge due. it shall be made on an official form; the foen may permit other forms. holders of landfills must send the canton a copy of the declaration.3 the declaration serves as the basis for determining the charge due; the right to conduct an official assessment is reserved.4 the persons liable to pay the charge must retain the documents relating to the declaration for a minimum of ten years.5 in the case of a delayed or incomplete declaration, default interest of 3.5 per cent per annum is payable on the amount of the charge due.art. 6 charge assessment6 1 the foen shall determine the amount of the charge in a ruling.2 if the person required to pay the charge, despite being sent a reminder, fails to submit their charge declaration to the foen or if the information required to determine the amount of the charge cannot be ascertained due to a lack of reliable documentation, the foen shall make the charge assessment according to its own best judgement.73 in doing so, the foen may base its assessment on the results of its own checks, information from the canton and historical figures.86 amended by annex 6 no 10 of the waste management ordinance of 4 dec. 2015, in force since 1 jan. 2016 (as 2015 5699).7 amended by annex 6 no 10 of the waste management ordinance of 4 dec. 2015, in force since 1 jan. 2016 (as 2015 5699).8 amended by annex 6 no 10 of the waste management ordinance of 4 dec. 2015, in force since 1 jan. 2016 (as 2015 5699).art. 6a9 period allowed for payment 1 the period allowed for payment amounts to 30 days.2 if payment is not made within the period allowed, default interest of 3.5 per cent per annum becomes due.9 inserted by annex 6 no 10 of the waste management ordinance of 4 dec. 2015, in force since 1 jan. 2016 (as 2015 5699).art. 7 additional claim if the foen has erroneously assessed the charge at an amount that is too low, it shall claim the shortfall within two years of issuing its ruling.art. 8 limitation period 1 the right to claim the charge is limited to ten years from the end of the calendar year in which it arises.2 the limitation period shall be interrupted and begin to run again:a.if the person required to pay the charge acknowledges the right to claim the charge;b.following any official act by which the right to claim the charge is asserted against the person required to pay the charge.3 the right to claim the charge is in every case limited to 15 years from the end of the calendar year in which it arises.chapter 3 subsidies section 1 subsidy requirements art. 9 principle 1 the confederation shall pay subsidies to the cantons under article 32e paragraphs 3 and 4 epa for:a.the investigation, monitoring and remediation of polluted sites;b.the investigation, monitoring and remediation of polluted sites at shooting ranges; andc.the investigation of sites that are not found to be polluted.2 it shall also pay subsidies for a clearly defined area of a polluted site if that area fulfils the requirements for a subsidy and further measures are not made more difficult or impossible.art. 10 special subsidy requirements for investigation and monitoring measures 1 for measures for the investigation and monitoring of polluted sites, subsidies shall be paid only if:a.the measures were begun after 1 july 1997;b.an application for a subsidy for a measure carried out before 1 november 2006 is submitted to the foen by 31 december 2010.2 if the person responsible for causing a polluted site cannot be identified or if he is unable to pay (art. 32e para. 3 let. b no 1 epa), subsidies shall be paid for investigation and monitoring measures:a.if the allowable investigation or monitoring costs amount to over 250 000 francs, provided a legally-binding ruling on the allocation of the costs is submitted;b.if the allowable investigation or monitoring costs amount to 250 000 francs or less, provided proper legal justification for the allocation of the costs is provided.3 for measures for the investigation of sites that are not found to be polluted, subsidies shall be paid only if the investigations were begun after 1 november 2006.art. 11 special subsidy requirements for remediation measures 1 the confederation shall pay subsidies for remediation measures only if:a.the measures were begun after 1 july 1997;b.an application for a subsidy for a measure carried out before 1 november 2006 is submitted to the foen by 31 december 2010.2 if the person responsible for causing a polluted site cannot be identified or if he is unable to pay (art. 32e para. 3 let. b no 1 epa), subsidies shall be paid for remediation measures:a.if the allowable remediation costs amount to over 250 000 francs, provided a legally-binding ruling on the allocation of the costs is submitted;b. if the allowable remediation costs amount to 250 000 francs or less, provided proper legal justification for the allocation of the costs is provided.section 2 chargeable costs art. 12 chargeable costs in the case of sites not in need of remediation 1 in the case of sites not in need of remediation, the costs of the following measures are deemed to be chargeable investigation costs:a.establishing that a site is not polluted where that site is already entered in the register or its entry in the register is planned;b.the preliminary investigation of a site requiring investigation under article 7 the contaminated sites ordinance of 26 august 199810 (cso).2 in the case of sites not in need of remediation, the costs of the following measures under article 13 paragraph 1 cso are deemed to be chargeable monitoring costs:a.planning the monitoring measures;b.construction, operation, maintenance and dismantling of the monitoring equipment;c.sampling and analysis.10 sr 814.680art. 13 chargeable costs in the case of sites in need of remediation in the case of sites in need of remediation, the costs of the following measures are deemed to be chargeable remediation costs:a.a preliminary investigation (art. 7 cso11) and detailed investigation (art. 14 cso) as well as monitoring (art. 13 para. 2 let. b cso) in accordance with article 12 paragraph 2;b.preparation of a remediation project (art. 17 cso);c.decontamination including disposal of waste (art. 16 let. a cso);d.construction, operation, maintenance and dismantling of installations and equipment for the long-term prevention and monitoring of the diffusion of environmentally hazardous substances (art. 16 let. b cso); e.proof that the remediation objectives have been achieved (art. 19 para. 1 cso).11 sr 814.680section 3 procedure art. 14 consultation of the foen 1 the canton shall consult the foen before it orders an investigation, monitoring or remediation measure.2 the foen need not be consulted in accordance with paragraph 1 if any one of the requirements of article 16 paragraph 3 is fulfilled.art. 15 application for a subsidy the canton shall submit any application for a subsidy to the foen. this must contain:a.proof that the measures fulfil the requirements of articles 9-11;b.the main principles and elements of the project;c.the official assessment of whether the measures are environmentally compatible and cost-effective and correspond to the state of the art;d.the probable costs of the measures and the probable chargeable costs;e.a copy of the ruling on the allocation of the costs or if applicable proper legal justification for the allocation of the costs if the person responsible cannot be identified or is unable to payart. 16 confirmation and payment of subsidy 1 if the requirements for the subsidy are fulfilled, the foen shall confirm that the subsidy will be paid within the scope of the available resources and shall indicate the probable amount of the subsidy.2 it shall order that the subsidies be paid if:a.it has received a summary audited by the canton of the total of the chargeable costs of the measures actually incurred; b.the income from the charge covers the resources required.3 if the implementation of the measures has begun before confirmation is issued, the foen may in application of article 26 paragraph 3 second sentence of the subsidies act of 5 october 199012 grant a subsidy in particular if:a.the investigation, monitoring or remediation measure costs less than 250 000 francs; orb.new information comes to light during the implementation of structural measures or other measures under the cso13 about the level of pollution at the site or about the costs of the measures required.4 if the income from the charge does not cover all the resources required, the foen shall when paying subsidies consider as a priority projects that were urgently required for reasons of environmental protection or in which a substantial ecological benefit was achieved when compared to the cost. projects that have been postponed shall be given first priority in the following years.12 sr 616.113 sr 814.680chapter 4 enforcement art. 17 responsibilities 1 the foen shall enforce this ordinance and shall provide information each year on the charges levied and the subsidies.2 it may delegate the official assessment of the charge declaration (art. 5 para. 3) wholly or in part to suitable public corporations or private entities. this assessment shall be funded from the income from the charge.3 the cantons shall support the foen in the enforcement of this ordinance. in particular, they shall notify the foen without delay if they establish that persons obliged to pay the charge have provided incomplete or false information.art. 1814 14 repealed by no. i 7.3 of the ordinance of 9 nov. 2011, with effect from 1 january 2012 (as 2011 5227).chapter 5 final provisions art. 19 repeal and amendment of current legislation the repeal and amendment of the current legislation is regulated in the annex.art. 2015 transitional provision the charge rate under article 3 paragraph 1 applies from 1 january 2017. until 1 january 2017, the charge rate for waste deposited in a landfill in switzerland is:a.in the case of type b landfills: chf 3 per tonne;b.in the case of type c landfills: chf 17 per tonne;c.in the case of type d and e landfills: chf 15 per tonne.15 amended by annex 6 no 10 of the waste management ordinance of 4 dec. 2015, in force since 1 jan. 2016 (as 2015 5699).art. 21 commencement this ordinance comes into force on 1 january 2009.annex (art. 19)repeal and amendment of current legislation ithe ordinance of 5 april 200016 on the charge for the remediation of contaminated sites is repealed.iithe following ordinances are amended as follows:.17168 [as 2000 1398, 2007 4525 no. ii 6]17 the amendments may be consulted under as 2008 4771.

814.91 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton non-human gene technology(gene technology act, gta)of 21 march 2003 (status as of 1 january 2018)the federal assembly of the swiss confederation,based on articles 74 paragraph 1, 104 paragraphs 2 and 3 letter b, 118 paragraph 2 letter a and 120 paragraph 2 of the federal constitution1,2in implementation of the convention of 5 june 19923 on biological diversity and the cartagena protocol of 29 january 20004 on biosafety to the convention on biodiversity,and having considered the dispatch of the federal council dated 1 march 20005and the report of the council of states' committee for science, education and culture dated 30 april 20016 7decrees:1 sr 1012 amended by no i of the fa of 16 june 2017, in force since 1 jan. 2018 (as 2017 6667; bbl 2016 6521).3 sr 0.451.434 sr 0.451.4315 bbl 2000 23916 official bulletin of the federal assembly (ab), enclosures, council of states summer session 2001, p. 22.7 amended by no i of the fa of 19 march 2010, in force since 1 aug. 2010 (as 2010 3233; bbl 2009 5435).chapter 1 general provisions art. 1 purpose 1 the purpose of this act is:a.to protect human beings, animals and the environment from abuses of gene technology;b.to serve the welfare of human beings, animals and the environment in the application of gene technology.2 in particular, it shall:a.protect the health and safety of human beings, animals and the environment;b.conserve biological diversity and the fertility of the soil permanently;c.ensure respect for the dignity of living beings;d.enable freedom of choice for consumers; e.prevent product fraud;f.promote public information;g.take account of the significance of scientific research on gene technology for human beings, animals and the environment.art. 2 precautionary and polluter-pays principles 1 early precautions shall be taken to prevent hazards or harm that may be caused by genetically modified organisms.2 any person who causes measures to be taken under the provisions of this act shall bear the costs. art. 3 area of validity 1 this act applies to the handling of genetically modified animals, plants and other organisms, as well as their metabolic products and wastes.2 for products obtained from genetically modified organisms, only the regulations on labelling and provision of public information (art. 17 and 18) apply.art. 4 reservation of other laws more detailed provisions in other federal laws concerning the protection of human beings, animals and the environment from hazards or harm caused by genetically modified organisms are reserved.art. 5 definitions 1 organisms means cellular or non-cellular biological entities capable of replication or of transferring genetic material. mixtures, articles and products that contain such entities are also regarded as organisms.2 genetically modified organism means organisms in which the genetic material has been altered in a way that does not occur under natural conditions by crossing or natural recombination.3 harm means any harmful effect or nuisance caused by genetically modified organisms to human beings, animals or the environment.4 handling means any activity undertaken in connection with organisms, in particular their production, experimental release, putting into circulation, import, export, keeping, use, storage, transport or disposal.5 putting into circulation means any supply of organisms to third parties in switzerland, in particular by sale, exchange, giving as a gift, renting, lending or sending on approval, as well as their import; supply for activities in contained systems or experimental release does not count as putting into circulation.6 installations means buildings, traffic routes and other fixed installations, as well as modifications to the land. appliances, machines, vehicles, ships and aircraft are also regarded as installations.chapter 2 handling genetically modified organisms section 1 general principles art. 6 protection of human beings, animals, environment and biological diversity 1 genetically modified organisms may only be handled in such a way that they, their metabolic products or wastes: a.cannot endanger human beings, animals or the environment;b.do not harm biological diversity or the sustainable use thereof.2 genetically modified organisms may be released for experimental purposes if:a.the information sought cannot be obtained through experiments in contained systems;b.the experiment also contributes to research on the biosafety of genetically modified organisms;c.they do not contain genes inserted by gene technology which cause resistance to antibiotics used in human or veterinary medicine; and d.according to the current state of knowledge, the dispersal of these organisms and their new traits can be excluded and the principles of paragraph 1 cannot otherwise be contravened.3 genetically modified organisms lawfully intended for use in the environment may only be put into circulation if they do not contain gene technologically inserted resistance genes to antibiotics used in human or veterinary medicine, and if experiments in contained systems and field trials have shown that they:a.do not harm the population of protected organisms or organisms that are important for the ecosystem in question;b.do not lead to the unintended extinction of a species of organism;c.do not severely or permanently harm the material balance of the environment;d.do not severely or permanently harm any important functions of the ecosystem in question, and in particular the fertility of the soil;e.do not disperse or spread their traits in an undesired way; and f.do not otherwise contravene the principles of paragraph 1.4 hazards and harm must be evaluated both individually and as a whole and in terms of their interaction; connections to other hazards and harm from causes other than genetically modified organisms should also be considered.art. 7 protection of production without genetically modified organisms and freedom of choice genetically modified organisms may be handled only in such a way that they, their metabolic products or wastes do not impair production that does not involve genetically modified organisms, or limit consumers' freedom of choice.art. 8 respect for the dignity of living beings 1 in animals and plants, modification of the genetic material by gene technology must not violate the dignity of living beings. in particular, violation is deemed to have occurred if such modification substantially harms species-specific properties, functions or habits, unless this is justified by overriding legitimate interests. in evaluating the harm, the difference between animals and plants must be taken into consideration. 2 whether the dignity of living beings has been respected is determined on a case-by-case basis, by evaluating the severity of the harm suffered by animals or plants against the significance of the legitimate interests. legitimate interests are, in particular: a.human and animal health;b.guaranteeing food security;c.the reduction of harm caused to the environment;d. the preservation and improvement of environmental conditions;e.securing a substantial economic, social or environmental benefit for society;f.increasing knowledge.3 the federal council determines the conditions under which genetic modifications to the genetic material are exceptionally permissible without a weighing of interests.art. 9 genetic modification of vertebrates genetically modified vertebrates may only be produced and put into circulation for purposes of research, therapy, or diagnostics in human or veterinary medicine. art. 10 activities in contained systems 1 any person who handles genetically modified organisms which may not be released for experimental purposes (art. 11) nor put into circulation (art. 12) is required to take all containment measures necessary in particular due to the hazards for human beings, animals or the environment that these organisms represent.2 the federal council shall introduce a notification or authorisation procedure for activities in contained systems.art. 11 experimental releases 1 any person who intends to release for experimental purposes genetically modified organisms which may not be put into circulation for use in the environment (art. 12) requires federal authorisation.2 the federal council determines the requirements and the procedure. in particular, it regulates:a.the consultation of experts;b.the guarantee of funding for measures with which any hazards or harm can be identified, averted or eliminated;c.the provision of information for the public.art. 12 putting into circulation 1 genetically modified organisms may be put into circulation only if the confederation has granted authorisation.2 the federal council determines the requirements and the procedure, and regulates the provision of information to the public. art. 12a8 opposition procedure 1 applications for authorisations for experimental releases of genetically modified organisms and for putting into circulation genetically modified organisms for lawful use in the environment are published by the authorising authority in the official federal gazette and made available for public inspection for 30 days.2 any person who is a party in accordance with the federal act of 20 december 19689 on administrative procedure may file opposition with the authorising authority during the inspection period. a party who fails to file opposition is excluded from subsequent proceedings.8 inserted by no i of the fa of 19 march 2010, in force since 1 aug. 2010 (as 2010 3233; bbl 2009 5435).9 sr 172.021art. 13 inspection of authorisations 1 authorisations are regularly inspected to determine whether they may continue to apply.2 authorised persons must voluntarily inform the authorising authority of new findings that could lead to a re-evaluation of hazards or harm as soon as they become aware of these findings.art. 14 exceptions to the notification or authorisation requirement; self-supervision 1 the federal council may simplify the requirement to notify or obtain authorisation or may grant exemptions if, according to the current state of knowledge or experience, a violation of the principles of articles 6-9 can be excluded.2 if there is no authorisation requirement for an activity in contained systems or for putting into circulation certain genetically modified organisms, the person or company responsible shall monitor compliance with the principles of articles 6-9 themselves. the federal council enacts regulations covering the form, extent and monitoring of the self-supervision.section 2 special provisions art. 15 informing the recipients 1 any person putting organisms into circulation must:a.inform the recipient of the properties that are significant for the implementation of articles 6-9;b. instruct the recipient in such a way that the principles of articles 6-9 are not violated if the organisms are handled appropriately.2 instructions from producers and importers must be followed.3 the supply to agricultural or forestry enterprises10 of genetically modified organisms that are subject to a labelling requirement requires the written permission of the enterprise owner.10 expression in accordance with no i of the fa of 19 march 2010, in force since 1 aug. 2010. (as 2010 3233; bbl 2009 5435). this amendment has been made throughout the text.art. 16 product flow segregation 1 any person handling genetically modified organisms must take appropriate care to avoid undesired mixing with non-genetically modified organisms.2 the federal council enacts regulations on product flow segregation and on measures to prevent contamination, taking account of international recommendations and foreign trade relations.art. 17 labelling 1 any person putting genetically modified organisms into circulation must label them as such for the benefit of the recipient, in order to ensure freedom of choice for the consumer under article 7 and to prevent product fraud. the labelling must contain the words "genetically modified". the federal council determines the details.2 the federal council lays down threshold values below which labelling is unnecessary for mixtures, articles and products that unintentionally contain traces of genetically modified organisms.3 traces of genetically modified organisms are considered to be unintentional if the person responsible for providing labelling proves that the product flows have been carefully monitored and recorded.4 the federal council regulates the labelling of products, in particular of foodstuffs and additives obtained from genetically modified organisms.5 it regulates how organisms that are not genetically modified may be labelled as such when they are put into circulation. it also enacts regulations concerning protection from any misuse of such labelling.6 in enacting the provisions of this article, the federal council takes account of international recommendations and foreign trade relations.art. 18 access to files and public information 1 the right to access information in official documents relating to the handling of genetically modified organisms or products obtained from them is governed by article 10g of the environmental protection act of 7 october 198311.122 after consulting the affected party, the authorities may publish information gathered during enforcement (art. 24 para. 1) and results from surveys or monitoring, insofar as these are of general interest. they may pass on this information in accordance with a federal act or international agreement to a foreign authority or international organisation. manufacturing and trade secrecy are reserved. 11 sr 814.0112 amended by art. 2 no 3 of the federal decree of 27 sept. 2013 (aarhus convention), in force since 1 june 2014 (as 2014 1021; bbl 2012 4323).art. 19 further federal council regulations 1 the federal council enacts further regulations governing the handling of genetically modified organisms, their metabolic products and wastes if, due to their properties, methods of use or quantities used, the principles of articles 6-9 could be contravened.2 in particular, it may:a.regulate their transport, import, export and transit;b.ban or restrict the handling of certain organisms or establish an authorisation procedure for handling them;c.prescribe measures to combat certain organisms or to prevent their occurrence;d.prescribe measures to prevent any harm to biological diversity and to its sustainable use;e.prescribe long-term studies of the handling of certain organisms;f.hold public consultations in connection with authorisation procedures.chapter 3 enforcement art. 20 enforcement powers 1 the confederation enforces this act. the federal council enacts implementing regulations.2 the federal council may delegate certain enforcement tasks under this act to the cantons insofar as these tasks have not already been allocated to them under other federal acts, relating in particular to the handling of articles and products.3 the federal council may also pass on certain enforcement tasks to organisations and persons under public or private law.4 the costs of measures that the authorities take to avert immediate hazards or harm, and the costs incurred in determining and remediating the same are passed on to the perpetrator.art. 21 coordination of enforcement 1 the federal authority carrying out the enforcement of regulations on genetically modified organisms on the basis of another federal act or an international treaty, is also responsible in doing so for enforcing this act. the federal authorities make their decisions with the agreement of the other federal agencies concerned and, where federal law provides, after consulting the cantons concerned.2 if the handling of genetically modified organisms is subject, in addition to a federal notification or authorisation procedure, to a cantonal planning and authorisation procedure, the federal council designates a competent authority to coordinate these procedures. art. 22 swiss expert committee for biosafety 1 the federal council appoints a swiss expert committee for biosafety, comprising experts from the various interested sectors. the interests of protection and use must be appropriately represented.2 the expert committee advises the federal council on issues of biosafety that arise in enacting regulations, and the authorities on their enforcement. it is consulted on authorisation applications. it may publish recommendations on these applications; in important and justified cases, it may commission expert opinions and inquiries.3 it collaborates with other federal and cantonal committees concerned with issues of biotechnology.4 it engages in public dialogue, and makes periodic reports to the federal council about its activities.art. 23 federal ethics committee on non-human biotechnology 1 the federal council appoints a federal ethics committee on non-human biotechnology. it comprises ethicists from outside the government and other persons from a range of subject areas who have scientific or practical knowledge of ethics. different ethical approaches must be represented in the committee.2 the committee pursues and evaluates from an ethical point of view the developments and applications of biotechnology and issues statements on associated scientific and social issues from an ethical point of view. 3 it advises:a.the federal council on enacting regulations;b.federal and cantonal authorities on enforcement. in particular, it issues statements on authorisation applications or planned research of fundamental or exemplary significance; for this purpose it may view documents, request information and consult further experts.4 it collaborates with other federal and cantonal committees concerned with issues of biotechnology.5 it engages in public dialogue on ethical issues of biotechnology, and makes periodic reports to the federal council about its activities. art. 24 duty to provide information; confidentiality 1 every person is obliged to provide the information required for enforcement to the authorities and if necessary to carry out or permit inquiries.2 the federal council may require registers with data about the type, quantity and evaluation of genetically modified organisms to be kept, stored and made available at the request of the authorities.3 the confederation carries out surveys of the handling of genetically modified organisms. the federal council determines which data about genetically modified organisms, recorded in pursuance of other federal acts, must be provided to the federal authority carrying out the survey.4 where there is a legitimate interest in keeping data secret, such as information about trade and manufacturing secrets, such data is treated as confidential.art. 24a13 environmental monitoring 1 the confederation shall organise the development and operation of a monitoring system that can detect the undesirable spread of genetically modified organisms and identify at an early stage potential effects on the environment and biological diversity of genetically modified organisms and their transgenic genetic material.2 the cantons shall provide the confederation with available information and data that is of significance to the environmental monitoring.13 inserted by no i of the fa of 16 june 2017, in force since 1 jan. 2018 (as 2017 6667; bbl 2016 6521).art. 25 fees the federal council sets the fees for enforcement by the federal authorities and may determine the framework for cantonal fees. it may grant exemptions from fee payment. art. 26 promotion of research, public dialogue and education 1 the confederation may commission or support research and technology assessments.2 it promotes public knowledge and public dialogue concerning the uses, opportunities and risks of biotechnology.3 it may promote the basic and continuing education and training of persons entrusted with tasks under this act.1414 the amendment in accordance with the federal act of 20 june 2014 on continuing education and training, in force since 1 jan. 2017, relates only to the french and italian texts (as 2016 689; bbl 2013 3729).chapter 4 legal procedures art. 2715 appeal procedure the appeal procedure is governed by the general provisions on the administration of federal justice. 15 amended by annex no. 93 of the administrative court act of 17 june 2005, in force since 1 jan. 2007 (as 2006 2197; bbl 2001 4202).art. 28 appeal by organisations 1 national environmental protection organisations have a right of appeal against authorisations for putting into circulation genetically modified organisms intended for lawful use in the environment, provided that the organisations were set up at least 10 years before the appeal is filed.2 the federal council designates the organisations with right of appeal.art. 29 appeal by the authorities 1 the federal office for the environment16 has the right to avail itself of cantonal and federal law in contesting decisions by cantonal authorities in application of this act and its implementing regulations.2 the same right of appeal is also accorded to the cantons, insofar as harm to their territory from neighbouring cantons is disputed. 16 the title of this administrative unit was modified by art. 16 para. 3 of the publications ordinance of 17 nov. 2004 (17nov.2004(as20044937).chapter 5 liability art. 30 principles 1 any person subject to the authorisation or notification requirement who handles genetically modified organisms in contained systems, releases such organisms for experimental purposes or puts them into circulation without permission is liable for any loss or damage that occurs during this handling that is due to the genetic modification.2 the person subject to the authorisation requirement is solely liable for any loss or damage that occurs to agricultural or forestry enterprises or to consumers of products of these enterprises through the permitted putting into circulation of genetically modified organisms that is a result of the modification of genetic material if the organisms:a.are contained in agricultural or forestry inputs17; orb.stem from such inputs.3 in relation to liability under paragraph 2, recourse against persons who have handled such organisms inappropriately or have otherwise contributed to the occurrence or exacerbation of the loss or damage is reserved.4 if any loss or damage is caused by any other permitted putting into circulation of genetically modified organisms as a result of the modification of the genetic material, the person subject to the authorisation requirement is liable if the organisms are defective. he or she is also liable for a defect which, according to the state of knowledge and technology at the time when the organism was put into circulation, could not have been recognised.5 genetically modified organisms are defective if they do not provide the safety that is to be expected taking all circumstances into account; in particular:a.the way in which they are presented to the public;b.the use that can reasonably be expected;c.the time at which they were put into circulation.6 a product made from genetically modified organisms is not considered defective for the sole reason that an improved product has later been put into circulation.7 the loss or damage must have been caused as a result of:a.the new properties of the organisms;b.the reproduction or modification of the organisms; orc.the transmission of the modified genetic material of the organisms.8 a person is exempt from liability if he or she can prove that the loss or damage was caused by an act of god or through gross misconduct by the injured party or a third party.9 articles 42-47 and 49-53 of the swiss code of obligations18 apply.10 the confederation, cantons and communes are also liable in accordance with paragraphs 1-9.17 expression in accordance with no i of the fa of 19 march 2010, in force since 1 aug. 2010 (as 2010 3233; bbl 2009 5435). this amendment has been made throughout the text.18 sr 220art. 31 damage to the environment 1 the person who is liable for handling genetically modified organisms must also reimburse the costs of necessary and appropriate measures that are taken to repair destroyed or damaged environmental components, or to replace them with components of equal value.2 if the destroyed or damaged environmental components are not the object of a right in rem or if the eligible person does not take the measures that the situation calls for, the damages are awarded to the community responsible.art. 32 limitation 1 the right to claim damages expires after three years from the time when the injured party becomes aware of the loss or damage and of the person liable, but at the latest after 30 years from:a.the time that the event that caused the loss or damage occurred in the company or installation, or ended; orb.the date on which the genetically modified organisms were put into circulation.2 the right to recourse is also limited in accordance with paragraph 1. the three-year term begins as soon as damages have been paid in full and the person who shares liability is known.art. 33 simplification of proof 1 it is the responsibility of the person claiming damages to prove a causal connection. 2 if this proof cannot be provided with certainty or if production of proof cannot be expected of the claimant, the court may satisfy itself on the balance of probabilities. the court may also have the facts determined ex officio.art. 34 guarantee the federal council may, to protect the injured party:a.require the person subject to the notification or authorisation requirement to provide a guarantee for their liability by taking out insurance or in some other way;b.set the scope and duration of this guarantee or leave this to the authority to decide on a case-by-case basis;c.require those providing a guarantee for the liability to notify the enforcement authority of the existence, suspension or cessation of the guarantee;d.require that the guarantee is not suspended or does not cease until 60 days after receipt of the notification.chapter 6 criminal provisions and administrative measures19 19 amended by no i of the fa of 16 june 2017, in force since 1 jan. 2018 (as 2017 6667; bbl 2016 6521). art. 35 criminal provisions20 1 any person who wilfully:a.handles genetically modified organisms in such a way that the principles of articles 6-9 are violated;b.in handling genetically modified or pathogenic organisms fails to take all necessary containment measures or carries out activities in contained systems without notification or authorisation (art. 10);c.releases genetically modified organisms for experimental purposes or puts them into circulation without permission (art. 11 para. 1 and 12 para. 1);d.21puts genetically modified organisms into circulation without informing and instructing the recipient appropriately (art. 15 para. 1);e.handles genetically modified organisms contrary to instructions (art. 15 para. 2);f.violates provisions on product flow segregation and on the precautions to prevent contamination (art. 16);g.22puts genetically modified organisms into circulation without labelling them as such for the recipient (art. 17 para. 1);h.violates the provisions on the labelling of products obtained from genetically modified organisms (art. 17 para. 4);i.puts genetically modified organisms into circulation and labels them as not genetically modified (art. 17 para. 5);j.violates special provisions on the handling of genetically modified organisms (art. 19).is liable to a custodial sentence not exceeding three years or to a monetary penalty.232 .243 if the offender acts through negligence, he or she is liable to a monetary penalty not exceeding 180 daily penalty units.2520 inserted by no i of the fa of 16 june 2017, in force since 1 jan. 2018 (as 2017 6667; bbl 2016 6521).21 amended by no i of the fa of 19 march 2010, in force since 1 aug. 2010 (as 2010 3233; bbl 2009 5435).22 amended by no i of the fa of 19 march 2010, in force since 1 aug. 2010 (as 2010 3233; bbl 2009 5435).23 amended by no i of the fa of 19 march 2010, in force since 1 aug. 2010 (as 2010 3233; bbl 2009 5435).24 repealed by no i of the fa of 19 march 2010, with effect from 1 aug. 2010 (as 2010 3233; bbl 2009 5435).25 amended by no i of the fa of 19 march 2010, in force since 1 aug. 2010 (as 2010 3233; bbl 2009 5435).art. 35a26 administrative measures the following administrative measures may be taken in respect of infringements of this act, its implementing provisions or decisions issued on the basis thereof:a.prohibition of activities;b.withdrawal of authorisations;c.substitute performance against reimbursement of costs;d.confiscation;e.forfeiture and destruction;f.a charge of up to chf 10,000 or the value of the gross receipts from products put unlawfully into circulation.26 inserted by no i of the fa of 16 june 2017, in force since 1 jan. 2018 (as 2017 6667; bbl 2016 6521).chapter 7 final provisions art. 36 amendment of current legislation the amendment of current legislation is regulated in the annex.art. 37 transitional period for the use of antibiotic resistance genes resistance genes to antibiotics used in human and veterinary medicine may be used in field trials until 31 december 2008.art. 37a27 transitional period for putting genetically modified organisms into circulation no authorisations may be granted until 31 december 2021 for putting into circulation genetically modified plants and parts of plants, genetically modified seeds and other plant propagation material and genetically modified animals for agricultural, horticultural or silvicultural purposes. 27 inserted by no i of the fa of 19 march 2010 as 2010 3233; bbl 2009 5435). amended by no i of the fa of 16 june 2017, in force since 1 jan. 2018 (as 2017 6667; bbl 2016 6521).art. 38 referendum and commencement 1 this act is subject to optional referendum.2 the federal council determines the commencement date.commencement date: 1 january 200428 annex no. 4 art. 54 para. 2 second sentence: 1 august 200529annex no. 3 art. 7a, 7c and 29 no. 1 let. abis and aquater: 2 may 200630the other articles in annex no. 3: at a later date28 federal council decree of 19 nov. 2003.29 as 2005 2601 229330 as 2006 1425annex (art. 36)amendment of current legislation .3131 the amendments may be consulted under as 2003 4803.

814.912english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon handling organisms in contained systems(containment ordinance, containo)of 9 may 2012 (status as of 1 january 2020)the swiss federal council,on the basis of articles 29b paragraphs 2 and 3, 29f, 38 paragraph 3, 39 paragraph 1, 41 paragraphs 2 and 3, 44 paragraph 3, 46 paragraphs 2 and 3, 48 paragraph 2 and 59b of the environmental protection act of 7 october 19831 (epa), and articles 10 paragraph 2, 14, 19, 20, 24 paragraphs 2 and 3, 25 and 34 of the gene technology act of 21 march 20032 (gta), on articles 26 paragraphs 2 and 3, 29 and 78 paragraph 1 of the epidemics act of 28 september 20123and in implementation of article 8 letters g, h and l and article 19 paragraph 4 of the convention of 5 june 19924 on biological diversity,5ordains:1 sr 814.012 sr 814.913 sr 818.1014 sr 0.451.435 amended by no i of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).chapter 1 general provisions art. 1 aim this ordinance is intended to protect human beings, animals and the environment, as well as biological diversity and its sustainable use, from hazards or harm caused by handling organisms, their metabolic products and wastes in contained systems.art. 2 subject matter and scope of application 1 this ordinance regulates the handling of organisms, in particular genetically modified, pathogenic or alien organisms, in contained systems.2 the transport of organisms intended for handling in contained systems is governed by articles 4, 15 and 25 only.3 handling organisms in the environment is governed by the release ordinance of 10 september 20086.4 the protection of people and the environment against serious damage resulting from major accidents involving microorganisms is regulated by the major accidents ordinance of 27 february 19917.85 the protection of employees when handling microorganisms is governed by the ordinance of 25 august 19999 on the protection of employees from dangerous microorganisms.6 this ordinance does not apply to the handling of organisms: a.in accordance with the ordinance of 20 september 201310 on clinical trials in human research;b.in the case of personal use of medical devices for the purposes of in-vitro diagnostics, the dispensing of which is authorised in accordance with article 17 paragraph 3 of the medical devices ordinance of 17 october 200111.126 sr 814.9117 sr 814.0128 amended by no iii 2 of the o of 29 april 2015, in force since 1 june 2015 (as 2015 1337). 9 sr 832.32110 sr 810.30511 sr 812.21312 amended by no i of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).art. 3 definitions in this ordinance:a.organisms means cellular or non-cellular biological entities capable of replication or of transferring genetic material, and in particular animals, plants and microorganisms. mixtures, articles and products containing such entities are also regarded as organisms;b.microorganisms means microbiological entities, in particular bacteria, algae, fungi, protozoa, viruses and viroids; cell cultures, parasites, prions and biologically active genetic material are also regarded as microorganisms;c.small invertebrates means arthropods, annelids, nematodes and flatworms;d.genetically modified organisms means organisms in which the genetic material has been altered by methods of gene technology in accordance with annex 1 in a way that does not occur under natural conditions by crossing or natural recombination, as well as pathogenic or alien organisms that have also been genetically modified;e.pathogenic organisms means organisms that can cause diseases in human beings, domesticated animals and plants, in wild flora or fauna or other organisms, as well as alien organisms that are also pathogenic;f.alien organisms means organisms of a species, sub-species or lower taxonomic level that:1.do not naturally occur in switzerland or in other efta and eu member states (not including overseas areas),2.have not undergone selection for use in agriculture or horticultural production to such an extent that their viability in the wild is reduced;g.invasive alien organisms means alien organisms of which it is known or must be assumed that they will spread in switzerland and could achieve such a high population density that biological diversity or its sustainable use could be harmed or human beings, animals and the environment could be endangered;h.contained system means a system that uses physical barriers or a combination of physical and chemical or biological barriers to limit or prevent contact between organisms and people or the environment;i.handling means any deliberate activity involving organisms, and in particular use, processing, propagation, modification, detection, transport, storage or disposal;j.13improper use means the handling of organisms subject to a containment obligation which illegally and intentionally endangers or harms humans, animals, the environment or biological diversity and their sustainable use.13 amended by no i of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).chapter 2 requirements for handling organisms in contained systems section 1 general requirements art. 4 duty of care 1 any person handling organisms in contained systems must take all due care to ensure that organisms, their metabolic products or wastes:a.cannot endanger people, animals or the environment;b.do not harm biological diversity or its sustainable use.2 the relevant regulations and the distributor's instructions and recommendations must be observed.3 compliance with the duty of care must be clearly documented. the documentation must be retained for ten years following the conclusion of the activity and must be made available on request to the enforcement authorities.art. 5 containment obligation and prior assessments 1 the following organisms must be handled only in contained systems unless they may be handled in the environment in accordance with the release ordinance of 10 september 2008,14 the plant protection products ordinance of 12 may 201015 or the biocidal products ordinance of 18 may 200516:a.genetically modified organisms;b.pathogenic organisms;c.17organisms subject to a containment obligation:1.alien small invertebrates,2.invasive alien organisms as defined in annex 2 of the release ordinance, and3.harmful organisms that are considered particularly dangerous in accordance with the ordinance issued by the federal department of economic affairs, education and research and the federal department of the environment, transport, energy and communications based on articles 4 paragraph 3, 24 paragraph 2 and 29 paragraph 2 of the plant health ordinance of 31 october 201818, and organisms that are considered potential quarantine organisms in accordance with the ordinance issued by the federal office for agriculture (foag) and the federal office for the environment (foen) based on article 5 paragraph 2 of the plant health ordinance.2 any person who handles organisms in contained systems must first determine and assess the risk of the occurrence of the organisms (allocate the organisms to a group) and thereafter determine and assess the risk due to the planned activities with the organisms (classify the activities).3 any person who handles genetically modified animals and plants in contained systems must first ensure by weighing the interests in accordance with article 8 gta that the dignity of living beings is respected.14 sr 814.91115 sr 916.16116 sr 813.1217 amended by annex 8 no 4 of the plant health ordinance of 31 october 2018, in force since 1 jan. 2020 (as 2018 4209).18 sr 916.20art. 5a19 primary detection outside contained systems 1 where a pathogenic organism with the potential to do considerable harm naturally occurs on a frequent basis, is released intentionally or unintentionally or if it is suspected that it has been released, its primary detection may take place exceptionally outside of contained systems if:a.there is no threat to humans, animals, the environment or biological diversity;b.the analyses are carried out in order help an assessment of the situation;c.appropriate security measures are respected; andd.the rapid detection systems used can be shown to be reliable.2 detection as defined in paragraph 1 is only permissible if carried out by employees of the following competent authorities who possess the requisite specialist expertise: a.the cantonal emergency services for b-incidents in accordance with article 3 letter e of the ordinance of 29 april20 on microbiological laboratories;b.the competent veterinary authorities responsible for measures to combat disease in accordance with article 63 of the epizootic diseases ordinance of 27 june 199521;c.the federal or cantonal plant protection services responsible for preventive measures in accordance with article 10, for monitoring in accordance with article 18 and for surveying in accordance with article 19 of the plant health ordinance of 31 october 201822 (pho);d.the establishments authorised in accordance with article 76 pho to conduct assessments in accordance with article 84 pho.19 inserted by no i of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).20 sr 818.101.3221 sr 916.40122 sr 916.20art. 6 grouping of organisms 1 in order to determine the risk of an occurrence of organisms, the extent and probability of harmful effects to human beings, animals or the environment and to biological diversity and its sustainable use must be estimated. in doing so, the criteria in annex 2.1 number 1 must be taken into account.2 in order to assess the risks determined, the organisms must be allocated to one of the following groups according to the criteria in annex 2.1 number 2:a.group 1: organisms whose occurrence presents no risk or a negligible risk;b.group 2: organisms whose occurrence presents a low risk;c.group 3: organisms whose occurrence presents a moderate risk;d.group 4: organisms whose occurrence presents a high risk.3 if certain organisms have already been grouped according to the list in article 26, no new risk determination and assessment need be carried out unless there are indications of an increased or reduced risk in an occurrence of these organisms. in the event of significant new findings, the risk must be determined and assessed again.art. 7 classification of activities 1 in order to determine the risk of a planned activity with organisms in the contained system, the extent and probability of harmful effects to human beings, animals or the environment, biological diversity and its sustainable use must be estimated. in doing so, the group of organisms concerned, the nature of the planned activity and the environmental conditions according to the criteria in annex 2.2 number 1 must be taken into account.2 in order to assess the risks determined, the planned activity must be allocated to one of the following classes according to the criteria in annex 2.2 number 2:a.class 1: activities with no risk or a negligible risk;b.class 2: activities with a low risk;c.class 3: activities with a moderate risk;d.class 4: activities with a high risk.3 the risk must be determined and assessed again if the activity is modified or significant new findings are made.4 in activities where employees may be exposed to microorganisms, the risk determination and assessment in accordance with this ordinance may be combined with the risk assessment in accordance with articles 5-7 of the ordinance of 25 august 199923 on the protection of employees from dangerous organisms.23 sr 832.321section 2 requirements for handling genetically modified or pathogenic organisms or alien organisms subject to a containment obligation art. 8 notification of class 1 activities 1 any person who wishes to carry out class 1 activities with genetically modified organisms must notify this globally, at the latest when beginning the activities.2 any change in the globally notified activities or their termination must be notified.art. 9 notification of class 2 activities 1 any person who wishes to carry out a class 2 activity with genetically modified or pathogenic organisms or alien organisms subject to a containment obligation must notify this at the latest when beginning the activity.2 any technical or administrative change in the notified activity or its termination must be notified.3 if an authorisation is required under article 49 paragraph 2 of the epizootic diseases ordinance of 27 june 199524 (ezdo), this must be obtained before starting the activity.24 sr 916.401art. 10 authorisation of activities in classes 3 and 4 1 any person who wishes to carry out a class 3 or a class 4 activity with genetically modified or pathogenic organisms or alien organisms subject to a containment obligation requires authorisation.2 any technical change in the authorised activity requires further authorisation.3 any administrative change must be notified.art. 11 submission to the authorities 1 notifications and authorisation applications must be submitted to the federal coordination centre for biotechnology.2 notifications and authorisation applications must include the information listed in annex 3. in the information, procedures and methods related in their nature, extent and purpose may be summarised.3 the information must be entered directly into the ecogen electronic database (art. 27a).25 25 amended by no i of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).art. 12 safety measures 1 any person involved in the contained handling of genetically modified or pathogenic organisms or alien organisms subject to a containment obligation must:a.ensure in the case of activities in classes 1 and 2 that any escape by these organisms is limited to the extent that human beings, animals and the environment as well as biological diversity and its sustainable use cannot be endangered;b.ensure in the case of activities in classes 3 and 4 that these organisms cannot escape.2 the general safety measures listed in annex 4 and the special safety measures required according to the type and class of activity must be taken, and an operational safety concept must be devised which takes appropriate account of whether organisms could potentially be put to improper use. the safety measures taken must take account of the risk determined in the individual case and the state of the art of safety technology.26 3 the competent federal office may order in specific cases that:a.individual special safety measures accordingly specified in annex 4 may be modified, replaced or omitted if the applicant has proven that the protection of human beings, animals and the environment as well as biological diversity and its sustainable use is nevertheless guaranteed;b.further special safety measures not listed in annex 4 for the relevant type and class of activity must be taken if such measures have been recommended by international organisations or the swiss expert committee for biosafety (secb) and are regarded as necessary by the competent federal office.26 amended by no i of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).art. 13 guarantee of liability 1 any person who carries out an activity in contained systems with genetically modified or pathogenic organisms of classes 3 or 4 must guarantee legal liability:a.of 20 million francs to cover damage to persons and property (art. 30 gta, art. 59abis para. 1 epa); andb.of 2 million francs to cover damage to the environment (art. 31 gta, art. 59abis para. 9 epa).2 the obligation to guarantee liability may be fulfilled:a.by obtaining liability insurance from an insurance company that is authorised to do business in switzerland;b.by providing security of equivalent value.3 the following are exempt from this guarantee of liability:a.the confederation, its public corporations and institutions;b.the cantons and their public corporations and institutions, provided the cantons cover their liabilities.art. 14 start, suspension and termination of the guarantee 1 the person who guarantees liability must notify the specialist agency appointed by the canton of the start, suspension and termination of the guarantee.2 the suspension and termination of the guarantee, unless previously replaced by a different guarantee, become effective 60 days after receipt of notification by the specialist agency appointed by the canton.art. 15 transport 1 any person transporting genetically modified or pathogenic microorganisms must observe the applicable national and international transport regulations, in particular with regard to labelling and packaging.2 in the case of transport in a manner not covered by paragraph 1 of genetically modified or pathogenic organisms or alien organisms subject to a containment obligation, it must be ensured that any escape of organisms is either limited or prevented, depending on the risk.3 the distributor must inform the recipient of:a.the identity and the quantity of the organisms;b.the properties of the organisms, and in particular whether they are genetically modified, pathogenic or alien organisms;c.that the organisms must be handled in contained systems.art. 16 reporting incidents 1 the specialist agency appointed by the canton must be informed immediately in the event that, when handling organisms in contained systems:a.organisms that should have been prevented from escaping into the environment under article 12 paragraph 1 have done so;b.there was a genuine risk of organisms being released into the environment in the course of activities in classes 3 and 4; orc.27there is a strong suspicion of improper use.2 the cantons shall inform the competent federal office of any reported incidents.27 inserted by no i of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).chapter 3 duties of the authorities section 1 examination of notifications and authorisation applications art. 17 federal coordination centre for biotechnology 1 the confederation operates a coordination centre for biotechnology within the federal office for the environment (foen).2 the coordination centre has the following administrative duties:a.it accepts notifications and authorisation applications under articles 8-12 as well as notifications under the ordinance of 25 august 199928 on the protection of employees from dangerous organisms;b.it examines the notifications and authorisation applications, requests any missing information within 20 days and confirms to the person filing the notification or application that the document is complete;c.it forwards complete notifications and authorisation applications to the competent federal office (art. 18 para. 1) for a decision and to the specialist agencies (art. 18 para. 2) for an opinion;d.it gives notice of receipt of notifications and authorisation applications in the official federal gazette and makes these notifications and authorisation applications available for public inspection unless they are confidential;e.it monitors progress in processing the notifications and authorisation applications received;f.29it maintains the ecogen electronic database (art. 27a);g.it maintains a register of notified and authorised activities and makes this information, and the results of surveys under article 27, publicly accessible via automated information and communications services unless they concern confidential information;h.it is the information and advice centre for enquiries about:1.procedures and the status of notification procedures and authorisation applications,2.forms, guidelines and foreign standards as well as contact addresses within the federal administration,3.the list of classified organisms;i.it may run courses and training sessions in its capacity as an information and advice centre;j.it receives information and reports from the cantons on their supervisory activities under article 23, forwards them immediately to the responsible federal offices and issues an annual report on supervisory activities under this ordinance.28 sr 832.32129 amended by no i of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).art. 18 competent federal office and specialist agencies 1 the following offices are competent to take the decisions required in connection with activities subject to notification or authorisation:a.the federal office of public health (foph) where the main risk of an activity concerns human beings;b.the foen for all other activities.2 the following are the specialist agencies:a.for all activities, the foph, the foen, the federal ethics committee on non-human biotechnology (ecnh), the specialist agency appointed by the canton, and, at its request, the state secretariat for economic affairs (seco);b.for activities in classes 24, the swiss national accident insurance fund (suva);c.for activities in classes 3 and 4 and applications under article 12 paragraph 3 letter a, the secb;d.for activities with organisms pathogenic to animals, the federal food safety and veterinary office (fsvo)30;e.for activities with organisms pathogenic to plants and alien organisms subject to a containment obligation, the federal office for agriculture (foag).3 if the foph, the foen, the foag or the fsvo are the specialist agencies, the competent federal office decides with their consent in cases where the matter in question relates to compliance with the legislation enforced by these agencies.4 in the case of activities with highly contagious epizootic diseases under article 2 ezdo31 that are intended to be carried out outside the institute for virology and immunology (ivi) 32, the competent federal office coordinates its decision with that of the fsvo under article 49 paragraph 2 ezdo.30 the name of the federal office was changed on 1 jan. 2014 in accordance with art. 16 para. 3 of the publications ordinance of 17 nov. 2004 (as 2004 4937). the change has been made throughout the text.31 sr 916.40132 the name of this administrative unit was modified in application of art. 16 para. 3 of the publications ordinance of 17 nov. 2004 (sr 170.512.1) on 1 may 2013. art. 19 notification procedure 1 the competent federal office verifies whether the requirements of articles 4-7 have been met. in doing so, it takes account of any opinions from the specialist agencies.2 the competent federal office may prohibit the activity entirely or in part if there is reason to assume that the requirements of articles 4-7 have not been met. it communicates its decision within 90 days of confirmation of its completeness to the notifying person, the specialist agencies, and the federal coordination centre for biotechnology.3 if the competent federal office fails to issue a decision within the said period, class 1 activities subject to notification and changes to class 2 activities of which the office has already been notified are deemed to be in compliance with this ordinance, unless this is contradicted by substantial new findings.33 33 amended by no i of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).art. 20 authorisation procedure 1 the competent federal office verifies whether the requirements of articles 4-7 and 13 have been met. in doing so, it takes account of the opinions received from the specialist agencies.2 the competent federal office decides on the authorisation application within 90 days of confirmation of its completeness. authorisation is valid for a maximum of five years.3 if there is a risk in delay, and in particular if a rapid diagnosis of new microorganisms is required, the competent federal office may, following a provisional examination of the risk determination and assessment and having informed the specialist agencies, grant authorisation limited until the conclusion of the ordinary procedure.4 the competent federal office communicates its decision to the applicant, the specialist agencies and the federal coordination centre for biotechnology.art. 21 authorisation to modify, replace or omit certain special safety measures 1 within 90 days of confirmation that the application is complete, the competent federal office authorises requested deviations from special safety measures provided the requirements (art. 12 para. 3 let. a) are met. in doing so, it takes account of the opinions received from the specialist agencies.2 the competent federal office communicates its decision the applicant, the specialist agencies and the federal coordination centre for biotechnology.art. 22 standard deadlines 1 if additional information must be submitted in order to consider notifications and authorisation applications, the standard deadlines in this section are extended accordingly.2 if the competent federal office is unable to comply with the deadline for issuing a decision under this section, it notifies the notifying person or applicant and the specialist agencies before expiry of the deadline and informs them when the decision is to be expected.section 2 monitoring in establishments art. 23 duties of the cantons 1 the cantons monitor shall compliance with the duty of care, the containment obligation and the safety measures.2 they also verify by means of spot checks whether:a.the documentation required by article 4 paragraph 3 has been prepared and preserved;b.notification has been given or authorisation granted, if required, for an activity that has been carried out;c.the information on the organisms to be used and the activity given in the notification or authorisation application corresponds with the organisms actually used and the activity carried out;d.a significant change in the proposed activity has been made such that the risk determination and assessment under article 7 paragraph 3 must be repeated;e.public liability is guaranteed.3 the samples, detection methods and materials required for monitoring are made available to the cantons.4 if the monitoring shows cause for complaint, the canton in question orders the required measures to be taken and inform the federal coordination centre for biotechnology.5 if there is justified doubt whether an activity that has only been documented is not subject to a notification or authorisation obligation, the canton informs the federal coordination centre for biotechnology.6 the cantons wherever possible coordinate monitoring under this and other legislation.7 the cantons submit an annual report to the federal coordination centre for biotechnology on their monitoring activities. to do so, they use the template provided by the coordination centre.art. 24 duties of the confederation 1 if the requirements for a notified activity or an authorisation are not met despite a complaint from the canton, the competent federal office, having consulted the canton, shall prohibit the continuation of the notified activity or revoke authorisation.2 the competent federal office decides based on information provided by the canton whether an activity that is only documented is subject to the notification or authorisation obligation or not.section 3 monitoring transport art. 25 the responsibility for monitoring the transport of genetically modified or pathogenic organisms or alien organisms subject to a containment obligation and for ordering any measures is governed by the relevant transport regulations.section 4 obtaining, processing and confidentiality of data art. 2634 lists of classified organisms 1 the foen maintains with consent of the foph, seco, fsvo, foag and suva and after consulting the secb a publicly accessible, non-conclusive list in which organisms are classified in one of the four groups according to the criteria in annex 2.1.2 the foph maintains with the consent of the foen and after consulting seco, the fsvo, the foag, the federal office for civil protection, suva and the secb, a publicly accessible, non-conclusive list of organisms with a high potential for improper use.3 the foen and the foph shall take account of existing lists, in particular those of the european union and its member states and of international organisations.34 amended by no i of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).art. 27 surveys the foen and the foph may carry out surveys of all activities involving genetically modified, pathogenic and alien organisms in contained systems, in particular as to the type and number of and time schedule for these activities.art. 27a35 ecogen electronic database 1 data required to conduct the following tasks are recorded and processed in the ecogen electronic database: a.the notification and authorisation procedures specified in articles 19 and 20;b.reporting incidents under article 16 paragraph 2;c.receiving information and reports on supervisory activities under article 17 paragraph 2 letter j;d.providing information and advice under article 17 paragraph 2 letter h;e.conducting other tasks relating to the implementation of this ordinance.2 the following persons have access to ecogen and may process the data it contains:a.employees of the federal coordination centre for biotechnology and of the offices and agencies responsible listed in article 18 paragraphs 1 and 2: in accordance with their appointed tasks;b.persons making a notification or application: to the extent that the data concerns them.35 inserted by no i of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).art. 28 confidentiality of information 1 the authorities responsible for the enforcement of this ordinance shall treat information as confidential where there is a legitimate and overriding interest in doing so. they classify this information as such when forwarding it to other authorities.2 there is a legitimate interest in particular in preserving trade and manufacturing secrecy.3 any person submitting documents to the authorities must:a.indicate the information which is to be treated as confidential; andb.justify the need for confidentiality.4 an authority that does not wish to accede to a request for confidentiality shall investigate whether the grounds given for confidentiality are justifiable. if its assessment differs from the proposal of the persons supplying the information, the authority, after hearing these persons, shall inform them in a ruling which information they do not find worthy of protection.5 the following information shall always be accessible to the public:a.the name of the persons responsible for the activity and for monitoring biological safety;b.address of the establishment and the installation (location of the activity);c.the type of installation, safety measures and waste disposal;d.a general description of the organisms and of their properties;e.a general description of the activity, and in particular its purpose and its approximate size (e.g. culture volume);f.a summary of the risk assessment;g.the class of the activity.section 5 fees art. 29 obligation to pay a fee 1 any person who causes the federal coordination centre for biotechnology, the foen or the foph to provide a service or the offices to issue a ruling under this ordinance must pay a fee.2 unless this ordinance contains special regulations, the provisions of the general fees ordinance of 8 september 200436apply.36 sr 172.041.1art. 30 level of fees 1 the fees are as follows: francsa.examination of notifications under article 19100-2000b.examination of authorisation applications under article 20300-4000c.examination of authorisation applications under article 21100-40002 the fee is assessed on a time and material basis. if the work involved is unusually high, the fee may be increased by up to 50 per cent.3 when examining applications for a re-assessment, fees of up to 50 per cent of the rates fixed may be charged.4 for services without a fee rate, the fee amounts to 130-190 francs per hour.art. 31 outlays outlays are the costs additionally incurred for an individual service, and in particular:a.remuneration for members of extra-parliamentary committees under the government and administration organisation ordinance of 25 november 199837;b.costs incurred in gathering evidence, conducting scientific investigations or special examinations or obtaining documents;c.costs of work that the federal coordination centre for biotechnology, the foen or the foph arranges to be carried out by third parties.37 sr 172.010.1section 6 guidelines, basic and continuing professional education art. 32 1 the foen and the foph may issue joint guidelines on the implementation of this ordinance, in particular on the determination and assessment of the risks posed by the occurrence of organisms or activities with organisms, transport of organisms, safety measures and related quality controls. they consult the specialist agencies (art. 18 para. 2) beforehand.2 the foen and the foph jointly ensure, in consultation in particular with the secb, that basic and continuing professional education events are held regularly for persons who carry out duties under this ordinance.chapter 4 final provisions art. 33 repeal of current legislation the following ordinances are repealed:1.containment ordinance of 25 august 199938;2.ordinance of 15 october 200139 on fees for services under the containment ordinance.38 [as 1999 2783, 2003 4793 no i 3, 2006 4705 no ii 82, 2007 4477 no iv 35, 2008 4377 annex 5 no 6]39 [as 2001 2878]art. 34 amendment of current legislation the amendment of current legislation is regulated in annex 5.art. 35 transitional provisions 1 activities that are authorised in the proper manner when this ordinance comes into force may be continued until expiry of authorisation in accordance with the previous law.2 activities that have been properly notified before this ordinance comes into force must within five years of this ordinance coming into force be reviewed by the notifying person to verify compliance herewith. if changes to the activity or the safety measures are required due to this ordinance, they must be notified within the same five-year deadline.3 notification of previous activities with genetically modified organisms in class 1 must be replaced within one year of this ordinance coming into force by a global notification under article 8.4 activities with alien organisms subject to a containment obligation may only be carried out without a notification or an authorisation application for one year from the date on which this ordinance comes into force.art. 35a40 transitional provision to the amendment of 31 october 2018 the duty to contain particularly dangerous plants as listed in annex 6 of the plant protection ordinance of 27 october 201041 in accordance with article 5 paragraph 1 letter c applies until 31 december 2023. 40 inserted by annex 8 no 4 of the plant health ordinance of 31 oct. 2018, in force since 1 jan. 2020 (as 2018 4209).41 as 2010 6167, 2011 3331, 2012 6385, 2014 4009, 2015 4567, 2016 2445 3215, 2017 6141, 2018 2041art. 36 commencement this ordinance comes into force on 1 june 2012.annex 1 (art. 3 let. d)definition of gene technology methods 1 gene technology methods means, in particular:a.recombinant nucleic acid techniques, in which nucleic acid molecules synthesised outside an organism are inserted into viruses, bacterial plasmids or other vector systems to produce novel combinations of genetic material, which are then transferred to a recipient organism in which they do not naturally occur but are capable of continued propagation;b.techniques in which genetic material produced outside the organism is inserted directly into an organism, in particular by microinjection, macroinjection and microencapsulation, electroporation or on microprojectiles;c.cell fusion or hybridisation techniques in which cells with novel combinations of genetic material are produced by the fusion of two or more cells through processes that do not occur under natural conditions.2 self-cloning of pathogenic organisms is regarded as a gene technology method. this consists of the removal of nucleic acid sequences from one cell of an organism and the complete or partial insertion of this nucleic acid or a synthetic equivalent (possibly after a previous enzymatic or mechanical treatment) into cells of the same species or cells which are closely related phylogenetically and which can exchange genetic material by natural physiological processes.3 self-cloning of non-pathogenic organisms and the following methods are not regarded as gene technology methods as long as they are not used in association with recombinant nucleic acid molecules or genetically modified organisms:a.mutagenesis;b.cell and protoplast fusion of prokaryotic microorganisms that exchange genetic material by natural physiological processes;c.cell and protoplast fusion of eukaryotic cells, including the production of hybridoma cell lines and the fusion of plant cells;d.in vitro fertilisation;e.natural processes such as conjugation, transduction and transformation;f.changes in ploidy level, including aneuploidy and the elimination of chromosomes.annex 2 determination and assessment of risk annex 2.142 42 corrected by no 2 of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131). (arts 6 and 26)assigning organisms to groups 1 risk determination 1 in order to determine the risk due to the occurrence of an organism for human beings, animals or the environment as well as biological diversity and its sustainable use, the following criteria in particular must be taken into account:a.pathogenicity and lethality;b.virulence or attenuation;c.mode of infection, effective infection dose and the infection routes;d.production of non-cellular components such as toxins and allergens;e.the reproductive cycle and survival structures;f.host range;g.the degree of natural or acquired immunity of the host;h.pattern of resistance or sensitivity to antibiotics and other specific agents;i.availability of appropriate prophylaxis and therapy;j.the presence of oncogenic nucleic acid sequences;k.mutagenicity;l.virus production and viral shedding in cell lines;m.parasitic properties;n.potential contamination with pathogenic microorganisms;o.environmental aspects;p.experience with the spread of closely related types of organism in switzerland or in other countries (invasive potential);q.the availability of suitable techniques to record, detect, identify, monitor and combat these organisms;r.potential for improper use.2 in order to determine the risk arising when a genetically modified organism occurs, both donor and receptor organisms, introduced genetic material (inserts), the vector or the vector-receptor system and the genetically modified organism itself must be taken into account, in particular according to the following criteria:a.function of the genetic changes;b.degree of purity and characterisation of the genetic material used in recombination;c.properties of vectors, in particular relating to replication capacity, host range, host specificity, existence of a transfer system, mobilisation and independent infectivity;d.properties of affected nucleic acid sequences, in particular regulatory effects on cell growth, cell cycle and immune system;e.production and supply of organisms and active pharmaceutical substances, allergens or toxins via the genetically modified organism;f.stability and expression of recombinant genetic material;g.mobilisation potential of recombinant genetic material;h.selection pressure for recombinant genetic material.3 in order to determine the risk due to the occurrence of an alien organism for human beings, animals or the environment as well as biological diversity and its sustainable use, the following criteria in particular must be taken into account:a.life cycle and reproduction, in particular with regard to asexual reproduction, generation time and the number of offspring;b.presence of host organisms in the environment;c.environmental aspects and viability, in particular cold tolerance and diapause;d.potential contamination with microorganisms that may be pathogenic for humans, animals and plants;e.invasiveness and ability to suppress native species;f.threat to human, animal and plant health by the organism due to its allergicity, pathogenicity, toxicity or property as a vector;g.harm to other organisms, in particular through competition and hybridisation;h.harm to resource cycles;i.effects on the functioning of the ecosystem;j.resistance or sensitivity to pesticides, herbicides and other agents;k.availability of suitable techniques to detect the organism in the environment and to combat it.2 risk assessment 1 when making a risk assessment, the effects of the organisms on healthy people, animals and plants must generally be considered.2 the risk is considered inexistent or negligible (group 1) if:a.it is unlikely that an organism will cause illness in people, animals or plants or some other damage to the environment or to biological diversity and its sustainable use; andb.such damage is not severe.3 the risk is considered low (group 2) if:a.an organism may cause illness in people, animals or plants or some other damage to the environment or to biological diversity and its sustainable use;b.such illness or damage is rarely severe;c.the organism is unlikely to spread; andd.normally effective preventive or therapeutic measures to combat the illness or damage are available.4 the risk is considered moderate (group 3), if:a.an organism may cause severe illness in people, animals or plants or other severe damage to the environment or to biological diversity and its sustainable use;b.the organism is likely to spread; andc.normally, effective preventive or therapeutic measures to combat the illness or damage are available.5 the risk is considered high (group 4), if:a.an organism may cause severe illness in people, animals or plants or other severe damage to the environment or to biological diversity and its sustainable use;b.the organism is likely to spread; andc.normally, no effective preventive or therapeutic measures to combat the illness or damage are available.6 if, in an individual case, it is unclear to which of two groups an organism belongs, the risk must be assessed by weighing the seriousness of the illness and damage, and the probability that the organism will spread, against the availability of effective preventive or therapeutic measures. in the event of any doubt, an organism must be assigned to the higher of two groups.annex 2.243 43 corrected by no 2 of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131). (art. 7)classification of activities 1 risk determination in order to determine the risk arising from planned activities with organisms in a contained system, the following criteria in particular should be taken into account while considering the group to which the organisms concerned have been assigned:a.the nature, extent and purpose of the activity, such as diagnosis, research, production or storage;b.the known or suspected geographical distribution and frequency in switzerland of the organisms concerned or of their hosts and vectors and if applicable of the recombinant genetic material involved endemically, by natural occurrence, immigration, reproduction or genetic transfer;c.the potential for survival, replication and dissemination of the organisms in switzerland, in particular the formation of long-lasting forms;d.the interaction of the organisms concerned with other organisms or involvement in biogeochemical processes;e.host or vector occurrence in switzerland;f.the impact of the activity on pathogenicity, detectability and transmissibility, ability to survive and disseminate, virulence, host spectrum or tropism of the organisms used;g.the influence of the activity on the effectiveness of vaccines, antibiotics, antivirals or other agents with a medical or agricultural use against pathogenic organisms;h.the purpose of the activity in producing novel pathogenic organisms or restoring extinct or extinct pathogenic organisms;i.the potential of the pathogenic organisms for improper use.2 risk assessment 2.1 in general 1 the class of an activity normally corresponds to the group to which the organisms have been assigned. however, the class differs from the group of organisms if the risk assessment indicates, based on the activity and environmental conditions, a considerably increased or reduced risk compared with the group to which the organisms have been assigned.2 an activity is assigned to class 1 if it presents no risk or a negligible risk to people, animals, the environment and biological diversity and its sustainable use, in particular if no impact or a negligible impact on these targets can be expected should organisms escape from the contained system.3 an activity is assigned to class 2 if it presents a low risk to people, animals, the environment and biological diversity and its sustainable use, in particular if a limited, reversible impact on these targets can be expected should organisms escape from the contained system.4 an activity is assigned to class 3 if it presents a moderate risk to people, animals, the environment and biological diversity and its sustainable use, in particular if an irreversible but limited impact on these targets can be expected should organisms escape from the contained system.5 an activity is assigned to class 4 if it presents a high risk to people, animals, the environment and biological diversity and its sustainable use, in particular if an irreversible impact on these targets can be expected or epidemics with serious consequences may possibly occur should organisms escape from the contained system.6 if, in an individual case, it is unclear to which of two classes an organism belongs, it must be assigned to the higher of two classes.2.2 in particular 1 the following activities are normally assigned to class 1:a.analyses of soil, water, air or food samples, provided it can be assumed that the samples are not so contaminated that they pose an increased risk to human beings, animals, the environment and biological diversity and its sustainable use;b.analyses of organisms in groups 1 and 2 from clinical and other biological material for diagnostic purposes, if organisms can be shown to be present by direct or indirect methods without propagation, or if organisms can be shown to be present following slight enrichment carried out exclusively in closed containers;c.activities with certain strains of group 2 organisms, provided such strains have proved in experiments or over many years of experience to be as safe as group 1 organisms.2 analyses of organisms from clinical and other biological material for diagnostic purposes with exception of analyses under paragraph 1 must normally be assigned to class 2. 3 where group 3 pathogenic organisms have been enriched for diagnostic purposes and if this results in an increased risk to human beings, animals or the environment as well as biological diversity and its sustainable use, this activity must be assigned to class 3.4 when group 4 organisms are processed, the activity should in most cases be assigned to class 4. however, if a primary diagnostics of group 4 organisms from non-inactivated clinical material is performed by direct or indirect methods without replication, this activity may be assigned to class 3. where further testing is carried out using the same source material containing group 4 organisms, this activity must in all cases be assigned to class 4.5 primary diagnosis of group 3 organisms that are pathogenic to animals may in exceptional cases and in accordance with article 49 para. 2 ezdo44 be assigned to class 2 if it can be assumed that there is a high probability that no pathogen organisms are present in the samples.44 sr 916.401annex 3 (art. 11 para. 2)information for the notification and authorisation of activities annex 3.1 information for the global notification of activities with class 1 genetically modified organisms the global notification under article 8 includes the following information:a.the names and postal addresses of the establishment, of the persons responsible for the activities and the persons responsible for monitoring biological safety;b.the location and type of the installations where the activities are carried out;c.confirmation that in these installations class 1 activities with genetically modified organisms are carried out;d.confirmation that a weighing of interests under article 8 gta has been carried out for activities with genetically modified animals covered by the animal protection ordinance of 23 april 200845.45 sr 455.1annex 3.246 46 corrected by no 2 of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).information for the notification and authorisation of activities in classes 2-4 1 principles 1 the extent and the level of detail of the technical information required depend on the risk of the activity. in the case of class 2 activities, the technical information for one organism may be used for other organisms with similar properties, provided the activities concerned carry similar risks.2 the documents must indicate what information must be treated as confidential. the need for confidentiality must be justified (art. 28).2 administrative information a.the names and postal addresses of the establishment, the persons responsible for the activities and persons responsible for monitoring biological safety;b.a description of the activities;c.the duration the activities;d.the location and type of the installation;e.confirmation of the guarantee of liability for activities with genetically modified and pathogenic organisms of classes 3 and 4 (art. 13);f.confirmation that a weighing of interests under article 8 gta has been carried out for activities with genetically modified animals covered by the animal protection ordinance of 23 april 200847.47 sr 455.13 technical information a.a description and the group of the organisms and genetic materials to be used or analysed, and in particular of the reference organisms;b.a description of the activities, and in particular of their purpose and the methods to be used;c.the maximum volume of culture media for the organisms to be used;d.a verifiable record of the procedure under article 7 for determining and assessing the risks of the activities;e.the type of waste and method of disposal;f.the planned safety levels and safety measures for the activities and, if applicable, the individual procedures;g.information on the time and place that the human pathogens in groups 3 and 4 are brought into the country.annex 448 48 corrected by no 2 of the o of 27 sept. 2019, in force since 1 jan. 2020 (as 2019 3131).(art. 12)safety measures 1 general safety measures the following safety measures apply to all species and classes of activity:a.compliance with the generally recognised codes of building practice in the construction and maintenance of buildings and installations, in particular with a view to their stability, the safety of persons and property and fire prevention;b.compliance with the operational safety concept and the related operating instructions and codes of conduct;c.employment of at least one person to monitor biological safety and prevent the improper use of organisms; the person must have sufficient knowledge of and competence in both technical matters and safety issues to carry out his or her duties; the tasks include in particular preparing, updating and implementing the safety concept, informing, advising and training staff, verifying compliance with biosafety rules and communicating with the authorities in relation to notifications, authorisation applications, safety measures and the safety concept;d.employment of a sufficient number of staff adequately trained on security issues;e.compliance with the principles of good microbiological practice in accordance with annex 3 number 1 paragraph 1 of the ordinance of 25 august 199949 on the protection of employees from dangerous organisms, including the provision of washing and decontamination facilities for the staff;f.appropriate inspections and maintenance of the monitoring measures and the equipment;g.if required, testing for the occurrence of viable forms of the organisms used outside the primary physical barriers;h.use of suitable storage facilities for equipment and materials that could be contaminated;i.provision of effective decontaminants and disinfectants and procedures in case of a release of organisms;j.measures against any pests and vermin;k.appropriate measures to minimise any previously identified risk of improper use of the organisms, such as restricting access to premises and recording the identity of persons with access to the organisms used. 49 sr 832.3212 special safety measures 2.1 activities with genetically modified or pathogenic organisms depending on the nature and class of the activity, special safety measures that go beyond the general safety measures must be taken which:a.must take account of the risk determined in the specific case;b.must correspond to the state of the art in safety technology;bbis.take account of the possibility of improper use of organisms; c.are listed according to the safety levels in specific installations in the following table, whereby the information under safety levels 1-4 corresponds to the requirements for the conduct of activities in classes 1-4;d.apply mutatis mutandis to the storage and the transport within the installation of organisms.tablekeyp means that the measure is required for production activities.l means that the measure is required for all other laboratory activities.g means that the measure is required for activities in greenhouses.v means that the measure is required for activities in installations with animals.[ ] means that the measure is required for the field of activity in brackets, but may be modified, replaced or omitted with the authorisation of the competent federal office.- means that the relevant measure is not required.msc ii/iii means the class ii/iii microbiological safety cabinet.hepa filter means high efficiency particulate air filternosafety measuressafety level1234building1separate work area- ---p ---p lgvp lgv2restricted access to the work area- ---p lgvp lgvp lgv3animal rooms separated by lockable doors- --vonly in installations with vertebrates- --vonly in installations with vertebrates- --v- --v4access to work area via airlock (separate room).the inside of the airlock must be separated from the outside by changing facilities, and preferably by lockable doors.- -- -- ---[p] [l][g][v]p lgvairlock doors lockable on both sides5shower area in airlock- ---- ---p lgvdepending on the risk this measure may be omitted without authorisation from the competent federal offices.[p] [l][g][v]6facilities for personal decontamination in the work area- ---p lgvp lgvp lgv7observation window or other means of monitoring the work area- ---- ---[p] [l][g][v]p lgv8biohazard warning sign- ---p lgvp lgvp lgv9rooms with easily cleanable floorsp l-vp lgvp lgvp lgv10rooms with easily cleanable walls- ---- ---p lgvp lgv11work area sealed so that fumigation is possible- ---[p] ---[p] [l][g][v]p lgv12work area under negative air pressure with respect to the immediate surroundings- ---- ---[p] [l][g][v]p lgv13air supply to the work area via hepa filter- ---- ---[p] ---[p] [l][g][v]14exhaust air outlet from the work area via hepa filter- ---- ---p [l][g][v]p lgvfor viruses that are not retained by hepa filters, additional measures are required.15microorganisms must be held in a primary contained system that physically separates the process from the rest of the work area. this primary contained system must be entirely within the work area.- ---p ---p ---p ---16the work area must be constructed so that a release of the entire contents of the primary contained system can be captured and retained.p ---p ---p ---p ---17requirements for the air outlet from the primary contained system- ---p ---minimise any escape of organisms p ---prevent any escape of organismsp ---prevent any escape of organisms18the work area must be ventilated so as to minimise the contamination of the air with organisms.- ---[p] ---[p] ---p ---equipment19surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontaminantsp lgvwork benchp lgvwork bench p lgvwork bench and floorp lgvwork bench, floor, ceiling and walls20work area with complete, independent equipment- ---- ---[p] [l][g][v]p lgv21microbiological safety cabinet (msc) when working with microorganisms - ---[p] [l][g][v]p lgvp lgvmsc iii including airlock entry and exit system or msc ii with full protection; full protection may be omitted for activities with animal and plant pathogens if authorised by the competent federal office 22measures against aerosol formation and dissemination- ---p lgvminimiseaerosol dissemination p lgvprevent aerosol disseminationp lgvprevent aerosol dissemination23.24for the animal species concerned, suitable systems for keeping animals (e.g. cages), that are easily decontaminated- --vwashable- --vdecontaminable- --vdecontaminable- --vdecontaminable25filter on isolation chambers (isolation chamber = transparent container in which the animal is kept when inside or outside a cage) or isolation rooms (for large animals)- ---- --[v]- --v- --v26requirements for seals on primary contained systems- ---p ---minimise any escape of organisms p ---prevent any escape of organismsp ---prevent any escape of organismswork organisation27suitable clothing for the work areap lgvfor laboratory activities: laboratory clothingp lgvfor laboratory activities: laboratory clothingp lgvsuitable protective clothing and, if applicable, shoesp lgvchange all clothing and shoes before entering or leaving28personal safety equipmentpersonal safety measures must be adapted to the activity and the organisms used.p lgvp lgvp lgvp lgv29regular disinfection of the workplaces- ---p lgvp lgvp lgv30inactivation of microorganisms in the outflow of sinks, pipes and showers- ---- ---[p] [l][g][v]p lgv31escape of contaminated waste water- -[g]-minimise- -[g]-minimise- -g-prevent- -g-prevent32escape of reproductive plant parts in the air or via vectors- -[g]-minimise- -[g]-minimise- -g-prevent- -g-prevent33.34inactivation of large volumes of culture medium prior to its removal from the primary contained system- ---p ---p ---p ---35minimise or prevent the escape of organisms during internal transport between various work areas p lgvminimisep lgvminimisep lgvpreventp lgvprevent36inactivation of the microorganisms in contaminated material, in waste and on contaminated apparatus, from animals, plants and process fluid in production activities 'p'.p lgvharmless disposal; inactivation of genetically modified microorganisms on site or disposal as hazardous waste; deactivation methods are permissible if their effectiveness is proven.[p] [l][g][v]autoclaving in the building, may take place outside the building if approval given by the federal office responsible;other equivalent deactivation methods are permissible if their effectiveness is proven;may be disposed of as hazardous waste:a. contaminated material, animal cadavers, diagnostic samples;b. solid cultures, if approval given by the federal office responsible[p] [l][g][v]autoclaving in the work area, may take place elsewhere in the building if approval given by the federal office responsible;other equivalent deactivation methods are permissible if validated;the autoclave may be omitted if approval given by the federal office responsible.p lgvdeactivation and pass-through autoclave in work area 2.2 activities with alien organisms subject to a containment obligation 1 for activities with alien organisms subject to a containment obligation, all potential escape paths must be secured by appropriate special safety measures so as to ensure that any escape of alien organisms subject to a containment obligation:a.is so limited in the case of class 1 and 2 activities that human beings, animals and the environment cannot be endangered and biological diversity and its sustainable use cannot be harmed;b.is prevented in the case of class 3 and 4 activities.2 the special safety measures in annex 4 number 2.1 apply mutatis mutandis.annex 5 (art. 34)amendment of current legislation .5050 these amendments may be consulted under as 2012 2777.

818.101english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton controlling communicable human diseases (epidemics act, epida)of 28 september 2012 (status as of 18 december 2021)the federal assembly of the swiss confederation,on the basis of articles 40 paragraph 2, 118 paragraph 2 letter b, 119 paragraph 2 and 120 paragraph 2 of the federal constitution1, and having considered the federal council dispatch dated 3 december 20102,decrees:1 sr 1012 bbl 2011 311chapter 1 general provisions and principles art. 1 subject matter this act regulates protecting people against communicable diseases and provides for the measures required to do so.art. 2 purpose 1 this act has the aim of preventing and controlling the outbreak and spread of communicable diseases.2 the measures under this act are intended to enable:a. communicable diseases to be monitored and basic knowledge about their spread and development to be made available;b. the dangers of the outbreak and spread of communicable diseases to be recognised, assessed and avoided at an early stage;c. individual persons, specific groups of persons and institutions to contribute to preventing and controlling communicable diseases;d. the organisational, technical and financial requirements for detecting, monitoring, preventing and controlling communicable diseases to be created;e. access to facilities and resources for protection against transmission to be ensured;f. the effects of communicable diseases on society and the persons affected to be reduced.art. 3 definitions in this act:a. communicable disease means an illness that may be transmitted to human beings by pathogens or their toxic products;b. observations means clinical findings (e.g. suspected diagnoses, confirmed diagnoses, deaths), laboratory analysis findings (e.g. test results, direct and indirect evidence of pathogens, typifications, resistance tests), epidemiological findings (e.g. key figures on healthcare-associated infections) and incidents (e.g. suspicious substances, objects) connected with communicable diseases; c. pathogens means natural and genetically modified organisms (e.g. viruses, bacteria, fungi, protozoa and other parasites), substances (e.g. prions, toxins) and genetic material that can cause or aggravate a communicable disease; d. handling pathogens means any activity involving pathogens, in particular their manufacture, reproduction, release, marketing, import, export, transit, retention, use, storage, disposal or transport.art. 4 goals and strategies 1 the federal council shall in consultation with the cantons determine the goals and strategies for detecting, monitoring, preventing and controlling communicable diseases.2 the following in particular must be taken into consideration in determining the goals and strategies:a. the findings of the reports under article 76;b. international recommendations and guidelines;c. the current state of scientific knowledge.3 the confederation and the cantons shall, based on the reports, review whether the goals have been achieved, and take the relevant measures as required.art. 5 national programmes 1 the federal office of public health (foph) shall, in consultation with the cantons, develop topic-specific national programmes for detecting, monitoring, preventing and controlling communicable diseases, in particular relation to:a. vaccinations;b. healthcare-associated infections and resistance in the case of pathogens;c. hiv and other sexually transmitted pathogens.2 the confederation and the cantons shall implement the national programmes within the scope of their powers.art. 6 special situation 1 a special situation arises if:a. the ordinary enforcement agencies are unable to prevent or control the outbreak and spread of communicable diseases, and one of the following risks is present: 1. a high risk of infection and of spread,2. a special risk to public health,3. serious consequences for the economy or for other areas of life;b. the world health organization (who) has announced a public health emergency of international concern and this emergency poses a risk to public health in switzerland. 2 the federal council may, after consulting the cantons, order the following measures:a. measures in relation to individual persons;b. measures in relation to the population;c. a requirement for doctors and other healthcare specialists to participate in combating communicable diseases;d. mandatory vaccinations for population groups at high risk, for persons who are particularly exposed to infection and for persons who carry out certain activities.3 the federal department of home affairs (fdha) shall coordinate the measures taken by the confederation.art. 7 extraordinary situation if an extraordinary situation so requires, the federal council may order the measures required for the entire country or for individual parts of the country.art. 8 preparatory measures 1 the confederation and the cantons shall take preparatory measures to limit the risks to and negative effects on public health at an early stage.2 the foph may instruct the cantons to take specific measures in view of a special risk to public health, in particular:a. measures to detect and monitor communicable diseases;b. measures in relation to individual persons; c. measures in relation to the population;d. measures to distribute therapeutic products.chapter 2 providing and exchanging information art. 9 providing information 1 the foph shall inform the public, specific groups of persons, authorities and experts about the dangers of communicable diseases and about the options for preventing and controlling such diseases.2 it shall regularly publish compilations and analyses about the nature, incidence, causes and spread of communicable diseases.3 it shall publish recommendations on measures against communicable diseases and on handling pathogens and shall adapt them regularly in line with the current state of scientific knowledge. if other federal offices are affected, the foph shall act in consultation with them.4 the foph and the competent cantonal authorities shall coordinate their information activities.art. 10 exchange of information 1 the foph shall ensure that the cantons receive the information pertaining to preventing and combating communicable diseases.2 the competent federal and cantonal bodies shall share research results, specialist knowledge and information on training and monitoring programmes with each other.chapter 3 detection and monitoring section 1 reports art. 11 early detection and monitoring systems the foph shall in cooperation with other federal agencies and the competent cantonal bodies operate systems for the early detection and monitoring of communicable diseases. it shall ensure coordination with international systems.art. 12 duty to report 1 doctors, hospitals and other public or private healthcare institutions shall report observations on communicable diseases, including the information required to identify the persons who are ill, infected or have been exposed and to establish the route of transmission:a. to the competent cantonal authority;b. in the case of certain pathogens, directly to the foph as well.2 laboratories shall report laboratory analysis findings on communicable diseases including the information required to identify the persons who are ill or infected to the competent cantonal authority and the foph.3 the federal council may require that measures taken to prevent and control the disease as well as their effect are reported and that samples and test results are sent to the laboratories designated by the responsible authorities.4 the competent cantonal authorities shall report observations that indicate a risk to public health to the foph.5 any person piloting a ship or an aircraft shall report observations that indicate a risk to public health to the port or airport operator.6 observations must be reported if they relate to communicable diseases that:a. may cause epidemics;b. may cause serious consequences;c. are novel or unexpected; ord. are subject to monitoring by international agreement.art. 13 regulation of reports 1 the federal council shall stipulate the observations on communicable diseases that must be reported, together with the methods, criteria and time limits for reporting. 2 in the case of specific report content, it may restrict the duty to report to selected doctors, to hospitals and other public or private healthcare institutions and to laboratories.art. 14 reports for epidemiological monitoring and for research purposes 1 the foph may agree for the purpose of epidemiological monitoring and for research purposes with doctors, laboratories, hospitals and other public or private healthcare institutions that they report observations that are not subject to the duty to report to a body designated by the foph.2 the report must be made in anonymised form.art. 15 epidemiological investigations 1 the competent cantonal authorities shall ensure the required epidemiological investigations, in particular on the nature, cause, source of infection and spread of a detected or suspected disease. they shall coordinate their activities and inform the foph about the results.2 the competent federal authority shall provide the cantonal authorities with professional support with the epidemiological investigations. it may conduct such investigations itself, particularly if the canton concerned requests it to do so.section 2 laboratories art. 16 licence requirement 1 laboratories that conduct microbiological tests for detecting communicable diseases require a licence from the competent federal authority.2 the federal council shall carry out the following tasks:a. designating the competent federal authority.b. regulating the requirements and procedure for granting the licence.c. specifying the licence holder's obligations.d. regulating supervision and in particular provide for the possibility of unannounced inspections.3 laboratories in doctors' practices, hospital laboratories, pharmacy dispensaries and other laboratories that conduct analyses as part of the universal provision of services under the federal act of 18 march 19943 on health insurance (health insurance act) are exempted from the licence requirement.3 sr 832.10art. 17 national reference centres and confirmation laboratories the foph may designate individual laboratories as national reference centres or as confirmation laboratories and entrust the same with special tests and other special tasks.art. 18 laboratory network the cantons shall operate a network of regional laboratories and ensure cooperation with the competent federal authorities and the high security laboratories.chapter 4 prevention section 1 general preventive measures art. 19 1 the confederation and the cantons shall take measures to control, reduce and eliminate the risks of disease transmission.2 the federal council may issue the following regulations:a. it may require hospitals, clinics and other healthcare institutions to decontaminate, disinfect and sterilise their medical devices.b. it may require businesses and event organisers whose activities increase the risk of transmitting the disease to provide prevention and information materials and comply with a specific code of conduct.c. it may require public health and education institutions to offer information on the dangers of communicable diseases and advice on their prevention and control.d. it may require public and private institutions that have a special obligation to protect the health of people in their care to take suitable preventive measures.e. it may make technical installations that can spread communicable diseases subject to a registration requirement.section 2 vaccinations art. 20 national vaccination plan 1 the foph, in cooperation with the federal commission for vaccination, shall draw up and publish vaccination recommendations in the form of a national vaccination plan.2 doctors and other healthcare specialists shall assist in implementing the national vaccination plan as part of their activities. 3 they shall inform the persons addressed by the vaccination recommendations about the national vaccination plan.art. 21 encouraging people to be vaccinated 1 the cantons shall encourage people to be vaccinated by:a. informing the persons addressed by the vaccination recommendations about the national vaccination plan;b. regularly reviewing the vaccination status of children and young people who are in compulsory education;c. ensuring that the persons addressed by the vaccination recommendations are fully vaccinated.2 they may in particular:a. offer vaccinations as part of school health services;b. administer vaccines free of charge or supply vaccines at below the market price.art. 22 mandatory vaccinations the cantons may declare vaccinations to be mandatory for population groups at high risk, persons who are particularly exposed to infection and persons that carry out certain activities, provided there is a significant risk.art. 23 international certificate of vaccination or other prophylaxis 1 the federal council may introduce a registration or licensing obligation for vaccinations for which an international certificate of vaccination or other prophylaxis under article 36 of the international health regulations (2005) of 23 may 20054 is required.2 the federal council shall carry out the following tasks:a. designating the competent authority;b. regulating the requirements and the procedure for granting licences;c. indicating the vaccination procedure and the permitted vaccines.4 sr 0.818.103art. 24 monitoring and evaluation 1 the competent federal authorities shall in consultation with the cantons regularly review the appropriateness and effectiveness of the vaccination measures.2 the competent cantonal authorities shall collect data on the numbers of persons who have been vaccinated and inform the foph regularly about the vaccination rate and about the measures taken to increase the rate.3 the foph shall regularly draw up reports on monitoring and evaluation and publish these in a suitable form.section 3 biosafety art. 25 duty of care any person who handles pathogens or their toxic products must take all the measures required to ensure that no one can come to any harm.art. 26 handling pathogens in contained systems 1 in the case of activities with pathogens in contained systems, all the containment measures that are required to prevent a risk to the population must be taken.2 the federal council shall introduce a registration or licensing obligation; it shall regulate the requirements and the procedure. 3 it may simplify the registration or licensing obligation or provide for exceptions in the case of specific pathogens and activities if current scientific knowledge and experience indicate that there is no risk to health.art. 27 release and marketing 1 any person who wishes to release or market pathogens for experimental purposes shall require a licence from the confederation.2 the federal council shall regulate the requirements and the procedure for granting the licence as well as the provision of information to the public on experimental releases.3 it may provide for exceptions from the licensing obligation for specific pathogens if current scientific knowledge and experience indicate that there is no risk to health.art. 28 duty to provide information to purchasers any person who markets pathogens must inform customers about their health-related properties and risks and about the required precautionary and preventive measures.art. 29 further regulations issued by the federal council the federal council may issue the following regulations:a. it may regulate the transport of pathogens and introduce a licensing requirement for their import, export and transit.b. it may restrict or prohibit the handling of specific pathogens.c.5 it may specify requirements for contained system equipment and the training of persons handling pathogens.d. it may require the marking of containers that hold pathogens.5 amended by annex no 34 of the fa of 20 june 2014 on continuing education and training, in force since 1 jan. 2017 (as 2016 689; bbl 2013 3729).chapter 5 disease control section 1 measures that apply to individual persons art. 30 principle 1 a measure in accordance with articles 33-38 may only be ordered if: a. less stringent measures to prevent the spread of a communicable disease are not sufficient or appropriate; andb. the measure serves to avert a serious risk to the health of other persons.2 the measure must be necessary and reasonable.art. 31 ordering measures 1 the competent cantonal authorities shall order the measures in accordance with articles 33-38.2 the competent federal authorities shall support the cantons in identifying and notifying persons, in particular persons travelling on international transport services.3 when ordering measures, the persons concerned must be given an explanation of why the measures are being ordered and how long they are expected to apply. 4 the measures may only apply for as long as is necessary to prevent the spread of a communicable disease and to avert a serious risk to the health of other persons. they must be regularly reviewed.art. 32 enforcement of the measures the competent cantonal authorities may compulsorily enforce their orders relating to medical monitoring, quarantine, isolation or medical testing.art. 33 identification and notification any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens may be identified and notified.art. 34 medical monitoring 1 any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens may be made subject to medical monitoring.2 the person concerned is required to inform the doctor responsible about their state of health and their contacts with other persons.art. 35 quarantine and isolation 1 if medical monitoring is insufficient, the following measures may be taken:a. a person who suspected of being ill or suspected of being infected may be placed in quarantine;b. a person who is ill or infected or who is spreading pathogens may be placed in isolation.2 the person concerned may if necessary be admitted to a hospital or another suitable institution.3 the hospital or the institution must ensure that its staff and other persons at risk are protected against infection.art. 36 medical examination any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens may be required to undergo a medical examination and to allow samples to be taken.art. 37 medical treatment any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens may be required to undergo medical treatment.art. 38 restriction of certain activities and on practising a profession 1 any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens may be wholly or partly prohibited from carrying out certain activities or practising their profession. they may be required to give notice of any change in their canton of residence, their activity or profession to the competent cantonal authority without delay.2 if a person is wholly or partly prohibited from carrying out certain activities or from practising their profession and if they have been required to give notice of a change in their canton of residence, their activity or profession, the competent cantonal authority shall notify the competent authority in the canton concerned about the prohibition or restriction.art. 39 duties of doctors doctors who are treating or monitoring a person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens shall take all the measures available to them to prevent the spread of a communicable disease. if official measures are required, this must be reported to the competent cantonal authority.section 2 measures in relation to the population and specific groups of persons art. 40 1 the competent cantonal authorities shall order measures to prevent the spread of communicable diseases among the population or within specific groups of persons. they shall coordinate their measures.2 they may in particular take the following measures:a. prohibit or restrict events;b. close schools, other public institutions and private businesses or issue regulations on their operation;c. revoke or restrict the right to enter or leave certain buildings or areas and to carry out specific activities at defined locations.3 the measures may only apply for as long as is necessary to prevent the spread of a communicable disease. they must be regularly reviewed.section 3 measures relating to international travel art. 41 entry and exit 1 the federal council shall issue regulations on international travel to prevent communicable diseases spreading from one country to another.2 if required to prevent the spread of a communicable disease, the foph may require persons entering or leaving switzerland:a. to make their identity, travel route and contact details known;b. to present a certificate of vaccination or other prophylaxis;c. to provide information on their state of health;d. to present proof of a medical test;e. to undergo a medical examination.3 the foph may require persons entering switzerland to submit to a measure in accordance with articles 34, 35, 37 and 38; articles 30-32 apply in an analogous manner. if required, the federal council may extend these measures temporarily to all persons entering switzerland from regions considered to pose a risk.4 the foph may temporarily deny any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens the right to leave switzerland if this is required to prevent the spread of a communicable disease.art. 42 operational preparation 1 operators of ports and airports shall make the required operational preparations for implementing the measures under article 41. they shall have their own emergency plans.2 the federal council shall designate the operators of ports and airports that must provide the required capacities in accordance with annex 1 b of the international health regulations (2005) of 23 may 20056.6 sr 0.818.103art. 43 duty to cooperate 1 companies that transport persons by rail, bus, ship or air internationally, airport operators, port operators, railway and bus stations and travel businesses are required to cooperate in carrying out the measures under article 41. they may within the limits of their operational and technical capacities be required:a. to inform travellers about the dangers of communicable diseases and the options for preventing and controlling such diseases;b. to collect the information required for the identification or early detection of persons who are ill, suspected of being ill, infected or suspected of being ill and persons suspected of spreading pathogens;c. to provide the competent authorities with lists of passengers or goods;d. to enable passengers to undergo medical tests;e. to enable the transport of persons who are ill, suspected of being ill, infected, suspected of being infected or who are spreading pathogens to a hospital or other suitable institution.2 they must provide the operational and staff capacities necessary to carry out the measures under paragraph 1.section 4 special measures art. 44 supply of therapeutic products 1 the federal council shall ensure that the population is supplied with the most important therapeutic products that are suitable for controlling communicable diseases, insofar as it is unable to guarantee supply by means of measures under the national economic supply act of 8 october 19827. 2 it may issue regulations on:a. allocating therapeutic products;b. distributing therapeutic products;c. facilitating the import and restricting or prohibiting the export of therapeutic products, provided this is necessary in order to avert a public health risk;d. maintaining stocks of therapeutic products in hospitals and other healthcare institutions.3 it may provide for measures to supply swiss citizens living abroad with therapeutic products.7 sr 531art. 45 goods transport 1 the federal council may issue regulations on the transport and on the import, export and transit of goods that may be carriers of pathogens. it may in particular:a. issue requirements for preventive measures relating to the transport of goods;b. require the testing of goods for specific pathogens;c. issue restrictions and bans on transport and on the import, export and transit of goods.2 it may instruct the cantons to take individual measures.art. 46 transport of dead bodies 1 the federal council shall issue the required regulations on the transport and the burial of dead bodies.2 it shall regulate the transport of dead bodies through switzerland, from another country to switzerland and from switzerland to another country.art. 47 control of organisms 1 if organisms occur that can transmit pathogens to human beings, the competent federal and cantonal bodies shall coordinate any measures required to control such organisms or to prevent their occurrence.2 companies that transport persons by rail, bus, ship or air, airport operators, port operators, railway and bus stations and travel businesses are required to cooperate in carrying out these measures.art. 48 disinfection and disinfestation 1 the competent cantonal authorities shall ensure that disinfection and disinfestation, in particular of means of transport and goods, are carried out to prevent the spread of communicable diseases.2 companies that transport persons by rail, bus, ship or air, airport operators, port operators, railway and bus stations and travel businesses are required to cooperate in carrying out disinfection and disinfestation measures.art. 49 certificates for shipping the competent cantonal authorities shall issue the required health certificates for international shipping.chapter 6 financial measures art. 50 financial assistance to public and private organisations the foph may within the limits of the authorised budget grant financial assistance to public and private organisations for measures in the national public interest for detecting, monitoring, preventing and controlling communicable diseases.art. 51 financial assistance for manufacturing therapeutic products 1 the confederation may provide financial assistance for manufacturing therapeutic products under article 44 in switzerland if supplies to the population in special or extraordinary situations cannot otherwise be guaranteed.2 it may provide the financial assistance within the limits of the authorised budget in the form of basic contributions, investment contributions or project-related contributions.3 it may make the contributions provided the manufacturer:a. is proven to have the knowledge and ability to develop or produce the therapeutic products concerned;b. undertakes to manufacture the therapeutic products in switzerland; andc. guarantees to prioritise the supply of such therapeutic products to the authorities in special or extraordinary situations.art. 52 compensatory payments made to laboratories the foph shall make compensatory payments to the laboratories designated as national reference centres or as confirmation laboratories for the expenses that they incur in carrying out their special tasks.chapter 7 organisation and procedures section 1 cantonal and federal bodies art. 53 chief medical officer 1 each canton shall appoint a chief medical officer. cantons may appoint a joint chief medical officer.2 chief medical officers shall coordinate their activities with other authorities and institutions involved in controlling communicable diseases. if a communicable disease arises in connection with a foodstuff, the chief medical officer shall notify the cantonal chemist.3 the federal council shall specify the required qualifications for chief medical officers.art. 54 coordination body 1 the confederation and the cantons shall establish a body to promote cooperation (coordination body). subsidiary bodies may be established to deal with specific fields, in particular detecting and monitoring, preventing and combating zoonoses.2 the coordination body and its subsidiary bodies shall be made up of federal and cantonal representatives. they may also include other specialists, as required.3 their tasks shall include the following:a. coordinating measures to prepare for situations that pose a particular risk to public health;b. coordinating measures to detect, prevent and control the disease;c. encouraging uniform implementation;d. coordinating the provision of information and communication;e. supporting the federal task force in managing special or extraordinary situations.4 the federal council shall regulate the establishment and management of the coordination body and its subsidiary bodies.art. 55 task force 1 the federal council shall have a task force at its disposal for events that may pose a special risk to public health, in particular to manage a special or extraordinary situation.2 the task force shall have the following tasks:a. advising the federal council;b. supporting the confederation and the cantons in coordinating the measures.art. 56 federal commission for vaccination 1 federal commission for vaccination shall advise the federal council on issuing regulations and the authorities on implementing this act.2 the commission's tasks shall include the following:a. drawing up vaccination recommendations for submission to the foph;b. devising medical criteria for assessing the severity of a vaccination reaction;c. advising the fdha on matters related to compensation (art. 64) or satisfaction (art. 65).3 it shall comprise specialists from outside the administration who have scientific or practical knowledge of vaccination matters.4 it shall work with other federal and cantonal bodies that deal with vaccination matters.art. 57 swiss expert committee for biosafety the swiss expert committee for biosafety shall advise the federal council on issuing regulations and the authorities on implementing this act.section 2 data processing art. 58 processing personal data 1 insofar as is required in order to identify persons who are ill, suspected of being ill, infected, suspected of being infected and persons suspected of spreading pathogens, the foph, the competent cantonal authorities and the public and private institutions entrusted with tasks under this act may process or arrange for the processing of personal data, including health data, with a view to taking measures to protect public health, in particular to detect, monitor and control communicable diseases.2 they shall be responsible for complying with the data protection regulations.3 the data may be retained for a maximum of ten years, unless the specifics of the disease require a longer retention period. thereafter they shall be destroyed or anonymised.art. 59 disclosure of personal data 1 the federal and cantonal bodies responsible for implementing this act may disclose to each other personal data, including data on health, which they require in order to carry out the tasks assigned to them under this act.2 in particular the following data may be disclosed:a. surname, first name, address, date of birth and occupation;b. details of travel routes, places of stay and contacts with persons, animals and objects;c. results of medical tests;d. results of epidemiological investigations;e. details of belonging to a specific risk category;f. details of measures to prevent and combat a communicable disease.3 the foph and the cantonal authorities responsible for implementing this act may disclose personal data, including data on health, which are required to prevent the spread of a communicable disease to the following persons and authorities: a. doctors required to treat communicable diseases;b. cantonal authorities that carry out tasks related to detecting, monitoring, preventing and controlling communicable diseases;c. other federal authorities, insofar as it is necessary in order to implement the legislation applied by those authorities.art. 60 information system 1 the foph shall operate an information system for storing data relating to persons who are ill, suspected of being ill, infected or suspected of being infected or who are spreading pathogens.2 the information system shall contain the following data:a. identification data that enable a person to be uniquely identified and to be contacted;b. details of travel routes, places of stay and contacts with persons, animals and objects;c results of medical tests;d. details of measures to prevent and control a communicable disease.3 the information system shall be used to:a. identify and notify persons who are ill, suspected of being ill, infected or suspected of being infected or who are spreading pathogens;b. organise measures in relation to individual persons in accordance with articles 33-38.4 it shall also assist with the uniform processing of data by the responsible authorities, the production of statistics and checks on implementation.5 the foph is responsible for the security of the information system and the legality of the processing of personal data. the cantons shall take appropriate organisational and technical measures to secure personal data in their area of responsibility.6 the foph shall check whether the data it receives are accurate. it shall correct inaccurate data and destroy unnecessary data and notify the data providers concerned.7 the information system shall be made available online to the foph, the cantonal bodies responsible for implementing this act and the coordinated medical services for tasks within their area of responsibility.8 the federal council shall stipulate the requirements for safeguarding and deleting data and regulate the access rights.9 the right to receive information on the data in the information system and the right to have the data corrected are governed by articles 5 and 8 of the federal act of 19 june 19928 on data protection. requests for information on personal data and for corrections to be made to the data must be sent to the foph.8 sr 235.1art. 60a9 proximity tracing system for the coronavirus 1 in addition to the information system under article 60, the foph shall operate a proximity tracing system for the sars-cov-2 coronavirus (pt system). the pt system records encounters between mobile telephones of persons that participate in the system, and notifies them if they have potentially been exposed to the coronavirus.2 the pt system and the data that it processes serve to notify the persons under paragraph 1 and produce statistics on the pt system. the pt system and the data must not be used for other purposes, in particular by cantonal authorities to order or enforce measures under articles 33-38 or by the police or the prosecution or intelligence services.3 participation in the pt system is voluntary for everyone. authorities, businesses and individuals may not give preference to or discriminate against any person based on their participation or non-participation in the pt system; any agreements to the contrary shall be invalid.4 any person who has been notified by the pt system that they have potentially been exposed to the coronavirus shall be entitled, on providing proof of notification, to be tested free of charge for infection with the coronavirus and for antibodies against the coronavirus.5 the pt system shall be designed according to the following principles:a. in relation to data processing, all appropriate technical and organisational measures must be taken to make it impossible to identify the participants.b. the data shall as far as possible be processed on decentralised components installed by the participants on their mobile telephones. in particular, data recorded on a participant's mobile telephone relating to other persons shall be processed and stored exclusively on that mobile telephone.c. the only data collected or processed in any other manner shall be data required to determine the distance and time of encounters and to issue the notifications; the data do not include location data.d. the data shall be destroyed as soon as they are no longer required for the notification.e. the source code and the technical specifications of all components of the pt system shall be made public. it must be evident that the machine-readable programmes were produced using this source code.6 the federal legislation on data protection applies.7 the federal council shall regulate the details on organising and operating the pt system and on processing the data.8 the federal council shall provide for the pt system to be terminated, and in particular for the deactivation or deinstallation of all components installed on mobile telephones, as soon as the pt system is no longer required to manage the epidemic caused by the coronavirus or if it proves to be insufficiently effective.9 inserted by no i of the fa of 19 june 2020, in force from 25 june 2020 to 31 dec. 2022 (as 2020 2191, 2727; 2021 878 no iii 3; bbl 2020 4461; 2021 2515).art. 61 statistical data the swiss federal statistical office shall, for statistical purposes, provide the foph each year with data from the statistics on causes of death and the medical statistics from hospitals.art. 62 disclosure of personal data to foreign authorities 1 in order to implement this act, the foph and the competent cantonal authorities may provide foreign authorities that have corresponding tasks and supranational and international organisations with personal data, including data on health, provided the state concerned and in particular its legislation or the supranational or international organisation guarantees an appropriate level of privacy protection for the person concerned.2 in particular the following data may be disclosed:a. surname, first name, address, date of birth and occupation;b. details of travel routes, places of stay and contacts with persons, animals and objects;c. results of medical tests;d. results of epidemiological investigations;e. details of belonging to a specific risk category;f. details of measures to prevent and combat a communicable disease.3 in the absence of legislation that guarantees appropriate protection, the data may only be disclosed if:a. adequate guarantees of an appropriate level of protection abroad are provided, for example in a contract;b. the person concerned has consented in the given case;c. disclosure in the given case is essential in order to safeguard public health; ord. disclosure in the given case is required to protect the life or physical integrity of the person concerned.art. 62a10 connecting the pt system to foreign systems the pt system under article 60a may be connected to equivalent foreign systems if an appropriate level of protection for personal privacy is guaranteed in the state concerned by:a. legislation; orb. adequate guarantees, for example in a contract.10 inserted by no i of the fa of 19 june 2020, in force from 25 june 2020 to 31 dec. 2022 (as 2020 2191, 2727; 2021 878 no iii 3; bbl 2020 4461; 2021 2515).chapter 8 compensation section 1 compensation for loss or damage as a result of official measures art. 63 the ordering authority may compensate persons who suffer loss or damage as a result of official measures in accordance with articles 33-38 and 41 paragraph 3, taking account of the financial circumstances of the persons concerned, insofar as the loss or damage is not otherwise covered. section 2 compensation and satisfaction for loss or damage as a consequence of vaccination art. 64 compensation 1 any person who is harmed by an officially ordered or officially recommended vaccination has the right to compensation.2 compensation shall only be awarded if the loss or damage cannot otherwise be covered through reasonable effort. art. 65 satisfaction 1 any person who is harmed by an officially ordered or officially recommended vaccination has the right to satisfaction if the harm is sufficiently serious to justify this; articles 47 and 49 of the code of obligations11 apply by analogy.2 the satisfaction is determined by the seriousness of the harm.3 it may not exceed 70,000 francs.4 satisfaction shall only be awarded if no payment or an insufficient payment is made by other persons. the satisfaction shall be reduced by the amount of any satisfaction payments made by other persons.11 sr 220art. 66 claim, deadlines and interest 1 any person who wishes to claim compensation or satisfaction must file a claim with the fdha.2 any person who has been harmed by a vaccination must file the claim for compensation or satisfaction before reaching the age of 21 or within five years of the vaccination.3 no interest shall be payable on the compensation or the satisfaction.art. 67 reduction or exclusion of compensation or satisfaction the fdha may reduce the compensation or satisfaction or forego making any payment if the person suffering harm was substantially to blame for the harm suffered.art. 68 allocation of costs 1 in the case of recommended vaccinations, the confederation and the canton in which the vaccination takes places shall each pay one half of the costs of the compensation or satisfaction.2 in the case of compulsory vaccinations, the entire costs of the compensation or satisfaction shall be paid by:a. the confederation if it has declared the vaccination to be mandatory;b. the canton that declared the vaccination to be mandatory.art. 69 responsibility and procedure 1 the fdha decides after consulting the federal commission for vaccination and the canton concerned whether compensation or satisfaction is to be paid.2 any person who claims compensation or satisfaction must credibly demonstrate that other persons have not made any payments or that the payments made by other persons are inadequate.3 appeal proceedings are governed by the general provisions on the administration of federal justice.section 3 cover for claims against manufacturers art. 70 1 the confederation may undertake to cover any loss or damage for which the manufacturer of a therapeutic product under article 44 may be held liable as the consequence of the product being used as recommended or ordered by the confederation in a special or extraordinary situation.2 the extent and the modalities of the cover shall be set out in an agreement between the confederation and the manufacturer.chapter 9 funding art. 71 costs borne by the cantons the cantons shall bear the cost of:a. measures in relation to the population or individual persons, insofar as the costs are not otherwise covered;b. epidemiological investigations under article 15 paragraph 1.art. 72 costs of disinfection or disinfestation the proprietor of a mode of transport, an installation or a product shall bear the costs of disinfection or disinfestation.art. 73 cost of supplying therapeutic products 1 the confederation shall bear the cost of supplying the population with therapeutic products pursuant to article 44.2 if therapeutic products are supplied, the costs shall be borne according to the requirements:a. of the federal act of 18 march 199412 on health insurance;b. of the federal act of 20 march 198113 on accident insurance;c. of the federal act of 19 june 199214 on military insurance.3 if the costs are not or not completely assumed in accordance with paragraph 2, they shall be borne by the confederation.12 sr 832.1013 sr 832.2014 sr 833.1art. 74 costs of international travel measures 1 the confederation shall bear the cost of testing, monitoring, quarantine, isolation and treatment ordered by its bodies for passengers on international transport services, as well as the costs incurred as a result of the duty to cooperate under article 43 paragraph 1 letters b, d and e.2 companies that transport persons internationally by rail, bus, ship or air, airport operators, port operators, railway stations and bus stations and travel businesses shall bear the costs incurred for preparations made under article 42 and as a result of the duty to cooperate under article 43 paragraph 1 letters a and c. the confederation may contribute to exceptional outlays and expenditures if these place the companies concerned under an unreasonable financial burden.chapter 10 implementation section 1 cantons art. 75 principle the cantons shall implement this act, unless the confederation is responsible.art. 76 reporting 1 the cantons shall report to the fdha on the implementation of the act. 2 the federal council shall regulate the frequency, form and content of the reports.section 2 confederation art. 77 monitoring and coordination 1 the confederation shall supervise the implementation of this act by the cantons.2 it shall coordinate the implementing measures taken by the cantons, insofar as there is an interest in uniform implementation. 3 it may for this purpose:a. specify the measures that the cantons must take to achieve uniform implementation;b. instruct the cantons to take specific implementing measures in response to risks to public health;c. require the cantons to inform the confederation about implementing measures; d. specify the requirements the cantons must meet in their preparatory and emergency plans.art. 78 implementing provisions 1 the federal council shall issue the implementing provisions.2 it may delegate the issuing of implementing provisions to the responsible federal office, taking account of their scope.art. 79 delegation of implementation tasks 1 the federal council may delegate implementation tasks to public or private organisations.2 it shall supervise the organisations and persons entrusted with implementation tasks.3 public or private organisations that carry out implementation tasks under paragraph 1 are entitled to compensation. the federal council shall regulate the extent and modalities of compensation.art. 80 international cooperation 1 the federal council may enter into international agreements on:a. the exchange of data used for epidemiological monitoring;b. the mutual provision of information on the outbreak and spread of communicable diseases;c. immediate notification where there is an imminent risk of communicable diseases crossing the national border;d. the harmonisation of measures for detecting, monitoring, preventing and controlling communicable diseases;e. the transport of dead bodies beyond the national border;f.15 the connection of the pt system under article 60a to corresponding foreign systems.2 the competent federal agencies shall work with foreign authorities and institutions and with international organisations.3 the foph shall carry out the tasks of the national ihr focal point in accordance with the international health regulations (2005) of 23 may 200516. in particular, it shall report events to the who that could lead to a public health emergency of international concern.15 inserted by no i of the fa of 19 june 2020, in force from 25 june 2020 to 31 dec. 2022 (as 2020 2191, 2727; 2021 878 no iii 3; bbl 2020 4461; 2021 2515).16 sr 0.818.103art. 81 evaluation the federal council shall periodically review the effectiveness, appropriateness and financial viability of the measures under this act.chapter 11 criminal provisions art. 82 misdemeanours 1 unless a more serious offence under the swiss criminal code17 has been committed, any person who wilfully commits any of the following acts shall be liable to a custodial sentence not exceeding three years or to a monetary penalty:a. failing to take the required containment measures when working with dangerous pathogens in contained systems (art. 26);b. releasing or marketing pathogens for experimental purposes without a licence (art. 27);c. marketing pathogens without duly informing customers about their health-related properties and risks and about the required precautionary and preventive measures (art. 28);d. breaching restrictions on certain activities or the practice of a profession (art. 38).2 a person acting through negligence shall be liable to a monetary penalty for misdemeanours under paragraph 1.17 sr 311.0art. 83 contraventions 1 any person who wilfully commits any of the following acts shall be liable to a fine:a. failing to comply with the duty to report (art. 12);b. conducting a microbiological test to detect communicable diseases without a licence (art. 16);c. failing to comply with the regulations on preventing the transmission of diseases (art. 19);d. issuing an international certificate of vaccination or of other prophylaxis without a licence (art. 23);e. failing to comply with the duty of care when handling pathogens or their toxic products (art. 25);f. failing to comply with other regulations on handling pathogens (art. 29);g. failing to comply with a medical monitoring order (art. 34);h. failing to comply with a quarantine or isolation order (art. 35);i. failing to comply with a medical examination order (art. 36);j. failing to comply with measures in relation to the population (art. 40);k. failing to comply with regulations relating to entering or leaving switzerland (art. 41);l. failing to comply with obligations to cooperate (arts 43, 47 para. 2 and 48 para. 2);m. failing to comply with regulations on transport or on the import, export and transit of goods (art. 45);n.18 refusing to provide a person with a service that is offered to the public because that person does not participate in the pt system (art. 60a para. 3).2 a person acting through negligence shall be liable to a fine not exceeding 5,000 francs for contraventions under paragraph 1.18 inserted by no i of the fa of 19 june 2020, in force from 25 june 2020 to 31 dec. 2022 (as 2020 2191, 2727; 2021 878 no iii 3; bbl 2020 4461; 2021 2515).art. 84 jurisdiction and administrative criminal law 1 the prosecution and adjudication of offences is a matter for the cantons.2 articles 6, 7 (offences by businesses) and 15 (forgery of documents, obtaining a false certificate by fraud) of the federal act of 22 march 197419 on administrative criminal law also apply to the cantonal authorities.19 sr 313.0chapter 12 final provisions art. 85 repeal of current legislation the following federal acts are repealed:1. federal act of 18 december 197020 on the control of communicable human diseases;2. federal act of 13 june 192821 on measures against tuberculosis.20 [as 1974 1071; 1985 1992 no i 2; 1991 362 no ii 405; 1997 1155 annex no 5; 2000 1891 no iii 2; 2001 2790 annex no 6; 2003 4803 annex no 7; 2004 4763 annex no ii 3; 2005 2293; 2006 2197 annex no 95 4137; 2008 3437 no ii 34; 2012 7281]21 [bs 4 363; as 1964 965 no iv let a; 1974 1071 art. 37; 1985 1992 no i 3; 1991 362 no ii 406; 2006 2197 annex no 96]art. 86 amendment of current legislation the following federal acts are amended as follows:.2222 the amendments may be consulted under as 2015 1435.art. 87 transitional provisions 1 licences under articles 5 paragraph 1bis, 29a paragraph 1 and 29c paragraph 2 of the epidemics act of 18 december 197023 remain valid until their expiry date or for for five years after this act comes into force, whichever is earlier.2 recognitions under article 5 paragraph 1 of the epidemics act of 18 december 1970 remain valid until their expiry date or for five years after this act comes into force, whichever is earlier.3 laboratories that did not require a licence and did not have valid recognition before this act came into force, but which require a licence after this act comes into force, must apply for the licence within one year after this act comes into force. they may continue to conduct tests until the competent federal authority issues its decision on the licence.23 as 1997 1155; 2001 2790art. 88 referendum and commencement 1 this act is subject to an optional referendum.2 the federal council shall determine the commencement date.commencement date: 1 january 20162424 fcd of 29 april 2015.

818.101.24english is not an official language of the swiss confederation. this translation is provided for information purposes only, has no legal force and may not be relied on in legal proceedings.ordinance 3on measures to combat the coronavirus (covid-19)(covid-19 ordinance 3)of 19 june 2020 (status as of 1 january 2022)the swiss federal council,based on articles 3, 4, 5 letters a and b and 8 of the covid-19 act of 25 september 20201, on article 63 paragraph 3 of the therapeutic products act of 15 december 20002,and on article 41 paragraph 1 of the epidemics act of 28 september 20123 (epida),4ordains:1 sr 818.1022 sr 812.213 sr 818.1014 amended by no i of the o of 19 march 2021 (employees at high risk - extension), in force from 1 april 2021 (as 2021 167).chapter 1 general provisions art. 1 subject matter and purpose 1 this ordinance orders measures applicable to the population, organisations and institutions and the cantons to combat the coronavirus (covid-19).2 the measures serve to ensure switzerland's capacities to manage the epidemic, in particular to maintain the provision of the population with adequate care and a sufficient supply of essential medical goods.art. 2 responsibility of the cantons unless this ordinance provides otherwise, the cantons shall retain their responsibilities.chapter 2 maintenance of capacities to provide healthcare section 1 principle art. 3 1 in order to maintain switzerland's capacities to manage the covid-19 epidemic and in particular to guarantee the provision of the population with adequate care and a sufficient supply of essential medical products, the following measures in particular must be taken: a. measures to restrict the entry of persons from high-risk countries and regions and the import and export of goods;b. measures to guarantee the provision of essential medical goods.2 high-risk countries or regions are countries or regions in which the coronavirus sars-cov-2 has been detected and in which:a. there is an increased risk of infection; orb. a variant of the virus is widespread that carries a higher risk of infection or causes a more severe form of the disease in comparison with the variant of the virus that is prevalent in the schengen area.53 the lists of high-risk countries and regions is published in annex 1.65 amended by annex 3 of the covid-19 ordinance on international travel measures of 23 june 2021, in force since 26 june 2021 (as 2021 380).6 inserted by annex 3 of the covid-19 ordinance on international travel measures of 23 june 2021, in force since 26 june 2021 (as 2021 380).section 2 restrictions on border crossings and the admission of foreign nationals art. 47 border crossings and controls 1 the following persons shall be refused entry for a period of stay of up to three months that does not require a permit and does not involve gainful employment (art. 10 of the foreign nationals and integration act of 16 december 20058 (fnia):foreign nationals who wish to enter switzerland from a high-risk country or from a high-risk region and who do not fall within the scope of the agreement of 21 june 19999 between the european community and its member states, of the one part, and the swiss confederation, of the other part, on the free movement of persons (afmp) or of the convention of 4 january 196010 establishing the european free trade association (efta convention);b. and c.11 . .122 the following persons are exempt from this ban on entry:a. persons who prove that they have been vaccinated against sars-cov-2; the persons who are regarded as having been vaccinated is regulated in annex 1a; orb. persons who provide credible evidence that they are in a situation of special necessity.132bis children under the age of 18 who enter switzerland accompanied by an adult who meets the requirements of paragraph 2 letter a are not required to prove that they have been vaccinated.142ter the exception in paragraph 2 letter a does not apply to persons who wish to enter switzerland from a country or region listed in annex 1 number 2.152quater the state secretariat for migration (sem) shall issue the required directives on exceptions to the ban on entry.163 decisions taken by the competent authorities may be enforced immediately. article 65 of the fnia applies mutatis mutandis. an appeal may be filed against the sem decision within 30 days of notification. the appeal does not have suspensive effect.4 the criminal provisions of article 115 fnia apply mutatis mutandis. in the event of any violation of the provision on entry, a ban on entry may also be imposed.7 amended by no i of the o of 24 june 2020 (relaxation of measures relating to borders, entry and admission for residence and employment), in force since 6 july 2020 (as 2020 2611).8 sr 142.209 sr 0.142.112.68110 sr 0.632.3111 repealed by annex 2 no 2 of the covid-19 ordinance on international travel measures of 27 jan. 2021, with effect from 8 feb. 2021 (as 2021 61).12 amended by no i of the o of 21 dec. 2020, in force since 21 dec. 2020 at 1pm (as 2020 6395).13 amended by annex 3 of the covid-19 ordinance on international travel measures of 23 june 2021, in force since 26 june 2021 (as 2021 380).14 inserted by annex 3 of the covid-19 ordinance on international travel measures of 23 june 2021, in force since 26 june 2021 (as 2021 380).15 inserted by annex 3 of the covid-19 ordinance on international travel measures of 23 june 2021, in force since 26 june 2021 (as 2021 380).16 inserted by annex 3 of the covid-19 ordinance on international travel measures of 23 june 2021, in force since 26 june 2021 (as 2021 380).art. 517 updating the annexes the federal department of justice and police (fdjp) shall update annexes 1 and 1a continuously in consultation with the federal department of home affairs (fdha) and the federal department of foreign affairs (fdfa).17 amended by annex 3 of the covid-19 ordinance on international travel measures of 23 june 2021, in force since 26 june 2021 (as 2021 380).art. 6 and 718 18 repealed by no i of the o of 24 june 2020 (relaxation of measures relating to borders, entry and admission for residence and employment), with effect from 6 july 2020 (as 2020 2611).art. 819 19 repealed by art. 6 no 1 of the covid-19 ordinance on international travel measures of 2 july 2020, with effect from 6 july 2020 (as 2020 2737).art. 9 provisions on cross-border movements of persons and goods 1 the fdjp in consultation with the fdha, the federal department of the environment, transport, energy and communications (detec), the fdf and the fdfa shall decide on restrictions on air passenger services from high-risk countries or regions.2 it may in particular suspend passenger movements for certain flights, close individual airfields with international borders to passenger movements from high-risk countries or regions or prohibit movements of persons to switzerland from high-risk countries or regions entirely.3 restrictions on cross-border movements of persons are set out in annex 2.art. 1020 granting of visas foreign nationals who wish to enter switzerland from a high-risk country or from a high-risk region and who do not fall within the scope of the afmp21 or the efta convention22 shall not be granted a schengen visa for periods of stay of up to three months that do not require a permit and do not involve gainful employment. exempted from the foregoing are applications from persons under article 4 paragraphs 2 and 2bis.20 amended by annex 3 of the covid-19 ordinance on international travel measures of 23 june 2021, in force since 26 june 2021 (as 2021 380).21 sr 0.142.112.68122 sr 0.632.31art. 10a23 extension of deadlines 1 foreign nationals who have been prevented from acting within the deadlines laid down in articles 47 or 61 fnia24 because of measures in connection with the coronavirus may carry out the act required at any time while this ordinance remains in force.2 by carrying out the required act, they shall achieve the position that would have been achieved had they acted within the prescribed deadline.3 if the deadlines under articles 59b or 102a fnia for updating biometric data in order to obtain or extend a permit cannot be met because of the coronavirus, the permit may still be issued or extended at any time while this ordinance remains in force.23 inserted by no i of the o of 24 june 2020 (relaxation of measures relating to borders, entry and admission for residence and employment), in force since 6 july 2020 (as 2020 2611).24 sr 142.20section 3 provision of essential medical goods art. 11 definition 1 medicinal products, medical devices and protective equipment (essential medical goods) that are important and urgently needed to prevent and combat the coronavirus (covid-19) are the goods listed in annex 4.2 the federal department of home affairs (fdha) is responsible for the list and shall update the same regularly in consultation with the interdepartmental working group on medical goods in accordance with article 12 and the spiez laboratory.253 the federal office of public health (foph) shall define the goods that need to be procured and how they should be used. based on these terms of reference, the foph shall determine the quantities required in consultation with:26a. the interdepartmental working group on medical goods: for active substances and drugs, medical devices, personal protective equipment and other equipment;b. the spiez laboratory: for covid-19 tests and associated reagents.25 amended by no i of the o of 18 dec. 2020 (sars-cov-2 rapid tests), in force since 21 dec. 2020 (as 2020 5801).26 amended by no i of the o of 18 dec. 2020 (sars-cov-2 rapid tests), in force since 21 dec. 2020 (as 2020 5801).art. 12 interdepartmental working group on medical goods 1 the interdepartmental working group on medical goods shall comprise as a minimum representatives from the following federal agencies:a. the foph;b. the therapeutic products division of the federal office for national economic supply;c. the swiss agency for therapeutic products (swissmedic);d. the national emergency operations centre (neoc);e. the medical services coordination committee (sanko) for resources management at federal level (resmab);f. the armed forces pharmacy;g. the coordinated medical services (cms).2 the federal council cms delegate chairs the working group.2727 amended by no i of the o of 12 may 2021, in force since 17 may 2021 (as 2021 274).art. 13 duty to report 1 the cantons are obliged on request to report to the cms on the current stocks of essential medical goods in their healthcare facilities.2 laboratories and manufacturers and distributors of in vitro diagnostics (covid-19 tests) are obliged to report regularly to the spiez laboratory on their current stocks of such tests.3 the cms may request details of stocks from companies that store essential medical goods.art. 14 procurement of essential medical goods 1 in order to support the provision of essential medical goods to the cantons and their healthcare facilities, charitable organisations (for example swiss red cross) and third parties (for example laboratories, pharmacies), essential medical goods may be procured if requirements cannot be covered through the normal procurement channels.2 the essential medical goods that are required shall be determined on the basis of the data transmitted in accordance with article 13.3 the armed forces pharmacy is responsible for procuring essential medical goods under paragraph 1 on behalf of the foph.4 the responsible authorities may delegate the procurement of essential medical goods to third parties.5 when procuring essential medical goods, the armed forces pharmacy may take calculated risks and diverge from the provisions of existing directives and the financial budget act of 7 october 200528 in relation to risks, such as prepayment without security or currency hedging.6 the armed forces pharmacy manages the procured essential medical goods as instructed by the interdepartmental working group on medical goods.28 sr 611.0art. 15 allocation of essential medical goods 1 the cantons shall submit requests for allocation to the resmab as required.292 allocation shall be made continuously based on the supply situation and the current number of cases in each canton.3 the cms in consultation with interdepartmental working group on medical goods may allocate essential medical goods to the cantons, to charitable organisations and to third parties.4 the spiez laboratory in consultation with the foph is responsible for allocating in vitro diagnostics (covid-19 tests). allocation when required applies to all tests available in switzerland.29 amended by no i of the o of 12 may 2021, in force since 17 may 2021 (as 2021 274).art. 16 delivery and distribution of essential medical goods 1 the confederation or the third parties that it instructs shall ensure the delivery of the essential medical goods procured under article 14 to a distribution centre for each canton. in exceptional cases, the confederation in consultation with the cantons may supply eligible facilities and organisations directly.2 the cantons shall designate cantonal distribution centres for goods that are not supplied directly to the recipient, and shall give notice of these to the responsible federal authorities.3 they shall ensure that essential medical goods that have been delivered are distributed as required and in good time on their territory.art. 17 direct sales by the confederation the confederation may sell the essential medical goods on the market in return for payment, either itself or through third parties.art. 18 costs 1 the costs of procuring essential medical goods shall be funded in advance by the confederation in the cases where it procures the goods.2 the cantons, charitable organisations and third parties shall notify the confederation as quickly as possible of the purchasing costs of the essential medical goods supplied to them where the confederation has assumed responsibility for their procurement in accordance with article 14 paragraph 1.3 the confederation shall bear the costs of delivering the procured essential medical goods to the cantons.4 the cantons shall bear the costs of distributing these essential medical goods within the canton.5 if the procured goods become freely available in the market again, the confederation may sell its stocks at market prices.3030 inserted by no i of the o of 12 may 2021, in force since 17 may 2021 (as 2021 274).art. 19 requisitioning 1 if the provision of essential medical goods cannot be guaranteed, the fdha at the request of the interdepartmental working group on medical goods may require individual cantons or public healthcare facilities that have adequate stocks of medicinal products under annex 4 number 1 to deliver part of their stocks to other cantons or healthcare facilities. the cantons or healthcare facilities shall charge the recipient directly for the costs of the goods and their delivery at the sale price.2 subject to the requirement of paragraph 1, the fdha at the request of the interdepartmental working group on medical goods may order the requisitioning of essential medical goods held by companies. the confederation shall pay compensation at the sale price.art. 20 manufacture 1 if the provision of essential medical goods cannot otherwise be guaranteed, the federal council at the request of the interdepartmental working group on medical goods may require manufacturers to produce essential medical goods, to prioritise the production of such goods or to increase production volumes.2 the confederation may contribute to the cost of production under paragraph 1 where manufacturers suffer financial disadvantages as a result of the changeover in production or the cancellation of private orders.art. 21 exceptions to the requirement of authorisation for medicinal products 1 medicinal products that are manufactured with active substances under annex 5 for the treatment of covid-19 patients may, provided an application for authorisation of a medicinal product containing one of these active substances has been filed, be placed on the market without authorisation pending swissmedic's decision on authorisation. when examining applications for authorisation, swissmedic may permit a relaxation of the relevant requirements for such medicinal products under the law on therapeutic products on the basis of a risk-benefit analysis.2 amendments to the authorisation for a medicinal product authorised in switzerland containing an active substance under annex 4 number 1 on the basis of which the medicinal product can be used to treat covid-19 patients in switzerland may be made immediately after filing a corresponding amendment application and pending swissmedic's decision on authorisation. swissmedic may, on the basis of a risk-benefit analysis, permit a relaxation of the relevant requirements under the law on therapeutic products for amendments to the authorisation of medicinal products containing an active substance listed in annex 4 number 1.313 the fdha shall regularly update the list in annex 5.324 swissmedic may on the basis of a risk-benefit analysis permit changes to the manufacturing process approved within the framework of the authorisation of medicinal products used to prevent and treat covid-19 in switzerland. it shall specify criteria according to which the person responsible for technical matters may grant an early market release for medicinal products used to prevent and treat covid-19 in switzerland.5 in derogation from article 9a paragraph 1 letter c of the therapeutic products act of 15 december 2000, temporary authorisations may be issued even if an authorised equivalent medicinal product that can be used as an alternative is available in switzerland, provided the authorisations serve to guarantee the supply of medicinal products to prevent and combat the coronavirus in switzerland.3331 amended by no i of the o of 12 may 2021, in force since 17 may 2021 (as 2021 274).32 amended by no i of the o of 18 dec. 2020 (sars-cov-2 rapid tests), in force since 21 dec. 2020 (as 2020 5801).33 inserted by no i of the o of 27 oct. 2021, in force since 28 oct. 2021 (as 2021 634).art. 22 exceptions to the provisions on the import of medicinal products 1 following the submission of a authorisation application for a medicinal product containing active substances listed in annex 5 for the treatment of covid 19 patients, the applicant may import the medicinal product prior to its authorisation or entrust the import of the medicinal product to a company with a wholesale or import licence.341bis pharmacists that have pharmaceutical responsibility in a hospital pharmacy may import non-authorised medicinal products with active substances under annex 5 for the treatment of covid-19 patients. a company with a wholesale or import licence may be instructed to import such medicinal products.352 notice of each import under paragraph 1bis must be given to swissmedic within 10 days of the arrival of goods.363 in order to prevent and treat covid-19 in switzerland, swissmedic may allow the temporary placing on the market of a medicinal product as a short-term solution for the temporary non-availability of an identical medicinal product authorised in switzerland, provided no essentially identical medicinal product is authorised and available in switzerland.4 after submitting its application for authorisation for a covid-19 vaccine and for an operating licence under article 10 paragraph 1 letter b of the therapeutic products act of 15 december 2000, the applicant may instruct a company with a wholesale or import licence to import the covid-19 vaccine before its authorisation and to store the vaccine until authorisation is granted. the company instructed must comply with the international rules on good distribution practice in accordance with annex 4 of the medicinal products licensing ordinance of 14 november 201837.3834 inserted by no i of the o of 12 may 2021, in force since 26 april 2021 (as 2021 274).35 originally para. 1.36 amended by no i of the o of 12 may 2021, in force since 26 april 2021 (as 2021 274).37 sr 812.212.138 inserted by no i of the o of 18 dec. 2020 (sars-cov-2 rapid tests), in force since 21 dec. 2020 (as 2020 5801).art. 23 exceptions for medical devices39 1 in response to an application, swissmedic may authorise the placing on the market and use of medical devices that have not undergone a conformity assessment procedure in accordance with article 23 the medical devices ordinance of 1 july 20204041 (meddo), provided their use for preventing and combating the coronavirus in switzerland is in the interests of public health or patient safety or health and provided, taking account of their intended purpose, their fulfilment of the essential requirements and their effectiveness and performance are adequately proven.2 when assessing the risks under paragraph 1, swissmedic shall in particular take account of the procurement needs identified by the foph for preventing and combating the coronavirus in switzerland.3 authorisation shall be granted to the swiss distributor or the applicant institution or healthcare facility. it may be made subject to a time limit and other conditions and requirements.4 facemasks which have not undergone a conformity assessment procedure under article 23 meddo may be placed on the market without authorisation under paragraph 1 provided they:a. are placed on the market exclusively for non-medical use; andb. are expressly labelled as being for non-medical use.5 facemasks placed on the market in accordance with paragraph 3bis may not be used in hospitals or medical practices by persons in direct contact with patients.5bis the swisscovid app as specified in the ordinance of 24 june 202042 on the proximity tracing system for the coronavirus sars-cov-2 and as specified in the ordinance of 30 june 202143 on a notification system for possible infection with the coronavirus sars-cov-2 at events is not subject to the provisions on the conformity assessment of medical devices.446 the obligations in relation to product surveillance under the meddo, in particular to collecting reports of incidents, continue to apply.39 amended by no i of the o of 25 aug. 2021, in force since 30 aug. 2021 (as 2021 507).40 sr 812.21341 the reference was amended on 26 may 2021 pursuant to art. 12 para. 2 of the publications act of 18 june 2004 (sr 170.512). the amendment has been made throughout the text.42 sr 818.101.2543 sr 818.102.444 inserted by art. 18 of the o of 30 june 2021 on a notification system for possible infection with the coronavirus sars-cov-2 at events, in force from 1 july 2021 until 30 june 2022 (as 2021 411).art. 23a45 45 inserted by no i of the o of 12 march 2021 (as 2021 145). repealed by no i of the o of 23 june 2021, with effect from 26 june 2021 (as 2021 378).art. 23b46 exception for ffp masks 1 ffp masks that do not comply with the principles and procedures for conformity assessment under article 3 paragraph 2 of the ppe ordinance of 25 october 201747 (ppeo) and whose non-compliance with these principles and procedure has not been approved based on article 24 paragraph 3 in its version of 22 june 202048 may not be placed on the market.2 ffp masks under paragraph 1 held in federal and cantonal stocks may be supplied to private hospitals, homes for the elderly and care homes and organisations that provide nursing services and other assistance at home as well as to federal and cantonal facilities such as the armed forces, civil defence units, hospitals and prisons provided the federal or cantonal authority responsible for the supply:a. guarantees by means of testing by a recognised european conformity assessment body for ffp masks that the masks provide a level of safety equivalent to that legally required under the ppeo; andb. guarantees their traceability.3 product information in at least one official language or in english must be available when the masks are supplied. it must be ensured that the user is able to use the product in accordance with the relevant provisions.46 originally art. 23a. inserted by no i of the o of 27 jan. 2021 (tests for sars-cov-2 and ffp masks), in force since 28 jan. 2021 (as 2021 54).47 sr 930.11548 as 2020 2195art. 2449 sars-cov-2 rapid tests for specialist use and the supply and use of sars-cov-2 self-tests50 1 non-automated single-patient rapid tests for direct detection of sars-cov-2 (sars-cov-2 rapid tests) for specialist use may only be carried out in the following facilities:51a. laboratories licensed under article 16 of the epidemics act of 28 september 201252 (epida) and sample collection stations that they operate;b.53 medical practices, pharmacies and hospitals, homes for the elderly and care homes and socio-medical institutions, and test centres operated by or on behalf of the canton.1bis they may also be carried out in and by organisations that provide nursing services and other assistance at home as well as by assistants as defined in the federal act of 19 june 195954 on invalidity insurance (invia).552 sars-cov-2 rapid tests may also be carried out at a location outside the facilities mentioned in paragraph 1 provided a laboratory manager, a doctor or a pharmacist accepts responsibility for complying with the requirements of this article and articles 24a and 24b.56 3 if facilities under paragraph 1 letter a offer sars-cov-2 rapid tests at a location outside the facilities, they must notify the canton of their offer.57 4 facilities under paragraphs 1 letter b and 1bis may carry out sars-cov-2 rapid tests for specialist use without a licence under article 16 epida and outside closed systems provided they comply with the following conditions:58a. suitable safety measures and precautionary measures plans to protect persons, animals, the environment and biological diversity have been prepared and implemented.b.59 the tests are only carried out by persons specifically trained for this purpose according to the instructions provided by the test manufacturer. c. the test results are interpreted under the supervision of persons with the required expertise; external experts may also be consulted.d. the facilities keep records that permit the traceability and prove the quality of the test systems used. the records must be preserved.e. the facilities are authorised by the canton to carry out such tests.4bis sars-cov-2 rapid tests for self-testing by the public (sars-cov-2 self-tests) may be supplied and used if they are intended for self-testing by the manufacturer and certified accordingly.60 5 sars-cov-2 rapid tests are direct detection methods that detect the antigens to sars-cov-2. the tests are not automated and are carried out with the minimum of instruments; only the reading of the test result may be automated.61 49 amended by no i of the o of 18 dec. 2020 (sars-cov-2 rapid tests), in force since 21 dec. 2020 (as 2020 5801).50 amended by no i of the o of 12 march 2021, in force since 15 march 2021 (as 2021 145).51 amended by no i of the o of 23 june 2021, in force since 26 june 2021 (as 2021 378).52 sr 818.10153 amended by no i of the o of 27 jan. 2021 (tests for sars-cov-2 and ffp masks), in force since 28 jan. 2021 (as 2021 54).54 sr 831.2055 inserted by no i of the o of 27 jan. 2021 (tests for sars-cov-2 and ffp masks) (as 2021 54). amended by no i of the o of 12 march 2021, in force since 15 march 2021 (as 2021 145).56 amended by no i of the o of 25 aug. 2021, in force since 30 aug. 2021 (as 2021 507).57 amended by no i of the o of 25 aug. 2021, in force since 30 aug. 2021 (as 2021 507).58 amended by no i of the o of 12 march 2021, in force since 15 march 2021 (as 2021 145).59 amended by no i of the o of 12 march 2021, in force since 15 march 2021 (as 2021 145).60 inserted by no i of the o of 12 march 2021 (as 2021 145). amended by no i of the o of 25 aug. 2021, in force since 30 aug. 2021 (as 2021 507).61 amended by no i of the o of 25 aug. 2021, in force since 30 aug. 2021 (as 2021 507).art. 24a62 permitted sars-cov-2 rapid tests for specialist use 1 the only test systems that may be used for sars-cov-2 rapid tests for specialist use are those authorised in the eu for issuing the eu's digital covid certificate.2 in derogation from paragraph 1, other test systems may also be used provided the sars-cov-2 rapid tests are carried out by laboratories licensed under article 16 epida and the sample collection stations that they operate.62 inserted by no i of the o of 18 dec. 2020 (sars-cov-2 rapid tests) (as 2020 5801). amended by no i of the o of 25 aug. 2021, in force since 30 aug. 2021 (as 2021 507).art. 24b63 notifying the canton of a positives test result in the absence of a confirmatory diagnosis if no confirmatory diagnosis is made following a positive result for a sars-cov-2 rapid test and if the fdha has not required a report on the result of sars-cov-2 rapid tests on the basis of article 19 of the epidemics ordinance of 29 april 201564, the facility or person responsible for conducting the tests must notify the cantonal authority or organisation responsible for contact tracing of the positive test result.63 inserted by no i of the o of 18 dec. 2020 (sars-cov-2 rapid tests) (as 2020 5801). amended by no i of the o of 12 march 2021, in force since 15 march 2021 (as 2021 145).64 sr 818.101.1art. 24c65 lists of sars-cov-2 rapid tests the foph shall maintain continuously updated lists of sars-cov-2 rapid tests for specialist use in accordance with article 24a and the sars-cov-2 self-tests in accordance with article 24 paragraph 4bis and shall publish the lists on its website.65 inserted by no i of the o of 18 dec. 2020 (sars-cov-2 rapid tests) (as 2020 5801). amended by no i of the o of 25 aug. 2021, in force since 30 aug. 2021 (as 2021 507).art. 24d66 responsibility of the cantons for carrying out sars-cov-2 rapid tests the cantons are responsible for monitoring and enforcing compliance with the conditions in articles 24-24b for sars-cov-2 rapid tests that are not carried out at the facilities referred to in article 24 paragraph 1 letter a.66 inserted by no i of the o of 18 dec. 2020 (sars-cov-2 rapid tests) (as 2020 5801). amended by no i of the o of 27 jan. 2021 (tests for sars-cov-2 and ffp masks), in force since 28 jan. 2021 (as 2021 54).art. 24e67 collecting samples for molecular-biological analyses for sars-cov-2 1 samples for molecular-biological analyses for sars-cov-2 may be collected:a. in laboratories licensed under article 16 epida and in sample collection stations that they operate; b. in facilities or by persons in accordance with article 24 paragraphs 1 letter b, 1bis and 2;c. in other sample collection stations, provided the samples are collected under the supervision of laboratories licensed under article 16 epida and the sample collection station has notified the canton that it is carrying out this activity.2 the sample collection station must verify the identity of the person being tested. the sample must be collected by a person trained for this purpose.3 the sample may also be collected by the person being tested themselves:a. in the facility, provided the facility verifies the identity of the person being tested and supervises the collection of the sample as it is being done; orb. outside the facility, provided the facility verifies the identity of the person being tested and guarantees that the sample is correctly assigned to the person being tested by taking suitable precautions, in particular by the video monitoring of the process.67 inserted by no i of the o of 25 aug. 2021, in force since 1 oct. 2021 (as 2021 507).art. 24f68 responsibility for monitoring the collection of samples for molecular-biological analyses for sars-cov-2 swissmedic is responsible for monitoring compliance with the requirements set out in article 24e by laboratories licensed under article 16 epida, including the collection of samples carried out under the supervision of such laboratories by facilities in accordance with article 24e paragraph 1 letter c, and the cantons are responsible for monitoring in the facilities in accordance with article 24e paragraph 1 letter b and for the supervision of collection stations in accordance with article 24e paragraph 1 letter c.68 inserted by no i of the o of 25 aug. 2021, in force since 1 oct. 2021 (as 2021 507).art. 24g69 disclosure of data swissmedic may disclose data on essential medical goods to the federal offices and organisations mentioned in article 12 paragraph 1, provided this is required in order to implement this ordinance. the data must not include sensitive personal data.69 originally art. 24e. inserted by no i of the o of 18 dec. 2020 (sars-cov-2 rapid tests), in force since 21 dec. 2020 (as 2020 5801).chapter 3 healthcare provision art. 25 hospitals and clinics 1 the cantons shall ensure that sufficient capacities (in particular beds and specialist staff) are available in the inpatient departments of hospitals and clinics for covid-19 patients and for other urgently required medical examinations and treatments, in particular in the intensive care units and the general internal medicine departments.2 for this purpose, they may require hospitals and clinics:a. to make their inpatient capacities available immediately or on demand; andb. to restrict or suspend non-urgent medical procedures and treatments.3 the hospitals and clinics must ensure that supplies of medicinal products for covid-19 patients and for other urgently required medical examinations and treatments is guaranteed in their outpatient and inpatient departments.art. 2670 payment of costs for analyses for sars-cov-2 1 the confederation shall pay the effective costs of analyses for sars-cov-2 subject to the requirements and maximum amounts set out in annex 6.712 every week, the foph shall publish on its website the number of molecular-biological analyses for sars-cov-2 in accordance with annex 6 number 1 that were conducted in the previous calendar week in switzerland and in liechtenstein. the fdha may adjust the maximum amounts paid in line with the effective costs.3 for analyses for sars-cov-2 under annex 6, the order to the laboratory must include the information required for electronic invoicing, in particular the tested person's health insurance number or client number.4 persons tested as specified in annex 6 shall not be required to pay a share of the costs in accordance with article 64 of the federal act of 18 march 199472 on health insurance (hia).5 service providers shall not charge persons tested as specified in annex 6 any additional costs. they must pass on any sums that directly or indirectly cover any part of the cost shares in accordance with annex 6 to the reimbursement debtor.6 if the service provider offers services in accordance with annex 6 that must be paid for by the person tested, it must inform the person concerned before carrying out the test that the costs may be covered under article 26b.7370 amended by no i of the o of 12 march 2021, in force since 15 march 2021 (as 2021 145).71 amended by annex no 1 of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).72 sr 832.1073 inserted by no i of the o of 25 aug. 2021, in force since 30 aug. 2021 (as 2021 507).art. 26a74 persons liable to pay for the services 1 where a service involving an analysis for sars-cov-2 under annex 6 number 1 is carried out by a service provider that has a paying agent register number (zsr number), payment for the service shall be made under the tiers payant system in article 42 paragraph 2 hia75 by the following insurers:76a. in the case of persons who have mandatory health insurance under the hia, by the health insurance company under article 2 of the health insurance oversight act of 26 september 201477 with which the person tested is insured;b. in the case of persons who have military insurance against illness, by the military insurance;c.78 in the case of persons who do not have mandatory health insurance under the hia, and in the case of persons who have died, by the joint institution under article 18 hia.2 where a service involving an analysis for sars-cov-2 under annex 6 number 1 is carried out by a service provider that does not have a zsr number, the canton in which the sample is taken shall pay for the services.3 where the analysis for sars-cov-2 is conducted in accordance with annex 6 sections 1.1.1 letters i and j, 1.4.1 letters h and i, 3.1.1 letter a and 3.2.1 letter a, the service providers may choose as the person liable to pay for the service:79a. the insurer under paragraph 1 that is liable to pay for the services under the tiers payant system in terms of article 42 paragraph 2 hia; orb. the canton in which the sample for sars-cov-2 is taken.4 where the analysis for sars-cov-2 under annex 6 sections 2, 3.1.1 letters b-d and 3.2.1 letters b and c is conducted, the canton in which the sample for sars-cov-2 is taken shall pay for the services.8074 inserted by no i of the o of 24 june 2020 (as 2020 2549). amended by no i of the o of 12 march 2021, in force since 15 march 2021 (as 2021 145).75 sr 832.1076 amended by no i of the o of 25 aug. 2021, in force since 1 oct. 2021 (as 2021 507).77 sr 832.1278 amended by no i of the o of 1 oct. 2021, in force since 11 oct. 2021 (as 2021 594).79 amended by no i of the o of 12 may 2021, in force since 17 may 2021 (as 2021 274).80 amended by no i of the o of 23 june 2021, in force since 26 june 2021 (as 2021 378).art. 26b81 procedure where the insurer is liable to pay for the service 1 where an insurer is liable to pay for the service under article 26a paragraphs 1 and 3 letter a, the service providers under article 26 paragraph 2 shall send an invoice for services under annex 6 for each person tested to the insurer concerned on a case-by-case basis or collectively every quarter at the latest nine months after providing the services. the invoice may only cover services under annex 6. the invoice shall preferably be sent electronically.2 service providers shall not charge for services under annex 6 as positions 3186.00, 3188.00 and 3189.00 of annex 3 to the health insurance benefits ordinance of 29 september 199582 (hibo).833 the insurers shall check the invoices and ascertain whether the service provider has charged correctly for the services under annex 6. they shall comply with articles 84-84b hia84 in processing the data.4 at the start of january, april, july and october, they shall notify the foph of the number of analyses for which they have paid the service providers, and of the amount paid in each case. the external auditors for the insurers shall each year review the figures and confirm that suitable checks in accordance with paragraph 3 are being made and submit a report to the foph. the foph may request additional information from the insurers on the amounts paid to each service provider.5 the confederation shall reimburse the insurers every quarter for the services that they have paid for.6 if the invoice for the service sent by the service provider is incorrect, the insurer may claim back any payments already made. once the confederation has paid for the service in accordance with paragraph 5, the right to reimbursement passes to the confederation. the insurers shall provide the confederation with the data required to exercise its right to reimbursement. the data may not include any sensitive personal data.6bis and 6ter .857 the joint institution shall invoice the foph every quarter on a time and material basis for the administrative costs of its activities as an insurer under article 26a paragraphs 1 letter c and 3 letter a. the hourly rate shall be 95 francs and includes salary costs, social insurance payments and infrastructure costs. the actual costs of any expenditure on audits, system modifications and negative interest not included in the administrative costs shall be reimbursed.8 invoices for analyses for sars-cov-2 that meet the requirements of annex 6 must be marked analysis for sars-cov-2 without meeting the testing criteria.81 inserted by no i of the o of 27 jan. 2021 (tests for sars-cov-2 and ffp masks) (as 2021 54). amended by no i of the o of 12 march 2021, in force since 15 march 2021 (as 2021 145).82 sr 832.112.3183 amended by no i of the o of 17 dec. 2021, in force since 18 dec. 2021 (as 2021 881).84 sr 832.1085 inserted by no i of the o of 12 may 2021 (as 2021 274). repealed by no i of the o of 25 aug. 2021, with effect from 1 oct. 2021 (as 2021 507).art. 26c86 procedure where the canton is liable to pay for the service 1 where the canton is liable to pay for the service under article 26a paragraphs 2, 3 letter b and 4, the service providers shall send a collective invoice on a quarterly basis to the canton concerned no later than nine months after the services were provided. the invoice may only cover services under annex 6. the invoice shall preferably be sent electronically.2 service providers shall not charge for services under annex 6 as position 3186.00 of annex 3 hibo87.3 the cantons shall check the invoices and ascertain whether the service provider has charged correctly for the services under annex 6. they shall comply with the relevant cantonal data protection provisions.4 at the start of january, april, july and october, they shall notify the foph of the number of analyses for which they have paid the service providers, and of the amount paid in each case.5 the confederation shall reimburse the cantons every quarter for the services that they have paid for. it shall also make a single start-up payment to cantons that arrange for the targeted and repetitive testing of their residents. the cantons shall invoice the confederation for the actual costs of such testing only, up to a maximum of 8 francs per resident. costs related to information technology and logistics may be included.6 if the invoice for the service sent by the service provider is incorrect, the insurer may claim back any payments already made. once the confederation has paid for the service in accordance with paragraph 5, the right to reimbursement passes to the confederation. the insurers shall provide the confederation with the data required to exercise its right to reimbursement. the data may not include any sensitive personal data.86 inserted by no i of the o of 27 jan. 2021 (tests for sars-cov-2 and ffp masks) (as 2021 54). amended by no i of the o of 12 march 2021, in force since 15 march 2021 (as 2021 145).87 sr 832.112.31chapter 4 company meetings art. 27 1 in the case of company meetings, the organiser may, regardless of the probable number of participants and without complying with the period of notice for convening meetings, order the participants to exercise their rights exclusively:a. in writing or online; orb. through an independent proxy appointed by the organiser.2 notification of the order must be given in writing or published online no later than four days before the event.8888 amended by no i of the o of 27 oct. 2021, in force since 28 oct. 2021 (as 2021 634).chapter 4a89 measures to protect employees at high risk 89 inserted by no i of the o of 13 jan. 2021 (employees at high risk) (as 2021 5). amended by no i of the o of 17 dec. 2021, in force from 1 jan. 2022 until 31 march 2022 (as 2021 881; art. 29 para. 7). art. 27a 1 employers shall enable their employees at high risk to carry out their working duties from home. they shall take the appropriate organisational and technical measures to achieve this. employees shall not be entitled to any compensation for expenses related to fulfilling their working duties from home as ordered by this this provision.2 where it is not possible for employees to carry out their regular working duties from home, employers shall, in derogation from the contract of employment and for the same pay, assign the employees concerned equivalent alternative work that can be performed from home.3 where for operational reasons the presence of employees at high risk in the workplace is essential at all or at certain times, they may carry out their regular activities in the workplace provided the following requirements are met:a. the workplace is organised so as to prevent any close contact with other persons, in particular by providing the employee concerned with his or her own room or a clearly separate working area.b. in cases where close contact cannot be avoided at all times, appropriate protective measures shall be taken in accordance with the stop principle (substitution, technical measures, organisational measures, personal protective equipment).4 if it is not possible for the employees concerned to work in accordance with paragraphs 1-3, the employer shall in derogation from the contract of employment assign them equivalent alternative work in their normal workplace for the same pay in conditions which meet the requirements of paragraph 3 letters a and b.5 before the employer takes any measures, he or she shall consult the employees concerned. the employer shall record the measures decided in writing and notify the employees of the same in a suitable manner.6 the employee concerned may decline to carry out work assigned to him or her if the employer fails to meet the requirements of paragraphs 1-4 or if the employee regards his or her personal risk of infection with the coronavirus for specific reasons as being too high despite the employer taking measures in accordance with paragraphs 3 and 4. the employer may request a medical certificate.7 if it is not possible for the employee concerned to work in accordance with paragraphs 1-4, or if the employee declines the work assigned in terms of paragraph 6, the employer shall furlough the employee while continuing to pay his or her salary.8 employees shall give notice that they are at high risk by making a personal declaration. the employer may request a medical certificate.9 article 2 paragraph 3quater of the covid-19 loss of earnings ordinance of 20 march 202090 governs claims for compensation for loss of earnings related to the corona pandemic.10 the following persons are regarded as being at high risk: a. pregnant women;b. persons with the diseases or genetic anomalies listed in annex 7 who cannot be vaccinated on medical grounds.11 the following persons are not regarded as being at high risk:a. pregnant women who have been vaccinated against covid-19, for 365 days from the date on which the vaccination is administered in full;b. persons specified in paragraph 10 who have been infected with sars-cov-2 and have recovered:1. when based on a molecular-biological analysis for sars-cov-2: for 365 days from the eleventh day after confirmation of infection,2. when based on an analysis for sars-cov-2 antibodies in accordance with article 16 paragraph 3 of the covid-19 ordinance on certificates of 4 june 202191: for the term of validity of the certificate concerned.12 the diseases and genetic anomalies referred to in paragraph 10 are defined in annex 7 on the basis of medical criteria. the list of these criteria is not exhaustive. a clinical assessment of the risk in specific cases remains reserved and may lead to persons being classed as being at high risk under paragraph 10bis.13 the fdha shall continually update annex 7 based on the state of science.14 for the general protection of employees, article 25 of the covid-19 special situation ordinance of 23 june 202192 applies.90 sr 830.3191 sr 818.102.292 sr 818.101.26chapter 5 final provisions art. 28 repeal of another enactment the covid-19 ordinance 2 of 13 march 202093 is repealed.93 [as 2020 773, 783, 841, 863, 867, 1059, 1065, 1101, 1131, 1137, 1155, 1199, 1245, 1249, 1333, 1401, 1501, 1505, 1585, 1751, 1815, 1823, 1835, 2097, 2099, 2213 art. 14 n. ii]art. 28a94 transitional provision to the amendment of 11 september 2020 personal protective equipment that was permitted under article 24 of the previous law may continue to be placed on the market until 30 june 2021.94 inserted by no i of the o of 11 sept. 2020 (extension; test costs), in force since 18 sept. 2020 (as 2020 3695).art. 28b95 transitional provisions to the amendment of 23 june 2021 1 licences for placing sars-cov-2 self-tests on the market that swissmedic has granted based on article 23a of the previous law remain valid until the licence expires.2 pharmacies may continue to supply sars-cov-2 self-tests licensed under article 23a of the previous law provided the requirements of article 24 paragraph 4bis letter b are met.3 applications that are pending when the amendment of 23 june 2021 comes into force shall be processed in accordance with article 23a of the previous law.95 inserted by no i of the o of 23 june 2021, in force since 26 june 2021 (as 2021 378).art. 28c96 transitional provision to the amendment of 25 august 2021 sars-cov-2 rapid tests for specialist use that are permitted based on article 24a of the previous law may continue to be used until 25 october 2021 provided the requirements of article 24 are met.96 inserted by no i of the o of 25 aug. 2021, in force since 30 aug. 2021 (as 2021 507).art. 29 commencement and term 1 this ordinance comes into force on 22 june 2020 at 00.00.2 it applies until 13 september 2020.973 .984 the term of application of this ordinance shall be extended to 31 december 2021, subject to paragraph 5.995 article 27 applies until the provisions on the conduct of general meetings in the amendment of 19 june 2020100 to the swiss code of obligations101 (company law) comes into force, but at the latest until 31 december 2023.1026 the term of application of this ordinance shall be extended to 31 december 2022, subject to paragraphs 5 and 7.1037 article 27a and annex 7 apply until 31 march 2022.10497 amended by no ii of the o of 12 aug. 2020 (requirement to wear masks in aircraft; large-scale events), in force since 15 aug. 2020 (as 2020 3547).98 repealed by no ii of the o of 12 aug. 2020 (requirement to wear masks in aircraft; large-scale events), with effect from 15 aug. 2020 (as 2020 3547).99 inserted by no i of the o of 11 sept. 2020 (extension; test costs) (as 2020 3695). amended by no i of the o of 27 oct. 2021, in force since 28 oct. 2021 (as 2021 634).100 as 2020 4005101 sr 220102 inserted by no i of the o of 27 oct. 2021, in force since 28 oct. 2021 (as 2021 634).103 inserted by no i of the o of 17 dec. 2021, in force since 1 jan. 2022 (as 2021 881).104 inserted by no i of the o of 17 dec. 2021, in force since 1 jan. 2022 (as 2021 881).annex 1105 105 amended by no i of the fdjp o of 15 dec. 2021, in force since 20 dec. 2021 (as 2021 880).(art. 3 para. 3, 4 para. 2ter and art. 5)list of high-risk countries and regions 1. high-risk countries and regions (art. 3 para. 2 let. a) all countries and regions outside the schengen area, with the exception of:- andorra- argentina- australia- bahrain- bulgaria- canada- chile- colombia- croatia- cyprus- holy see- hong kong- indonesia- ireland- kuwait- macau- monaco- new zealand- qatar- peru- romania- rwanda- san marino- saudi arabia- south korea- taiwan (chinese taipei)- united arab emirates- uruguay2. high-risk countries and regions with a variant of the sars-cov-2 virus that carries a higher risk of infection or causes a more severe form of the disease in comparison with the variant of the virus prevalent in the schengen area (art. 3 para. 2 let. b) - botswana- eswatini- lesotho- mozambique- namibia- south africa- zimbabweannex 1a106 106 inserted by annex 3 of the covid-19 ordinance on international travel measures of 23 june 2021 (as 2021 380). revised in accordance with annex no 3 i of the o of 17 sept. 2021 (as 2021 563) and annex no 1 of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).(art. 4 para. 2 let. a and art. 5)persons who have been vaccinated 1 persons who have been vaccinated are persons who have been vaccinated with a vaccine that:a. is authorised in switzerland and which has been administered in full in accordance with the foph recommendations;b. has been authorised by the european medicines agency for the european union and has been administered in full in accordance with the requirements or recommendations of the country in which the vaccination was administered; c. has been authorised under the who emergency use listing and has been administered in full in accordance with the requirements or recommendations of the country in which the vaccination was administered; ord. has been shown to have the same composition as a vaccine licensed under letters a, b or c, but marketed by the licence holder under another name, and which has been administered in full in accordance with the requirements or recommendations of the country in which the vaccination was carried out.2 the period during which persons who have been vaccinated are exempt from the ban on entry under article 4 paragraph 1 amounts to 365 days from the date of vaccination in full; the janssen ad26.cov2.s / covid-19 vaccinevaccine is regarded as being effective for 365 days from the 22nd day after it was administered in full.3 proof of vaccination may be provided in the form of a covid-19 certificate in accordance with article 1 letter a number 1 of the covid-19 ordinance on certificates of 4 june 2021107 or a recognised foreign certificate in accordance with section 7 of the covid-19 ordinance on certificates.4 proof may also be provided in a different form from that in number 3. it must be a form of proof that is customary at the time. in addition to the surname, forename and date of birth of the person concerned, it must include the following information:a. the date of vaccination;b. the vaccine used.107 sr 818.102.2annex 2108 108 rendered obsolete by the repeal of art. 8 (see art. 6 no 1 of the covid-19 ordinance on international travel measures of 2 july 2020, as 2020 2737).annex 3109 109 amended by no i of the fdjp o of 27 nov. 2021 (as 2021 780). revised by no iii of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).(art. 9 para. 3)restrictions on cross-border movements of persons there are no entries currently on this list.annex 4110 110 amended by no i of the foph o of 6 oct. 2020 (list of important medical products and list of active substances for the treatment of covid-19) (as 2020 4129). revised by no ii para. 1 of the o of 27 jan. 2021 (tests for sars-cov-2 and ffp masks) (as 2021 54), no i para. 1 of the fdha o of 14 april 2021 (amendment of the lists of important medical products and of active substances for the treatment of covid-19 (as 2021 212), no ii of the o of 12 may 2021 (as 2021 274), and no i of the fdha o of 17 aug. 2021 (amendment of the list of important medical products and list of active substances for the treatment of covid-19), in force since 25 aug. 2021 (as 2021 493).(art. 11 para. 1, 19 para. 1 and 21 para. 2)list of important medicinal products, medical devices and protective equipment (essential medical goods) 1. active substances or medicinal products with the listed active substances 1. tocilizumab 2. remdesivir 3. propofol 4. midazolam 5. ketamine 6. dexmedetomidine 7. dobutamine 8. sufentanil 9. remifentanyl10. rocuronium11. atracurium12. suxamethonium13. noradrenalin14. adrenalin15. insulin16. fentanyl17. heparin18. argatroban19. morphine20. paracetamol (parenteral)21. metamizol (parenteral)22. lorazepam23. dexamethasone24. co-amoxicillin25. piperacillin/tazobactam26. meropenem27. imipenem/cilastatin28. cefuroxime29. ceftriaxone30. amikacin31. posaconazole32. fluconazole33. voriconazole34. caspofungin35. esmolol (parenteral)36. metoprolol (parenteral)37. labetalol (parenteral)38. clonidine39. amiodarone40. furosemide41. vaccines against covid-1942. vaccines against influenza43. vaccines against bacterial pneumonia (prevnar 13)44. medical gases45. casirivimab/imdevimab46. bamlanivimab/etesevimab47. medical oxygen 48. infusion solutions49. sotrovimab2. medical devices within the meaning of the medical devices ordinance of 17 october 2001111 111 sr 812.213 1. ventilators2. monitoring equipment for intensive care3. in vitro diagnostics (covid-19 tests), including pre-analytical components and instruments4. surgical masks / op masks (hygiene masks)5. surgical gloves / examination gloves6. infusion sets7. pipette tips with filters8. test kits (tubes and swabs)9. single-use syringes and cannulae10. blood gas syringes3. personal protective equipment and other equipment 3.1 personal protective equipment within the meaning of the ppe ordinance of 25 october 2017112 112 sr 930.115 1. respirators (ffp2 and ffp3)2. aprons 3. protective overalls 4. protective eyewear 5. disposable caps3.2 further equipment 1. hand disinfectants 2. surface disinfectants 3. ethanol4. hygiene products for intensive care (such as absorbent pads, diapers, faecal collectors, oral hygiene items)annex 5113 113 amended by no i para. 2 of the fdha o of 14 april 2021 (amendment of lists of important medical products and of active substances for the treatment of covid-19) (as 2021 212). revised by no i of the fdha o of 17 aug. 2021 (amendment of the list of important medical products and list of active substances for the treatment of covid-19), in force since 25 aug. 2021 (as 2021 493).(art. 21 paras 1 and 3, as well as 22 para. 1)list of active substances for the treatment of covid-19 1. casirivimab/imdevimab2. bamlanivimab/etesevimab3. sotrovimabannex 5a114 114 inserted by no iii para. 1 of the o of 18 dec. 2020 (sars-cov-2 rapid tests) (as 2020 5801). repealed by no ii para. 1 of the o of 25 aug. 2021, with effect from 30 aug. 2021 (as 2021 507).annex 6115 115 inserted by no ii of the o of 28 oct. 2020 (sars-cov-2 rapid antigen tests) (as 2020 4495). amended by no iii of the o of 12 march 2021 (as 2021 145). revised by no ii of the o of 12 may 2021 (as 2021 274), of 23 june 2021 (as 2021 378), the correction dated 29 june 2021 (as 2021 407), annex no 3 i of the o of 17 sept. 2021 (as 2021 563), no ii para. 2 of the o of 25 aug. 2021 (as 2021 507), no ii of the o of 1 oct 2021 (as 2021 594), annex no 1 of the o of 3 nov. 2021 (as 2021 653) and no ii para. 1 of the o of 17 dec. 2021 in force since 18 dec. 2021 (as 2021 881).(art. 26, 26a, 26b and 26c)services and maximum amounts paid for sars-cov-2 analyses 1 standard tariff for symptom- and case-based testing 1.1 molecular-biological analyses for sars-cov-2 1.1.1 the confederation shall pay the costs of molecular-biological analyses for sars-cov-2 in following cases only:a. persons who have symptoms;b. persons who have been in close contact with an infected person as defined in article 7 paragraph 1 of the covid-19 special situation ordinance of 23 june 2021116;c. persons who wish to leave contact quarantine early in accordance with article 8 of the covid-19 special situation ordinance;d. . e. persons who have been notified by the swisscovid app that they have potentially been in close contact with a person infected with sars-cov-2; the confederation shall pay the costs of a single test;f. persons resident abroad who work, study or train in switzerland, in cases where they are required to produce a negative molecular-biological test result for sars-cov-2 when entering their foreign country of residence and no other authority will cover the costs;g. persons resident in switzerland who work, study or train abroad where they are required to produce a negative molecular-biological test result for sars-cov-2 when entering the foreign country concerned and no other authority will cover the costs;h. following a positive result from a:- sars-cov-2-rapid test for specialist use,- sars-cov-2 self-test;i. following a positive result from a pooled molecular-biological analysis:1. in accordance with number 1.2,2. in accordance with numbers 1.7, 2.2 and 3.2;j. as part of outbreak investigation and control procedures ordered by a doctor.1.1.2 it shall pay the costs only if the services are provided:a. when collecting a sample, by:1. the following service providers under the hia117:- doctors- pharmacists- hospitals- laboratories under article 54 paragraph 3 of the ordinance of 27 june 1995118 on health insurance (hio) and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida- care homes- organisations that provide nursing services and other assistance at home,2. test centres operated by or on behalf of a canton,3. socio-medical institutions that admit persons for treatment or care, for rehabilitation or for socio-professional rehabilitation or employment,4. assistants as defined in the invia119;b. when an analysis is conducted, by laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida.1.1.3 it shall pay a maximum of 153.50 francs of the cost of molecular-biological analyses for sars-cov-2. this amount covers the following services and cost components:a. for collecting a sample:servicemaximum amountpatient consultation and taking sample, including protective materials22.50 fr.for supervising the taking of the sample by the person tested and assigning the sample to the person concerned15 fr.reporting the test result to the person tested and to the responsible authorities under article 12 paragraph 1 epida, and requesting the activation code generated by the proximity tracing system for the coronavirus sars-cov-2 (pt system) when infection is detected and for issuing the covid-19 test certificate 2.50 fr.detailed doctor-patient consultation on the indications, where such is carried out22.50 fr.b. for the molecular-biological analysis:servicemaximum amountif conducted on behalf of another service provider, comprising:- analysis and report to the authorities under article 12 paragraph 2 epida, if the number of analyses conducted in switzerland and liechtenstein during a calendar week amounts to:106 fr.- < 100 000 82 fr.- 100 000 - < 150 000 74 fr.- 150 000 - < 200 000 70 fr.- > 200 000 64 fr.- ordering processing, overheads and sampling material 24 fr.if conducted without being requested by another service provider, comprising:- analysis and report to the authorities under article 12 paragraph 2 epida, if the number of analyses conducted in switzerland and liechtenstein during a calendar week amounts to: 87 fr.- < 100 000 82 fr.- 100 000 - < 150 000 74 fr.- 150 000 - < 200 000 70 fr.- > 200 000 64 fr.- ordering processing, overheads and sampling material 5 fr.116 sr 818.101.26117 sr 832.10118 sr 832.102119 sr 831.201. 2 pooled molecular-biological analyses for sars-cov-2 1.2.1 the confederation shall pay the costs of pooled molecular-biological analyses for sars-cov-2 only as part of outbreak investigation and control procedures ordered by a doctor.1.2.2 it shall pay the costs only if the services are provided:a. when collecting a sample, by:1. the following service providers under the health insurance act:- doctors- pharmacists- hospitals- laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida- care homes- organisations that provide nursing services and other assistance at home,2. test centres operated by or on behalf of a canton,3. socio-medical institutions that admit persons for treatment or care, for rehabilitation or for socio-professional rehabilitation or employment,4. assistants as defined in the invia;b. when an analysis is conducted, by laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida.1.2.3 it shall pay a maximum of 315 francs for pooled molecular-biological analyses for sars-cov-2. this amount covers the following services and cost components:a. for collecting a sample:servicemaximum amountpatient consultation and taking sample, including protective materials22.50 fr.for supervising the taking of the sample by the person tested and assigning the sample to the person concerned15 fr.b. for the pooled molecular-biological analysis:servicemaximum amountif conducted on behalf of another service provider, comprising:274 fr.- analysis with a minimum pool size of 4 82 fr.- ordering processing, overheads and sampling material 24 fr.- surcharge for additional sampling up to a maximum pool size of 25 8 fr.if conducted without being requested by another service provider, comprising:255 fr.- analysis with a minimum pool size of 4 82 fr.- ordering processing, overheads and sampling material 5 fr.- surcharge for additional sampling up to a maximum pool size of 25 8 fr.c. for centralised pooling: servicemaximum amountwhen conducted at compulsory school level and at upper secondary level in cases under number 1.2.1 for the creation of each pool 18.50 fr.1.3 analyses for sars-cov-2 antibodies 1.3.1 the confederation shall pay the costs of analyses for sars-cov-2 antibodies:a. if instructed to do so by the responsible cantonal body;b. if instructed to do so by a doctor four weeks after full vaccination in accordance with foph recommendations in the case of persons with severe immodeficiency;c. if instructed to do so by a doctor with a view to deciding whether a specific person should undergo therapy with monoclonal antibodies.1.3.2 it shall pay the costs only if the services are provided:a. when collecting a sample, by:1. the following service providers under the health insurance act:- doctors- pharmacists- hospitals- laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida- care homes- organisations that provide nursing services and other assistance at home,2. test centres operated by or on behalf of a canton,3. socio-medical institutions that admit persons for treatment or care, for rehabilitation or for socio-professional rehabilitation or employment,4. assistants as defined in the invia;b. when an analysis is conducted, by laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida.1.3.3 it shall pay a maximum of 96.50 francs for the analysis for sars-cov-2 antibodies. this amount covers the following services and cost components:a. for collecting a sample:servicemaximum amountpatient consultation and taking sample,including protective materials22.50 fr.reporting the test result to the person tested and to the responsible authorities under article 12 paragraph 1 epida 2.50 fr.detailed doctor-patient consultation on the indications, where such is carried out22.50 fr.b. for the analysis for sars-cov-2 antibodies:servicemaximum amountif conducted on behalf of another service provider, comprising:49 fr.- analysis and report to the authorities under article 12 paragraph 2 epida25 fr.- ordering processing, overheads and sampling material24 fr.if conducted without being requested by another service provider, comprising:30 fr.- analysis and report to the authorities under article 12 paragraph 2 epida25 fr.- ordering processing, overheads and sampling material 5 fr.1.4 immunological analyses for sars-cov-2 antigens and sars-cov-2 rapid tests for specialist use 1.4.1. the confederation shall pay the costs of immunological analyses for sars-cov-2 antigens and for sars-cov-2 rapid tests for specialist use according to the diagnostic standard in the following cases only:a. persons who have symptoms;b. persons who have been in close contact with an infected person as defined in article 7 paragraph 1 of the covid-19 special situation ordinance;c. persons who wish to leave contact quarantine early in accordance with article 8 of the covid-19 special situation ordinance;d. . e. persons who have been notified by the swisscovid app that they have potentially been in close contact with a person infected with sars-cov-2; the confederation shall pay the costs of a single test;f. persons resident abroad who work, study or train in switzerland, in cases where they are required to produce a negative molecular-biological test result for sars-cov-2 when entering their foreign country of residence and no other authority will cover the costs;g. persons resident in switzerland who work, study or train abroad where they are required to produce a negative molecular-biological test result for sars-cov-2 when entering the foreign country concerned and no other authority will cover the costs;h. following a positive result from a pooled molecular-biological analysis;1. in accordance with number 1.2, 2. in accordance with numbers 1.7, 2.2 and 3.2;i. as part of outbreak investigation and control procedures ordered by a doctor:j.120 .k. children under the age of 16;l. persons who can prove that they cannot be vaccinated on medical grounds; as proof, a medical certificate is required from a doctor who who is authorised to practise their profession under their own professional responsibility under the medical professions act of 23 june 2006121;m. visitors to hospitals, homes for the elderly and care homes and other socio-medical institutions that admit persons for treatment or care, rehabilitation or for socio-professional rehabilitation or employment;n. persons who do not fall under letters a-m, provided they have already received one dose of a vaccine but they are not vaccinated in accordance with annex 1a number 1, for six weeks from receiving the single dose of the vaccine, in the case of the janssen ad26.cov2.s / covid-19 vaccine, for 22 days.o. any persons who do not fall under letters a-n.1.4.2 .1.4.3 it shall pay the costs only if the services are provided:a. when collecting a sample and conducting an analysis, by:1. the following service providers under the health insurance act:- doctors- pharmacists- hospitals- laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida- care homes- organisations that provide nursing services and other assistance at home,2. test centres operated by or on behalf of a canton,3. socio-medical institutions that admit persons for treatment or care, for rehabilitation or for socio-professional rehabilitation or employment,4. assistants as defined in the invia.1.4.4 it shall pay a maximum of 88.50 francs for immunological analyses for sars-cov-2 antigens and for sars-cov-2 rapid tests for specialist use. this amount includes the following services and cost components:a. for collecting a sample:servicemaximum amountpatient consultation and taking sample, including protective materials22.50 fr.reporting the test result to the person tested and to the responsible authorities under article 12 paragraph 1 epida and requesting the activation code generated by the pt system when infection is detected and for issuing the covid-19 test certificate 2.50 fr.detailed doctor-patient consultation on the indications, where such is carried out22.50 fr.b. for the immunological analysis for sars-cov-2 antigens and for a sars-cov-2 rapid test for specialist use:servicemaximum amountif carried out without being requested by another authorised service provider, comprising:11 fr. - analysis and report to the authorities under article 12 paragraph 2 epida 6 fr.- ordering processing 5 fr.if carried out on behalf of another authorised service provider, comprising:30 fr.- analysis and report to the authorities under article 12 paragraph 2 epida 6 fr.- order processing, overheads and samplingmaterials24 fr.120 in force until 10 oct. 2021 (as 2021 145, 507, 582).121 sr 811.111.5 molecular-biological detection of one or more sars-cov-2 variants of concern 1.5.1 on the order of the competent cantonal authority and provided the results lead to specific measures by the canton, the confederation shall, if a molecular-biological analysis produces a positive result, pay the costs of the molecular-biological detection of one or more sars-cov-2 variants of concern (vocs), but only.1.5.2 it shall pay the costs only if the services are provided by laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida.1.5.3 on the order of the competent cantonal authority, molecular biological detection may be carried out by one of the following methods:a. mutation-specific pcr testing;b. partial genome sequencing.1.5.4 it shall pay 106 francs for the molecular-biological detection of one or more sars-cov-2 variants of concern. the amount covers the following services and cost components:servicemaximum amountif carried out without being requested by another authorised service provider, for the analysis and report to the authorities under article 12 paragraph 2 epida82 fr.if carried out on behalf of another service provider, comprising:106 fr.- analysis and report to the authorities under article 12 paragraph 2 epida82 fr.- order processing, overheads and sampling materials24 fr.1.6 diagnostic sequencing for sars-cov-2 1.6.1 the confederation shall pay the costs of diagnostic sequencing for sars-cov-2 2 by means of whole genome sequencing only if ordered by the competent cantonal authority and only in the following cases:a. in cases where there is reasonable suspicion of the presence of a sars-cov-2 variant, in particular in the case of specific severe cases in hospitals and in selected cases in persons suffering from severe immunosuppression;b. the targeted sequencing of samples in the case of outbreaks in hospitals, homes for the elderly and care homes;c. targeted and random sequencing in the event of major outbreaks.1.6.2 it shall pay the costs only if the services are provided by:a. micro-biological diagnostic laboratories that hold a licence under article 16 epida;b. reference laboratories that meet the requirements of article 17 epida.1.6.3 it shall pay a maximum of 221 francs for sequencing for sars-cov-2. the amount covers the following services and cost components:servicemaximum amountconduct of the analysis, comprising:221 fr.- analysis and report to the authorities under article 12 paragraph 2 epida197 fr.- order processing, overheads and samplingmaterials 24 fr.1.7 pooled molecular-biological analyses for sars-cov-2 for individual persons 1.7.1 the confederation shall pay the costs of pooled molecular-biological saliva analyses for sars-cov-2 for the following persons on an individual basis, provided they are not symptomatic:a. persons in accordance with number 1.4.1 letter k;b. persons in accordance with number 1.4.1 letter l;c. persons in accordance with number 1.4.1 letter n;d. all persons who do not fall under letters a-c.1.7.2 it shall pay the costs only if the services are provided by the following service providers:a. for the supervision of the person being tested when taking the sample by:1. the following service providers under the hia:- doctors- pharmacists- hospitals- laboratories in accordance with article 54 paragraph 3 hio and hospital laboratories in accordance with article 54 paragraph 2 hio that hold a licence in accordance with article 16 paragraph 1 epida- care homes- organisations that provide nursing services and other assistance at home,b. when an analysis is conducted, by laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida.1.7.3 in the case of pooled molecular-biological analyses for sars-cov-2 for individual persons, it shall pay a maximum of 36 francs. the amount covers the following services and cost components:a. for taking the sample:servicemaximum amountfor supervising the taking of the sample by the person tested and assigning the sample to the person concerned 15 fr.for reporting the test result to the person tested and issuing the covid-19 test certificate 2.50 fr.b. for pooled molecular-biological analyses for individual persons:servicemaximum amountif carried out on behalf of another authorised service provider, comprising: 16 fr.- for the analysis 13 fr.- order processing, overheads and samplingmaterials 3 fr.if carried out on behalf of another authorised service provider, comprising: 13.50 fr.- for the analysis 13 fr.- order processing, overheads and samplingmaterials 0.50 fr.c. for centralised pooling: servicemaximum amountfor organising the pool, per person 2.50 fr.2 reduced tariff for targeted and repetitive testing 2.1 sars-cov-2 rapid tests rapid tests for specialist use 2.1.1 the confederation shall pay the costs of sars-cov-2 rapid tests for specialist use only in following cases:a. in the case of targeted and repetitive testing in schools, universities and training centres in order to prevent and detect outbreaks, provided the responsible authority or organisation in the canton makes provision for this and submits a plan to the foph;b. in situations with a significantly higher probability of transmission, provided the responsible authority or organisation in the canton makes provision for this and submits a plan to the foph;c. in relation to testing over a limited period in connection with uncontrolled outbreaks of infection, provided the responsible authority or organisation in the canton makes provision for this;d. in the case of tests before and during school camps for participants and supervisors, provided the responsible authority or organisation in the canton makes provision for this and submits a plan to the foph.2.1.2 it shall pay the costs only if the services are provided:a. when collecting a sample and conducting an analysis, by:1. the following service providers under the health insurance act:- doctors- pharmacists- hospitals- laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida- care homes- organisations that provide nursing services and other assistance at home,2. test centres operated by or on behalf of a canton,3. socio-medical institutions that admit persons for treatment or care, for rehabilitation or for socio-professional rehabilitation or employment,4. assistants as defined in the invia.2.1.3 it shall pay shall pay a maximum of 30.50 francs for a sars-cov-2-rapid test for specialist use. the amount covers the following services and cost components:servicemaximum amountif the sample is not taken by the tested person him- or herself: taking the sample and conducting a test, including the test materials, the protective materials and working time, and for the analysis and order processing28 fr.if the sample is taken by the tested person him- or herself: taking the sample and conducting a test, including the test materials, the protective materials and working time, and for the analysis and order processing14 fr.for issuing the covid-19 test certificate 2.50 fr.2.2 pooled molecular-biological analyses for sars-cov-2 2.2.1 the confederation shall pay the costs of pooled molecular-biological analyses for sars-cov-2 only in following cases:a. in the case of targeted and repetitive testing in schools, universities and training centres in order to prevent and detect outbreaks, provided the responsible authority or organisation in the canton makes provision for this and submits a plan to the foph or provided the testing is coordinated via a platform made available by the confederation;b. in situations with a significantly higher probability of transmission, provided the responsible authority or organisation in the canton makes provision for this and submits a plan to the foph or provided the testing is coordinated via a platform made available by the confederation;c. in relation to testing over a limited period in connection with uncontrolled outbreaks of infection, provided the responsible authority or organisation in the canton makes provision for this or provided the testing is coordinated via a platform made available by the confederation;d. in the case of testing for participants and supervisors before and during camps, provided the responsible authority or organisation in the canton submits a plan to the foph or provided the testing is coordinated via a platform made available by the confederation.2.2.2 it shall pay the costs only if the services are provided:a. when collecting a sample and conducting an analysis, by:1. the following service providers under the health insurance act:- doctors- pharmacists- hospitals- laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida- care homes- organisations that provide nursing services and other assistance at home,2. test centres operated by or on behalf of a canton,3. socio-medical institutions that admit persons for treatment or care, for rehabilitation or for socio-professional rehabilitation or employment,4. assistants as defined in the invia;b. it shall pay the costs only if the services are provided by laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida.2.2.3 it shall pay a maximum of 311.50 francs for pooled molecular-biological analyses for sars-cov-2. the amount covers the following services and cost components:a. for collecting a sample: servicemaximum amounttaking the sample, including the protective materials and working time16.50 fr.b. for the pooled molecular-biological analysis:servicemaximum amountif conducted on behalf of another service provider, comprising:274 fr.- analysis with a minimum pool size of 4 82 fr.- ordering processing, overheads and sampling material 24 fr.- surcharge for additional sampling up to a maximum pool size of 25 8 fr.if conducted without being requested by another service provider, comprising:255 fr.- analysis with a minimum pool size of 4 82 fr.- ordering processing, overheads and sampling material 5 fr.- surcharge for additional sampling up to a maximum pool size of 25 8 fr.c. for centralised pooling: servicemaximum amountwhen conducted at compulsory school level, at upper secondary level and at school camps, for the creation of each pool 18.50 fr.d. for the certificate:servicemaximum amountfor issuing the covid-19 test certificate 2.50 fr.3 basic tariff for targeted and repetitive testing 3.1 sars-cov-2 rapid tests for specialist use 3.1.1 the confederation shall pay the costs of sars-cov-2 rapid tests for specialist use only in following cases:a. where targeted and repetitive testing is carried out in hospitals, homes for the elderly and care homes and other socio-medical institutions that admit persons for treatment or care, for rehabilitation or for socio-professional rehabilitation or employment;b. where targeted and repetitive testing is carried out in businesses and clubs, provided the responsible authority or organisation in the canton submits a plan to the foph;c. where a contact person is in quarantine and targeted and repetitive testing is carried in the business where the contact person works, with at least one test per week;d. .3.1.2 .3.1.3 it shall pay the costs of sars-cov-2 rapid tests for specialist use under section 3.1.1 only if the services are provided by:1. the following service providers under the health insurance act:- doctors- pharmacists- hospitals- laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida- care homes- organisations that provide nursing services and other assistance at home,2. test centres operated by or on behalf of a canton;3. socio-medical institutions that admit persons for treatment or care, for rehabilitation or for socio-professional rehabilitation or employment;4. assistants as defined in the invia.3.1.4 it shall pay a maximum of 8.50 francs for a sars-cov-2 rapid test for specialist use under section 3.1.1. this amount covers the following services and cost components:servicemaximum amountconducting the sars-cov-2 rapid test for specialist use, test materials only 6.00 fr.for issuing the covid-19 test certificate 2.50 fr.s3.2 pooled molecular-biological analyses for sars-cov-2 3.2.1 the confederation shall pay the costs of pooled molecular-biological analyses for sars-cov-2 only in following cases:a. where targeted and repetitive testing is carried out in hospitals, homes for the elderly and care homes and other socio-medical institutions that admit persons for treatment or care, for rehabilitation or for socio-professional rehabilitation or employment;b. where targeted and repetitive testing is carried out in businesses and clubs, provided the responsible authority or organisation in the canton submits a plan to the foph or provided the testing is coordinated via a platform made available by the confederation;c. where a contact person is in quarantine and targeted and repetitive testing is carried out in the business where the contact person works, with at least one test per week.3.2.2 it shall pay the costs only if the services are provided by laboratories under article 54 paragraph 3 hio and hospital laboratories under article 54 paragraph 2 hio that are licensed under article 16 paragraph 1 epida.3.2.3 it shall pay a maximum of 295 francs for pooled molecular-biological analyses for sars-cov-2. the amount covers the following services and cost components:servicemaximum amountif conducted on behalf of another service provider, comprising:274 fr.- analysis with a minimum pool size of 4 82 fr.- order processing, overheads and sampling materials 24 fr.- surcharge for additional sampling up to a maximum pool size of 25- for conducting a centralised pool in cases under number 3.2.1 letters b and c for the creation of each pool 8 fr. 18.50 fr.if conducted without being requested by another service provider, comprising:255 fr.- analysis with a minimum pool size of 4 82 fr.- order processing, overheads and sampling materials 5 fr.- surcharge for additional sampling up to a maximum pool size of 25- for conducting a centralised pool in cases under number 3.2.1 letters b and c for the creation of each pool 8 fr.18.50 fr.for issuing the covid-19 test certificate 2.50 fr.3.3122 . 122 in force until 30 sept. 2021 (as 2021 507). 4 limitations 4.1 if both a molecular-biological analysis for sars-cov-2 in accordance with number 1.1 and an analysis for sars-cov-2 antibodies in accordance with number 1.3 are carried out on the same person on the same day, the confederation shall make only one payment of the amount due for collecting a sample in accordance with number 1.1.3 letter a and 1.3.3 letter a and the amount due for the order processing, overheads and sampling materials in accordance with the number 1.1.3 letter b and 1.3.3 letter b.4.2 .4.3 if both a molecular-biological analysis for sars-cov-2 in accordance with number 1.1 and the molecular-biological detection of one or more sars-cov-2 variants of concern in accordance with number 1.5 or sequencing for sars-cov-2 in accordance with number 1.6 are carried out by the same service provider, the confederation shall make only one payment in respect of its share of the costs for order processing and overheads in accordance with numbers 1.1.3 letter b and 1.5.3 letter a or 1.6.3.4.4 in the case of analyses for sars-cov-2, where the person tested can take the sample, no charge may be made for collecting a sample.annex 7123 123 inserted by no ii of the o of 13 jan. 2021 (employees at high risk), in force from 18 jan. 2021 to 31 dec. 2021 (as 2021 5) (as 2021 5). amended by no ii para. 1 of the o of 17 dec. 2021, in force from 1 jan. 2022 until 31 march 2022 (as 2021 881; art. 29 para. 7).(art. 27a para. 10 let. b, 12 and 13 and art. 29 para. 7)diseases and genetic anomalies that make the persons concerned persons at high risk according to the current state of science, a high risk can only be assumed for certain categories of adult person. the following criteria therefore apply to adults only.1. high blood pressure (hypertension) - arterial hypertension with end-organ damage- therapy-resistant arterial hypertension2. cardio-vascular diseases 2.1 general criteria - patients with dyspnoea of functional class nyha ii and nt per bnp > 125 pg/ml- patients with 2 cardio-vascular risk factors (one of which is diabetes or arterial hypertension)- prior stroke and/or symptomatic vasculopathy- chronic renal insufficiency (stage 3, gfr <60ml/min)2.2 other criteria 2.2.1 coronary heart disease - myocardial infarction (stemi and nstemi) in the past 12 months- symptomatic chronic coronary syndrome despite medical treatment (irrespective of any prior revascularisation)2.2.2 disease of the heart valves - moderate or serious stenosis and/or regurgitation in addition to at least one general criterion- any surgical or percutaneous valve replacement in addition to at least one general criterion2.2.3 cardiac insufficiency - patients with dyspnoea of functional class nyha ii-iv or nt-pro bnp > 125pg/ml despite medical treatment for any lvef (hfpef, hfmref, hfref)- cardiomyopathy with any cause- pulmonary arterial hypertension2.2.4 arrhythmia - atrial fibrillation with a cha2ds2-vasc score of at least 2 points- prior implant of pacemaker (incl. icd and/or crt implantation) in addition to one general criterion2.2.5 adults with congenital heart disease - congenital heart disease according to the individual assessment of the attending cardiologist3. chronic lung and respiratory diseases - chronic obstructive lung diseases gold grade ii-iv- pulmonary emphysema- unmanaged asthma, in particular serious bronchial asthma- interstitial lung diseases / pulmonary fibrosis- active lung cancer- pulmonary arterial hypertension- pulmonary vascular disease- active sarcoidosis- cystic fibrosis- chronic lung infections (atypical mycobacteriosis, bronchiectasis, etc.)- ventilated patients- diseases involving a severely reduced lung capacity4. diabetes - diabetes mellitus, with long-term complications or a hba1c of > 8% or more5. diseases/therapies that weaken the immune system - serious immunosuppression (e.g. hiv infection with a cd4+ t-cell count < 200l)- neutropenia 1 week- lymphocytopenia <0.2x109/l- hereditary immunodeficiencies- use of medication that suppresses the immune defences (such as long-term use of glucocorticoids (prednisolone equivalent > 20 mg/day), monoclonal antibodies, cytostatics, biologics, etc.)- aggressive lymphomas (all entities)- acute lymphatic leukaemia- acute myeloid leukaemia- acute promyelocytic leukaemia- t-cell prolymphocytic leukaemia- primary lymphomas of the central nervous system- stem cell transplantation- amyloidosis (light-chain (al) amyloidosis)- chronic lymphatic leukaemia- multiple myeloma- sickle-cell disease- bone marrow transplants- organ transplants- persons on a waiting list for a transplant6. cancer - cancer undergoing medical treatment7. obesity - patients with a body mass index (bmi) of 40 kg/m2 or more8. liver disease - cirrhosis of the liver9. kidney disease - chronic renal insufficiency from gfr < 60 ml/min10. trisomy 21

818.101.25 english is not an official language of the swiss confederation. this translation is provided for information purposes only, has no legal force and may not be relied on in legal proceedings.ordinance on the proximity tracing system for the sars-cov-2 coronavirus(ptso)of 24 june 2020 (status as of 18 march 2021)the swiss federal council, on the basis of article 60a paragraph 7 of the epidemics act of 28 september 20121 (epida),ordains:1 sr 818.101art. 1 subject matter this ordinance regulates the details of the organisation, operation and data processing of the proximity tracing system for the sars-cov-2 coronavirus under article 60a epida (pt system).art. 2 structure 1 the pt system comprises the following components:a.a proximity data management system (the pdm system), consisting of a software application that users install on their smartphones (the swisscovid app), and a back end (pdm back end);b.a system for managing codes for releasing the notifications (the code management system), consisting of a web-based front end and a back end.2 the pdm back end and the code management system are operated as a central server by the federal office of public health (foph).art. 3 voluntary nature 1 installation and use of the swisscovid app are voluntary.2 the express consent of the infected person is required before a notification is sent to app users who have potentially been exposed to the coronavirus.art. 4 federal authority responsible the foph is the federal authority responsible for all components of the pt system under data protection law.art. 5 basic operation procedure 1 during basic operations, the pdm back end makes its content available online to the swisscovid apps. the content comprises a list with the following data:a.the private keys of infected app users which were effective in the period in which other app users were potentially exposed to the coronavirus ("the relevant period");b.the date of each key.2 the swisscovid app carries out the following functions via an interface to the mobile phone's operating system: a.it generates a new private key at least every day that does not permit the swisscovid app, the mobile telephone or the user to be traced.b.it exchanges a variable identification code at least every half-hour with all compatible apps within bluetooth range; the identification code is derived from the current private key but may not be traced back to that key and does not permit the swisscovid app, the mobile telephone or the user to be traced.c.it stores the identification codes received, details of the strength of the signal, the date and the estimated duration of the encounter.d.it periodically retrieves the list of private keys belonging to infected app users from the pdm back end and checks whether any of the identification codes it has stored locally were generated using a private key on the list.e.2if it establishes that any one of the locally stored identification codes was generated using a private key on the list, and if the encounter requirements set out in the annex number i are met, the app issues a notification; the distance of the encounter is estimated based on the strength of the signal received.3 the operating systems' functions used via the interface must meet the requirements of article 60a epida and this ordinance; this does not apply to the rule relating to the source code under article 60a paragraph 5 letter e epida. the foph shall ensure that these requirements are met, in particular by obtaining related assurances.4 .32 amended by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).3 repealed by no i of the o of 18 nov. 2020, with effect from 19 nov. 2020 (as 2020 4733).art. 6 procedure following an infection 1 if a user tests positive for the coronavirus, an authorised agency may with the consent of the infected person request a unique activation code with time-limited validity from the code management system; to do so, the agency sends the code management system the date on which the first symptoms occurred or, if the infected person has not displayed any symptoms, the date of the test.42 the authorised agency gives the activation code to the infected person.5 the infected person may choose to enter the activation code into their swisscovid app.3 the code management back end sends confirmation to the swisscovid app that the code entered is valid. it deducts the number of days specified in annex number 2 from the recorded date.6 the resulting date is the start of the relevant period. the code management back end sends this date to the infected person's swisscovid app.4 the infected person's swisscovid app sends the private keys that were effective in the relevant period to the pdm back end, together with their dates.5 the pdm back end records the received private keys with their dates on its list.6 after the private keys have been sent, the swisscovid app generates a new private key. this key cannot be used to identify earlier private keys.4 amended by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).5 amended by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).6 second sentence amended by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).art. 7 content of the notification 1 the notification contains:a.the information that the app user has potentially been exposed to the coronavirus;b.7a note of the days on which exposure may have occurred;c.the information that the foph operates an infoline that provides advice free of charge;d.recommendations from the foph on what to do.2 the pt system does not issue any instructions to app users.7 amended by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).art. 8 content of the code management system 1 the code management system contains the following data:a.the activation codes;b.the date on which the first symptoms occurred, or, if the infected person has not displayed any symptoms, the date of the test;c.the time when the data in accordance with letters a and b will be destroyed.2 these data cannot be used to identify app users.art. 8a8 form of access to the code management system the code management system may be accessed via:a.a specialist from the authorised agency via the front end; orb.an interface between the code management system and a system operated by the authorised agency.8 inserted by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).art. 9 access to the code management system via the front end9 1 the following persons acting for the authorised agency may request the activation code via the front end:10a.cantonal medical officers;b.the armed forces surgeon general;c.other staff of the cantonal medical services or of the armed forces medical services;d.third parties acting on behalf of the cantonal medical services or the armed forces medical services;e.11staff at medical practices;f.12staff at laboratories with authorisation under article 16 epida;g.13staff at the facilities specified in article 24 paragraph 1 letter b of the covid 19 ordinance 3 of 19 june 202014;h.15staff of the infoline under article 7 paragraph 1 letter c.2 the code management system is accessed via the federal administration's central access and permission system for web applications. the provisions of the ordinance of 19 october 201616 on federal identity management systems and directory services apply.3 the foph assigns and manages access rights to the code management system. it may authorise cantonal medical officers and the armed forces surgeon general or a specific member of their auxiliary personnel to grant access rights to auxiliary personnel.9 amended by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).10 amended by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).11 amended by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).12 inserted by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).13 inserted by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).14 sr 818.101.2415 inserted by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).16 sr 172.010.59art. 9a17 access to the code management system via the interface the foph shall enable the authorised agencies under article 9 paragraph 1 to connect their systems via the interface to the code management system, provided the systems concerned provide an appropriate level of security.17 inserted by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).art. 10 services from third parties 1 the foph may instruct third parties to provide the swisscovid app with online access to the list of data required for notifications.2 it may the assign the task of granting rights of access to the code management system to third parties. the third party concerned must guarantee that the authorisation of specialists is verified reliably and in accordance with the law.3 the third parties must be contractually required to comply with the requirements of article 60a epida and of this ordinance; this does not apply to the regulation relating to the source code under article 60a paragraph 5 letter e epida. the foph shall verify compliance with the requirements.art. 11 records of access 1 articles 57i-57q of the government and administration organisation act of 21 march 199718 and the ordinance of 22 february 201219 on the processing of personal data accumulated through the use of the confederation's electronic infrastructure apply to the storing and the evaluation of the records of access to the pdm back end, the code management system and the list under article 10 paragraph 1.2 apart from these records and records of encounters, the pt system does not maintain any record of the activities of the front end of the code management system and the swisscovid app.18 sr 172.01019 sr 172.010.442art. 12 disclosure for statistical purposes the foph shall regularly provide the swiss federal statistical office (fso) with the latest collection of data in the two back ends in a completely anonymised form for statistical assessment.art. 13 destruction of the data 1 the data in the pdm system shall be destroyed both on the smartphones and in the pdm back end 14 days after they are recorded.2 the data in the code management system shall be destroyed 24 hours after they are recorded.3 the record data of third parties assigned tasks under article 10 paragraph 1 shall be destroyed 7 days after they are recorded.4 in addition, the destruction of record data is governed by article 4 paragraph 1 letter b the ordinance of 22 february 201220 on the processing of personal data accumulated through the use of the confederations electronic infrastructure.5 the data made available to the fso shall also be destroyed in accordance with this article.20 sr 172.010.442art. 14 verification of the source code 1 the foph shall publish the data that allows verification of whether the machine readable programmes of all components of the pt system have been produced using the published source code.2 it shall also verify this itself.art. 15 deactivation of the swisscovid app and reporting 1 when this ordinance ceases to apply, the foph shall deactivate the swisscovid app and instruct users of the swisscovid app to remove the app from their mobile phones.2 the foph shall submit a report to the federal council within six months of this ordinance ceasing to apply.art. 15a21 connection of the pt system to related foreign systems 1 the pt system may only be connected to a foreign system (art. 62a epida) if that system meets the requirements of article 60a paragraph 5 letters a-d epida.2 when connected, the va backend and the foreign system are linked to an interconnection system for the mutual transmission of the private keys of infected app users.3 the connection system is subject to the following rules:a.it is operated by the foph or the responsible foreign body.b.article 60a paragraph 5 letter e epida and article 14 of this ordinance apply to the source code and the technical specifications of the connection system that the foph operates.c.the data processing purposes are governed by article 60a paragraph 2 epida. d.the data in the system may be passed on to the fso and the responsible foreign body in completely anonymised form for statistical purposes. e.the data shall be erased as soon as they are no longer required in order to notify app users, but at the latest 14 days after their transmission to the system.4 if the pt system is connected to a foreign system, the following applies in relation to the pt system's operating procedures in addition to articles 5 and 6:a.during basic operations, the va backend retrieves the private keys of infected users of the foreign system and the date of these keys from the connection system and places them on its list.b.following an infection, the va backend transmits the private keys of the infected persons with the relevant date to the foreign system via the connection system.21 inserted by no i of the o of 12 march 2021, in force since 18 march 2021 (as 2021 144).art. 16 repeal of other legislation the covid-19 ordinance of 13 may 202022 on the proximity tracing pilot trial is repealed.22 [as 2020 1589]art. 16a23 updating the annex the federal department of home affairs (fdha) shall update the annex to this ordinance in accordance with the current state of the art.23 inserted by no i of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).art. 17 commencement and duration this ordinance comes into force on 25 june 2020 at 00.00 and applies until 30 june 2022.annex24 24 amended by no ii of the o of 18 nov. 2020, in force since 19 nov. 2020 (as 2020 4733).(art. 5 para. 2 let. e and 6 para. 3)epidemiological conditions for an encounter and relevant period 1. epidemiological conditions for an encounter the epidemiological conditions for an encounter to have taken place are fulfilled if the following requirements are met:a.there has been physical proximity of 1.5 metres or less to at least one mobile phone that pertains to an infected user.b.the sum of the duration of all encounters in terms of letter a within any single day is equal to or in excess of fifteen minutes.2. start of the relevant epidemiological period number of days to be deducted: two.

818.101.26english is not an official language of the swiss confederation. this translation is provided for information purposes only, has no legal force and may not be relied on in legal proceedings.ordinanceon measures during the special situation to combat the covid-19 epidemic(covid-19 special situation ordinance)of 23 june 2021 (status as of 10 january 2022)the swiss federal council,on the basis of article 6 paragraph 2 letters a and b of the epidemics act of 28 september 20121 (epida),ordains:1 sr 818.101section 1 general provisions art. 1 subject matter and purpose 1 this ordinance introduces measures to combat the covid-19 epidemic that apply to the general public, organisations and institutions, and the cantons.2 the measures serve to prevent the spread of the coronavirus (covid-19) and to break chains of transmission.art. 2 responsibility of the cantons 1 unless this ordinance provides otherwise, the cantons shall retain their responsibilities in accordance with the epida.2 face masks must be worn in upper secondary schools in accordance with article 6. the cantons are responsible for measures relating to compulsory and upper secondary schools.22 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).art. 33 certificates 1 in this ordinance:a. vaccination certificate means a covid-19 vaccination certificate under article 1 letter a number 1 of the covid-19 certificates ordinance of 4 june 20214 or a recognised foreign certificate certifying vaccination under section 7 of the covid-19 certificates ordinance;b. recovery certificate means a covid-19 recovery certificate under article 1 letter a number 2 of the covid-19 certificates ordinance or a recognised foreign certificate certifying recovery under section 7 of the covid-19 certificates ordinance;c. test certificate means a test certificate under article 1 letter a number 3 of the covid-19 certificates ordinance or a recognised foreign certificate certifying recovery under section 7 of the covid-19 certificates ordinance;d. exemption certificate means a covid-19 exemption certificate under article 1 letter a number 4 of the covid-19 certificates ordinance.3 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021, let. d from 10 jan. 2022, to 24 jan. 2022 (as 2021 882).4 sr 818.102.2art. 3a5 access restrictions 1 restrictions on access to businesses, establishments and events for people with specific certificates apply only to person aged 16 or above.2 if access is restricted to persons who hold either a vaccination or recovery certificate and a test certificate, a person does not need a test certificate unless their vaccination or recovery certificate has been valid for more than 120 days. this does not apply to persons with a recovery certificate based on antibody tests in accordance with article 16 paragraph 3 covid-19 certificates ordinance of 4 june 20216.3 persons holding an exemption certificate have the same access to businesses, establishments and events as persons who hold both a vaccination or recovery certificate and a test certificate. the exemption from the requirement to wear a face mask in accordance with article 6 paragraph 2 letter i does not apply to them.4 persons who have a medical certificate confirming that they cannot be vaccinated for a medical reason in accordance with annex 4 shall be treated in the same way as persons with a vaccination or recovery certificate with regard to access to businesses, establishments and events, provided they present a test certificate. the exemption from the mask requirement under article 6 paragraph 2 letter i does not apply to them.5 the medical certificate must be issued by a doctor registered in switzerland who is authorised to practise their profession under their own professional responsibility under the medical professions act of 23 june 20067 and holds a federal postgraduate qualification in the field of medicine that encompasses the reason provided.5 inserted by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate) (as 2021 813). amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021, para. 3 from 10 jan. 2022, to 24 jan. 2022 (as 2021 882).6 sr 818.102.27 sr 811.11section 2 measures involving persons art. 4 principle every person shall follow the recommendations of the federal office of public health (foph) on hygiene and social distancing during the covid-19 epidemic8.8 available at www.bag.admin.ch > diseases > infections diseases: outbreaks, epidemics, pandemics > current outbreaks and epidemics > new coronavirus > protect yourself and others.art. 5 persons travelling on public transport 1 persons travelling on public transport vehicles, such as trains, trams, buses, ships, aircraft and cableways, must wear a face mask in enclosed areas of such vehicles. the following persons are exempt from this requirement:a. children under the age of 12;b. persons who can prove that they are unable to wear face masks for compelling reasons, in particular medical reasons; in order to prove medical reasons, a medical certificate is required from a professional who is authorised to practise their profession under their own professional responsibility in accordance with the medical professions act of 23 june 20069 or the psychology professions act of 18 march 201110.2 public transport vehicles are:a. vehicles operated by companies with a concession under article 6 or a licence under article 7 or 8 of the passenger transport act of 20 march 200911;b. aircraft operated by companies holding an operating licence in accordance with articles 27 or 29 of the civil aviation act of 21 december 194812 that are used for scheduled or charter flights.9 sr 811.1110 sr 935.8111 sr 745.112 sr 748.0art. 6 persons in publicly accessible areas of businesses and establishments 1 a face mask must be worn in publicly accessible indoor areas of businesses and establishments.2 the following persons are exempt from the requirement in paragraph 1:a. children under the age of 12;b. persons who can prove that they are unable to wear a face mask for compelling reasons, in particular medical reasons; proof of medical reasons must be provided in accordance with article 5 paragraph 1 letter b;c. persons in institutions that provide childcare outside the family or in educational institutions, in the event that wearing a face mask significantly impedes the provision of care or the ability to teach;d. persons undergoing a medical or cosmetic procedure to the face;e. performers, in particular speakers;f.13 persons in the sport and culture sectors who are exempted under a provision of this ordinance from the requirement to wear a mask;g.14 persons in restaurants, bars and clubs: if they sit at a table;h.15 persons in the public area at events: when consuming food or drink while seated;i.16 persons in in publicly accessible businesses and establishments or at events to which access is restricted to persons who have both a vaccination or recovery certificate and a test certificate.3 and 4 .175 socio-medical institutions may in consultation with the responsible cantonal authority provide in their precautionary measures plans that the following persons are exempted from the requirement under paragraph 1 in their publicly accessible areas:a. residents who have been vaccinated against covid-19: for the period specified in annex 2; b. residents who were infected with sars-cov-2 and have recovered: for the period specified in annex 2.6 the persons who are regarded as vaccinated in terms of paragraph 5 letter a are defined in annex 2.13 amended by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate), in force from 13 sept. 2021 to 24 jan. 2022 (as 2021 542).14 inserted by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate) (as 2021 542). amended by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), in force from 6 dec. 2021 until 24 jan. 2022 (as 2021 813).15 inserted by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), in force from 6 dec. 2021 until 24 jan. 2022 (as 2021 813).16 inserted by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate) (as 2021 813). amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).17 repealed by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate), with effect from 13 sept. 2021 to 24 jan. 2022 (as 2021 542).section 3 measures relating to contact quarantine and isolation art. 7 ordering contact quarantine 1 the responsible cantonal authority shall place into quarantine persons who within the periods specified below have had close contact with the following infected persons:a. a person whose infection with sars-cov-2 has been confirmed or is probable and who is displaying symptoms, where contact takes place in the period from 48 hours before the symptoms began until 10 days thereafter;b. a person whose infection with sars-cov-2 has been confirmed but who is asymptomatic, where contact takes place in the period from 48 hours before the person was tested until the person goes into isolation.2 the following persons are exempt from contact quarantine:a. persons who prove that they have been vaccinated against covid-19: for the period specified in annex 2;b. persons who prove that they were infected with sars-cov-2 and have recovered: for the period specified in annex 2; c. persons who carry out an activity that is of high importance to society and for which there is an acute shortage of staff; while working and when travelling to work.3 the persons who are regarded as vaccinated in terms of paragraph 3 letter a are defined in annex 2.4 persons working for businesses that have a testing plan that meets the following requirements are exempted from contact quarantine while working and when travelling to work:the plan allows employees simple access to tests and provides that employees are regularly informed of the advantages of the tests.employees are able to take a test at least once a week.c. the requirements are met for the confederation to pay the cost of the tests in accordance with annex 6 sections 3.1 and 3.2 the covid-19 ordinance 3 of 19 june 202018.5 the persons specified in paragraph 4 must remain in contact quarantine when not at work or travelling to work.6 in respect of specific persons or categories of persons, the responsible cantonal authority may:a. in justified cases authorise additional exemptions from or relaxations of the regulations on contact quarantine for specific persons;b. in cases other than those under paragraph 1 or even if the requirements under paragraphs 2 and 3 are met, place a person in contact quarantine if this is necessary in order to prevent the spread of covid-19.7 it shall notify the foph of measures taken in respect of specific categories of persons under paragraph 6.18 sr 818.101.24art. 8 duration and early termination of contact quarantine 1 contact quarantine shall last for 10 days from the time of last close contact with the person under article 7 paragraph 1.2 persons in contact quarantine may leave quarantine early if the following requirements are met:a. the person provides the responsible cantonal authority with proof of a negative result for one of the following tests on or after the seventh day of quarantine:1. a molecular-biological test for sars-cov-2,2.19 a sars-cov-2-rapid test for specialist use,3.20 a laboratory immunological analysis for sars-cov-2 antigens;b. the responsible cantonal authority agrees to the early termination of quarantine.3 persons over the age of 12 who leave quarantine early pursuant to paragraph 4 must wear a face mask and maintain a distance of at least 1.5 metres from other persons when outside their home or accommodation until the point in time at which quarantine would have ended.19 amended by annex no 1 of the o of 17 dec. 2021, in force since 18 dec. 2021 (as 2021 881).20 inserted by annex no 1 of the o of 17 dec. 2021, in force since 18 dec. 2021 (as 2021 881).art. 9 isolation 1 the responsible cantonal authority shall order persons who are suffering from covid-19 or who have been infected with sars-cov-2 to isolate for 10 days.2 if a person displays particularly serious symptoms or if he or she suffers from severe immunosuppression, the responsible cantonal authority may order a longer period in isolation.3 the period in isolation begins:a. on the day that symptoms begin;b. if the person suffering from covid-19 or infected with sars-cov-2 is asymptomatic: on the day the test is carried out.4 the responsible cantonal authority shall terminate isolation after 10 days at the earliest, provided the person in isolation:a. has been symptom-free for at least 48 hours; orb. continues to display symptoms but these are such that the continuation of isolation is no longer justified.section 4 measures relating to publicly accessible establishments, businesses and events art. 10 precautionary measures plan 1 operators of publicly accessible businesses and establishments, including education and training institutions, and organisers of events must draw up and implement a precautionary measures plan. 2 the precautionary measures plan must provide for the following:a. measures relating to hygiene and ventilation;b. measures relating to compliance with the requirement to wear a mask under article 6;c. the recording of the contact data of persons present in accordance with article 11 where required by this ordinance. d. measures relating to persons who are not required to wear a mask in accordance with article 6 paragraph 2;e.21 measures relating to maintaining the required distance, unless access is restricted to persons with a vaccination, recovery or test certificate or is more strictly restricted.223 if entry is restricted to persons with a vaccination, recovery or test certificate, the precautionary measures plan must also include the following measures:23a. measures on implementing the entry restrictions;b.24 measures relating to persons with a covid-19 exemption certificate under article 21a of the covid-19 certificates ordinance of 4 june 202125;c.26 measures concerning persons with a certificate under article 3a paragraph 4 confirming that they cannot be vaccinated for medical reasons.274 the requirements of paragraphs 2 and 3 are specified in more detail in annex 1.5 a person must be designated in the precautionary measures plan as responsible for implementing the plan and as the contact for the competent authorities.21 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).22 amended by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), in force from 6 dec. 2021 until 24 jan. 2022 (as 2021 813).23 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882). 24 in force since 10 jan. 2022 (as 2021 813 no vi para. 2).25 sr 818.102.226 inserted by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).27 amended by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), in force from 6 dec. 2021 until 24 jan. 2022 (as 2021 813).art. 11 recording contact data 1 if contact data are recorded in accordance with annex 1 number 1.4, the persons concerned must be informed about the recording and its purpose. if the contact data are already known, the persons concerned must be informed that the data will be used and of the purpose for which they are used.2 the contact data must on request be passed on in electronic form without delay to the responsible cantonal authority or organisation in accordance with article 33 epida for the purpose of identifying and notifying persons who may have been infected. 3 the data recorded may not be used for any purposes other than those provided for in this ordinance, must be retained for 14 days after the persons concerned participated in the event or visited the establishment or business, and must be destroyed immediately thereafter.art. 12 special provisions for restaurants, bars and clubs 1 in restaurants, bars and clubs in which food and drinks are consumed on the premises, the following applies:a. proprietors must restrict access to indoor areas to persons with a vaccination or recovery certificate. proprietors must ensure that the premises are effectively ventilated. guests must be seated, unless access for persons is restricted to persons with either a vaccination or recovery certificate and a test certificate.b. proprietors may restrict access to outdoor areas to persons with a vaccination, recovery or test certificate. if access to outdoor areas is not restricted, either the required distance must be maintained between each group of guests or effective partitioning must be in place.c. if the outdoor area of a restaurant, bar or club is at an event venue with access restriction, this access restriction also applies to the outdoor area of the restaurant, bar or club.282 .29 3 workplace canteens, restaurants and food outlets in airport transit zones and social institutions, in particular those open to the public, may choose not to restrict entry provided appropriate precautionary measures are in place, such as requiring guests or groups of guests to maintain the required distance from each other and to remain seated while consuming food and drinks.304 .31 28 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).29 repealed by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate), with effect from 13 sept. 2021 to 24 jan. 2022 (as 2021 542).30 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).31 repealed by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), with effect from 6 dec. 2021 until 24 jan. 2022 (as 2021 813). art. 1332 special provisions for discotheques and dance venues and other businesses and establishments in the culture, entertainment, leisure and sport sectors 1 discotheques and dance venues must restrict entry to persons with a test or recovery certificate and a test certificate. they must also record guests' contact details.2 publicly accessible businesses and establishments in the culture, entertainment, leisure and sport sectors in which visitors do not only have access to outdoor areas must restrict entry for persons aged 16 and over to those with a certificate.32 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).art. 1433 outdoor events 1 access to outdoor events for persons aged 16 or over must be restricted to persons with a vaccination, recovery or test certificate. the organisers may restrict access to persons with a vaccination or recovery certificate or by other means.342 a restriction on access is not required if the following requirements are met:a. the maximum number of persons, whether visitors or participants, is 300;b. the visitors do not dance.3 in the case of events involving family and friends (private events) with a maximum of 50 persons that take place outdoors but not in publicly accessible businesses and establishments, a restriction on access is not required and there is no requirement to draw up and implement a precautionary measures plan; only article 4 applies.33 amended by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), in force from 6 dec. 2021 until 24 jan. 2022 (as 2021 813).34 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882). art. 14a35 35 inserted by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate), (as 2021 542). repealed by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), with effect from 6 dec. 2021 (as 2021 813).art. 1536 indoor events 1 access to indoor events must be restricted to persons with a vaccination or recovery certificate. the organisers may restrict access to persons with both a vaccination or recovery certificate and a test certificate.37 2 in the case of religious events, funerals, events relating to the usual activities and services of authorities, events relating to the formation of political opinion and meetings of established self-help groups for addiction and mental health issues that are held indoors, a restriction on access is not required if the following requirements are met:a. the maximum number of persons, whether visitors or participants, is 50.b. the requirement to wear a face mask in accordance with article 6 is observed; in addition, the required distance must be maintained where possible.c. no food or drinks may be consumed.d. the organiser must draw up a precautionary measures plan in accordance with article 10 and implement the same.e. the organiser must record the contact data of the persons present.3 in the case of private events with a maximum of 30 persons that are not held in indoor areas of publicly accessible establishments or businesses, it is not necessary to draw up and implement a precautionary measures plan. if no more than 10 persons are present, nor is it necessary to restrict access; in this case, article 4 only applies.3836 amended by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), in force from 6 dec. 2021 until 24 jan. 2022 (as 2021 813).37 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882). 38 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).art. 16 special provisions for large-scale events39 1 any person planning to hold an event involving more than 1000 persons, whether visitors or participants, (large-scale events), shall require authorisation from the competent cantonal authority.2 authorisation shall be granted provided:a. it can be assumed that the epidemiological situation in the canton or region concerned permits the event to be held;b. it can be assumed that at the time the event is held the canton has the required capacities in the following areas:1. capacities to identify and notify persons who may have been infected as required under article 33 epida,2. capacities in the healthcare sector to treat both covid-19-patients and other patients without restriction; this includes in particular the capacity to carry out non-urgent medical procedures;c.40 the organiser submits a precautionary measures plan under article 10.3 if a large-scale event is being held in two or more cantons, authorisation is required from each canton. the cantons shall coordinate the procedure together.4 any person who wishes to hold similar events regularly in the same establishment may request authorisation to do so in a single application.4bis the competent cantonal authority may grant exemptions from the obligation to restrict access in the case of outdoor sporting events that take place over long distances or over areas in open terrain and where neither access controls nor barriers are possible due to local conditions.415 the canton shall revoke authorisation or shall issue additional restrictions if:a. the epidemiological situation has deteriorated to the extent that holding the event is no longer possible, in particular because the required capacities under paragraph 2 letter b can no longer be guaranteed; orb. an organiser did not comply with the measures set out in the precautionary measures plan at an event that has already been held and cannot guarantee that the measures will be complied with in future.39 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).40 amended by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), in force from 6 dec. 2021 until 24 jan. 2022 (as 2021 813).41 inserted by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).art. 1742 42 repealed by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).art. 1843 special provisions for trade and consumer fairs the following applies to trade and consumer fairs: a.44 if the fair does not take place exclusively outdoors, access must be restricted to persons with a vaccination or recovery certificate; the organisers may also restrict access to persons who have either a vaccination or recovery certificate and a test certificate.b. the organiser must draw up and implement a precautionary measures plan in accordance with article 10. c. if more than 1000 persons are present on any day, whether they are visitors or participants, the fair must be authorised by the competent cantonal authority; the authorisation requirements and the requirements for revoking authorisation in article 16 paragraphs 2, 4 and 5 apply.43 amended by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate), (as 2021 542).44 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).art. 19 special provisions for meetings of political bodies, political and civil society demonstrations and collecting signatures 1 restrictions on numbers do not apply to the following events:a. meetings of the legislatures at federal, cantonal and communal level;b. meetings of public-sector bodies that cannot be postponed;c. meetings required to ensure the proper functioning of institutional beneficiaries under article 2 paragraph 1 of the host state act of 22 june 200745;d.46 hearings before arbitration or judicial authorities.2 articles 10 and 11 do not apply to political and civil society demonstrations and to collecting signatures.3 articles 14-17 do not apply to events in accordance with paragraphs 1 and 2.45 sr 192.1246 inserted by no 1 of the o of 17 dec. 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).art. 19a47 special provisions for tertiary-level education, professional education and training and continued education and training in the case of the following education and training and continued education and training programmes and activities, access must be restricted to persons with a vaccination, recovery or test certificate: a. teaching and research activities in a bachelor or master degree course or a phd programme and examinations at tertiary education institutions;b. teaching activities for federally recognised courses and post-graduate studies at professional education institutions and examinations at professional education institutions;c. federal professional examinations and advanced federal professional examinations;d. examinations as part of continuing education and training programmes in accordance with article 3 letter a of the federal act of 20 june 201448 on continuing education and training (ceta); e. officially ordered continuing education and training; f. preparatory courses for federal examinations; g. programmes for acquiring basic skills in accordance with article 13 ceta;h. programmes for fulfilling integration criteria in accordance with article 58a of the foreign nationals and integration act of 16 december 200549.47 inserted by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate), (as 2021 542). amended by no i of the o of 17 dec. 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).48 sr 419.149 sr 142.20art. 2050 special provisions for sports or cultural activities 1 the following applies to sports and cultural activities outdoors:a. there is no requirement to restrict access. b. there is no requirement to wear a face mask. c. there is no requirement to maintain the required distance.2 the following applies to sports and cultural activities involving two or more persons in publicly accessible indoor areas of businesses and establishments: a. access must be restricted to persons with a vaccination or recovery certificate; it may also be restricted to persons that have both a vaccination or recovery certificate and a test certificate.b. the requirement to wear a face mask is governed by article 6.c. the premises must be adequately ventilated.3 the following persons shall have access with a vaccination, recovery or test certificate to sports or cultural activities in publicly accessible indoor areas of businesses and establishments but are not required to wear a face mask there:a. in the case of sports activities, including sports events:1. elite athletes who hold a national or regional swiss olympic card or members of the national squad of a national sports association,2. athletes in teams competing in a professional or semi-professional league or a national junior league; if play is only professional or semi-professional in the male or female league, the exemption from the mask requirement also applies to the league of the other sex;b. in the case of cultural activities, including events:1. professional artists,2. professional artists in training.4 children and young adults under the age of 16 are not required to wear a face mask for sports or cultural activities in publicly accessible indoor areas of businesses and establishments.5 where a sports or cultural activity is carried out as part of an event at which stricter access restriction apply than for the activity, the access restrictions for the event also apply to the persons carrying out the activity. the foregoing does not apply to the persons specified in paragraph 3. 6 for sports and cultural activities, a precautionary measures plan must be drawn up and implemented only if the activities are carried out in groups of more than five persons; in the case of persons who carry out activities in terms of their employment, the requirements in article 25 apply.50 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).art. 2151 special provisions for child and youth work in the case of the activities of organisations and institutions involved in public child and youth work involving persons under the age of 16, only the requirement to draw up and implement a precautionary measures plan in accordance with article 10 applies. the precautionary measures plan shall indicate the permitted activities.51 amended by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate), in force from 13 sept. 2021 to 24 jan. 2022 (as 2021 542).art. 22 relaxation of requirements by the cantons the responsible cantonal authority may authorise a relaxation of the requirements under article 10 paragraphs 2-4 provided:52overriding public interests so require; b. the epidemiological situation in the canton or the region concerned permits this; andc. the organiser or operator submits a precautionary measures plan under article 10 that includes specific measures to prevent the spread of the coronavirus and to break transmission chains.52 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).art. 23 additional measures by the cantons 1 the canton shall take additional measures under article 40 epida if:a. the epidemiological situation in the canton or in a region so requires; it shall assess the situation in particular based on recognised indicators and their trends;b. as a result of the epidemiological situation, it is no longer able to provide the capacities required to identify and notify persons who may have been infected as stipulated in article 33 epida.2 it shall in particular guarantee freedom of religion and conscience and that political rights may be exercised.art. 24 inspections and obligations to cooperate 1 the operator and organisers must:a. submit their precautionary measures plan to the responsible cantonal authorities if requested to do so; b. allow the responsible cantonal authorities access to the establishments, businesses or events.2 the responsible cantonal authorities shall conduct regularly checks on compliance with the precautionary measures plans, in particular in restaurant-type establishments.3 if they establish that no adequate precautionary measures plan has been drawn up or that a plan has not been implemented or only in part, they shall take appropriate measures immediately. they may issue reminders, close down establishments or businesses or prohibit or break up events.section 5 measures to protect workers art. 2553 preventive measures 1 employers must guarantee that their employees are able to comply with the foph recommendations on hygiene and social distancing. to do so, they must plan and implement the related measures.2 in indoor areas, including vehicles, in which two or more persons are present, each person must wear a face mask. the requirement does not apply to persons who:a. engage in activities during which a mask cannot be worn on safety grounds or because of the nature of the activity; orb. are not required to wear a face mask in accordance with article 6 paragraph 2 letters b, c, e and f.3 employers shall arrange for further measures in accordance with the stop principle (substitution, technical measures, organisational measures, personal protective equipment), in particular the option of physical separation, separate teams, regular ventilation of rooms or wearing face masks outdoors.4 they are entitled under the following conditions to verify that their employees hold a vaccination, recovery or test certificate: a. verification is to ensure appropriate precautionary measures or implementation of a testing plan pursuant to article 7 paragraph 4.b. the result of such a verification may not be used for any other purpose.c. verification and any resulting measures are recorded in writing.d. the employees or their representatives are consulted in advance.5 employers are required to ensure that their employees are able to work from home where the nature of the activity permits and provided this can be reasonably expected. they shall implement the required organisational and technical measures. 6 for the protection of particularly vulnerable employees, article 27a of covid-19 ordinance 3 of 19 june 202054 also applies.53 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).54 sr 818.101.24art. 26 implementation, inspections and obligations to cooperate 1 pursuant to the health protection provisions in article 6 of the employment act of 13 march 196455, the authorities implementing the employment act and the federal act of 20 march 198156 on accident insurance are responsible for implementing article 25.2 the competent implementing authorities may conduct inspections of businesses and locations at any time without prior notice.3 employers must allow the competent implementing authorities access to their premises and locations.4 the instructions given by the competent implementing authorities during their on-site inspections must be implemented immediately.55 sr 822.1156 sr 832.20section 6 reporting obligation of the cantons relating to capacities in the provision of healthcare art. 27 the cantons are required to report the following to the coordinated medical services regularly:a. the total number and occupancy of hospital beds;b. the total number and occupancy of hospital beds that are intended for the treatment of covid-19 cases, and the number of patients currently being treated for covid-19;c. the total number and occupancy of hospital beds in intensive care and the number of patients with covid-19 currently being treated and ventilated in intensive care;d. the total number and occupancy of devices for extracorporeal membrane oxygenation (ecmo);e. the details of availability of medical and nursing staff in hospitals;f. the maximum numbers, i.e. the total number of patients and total number of covid-19 patients, that can be treated by their hospitals, taking account of the available beds and the available staff.section 7 criminal provisions art. 28 any person who commits any of the following acts shall be liable to a fine:a.57 as an operator or organiser, wilfully or negligently failing to comply with any of the following provisions: article 10 paragraphs 1-3, articles 12, 13, 14 paragraphs 1 and 2, 15, 18 letters a and b, 19a and 20 paragraphs 2, 3 and 5;b. as an operator or organiser, wilfully or negligently processing contact data recorded pursuant to article 11 for other purposes in contravention of article 11 paragraph 3 or retaining such details for longer than 14 days after the person or persons concerned participated in the event or visited the establishment or business;c.58 wilfully holding an event involving more persons than are permitted under articles 14 paragraphs 2 and 3; and 15 paragraphs 2 and 3 with the applicable access restrictions;d.59 wilfully holding a large-scale event under article 16 paragraph 1 or a trade or consumer fair under article 18 letter c without the required authorisation or in derogation from the approved precautionary measures plan;e.60 wilfully or negligently failing to wear a face mask in contravention of articles 5 paragraph 1, 6 paragraph 1 or 15 paragraph 2 letter b in enclosed areas of public transport vehicles or in publicly accessible indoor and outdoor areas of businesses and establishments, unless an exception pursuant to article 5 paragraph 1 or 6 paragraph 2 applies;f. 61 .g.62 as a guest in a restaurant, wilfully contravening the requirement to be seated in article 12 paragraph 1 letter a;h.63 wilfully obtaining access without the required certificate to an establishment, business or event for which such a certificate is required.57 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).58 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).59 amended by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate), in force from 13 sept. 2021 to 24 jan. 2022 (as 2021 542).60 amended by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), in force from 6 dec. 2021 until 24 jan. 2022 (as 2021 813).61 repealed by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate), with effect from 13 sept. 2021 to 24 jan. 2022 (as 2021 542).62 inserted by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate) (as 2021 542). amended by no i of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), in force from 6 dec. 2021 until 24 jan. 2022 (as 2021 813).63 inserted by no i of the o of 8 sept. 2021 (extension of use of covid-19 certificate) (as 2021 542). amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).section 8 updating the annexes art. 29 1 the federal department of home affairs shall update annexes 1, 2 and 4 in accordance with the latest scientific knowledge.642 it shall update annex 1 in consultation with the federal department of economic affairs, education and research and annex 2 in consultation with the federal commission for vaccination.64 amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).section 9 final provisions art. 30 repeal of another ordinance the covid-19 special situation ordinance of 19 june 202065 is repealed.65 [as 2020 2213, 2735, 3547, 3679, 4159, 4503, 5189; 2021 52, 60, 110, 145, 213, 222, 275, 297, 300, 308]art. 31 amendment of other legislation the amendment of other legislation is regulated in annex 3.art. 32 transitional provision authorisations for pilot projects that have been granted on the basis of article 6bquater of the covid-19 special situation ordinance of 19 june 202066 remain valid until 30 june 2021.66 as 2021 297art. 32a67 transitional provision to the amendment of 17 december 202 1 until 24 january 2022, persons who can provide a certificate confirming that they can neither be vaccinated nor tested on medical grounds may have the same access to businesses, establishments and events as persons who have a vaccination, recovery or test certificate. the exception to the requirement to wear a mask under article 6 paragraph 2 letter i does not apply to them. 2 the certificate must be issued by a doctor registered in switzerland who is authorised to practise their profession under their own professional responsibility in accordance with the medical professions act of 23 june 200668.67 inserted by annex no 2 of the o of 3 nov. 2021 (as 2021 653). amended by no i of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).68 sr 811.11art. 33 commencement and duration this ordinance comes into force on 26 june 2021 at 00.00.annex 169 69 revised by no ii of the o of 8 sept. 2021 (extension of use of covid-19 certificate) (as 2021 542), of 1 oct. 2021 (proof for persons who can neither be vaccinated nor tested on medical grounds) (as 2021 590), annex no 2 of the o of 3 nov. 2021 (as 2021 653), no ii of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate) until 24 jan. 2022 (as 2021 813) and no ii para. 1 of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).(arts 10 para. 4, 11 para. 1 and 29)requirements for precautionary measures plans 1 precautionary measures plans for publicly accessible businesses and establishments and for events to which entry for persons aged 16 and over is not restricted to those with a certificate 1.1 general remarks 1.1.1 principlethere is an increased risk of infection if persons are unable to keep a distance of 1.5 metres from each other for more than 15 minutes.1.1.2 protection against infection with covid-19 1 the operator or organiser shall ensure when choosing the measures under article 10 paragraph 2 that guests, persons in attendance and participants are provided with effective protection against infection with covid-19. 2 where employees are at work in publicly accessible businesses and establishments and at events, the precautionary measures plan must reconcile the measures for guests, persons in attendance or participants with the measures to protect the employees under article 25. 3 in order to achieve effective protection in accordance with paragraphs 1 and 2, the operator or organiser shall if necessary take different measures for individual areas of the establishment business or event, for example for seating or catering areas, or for individual groups of persons, for example, by forming permanent teams.1.1.3 reason for recording contact dataif provision must be made in the precautionary measures plan in accordance with article 10 paragraph 2 letter d for recording contact data, the reasons for doing so must be stated in the plan.1.1.4 informing the persons present the operator or organiser shall inform the persons present (guests, participants, persons in attendance) about the measures that apply in the establishment, business or at the event, such as any requirement to wear a face mask, the recording of contact data.1.2 hygiene 1.2.1 all persons must be able to wash their hands regularly. hand sanitiser and, in the case of publicly accessible washbasins, soap must be made available.1.2.2 all contact surfaces must be regularly cleaned.1.2.3 a sufficient number of waste bins must be provided, in particular for disposing of paper handkerchiefs and face masks.1.3 social distancing 1.3.1 persons must keep a minimum of 1.5 metres distance from each other (the required distance).1.3.2 in derogation from number 1.3.1, the seating area seats must be arranged or occupied so that where possible and one seat remains free or an equivalent distance is maintained between the seats.1.3.3 .1.3.4 the movement of persons should be controlled so that the required distance can be maintained between all persons.1.3.5 the requirements on distancing do not apply to groups of persons for whom compliance with social distancing is not expedient, in particular in the case of schoolchildren, families or persons who live in the same household.1.4 recording of contact data 1.4.1 .1.4.2 if contact data are recorded, the operator or organiser must inform the participants of the following:a. that it is likely that the required distance cannot be maintained and that there is therefore an increased risk of infection;b. that participants may be contacted by the competent authority or organisation in the canton, and that this authority or organisation has the power to order quarantine for persons who have been in contact with a person who has covid-19.1.4.3 contact details may in particular be recorded via booking or membership systems or by using a contact form.1.4.4 the following details must be recorded:a. surname and first name;b. address;c. telephone number.1.4.5 the operator or organiser must take appropriate measures to ensure that the contact data recorded are accurate.1.4.6 in the case of families or other groups with persons who know each other, it is sufficient to record the contact data of only one person in the family or group concerned.1.4.7 the operator or organiser must guarantee the confidentiality of the contact data when recording the same, and data security, in particular in storing the data. 2 precautionary measures plans for publicly accessible businesses and establishments and events to which entry is restricted to persons with a vaccination, recovery or test certificate or more strictly the precautionary measures plan shall include measures related to:a. the orderly and uninterrupted conduct of entry checks, including the training of staff and the electronic verification of certificates with the verification app pursuant to article 29 of the covid-19 ordinance on certificates of 4 june 202170 or a different app that can verify certificates with data minimisation pursuant to article 28 of the covid-19 ordinance on certificates and that complies with the principles set out in article 29 paragraph 2 letters a and b of the covid-19 ordinance on certificates;abis. checking the identity of persons during entry checks pursuant to letter a; suitable photo id must be shown; ater. recording personal data during entry checks pursuant to letter a; the following shall apply: 1. the operator or organiser must inform the persons affected in advance that their data will be processed.2. the data may not be used for any other purpose.3. the data may only be retained if this is required for the purposes of the entry check; it must be destroyed no later than 12 hours after the end of the event.b. the provision of information to visitors and participants on the requirement to have a certificate and on the applicable hygiene and social distancing measures;c. hygiene, in particular the provision of disinfectant, regular cleaning, and ventilation;d. a requirement to wear a face mask for staff and other persons working at the event who come into contact with visitors on the premises.e. the presence of persons holding documentary proof in accordance with article 3a paragraph 4 or 32a paragraph 1, such as the requirement for these persons to wear a face mask or, if they are able to provide a certificate exempting them from this requirement under article 5 paragraph 1 letter b, specifications on maintaining the required distance.70 sr 818.102.2annex 271 71 revised by annex no 4 of the o of 17 sept. 2021 (as 2021 563), annex no 2 of the o of 3 nov. 2021 (as 2021 653), no ii of the fdha o of 29 nov. 2021 (as 2021 785) and annex no 1 of the o of 17 dec. 2021, in force since 18 dec. 2021 (as 2021 881).(art. 6 para. 5 and 6, 7 para. 2 and 3 and 29)requirements for an exemption from the requirement to wear a mask and from contact quarantine for persons who have been vaccinated or who have recovered 1 persons who have been vaccinated 1.1 persons who have been vaccinated in terms of this ordinance are persons, who have been vaccinated with a vaccine that: a. is authorised in switzerland and which has been administered in full in accordance with the foph recommendations; b. has been authorised by the european medicines agency for the european union and has been administered in full in accordance with the requirements or recommendations of the country in which the vaccination was administered;c. has been authorised under the who emergency use listing and has been administered in full in accordance with the requirements or recommendations of the country in which the vaccination was administered;d. has been shown to have the same composition as a vaccine licensed under letters a, b or c, but marketed by the licence holder under another name, and which has been administered in full in accordance with the requirements or recommendations of the country in which the vaccination was carried out.1.2 the period during which vaccinated residents of socio-medical institutions are exempt from the requirement to wear a mask (art. 6 para. 5) and persons who have been vaccinated are exempt from contact quarantine (art. 7 para. 2 let. a) shall amount to 365 days from the date of vaccination in full; the janssen ad26.cov2.s / covid-19 vaccine is regarded as being effective for 365 days from the 22nd day after it was administered in full.2 persons who have recovered residents of socio-medical institutions who have recovered are exempt from the requirement to wear a mask (art. 6 para. 5 let. b) and persons who have recovered are exempt from contact quarantine (art. 7 para. 2 let. b) for the following periods: a. when based on a molecular-biological analysis for sars-cov-2 or a sars-cov-2-rapid test for specialist use or a laboratory immunological analysis for sars-cov-2 antigens: from the 11th to the 365th day after confirmation of infection;b. when based on an analysis for sars-cov-2 antibodies in accordance with article 16 paragraph 3 of the covid-19 ordinance on certificates of 4 june 202172: for the term of validity of the certificate concerned.72 sr 818.102.2annex 3 (art. 31)amendment of other legislation the legislation below is amended as follows:.7373 the amendments may be consulted under as 2021 379.annex 474 74 inserted by no ii para. 2 of the o of 17 dec 2021 (mask requirement at upper-secondary level, restrictions on access to persons with a vaccination or recovery certificate, restrictions on private events. requirement to work from home, requirements at tertiary level and in cet), in force from 20 dec. 2021 to 24 jan. 2022 (as 2021 882).(art. 3a para. 4)medical reasons why a person may not be able to receive a vaccine medical reasons why a person may not be able to receive a vaccine are as follows:a. severe allergies to components of vaccines authorised in switzerland confirmed by a specialist in allergology and immunology, namely the following absolute or relative contraindications of an allergic nature before or after vaccination where there is no option or recommendation to administer a different vaccine of the same or a different technology:1. severe anaphylaxis (grade iii or iv) with unclear or as yet undetermined cause,2. idiopathic anaphylaxis,3. a general reaction or anaphylaxis to ingredients of the vaccine,4. known or probable immediate-type sensitisation to polyethylene glycol, tromethamine or polysorbate 80, 5. anaphylaxis following the first dose of the vaccine;b. severe non-allergic vaccination reactions after the first or second dose of an mrna vaccine, namely myocarditis or pericarditis, with no option or recommendation to perform the second vaccination or booster with a vaccine of the same or a different technology;c. capillary leak syndrome with no option or recommendation to be vaccinated with a vaccine other than the janssen covid-19 vaccine;d. pregnancy for the first 12 weeks of pregnancy and the time needed to establish the vaccination schedule;e. severe mental impairment that generally makes vaccination impossible despite psychological or medical support and individual care.

818.101.27english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinance on measures to combat the covid-19 epidemic in international travel(covid-19 ordinance on international travel)1of 23 june 2021 (status as of 20 december 2021)1 ru 2021 380 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).the swiss federal council,on the basis of articles 41 paragraphs 1 and 3 and 79 paragraph 1 of the epidemics act of 28 september 20122 (epida),3ordains:2 sr 818.1013 amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).section 1 purpose and subject matter art. 14 1 this ordinance aims to prevent the cross-border spread of the sars-cov-2 coronavirus.2 it regulates the following for persons entering switzerland:a. the recording of contact data and any other health data required;b. the test requirement.3 it also regulates for persons who enter switzerland from a country or region with a variant of the virus of concern, quarantine and its enforcement.4 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).section 2 countries and regions with a variant of the virus of concern art. 2 1 categorisation as a country or region with a variant of the virus of concern requires proof or the presumption that in this country or region a variant of the virus is widespread:a. that carries a higher risk of infection or causes a more severe form of the disease than the variants of the virus that are present in switzerland; orb. that escapes detection and for which there is no defence through pre-existing immunity to the variants of the virus present in switzerland (immune evasive).52 the list of countries and regions with a variant of the virus of concern that is immune evasive or the immune evasive status of which is unclear is provided in annex 1 number 1.3 the list of countries and regions with a variant of the virus of concern that is not immune evasive is provided in annex 1 number 2.4 regions on the border with switzerland which have close economic, social and cultural ties with switzerland may be exempted from inclusion in the lists mentioned in paragraphs 2 and 3 even if they meet the requirements set out in paragraph 1. the regions deemed to be border regions are listed in annex 1a.65 amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).6 amended by no i of the o of 1 oct. 2021, in force since 4 oct. 2021 (as 2021 591).section 3 recording contact data art. 3 persons subject to the requirement 1 the requirement to record contact data pursuant to article 49 of the epidemics ordinance of 29 april 20157 and where necessary to record health data applies to all persons entering the country.8 2 an exemption to the requirement under paragraph 1 applies to persons who:9a. carry goods or passengers across the border in terms of their professional activities;b. travel through switzerland without a stopover;c.10 enter the country as a cross-border commuter; ord.11 enter the country from a region listed in annex 1a.3 the exemptions under paragraph 2 letters c and d do not apply to persons entering switzerland with an airline or coach company that offers long-distance travel.127 sr 818.101.18 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).9 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).10 inserted by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).11 inserted by no i of the o of 17 sept. 2021 (as 2021 563). amended by no i of the o of 1 oct. 2021, in force since 4 oct. 2021 (as 2021 591).12 inserted by no i of the o of 17 dec. 2021, in force since 20 dec. 2021 (as 2021 883).art. 4 obligations of persons subject to the requirement 1 the persons specified in article 3 must record their contact data before entry as follows:a. online by means of the platform for recording contact data for travellers13 provided by the federal office of public health (foph); or b.14 on the paper passenger locator forms provided by the foph, in duplicate.2 persons who enter switzerland but not as a passenger with a travel operator pursuant to article 5 and who record their contact details on a passenger locator form must retain the form for 14 days.1513 the platform for recording contact data for travellers can be accessed at https://swissplf.admin.ch14 amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).15 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).art. 5 obligations for travel operators 1 rail, coach, ship or airline operators carrying passengers specified in article 3 internationally shall ensure that passengers provide their contact data in accordance with article 4 paragraph 1. 2 they shall send the contact data under article 4 paragraph 1 letter b to the foph on request within 24 hours. 3 they shall retain the contact data for 14 days and thereafter destroy the data.4 they shall send the foph on request within 48 hours lists of all cross-border train, coach or ship journeys or flights that they have scheduled for the following month. 5 they shall send the contact data under article 4 paragraph 1 letter b and the lists under paragraph 4 via the platform for travel operators16 provided by the foph.16 the platform for passenger transport operators can be accessed at https://swissplf.admin.chart. 6 duties of the foph and the cantons 1 the foph shall ensure that the contact data is available in order to enforce the provisions on the test requirement under article 8 and the quarantine requirement under article 9. it shall also ensure that the data is forwarded immediately to the cantons responsible for the persons entering switzerland.172 as soon as it is notified that a person infected with sars-cov-2 has entered switzerland, the foph shall take the following measures:a. it shall request the travel operator to provide the contact data recorded on paper relating to the persons who entered switzerland at the same time as the person infected with sars-cov-2.b. it shall establish the identity of the persons who were in close contact with the person infected with sars-cov-2 on the basis of contact data recorded online and the contact data in accordance with letter a.c. it shall forward the processed contact data immediately to the cantons responsible for the persons entering switzerland.3 the foph may delegate its duties under paragraphs 1 and 2 to third parties. in doing so, it shall ensure that data protection and data security are guaranteed.4 the foph or the third parties shall destroy the data one month after the entry of the persons concerned.5 the cantons shall destroy the data one month after they have received the same from the foph or from third parties.17 amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).section 418 requirement to be tested before departure 18 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).art. 7 1 airlines and coach companies offering long-distance journeys must inform their passengers that they must be tested for sars-cov-2 before departure for switzerland and that they will only be permitted to board the aircraft or coach if they can provide a negative test result.192 airlines must verify before departure whether a negative test result is available. the requirements for the test and for proof of testing are regulated in annex 2a.203 airlines and coach companies must not permit passengers who are unable to provide a negative test result to board the aircraft or coach. 4 they may carry the following passengers without these passengers being required to produce a negative test result: a. persons under 16 years of age; b. persons who can provide a medical certificate to prove that they must be transported to switzerland as a matter of urgency on medical grounds;c.21 persons who enter switzerland from from countries or regions that are not specified in annex 1 number 1 and are using a swiss airport while in transit without leaving that airport before continuing their journey;cbis.22 persons who travel through switzerland with a coach company without leaving the coach;d. and e.23 .f. persons who provide proof in the form of a medical certificate that they are unable on medical grounds to take a sars-cov-2 test.5 persons aged six and over who enter switzerland from a country or region specified in annex 1 number 1 must be able to provide a negative test result in accordance with paragraph 2.2419 amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).20 amended by no i of the o of 17 dec. 2021, in force since 20 dec. 2021 (as 2021 883).21 amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).22 inserted by no i of the o of 1 oct. 2021, in force since 4 oct. 2021 (as 2021 591).23 repealed by no i of the o of 3 dec. 2021, with effect from 4 dec. 2021 (as 2021 814).24 amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).section 5 requirement for persons entering switzerland to be tested, to quarantine and to report art. 825 test requirement 1 persons entering switzerland must be able to show a negative test result. the requirements for tests and proof of testing are regulated in annex 2a.262 persons who are unable to provide proof of a negative test under paragraph 1 on entering switzerland must immediately undergo one of the following tests on entry:27a. a molecular-biological analysis for sars-cov-2; orb.28 a sars-cov-2 rapid test for specialist use in accordance with article 24a paragraph 1 of covid-19 ordinance 3 of 19 june 202029 unless it is based on a sample taken solely from the nasal cavity or on a saliva sample;c.30 a laboratory immunological analysis for sars-cov-2 antigens in accordance with article 19 paragraph 1 letter c of the covid-19 certificates ordinance of 4 june 202131.2bis the persons specified in paragraphs 1 and 2 must also take a test between the fourth and seventh day after entering switzerland. the test and the proof of testing requirements are regulated in annex 2a.323 persons who test negative between the fourth and seventh day after entering switzerland must provide the canton with a covid-19 test certificate in accordance with the covid-19 certificates ordinance of 4 june 202133. persons who test positive must notify the canton of the test result.344 on entry into switzerland from a country or region specified in annex 1 number 1, paragraph 1 applies to all persons aged six or over.3525 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).26 amended by no i of the o of 17 dec. 2021, in force since 20 dec. 2021 (as 2021 883).27 amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).28 amended by annex no 2 of the o of 17 dec. 2021, in force since 18 dec. 2021 (as 2021 881).29 sr 818.101.2430 inserted by annex no 2 of the o of 17 dec. 2021, in force since 18 dec. 2021 (as 2021 881).31 sr 818.102.232 inserted by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).33 sr 818.102.234 amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).35 inserted by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).art. 936 quarantine requirement 1 on entering switzerland, persons who in the ten days before entry have stayed in a country or region listed in annex 1 must travel immediately and directly to their home or to other suitable accommodation. they must remain there without leaving at any time for 10 days following their entry (quarantine on entry).372 where a person has entered switzerland from a country or region that does not have a variant of the virus of concern, the competent cantonal authority may take account of the duration of the person's stay in that country or region when calculating the time to be spent in quarantine.3 persons required to quarantine on entry who have entered switzerland from a country that is not specified in annex 1 number 1 may leave quarantine within 10 days provided they undergo either a molecular-biological analysis for sars-cov-2, a sars-cov-2-rapid test for specialist use in accordance with article 24a paragraph 1 of covid-19 ordinance 3 of 19 june 202038 or a laboratory immunological analysis for sars-cov-2 antigens in accordance with article 19 paragraph 1 letter c of the covid-19 certificates ordinance of 4 june 202139 and the result is negative. the test may be carried out at the earliest on the seventh day of quarantine. the competent cantonal authority may, in justified cases, suspend the early termination of quarantine.403bis the persons mentioned in paragraph 3 may leave quarantine in order to be tested. when doing so, they must wear a face mask and maintain a distance of at least 1.5 metres from other persons.414 persons who leave quarantine early pursuant to paragraph 5 must wear a face mask and maintain a distance of at least 1.5 metres from other persons when outside their home or accommodation until the point in time at which quarantine under paragraph 2 would have ended.36 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).37 amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).38 sr 818.101.2439 sr 818.102.240 amended by annex no 2 of the o of 17 dec. 2021, in force since 18 dec. 2021 (as 2021 881).41 inserted by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).art. 9a42 exemptions from the test and quarantine requirement 1 the following persons are exempt from the requirement to be tested under article 8 and to quarantine from the requirement to under article 9:a. . 43b. persons who in the course of their professional activities transport passengers or goods across borders;c.44 .d. persons who travel through switzerland without stopping;e. and f.45 .g. who enter switzerland on important and immediate medical grounds;h. who enter switzerland as cross-border commuters.2 the following persons are also exempt from the requirement to be tested in article 8:a.46 persons under the age of 16, unless they are entering switzerland from a country or region specified in annex 1 number 1;b. persons who can prove that they are unable on medical grounds to take a sars-cov-2 test.c.47 persons who enter switzerland from a region listed in annex 1a, provided the country or region concerned is not listed in annex 1 number 1.d.48 persons whose activity in switzerland is essential to maintain the proper functioning of institutional beneficiaries in terms of article 2 paragraph 1 of the host state act of 22 june 200749 and who can prove this by providing confirmation from the federal department of foreign affairs (fdfa);e.50 persons whose activity in switzerland is essential to maintain switzerland's diplomatic and consular relations and who can prove this by providing confirmation from the fdfa.2bis the test requirement in accordance with article 8 paragraph 2bis does not apply to:a. persons who enter switzerland from countries or regions that are not specified in annex 1 number 1 and who provide proof that they have been vaccinated against sars-cov-2; the persons who are regarded as having been vaccinated, the duration for which the vaccination is regarded as effective and the accepted forms of proof are regulated in annex 2;b. persons who enter switzerland from countries or regions that are not specified in annex 1 number 1 and who provide proof that they have been infected with sars-cov-2 and have recovered; the duration of the exemption and the accepted forms of proof are regulated in annex 2.512ter the quarantine requirement in accordance with article 9 does not apply to the following persons:a. persons whose activity in switzerland is essential to maintaining: 1. the proper functioning of the health service,2. public security and order,3. the proper functioning of institutional beneficiaries in terms of article 2 paragraph 1 of the host state act,4. switzerland's diplomatic and consular relations;b. persons who as transit passengers have spent less than 24 hours in a country or region specified in annex 1;c. persons who re-enter switzerland after participating in an event in a country or region specified in annex 1, provided they can prove that their participation and stay took place in compliance with a specific precautionary measures plan; participation in an event includes in particular participation on a professional basis in a sporting competition, cultural event or specialist conference;d. persons who enter switzerland from a country or region specified in annex 1 in order to participate in an event in switzerland; participation in an event includes in particular participation on a professional basis in a sporting competition, cultural event or specialist conference;e. persons who enter switzerland from countries or regions that are not specified in annex 1 number 1 and who provide proof that they have been vaccinated against sars-cov-2; the persons who are regarded as having been vaccinated, the duration for which the vaccination is regarded as effective and the accepted forms of proof are regulated in annex 2;f. persons who enter switzerland from countries or regions that are not specified in annex 1 number 1 and who provide proof that they have been infected with sars-cov-2 and have recovered; the duration of the exemption and the accepted forms of proof are regulated in annex 2.523 the exemptions under paragraphs 1-2ter do not apply to persons displaying symptoms of covid-19, unless the person concerned can provide certified medical evidence that the symptoms have a different cause.534 the competent cantonal authority may in justified cases permit further exemptions from the requirement to be tested and to quarantine or may relax certain conditions.42 inserted by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).43 repealed by no i of the o of 1 oct. 2021, with effect from 4 oct. 2021 (as 2021 591).44 repealed by no i of the o of 3 dec. 2021, with effect from 4 dec. 2021 (as 2021 814).45 repealed by no i of the o of 3 dec. 2021, with effect from 4 dec. 2021 (as 2021 814).46 amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).47 amended by no i of the o of 1 oct. 2021, in force since 4 oct. 2021 (as 2021 591).48 inserted by no i of the o of 1 oct. 2021, in force since 4 oct. 2021 (as 2021 591).49 sr 192.1250 inserted by no i of the o of 1 oct. 2021, in force since 4 oct. 2021 (as 2021 591).51 inserted by no i of the o of 17 dec. 2021, in force since 20 dec. 2021 (as 2021 883).52 originally para. 2bis. inserted by no i of the o of 1 oct. 2021 (as 2021 591). amended by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).53 amended by no i of the o of 17 dec. 2021, in force since 20 dec. 2021 (as 2021 883).art. 10 requirement to report54 1 persons who must take a test under article 8 paragraph 3 must provide the competent cantonal authorities with the covid-19 test certificate in accordance with the covid-19 certificates ordinance of 4 june 202155 or the positive test result within two days and:56a. inform them of the number of the passenger locator form completed in accordance with article 4 paragraph 1 letter a; orb. provide them with a copy of the paper passenger locator form in accordance with article 4 paragraph 1 letter b.2 persons required to quarantine on entry under article 9 must report to the competent cantonal authority within two days of their arrival in switzerland and must follow the instructions given by the authority.54 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).55 sr 818.102.256 amended by no i of the o of 1 oct. 2021, in force since 4 oct. 2021 (as 2021 591).section 6 checks and reports57 57 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563). art. 11 border control authorities58 1 the border control authorities may conduct risk-based checks on persons entering switzerland. in doing so, they shall verify:59a.60 that the person checked has tested negative in accordance with article 8 paragraphs 1 and 4; b. that the contact data of the person checked has been recorded in accordance with article 4 paragraph 1.2 if the person checked is unable to produce a negative test result or show that their contact data has been recorded, the border control authority shall report the matter to the competent cantonal authority. the report shall include the details of the person checked, the time and place of the check, the address the person has specified in switzerland, and the outcome of the check.3 the border control authorities may impose fixed penalty fines.58 inserted by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).59 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).60 amended by no i of the o of 17 dec. 2021, in force since 20 dec. 2021 (as 2021 883).art. 11a61 cantons the cantons may check that a negative test result has been provided in accordance with article 8 paragraph 3.61 inserted by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).art. 11b62 obligation on private individuals to conduct checks 1 any person who provides accommodation on a commercial basis to persons staying in switzerland for tourist or business purposes must check whether they can provide test results pursuant to article 8 paragraphs 1, 2bis and 4.2 persons who are unable to provide a negative test result must be reported to the competent cantonal authority. 62 inserted by no i of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).section 7 updating the annexes art. 12 1 the federal department of home affairs shall update annex 1 continuously in consultation with the federal department of justice and police, the federal department of finance and the federal department of foreign affairs.2 it shall update annex 2 in accordance with the latest scientific knowledge and in consultation with the federal commission for vaccination.3 it shall update annex 2a in accordance with the latest scientific knowledge.6363 inserted by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 563).section 8 final provisions art. 13 repeal and amendment of other legislation 1 the covid-19-ordinance on international passenger transport of 27 january 202164 is repealed.2 the amendment of other legislation is regulated in annex 3.64 [as 2021 61, 94, 276, 298, 352]art. 14 commencement this ordinance comes into force on 26 june 2021 at 00.00.annex 165 65 amended by no i of the fdha o of 3 aug. 2021 (as 2021 465). revised by no ii of the o of 3 dec. 2021, in force since 4 dec. 2021 (as 2021 814).(art. 2 paras 2 and 3, 3 para. 1 let. a, 7 para. 4 let. c and 5, 8 para. 4, 9 paras 1 and 3, 9a para. 2 lets a and c and 2bis lets b-f, and 12 para. 1)list of countries and regions with a variant of the virus of concern66 66 if a state is on the list, this includes all its areas, islands and overseas territories, even if these are not separately listed.1. countries and regions with a variant of the virus of concern that is immune evasive is or the immune evasive status of which is unclear (art. 2 paras. 1 and 2) there are no entries currently on this list2. countries and regions with a variant of the virus of concern that is not immune evasive (art. 2 paras. 1 and 3) there are no entries currently on this listannex 1a67 67 inserted by no ii of the o of 1 oct. 2021, in force since 4 oct. 2021 (as 2021 591).(art. 2 para. 4, 3 para. 2 let. d and 9a para. 2 let. c)regions bordering switzerland regions in germany:- baden-wrttemberg- bavariaregions in france:- grand-est- burgundy / franche comt- auvergne / rhne-alpesregions in italy:- piedmont- aosta valley- lombardy- trentino / south tyrolregions in austria:- tyrol- vorarlbergregions in liechtenstein:- entire principalityannex 268 68 revised by no ii para. 1 of the o of 17 sept. 2021 (as 2021 563), annex no 3 of the o of 3 nov. 2021 (as 2021 653) and no ii of the o of 17 dec. 2021, in force since 20 dec. 2021 (as 2021 883).(art. 9a para. 2bis lets a and b, 2ter lets e and f and 12 para. 2)persons who have been vaccinated and who have recovered 1 persons who have been vaccinated 1.1 persons who have been vaccinated are persons who have received a vaccine that: a. is authorised in switzerland and which has been administered in full in accordance with the foph recommendations; b. has been authorised by the european medicines agency for the european union and has been administered in full in accordance with the requirements or recommendations of the country in which the vaccination was administered;c. is authorised under the who emergency use listing and has been administered in full in accordance with the requirements or recommendations of the country in which the vaccination was administered; ord. has been shown to have the same composition as a vaccine licensed under letter a or b but marketed by a licence holder under a different name, and which has been administered in full in accordance with the requirements or recommendations of the country in which the vaccination was carried out.1.2 the vaccination is regarded as being effective for 365 days from the date on which it was administered in full; the janssen ad26.cov2.s / covid-19 vaccine is regarded as being effective for 365 days from the 22nd day after it was administered in full. 1.3 proof of vaccination may be provided in the form of a covid-19 certificate in accordance with article 1 letter a number 1 of the covid-19 certificates ordinance of 4 june 202169 or a recognised foreign certificate in accordance with section 7 of the covid-19 certificates ordinance.1.4 proof may also be provided in a different form from that in number 1.3. it must be a form of proof that is customary at the time. in addition to the surname, forename and date of birth of the person concerned, it must include the following information:a. the date of vaccination;b. the vaccine used.69 sr 818.102.22 persons who have recovered 2.1 recovery is valid for the following duration:a. when based on a molecular-biological analysis for sars-cov-2: from the eleventh to the 365th day after confirmation of infection;b. when based on an analysis for sars-cov-2 antibodies in accordance with article 16 paragraph 3 of the covid-19 ordinance on certificates of 4 june 202170: for the term of validity of the certificate concerned.2.2 proof of recovery may be provided in the form of a covid-19 certificate in accordance with article 1 letter a number 2 of the covid-19 certificates ordinance of 4 june 2021 or a recognised foreign certificate in accordance with section 7 of the covid-19 certificates ordinance.2.3 proof may also be provided in a different form from that in number 2.2. it must be a form of proof that is customary at the time. in addition to the surname, forename and date of birth of the person concerned, it must include the following information:a. confirmation of the infection including the name and address of the confirming body (test centre, doctor, pharmacy, hospital);b. confirmation that isolation has been terminated or confirmation from a doctor of recovery.70 sr 818.102.2annex 2a71 71 inserted by no ii para. 1 of the o of 17 sept. 2021(as 2021 563). revised by no ii of the o of 3 dec. 2021 (as 2021 814) and annex no 2 of the o of 17 dec. 2021, in force since 18 dec. 2021 (as 2021 881).(art. 7 para. 2, 8 paras 1 and 2bis and 12 para. 3)test and proof of testing requirements 1. the test procedure must be an up-to-date scientific and technical procedure, whereby:a. a molecular-biological analysis for sars-cov-2 may not have been taken more than 72 hours previously;b. a sars-cov-2 rapid test for specialist use or a laboratory immunological analysis for sars-cov-2 antigens may not have been taken more than 24 hours previously.2. the document showing the test result must contain the following information:a. surname, first name and date of birth of the person tested;b. date and time the test was carried out;c. type of test under no 1 letter a or b;d. test result.annex 3 (art. 13 para. 2)amendment of another enactment .7272 the amendments may be consulted under as 2021 380.

818.102.2english is not an official language of the swiss confederation. this translation is provided for information purposes only, has no legal force and may not be relied on in legal proceedings.ordinance on certificates to prove covid-19 vaccination, covid-19 recovery or a covid-19 test result(covid-19 certificates ordinance)of 4 june 2021 (status as of 10 january 2022)the swiss federal council,based on article 6a paragraphs 1, 4 and 5 of the covid-19 act of 25 september 20201,ordains:1 sr 818.102section 1 subject matter art. 1 this ordinance regulates:a. the form, content, issuance and revocation of the following covid-19 certificates to prove:1. vaccination against covid-19 (covid-19 vaccination certificate),2. recovery from sars-cov-2 infection (covid-19 recovery certificate),3. a negative result following sars-cov-2 test analysis (covid-19 test certificate);4.2 that the holder can neither be vaccinated nor tested on medical grounds (covid-19 exemption certificate);b. the specifications for verifying these certificates;c. the recognition of corresponding foreign certificates;d. the information systems operated by the confederation in connection with these certificates;e. the apps offered by the confederation for certificate holders and checkers;f. the tasks of the cantons in connection with issuing and revoking certificates;g.3 the payment of costs by requesting persons.2 inserted by no i of the o of 3 nov. 2021, in force since 10 jan. 2022 (as 2021 653, 813).3 inserted by no i of the o of 1 oct. 2021, in force since 11 oct. 2021 (as 2021 592).section 2 issuance, form and revocation of covid-19 certificates art. 2 request any person wishing to obtain a covid-19 certificate must submit a request to an issuer specified in article 6 or 7.art. 3 information and identification of the requesting person 1 the issuer shall inform the requesting person about:a. the type and extent of the data processing required to create and sign the covid-19 certificate;b. the conditions under which the issued certificate is revoked.2 the issuer shall verify the identity of the requesting person, with presentation of an identity document for this purpose where necessary.art. 4 retrieval of the covid-19 certificate from the system for issuing covid-19 certificates 1 the issuer shall transmit the information to be included in the certificate to the system operated by the federal office of information technology, systems and telecommunication (foitt) for issuing covid-19 certificates in accordance with article 26.2 the system generates the certificate. it shall transmit it to the issuer, provided the issuer is responsible for transmitting or delivering the certificate to the requesting person.art. 5 transmission or delivery of the covid-19 certificate to the requesting person 1 the issuer shall ensure the rapid and secure transmission or delivery of the covid-19 certificate to the requesting person.2 the issuer is responsible for compliance with data protection requirements during transmission and delivery. in particular, it must be ensured that third parties are unable to obtain knowledge of the information contained on the certificate.3 the confederation may propose to the cantons that it take care of printing the certificates in hard copy and transmitting certificates to requesting persons.4 it shall charge the cantons for the costs of printing and transmitting covid-19 vaccination certificates of people vaccinated from 15 july 2021 onwards.44 inserted by no i of the o of 30 june 2021, in force since 3 july 2021 (as 2021 410).art. 6 general provisions concerning the issuers of covid-19 certificates 1 the cantons and the surgeon general shall designate the respective issuers for the various types of covid-19 certificates.2 issuers shall be natural persons who:a. have the necessary expertise to assess the requirements for issuing certificates;b. use it systems and products that allow issuers to be uniquely identified and securely authenticated;c. guarantee compliance with the applicable law and in particular with this ordinance.3 the cantons and the surgeon general shall notify the foitt of the designated issuers. notification shall include the following information:a. first name, surname, address, email address and telephone number of the issuer;b. details of the identification provider used and the identifier this provider uses to identify the person concerned;c. details of which certificates the issuer is authorised to issue;d. the date on which designation becomes valid and expires.4 the designated issuers may call on the services of other persons to whom they have the right to give instructions in order to issue certificates. they shall be responsible for the acts and omissions of these persons.5 the cantons and the surgeon general shall supervise the issuance and revocation of certificates by the issuers in accordance with the applicable federal and cantonal regulations.6 they shall revoke such designation if there are clear indications that the issuer no longer meets the requirements. they shall notify the foitt of the revocation of a designation.art. 7 issuers with more extensive rights 1 the cantons and the surgeon general shall ensure that in the following cases requests for a covid-19 vaccination certificate or covid-19 recovery certificate pursuant to article 16 paragraph 1 are processed, even if an issuer under article 6 has no access to the relevant medical history or primary documentation for this purpose:5a. if the person received the vaccination or recovered from the illness in switzerland;b. if the person received the vaccination or recovered from the illness abroad:1. in the case of swiss citizens,2. in the case of foreign nationals who are entitled to enter switzerland under article 4 of the covid-19 ordinance of 19 june 20206 and can credibly demonstrate that they are planning to enter switzerland or are already in switzerland.72 they shall designate at least one issuer for dealing with such requests.3 the request for issuance of a covid-19 vaccination certificate or covid-19 recovery certificate under paragraph 1 must be submitted in an official language of the canton, in english or an officially certified translation into one of these languages must be provided together with the documents listed in articles 13 paragraph 2 letter c and 16.84 if there is any doubt as to whether the documents submitted are genuine, the issuer may:a. demand that the requesting person: 1. appear in person,2. submit officially certified documents,3. submit the information or documents required to assess the request;b. obtain further information from the competent foreign authorities in compliance with article 62 of the epidemics act of 28 september 20129.105 if there is still doubt as to whether the documents submitted are genuine despite taking the foregoing measures, the issuer may decline the request. in such an event, the requesting person is not entitled to a refund of any fee paid.115 amended by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).6 sr 818.101.247 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 564).8 inserted by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 564).9 sr 818.10110 inserted by no i of the o of 1 oct. 2021, in force since 11 oct. 2021 (as 2021 592).11 inserted by no i of the o of 1 oct. 2021, in force since 11 oct. 2021 (as 2021 592).art. 8 automated procedure for issuing covid-19 recovery certificates 1 for the purpose of issuing covid-19 recovery certificates, the cantons may use an automated procedure to retrieve information on the requesting person's recovery from the information system in accordance with article 60 of the epidemics act of 28 september 201212 and compare it with the information in the request.2 for this purpose, they may provide the requesting person with an electronic request form supplied by the confederation.3 if the comparison with the data retrieved from the information system shows that the requirements for issuing a certificate are met, the system for issuing covid-19 certificates (art. 26) shall generate the certificate.4 if the result of the comparison is unclear or negative, the competent cantonal body shall contact the requesting person and manually check whether the requirements for issuing a certificate are met.5 the cantons shall ensure that the requesting person may also submit the request in hard copy or in any other suitable form.12 sr 818.101art. 9 form of the covid-19 certificates 1 the requesting person may choose to have the covid-19 certificate issued in hard copy or electronic format.2 the covid-19 certificates bear a regulated electronic seal of the federal office of public health (foph) as the means of verification of the authenticity and integrity of the information.3 both forms of certificate display the content as a human-readable text and two-dimensional machine-readable code (barcode). however, the barcode and the data stored in it in sealed electronic format are also considered to be a certificate.4 certificates are issued in an official language of the confederation as chosen by the requesting person and in english.5 they contain a unique certificate identifier.art. 10 revocation of covid-19 certificates 1 the issuers specified in articles 6 and 7 and the competent cantonal authorities shall revoke a covid-19 certificate at the request of the holder if the holder credibly demonstrates that:a. the certificate contains incorrect information; orb. errors have repeatedly occurred when verifying the authenticity, validity or integrity of the certificate.2 a revocation request must contain the following:a. the unique certificate identifier;b. information on the identity of the holder, insofar as is necessary to assess the grounds for revocation in accordance with paragraph 1, as well as the further details required to assess the grounds for revocation.3 even in the absence of a request, issuers are obliged without delay to revoke the certificates they have issued which do not meet the requirements of this ordinance or which attest to facts which turn out to be incorrect.4 the foitt and the competent cantonal authorities shall revoke certificates in the issuer's place if the issuer fails to do so within a reasonable period in accordance with paragraphs 1 or 3.5 issuers, the foitt and the competent cantonal authorities shall revoke certificates in the system for issuing covid-19 certificates (art. 26), which shall transmit the identifiers of the revoked certificates to the system for retrieving revoked certificates (art. 27).6 issuers, the foitt and the competent cantonal authorities shall document the revocation of certificates with the following information:a. the unique certificate identifier;b. information that makes it clear why the decision to revoke the certificate was made.1313 inserted by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 564).art. 11 free of charge 1 the requesting person shall not be charged for the issuance or revocation of covid-19 certificates with the exception of the cases specified in paragraph 2 and article 26a paragraph 3.142 the cantons may make provision for issuers to charge an appropriate share of the cost in the following cases:a. when a certificate has to be reissued repeatedly due to loss;b. when issuing a certificate to persons in accordance with article 7 paragraph 3 who do not have a place of residence in the canton concerned or, in the case of swiss citizens living abroad, do not have their last place of residence or their home commune in the canton concerned.1514 amended by no i of the o of 1 oct. 2021, in force since 11 oct. 2021 (as 2021 592).15 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 as 2021 564).section 3 general content of all covid-19 certificates art. 12 1 all covid-19 certificates shall contain the following information in accordance with annex 1:a. details of the identity of the holder;b. details of the electronic seal issuer;c.16 .2 covid-19 certificates in human-readable form shall also contain the following information:a. a general statement on the meaning of the certificate in accordance with annex 1 number 3;b.17 in the case of a covid-19 vaccination certificate pursuant to article 15 paragraph 318, a covid-19 recovery certificate pursuant to article 16 paragraph 3 or a covid-19 exemption certificate pursuant to article 21a19: a reference to the certificate being valid for a limited period and only in certain geographical areas in accordance with annex 1 number 4.2016 repealed by no i of the o of 3 nov. 2021, with effect from 16 nov. 2021 (as 2021 653).17 correction of 24 nov. 2021 (as 2021 750).18 words in force since 30 nov. 2021 (as 2021 653, 750).19 words in force since 10 jan 2022 (as 2021 653, 750, 813 no v).20 inserted by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).section 4 covid-19 vaccination certificates art. 13 requirements 1 a covid-19 vaccination certificate shall be issued for vaccines that:a. are authorised in switzerland;b. are authorised by the european medicines agency for the eu in accordance with regulation (ec) no 726/200421;c. are authorised in accordance with the who emergency use listing; ord. can be shown to have the same composition as a vaccine authorised in accordance with letters a, b or c, but which is marketed by the licence holder under another name (licensed products).222 a covid-19 vaccination certificate shall be issued for each dose:a. at the time of vaccination;b. subsequent to the vaccination if the administration of the vaccine, including the information in accordance with article 14, is evident from the medical history or primary documentation that the issuer has on the person requesting the certificate;c. subsequent to the vaccination if no medical history or primary documentation is available and the administration of the vaccine, including the information in accordance with article 14, can be reliably established from one of the following supporting documents:1. an international certificate of vaccination in accordance with the model in annex 6 to the international health regulations (2005) of 23 may 200523, indicating the vaccine administered and bearing the signature and stamp of the body responsible,2. confirmation of vaccination issued by a cantonal vaccination centre,3. a vaccination record indicating the vaccine administered and bearing the signature or stamp of the body responsible in switzerland,4. any other swiss or foreign document equivalent to one of the documents mentioned in numbers 1 to 3.2bis .242ter in the case of vaccines and their licensed products that are not authorised for switzerland nor for the eu but which are permitted under the who emergency use listing, a certificate may be issued to persons in the following categories provided the person concerned attends in person at the issuer's office:a. swiss citizens;b. foreign nationals holding a short stay permit, residence permit, settlement permit or cross-border commuter permit in accordance with articles 32-35 of the foreign nationals and integration act of 16 december 200525 (fnia);c. persons temporarily admitted under article 83 paragraph 1 fnia;d. persons requiring protection in accordance with article 66 of the asylum act of 26 june 199826;e. persons seeking asylum who hold a permit or confirmation of their status in accordance with article 30 of asylum ordinance 1 of 11 august 199927;f. holders of a legitimation card in accordance with article 17 of the host state ordinance of 7 december 200728;g. holders of a ci permit in accordance with article 22 paragraph 3 of the host state ordinance.293 covid-19 certificates in accordance with paragraph 2 letter c may only be issued by the issuers specified in article 7 if the person concerned has been vaccinated in full in accordance with annex 2 number 3.3021 regulation (ec) no 726/2004 of the european parliament and of the council of 31 march laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency, oj l 136, 30.4.2004, p. 1; last amended by regulation (eu) no 2019/5, oj l 4, 7.1.2018, p. 24.22 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 564).23 sr 0.818.10324 inserted by no i of the o of 17 sept. 2021 (as 2021 564). repealed by no i of the o of 3 nov. 2021, with effect from 16 nov. 2021 (as 2021 653).25 sr 142.2026 sr 142.3127 sr 142.31128 sr 192.12129 inserted by no i of the o of 17 sept. 2021 (as 2021 564). amended by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).30 amended by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).art. 1431 content in addition to the general content of all covid-19 certificates, covid-19 vaccination certificates shall contain the details in accordance with annex 2 on the covid-19 vaccination carried out, and in particular whether the vaccine has been administered in full.31 amended by no i of the o of 30 june 2021, in force since 3 july 2021 (as 2021 410).art. 15 validity 1 the start and duration of the validity of covid-19 vaccination certificates are governed by annex 2.2 the period of validity begins at the earliest on the day on which the final dose is administered, provided the vaccine is administered in full in accordance with the requirements of annex 2.323 in the case of persons that do not belong to any of the categories specified in article 13 paragraph 2ter, covid-19 vaccination certificates for vaccines and their licensed products that are neither authorised for switzerland nor for the eu but which are permitted under the who emergency use listing are valid only in switzerland and for a maximum of 30 days from issuance; the validity of such certificates otherwise ends in accordance with the provisions of annex 2 number 1.2.3332 amended by no i of the o of 30 june 2021, in force since 3 july 2021 (as 2021 410).33 inserted by no i of the o of 3 nov. 2021, in force since 30 nov. 2021 (as 2021 653).section 5 covid-19 recovery certificates art. 16 requirements 1 a covid-19 recovery certificate shall be issued when a person has been infected with sars-cov-2 and has recovered. the finding that the person has been infected with the virus must be based on the positive result of a molecular-biological analysis for sars-cov-2.2 a request for the issuance of a covid-19 certificate that cannot be processed under the automated procedure for issuing covid-19 recovery certificates pursuant to article 8 must be accompanied by the following documents:a. proof of a positive molecular-biological analysis for sars-cov-2 that includes the following information:1. the requesting person's surname, first name and date of birth,2. the date and time at which the sample was taken,3. the name and address of the test centre or the institution where the test was carried out;b. confirmation of termination of isolation or a medical certificate confirming recovery from a competent authority with official duties, including the name and address of this authority.343 a covid-19 recovery certificate shall be issued to persons who have tested positive for sars-cov-2 antibodies provided:a. the sample was taken in switzerland by a facility specified in annex 6 number 1.3.2 letter a of the covid-19 ordinance 3 of 19 june 202035;b. the analysis was carried out in switzerland by a facility specified in annex 6 number 1.3.2 letter b covid-19 ordinance 3;c. the sample was taken after 15 november 2021;d. a clearly positive serology was detected by analysis using a ce-marked certified immunoassay in the form of a quantifiable result.364 covid-19 recovery certificates pursuant to paragraph 3 may only be issued by a facility specified in annex 6 number 1.3.2 letter a of the covid-19 ordinance 3 or by a facility specified in annex 6 number 1.3.2 letter b of the covid-19 ordinance 3 that has been instructed by a facility specified in annex 6 number 1.3.2 letter a of the covid-19 ordinance 3 to carry out the analysis.3734 inserted by no i of the o of 1 oct. 2021, in force since 11 oct. 2021 (as 2021 592).35 sr 818.101.2436 inserted by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).37 inserted by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).art. 1738 content in addition to the general content of all covid-19 certificates, covid-19 recovery certificates shall specify that the holder contracted covid-19 or tested positive for covid-19 antibodies, as well as the dates on which the samples were taken and the analyses in accordance with annex 3 number 2 were carried out.38 amended by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).art. 18 validity 1 the start and duration of the validity of covid-19 recovery certificates are governed by annex 3.2 a covid-19 recovery certificate pursuant to article 16 paragraph 1 shall be valid at the earliest from the eleventh day after infection was confirmed by the positive result of a molecular-biological analysis for sars-cov-2.393 a covid-19 recovery certificate pursuant to article 16 paragraph 3 shall be valid at the earliest from the day on which the sample was taken.404 covid-19 recovery certificates pursuant to article 16 paragraph 3 are only valid in switzerland.415 covid-19 recovery certificates pursuant to article 16 paragraph 1 shall contain an expiry date that is compatible with the requirements of regulation (eu) 2021/95342. under annex 3 number 1.2 letter a, they may remain valid beyond the date specified.4339 amended by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).40 inserted by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).41 inserted by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).42 regulation (eu) 2021/953 of the european parliament and of the council of 14 june 2021 on a framework for the issuance, verification and acceptance of interoperable covid-19 vaccination, test and recovery certificates (eu digital covid certificate) to facilitate free movement during the covid-19 pandemic, amended by oj l 211 of 15.6.2021, p. 1.43 inserted by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).section 6 covid-19 test certificates art. 19 requirements 1 a covid-19 test certificate shall be issued in the event of a negative result of:a. a molecular-biological analysis for sars-cov-2;b.44 a sars-cov-2 rapid test for specialist use in accordance with article 24a of the covid-19 ordinance 3 of 19 june 202045, unless it is based on a sample taken only from the nasal cavity or on a saliva sample.c.46 a laboratory immunological analysis for sars-cov-2 antigens, provided: 1. the analysis was carried out by a laboratory licensed under article 16 of the epidemics act of 28 september 201247,2. the test is authorised in eu for issuing an eu digital covid certificate,3. the sample was taken by a facility specified in annex 6 number 1.4.3 letter a of the covid-19 ordinance 3, and4. the test is not based on a sample taken solely from the nasal cavity or on a saliva sample.1bis the foph shall maintain an updated list of sars-cov-2 rapid tests in accordance with paragraph 1 letter b of laboratory immunological analyses for sars-cov-2 antigens in accordance with paragraph 1 letter c, and publish it on its website.481ter in derogation from paragraph 1, no certificates shall be issued for analyses for sars-cov-2 in respect of which the confederation pays the costs in accordance with annex 6 numbers 1.1.1 letters a-e h, i number 1 and j, 1.2.1, 1.4.1 letters a-e, h number 1, i and m, 2.1.1 letter c, 2.2.1 letter c, 3.1.1 letter c and 3.2.1 letter c of the covid-19 ordinance 3.492 requests for test certificates may be submitted at the latest when the sample is taken.44 amended by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).45 sr 818.101.2446 inserted by annex no 3 of the o of 17 dec. 2021, in force since 18 dec. 2021 (as 2021 881).47 sr 818.10148 inserted by no i of the o of 30 june 2021 (as 2021 410). amended by annex no 3 of the o of 17 dec. 2021, in force since 18 dec. 2021 (as 2021 881).49 inserted by no iv of the o of 25 aug. 2021 (as 2021 507). amended by no iii of the o of 1 oct. 2021, in force since 11 oct. 2021 (as 2021 594).art. 20 content in addition to the general content of all covid-19 certificates, covid-19 test certificates shall contain information on the test carried out in accordance with annex 4.art. 21 validity 1 covid-19 test certificates shall be valid from the time they are issued.2 the duration of validity is governed by annex 4.3 it shall be a maximum of 72 hours from the time the sample was taken.section 6a50 covid-19 exemption certificates 50 inserted by no i of the o of 3 nov. 2021, in force since 10 jan. 2022 (as 2021 653, 813). art. 21a requirements a covid-19 exemption certificate shall be issued to persons who can neither be vaccinated nor tested on medical grounds. proof must be provided in the form of a medical certificate from a doctor based in switzerland who is authorised to practise their profession under their own professional responsibility in accordance with the medical professions act of 23 june 200651.51 sr 811.11art. 21b content in addition to the general content of all covid-19 certificates, covid-19 exemption certificates shall contain the information specified in annex 4a numbers 2 and 3, in machine-readable form, and in particular the statement that the holder may be subject to alternative protective measures.art. 21c validity 1 the start and duration of the validity of covid-19 exemption certificates is governed by annex 4a number 1.2 validity begins at the earliest on the day on which the medical certificate is issued stating that the person concerned can neither be vaccinated nor tested on medical grounds.3 covid-19 exemption certificates are valid only in switzerland.section 7 foreign certificates art. 22 recognition of certificates issued by an eu member state or an efta state 1 the recognised vaccination, recovery and test certificates issued by a member state of the european union (eu) or a state of the european free trade association (efta) are listed in annex 5.2 the federal department of home affairs (fdha) shall update annex 5 continuously in consultation with the federal department of finance (fdf) and the federal department of foreign affairs (fdfa).523 it shall include in the annex certificates that were issued in accordance with the provisions applicable in the eu and whose states of origin grant reciprocal rights. however, it may decide not to include certificates for vaccines that are not authorised for the eu by the european medicines agency in accordance with regulation (ec) no. 726/200453.52 amended by no i of the o of 1 sept. 2021, in force since 7 sept. 2021 (as 2021 522).53 regulation (ec) no. 726/2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency, oj l 136 of 30.04.2004, p. 1; last amended by regulation (ec) no. 2019/5, oj l 4 of 7.1.2018, p. 24.art. 23 recognition of other foreign certificates 1 the recognised foreign certificates attesting vaccination, recovery or testing that have not been issued by an eu or efta member state are listed in annex 5.2 as soon as the european commission makes a decision regarding the equivalence of one or more interoperable certificates from third countries, the fdha shall update annex 5 accordingly. however, it shall only accept certificates from the third countries listed in annex 5, which grant switzerland reciprocal rights.543 it may include certificates from other states provided the following requirements are met:a. the foreign certificate contains the information specified in article 12 and in articles 14, 17 or 20 in conjunction with the relevant annexes.b. the information under letter a can be checked electronically for authenticity, integrity and validity.c. requirements equivalent to those under this ordinance apply to the issuance of the respective certificates.4 it shall delete those certificates that no longer meet the requirements from the list.54 amended by no i of the o of 17 sept. 2021, in force since 20 sept. 2021 (as 2021 564).art. 24 significance of recognition recognised foreign certificates shall be equivalent to the covid-19 certificates issued in accordance with this ordinance. in particular, the apps for storing and verifying certificates (arts. 28 and 29) shall treat them as certificates issued in accordance with this ordinance.section 8 federal information systems and software provided by the confederation art. 25 system for managing signature certificates 1 the foitt shall operate an information system that is used to do the following with signature certificates in order to check the authenticity, integrity and validity of electronic signatures of covid-19 certificates:a exchange them with corresponding foreign systems, particularly within the framework of the eu digital covid certificate system of the european union;b make them available to the apps that are used to store and verify certificates.2 signature certificates for the following covid-19 certificates are not delivered to foreign systems:a. covid-19 vaccination certificates pursuant to article 15 paragraph 3;b. covid-19 recovery certificates pursuant to article 16 paragraph 3;c. covid-19 exemption certificates pursuant to article 21a paragraph 1.5555 inserted by no i of the o of 3 nov. 2021, in force since 16 nov. 2021, let. a since 30 nov. and let. c since 10 jan. 2022 (as 2021 653, 750, 813).art. 26 system for issuing covid-19 certificates 1 the foitt shall operate an information system for generating, transmitting and revoking covid-19 certificates.2 the personal data of requesting persons may not be retained for longer than is necessary for generating, signing and transmitting the certificate, or for revoking it.3 in order to detect and prevent misuse and for the purpose of any subsequent revocation of certificates, the system shall log which issuer retrieved which certificates and when.art. 26a56 system for requesting covid-19 certificates for vaccination or recovery abroad 1 the foitt shall operate a system that can be used to submit requests under article 7 paragraph 1 letter b and by issuers to process these requests.2 the system shall allocate the requests as follows:a. requests for the issuance of a certificate to a person resident or with place of origin in switzerland: to the canton of residence or in the case of swiss citizens living abroad, to the last canton of residence, or, if the person has never been resident in switzerland, the canton in which the place of origin is located;b. requests for the issuance of a certificate to a person who does not fall under letter a: to the canton in which the person spends or plans to spend their first night in switzerland. 3 the confederation shall charge the issuer in advance a fee of 30 francs for processing a request for the issuance of a certificate to a person pursuant to paragraph 2 letter b. it shall pass on the revenues from this fee to the canton at the end of each quarter. requests for which no fee has been paid may be declined. the provisions of the general fees ordinance of 8 september 200457 also apply.4 the requests, the documents submitted and the unique certificate identifier shall be retained for 30 days and then deleted from the system.56 inserted by no i of the o of 1 oct. 2021, in force since 11 oct. 2021 (as 2021 592).57 sr 172.041.1art. 27 system for retrieving revoked certificates 1 the foitt shall operate a system that is used to retrieve revoked certificates and contains the unique certificate identifier for this purpose.2 the list of revoked certificate identifiers shall be made available to apps used for checking and storing covid-19 certificates.art. 28 storage app: general58 1 the foitt shall provide software that the holders of covid-19 certificates can install on their mobile telephones or similar devices and use for the secure transmission and electronic storage of the certificates.2 the following principles apply to the software:a. it may disclose the contents of certificates or make statements about it solely with the holder's consent in the individual case.b. the contents of certificates must be protected against unauthorised access by means of appropriate measures.c. the foitt shall publish the source code and technical specifications for the software it makes available.58 amended by no i of the o of 30 june 2021, in force since 12 july 2021 (as 2021 410).art. 28a59 storage app: retrieval of certificates with data minimisation 1 the app for storing covid-19 certificates shall enable holders to obtain a certificate with data minimisation for use in switzerland.2 to do so, the holder uses the app to send a covid-19 certificate to the system for issuing covid-19 certificates. if the certificate sent is valid, the system generates the data-minimised certificate and send it to the storage app.3 the certificate with data minimisation contains:a. the general content in accordance with article 12 letter a and annex 1 section 1; b. the designation of swiss covid-19 certificate with data minimisation;c. the expiry date.4 the period of validity of the certificate with data minimisation shall correspond to the shortest period of validity of covid-19 test certificates in accordance with annex 4; however, it shall end in any case when the underlying certificate expires.59 inserted by no i of the o of 30 june 2021, in force since 12 july 2021 (as 2021 410).art. 29 verification app 1 the foitt shall provide one or more software programs that can be installed on mobile telephones or similar devices and used for the electronic verification of the authenticity, integrity and validity of covid-19 certificates, including certificates with data minimisation, and corresponding foreign certificates.602 the following principles apply to the software programs:a. they shall verify the authenticity, integrity and validity of covid-19 certificates without transmitting or storing personal data.b. they shall verify foreign certificates according to the rules applicable to covid-19 certificates.c. they shall issue the result of the verification solely in the following form:1. verification successful (green background) or unsuccessful (red background) and, if applicable, information on the reasons for the failure of verification;2. information in accordance with annex 1 that allows the certificate to be assigned to the holder.d. they can verify the authenticity, integrity and validity of the certificates without being connected to the internet at the time of verification; however, the verification of validity requires an updated list from the system for retrieving revoked certificates, which requires an internet connection.e. the foitt shall publish the source code and technical specifications for the software programs it makes available.3 any person who is shown a certificate for verification may not retain it or the information read from it or use it for any purpose other than verification. the foregoing does not apply to storing information on the period of validity of certificates at facilities that may only be accessed by persons who have personal authorisation for repeated access. the data subject must be appropriately informed about the nature and extent of the data processing and must expressly consent to that processing.6160 amended by no i of the o of 30 june 2021, in force since 12 july 2021 (as 2021 410).61 amended by no i of the o of 3 nov. 2021, in force since 16 nov. 2021 (as 2021 653).art. 30 access to the systems for issuing covid-19 certificates and for retrieving revoked covid-19 certificates 1 users shall log on to the system for issuing covid-19 certificates via the federal administration's central access and authorisation system for web applications. the provisions of the ordinance of 19 october 201662 on federal identity management systems and directory services (iamo) apply.2 the foitt may go beyond article 21 of the iamo and connect other external iam systems to the confederation's iam systems, provided these allow for secure identification.3 it may deny or revoke access especially in the event of concerns about ict security.62 sr 172.010.59art. 31 federal body responsible the foitt is the federal body responsible under the data protection legislation for:a. the implementation of the necessary technical and organisational measures for the systems it operates;b. the apps it makes available.art. 32 costs of information systems and apps63 1 the confederation shall bear the costs of the procurement and operation of the information systems, and of the provision of the apps.2 it shall not collect any fees for the use of the systems and apps.63 amended by no i of the o of 1 oct. 2021, in force since 11 oct. 2021 (as 2021 592).section 9 final provisions art. 3364 updating annexes 1 to 4 in consultation with the fdf and the fdfa, the fdha shall update annexes 1 to 4 in accordance with the internationally harmonised standards in order to achieve interoperability with the certificates of as many states as possible and international recognition of the certificates issued in accordance with this ordinance.64 amended by no i of the o of 1 sept. 2021, in force since 7 sept. 2021 (as 2021 522).art. 34 conclusion of international treaties in connection with the development and implementation of the eu digital covid certificate the fdha shall be responsible for concluding international treaties for the adoption of delegated and implementing acts issued by the european commission for the development and technical implementation of the eu digital covid certificate.art. 35 commencement this ordinance comes into force on 7 june 2021 at 00.00 and applies until 31 december 2022.annex 165 65 revised by no ii of the o of 30 june 2021 (as 2021 410), of 17 sept. 2021 (as 2021 564), by no ii para. 1 of the o of 3 nov. 2021 (as 2021 653) and no i of the fdha o of 29 nov. 2021, in force since 30 nov. 2021 (as 2021 785).(arts 12, 28a para. 3 let. a, 29 para. 2 let. c no 2 and 33)general content of covid-19 certificates 1 details of the holder a. officially recorded surname and first name(s) (in that order)b. date of birth2 details of the country in which the vaccine was administered or the test was carried out, and details of the electronic seal issuer a. country in which the vaccine was administered or the test was carried out or, if this information is not available and the vaccination was administered or the test carried out by an international organisation, an internationally recognised code for this organisationb. electronic seal issuer (federal office of public health)3 statement for covid-19 certificates in a human-readable form covid-19 certificates that are in a human-readable form must contain the following statement:"this certificate is not a travel document.the scientific evidence on covid-19 vaccination, testing and recovery continues to evolve, also in view of new variants of concern of the virus.before travelling, please check the applicable public health measures and related restrictions applied at the point of destination."4 statement for certificates that are only valid in switzerland "this certificate is only valid in switzerland."annex 266 66 revised by no ii of the o of 30 june 2021 (as 2021 410), by no ii para. 1 of the o of 3 nov. 2021 (as 2021 653), no i of the fdha o of 15 nov. 2021 (as 2021 669), annex no 3 of the o of 17 dec. 2021 (as 2021 881) and no i of the fdha o of 5 jan. 2022, in force since 6 jan. 2022 (as 2022 2).(arts. 14, 15 and 33)special provisions concerning covid-19 vaccination certificates 1 start of validity and maximum duration 1.1 start of validity:a. for double-dose vaccination in accordance with numbers 3.2, 3.4 and 3.5: on the day of administration of the second dose;b. for single-dose vaccination in accordance with numbers 3.1 and 3.5: on the 22nd day after administration of the dose;c. for a vaccination in accordance with the requirements of number 3.3: on the day of administration of a dose of a vaccine in accordance with numbers 3.1 and 3.2,d. in the case of additional doses: on the day the additional dose is administered.1.2 duration of validity: a. for a vaccination in accordance with number 1.1 letter a: 365 days from the date of administration of the final dose;b. for a vaccination in accordance with number 1.1 letter b: 365 days from the 22nd day after the first dose was administered;c. for a vaccination in accordance with number 1.1 letter d: 365 days.2 details of the vaccine administered a. disease against which the vaccination was administered (covid-19)b. vaccination/prophylaxis (type of vaccine/how it works) c. immunologic agent (name of vaccine/product name)d. holder of the vaccine authorisation or, if not indicated for vaccine doses administered abroad, information on the manufacturer e. number of vaccine doses administered in a series and the total number of doses administeredf. date on which the final dose was administered3 requirements for full vaccination 3.1 a person is regarded as fully vaccinated after receiving at least one dose of the janssen ad26.cov2.s/covid-19 vaccine.3.2 a person is regarded as fully vaccinated after receiving at least two doses of the following vaccines: a. bnt162b2 / comirnaty / tozinameran;b. mrna-1273 / spikevax / moderna covid-19 vaccine;c. azd1222 / vaxzevria / astrazeneca covid-19 vaccine;d. sars-cov-2 vaccine from the sinopharm beijing institute of biological products (bibp) co., ltd.; e. coronavac (vaccine from sinovac life sciences co., ltd);f. bharat biotech covid-19 vaccine / covaxin.g. nuvaxovid / nxv-cov2373 / novavax.3.3 a person is regarded as fully vaccinated after receiving one dose of a vaccine specified in number 3.2, provided the person has already been infected with sars-cov-2. the following requirements apply when establishing that the person has been infected with sars-cov-2:a. the finding that the person has been infected must be based on one of the following tests:1. the positive result of a molecular-biological analysis for sars-cov2;2. the positive result of a sars-cov-2 rapid test for specialist use pursuant to article 24a paragraph 1 of the covid-19 ordinance 3 of 19 june 202067;3. a positive analysis for sars-cov-2 antibodies pursuant to article 16 paragraph 3.4. the positive result of a laboratory immunological analysis for sars-cov-2 antigens.b. at least 28 days must have elapsed between taking the sample and administering the vaccine.3.4 a person is regarded as fully vaccinated after receiving the following combination of vaccines:a. bnt162b2 / comirnaty / tozinameran and mrna-1273 / spikevax / moderna covid-19 vaccine;b. azd1222 / vaxzevria / astrazeneca covid-19 vaccine and bnt162b2 / comirnaty / tozinameran;c. azd1222 / vaxzevria / astrazeneca covid-19 vaccine and mrna-1273 / spikevax / moderna covid-19 vaccine.3.5 vaccines that demonstrably have the same composition but have been placed on the market by the licence holder under a different name are deemed equivalent to the vaccines specified in numbers 3.1-3.4. proof is considered to be provided for the following licensed vaccine products:a. licensed products of azd1222 / vaxzevria / astrazeneca covid-19 vaccine:- covishield / chadox1_ncov-19- covid-19 vaccine recombinant (vaccine from the fundao instituto oswaldo cruz [fiocruz])- r-covi (vaccine from r-pharma)b. licensed products of nuvaxovid / nxv-cov2373 / novavax:- nxv-cov2373 / covovax67 sr 818.101.24annex 368 68 revised by no ii para. 1 of the o of 3 nov. 2021 (as 2021 653) and by no i of the o of the fdha of 22 nov. 2021, in force since 23 nov. 2021 (as 2021 721).(arts. 17, 18 para. 1 and 33)special provisions concerning covid-19 recovery certificates 1 start of validity and maximum duration 1.1 the period of validity shall begin a. for covid-19 recovery certificates pursuant to article 16 paragraph 1: on the eleventh day after the positive result of a molecular biological analysis for sars-cov-2;b. for covid-19 recovery certificates pursuant to article 16 paragraph 3: on the day on which the sample was taken for analysis for sars-cov-2 antibodies.1.2 period of validity: a. for covid-19 recovery certificates pursuant to article 16 paragraph 1: 365 days from the date of the test result referred to in number 1.1 letter a;b. for covid-19 recovery certificates pursuant to article 16 paragraph 3: 90 days from the date on which the sample was taken in accordance with number 1.1 letter b.2 details of the disease contracted and the date of recovery 2.1 for recovery certificates pursuant to article 16 paragraph 1:a. disease from which the holder has recovered (covid-19)b. date of the first positive result of a molecular-biological analysis for sars-cov-2 c. start of validityd. end of validity2.2 for recovery certificates pursuant to article 16 paragraph 3:a. disease for which an analysis has been carried out to establish the presence of antibodies (covid-19);b. date on which the sample was taken for analysis for sars-cov-2 antibodies;c. finding (confirmed);d. facility or institution responsible for carrying out the analysis for antibodies.annex 469 69 revised by annex 3 no 3 of the covid-19 special situation ordinance of 23 june 2021 (as 2021 379), no ii of the o of 30 june 2021 (as 2021 410) and no iv of the o of 3 dec. 2021 (extension of the requirement to wear a face mask and access restrictions to persons with a certificate), in force until 24 jan. 2022 (as 2021 813) and annex no 3 of the o of 17 dec. 2021, in force since 18 dec. 2021 (as 2021 881).(arts. 20, 21 para. 2, 28a para. 4 and 33)special provisions concerning covid-19 test certificates 1 . 2 duration of validity the duration is calculated from the time the sample is taken and is as follows: a. for pcr tests: 72 hours;b. for sars-cov-2 rapid tests for specialist use: 24 hours.c. for laboratory immunological analyses for sars-cov-2 antigens: 24 hours.3 details of the test carried out a. disease tested for (covid-19)b. type of test (pcr or sars-cov-2 rapid test or laboratory immunological analysis for sars-cov-2 antigens)c. name of the test (if sars-cov-2 rapid test or laboratory immunological analysis for sars-cov-2 antigens)d. manufacturer of the test (if sars-cov-2 rapid test or laboratory immunological analysis for sars-cov-2 antigens)e. date and time of the test sample collectionf. test result (negative)g. test centre or institution where the test was carried outannex 4a70 70 inserted by no ii para. 2 of the o of 3 nov. 2021, in force since 10 jan. 2022 (as 2021 653, 813).(art. 21b and 21c)special provisions concerning covid-19 exemption certificates 1 duration of validity the certificates are valid for 365 days. 2 information provided on covid-19 exemption certificates a. start of validityb. issuing body3 statement on compliance with alternative protective measures the holder may be required to wear a face mask at events and in establishments where a certificate is required in accordance with the applicable precautionary measures plan.annex 571 71 amended by no i of the o of 7 july 2021 (as 2021 428). revised by no ii of the o of 17 sept. 2021 (as 2021 564), no i of the fdha o of 22 nov. 2021 (as 2021 721), of 21 dec. 2021 (as 2021 896) and of 5 jan. 2022, in force since 6 jan. 2022 (as 2021 2).(arts. 22, 23 paras. 1 and 2)list of recognised foreign certificates 1 recognised certificates issued by an eu member state or an efta state 1.1 vaccination, recovery and test certificates issued by an eu member state or efta state in accordance with regulation (eu) 2021/95372 and the eu legislative acts adopted on the basis thereof are recognised.1.2 vaccination certificates are recognised only if they have been issued for vaccinations with a vaccine that: a. has authorisation for the eu from the european medicines agency; b. is authorised in accordance with the who emergency use listing procedure; orc. has been shown to have the same composition as a vaccine licensed under letter a or b but is marketed by a licence holder under a different name and which has been administered in full in accordance with the requirements or recommendations of the country in which the vaccination was carried out.2 other recognised certificates 2.1 vaccination, recovery and test certificates that are interoperable in accordance with regulation (eu) 2021/953 and have been issued by the following countries are recognised:- albania- andorra- armenia- cape verde- el salvador- faroe islands- georgia- holy see- israel- morocco- moldova- monaco- montenegro- north macedonia- panama- san marino- serbia- thailand- turkey- ukraine- united kingdom- uruguay2.2 vaccination and test certificates that are interoperable in accordance with regulation (eu) 2021/953 and have been issued by the following countries are recognised:- new zealand- singapore- togo- united arab emirates2.3 vaccination certificates that are interoperable in accordance with regulation (eu) 2021/953 and have been issued by the following countries are recognised:- lebanon- tunisia2.4 vaccination certificates are only recognised if they have been issued for vaccinations with a vaccine that meets the requirements of number 1.2.72 regulation (eu) 2021/953 of the european parliament and of the council of 14 june 2021 on a framework for the issuance, verification and acceptance of interoperable covid-19 vaccination, test and recovery certificates (eu digital covid certificate) to facilitate free movement during the covid-19 pandemic, as amended by oj l 211, 15.6.2021, p. 1.

830.2 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton the institution for the administration of the swiss federal social security funds ahv, iv and eo(social security funds act)of 16 june 2017 (status as of 1 january 2019)the federal assembly of the swiss confederation, based on articles 59 paragraph 4, 61 paragraph 4, 112 paragraph 1 and 116 paragraphs 3 and 4 of the federal constitution1, and having considered the federal council dispatch dated 18 december 20152,decrees:1 sr 1012 bbl 2016 311section 1 legal form, seat and task art. 1 legal form and seat 1 a public law institution with its own legal personality is established by the confederation to administer the oasi, invi and lec (ahv/avs, iv/ai, eo/apg) social security funds.2 the institution organises itself, unless this act provides otherwise, and keeps its own accounts.3 it is run in accordance with business management principles.4 the federal council determines its seat.5 the institution is entered in the commercial register under the name compenswiss (ausgleichsfonds ahv/iv/eo) / compenswiss (fonds de compensation avs/ai/apg) / compenswiss (fondi di compensazione avs/ai/ipg) / compenswiss (fonds da cumpensaziun avs/ai/ucg).art. 2 task the institution administers the following social security funds:a.the social security fund for old age and survivors' insurance (the oasi/ahv/avs social security fund) under article 107 of the federal act of 20 december 19463 on old-age and survivors insurance (oasia/ahvg/lavs);b.the social security fund for invalidity insurance (invi/iv/ai social security fund) under article 79 of the federal act of 19 june 19594 on invalidity insurance (invia/ivg/lai);c.the social security fund for the loss of earnings compensation scheme (lec/eo/apg social security fund) under article 28 of the loss of earnings compensation act of 25 september 19525 (leca/eog/lapg).3 sr 831.104 sr 831.205 sr 834.1section 2 asset management, legal transactions and liability art. 3 asset management 1 each social security fund has its own segregated pool of assets within the institution. these are managed jointly.2 a separate investment and risk profile is to be defined for each social security fund.3 as a rule, the assets of the social security funds are jointly invested. the share of each social security fund in the jointly invested assets and in the return on investment is determined by the degree to which it participates in the individual investments.4 the assets of the social security funds must be managed in such a manner that each social security fund is guaranteed the best possible relationship between security and achieving a return consistent with market conditions in accordance with its investment and risk profile.5 each social security fund must retain sufficient liquidity at all times in order that the compensation offices:a.may be paid the clearing balances in their favour; and b.may receive the advances required to provide the statutory benefits under the oasi/ahv/avs, invi/iv/ai and lec/eo/apg.6 cross-financing between the social security funds is prohibited; the foregoing does not apply to short-term cash flows within the treasury.art. 4 legal transactions the institution may carry out any legal transactions required in order to fulfil its tasks under article 2, and in particular it may acquire and dispose of securities, other financial instruments and real estate.art. 5 liability the institution is liable for its obligations with its entire assets.section 3 organisation art. 6 management bodies the management bodies of the institution are:a.the board of directors;b.the executive board;c.the auditor.art. 7 board of directors 1 the board of directors is the supreme governing body.2 it comprises eleven qualified members, who must guarantee irreproachable business conduct. swiss employer and employee associations and the confederation must be appropriately represented.3 the federal council determines a profile of requirements for holding office on the board of directors.4 it appoints the members for a term of office of four years and names the chair and vice-chair. each member may be reappointed twice and removed at any time for good cause.5 the federal council determines the fee paid to the members of the board and their other contractual conditions. 6 the contract between the members of the board of directors and the institution is governed by public law. in addition, the provisions of the code of obligations6 apply by analogy.7 the members of the board of directors must perform their tasks and duties with all due diligence and safeguard the institution's interests in good faith. they are required to observe secrecy on official matters both during their term of office as members of the board of directors and after the termination of their mandate.8 they must disclose their interests to the federal council prior to their appointment and give immediate notice of any changes during their membership of the board. the board of directors provides information on such interests in the management report (art. 16 para. 1 let. b).6 sr 220art. 8 tasks of the board of directors 1 the board of directors has the following tasks:a.it issues the institution's organisational regulations and submits these to the federal department of home affairs (fdha) for approval. b.it issues the investment regulations and determines the investment strategy.c.it issues the institution's personnel ordinance and submits it to the federal council for approval.d.it takes organisational and contractual measures to safeguard the institution's interests and prevent conflicts of interest.e.it approves the institution's personnel budget.f.it decides on the establishment, amendment and termination of the employment relationship with the chief executive officer and the other members the executive board.g.it supervises the executive board.h.it ensures that the institution has suitable internal control and risk management systems.i.it ensures the solvency of the institution as an undertaking and of each social security fund.j.it determines the accounting policies based on the requirements laid down by the federal council in accordance with article 13 paragraph 3.k.it adopts the budget for the institution's operating and administrative expenses.l.it prepares and adopts the annual report in accordance with article 16, submits it to the federal council for approval and requests its own discharge.m.it publishes the annual report following approval by the federal council.n.it provides the general public with information on the investment performance achieved by the social security funds.o.it represents the institution as a contracting party as defined in article 32d paragraph 2 of the federal personnel act of 24 march 20007 (fpa).2 the board of directors may delegate the preparation and implementation of its decisions to individual committees and assign to them the related decision-making powers. it must ensure that appropriate reports are made to its members.7 sr 172.220.1art. 9 executive board 1 the executive board is the institution's operational management body. it is headed by a chief executive officer.2 the executive board has the following tasks in particular:a.it conducts the business.b.it prepares the business of the board of directors and of the committees.c.it prepares the budget for the institution's operating and administrative expenses.d.it reports to the board of directors regularly and in the case of special events immediately.e.it represents the institution externally.f.it decides on the establishment, amendment and termination of the employment relationships with the institution's personnel; article 8 paragraph 1 letter f is reserved.g.it performs all the tasks which are not assigned to another management body under this act, the organisational regulations or the specifications set by the board of directors.3 the organisational regulations regulate the details.4 the chief executive officer attends the meetings of the board of directors in an advisory capacity.art. 10 auditor 1 the federal council appoints the auditor at the request of the board of directors. the auditor is responsible for auditing the institution, including the annual financial statements of the oasi/ahv/avs, invi/iv/ai and lec/eo/apg. it examines the annual financial statements for asset management and confirms that internal control and risk management systems are in place; it also examines the information on personnel development disclosed in the management report (art. 16 para. 1 let. b).2 the provisions of company law on ordinary audits apply by analogy.3 the auditor provides the board of directors and the federal council with a comprehensive report on the results of its audit. 4 the institution must ensure that the contractual terms governing its business relationships with custodian banks provide the auditor with access to the relevant results of the external audit conducted in respect of such banks. provided it has been contractually arranged, the institution's auditor may instruct the custodian banks' auditor to conduct additional audits.section 4 personnel art. 11 employment terms 1 the executive board and other personnel are subject to the fpa8.2 the institution is an employer as defined in article 3 paragraph 2 fpa.3 the board of directors regulates in the institution's personnel ordinance in particular the salaries, the fringe benefits and the other contractual conditions. 8 sr 172.220.1art. 12 occupational pension scheme the executive board and other personnel are insured with publica in accordance with articles 32a-32m fpa9.9 sr 172.220.1section 5 accounts, administrative expenses, annual report and taxes art. 13 financial reporting 1 the financial statements present a true and fair view of the institution's financial position and performance.2 they comply with generally accepted accounting standards, and in particular the principles of materiality, completeness, comprehensibility, consistency and gross presentation.3 the federal council may issue regulations on financial reporting.4 the accounting polices derived from the accounting standards must be disclosed in the notes to the balance sheet.art. 14 accounting 1 the institution is responsible for keeping accounts for its asset management, including the related operating and administrative expenses. it assigns the financial result to each of the three social security funds on a monthly basis in proportion to their share in the relevant investments.2 the institution prepares aggregated financial statements; it does so on the basis of the annual financial statements for the oasi/ahv/avs, invi/iv/ai and lec/eo/apg prepared by the central compensation office in accordance with article 71 paragraph 1bis oasia/ahvg/lavs10.10 sr 831.10art. 15 operating and administrative expenses the institution's operating and administrative expenses are charged to the three social security funds in proportion to their total assets.art. 16 annual report 1 the annual report contains:a.the institution's annual financial statements;b.the institution's management report;c.the separate financial statements for the oasi/ahv/avs, invi/iv/ai and lec/eo/apg prepared by the central compensation office in accordance with article 71 paragraph 1bis oasia/ahvg/lavs11.2 the annual financial statements of the institution and the three social insurance schemes comprise the balance sheet, the income statement and the notes. the institution's annual financial statements provide information on the status and development of investments in particular.3 the institution's management report contains in particular information on risk management, personnel development and the interests of the members of the board of directors in accordance with article 7 paragraph 8.4 the board of directors completes the annual report at the end of the calendar year11 sr 831.10art. 17 taxes the institution is exempt from direct federal, cantonal and communal taxes and from cantonal and communal inheritance and gift taxes. the levying of capital gains tax on real estate that has no necessary and direct relationship with the administrative activities of the social security funds is reserved.section 6 supervision art. 18 1 the institution is subject to administrative supervision by the federal council. 2 the federal council exercises its supervision in particular by:a.appointing and removing the members of the board of directors, its chair and vice-chair;b.approving the institution's personnel ordinance;c.approving the annual report;d.discharging the board of directors.3 it may at any time inspect any of the institution's business documents and request information on its business operations.4 the fdha may have specific matters clarified by the auditor.5 the institution communicates with the federal council via the fdha.section 7 final provisions art. 19 establishment of the institution 1 the oasi/ahv/avs, invi/iv/ai and lec/eo/apg social security funds will be transferred into the institution and lose their legal personality. at the same time, the institution will acquire its own legal personality. the institution will take over the existing legal relationships and amend these where required.2 the federal council determines the date of transfer. it approves the opening balance sheet of the institution, makes all the decisions required for the transfer and takes any further measures required to this effect.3 the transfer of the three social security funds and the establishment of the institution are exempt from any direct or indirect federal, cantonal or communal taxes. entries in the land register, commercial register and any other public registers in connection with the carrying out of the transfer are exempt from taxes and fees.4 the provisions of the mergers act of 3 october 200312 do not apply to the establishment of the institution.12 sr 221.301art. 20 transfer of employment relationships 1 the employment relationships of the personnel of the current management office will be transferred to the institution on the date determined by the federal council and become subject to the legislation governing its personnel from that date.2 the institution will replace existing contracts with contracts issued in the name of the new employer within a reasonable time. no probationary periods may be included therein.3 there is no right to the continuation of any function, field of work, place of work or position within the organisational system. however, the personnel remain entitled to their current salary for a period of one year. the years of service completed for the oasi/ahv/avs, invi/iv/ai and lec/eo/apg social security funds before this act comes into force will be taken into account.4 appeals by the personnel that are pending on the date of transfer of the employment relationships will be judged according to the previous law.art. 21 competent employer 1 the institution is deemed to be the responsible employer for employees and beneficiaries of pensions:a.who were assigned to the management office under the previous law; andb.who began to draw an old age, survivors' or invalidity pension from publica under the occupational pension scheme before this act entered into force.2 the institution is also deemed to be the responsible employer where an invalidity pension is not drawn until after this act enters into force but where the incapacity to work, the cause of which subsequently led to the invalidity, occurred before this act entered into force.art. 22 debts owed by the invi/iv/ai social security fund to the oasi/ahv/avs social security fund 1 until the invi/iv/ai scheme is completely clear of debt, that portion of cash and cash equivalents and investments held by the iv/ai social security fund which exceeds 50 per cent of its annual expenditure at the end of the financial year will be credited to the oasi/ahv/avs social security fund.2 in derogation of article 78 invia/ivg/lai13, the confederation will bear the annual interest expense on the invi/iv/ai losses carried forward for the period from 1 january 2011 until 31 december 2017.3 from 1 january 2018, the board will set a market-based rate of interest for the debts owed by the invi/iv/ai social security fund to the oasi/ahv/avs social security fund.13 sr 831.20art. 23 repeal and amendment of other legislation the repeal and amendment of other legislation are regulated in the annex.art. 24 referendum and commencement 1 this act is subject to an optional referendum.2 the federal council determines the date on which this act comes into force.commencement date:14 1 january 2018 article 1 paragraphs 1-3 and 5, 2-5, 8 paragraph 1 letters l-n, 11, 12, 14, 16, 19 paragraph 1, 21 and annex number i, number ii 1 and 3-6: 1 january 2019.14 fcd of 22 nov. 2017.annex (art. 23)repeal and amendment of other legislation ithe federal act of 13 june 200815 on the reform of invalidity insurance is repealed.iithe enactments below are amended as follows:.1615 [as 2010 3835 3839]16 the amendments may be consulted under as 2017 7563.

910.124 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.eaer ordinance on the minimum requirements for control procedures of protected designations of origin and geographical indications(ordinance on the control of pdos and pgis)of 11 june 1999 (status as of 1 january 2017)the federal department of economic affairs, education and research (eaer)1,on the basis of article 18 paragraph 2 of the pdo/pgi ordinance of 28 may 19972,ordains:1 the name of this administrative unit was amended by art. 16 para. 3 of the publications ordinance of 17 nov. 2004 (as 2004 4937) on 1 jan. 2013. the amendment has been made throughout the text.2 sr 910.12art. 1 minimum requirements for control procedures the certification body must:a.3carry out an initial authorisation of all production, processing and refining undertakings;b.verify the flow of goods;c.control the correct use of the traceability marks;d.ensure that processing requirements are complied with;e.oversee final product testing.3 amended by no i of the eaer ordinance of 29 oct. 2014, in force since 1 jan. 2015 (as 2014 3907).art. 2 frequency of control procedures 1 the certification body shall control the structural requirements in the context of the initial authorisation procedure.42 control procedures relating to the flow of goods, traceability and processing requirements shall take place at least every two years for each processing and refining undertaking, or every four years in the case of summer pasture holdings. for production undertakings, such procedures shall be carried out on the basis of a statistically representative random sample.53 in the case of the protected geographical indications (pgis), testing of the final product shall be carried out once annually on the basis of a statistically representative sample of undertakings. in the case of protected designations of origin (pdos), these tests will take place at least once per year in every production, processing or refining undertaking which markets the final product. where an undertaking markets the production of several operators, testing of the final product should be performed on a random sample of lots of each operator.64 undertakings where irregularities are found are subject to retesting on a systematic basis.4 amended by no i of the eaer ordinance of 29 oct. 2014, in force since 1 jan. 2015 (as 2014 3907).5 amended by no i of the eaer ordinance of 29 oct. 2014, in force since 1 jan. 2015 (as 2014 3907).6 amended by no i of the eaer ordinance of 29 oct. 2014, in force since 1 jan. 2015 (as 2014 3907).art. 3 structural and process requirements7 the product specification includes the following requirements essential to the character of the product:a.requirements with regard to the technical installations (structural requirements); andb.requirements with regard to the production, processing and refining process (process requirements).7 amended by no i of the eaer ordinance of 29 oct. 2014, in force since 1 jan. 2015 (as 2014 3907).art. 4 traceability mark the traceability marking is an indelible mark which must be affixed to every individual product and which allows for the identification of the batch and the producer. where it is not suitable to affix the label to the product itself, the traceability mark may be placed on the packaging of the product which is ready for consumption.art. 58 final product testing 1 in the case of agricultural products and processed agricultural products, testing of the final product shall comprise physical and chemical testing, as well as an organoleptic test.2 the organoleptic test is to verify the product's conformity with the sensory description in the product specification.3 in the case of forestry products and processed forestry products, testing of the final product shall comprise testing of the physical and other characteristic properties.4 the responsibility for sampling is that of the certification body. the certification body is also responsible for organoleptic testing, which shall be conducted by the applicant group.8 amended by no i of the eaer ordinance of 16 sept. 2016, in force since 1 jan. 2017 (as 2016 3289).art. 6 reporting the certification body shall provide an annual report to the federal office for agriculture for each protected indication, containing the following information:a.the list of undertakings under review, categorized by production, processing and refining;b.the total amount of products marketed with the protected indication;c.the number and the type of corrective measures enacted and any suspension of certificates for each protected indication.art. 7 access to undertakings and documentation the certification body shall ensure that it receives:a.unrestricted access to the undertakings;b.access to any documents of use to it in the context of certification.art. 8 control manual 1 the certification body or the certification bodies shall clarify, in a control manual, the procedures under the present ordinance, together with the groups who have applied for registration of a pdo or a pgi.2 the control manual shall be an integral component of the quality assurance scheme of the certification body or the certification bodies.3 the latest version of the quality assurance scheme shall be deposited with the federal office for agriculture.art. 9 commencement this ordinance comes into force on 1 july 1999.

921.01english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon forest(forest ordinance, foro)of 30 november 1992 (status as of 1 july 2021)the swiss federal council,on the basis of article 49 of the forest act of 4 october 19911 (fora), and article 29 of the environmental protection act of 7 october 19832,ordains:1 sr 921.02 sr 814.01chapter 1 definition of forest art. 1 definition of forest (art. 2 para. 4 fora)1 the cantons shall define the parameters according to which a wooded area is defined as forest, within the following ranges:a. area, including an appropriate forest margin: 200-800 m2;b. width, including an appropriate forest margin: 10-12 m;c. age of stands in newly colonised areas: 10-20 years.2 if the stand fulfils particularly important social or protective functions, it is defined as forest, irrespective of its area, its width or its age.art. 2 wooded pastures (art. 2 para. 2 fora)wooded pastures are areas consisting of a mosaic of wooded areas and open pastures and which fulfil both livestock husbandry and forestry purposes.art. 3 check dams and foreground (art. 2 para. 3 fora)1 check dams are structures that hinder the natural flow of water and create a backwater.2 the immediate foreground of a check dam is the terrain bordering the installation on the airside. it normally covers a 10-metre-wide strip.chapter 2 protection of the forest against intervention section 1 deforestation art. 4 definition (art. 4 and 12 fora)the following are not defined as deforestation:a. the use of forest land for forestry buildings and installations and for small structures and installations not used for forestry purposes;b. the allocation of forest to a protection zone in accordance with article 17 of the spatial planning act of 22 june 19793 (spa), if the protection objective is compatible with forest conservation.3 sr 700art. 54 deforestation application, publication and consultation 1 in the case of works for which the confederation is the competent authority, the deforestation application must be submitted to the lead federal authority, and in the case of works for which the canton is the competent authority, the deforestation application must be submitted to the competent authority under cantonal law.2 the authority shall publish the application and provide access to the files for consultation.3 the federal office for the environment5 (the foen6) shall issue guidelines on the contents of a deforestation application.4 amended by no ii 17 of the o of 2 feb. 2000 (coordination and simplification of decision-making procedures), in force since 1 march 2000 (as 2000 703).5 the designation of the administrative entity was amended according to art. 16 para. 3 of the publication ordinance of 17 nov. 2004 (as 2004 4937).6 name in accordance with no i 5 of the o of 28 jan. 2015 on the amendment of ordinance law on the environment, in particular with regard to the programme agreements for the programme period 2016-2019, in force since 1 jan. 2016 (as 2015 427). this change has been made throughout the text.art. 67 cooperation between the federal authority and the cantons 1 if the confederation is responsible for the deforestation permit, the cooperation between the foen and the cantons is subject to article 49 paragraph 2 fora. the cantons shall support the federal authorities in the clarification of the facts.2 included in the calculation of the deforestation area, based on which the obligation to hear the foen (art. 6 para. 2 fora) is determined, are all deforestation areas that:a. are included in the deforestation application;b. were deforested for the same works in the 15 years previous to the submission of the deforestation application, or for which deforestation is still allowed.7 amended by no ii 17 of the o of 2 feb. 2000 (coordination and simplification of decision-making procedures), in force since 1 march 2000 (as 2000 703).art. 7 deforestation decision 1 the deforestation decision covers the following:a. the areas in which deforestation is authorised or refused and the affected plots with specification of the coordinates;b. the nature and scope of the compensatory measures and the affected plots with specification of the coordinates;c. the deadlines for the use of the deforestation permit and for the fulfilment of the obligations associated with the deforestation, in particular those involving compensatory measures;d. the unresolved objections;e. any further conditions and requirements.2 the foen shall keep statistics on the deforestation projects authorised by the confederation and the cantons. the cantons shall make the necessary information available to the foen.88 inserted by no ii 17 of the o of 2 feb. 2000 (coordination and simplification of decision-making procedures), in force since 1 march 2000 (as 2000 703).art. 8 compensation in kind (art. 7 para. 1 fora)91 compensation in kind is made by creating an area of forest of the same size in a location offering qualitatively similar conditions to the deforested area.2 compensation in kind includes the acquisition of the land, the planting and all of the measures necessary for the long-term safeguarding of the compensatory area.3 areas in which forest is expanding and voluntarily afforested areas which have not yet become forest may be recognised as compensation in kind.9 amended by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983).art. 8a10 areas with increasing forest area (art. 7 para. 2 let. a fora)the cantons shall designate areas with increasing forest area after consulting the foen. their boundaries shall be based on federal and cantonal surveys, in principle following topographical features and taking account of existing settlements and uses.10 inserted by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983).art. 9 conservation of arable land and areas of ecological or landscape value (art. 7 para. 2 let. b fora)111 compensation in kind may be dispensed with in particular in the case of crop rotation areas.122 areas of particular ecological value are, in particular:a. biotopes in accordance with article 18 paragraph 1bis of the federal act of 1 july 196613 on the protection of nature and cultural heritage;b. areas designated as nature protection areas in accordance with article 17 spa14.3 areas of particular landscape value are, in particular:a. objects of national importance in accordance with the ordinance of 10 august 197715 on the federal inventory of landscapes and natural monuments of national importance;b. mire landscapes of outstanding beauty and national importance in accordance with article 24sexies paragraph 5 of the federal constitution of the swiss confederation16;c. areas designated as landscape protection zones in accordance with article 17 spa.11 amended by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983).12 amended by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983).13 sr 45114 sr 70015 [as 1977 1962, 1983 1942, 1996 3264, 1998 788, 2010 1593 annex no 2. as 2017 2815 art. 11]. see now: the o of 29 mrch 2017 (sr 451.11).16 [bs 1 3; as 1988 352]. the specified provision now corresponds to art. 78 para. 5 of the federal constitution of the swiss confederation of 18 april 1999 (sr 101).art. 9a17 dispensing with compensation for deforestation (art. 7 para. 3 let. b fora)compensation for deforestation may be dispensed with in the case of projects to guarantee flood protection and the rehabilitation of waters in particular in the case of areas that can no longer be stocked as forest.17 inserted by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983).art. 1018 18 repealed by no i of the o of 14 june 2013, with effect from 1 july 2013 (as 2013 1983).art. 11 record in the land register and notification 1 at the request of the competent cantonal forest authority, a record must be made in the land register of the obligation to provide:19a. compensation in kind or measures for the benefit of nature and landscape conservation;b. retrospective compensation for deforestation in the event of a change of use in accordance with article 7 paragraph 4 fora.202 the cantons shall monitor all compensatory measures and notify the foen of the final approval of the works.19 amended by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).20 amended by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983).section 2 declaration as forest21 21 amended by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983). art. 12 ruling on declaration as forest (art. 10 para. 1 fora)221 the ruling on declaration as forest records whether a stocked or unstocked area is a forest or not and specifies its coordinates.2 it specifies on a map the location and size of the forest and the location of the affected plots.22 inserted by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983).art. 12a23 specification of static forest boundaries outside development zones (art. 10 para. 2 let. b fora)areas where the canton wants to prevent an increase in forest must be specified in the cantonal structure plan.23 inserted by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983).section 3 motorised vehicular traffic (art. 15 para. 1 fora)art. 13 1 forest roads may be accessed by motorised vehicular traffic for the following purposes:a. for rescue and recovery purposes;b. for police controls;c. for military exercises;d. for the implementation of measures for the protection against natural events;e.24 for the maintenance of the network lines of the providers of telecommunications services.2 the rest of the forest may only be accessed by motorised vehicular traffic if such access is unavoidable for the fulfilment of a purpose in accordance with paragraph 1.3 events involving vehicular motorised traffic are prohibited on forest roads and in the rest of the forest.24 amended by no ii 61 of the o of 1 dec. 1997, in force since 1 jan. 1998 (as 1997 2779).section 4 buildings and installations in the forest 25 25 amended by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983). art. 13a26 forest structures and installations (art. 2 para. 2 let. b and 11 para. 1 fora)1 forest structures and installations, such as forest maintenance depots, log stores, covered wood fuel stores and forest roads may be constructed or altered with official permission in accordance with article 22 spa27.282 a requirement for permission is that:a. the structures and installations facilitate regional forest management;b. a need is proven for the structures and installations, their location is suitable and their size is adapted to regional conditions; andc. there is no overriding public interest in refusing permission.3 other requirements under federal or cantonal law also apply.26 inserted by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983).27 sr 70028 amended by no i of the o of 12 may 2021, in force since 1 july 2021 (as 2021 294).art. 14 consultation of the cantonal forest authority (art. 11 para. 1 and 16 fora)291 the granting of permission for the construction of forestry buildings or installations in the forest in accordance with article 22 spa30 is subject to a hearing of the competent cantonal forestry authority.2 exceptional permission for the construction of small structures and installations in the forest that are not used for forestry purposes in accordance with article 24 spa may only be granted in agreement with the competent cantonal forestry authority.29 inserted by no i of the o of 14 june 2013, in force since 1 july 2013 (as 2013 1983).30 sr 700chapter 3 protection against natural events art. 15 basic documentation 1 the cantons shall compile the basic documentation required for protection. they shall:a. keep inventories of buildings and installations that that are of relevance in providing protection against natural events (protective structure register);b. document events causing damage (event register) and analyse, if required, larger events causing damage;c. prepare hazard maps and emergency plans for potential events, and update these regularly.312 when compiling this basic documentation, they shall take into account the work carried out by specialist federal agencies and their technical guidelines.3 the cantons shall take account of this documentation in all their activities with a spatial impact, in particular structural and land-use planning.4 they shall make this documentation available to the foen on request and make then accessible to the general public in a suitable form.3231 amended by no i 5 of the o of 28 jan. 2015 on the amendment of ordinance law on the environment, in particular with regard to the programme agreements for the programme period 2016-2019, in force since 1 jan. 2016 (as 2015 427).32 inserted by no i 21 of the o of 7 nov. 2007 on the new system of financial equalisation and division of tasks between the confederation and the cantons (as 2007 5823). amended by annex 2 no 13 of the o of 21 may 2008 on geoinformation, in force since 1 july 2008 (as 2008 2809).art. 16 early warning services 1 where necessary for the protection of human life and significant material assets, the cantons shall set up early warning services. they shall ensure the development and operation of the related monitoring stations and information systems.2 when setting up and operating the early warning services, they shall take into account the work carried out by specialist federal agencies and their technical guidelines.3 they shall ensure that the data from the monitoring stations and information systems are made available to the foen on request, and are made accessible to the general public in a suitable form.3333 inserted by no i 21 of the o of 7 nov. 2007 on the new system of financial equalisation and division of tasks between the confederation and the cantons (as 2007 5823). amended by annex 2 no 13 of the o of 21 may 2008 on geoinformation, in force since 1 july 2008 (as 2008 2809).art. 17 securing of hazard areas (art. 19 fora)1 the securing of hazard areas includes:a. silvicultural measures;b. structural measures for the prevention of damage due to avalanches, as well as, in exceptional cases, the erection of installations for preventive avalanche release;c. accompanying measures in torrents channels which are linked to forest conservation (torrent control works in forests);d. landslide and gully control structures, the corresponding drainage works and erosion protection;e. rockfall and rock avalanche control structures, retention structures, as well as, in exceptional cases, the preventive release of material at risk of falling;f. the removal to a safe location of buildings and installations at risk.2 the works shall if possible be combined with biological engineering and silvicultural measures.3 the cantons shall ensure that planning is integrated; in particular, the planning shall balance the interests of forest management, nature and landscape protection, hydraulic engineering, agriculture and spatial planning.chapter 4 maintenance and use of the forest section 1 forest management art. 18 forestry planning (art. 20 para. 2 fora)1 the cantons shall issue regulations for the planning of forest management. these shall define, in particular:a. the types of plans and their content;b. the instances responsible for planning;c. the planning goals;d. how the planning data are acquired and used;e. the planning and control procedures;f. the regular reviewing of the plans.2 the forestry planning documents must describe, at least, the location conditions as well as the forest functions and their importance.3 in the case of interoperational planning, the cantons shall ensure that the population:a. is informed of the goals and progress of the planning;b. may be involved in a suitable manner;c. may inspect it.4 they shall take account of the spatial impact of forestry planning in their structural planning.3434 inserted by no i 5 of the o of 28 jan. 2015 on amendments to the ordinance law on the environment, in particular in relation to the programme agreements for the programme period 2016-2019, in force since 1 march 2015 (as 2015 427).art. 19 silvicultural measures (art. 20 fora)1 all maintenance interventions that contribute to the conservation or restoration of the stability and the quality of a stand are classified as silvicultural measures.2 measures carried out as part of young forest maintenance are:a.35 young growth maintenance, thicket maintenance and stem thinning in order to create resistant and adaptable stands suitable to the location;b. specific measures to maintain regrowth in selection forests, in other multi-layered forests, in coppices with standards and coppice forests as well as in multi-layered forest margins;c. protective measures against damage caused by game;d. the creation of paths in areas of difficult access.3 thinning and regeneration measures are:a. slash removal and the creation of new stands and the necessary accompanying measures;b. wood harvesting and transport.4 minimum maintenance measures for conserving the protective function of the forest are maintenance interventions that are restricted to ensuring the long-term stability of the stand; felled wood is used locally or left on site, as long as it does not pose a risk.35 amended by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).art. 20 clearcutting (art. 22 fora)1 clearcutting is the complete or almost complete removal of a stand, which gives rise to ecological conditions similar to those on open lands in the cutting area or causes serious detrimental effects to it or to the nearby stands.2 clearcutting does not arise, if the old stand is cleared following sufficient and secured regeneration.section 2 forest reproductive material art. 21 production and use (art. 24 fora)1 the cantons shall guarantee the supply of appropriate suitable forest reproductive material.2 the competent cantonal forest authority shall select the forests stands, from which forest reproductive material may be obtained. it shall notify the seed stands to the foen.3 it shall control the commercial and industrial production of seeds and plant parts and issues certificates of origin.4 only forest reproductive material of certified origin may be used for forestry purposes.5 the foen shall advise the cantons about:a. the production, supply and use of forest reproductive material;b. the safeguarding of genetic diversity.6 it keeps a register of the seed stands and a register of the genetic reserves.art. 22 import and export (art. 24 fora)1 the import of forest reproductive material requires the authorisation of the foen.2 the authorisation is granted if:a. the forest reproductive material is appropriate for cultivation and its origin is confirmed by an official certificate; orb. the importer declares in writing that the reproductive material will be used exclusively outside of the forest.2bis the authorisation to import genetically modified forest reproductive material is regulated by the release ordinance of 10 september 200836; the terms of reference of the present ordinance are also applicable.373 the federal department of the environment, transport, energy and communications38 (detec39) shall enact regulations on the issuing of export documents for forest reproductive material.36 sr 814.91137 inserted by art. 51 no 3 of the plant protection ordinance of 28 feb. 2001 (as 2001 1191). amended by annex 5 no 16 of the release ordinance of 10 sept. 2008, in force since 1 oct. 2008 (as 2008 4377).38 the designation of the administrative entity was amended according to art. 16 para. 3 of the publications ordinance of 17 nov. 2004 (as 2004 4937).39 name in accordance with no i 5 of the o of 28 jan. 2015 on the amendment of ordinance law on the environment, in particular with regard to the programme agreements for the programme period 2016-2019, in force since 1 jan. 2016 (as 2015 427). this change has been made throughout the text.art. 23 business management (art. 24 fora)1 public and private seed extractories, tree nurseries, forest gardens and retailers must keep a record of the origin, processing, breeding and supply of forest reproductive material as well an inventory of such material.2 they shall inform the purchasers of forest reproductive material of its classification and origin in their quotations, on their goods and in their invoices.3 the foen shall control their business management. it may require the assistance of the cantons for this.art. 24 technical provisions 1 detec shall issue an ordinance on the implementation of the provisions of this section.2 it may allow, for scientific purposes, the import and use of forest reproductive material, the suitability and origin of which are not proven.section 3 use of environmentally hazardous substances art. 2540 the exceptional use of environmentally hazardous substances in the forest is governed by the ordinance on chemical risk reduction of 18 may 200541.40 amended by no ii 21 of the o of 18 may 2005 on the repeal and amendment of ordinances in connection with the commencement of the chemicals act, in force since 1 aug. 2005 (as 2005 2695).41 sr 814.81art. 26 and 2742 42 repealed by no ii 21 of the o of 18 may 2005 on the repeal and amendment of ordinances in connection with the commencement of the chemicals act, with effect from 1 aug. 2005 (as 2005 2695).section 4 prevention and remediation of forest damage art. 2843 principles (art. 26 fora)1 forest damage is damage that poses a considerable threat to the function of the forest and that is caused by: a. natural events such as storms, forest fires or drought; b. harmful organisms such as certain viruses, bacteria, larvae, insects, fungi or plants.2 particularly harmful organisms shall be monitored and controlled in accordance with the provisions of the plant health ordinance of 30 october 201844.4543 amended by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).44 sr 916.2045 amended by annex 8 no 7 of the plant health ordinance of 31 oct. 2018, in force since 1 jan. 2020 (as 2018 4209).art. 2946 prevention and remediation of forest damage (art. 27 para. 1 fora)the cantons shall take measures to prevent and remediate forest damage, in particular:technical and silvicultural measures to prevent and combat fire;measures to reduce the physical load applied to the soil;measures to monitor and combat harmful organisms with the aim of eradicating or curbing them or restricting the damage they cause.46 amended by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).art. 3047 coordination, information and advice (art. 26 para. 3 and 27a para. 2 fora)1 the foen shall establish the principles for the prevention and remediation of forest damage. it shall coordinate the cross-cantonal measures and where necessary shall itself establish such measures.2 the swiss federal institute for forest, snow and landscape research (wsl) has the following tasks:a. it organises, together with the cantonal forestry services, the collection of data of relevance to forest protection;b. it provides information about the occurrence of harmful organisms and other factors that may damage the forest;c. it advises the cantonal forestry services in matters of forest protection.47 amended by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).section 5 damage caused by game (art. 27 para. 2 fora)art. 31 1 where game damage arises despite the regulation of game populations, a plan shall be developed for its prevention.2 the plan shall include forestry measures, hunting measures, measures to improve and protect habitats against disturbance, and a performance review.483 the plan is a component of the forestry planning.48 amended by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).chapter 5 training and basic data49 49 amended by annex 2 no 13 of the o of 21 may 2008 on geoinformation, in force since 1 july 2008 (as 2008 2809). section 1 basic training and continuing education and training art. 3250 theoretical and practical basic and continuing education and training (art. 29 para. 1 and 2 fora)1 the foen shall ensure, together with the universities, the cantons and other organisations, institutions, and professional associations concerned, that the knowledge and skills acquired during education and training are maintained, and that forestry engineers are introduced to new theoretical and practical advances.2 the cantons shall offer sufficient places for practical continuing education and training and coordinate this offer with each other. practical continuing education and training shall in particular:a. focus on forest planning, forest management and forest conservation in the context of all forest functions;b. aim to improve management skills and administrative knowledge;c. be attested by a certificate detailing the acquired skills and knowledge.50 amended by no i of the o of 17 aug. 2016, in force since 1 jan. 2018 (as 2016 3215).art. 3351 forestry personnel (art. 29 para. 4 and 51 para. 2 fora)1 the cantons shall provide:a. the higher vocational training of forest wardens and operate the professional colleges required for this purpose;b. together with the responsible organisations, the working environment for the continuing professional education and training of forestry personnel.2 in accordance with articles 19 paragraph 1, 28 paragraph 2 and 29 paragraph 3 of the vocational and professional education and training act of 13 december 200252 (vpeta), the enactment or approval of regulations in the field of forestry education and training shall be subject to a hearing of the foen.51 amended by annex no ii 2 of the vocational and professional education and training ordinance of 19 nov. 2003, in force since 1 jan. 2004 (as 2003 5047).52 sr 412.10art. 3453 worker safety (art. 21a and 30 fora)1 the cantons shall work with agricultural and forestry organisations to organise courses to improve worker safety during wood harvesting for workers with no forestry training.2 federally recognised courses must provide basic skills in worker safety, in particular the correct and safe felling of trees, removal of branches, and the scoring and dragging of trees and tree trunks. such courses must run for at least 10 days in total.53 amended by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).art. 35 coordination and documentation (art. 29 para. 1 fora)1 .542 the foen shall operate a central coordination and documentation agency for measures concerning forestry education and training.54 repealed by no i 7.4 of the o of 9 nov. 2011 (review of extra-parliamentary commissions), with effect from 1 jan. 2012 (as 2011 5227).section 2 . art. 36 and 3755 55 repealed by no i 7.4 of the o of 17 aug. 2016, with effect from 1 jan. 2018 (as 2016 3215).section 356 surveys 56 inserted by annex 2 no 13 of the o of 21 may 2008 on geoinformation, in force since 1 july 2008 (as 2008 2809). art. 37a57 (art. 33 and 34 fora)1 the foen is responsible for the collection of survey data on the forest.2 in cooperation with the wsl, it surveys:a. by means of the national forest inventory, the basic data relating to the locations, functions and condition of the forest;b. the long-term development processes in natural forest reserves.3 as part of its basic remit, the wsl shall conduct long-term research programmes to survey the pressure on the forest ecosystem.4 the foen shall inform the authorities and the general public about these surveys.57 amended by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).section 458 timber production 58 inserted by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215). art. 37b marketing and use of sustainably produced timber (art. 34a fora)1 the marketing and use of sustainably produced timber shall be promoted only in pre-competitive circumstances not relating to one particular company. 2 in particular, innovative research and development projects that promote sustainable forest management by improving data, opportunities for marketing and use, resource efficiency or public relations may be promoted.3 results and findings relating to the supported activities shall be made available to the foen on request. art. 37c use of timber in federal buildings and installations (art. 34b fora)1 in the planning, construction and operation of federal buildings and installations the use of timber and timber products shall be promoted. 2 the sustainability of timber and timber products shall be assessed in accordance with existing guidelines and recommendations such as those issued by the coordination coordination group for construction and property services.chapter 659 financial assistance (excluding investment credits) and compensatory payments 59 amended by no i 21 of the o of 7 nov. 2007 on the new system of financial equalisation and division of tasks between the confederation and the cantons, in force since 1 jan. 2008 (as 2007 5823).section 1 general provisions60 60 amended by no 1 5 of the o of 28 jan. 2015 on the amendment of ordinance law on the environment, in particular with regard to the programme agreements for the programme period 2016-2019, in force since 1 jan. 2016 (as 2015 427). (art. 35 fora)art. 38 general precondition for awarding federal aid (art. 35 para. 2 fora)financial assistance and compensatory payments are only provided by the confederation if:a. the measures comply with the forestry planning;b. the measures are necessary and appropriate;c. the measures satisfy the applicable technical, economic and ecological requirements;d. the other requirements of federal law are fulfilled;e. coordination with the public interests of other sectors is ensured;f. further maintenance is guaranteed.art. 38a61 attributable costs 1 for compensatory payments under articles 39 paragraph 1 and 2 and 40 paragraph 1 letter c, costs are attributable only if they are in fact incurred and are directly required for the proper fulfilment of the task for which a contribution is due. they include the costs of planning, acquisition of land and implementation, as well as marking costs.2 not attributable are in particular charges and taxes and costs that can be passed on to third parties who are significant beneficiaries or originators of damage.61 inserted by no 1 5 of the o of 28 jan. 2015 on the amendment of ordinance law on the environment, in particular with regard to the programme agreements for the programme period 2016-2019, in force since 1 jan. 2016 (as 2015 427).section 2 measures art. 3962 protection against natural events (art. 36 fora)1 compensatory payments for the measures and the compilation of basic documentation on natural events are normally allocated on a global basis. the level of the global compensatory payments is negotiated between the foen and the canton concerned and is based on:a. the hazard and damage potential;b. the scope and the quality of the measures and of their planning.2 compensatory payments may be awarded on a case by case basis, if the measures:a. have a supracantonal dimension;b. concern protected areas or objects listed in national inventories;c. require particularly complex or expert assessment due to the possible alternatives or for other reasons; ord. were unforeseeable.3 the contribution to the costs of the measures in accordance with paragraph 2 amounts to 35 to 45 per cent of the cost of the measures and is based on:a. the hazard and damage potential;b. the degree of implementation of a comprehensive risk assessment;c. the scope and the quality of the measures and of their planning.4 if a canton incurs considerable expenses due to exceptional protective measures, in particular following damage caused by bad weather, the contribution under paragraph 3 may be increased exceptionally to a maximum of 65 per cent of the cost of the measures.5 no compensatory payments are awarded for:a.63 measures required for the protection of buildings and installations which at the time of construction:1. were in already designated hazard zones or known hazard areas, and2. are not necessarily attached to that location;b. measures for the protection of tourist buildings and installations, such as cableways, ski lifts, ski runs or hiking trails, that are situated outside of the inhabited area.62 amended by no i 3 of the o of 2 feb. 2011 (development of programme agreements in the environment sector), in force since 1 march 2011 (as 2011 649).63 amended by no 1 5 of the o of 28 jan. 2015 on the amendment of ordinance law on the environment, in particular with regard to the programme agreements for the programme period 2016-2019, in force since 1 jan. 2016 (as 2015 427).art. 40 protective forest (art. 37 fora)1 the level of the global compensatory payments awarded for measures required to enable the protective forest to fulfil its protective function is based on:a. hazard and damage potential;b. the number of hectares of the protective forest to be maintained;c. the scope and the planning of the infrastructure required for the maintenance of the protective forest;d. the quality of the services provided.2 the amount is negotiated between the foen and the canton concerned.3 the contribution awarded by ruling to the costs of projects resulting from exceptional natural events shall not exceed 40 per cent of the costs and shall be in accordance with paragraph 1 letters a, c and d.6464 inserted by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).art. 40a65 measures against forest damage outside the protective forest (art. 37a fora)1 the amount of global financial assistance for measures to prevent and mitigate forest damage outside the protective forest is determined by:a. the degree of threat to forest functions; b. the number of hectares over which measures are taken;c. the quality of the services.2 the foen and the cantons concerned shall negotiate the amount.3 financial assistance may be awarded in individual cases in which the measures were unforeseeable and particularly costly. the amount shall not exceed 40 per cent of the costs and is determined in accordance with paragraph 1 letters a and c.65 inserted by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215). see also the transitional provisions to these amendments at the end of this text. art. 40b66 compensation of costs (art. 37b fora)1 compensation may be paid in cases of hardship if individuals are particularly badly effected and cannot be expected to meet the cost of the damage themselves.2 applications for compensation are to be submitted, with reasons given, once the damage has been ascertained but no later than one year after the measures have been put in place by the competent cantonal authorities.3 no compensation is paid for loss of yield or immaterial damage.4 the confederation shall reimburse the cantons between 35 and 50 per cent of the cost of compensation payments in accordance with the provision on global financial assistance in article 40a.66 inserted by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).art. 41 biological diversity of the forest (art. 38 para. 1 fora)671 the level of global financial assistance for measures that contribute to the maintenance and improvement of the biological diversity of the forest is based on:the number of hectares of forest reserves that are to be designated and maintained;b.68 .c. the number of hectares of habitats to be maintained, in particular the forest margins, which provide habitat connectivity; d. the extent and quality of the measures for the promotion of animal and plant species, the conservation of which is a matter of priority for biological diversity;e.69 the number of hectares outside forest reserves to be designated as areas with a high proportion of old wood and deadwood or with sufficient trees demonstrating characteristics that are of particular value to biological diversity (biotope tree);f. the number of hectares of the forms of forest cultivation to be maintained, such as wooded pastures, coppices with standards and coppice forests and chestnut or walnut groves;g. the quality of the services provided.2 the amount is negotiated between the foen and the canton concerned.3 the financial assistance may only be allocated, if the protection of the ecological as listed under paragraph 1 letters a and c-f is guaranteed contractually or in any other suitable way.4 . 7067 amended by no 1 5 of the o of 17 aug. 2016, with effect from 1 jan. 2017 (as 2016 3215).68 repealed by no 1 5 of the o of 17 aug. 2016, with effect from 1 jan. 2017 (as 2016 3215).69 amended by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).70 repealed by no 1 5 of the o of 17 aug. 2016, with effect from 1 jan. 2017 (as 2016 3215).art. 4271 71 repealed by no 1 5 of the o of 17 aug. 2016, with effect from 1 jan. 2017 (as 2016 3215).art. 43 forest management72 (art. 38a fora)1 the level of global financial assistance for measures improve the cost-effectiveness of forest management is determined:a.73 for cantonal planning bases: by the size of the forest area in the canton and the size of forest area included in the plan or an impact assessment;b.74 for the improvement of management conditions in forestry operations: by the scale and quality of the optimisation measures planned and implemented by the canton;c. for the storage of wood in cases of exceptional wood supply: by the volume of wood that the market is temporarily unable to absorb;d. by the quality of the services provided;e.75 for promoting the training of forest workers: by the number of days attended on courses run by federally certified course providers; f.76 for the practical training of forestry specialists at university level: by the number of training days attended; g.77 for young forest maintenance: by the number of hectares of young forest requiring maintenance;h.78 for adapting forest stands specifically to changing climatic conditions: by the number of hectares over which measures are taken; i.79 for obtaining forest reproductive material: by the infrastructure and level of mechanisation in seed extractories and the number of tree species necessary for maintaining genetic diversity in the seed harvesting plantations; j.80 for adapting or reconstituting public infrastructure facilities: by the number of hectares of forest served by them.2 the amount is negotiated between the foen and the canton concerned.3 global financial assistance for the improvement of the management conditions in forestry operations is only awarded if:a. the cooperation between or merging of enterprises is undertaken as a long-term measure;b. an economically significant volume of wood is harvested or marketed jointly; andc. business accounts are kept.4 global financial assistance for young forest maintenance and for adapting forest stands specifically to changing climatic conditions shall only be awarded if the measures are in accordance with near-natural silviculture methods.815 global financial assistance for obtaining forest reproductive material shall only be afforded if a construction project or operating concept including cost proposals and proof of funding has been approved by the canton.8272 amended by no 1 5 of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).73 amended by no i of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).74 amended by no 1 5 of the o of 28 jan. 2015 on the amendment of ordinance law on the environment, in particular with regard to the programme agreements for the programme period 2016-2019, in force since 1 jan. 2016 (as 2015 427).75 inserted by no 1 5 of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).76 inserted by no 1 5 of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).77 inserted by no 1 5 of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).78 inserted by no 1 5 of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).79 inserted by no 1 5 of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).80 inserted by no 1 5 of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215). see also the transitional provisions to these amendments at the end of this text.81 inserted by no 1 5 of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).82 inserted by no 1 5 of the o of 17 aug. 2016, in force since 1 jan. 2017 (as 2016 3215).art. 44 promotion of education and training (art. 39 fora)1 .832 the confederation shall award financial assistance in compensation for the occupation-specific costs arising from the on-site practical training of forestry personnel in the form of a flat-rate payment of 10 per cent of the training costs of the schools for forest wardens and of the courses.3 the confederation shall award financial assistance for the creation of teaching material for forestry personnel, on a case by case basis and amounting to a maximum of 50 per cent of the recognised costs.4 .8483 repealed by no 1 5 of the o of 17 aug. 2016, with effect from 1 jan. 2017 (as 2016 3215).84 repealed by no 1 5 of the o of 17 aug. 2016, with effect from 1 jan. 2017 (as 2016 3215).art. 45 research and development (art. 31 fora)1 the confederation may award financial assistance to research and development projects that it has not commissioned itself, on a case by case basis and amounting to a maximum of 50 per cent of the project costs.2 it may award financial assistance to organisations for the promotion and coordination of research and development, on a case by case basis and equal to at most the funding provided by third parties, provided it receives an adequate right of co-decision in these organisations.section 3 procedure for granting global compensatory payments or financial assistance art. 46 application 1 the canton shall submit the application for global compensatory payments or financial assistance to the foen.2 the application shall contain details of:a. the programme objectives to be achieved;b. the measures probably required to achieve the objectives and their implementation;c. the effectiveness of the measures.3 in the case of measures that affect more than one canton, the cantons shall ensure the coordination of the applications with the other cantons concerned.art. 47 programme agreement 1 the foen shall enter into a programme agreement with the competent cantonal authority.2 the subject matter of the programme agreement is in particular:a. the strategic programme objectives to be jointly achieved;b. the services to be provided by the canton;c. the contribution to be paid by the confederation;d. controlling.3 the programme agreement shall have a maximum term of four years.4 the foen shall issue guidelines on the procedure for programme agreements and on the information and documents required in connection with the subject matter of the programme agreement.art. 48 payment global compensatory payments or financial assistance are paid in instalments.art. 49 reporting and controlling 1 the canton shall provide the foen with a report each year on the use of the global subsidies.2 the foen shall control by random sample:a. the implementation of individual measures in accordance with the programme objectives;b. the use of the subsidies paid.art. 50 substandard fulfilment and non-intended use 1 the foen shall withhold the instalment payments during the programme in full or in part if the canton:a. fails to comply with its reporting obligation (art. 49 para. 1);b. culpably causes serious disruption to its own services.2 if it becomes apparent after the programme that the services provided are substandard, the foen shall require the canton to rectify the defects; it shall allow the canton an appropriate period within which to do this.3 if installations or equipment for which financial assistance or compensatory payments have been provided are used for a purpose other than that intended, the foen may require the canton to arrange for the non-intended use to be stopped or reversed within a reasonable period.4 if the defects are not rectified or the non-intended use is not stopped or reversed, the recovery of the payments made is governed by articles 28 and 29 of the subsidies act of 5 october 199085.85 sr 616.1section 4 procedure for granting compensatory payments or financial assistance in specific cases art. 51 applications 1 applications for compensatory payments or financial assistance in specific cases without the involvement of a canton must be submitted to the foen; all other applications must be submitted to the canton.2 the canton shall examine the applications that it receives and pass them on to the foen with a justified proposal, the cantonal authorisations already available and the cantonal decision on the subsidy.3 the foen shall issue guidelines on the information and documents required in connection with the application.art. 52 granting and payment of subsidies 1 the foen shall issue a ruling determining the amount of the compensatory payment or the financial assistance or shall enter into an agreement with the recipient of the subsidy.2 payment of subsidies shall be dependent on the progress made with the measures.art. 53 substandard fulfilment and non-intended use 1 if, despite receiving a warning, a recipient, whose application for compensatory payments or financial assistance has been approved, fails to carry out the measures or carries them in a substandard manner, the compensatory payments or financial assistance shall not be paid out or shall be reduced.2 if compensatory payments or financial assistance have been paid out and if, despite receiving a warning, the recipient fails to carry out the measures or carries them out in a substandard manner, the recovery of the payments made is governed by article 28 of the subsidies act of 5 october 199086.3 if installations or equipment for which compensatory payments or financial assistance have been paid out are not used for the intended purpose, the foen may require the canton to arrange for the non-intended use to be stopped or reversed within a reasonable period.4 if the non-intended use is not stopped or reversed, the recovery of the payments made is governed by articles 28 and 29 of the subsidies act of 5 october 1990.86 sr 616.1art. 54 reporting and controlling article 49 applies by analogy to reporting and controlling.art. 55-59 repealedchapter 7 investment credits art. 60 requirements 1 investment credits shall be granted if:a. the investment is necessary and suitable to protect against natural events or for the maintenance and use of the forest; andb. the investment is required due to the applicant's financial circumstances.2 the applicant must be able to support the total financial burden.3 the applicant must exhaust his or her own financial resources and claim any contributions available from third parties.4 investment credits may not be accumulated with credits granted under the federal act of 23 march 196287 on agricultural investment credits and business subsidies or the federal act of 28 june 197488 on investment subsidies for mountain regions.5 the cantons are not entitled to credits for their own investments.6 .8987 [as 1962 1273, 1972 2699, 1977 2249 no i 961, 1991 362 no ii 52 857 annex no 27, 1992 288 annex no 47 2104. as 1998 3033 annex let. f]88 [as 1975 392, 1980 1798, 1985 387, 1991 857 annex no 24, 1992 288 annex no 43. as 1997 2995 art. 25]. see now: the fa of 6 oct. 2006 on regional policy (sr 901.0).89 repealed by no i 21 of the o of 7 nov. 2007 on the new system of financial equalisation and division of tasks between the confederation and the cantons, with effect from 1 jan. 2008 (as 2007 5823).art. 61 federal credits 1 the foen shall grant the canton global loans to cover the payment of investment credits. the loans shall be interest free and repayable over 20 years.2 the canton shall notify the foen each year of its probable borrowing requirements for the coming year.3 the available funds are allocated according to demand.9090 amended by no i 21 of the o of 7 nov. 2007 on the new system of financial equalisation and division of tasks between the confederation and the cantons, in force since 1 jan. 2008 (as 2007 5823).art. 62 applications (art. 40 para. 3 fora)1 applications for investment credits must be submitted to the canton.2 the following documents must be enclosed with each application:a. the general operational plan;b. the operating accounts;c. a report on the applicant's financial circumstances.3 companies that are commercially contracted to maintain or use the forest must include the balance sheets and profit and loss accounts for the last two years in their application.art. 63 amount of credit and rate of interest (art. 40 para. 1 fora)1 investment credits shall be granted:a. as construction credits to cover up to 80 per cent of the construction costs;b.91 to fund the remaining costs of measures in accordance with the articles 39, 40 and 43;c. to cover up to 80 per cent the purchase costs of forestry vehicles, machines and devices;d. to cover up to 80 per cent the costs of creating forestry installations.2 investment credits are normally interest free. however, if the applicant can support the total financial burden, an appropriate rate of interest shall be charged.3 no loan shall be granted for less than 10,000 francs.91 amended by no i 21 of the o of 7 nov. 2007 on the new system of financial equalisation and division of tasks between the confederation and the cantons, in force since 1 jan. 2008 (as 2007 5823).art. 64 term, repayment, recovery (art. 40 fora)1 investment credits shall be repayable over a period of not exceeding 20 years.2 the repayment instalments are determined according to the nature of the measure and the financial circumstances of the borrower.3 repayment begins:a. for investments under article 63 paragraph 1 letters a and b, one year after completion of the project, but no more than five years after payment of the first instalment of the credit;b. for other investments, in the year following that in which the credit is paid.4 the borrower may repay all or part of the credit without notice at any time.5 .926 interest of 5 per cent shall be charged on arrears of credits or repayment instalments.92 repealed by no i 21 of the o of 7 nov. 2007 on the new system of financial equalisation and division of tasks between the confederation and the cantons, with effect from 1 jan. 2008 (as 2007 5823).chapter 8 final provisions section 1 implementation art. 65 implementation by the confederation (art. 49 fora)1 detec is authorised to independently carry out operations arising from the implementation of the fora.2 if the federal authorities apply other federal acts or agreements or decisions under international law which relate to the subject matter of this ordinance, they also implement this ordinance. cooperation between the foen and the cantons is governed by article 49 paragraph 2 fora; statutory duties of confidentiality are reserved.9393 inserted by no ii 17 of the o of 2 feb. 2000 (coordination and simplification of decision-making procedures), in force since 1 march 2000 (as 2000 703).art. 66 implementation by the cantons (art. 50 fora)1 the cantons shall issue the implementing provisions to the fora and to this ordinance within five years of the act coming into force.2 they shall inform the foen of any rulings and decisions on deforestation.9494 inserted by no ii 17 of the o of 2 feb. 2000 (coordination and simplification of decision-making procedures), in force since 1 march 2000 (as 2000 703).art. 66a95 geoinformation the foen shall determine the minimum geodata models and modelling for geobasis data in accordance with this ordinance for which it is designated the competent federal authority in annex 1 to the ordinance on geoinformation of 21 may 200896.95 inserted by annex 2 no 13 of the o of 21 may 2008 on geoinformation, in force since 1 july 2008 (as 2008 2809).96 sr 510.620section 2 repeal and amendment of current legislation art. 67 repeal of current legislation the following are repealed:a. the ordinance of 1 october 196597 on the federal supervision of the forest police;b. the ordinance of 23 may 197398 on the appointment of senior forestry officers;c. the ordinance of 28 november 198899 on extraordinary measures for the conservation of forest;d. articles 2-5 the ordinance of 16 october 1956100 on the forest plant protection;e. the federal council decree of 16 october 1956101 on the origin and use of forest reproductive material and forest plants;f. the ordinance of 22 june 1970102 on investment credits for the forestry sector in the mountain region.97 [as 1965 861, 1971 1192, 1977 2273 no i 18.1, 1985 670 no i 3 685 no i 6 2022]98 [as 1973 964, 1987 608 art. 16 para. 1 let. e]99 [as 1988 2057, 1990 874 no i, ii]100 [as 1956 1220, 1959 1626, 1977 2325 no i 19, 1986 1254 art. 70 no 3, 1987 2538, 1989 1124 art. 2 no 2, 1992 1749 no ii 4. as 1993 104 art. 42 let. a]101 [as 1956 1227, 1959 1628, 1975 402 no i 15, 1987 2540]102 [as 1970 765, 1978 1819]art. 68 amendment of current legislation .103103 the amendments can be consulted under as 1992 2538.section 3 commencement art. 69 1 this ordinance, with the exception of articles 60-64 and 67 letter f, comes into force on 1 january 1993.2 articles 60-64 and 67 letter f come into force on 1 january 1994.transitional provision to the amendment of 2 february 2000104 104 as 2000 703deforestation applications for works that are the responsibility of the cantons and which are pending on 1 january 2000 shall be governed by the previous law.transitional provision on the amendment of 17 august 2016105 105 as 2016 32151 instead of the criterion stated in article 40a paragraph 1, the amount of financial assistance awarded for measures to deal with forest damage outside the protective forest carried out before 31 december 2019 may be assessed according to the scope and quality of the measures.2 instead of the criteria stated in article 43 paragraph 1 letter j, the amount of financial assistance awarded for public infrastructure facilities adapted or reconstituted before 31 december 2024 may be assessed according to the scope and quality of the measures.106106 amended by no i 2 of the o of 17 april 2019 on amendments to ordinances to take account of changes to programme agreements in the environment field for the programme period 2020-2024, in force since 1 jan. 2020 (as 2019 1487).annex107 107 repealed by no i 21 of the o of 7 nov. 2007 on the new system of financial equalisation and division of tasks between the confederation and the cantons, with effect from 1 jan. 2008 (as 2007 5823).

935.41 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal act on private security services provided abroad(pssa)of 27 september 2013 (status as of 1 december 2021)the federal assembly of the swiss confederation,based on articles 54 paragraph 1, 95 paragraph 1 and 173 paragraph 2 of the federal constitution1, and having considered the federal council dispatch dated 23 january 20132,decrees:1 sr 1012 bbl 2013 1745section 1 general provisions art. 1 aim the aim of this act is to contribute to:a. safeguarding the internal and external security of switzerland;b. realising switzerland's foreign policy objectives;c. preserving swiss neutrality;d. guaranteeing compliance with international law and, in particular, of human rights and of international humanitarian law.art. 2 scope of application 1 this act applies to legal entities and business associations (companies) that engage in any of the following activities:a. provide, from switzerland, private security services abroad;b. provide services in switzerland in connection with private security services provided abroad;c. establish, base, operate, or manage a company in switzerland that provides private security services abroad or provides services in connection therewith in switzerland or abroad;d. exercise control from switzerland over a company that provides private security services abroad or provides services in connection therewith in switzerland or abroad.2 it applies to persons in the service of companies subject to the present act.3 the provisions of this act pertaining to companies also apply to natural persons exercising the activities designated in paragraphs 1 and 2.4 it also applies to federal authorities that contract with a company for the performance of protection tasks abroad.art. 3 exemptions from the scope of application 1 this act does not apply to companies that provide, from switzerland, in territories subject to the agreement of 21 june 19993, between the swiss confederation, of the one part, and the european community and its member states, of the other, on the free movement of persons or subject to the convention of 4 january 19604 establishing the european free trade association, any of the following private security services:a. the protection of persons;b. the guarding or surveillance of goods and properties;c. security services at events.2 it also does not apply to companies that:a. provide, in switzerland, a service in connection with a private security service under paragraph 1;b. establish, base, operate, or manage in switzerland a company that provides services under paragraph 1 or paragraph 2 letter a;c. exercise control, from switzerland, over a company that provides services under paragraph 1 or paragraph 2 letter a.3 sr 0.142.112.6814 sr 0.632.31art. 4 definitions in this act:a. private security service means, in particular, the following activities carried out by a private company:1. the protection of persons in complex environments,2. the guarding or surveillance of goods and properties in complex environments,3. security services at events,4. the checking, detention, or searching of persons, searching of premises or containers, and seizure of objects,5. guarding, caring for, and transporting prisoners; operating prison facilities; and assisting in operating camps for prisoners of war or civilian detainees,6. operational or logistical support for armed or security forces, insofar as such support is not provided as part of a direct participation in hostilities as set out in article 8,7. operating and maintaining weapons systems,8. advising or training members of armed or security forces,9. intelligence activities, espionage, and counterespionage;b. service in connection with a private security service means:1 recruiting or training personnel for private security services abroad,2. providing personnel, directly or as an intermediary, for a company that offers private security services abroad;c. direct participation in hostilities means:direct participation in hostilities abroad in the context of an armed conflict within the meaning of the geneva conventions5 and the protocols i and ii6.5 sr 0.518.12;0.518.23; 0.518.42; 0.518.516 sr 0.518.521; 0.518.522art. 5 control over a company 1 a company exercises control over another company if it:a. directly or indirectly holds a majority of the votes in the highest decision-making body thereof;b. directly or indirectly holds the right to appoint or remove a majority of the members of the highest executive or management body thereof; orc. pursuant to the articles of incorporation, foundation charter, a contractual agreement, or similar instrument, is able to exert a controlling influence thereon.2 business associations are considered to be controlled if:a. another company is a member with unlimited liability of that business association;b. the controlling company, as a general partner in the business association, contributes funds in an amount exceeding one third of the equity of the business association; orc. the controlling company furnishes the business association or the general partners thereof with reimbursable funds in an amount exceeding one half of the difference between the association's assets and its liabilities towards third parties.art. 6 subcontracting 1 where a company subcontracts the provision of a security service or of a service connected therewith to another company, it shall ensure that the other company performs that service in keeping with the constraints to which the subcontracting company is itself subject.2 the liability of the subcontracting company for harm caused by the other company is determined in accordance with the code of obligations7.7 sr 220art. 7 accession to the international code of conduct for private security service providers 1 companies subject to article 2 paragraphs 1, 3 and 4 must become signatories to the international code of conduct for private security providers, in the version dated 9 november 2010 (code of conduct)8.2 the federal department to which the competent authority is subordinate may determine that an amendment to the code of conduct applies to matters governed by this act, provided that such amendment is not contrary to the provisions of this act.8 the international code of conduct for private security service providers may be consulted at the following internet address: www.icoc psp.orgsection 2 prohibitions art. 8 direct participation in hostilities 1 it is prohibited:a. to recruit or train personnel in switzerland for the purpose of direct participation in hostilities abroad;b. to provide personnel, from switzerland, directly or as an intermediary, for the purpose of direct participation in hostilities abroad;c. to establish, base, operate, or manage, in switzerland, a company that recruits, trains, or provides personnel, directly or as an intermediary, for the purpose of direct participation in hostilities abroad;d. exercise control, from switzerland, over a company that recruits, trains, or provides personnel, directly or as an intermediary, for the purpose of direct participation in hostilities abroad.2 persons who are domiciled, or have their habitual place of residence, in switzerland and are in the service of a company that is subject to this act shall be prohibited from directly participating in hostilities abroad.art. 9 serious violations of human rights it is prohibited:a. to provide, from switzerland, private security services or services in connection therewith if it may be assumed that the recipients will use the services in connection with the commission of serious human rights violations;b. to establish, base, operate, or manage, in switzerland, a company that provides private security services, or services in connection therewith, if it may be assumed that the recipients will use the services in connection with the commission of serious violations of human rights;c. to exercise control, from switzerland, over a company that provides private security services, or services in connection therewith, if it may be assumed that the recipients will use the services in connection with the commission of serious human rights violations.section 3 procedure art. 10 declaration requirement 1 any company intending to carry out an activity under article 2 paragraph 1 shall declare to the competent authority, in particular, the following information:a. the nature, provider, and place of performance of the intended activity;b. such details on the principal and on the recipient of the service as are necessary for an evaluation of the situation;c. the personnel to be deployed for the intended activities, and the training they have received;d. an overview of the business sectors in which the company is active;e. proof of accession to the code of conduct9;f. the identity of all persons bearing responsibility for the company.2 for companies under article 2 paragraph 1 letter d, the declaration requirement applies both to the company's own exercise of control and to the activities of the controlled company.3 if any significant change in circumstances occurs subsequent to the declaration, the company shall notify the competent authority without delay. the competent authority shall inform the company forthwith as to whether it may continue to carry out the activity in question.9 the international code of conduct for private security service providers may be consulted at the following internet address: www.icoc psp.orgart. 11 requirement to refrain from activities 1 until such time as the company has received from the competent authority notification or a decision pursuant to articles 12-14, it shall refrain from carrying out the declared activities.2 where the competent authority initiates a review procedure pursuant to article 13, it may, by way of exception, release the company from its duty to refrain from activities for the duration of the procedure, if there is overriding public or private interest in doing so.art. 12 notification by the authority the competent authority shall notify the company within fourteen days of receipt of the declaration as to whether the declared activity gives cause for initiating a review procedure at that time.art. 13 review procedure 1 the competent authority shall initiate a review procedure where:a. there are indications to suggest that the declared activity could be in conflict with the aims set out in article 1;b. a significant change in the circumstances relating to a declared activity has occurred subsequent to notification pursuant to article 12;c. it becomes aware of the exercise of an activity that has not been declared;d. it becomes aware of a violation of swiss law or of international law.2 where the competent authority becomes aware of the exercise of an activity that has not been declared, it shall inform the company of the initiation of a review procedure, and shall allow the company an opportunity to submit within ten days a statement in that regard. article 11 paragraph 1 applies mutatis mutandis. 3 the competent authority shall consult with the authorities concerned. 4 it shall inform the company of the outcome of the review procedure within thirty days. this time limit may be extended as circumstances require.art. 14 prohibition by the competent authority 1 the competent authority shall prohibit in full or in part any activity that is contrary to the aims set out in article 1. in the case of the following activities, in particular, conformity with those aims is subject to thorough review:a. private security services provided to, persons or companies and to foreign institutions in crisis or conflict regions;b. private security services, or a service in connection therewith, that may be of service to institutions or persons in the commission of human rights violations;c. operational or logistical support for foreign armed or security forces;d. services in the domain of military expertise in connection with a private security service;e. private security services, or a service in connection therewith, that may be of service to terrorist groups or criminal organisations;f. the establishment, basing, operating, management, or control of a company that provides such services as set out under the foregoing letters a-e.2 the competent authority shall prohibit in full or in part the exercise of an activity by a company that:a. has in the past committed serious human rights violations and has not taken sufficient precautions to ensure that there is no recurrence thereof;b. deploys personnel who do not possess the required training for the intended activity;c. does not comply with the provisions of the code of conduct10.3 the competent authority shall prohibit a company from subcontracting the providing of a private security service, or a service in connection therewith, where the company that is to provide that service fails to comply with the constraints set out in article 6, paragraph 1.10 the international code of conduct for private security service providers may be consulted at the following internet address: www.icoc psp.orgart. 15 exceptional authorisation 1 where a manifest national interest clearly prevails, the federal council may by way of exception authorise an activity to which articles 8 and 9 do not apply, but which would be subject to prohibition pursuant to article 14.2 the competent authority shall submit the case to the federal council for a ruling.3 the federal council shall determine the necessary control measures.art. 16 coordination 1 where a matter falls within the scope of this act as well as within that of the war material act of 13 december 199611, the control of goods act of 13 december 199612, or the embargo act of 22 march 200213, the authorities concerned shall determine which authority coordinates the procedure.2 that authority shall ensure that the procedure is conducted in as simple a manner as possible, and shall make certain that the company is informed of all results of the procedure within the statutory time limits.11 sr 514.5112 sr 946.20213 sr 946.231art. 17 fees 1 the federal council shall regulate the charging of cost-covering fees for:a. the review procedure under article 13;b. prohibitions issued under article 14;c. control measures under article 19.2 for the rest, article 46a of the government and administration organisation act of 21 march 199714 applies.14 sr 172.010section 4 oversight art. 18 requirement to cooperate companies shall provide the competent authority with all the information required for the review of activities governed by this act, and shall submit to it all the necessary documents.art. 19 oversight powers of the authority 1 where a company attempts to influence the competent authority or fails to satisfy its requirement to cooperate, and where all efforts on the part of the competent authority to obtain the necessary information and documents remain fruitless, that authority may in the cases set out in article 13 paragraph 1 take the following oversight measures:a. unannounced on-site inspection of company premises;b. examination of relevant documents;c. seizure of material.2 the competent authority may to that end call on the assistance of other federal authorities as well as cantonal and communal police forces.art. 2015 15 repealed by annex no ii 2 of the fa of 18 dec. 2020 on the processing of personal data by the fdfa, with effect from 1 dec. 2021 (as 2021 650; bbl 2020 1349).section 5 sanctions art. 21 offences against statutory prohibitions 1 any person who, in contravention of article 8, carries out an activity in connection with direct participation in hostilities, or who directly participates in hostilities, is liable to a custodial sentence not exceeding three years or to a monetary penalty.2 any person who carries out an activity in contravention of article 9 shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.3 this provision does not preclude the prosecution of the person concerned under the criminal code16 or to the military criminal code of 13 july 192717 for a more serious offence under those codes.16 sr 311.017 sr 321.0art. 22 offences against prohibitions by the competent authority any person who contravenes a prohibition issued by the competent authority pursuant to article 14 is liable to a custodial sentence not exceeding one year, or to a monetary penalty.art. 23 offences against the declaration requirement or the requirement to refrain from activities 1 any person who:a. violates article 10 by failing to declare an activity;b. carries out, in full or in part, an activity in breach of the requirement to refrain from activities under article 11 or article 39 paragraph 2,is liable to a custodial sentence not exceeding one year, or to a fine.2 where the act has been committed through negligence, a monetary penalty is imposed.art. 24 offences against the requirement to cooperate 1 any person who:a. refuses to furnish information, to allow the examination of documents, or to grant access to premises pursuant to article 18 or article 19, paragraph 1;b. makes false statements,shall be liable to a fine not exceeding 100,00 francs.2 where the act has been committed through negligence, a fine not exceeding 40,000 francs is imposed.3 attempts and complicity are also offences.4 the right to prosecute is limited to a period of five years.art. 25 offences within a business undertaking 1 article 6 of the federal act of 22 march 197418 on administrative criminal law (acla) applies to offences committed within a business undertaking.2 pursuant to article 7 of acla, an investigation to identify the offenders may be dispensed with and the business undertaking may be ordered to pay the fine instead in cases in which:a. the identification of the persons criminally liable under article 6 of acla necessitates investigative measures that would be disproportionate to the penalty incurred; andb. the penalty for the contraventions governed by this act does not exceed 20,000 francs.18 sr 313.0art. 26 dissolution and liquidation 1 where the activity of a legal entity, or of a general or limited partnership, contravenes a statutory or official prohibition, the competent authority may order the dissolution and liquidation of the legal entity or partnership concerned in accordance with the federal act of 11 april 188919 on debt enforcement and bankruptcy.2 where the business undertaking is a sole proprietorship, the competent authority may order the liquidation of the business assets and, as the case may be, deletion of the undertaking from the commercial register.3 the competent authority may confiscate any surplus resulting from the liquidation.19 sr 281.1art. 27 jurisdiction and requirement to report 1 offences under this act are subject to federal jurisdiction.2 the authorities competent for the implementation of this act are subject to a requirement to report any infringements of which they obtain knowledge in the course of carrying out their official activities to the office of the attorney general of switzerland.section 6 mutual administrative assistance art. 28 mutual administrative assistance within switzerland 1 the public authorities of the confederation and of the cantons shall provide the competent authority with the information and personal data required for the enforcement of this act.2 the competent authority shall disclose information and personal data to the following public authorities for the performance of their legal tasks:a. the federal and cantonal public authorities responsible for the enforcement of this act;b. the public authorities responsible for enforcing the war material act of 13 december 199620, the control of goods act of 13 december 199621, and the embargo act of 22 march 200222;c. the criminal authorities, insofar as the prosecution of felonies or misdemeanours is at issue;d. the federal and cantonal authorities responsible for maintaining internal security;e. the federal authorities responsible for foreign affairs and for maintaining external security;f. the cantonal authorities responsible for the licensing and oversight of private security services.20 sr 514.5121 sr 946.20222 sr 946.231art. 29 mutual administrative assistance between swiss and foreign authorities 1 the competent authority may request foreign authorities to provide information and personal data required for the enforcement of this act. to this end, it may disclose to them, in particular, information concerning:a. the nature, provider, principal, recipient, and place of performance of the activity;b. the sectors in which the company offering private security services abroad is active, and the identity of all persons who are responsible for the company.2 where the foreign state grants reciprocity, the competent authority may disclose to it the information set out in paragraph 1, subject to the assurance from the foreign authority that the data:a. will be processed only for aims in conformity with this act; andb. will be used in criminal proceedings only in accordance with the provisions on international mutual legal assistance.section 7 contracting of security companies by federal authorities art. 30 protection tasks 1 the confederation is authorised to contract with companies that provide private security services for the performance of the following protection tasks abroad:a. the protection of persons;b. the guarding or surveillance of goods and properties.2 the federal authority that contracts with a company (contracting authority) shall consult with the competent authority under article 38 paragraph 2 and with the federal department of defence, civil protection, and sport.art. 31 requirements with regard to the company 1 prior to contracting with a company, the contracting authority shall ascertain that the company in question meets the following requirements:a. it is able to provide the required guarantees concerning the recruitment, training, and oversight of its personnel;b. its good reputation and irreproachable conduct in business are attested to both by its adherence to the code of conduct23 and compliance with the provisions therein and, in particular, by:1. experience in the field,2. references, or3. membership of a professional association;c. it is solvent;d. it has an adequate internal control system which ensures that its personnel comply with established standards of conduct and that disciplinary measures are taken where misconduct occurs;e. it is authorised under the applicable law to carry out activities in the domain of private security;f. it has liability insurance coverage in an amount commensurate with the risk incurred.2 the contracting authority may, by way of exception, contract with a company that does not possess liability insurance coverage, where:a. purchasing such insurance would engender disproportionate costs to the company; andb. the liability risk and the amount of any compensatory damages to be borne by the confederation may be assessed as low.23 the international code of conduct for private security service providers may be consulted at the following internet address: www.icoc psp.orgart. 32 training of personnel 1 the contracting authority shall ascertain that the security personnel of the company have received adequate training, commensurate with the protection task assigned to them and in accordance with applicable international and national law.2 training shall cover, in particular, the following issues:a. respect for fundamental rights, personal privacy rights, and procedural law;b. the use of physical force and weapons when acting in self-defence or in situations of necessity;c. dealing with persons offering resistance or prepared to resort to violence;d. providing first aid;e. assessing health risks entailed in the use of force;f. combating corruption.3 the contracting authority may, by way of exception, contract with a company that does not fully meet the requirements set out in paragraphs 1 and 2, on condition that there is no other company that meets those requirements at the place at which the service is to be provided and that the protection task cannot otherwise be accomplished.4 in such a case, the maximum duration for which a contract may be concluded is six months. the contracting authority shall take measures to ensure that the company fulfils the requirements set out in paragraphs 1 and 2 within as short a time as possible. such measures shall be stipulated in the contract.art. 33 identification of personnel the contracting authority shall make certain that personnel are identifiable when acting in the exercise of their function.art. 34 arming of personnel 1 all personnel shall, as a general rule, be unarmed.2 where the situation abroad requires that any personnel, by way of exception, carry a weapon so as to be able to react in self-defence or in a situation of necessity, the contracting authority shall specify this in the contract.3 the contracting authority shall ascertain that the personnel are in possession of the permits required under the applicable law.4 the weapons legislation of the place at which the protection task is to be performed applies.art. 35 use of force and other police measures 1 where it is possible to accomplish a protection task only through the use of force or other police measures as defined in the use of force act of 20 march 200824, the federal council may grant permission to do so even in situations other than those of self-defence or of necessity.2 the federal council shall make certain that the personnel have received the appropriate training.3 the law at the place of deployment applies.24 sr 364art. 36 subcontracting of protection tasks the subcontracting of protection tasks is prohibited without the prior written consent of the contracting authority.section 8 reporting art. 37 1 the competent authority shall prepare a report on its activities, to be submitted to the federal council each year.2 the report shall be made public.section 9 final provisions art. 38 implementation provisions 1 the federal council shall enact provisions for the implementation of this act. in particular, it shall determine:a. the specifics of the declaration procedure (art. 10);b.25 the list of particularly sensitive personal data and the categories of data to be processed under article 28, as well as their retention periods;c. the required terms and conditions of contracts by a federal authority for the services of a company.2 it shall appoint the competent authority.25 amended by annex no ii 2 of the fa of 18 dec. 2020 on the processing of personal data by the fdfa, in force since 1 dec. 2021 (as 2021 650; bbl 2020 1349).art. 39 transitional provision 1 any activity subject to declaration under this act, and which is being carried out at the time of the act's entry into force, must be declared to the competent authority within three months of the commencement date of this act.2 where the competent authority initiates a review procedure, it shall inform the company as to whether it must provisionally refrain, in full or in part, from carrying out the declared activity.3 where the competent authority intends to prohibit an activity that is being carried out at the time of this act's entry into force, and which the company concerned plans to continue, the authority may grant the company a reasonable period of grace in order to achieve compliance with the statutory provisions.art. 40 referendum and commencement. 1 this act is subject to an optional referendum.2 the federal council shall determine the commencement date.commencement date: 1 september 20152626 fcd of 24 june 2015.

935.411 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon private security servicesprovided abroad (opsa)of 24 june 2015 (status as of 1 january 2021)the swiss federal council,based on articles 17 and 38 of the federal act of 27 september 20131 on private security services provided abroad (pssa),ordains:1 sr 935.41section 1 general provisions art. 1 complex environment 1 a complex environment is any area:a.experiencing or recovering from unrest, or instability due to natural disaster or armed conflict in terms of the geneva conventions2 and additional protocols i and ii3;b.where the rule of law has been substantially undermined; andc.in which the capacity of the state authority to handle the situation is limited or non-existent.2 if the confederation contracts with a company for the performance of protection tasks in an area that is not a complex environment in terms of paragraph 1, the ordinance of 24 june 20154 on the use of private security companies applies.2 sr 0.518.12; 0.518.23; 0.518.42; 0.518.513 sr 0.518.521; 0.518.5224 sr 124art. 1a5 operational and logistical support for armed or security forces 1 operational support for armed or security forces comprises activities that a company carries out for the benefit of armed or security forces in connection with their core tasks as part of ongoing or planned operations.2 logistical support for armed or security forces comprise activities that a company carries out for the benefit of armed or security forces in close connection with their core tasks, in particular:a.servicing, repairing or upgrading war materiel pursuant to the war materiel act of 13 december 19966 (wma) or goods pursuant to the goods control act of 13 december 19967 (gca);b.converting goods into war materiel pursuant to the wma or into goods pursuant to the gca; c.constructing, operating or maintaining infrastructure;d.managing supplies;e.transporting, storing or handling war materiel pursuant to the wma or specific military goods pursuant to the gca;f.transporting members of armed or security forces.5 inserted by no i of the o of 11 nov. 2020, in force since 1 jan. 2021 (as 2020 5323).6 sr 514.517 sr 946.202art. 1b8 operating and servicing weapons systems 1 the operation of weapons systems comprises the use of war materiel pursuant to the wma9 with a view to armed or security forces conducting exercises.2 the servicing of weapons systems comprises the maintenance or repair of war materiel pursuant to the wma for the benefit of armed or security forces.8 inserted by no i of the o of 11 nov. 2020, in force since 1 jan. 2021 (as 2020 5323).9 sr 514.51art. 1c10 advising and training members of armed or security forces 1 advising members of armed or security forces comprises the provision of technical, tactical or strategic advice to members of armed or security forces in close connection with their core tasks.2 training members of armed or security forces comprises the technical, tactical or strategic instruction or training of members of armed or security forces in close connection with their core tasks.10 inserted by no i of the o of 11 nov. 2020, in force since 1 jan. 2021 (as 2020 5323).art. 2 accession to the international code of conduct for private security service providers companies are deemed to have acceded to the international code of conduct for private security service providers (the code of conduct) in its version of 9 november 2010 if they are members of the international code of conduct for private security service providers association (icoca)11.11 the international code of conduct for private security service providers may be consulted at the following internet address: www.icoc-psp.orgsection 2 procedures art. 3 competent authority the competent authority is the state secretariat of the federal department of foreign affairs (state secretariat fdfa)12.12 the name of the administrative unit was modified on 1 jan. 2021 in application of art. 20 para. 2 of the publications ordinance of 7 oct. 2015 (sr 170.512.1). this modification has been made throughout the text.art. 4 content of the declaration requirement the declaration requirement covers:a.with regard to the intended activity:1.the nature of the service under article 4 letters a and b pssa,2.the weapons and other means used to provide the private security service,3.the extent and duration of the operation and the number of persons deployed,4.the place where the activity is carried out,5.the special risks that the activity entails;b.with regard to the company:1.the company name, registered office and legal form as well as, if available, an extract from the commercial register,2.the objects, areas of business, areas of operation abroad and main categories of clients,3.proof of accession to the code of conduct,4.the name, first name, date of birth, nationality and certificate of residence of the members of the management and the supervisory bodies,5.the measures taken for the basic and advanced training of personnel,6.the internal control system for personnel;c.with regard to the persons who carry out management duties within the company or on its behalf or who are permitted to carry a weapon in the course of their activities for the company:1.the name, first name, date of birth, nationality and certificate of residence,2.confirmation of good character,3.the required authorisation under the relevant law for exporting, carrying and using weapons, weapons accessories and ammunition,4.basic and advanced training in the fields of fundamental rights and humanitarian international law,5.basic and advanced training in the use of weapons and aids as well as the use of force and other police measures.art. 5 requirement to report identity the company shall inform the state secretariat fdfa of the identity of the principal or the recipient of a service under article 4 letters a and b pssa if the person or entity concerned is:a.a foreign state or its institutions;b.an international organisation or its institutions;c.a group that regards itself as the government or as a state institution, or its institutions;d.an organised armed group or its units participating in an armed conflict in terms of the geneva conventions13 and the additional protocols i and ii14;e.a high representative of a foreign state or of an international organisation, a leader or a senior executive of a group under letters c and d, irrespective of whether the person concerns acts in the course of their duties or as a private individual.13 sr 0.518.12; 0.518.23; 0.518.42; 0.518.5114 sr 0.518.521; 0.518.522art. 6 declaration in the case of a private security service in standardised form where a company has declared a private security service under article 4 letter a number 1 or 2 pssa and intends to provide this service in standardised form to similar recipients subject to the same conditions, it shall report the conclusion of each new contract to the state secretariat fdfa and state that the service agreed therein will be provided in standardised form.art. 7 declaration when continuing the same activity where a company intends to continue to carry on an activity that it has declared in same manner, and if the information provided under article 4 is still correct, so the company shall confirm to the state secretariat fdfa that the intended activity corresponds to the reported activity.art. 8 accelerated procedure where a private security service under article 4 letter a sections 1-3 pssa must be provided in an emergency situation, the state secretariat fdfa shall notify the company if possible within two working days of receipt of the declaration of whether the review procedure will be initiated.art. 8a15 reporting obligation in connection with war materiel pursuant to the wma or goods pursuant to the gca 1 if a company exports war materiel pursuant to the wma16 or goods pursuant to the gca17 and if it subsequently carries out servicing, maintenance, or a repair in close connection therewith, the company is not obliged to report these activities provided the export would still be permitted at the time the activities are carried out.2 if a company war exports materiel pursuant to the wma or goods pursuant to the gca and if it subsequently provides advice or training in close connection therewith relating to the servicing, maintenance, repair, development, manufacture or use of the materiel, the company is not obliged to report these activities provided the export would still be permitted at the time the activities are carried out. 3 if a company transfers intellectual property including knowhow or rights thereto pursuant to the wma and if it subsequently provides advice or training in close connection therewith relating to servicing, maintenance, repair, development, manufacture or use, the company is not obliged to report these activities provided the transfer would still be permitted at the time the activities are carried out.4 this article does not apply if the activity constitutes operational support.15 inserted by no i of the o of 11 nov. 2020, in force since 1 jan. 2021 (as 2020 5323).16 sr 514.5117 sr 946.202art. 8b18 decision in the review procedure 1 the state secretariat fdfa shall decide on whether to prohibit the reported activity in agreement with the state secretariat for economic affairs (seco) and the responsible body at the federal department of defence, civil protection and sport (ddps) after consulting the federal intelligence service.2 if the state secretariat fdfa, seco and the responsible body at the ddps are unable to reach an agreement or if they conclude that the reported activity is of considerable importance to foreign or security policy, the federal department of foreign affairs (fdfa) shall submit the matter to the federal council for a decision.3 in cases of minor importance or in cases where there is a precedent for the decision, the authorities concerned may decide to dispense with joint consideration and authorise the state secretariat fdfa to decide on its own.18 inserted by no i of the o of 11 nov. 2020, in force since 1 jan. 2021 (as 2020 5323).art. 9 withdrawal or exclusion from the icoca 1 where a company withdraws from the icoca or if the icoca decides to exclude the company, the company shall immediately notify the state secretariat fdfa of this and provide the reasons.2 if the reasons for the company's withdrawal or exclusion from the icoca do not fundamentally preclude its renewed accession, the state secretariat fdfa shall request the company to take the measures required to join again within six months.3 where the company does not join the icoca again within the period specified in paragraph 2, the state secretariat fdfa shall prohibit all or part of its activities.art. 10 assessment of fees 1 the fee is assessed on the basis of the time worked.2 an hourly rate of 150-350 francs applies. the rate is based in particular on the seniority of the employee concerned.3 otherwise, the general fees ordinance of 8 september 200419 applies.19 sr 172.041.1section 3 controls art. 11 duty to keep records 1 the company is obliged to keep records of its activities. it must be able to provide the state secretariat fdfa with the following information and documents at any time:a.the identity and address of the principal, the provider and the recipient of the service;b.a copy of the contract concluded with the principal;c.the identity of the persons implementing the contract;d.details of the equipment used, in particular weapons;e.documentary evidence of performance of the contract.2 the members of management board shall retain the information and documents mentioned in paragraph 1 for ten years. this period does not end if the company ceases business operations.art. 12 processing of personal data 1 in order to fulfil its statutory duties, the state secretariat fdfa is authorised to process particularly sensitive personal data on administrative or criminal prosecutions and sanctions as well as other personal data provided it relates to the following persons:a.the members of the management board and the supervisory bodies;b.the company personnel;c.the company concerned;d.the principal and the recipient of the service within the limits set out in article 5.2 the following personal data may be processed:a.name, first name, date of birth, domicile and nationality of the person concerned;b.all personal data related to the company concerned;c.all information related to the company's business operations.3 the state secretariat fdfa is also authorised to process the following particularly sensitive personal data on administrative or criminal prosecutions and sanctions:a.name, first name, date of birth, domicile and nationality the person concerned;b.identity of the company concerned;c.the offence with which the person concerned is charged;d.details on the form of procedure;e.name of the authorities concerned;f.copy of the judgment and any other information connected with the judgment.4 personal data and particularly sensitive personal data shall be offered 15 years after its final processing to the federal archives for archiving (art. 21 of the federal act of 19 june 199220 on data protection).20 sr 235.1section 4 administrative assistance in switzerland art. 13 1 the state secretariat fdfa shall provide the authorities mentioned in article 28 pssa, ex officio or on request, with the following information and personal data:a.with regard to the intended activity:1.the type of service under article 4 letters a and b pssa,2.the identity of the principal or the recipient of the service within the limits set out in article 5,3.the location abroad where the activity is being carried out;b.with regard to the company:1.company name, registered office and legal form as well as, if available, an extract from the commercial register,2.objects, areas of business, areas of operation abroad and main categories of clients,3.name, first name, date of birth, nationality and certificate of residence for the members of the management board and the supervisory bodies.2 it shall also provide the authorities mentioned in article 28 paragraph 2 letters c and d pssa and the federal authorities responsible for safeguarding external security (art. 28 para. 2 let. e pssa), ex officio or on request, with the following particularly sensitive personal data:a.name, first name, date of birth, domicile and nationality of the person concerned;b.identity of the company concerned;c.the offence with which the person concerned is charged;d.details on the form of procedure;e.name of the authorities concerned;f.copy of the judgment and any other information connected with the judgment.section 5 use by federal authorities of private security companies for protection tasks abroad art. 14 content of the contract 1 the contract with the company shall require the company in particular to:a.provide information on progress with the performance of the contract if the contracting authority so requests;b.disclose the identity of the personnel deployed to the contracting authority;c.prepare a report for submission to the contracting authority;d.immediately replace any personnel who do not have the required skills or who adversely affect the performance of the contract;e.immediately report to the contracting authority any circumstances that could adversely affect the performance of the contract;f.immediately report to the contracting authority any incidents in which personnel have used force or police measures in accordance with article 35 pssa or have acted in self-defence or in a situation of necessity;g.immediately report to the contracting authority if the requirements for the company or for training are no longer being met.2 the contract shall also contain:a.the details required by articles 34 paragraph 2 and 35 pssa;b.provision for contractual penalties in the event of non-fulfilment.art. 15 model contract 1 the fdfa shall issue a model contract.212 the model contract shall be made accessible online.21 amended by no i of the o of 11 nov. 2020, in force since 1 jan. 2021 (as 2020 5323).art. 16 communication the contracting authority shall provide the state secretariat fdfa and the head of security of its department with a copy of the contract concluded with the company and inform the head of security of any problem related to the performance of the contract.art. 17 support from the fdfa in regions where there is no company that is a member of the icoca, the fdfa shall endeavour to ensure that companies joint the association.section 6 final provisions art. 18 transitional provision the contracting authority shall by 1 september 2018 amend existing contracts that do not meet the requirements of this ordinance.art. 19 commencement this ordinance comes into force on 1 september 2015.

935.62 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton patent attorneys(patent attorney act, pataa)of 20 march 2009 (status as of 1 january 2013)the federal assembly of the swiss confederation,on the basis of article 95 of the federal constitution1, and having considered the federal council dispatch of 7 december 20072,decrees:1 sr 1012 bbl 2008 407section 1: subject matter and scope of application art. 1 1 this act governs:a.the requirements for the use of the professional titles "patent attorney", "patentanwltin" or "patentanwalt", "conseil en brevets" and "consulente in brevetti";b.professional confidentiality applicable to patent attorneys;c.the protection of the professional titles "european patent attorney", "europische patentanwltin" or "europischer patentanwalt", "conseil en brevets europens" and "consulente in brevetti europei".2 it is applicable to persons who provide advice or representation in patent matters in switzerland using any of the professional titles mentioned in paragraph 1 letter a or c.3 the representation of parties in proceedings before the swiss federal institute of intellectual property (ipi) by natural and legal persons residing or having their principal place of business in the principality of liechtenstein is governed by article 8 of the patent treaty of 22 december 19783 between the swiss confederation and the principality of liechtenstein.3 sr 0.232.149.514section 2: protection of titles art. 2 patent attorney any person who uses the title "patent attorney", "patentanwltin" or "patentanwalt", "conseil en brevets" or "consulente in brevetti" must:a.possess a recognised higher education qualification in natural sciences or engineering (art. 4 and 5);b.have passed the swiss federal patent attorney examination or a recognised foreign patent attorney examination (art. 6 and 7);c.have completed practical training (art. 9);d.possess at least an address for service in switzerland; ande.be registered in the patent attorney register (art. 11 et seq.).art. 3 european patent attorney any person who uses the title "european patent attorney", "europische patentanwltin" or "europischer patentanwalt", "conseil en brevets europens" or "consulente in brevetti europei" must be registered in the list of professional representatives maintained by the european patent office.art. 4 recognised swiss higher education qualifications 1 natural sciences or engineering degrees (bachelor's, master's, diplom or lizenziat) issued by an accredited swiss higher education institution are considered to be recognised swiss higher education qualifications in terms of this act.2 the federal council shall regulate the accreditation of swiss higher education institutions.art. 5 recognition of foreign higher education qualifications 1 a foreign higher education qualification in natural sciences or engineering is recognised where its equivalence to a recognised swiss higher education qualification:a.is provided for in a treaty pertaining to mutual recognition with the respective state or supranational organisation; orb.is proven in an individual case.2 the federal council shall designate the competent bodies for such recognition. it shall designate a single body where possible.3 where the competent bodies do not recognise a foreign higher education qualification, they shall decide how the requirement of article 2 letter a may be fulfilled.art. 6 swiss federal patent attorney examination 1 the swiss federal patent attorney examination serves as proof of the specialised knowledge required for professional qualification.2 the federal council shall regulate:a.the admission requirements for the examination;b.the content of the examination;c.the examination procedure.3 it shall designate:a.the body competent for conducting the examination;b.the body competent for the supervision of the examination.art. 7 recognition of foreign patent attorney examinations 1 a foreign patent attorney examination is recognised where its equivalence to the swiss federal patent attorney examination:a.is provided for in a treaty pertaining to mutual recognition with the respective state or supranational organisation; or b.is proven in an individual case.2 the federal council shall designate the competent body for such recognition.3 where the competent body does not recognise a foreign patent attorney examination, it shall decide how the requirements of article 2 letter b may be fulfilled.art. 8 delegation of tasks to organisations and persons of public or private law 1 the federal council may entrust organisations and persons of public or private law with:a.conducting the swiss federal patent attorney examination;b.deciding on the recognition of foreign patent attorney examinations;c.issuing rulings concerning the passing of the swiss federal patent examination or the recognition of a foreign patent attorney examination.2 the organisations and persons mentioned in paragraph 1 may levy fees for the rulings and services rendered by them. their fee regulations are subject to approval by the federal council.3 an objection may be filed with the state secretariat for education, research and innovation4 to rulings issued by the organisations and persons mentioned in paragraph 1.4 term in accordance with no i 31 of the ordinance of 15 june 2012 (reorganisation of the departments), in force since 1 jan. 2013 (as 2012 3655).art. 9 practical training 1 practical training as defined in article 2 letter c must be completed under the supervision of a registered patent attorney (art. 11 et seq.) or a person with an equivalent professional qualification.2 the duration of practical training must amount to three years on a full-time basis for persons with a higher education qualification (master's, diplom or lizenziat degree) or a recognised equivalent qualification, and four years on a full-time basis for persons with a bachelor's degree or a recognised equivalent qualification. at least one year of the practical training must be related to switzerland.3 the federal council shall regulate the particulars, including:a.the objectives and content of the practical training;b.the requirements to be fulfilled by a supervisor who is not registered in the patent attorney register;c.the requirements with regard to how the practical training is related to switzerland in terms of territory and content.section 3: professional confidentiality art. 10 1 patent attorneys are obliged to maintain confidentiality concerning all secrets that are entrusted to them in their professional capacity or which come to their knowledge in the course of their professional activities, this obligation being unlimited in time.2 they must ensure that persons assisting them maintain professional confidentiality.section 4: patent attorney register art. 11 maintenance of the register the ipi shall maintain the patent attorney register. it may maintain the register in electronic form.art. 12 registration in the register 1 on application and on payment of a fee, the ipi shall register persons who fulfil the requirements of article 2 in the patent attorney register. it shall issue a certificate of registration.2 the person making the application must prove by way of suitable documentation that he or she fulfils the requirements of article 2.3 the federal council may authorise the ipi to regulate electronic communication in accordance with the general provisions on the administration of federal justice.4 the dossier and files may be maintained and stored in electronic form.art. 13 supervision 1 where the professional conduct of a patent attorney gives rise to complaints, the swiss federal department of justice and police (fdjp) may, after hearing the person concerned:a.admonish him or her;b.authorise the ipi to disqualify him or her temporarily or permanently from using the professional title.2 in assessing professional conduct within the meaning of paragraph 1, the patent attorney's entire business activities in switzerland and abroad shall be taken into consideration.3 the fdjp may order the publication of the admonition or the disqualification as well as the deletion of the registration from the patent attorney register.art. 14 register content 1 when registering patent attorneys in the patent attorney register, the ipi shall enter the following particulars:a.date of registration;b.surname, first name, date of birth and place of origin or citizenship;c.address for service or business address in switzerland; andd.name of employer, if applicable.2 patent attorneys must notify the ipi immediately of any changes to their registered particulars so that they may be registered in the patent attorney register.art. 15 public access to the register 1 any person may view the register and obtain information on its content.2 the ipi may make the content of the register available to third parties by way of electronic retrieval.section 5: criminal provisions art. 16 abuse of title 1 a fine shall be imposed on any person who, in his or her business documents, advertising of any kind, or other documents intended for use in business in switzerland:a.uses the title "patent attorney", "patentanwltin" or "patentanwalt", "conseil en brevets" or "consulente in brevetti" without being registered in the patent attorney register;b.uses the title "european patent attorney", "europische patentanwltin" or "europischer patentanwalt", "conseil en brevets europens" or "consulente in brevetti europei" or a title that may be confused with any of these titles without being registered in the list of professional representatives maintained by the european patent office.2 the use of a professional title in accordance with article 9 of the liechtenstein act of 9 december 19925 on patent attorneys for the representation of parties in proceedings before the ipi by natural and legal persons residing or having their principal place of business in the principality of liechtenstein is reserved.5 liechtenstein law gazette 1993 no. 43art. 17 criminal prosecution the prosecution of criminal offences is the responsibility of the cantons.section 6: final provisions art. 18 amendment of legislation the amendment of current legislation is regulated in the annex.art. 19 transitional provisions 1 a person shall be registered in the patent attorney register on application and on payment of a fee provided that, on commencement of this act, he or she has been working professionally as a patent attorney on a full-time basis in switzerland:a.for more than six years, possesses a higher education qualification in natural sciences or engineering from a swiss higher education institution or a foreign higher education qualification as defined in article 5 paragraph 1, and has an address for service in switzerland; orb.for more than three years, is registered in the list of professional representatives maintained by the european patent office and has an address for service in switzerland.2 application must be made within two years of commencement of this act.3 the applicant must prove, by means of suitable documentation, that he or she fulfils the requirements of paragraph 1 letter a or b.4 the ipi shall issue a certificate of registration. art. 20 referendum and commencement. 1 this act is subject to an optional referendum.2 the federal council shall determine the commencement date.commencement date: 1 july 201166 federal council decree of 11 may 2011annex (art. 18)amendment of current legislation the following enactments are amended as follows:.77 the amendments may be consulted under as 2011 2259.

935.621 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.patent attorney ordinance(patao)of 11 may 2011 (status as of 1 january 2013)the swiss federal council,based on article 6 paragraphs 2 and 3, article 7 paragraph 2, article 8 paragraph 1, article 9 paragraph 3 and article 12 paragraph 3 of the patent attorney act of 20 march 20091 (pataa),ordains:1 sr 935.62chapter 1: subject matter art. 1 this ordinance regulates:a.the requirements to be fulfilled by a higher education qualification in natural sciences or engineering (art. 2 let. a pataa);b.the swiss federal patent attorney examination and the recognition of foreign patent attorney examinations (art. 6-8 pataa);c.the requirements concerning practical training and the recognition of professional experience acquired abroad (art. 9 pataa);d.the patent attorney register (art. 11-15 pataa).chapter 2: higher education qualifications art. 2 1 a higher education qualification in natural sciences or engineering must be obtained by completing a full-time study course with a minimum duration of three years or a part-time study course of equivalent study duration. a minimum of 80 percent of the course hours required to obtain this qualification must be devoted to natural sciences or engineering subjects.2 the following subjects in particular are considered natural sciences or engineering subjects: civil engineering, biochemistry, biology, biotechnology, chemistry, electronics, electrical engineering, information technology, mechanical engineering, mathematics, medicine, pharmacy and physics.chapter 3: swiss federal patent attorney examination section 1: organisation of the examination art. 3 examination board 1 the federal council assigns to the joint association (examination board) of the association of swiss and european patent attorneys in private practice (vespa), the association of patent attorneys in swiss industry (vips) and the association of swiss patent and trademark attorneys (aspta) the following duties:a.administration of the swiss federal patent attorney examination.b.issuing guidelines for the patent attorney examination.c.appointment of examiners.d.deciding on the passing or failing of the examination.e.deciding on the recognition of foreign patent attorney examinations.f.establishing fee regulations and submitting them to the federal council for approval.g.maintenance of an office.2 the examination board is financed by the fees levied for its rulings and services and by contributions from its members.3 the duties of the examination board are performed by the examination committee.art. 4 examination committee 1 the examination committee consists of two representatives each of the vespa, vips and aspta patent attorney associations. they are elected by the executive board of the examination board.2 the examination committee is quorate when the chair or his or her deputy and at least three other members are present.3 the decisions of the examination committee are reached by a majority of the members present. the chair also has a vote; where a vote is tied, his or her vote or, where he or she is absent, the vote of his or her deputy, shall be decisive.4 the president of the federal patent court or a legal member of this court designated by the president shall attend the meetings of the examination committee as an observer in an advisory capacity. the examination committee may invite other persons without voting rights to the meetings.art. 5 examiners 1 patent attorneys registered in the patent attorney register and other experts with proven knowledge in the subject areas to be examined (art. 7), such as lecturers in higher education, attorneys and judges, shall be appointed by the examination committee as examiners.2 examiners may not simultaneously be members of the examination committee.3 examiners are appointed for a period of two years. they may be reappointed.art. 6 supervision 1 responsibility for the supervision of the swiss federal patent attorney examination lies with the state secretariat education, research and innovation (seri)2.2 seri approves the examination committee's guidelines for the patent attorney examination.2 the name of this administrative unit was amended in application of art. 16 para. 3 of the publications ordinance of 17 nov. 2004 (sr 170.512.1) on 1 jan. 2013. the amendment has been made throughout the text.section 2: content of the examination art. 7 examination of specialised knowledge in the swiss federal patent attorney examination, specialised knowledge is examined in the following areas:a.european and international patent law;b.swiss patent law;c.swiss procedural and organisational law relevant to industrial property rights;d.trade mark, design, copyright, competition and civil law to the extent required for working professionally as a patent attorney in switzerland.art. 8 parts of the examination 1 the swiss federal patent attorney examination consists of four parts. the candidate is free to decide on the order in which the parts of the examination are completed.2 parts 1 and 2 (art. 7 let. a) are conducted in accordance with the provisions of the administrative council of the european patent organisation (art. 134a para. 1 let. b of the european patent convention of 5 october 1973, revised on 29 november 20003) on the european qualifying examination for professional representatives before the european patent office. they cover the following:a.part 1: drafting of patent claims and the introductory part of a patent application (examination paper a);b.part 2: replying to an official communication in which prior art has been cited (examination paper b). 3 part 3 (art. 7 let. a-c) covers:a.swiss patent law including the special provisions pertaining to international procedures;b.the swiss provisions in the area of administrative, criminal and civil procedure as well as the organisation of authorities and court applicable to patent matters.4 part 4 (art. 7 let. d) covers trade mark, design, copyright, competition and civil law to the extent required for working professionally as a patent attorney in switzerland.3 sr 0.232.142.2section 3: examination procedure art. 9 conduct of the examination 1 parts 3 and 4 of the swiss federal patent attorney examination are held at least once a year. if less than four applications have been received, the examination committee may postpone the examination, whereby there may be no more than 25 months between two examination dates of any examination part. 2 the examination committee determines the application deadlines, the examination dates and the examination location and publishes these.3 neither part 3 nor part 4 of the examination may be split across more than one examination date.art. 10 admission 1 admission to the swiss federal patent attorney examination shall be granted to:a.any person who, on applying to take the examination, can provide proof of the requisite higher education qualification (art. 2) and of the requisite practical training (art. 27-30); andb.has paid the examination fee by the application deadline.2 any person who applies for admission to the examination must submit the following:a.the documents evidencing his or her higher education qualification;b.a certificate confirming the completion of practical training (art. 30).3 the examination committee may require a candidate, the candidate's institution of higher education or the candidate's supervisor (art. 28) to provide additional information or proof.4 the examination committee shall decide on admission to the examination by issuing a ruling.art. 11 examination language 1 the candidate may take the examination parts administered by the examination committee in german, french or italian.2 the candidate must indicate the examination language on applying to take the examination.art. 12 parts 1 and 2 of the examination 1 parts 1 and 2 must be completed within the framework of the european qualifying examination conducted by the european patent office.2 in exceptional circumstances, the examination committee may offer substitute examinations that are equivalent to examination papers a and b of the european qualifying examination.art. 13 preparation of examination content 1 the examination questions are prepared by at least two examiners. they establish the marking criteria.2 the examiners must submit the examination questions and the marking criteria to the examination committee for approval.3 the examination committee ensures the examination papers are translated into the respective languages for which applications have been received.art. 14 part 3 of the examination 1 part 3 of the examination is conducted in writing.2 at least one of the examiners who prepared this part of the examination must be present. he or she advises the candidate on the details pertaining to the conduct of the examination prior to commencement of the examination.3 this part of the examination shall have a duration of six hours.4 the candidate shall provide the answers to the examination in anonymised form. 5 the examiners entrusted with marking the examinations shall determine their assessment jointly.art. 15 part 4 of the examination 1 part 4 of the examination is conducted orally.2 two of the examiners who prepared this part of the examination must be present for part 4.3 this part of the examination shall have a duration of one hour. in justified cases, it may be extended to a maximum of 75 minutes.4 the examiners shall determine their assessment jointly.art. 16 presence of third parties at the examination 1 the swiss federal patent attorney examination is not public.2 the examination committee may grant persons with a proven justified interest to be present during the examination.3 the members of the examination committee and seri representatives are permitted to be present ex officio.art. 17 passing of parts 1 and 2 of the examination and resitting the substitute examination 1 parts 1 and 2 of the examination in accordance with article 12 paragraph 1 are deemed to have been passed when the person:a.has passed both papers a and b of the examination; orb.has passed the european qualifying examination in full.2 parts 1 and 2 of the substitute examination taken in accordance with article 12 paragraph 2 are deemed to have been passed if both parts of the examination have been passed individually.3 any person who twice fails one part of the substitute examination taken in accordance with article 12 paragraph 2 shall be excluded from any further examinations.art. 18 passing and resitting parts 3 and 4 of the examination 1 parts 3 and 4 of the examination are deemed to have been passed if both parts of the examination have been passed individually.2 any person who twice fails one of the examination parts shall be excluded from any further examinations.art. 19 withdrawal 1 candidates may withdraw their application up to 14 days prior to the commencement of the examination. the examination fee will only be refunded in this case.2 after this time, withdrawal is only possible where the candidate has a valid excuse. in particular, the following are deemed to be valid excuses:a.maternity;b.illness or accident;c.death of a closely related person;d.unforeseen military, civil defence or civilian service.3 notice of withdrawal must be given immediately in writing and the reasons therefor must be documented.4 candidates who do not withdraw from the examination in due time in accordance with paragraph 1 or who do not have a valid excuse are deemed not to have passed the relevant part of the examination.5 where a candidate withdraws, with a valid excuse, from an examination that has already commenced, the candidate must apply for the next examination date, or this part of the examination will be deemed not to have been passed.6 the candidate must resit the interrupted examination in full and pay the examination fee again.art. 20 examination results 1 the examination committee shall decide at a meeting on whether the examination parts have been passed. a representative of seri shall be invited to attend this meeting.2 the examination committee shall notify the candidate, within three months, in a written ruling of the result of the examination parts taken by him or her.3 the swiss federal patent attorney examination has been passed when all four examination parts in accordance with article 8 are deemed to have been passed. in this case, the examination committee issues confirmation in the form of a certificate.art. 21 retention of examination scripts 1 the examination committee shall ensure that all examination scripts are retained for a period of two years following notification of the examination results.2 where an objection is filed, the examination scripts must be retained until the decision on the objection has become legally binding.3 the candidate may request to view his or her examination scripts retained in accordance with paragraph 1 or 2.art. 22 sanctions 1 where it is established that the candidate obtained admission to the examination under false pretences by providing incorrect or incomplete information, the examination committee shall declare the passed examination parts to be invalid.2 where a candidate attempts to influence the examination result during an examination by dishonest means, the examiner shall report this to the examination committee. the examination committee shall decide whether, as a result, the respective examination part is deemed not to have been passed. where a candidate is caught attempting to cheat during an examination, he or she may complete the examination subject to reservation.section 4: recognition of foreign patent attorney examinations art. 23 general principles 1 the examination committee is responsible for the recognition of foreign patent attorney examinations.2 it decides by issuing a written ruling on the recognition of the foreign patent attorney examination and on the content and conduct of a qualifying examination.3 the agreement of 21 june 19994 between the swiss confederation and the european community and its member states on the free movement of persons applies to the recognition of foreign patent attorney examinations for the persons subject to this agreement.4 sr 0.142.112.681art. 24 application for recognition 1 any person who seeks to have a foreign patent attorney examination recognised must submit a written application to the examination committee. 2 the application must include documentation evidencing:a.that the applicant has taken a patent attorney examination; b.the specialised knowledge examined in the patent attorney examination. art. 25 qualifying examination 1 where the examination committee does not recognise the foreign patent attorney examination or recognises it only in part, the applicant may take a qualifying examination.2 any person who can, at the time of application, provide proof of a higher education qualification (art. 2) and practical training (art. 27-30), shall be admitted to the qualifying examination.3 the examination committee may require the applicant to submit documentation on the nature and duration of the professional experience acquired by him or her.art. 26 content and conduct of the qualifying examination 1 the qualifying examination covers the specialised knowledge which forms the subject matter of the swiss federal patent attorney examination and which has not already been examined in the course of education in the country in which the patent attorney examination was taken.2 in determining the content of the qualifying examination, the applicant's relevant professional experience may be taken into consideration.3 the examination committee shall decide on a case by case basis on the form, conduct and marking of the qualifying examination.4 the provisions pertaining to the examination language (art. 11), withdrawal (art. 19) and sanctions (art. 22) apply by analogy to the qualifying examination.5 the examination committee shall notify the applicant in a written ruling of the result of the qualifying examination taken by him or her within three months.6 any person who twice fails the qualifying examination or parts of it shall be excluded from further examinations.chapter 4: practical training art. 27 objective and content 1 practical training allows the candidate to obtain, under supervision, practical experience that enables him or her to work independently as a patent attorney under the pataa.2 within the scope of obtaining the requisite practical training, the candidate shall, in particular:a.acquire specialised knowledge in accordance with article 7 and apply it in practice;b.become familiar with the authorities competent for patent matters in switzerland;c.learn to draft patent applications on the basis of documentation provided by a client and represent the client in grant procedures;d.become familiar with the formalities and time limits for the procedure of the grant of a patent in switzerland.art. 28 supervisor the following persons may supervise practical training:a.any person who is registered in the patent attorney register as a patent attorney;b.any person who has worked professionally as a patent attorney in switzerland for at least ten years on a full-time basis without being registered in the swiss patent attorney register;c.any person who has worked professionally as a patent attorney abroad for at least six years on a full-time basis as a regulated profession under the laws of the country of origin; ord.any person who is registered in the list of professional representatives maintained by the european patent office and has worked professionally as a patent attorney in switzerland for at least one year on a full-time basis.art. 29 territorial requirements 1 a minimum of twelve months of the practical training must be completed on a full-time basis under a supervisor with a place of business in switzerland.2 supervised professional work as a patent attorney in a foreign country will be recognised when it was completed on a full-time basis for at least eighteen months and where, as a result, the candidate:a.acquired the specialised knowledge in accordance with article 7 and applied it in practice;b.became familiar with the authorities competent for patent matters in switzerland; andc.became familiar with the formalities and time limits for the procedure of the grant of a patent in switzerland. art. 30 proof of practical training 1 on completion of the candidate's practical training, the supervisor must certify the following in writing:a.the duration of practical training;b.the level of employment in relation to a full-time equivalent;c.the place of employment;d.the activities performed.2 in cases of practical training in accordance with article 29 paragraph 2, the supervisor must also indicate in writing the extent to which the candidate achieved the training objectives in accordance with article 29 paragraph 2 by means of the performed activities.chapter 5: patent attorney register art. 31 application for registration in the patent attorney register 1 any person who wishes to be registered in the patent attorney register must submit the following to the swiss federal institute of intellectual property (ipi):a.the information in accordance with article 14 paragraph 1 letters b, c and, if applicable, letter d pataa; andb.the following documents:1.the certificate confirming that the swiss federal patent attorney examination has been passed, or2.the examination committee's decision on the recognition of the foreign patent attorney examination and, if applicable, the examination committee's decision that the qualifying examination in accordance with article 23 paragraph 2 and article 26 paragraph 5 has been passed, or proof that the requirements in terms of article 23 paragraph 3 are fulfilled.2 the application for registration will not be deemed to have been made unless the registration fee has been paid within the time limit set by the ipi.3 where the documents submitted are incomplete or where there is doubt as to their correctness, the ipi may request that additional information or proof be provided.4 where the applicant does not fulfil the requirements for registration in the register, the ipi shall reject the application. the registration fee shall not be refunded.art. 32 modification and deletion of particulars in the register 1 the ipi shall modify or delete particulars in the register on application by the registered person or ex officio.2 it shall modify or delete particulars ex officio when the information required for registration has changed, in particular, when the registered person no longer has an address for service in switzerland or the registered person's address for service in switzerland has changed.3 where the ipi modifies or deletes particulars ex officio, it shall notify the registered person of the intended amendment or deletion and set a time limit to respond. if the registered person does not comply with the time limit to respond, the ipi shall modify or delete the corresponding particulars.4 the ipi may delete particulars ex officio without invitation to respond where:a.the swiss federal department of justice and police orders the deletion;b.the examination committee subsequently declares an examination to be invalid;c.the registered person is deceased.art. 33 application for re-entry in the register 1 where a person whose registration has been deleted wishes to be re-entered in the register, and where the requirements for registration are fulfilled, submission of the certificate in accordance with article 12 paragraph 1 pataa shall suffice. 2 the registration fee must be paid in full for re-entry in the register.art. 34 dossier 1 the dossier shall be retained for a period of five years following deletion of a registration in the register or for a period of five years following rejection of an application for registration.2 the following persons may view the dossier:a.the person registered in the register;b.third parties who can prove a justified interest.art. 35 electronic communication 1 the ipi may permit electronic communication.2 it shall establish the technical details and publish them in a suitable manner.chapter 6: final provisions section 1: transitional provisions art. 36 higher education qualifications natural sciences or engineering degrees (bachelor's, master's, diplom or lizenziat) obtained at higher education institutions as defined in article 3 of the university funding act of 8 october 19995 are recognised as swiss higher education qualifications in accordance with article 4 pataa even if the higher education institution was not accredited at the time the qualification was awarded.5 sr 414.20art. 37 registration in the patent attorney register in accordance with article 19 pataa 1 any person who wishes to be registered in the patent attorney register in accordance with article 19 pataa must submit the following to the ipi:a.for applications in accordance with article 19 paragraph 1 letter a pataa, proof of working professionally as a patent attorney in switzerland and of a higher education qualification;b.for applications in accordance with article 19 paragraph 1 letter b pataa, proof of working professionally as a patent attorney in switzerland and proof of registration in the list of professional representatives before the european patent office.2 the application will not be deemed to have been made unless the registration fee has been paid within the time limit set by the ipi.3 where the documents submitted are incomplete or where there is doubt as to their correctness, the ipi may require that additional information or proof be provided.4 where the applicant does not fulfil the requirements for registration in the register, the ipi will reject the application. the registration fee will not be refunded.art. 38 use of the professional title during the transitional period persons who fulfil the requirements for registration in the patent attorney register in accordance with article 19 paragraph 1 pataa may use the professional titles "patent attorney", "patentanwltin" or "patentanwalt", "conseil en brevets" or "consulente in brevetti" during the time period for submitting their application in accordance with article 19 paragraph 2 pataa, even if they have not yet been registered in the patent attorney register.section 2: commencement art. 39 this ordinance comes into force on 1 july 2011.

935.91 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton mountain guides and organisers of other high-risk activitiesof 17 december 2010 (status as of 1 january 2014)the federal assembly of the swiss confederation,on the basis of articles 63 paragraph 1, 95 and 97 of the federal constitution1,and having considered the report of the national council legal affairs committee dated 27 march 20092,and the federal council report dated 26 august 20093,decrees:1 sr 1012 bbl 2009 60133 bbl 2009 6051section 1: general provisions art. 1 scope of application 1 this act applies to commercially offered high-risk activities in mountainous or rocky terrain and in or around streams or rivers where:a.there is a risk of slipping or falling or an increased risk due to rising water levels, falling rock or ice, or avalanches; andb.the activities require special knowledge or special safety precautions.2 the following activities are governed by this act:a.the activities of mountain guides;b.the activities of snow sports instructors that do not fall within the responsibility of ski lift or cableway operators;c.canyoning;d.river rafting and white water rafting;e.bungee jumping.3 the federal council may make further comparable high-risk activities subject to this act; in doing so, it must familiarise itself with the objective risks that may be expected when carrying out the activities concerned.art. 2 duties of care 1 any person who offers an activity that is subject to this act must take the measures that experience indicates are required, that are possible according to the state of the art and that are appropriate in the given conditions, so that the lives and health of the participants are not endangered.2 he or she must in particular:a.alert clients to the specific dangers that may be related to carrying out the activity concerned;b.assess whether the clients have the capacity to carry out the activity concerned;c.ensure that equipment is free of defects and installations are in a good condition;d.assess the suitability of the weather and snow conditions;e.ensure that staff are adequately qualified;f.ensure that a sufficient number of support staff are available according to the degree of difficulty and the danger;g.show consideration for the environment and in particular the habitats of flora and fauna.section 2: licensing art. 3 licensing requirement any person offering an activity subject to this act requires a licence.art. 4 licence for mountain guides 1 mountain guides are granted a licence if they:a.hold a federal professional education and training diploma as a mountain guide under article 43 of the vocational and professional training act of 13 december 20024 or have been awarded an equivalent swiss or foreign professional qualification; and b.guarantee that they will comply with the obligations under this act.2 the federal council regulates:a.the recognition of swiss or foreign professional qualifications;b.which activities under article 1 paragraph 2 letters c-e mountain guides may offer as individuals.4 sr 412.10art. 5 licence for snow sports instructors 1 snow sports instructors are granted a licence to guide clients in areas that do not fall within the responsibility of ski lift or cableway operators if they:a.hold a federal professional education and training diploma as a snow sports instructor under article 43 of the vocational and professional training act of 13 december 20025 or have been awarded an equivalent swiss or foreign professional qualification; andb.guarantee that they will comply with the obligations under this act.2 the federal council regulates the recognition of swiss or foreign professional qualifications.5 sr 412.10art. 6 licence for businesses offering activities under article 1 paragraph 2 letters c-e 1 businesses that offer activities under article 1 paragraph 2 letters c-e are granted a licence if they:a.are certified for the conduct of the activities concerned; andb.guarantee compliance with the obligations under this act.2 the federal council regulates the minimum requirements for certification.art. 7 granting and renewing the licence 1 the cantonal authority at the place of residence or registered office of the applicant grants the licence.2 licences are renewed in a simplified procedure.3 licences for mountain guides and for snow sports instructors are renewed if the holder meets the requirements under articles 4 and 5 and can provide proof of appropriate continuing education and training.4 the federal council issues the implementing provisions on granting and renewing licences, and in particular on granting and renewing licences for persons staying, resident or with registered office abroad.art. 8 effect of the licence 1 a licence from a cantonal authority is valid for the entire territory of switzerland.2 a licence for a mountain guide or for a snow sports instructor is personal and non-assignable.3 the foregoing provisions are subject to cantonal jurisdiction over stationary installations for carrying out activities governed by this act.art. 9 term of the licence 1 a licence for a mountain guide or a snow sports instructor is valid for four years.2 a licence for a business that offers activities under article 1 paragraph 2 letters c-e is valid for two years.3 licences for persons staying, resident or with registered office abroad may be made valid for a shorter term.art. 10 withdrawal of the licence the cantonal authority shall withdraw the licence if the holder no longer fulfils the requirements for being granting the licence.art. 11 fees 1 the cantons charge fees for granting, renewing and withdrawing the licence.2 the federal council regulates the level of the fees.art. 12 information the cantonal authority must provide third parties with information on whether a person holds a licence without proof of a legitimate interest being required.section 3: insurance and duty to provide information art. 13 1 any person holding a licence under this act must obtain professional indemnity insurance for the licensed activities according to the nature and extent of the risks related to his or her work or must provide equivalent financial security, and must inform his or her clients about his or her insurance cover.2 the federal council regulates the minimum amount to be insured and the requirements for equivalent security.section 4: cantonal restrictions on access to specific areas art. 14 the cantons may prohibit access to specific areas, in particular if this is required for nature or water protection reasons.section 5: criminal provisions art. 15 contraventions 1 any person who wilfully:a.provides incomplete, incorrect or misleading information in order to obtain a licence;b.works as a mountain guide or snow sports instructor without a licence or offers activities under article 1 paragraph 2 letters c-e,is liable to a fine not exceeding 10,000 francs.2 if the offender acts through negligence, he or she is liable to a fine not exceeding 5000 francs.art. 16 prosecution prosecution is the responsibility of the cantons.section 6: support for private legal entities art. 17 the confederation may establish or provide financial support to or hold participations in private legal entities. such entities must have the object of improving the safety of the activities governed by this act by introducing safety concepts and safety inspections.section 7: final provisions art. 18 implementation 1 the cantons implement this act, unless the confederation is declared responsible.2 the federal council issues the implementing provisions.art. 19 transitional provisions 1 cantonal licences for mountain guides and snow sports instructors that have been issued in accordance with previous cantonal regulations remain valid until their expiry date or for two years following the commencement of this act, whichever is sooner.2 persons working as mountain guides or as snow sports instructors on the commencement of this act who do not hold a cantonal licence must apply for a licence in their canton of residence within six months of the commencement of this act.3 the federal council regulates when businesses offering activities under article 1 paragraph 2 letters c-e that are already operating on the commencement of this act must fulfil the requirements hereof.art. 20 referendum and commencement 1 this act is subject to an optional referendum.2 the federal council determines the commencement date.commencement date: 1 january 201466 federal council decree of 30 nov. 2012

935.911english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinance on mountain guides and organisers of other high-risk activities(high-risk activities ordinance)of 30 january 2019 (status as of 7 april 2020)the swiss federal council,on the basis of articles 1 paragraph 3, 4 paragraph 2, 5 paragraph 2, 6 paragraph 2,7 paragraph 4, 11 paragraph 2, 13 paragraph 2, 18 paragraph 2 and 19 paragraph 3 of the federal act of 17 december 20101 on mountain guides and organisers of other high-risk activities (the act), ordains:1 sr 935.91chapter 1 general provisions art. 1 additional activities to which the act applies the act applies to the following activities in addition to those named in article 1 paragraph 2 thereof:a.the activities of aspiring mountain guides;b.the activities of climbing instructors;c.2the activities of mountain leaders.2 the correction of 7 april 2020 concerns the italian text only (as 2020 1191).art. 2 commercial activity 1 a person who earns a primary or secondary income by carrying on activities defined in article 3 paragraph 1 on the territory of the swiss confederation is considered to be carrying on a commercial activity. 2 a person who carries on activities defined in article 3 paragraph 1 of this ordinance exclusively under the supervision and responsibility of not-for-profit organisations whose internal structures and requirements guarantee the safety of the participants is not considered to be carrying on a commercial activity.chapter 2 licensing section 1 activities for which a licence is required art. 3 1 a licence is required in order to offer the following activities:a.mountaineering;b.alpine hiking from difficulty level t4 in accordance with annex 2 number 1;c.touring with skis, snowboards and similar snow sports equipment;d.snowshoe tours from difficulty level wt3 in accordance with annex 2 number 3, with the exception of snowshoe tours on signposted, open winter hiking trails or snowshoe routes;e.off-piste skiing from difficulty level ws in accordance with annex 2 number 2;f.use of vie ferrate;g.climbing frozen waterfalls and steep ice climbing;h.multi-pitch rock climbing;i.canyoning;j.river-rafting on flowing water from difficulty level whitewater iii in accordance with annex 3 with a raft as defined in article 2 paragraph 1 letter a number 12 of the inland navigation ordinance of 8 november 19783;k.whitewater sports on flowing water from difficulty level whitewater iii in accordance with annex 3 with a boat or other sports equipment such as a canoe, kayak, riverboard (hydrospeed), funyak or tube; l.bungee jumping, with the exception of activities performed by exhibitors who are licensed in accordance with article 25 paragraph 2 of the ordinance of 4 september 20024 on itinerant trade.2 off-piste skiing is considered to be downhill skiing using snow sports equipment in locations accessible by mountain railways but not within the area of responsibility of ski lift or cableway operators.3 canyoning is defined as entering or travelling in streambeds or riverbeds with limited escape options for which swimming or climbing techniques are required.4 bungee jumping is considered to be jumping from heights in a free fall while attached to an elastic cord, or a pendulum jump.3 sr 747.201.14 sr 943.11section 2 licensing art. 4 mountain guides 1 licensed mountain guides are authorised to guide clients within the scope of the activities defined in article 3 paragraph 1 letters a-h.2 the following are considered to be equivalent to a federal professional education and training diploma as a mountain guide (federal pet diploma):a.licences issued under previous laws in accordance with annex 4 number 1, if the holder can demonstrate that he or she has pursued the activity regularly and has completed sufficient further training; b.foreign certificates of competence which are recognised by the state secretariat for education, research and innovation (seri) as equivalent;c.5a diploma as an international mountain guide recognised by the international federation of mountain guide associations (ifmga).3 licensed mountain guides are authorised to conduct canyoning if the guide has completed additional training with the swiss mountain guide association (sbv) or holds a diploma recognised by the ifmga.6 5 correction of 15 oct. 2019 (as 2019 3159).6 correction of 15 oct. 2019 (as 2019 3159).art. 5 aspiring mountain guides 1 licensed aspiring mountain guides are authorised to guide clients within the scope of activities defined in article 3 paragraph 1 letters a-h if they do so under the direct or indirect supervision of and in joint responsibility with a mountain guide licensed in accordance with article 4.2 aspiring mountain guides are granted a licence if they:a.have passed the aspirant course of the swiss mountain guide association, an aspirant course recognised by the ifmga, or a foreign aspirant course recognised by the federal office of sport (fospo) as equivalent;b.guarantee that they will comply with their obligations under the act and this ordinance.3 licensed aspiring mountain guides are authorised to guide canyoning if the aspirant has completed additional training with the swiss mountain guide association or holds a diploma recognised by the ifmga and conducts the activity under the direct or indirect supervision of and in joint responsibility with a mountain guide licensed in accordance with article 4 paragraph 3.7 7 correction of 15 oct. 2019 (as 2019 3159).art. 6 climbing instructors 1 licensed climbing instructors are authorised to accompany clients within the scope of the activities defined in article 3 paragraph 1 letter h on condition that a safe ascent or descent:a.does not require the use of short roping;b.does not require crossing glaciers; andc.does not require the use of technical aids such as ice axes or crampons.2 climbing instructors are granted a licence if they:a.are a climbing instructor with federal pet diploma as defined in article 43 of the vocational and professional education and training act of 13 december 20028 (vpeta) or have earned a foreign certificate of competence recognised by seri as equivalent;b.guarantee that they will comply with their obligations under the act and this ordinance.3 licences issued under previous laws in accordance with annex 4 section 2 are considered to be equivalent to a climbing instructor with federal pet diploma if the holder can demonstrate that he or she has pursued the activity regularly and has completed sufficient further training.4 licensed climbing instructors are also authorised to accompany clients within the scope of the activities defined in article 3 paragraph 1 letter f on condition that the climbing instructor has completed additional training provided by or recognised by the swiss rock guides association or the swiss mountain guide association which covers the areas of safety and risk management when using vie ferrate. 5 trainee climbing instructors may conduct these activities under the direct supervision and responsibility of a person licensed for the activities defined in article 3 paragraph 1 letter h if this is necessary for their further training. 8 sr 412.10art. 7 snow sports instructors 1 licensed snow sports instructors are authorised to accompany clients within the scope of the activities defined in article 3 paragraph 1 letters c-e on the following conditions:a.the tour corresponds at a maximum to the following difficulty levels:1.ski tours: ws as defined in annex 2 section 2,2.snowshoe tours: wt3 as defined in annex 2 section 3,3.off-piste skiing: s as defined in annex 2 section 2, provided there is no risk of falling;b.no glaciers are crossed;c.apart from snow sports equipment, skins, ski crampons and snowshoes, no other technical aids such as ice axes, crampons or ropes have to be used in order to ensure the safety of the clients.2 the following are considered to be equivalent to a snow sports instructor with federal pet diploma:a.licences issued under previous laws in accordance with annex 4 section 3, if the holder can demonstrate that he or she has pursued the activity regularly and has completed sufficient further training;b.swiss certificates of competence recognised by fospo as equivalent;c.foreign certificates of competence recognised by seri as equivalent.3 trainee snow sports instructors may conduct these activities under the direct supervision and responsibility of a person licensed for the activities defined in article 3 paragraph 1 letters c-e if this is necessary for their further training.art. 8 mountain leaders 1 licensed mountain leaders are authorised to accompany clients within the scope of the activities defined in article 3 paragraph 1 letter d on the following conditions:a.the tour corresponds at a maximum to difficulty level wt3 in accordance with annex 2 section 3;b.no glaciers are crossed;c.apart from snowshoes, no technical aids such as ice axes, crampons or ropes have to be used in order to ensure the safety of the clients.2 the licence shall be granted if the mountain leader:a.is a mountain leader with federal pet diploma as defined in article 43 vpeta9;b.guarantees that he or she will comply with the obligations under the act and this ordinance.3 the following are considered to be equivalent to a mountain leader with federal pet diploma as defined in article 43 vpeta:a.foreign certificates of competence recognised by seri as equivalent;b.an international mountain leader (iml) qualification recognised by the union of international mountain leader associations (uimla).4 licensed mountain leaders are also authorised to accompany clients within the scope of the activities defined in article 3 paragraph 1 letter b on the following conditions:a.the alpine hike corresponds at a maximum to difficulty level t4 in accordance with annex 2 section 1; b.the mountain leader has completed additional training provided by or recognised by the berufsverband schweizer wanderleiter (association of swiss mountain leaders) or the swiss mountain guide association (sbv) which covers the areas of safety and risk management when undertaking alpine hikes up to level t4;c.the provisions of paragraph 1 letters b and c are fulfilled.5 trainee mountain leaders may conduct these activities under the direct supervision and responsibility of a person licensed for the activities defined in article 3 paragraph 1 letter d if this is necessary for their further training.9 sr 412.10art. 9 whitewater sports guides 1 licensed whitewater sports guides are authorised to accompany clients within the scope of the activities defined in article 3 paragraph 1 letter k.2 the licence shall be granted if the whitewater sports guide:a.is a canoeing instructor with federal pet diploma as defined in article 43 vpeta10 or has earned a foreign certificate of competence recognised by seri as equivalent;b.guarantees that he or she will comply with the obligations under the act and this ordinance.3 trainee whitewater sports guides may conduct these activities under the direct supervision and responsibility of a person licensed for the activities defined in article 3 paragraph 1 letter k if this is necessary for their further training.10 sr 412.10art. 10 businesses under article 6 of the act under article 6 of the act, businesses are authorised to accompany clients within the scope of the activities defined in article 3 paragraph 1 for which the business is certified.section 3 certification art. 11 certification body certification of businesses providing the activities defined in article 3 paragraph 1 must be undertaken by a certification body recognised by the federal department of defence, civil protection and sport (ddps).art. 12 recognition of certification bodies by the ddps 1 the ddps recognises certification bodies if they:a.certify in accordance with standard en iso/iec 17021-1:201511;b.use iso standards 21101:2014 adventure tourism - safety management systems - requirements12 and 21103:2014 adventure tourism - information for participants13 and the associated technical report iso/tr 21102:2013 adventure tourism - leaders - personnel competence14 for their safety management system;c.only use auditors who can demonstrate specialist knowledge of the activities defined in article 3 paragraph 1;d.ensure that the practical implementation of safety standards is monitored on the spot.2 recognition is valid for a maximum of five years. on application it may be extended for a maximum of five years at a time, following a reassessment of the requirements for recognition.3 recognised certification bodies are required to notify the ddps, immediately and without being asked, of any material changes relating to their recognition.4 if there are indications that a recognised certification body no longer meets the requirements for recognition, the ddps will conduct the necessary investigations. 5 the ddps may suspend or withdraw recognition with immediate effect if the requirements for recognition are no longer met. in minor cases, the ddps may impose restrictions or attach conditions to recognition until the deficiencies have been remedied.11 the standard may be viewed free of charge and obtained for a fee from the swiss association for standardisation, sulzerallee 70, 8404 winterthur; www.snv.ch.12 the standards may be viewed free of charge and obtained for a fee from the swiss association for standardisation, sulzerallee 70, 8404 winterthur; www.snv.ch.13 the standard may be viewed free of charge and obtained for a fee from the swiss association for standardisation, sulzerallee 70, 8404 winterthur; www.snv.ch.14 the technical report may be viewed free of charge or obtained for a fee from the swiss association for standardisation, sulzerallee 70, 8404 winterthur; www.snv.ch.art. 13 certification requirements 1 the minimum certification requirements as defined in article 6 paragraph 1 letter a of the act are met if:a.the safety management system of the business is based on the standards defined in article 12 paragraph 1 letter b;b.the business takes the necessary steps to achieve the protection objective defined in paragraph 2, using the risk analysis templates in annex 5;c.activities defined in article 3 paragraph 1 are implemented only by leaders and assistants who hold a recognised certificate of competence as defined in article 15.2 the protection objective for the conduct of activities as defined in article 3 paragraph 1 is fewer than five deaths per 10 million hours of activity.3 the federal department of defence, civil protection and sport (ddps) shall amend annex 5 whenever the risk analysis templates are revised.art. 14 recognition of certification obtained abroad 1 fospo recognises certification obtained abroad provided that the requirements defined in article 13 are met.2 before reaching a decision, it shall obtain an expert opinion on the institution in accordance with article 16 paragraph 1.3 it may suspend or withdraw recognition with immediate effect if the requirements for recognition are no longer met. in minor cases, fospo may impose restrictions or attach conditions to recognition until the deficiencies have been remedied.art. 15 recognition of certificates of competence for leaders and assistants 1 fospo recognises swiss and foreign certificates of competence for leaders and assistants (art. 13 para. 1 letter c) provided that the certificates were issued in compliance with the following requirements:a.the person has passed an examination and provided evidence of sufficient practical experience before the start of the examination.b.the examination was both theoretical and practical in nature and covered knowledge and skills relevant to safety.c.the examination lasted for at least one working day.d.the examination was conducted by at least two specialists, of whom at least one was neither the employer nor the person who provided training.e.the qualifications meet the requirements of a reputable switzerland-wide industry association, or a government body.2 before reaching a decision, fospo shall obtain an expert opinion on the institution in accordance with article 16 paragraph 1.3 the granting of recognition is published on the internet.4 fospo may suspend or withdraw recognition with immediate effect if the requirements for recognition are no longer met. in minor cases, fospo may impose restrictions or attach conditions to recognition until the deficiencies have been remedied.art. 16 safety plans and safety checks 1 fospo shall designate an appropriate institution which draws up and develops safety plans and safety checks, especially in the area of risk analysis templates, evaluating qualifications, evaluating foreign certification and providing resources for the certification process.2 it may conclude a service agreement with the institution, setting out the objectives of the collaboration, the services to be provided, the reporting and controlling specifications, and compensation.section 4 compulsory registration for persons from the eu and efta states art. 17 nationals of a member state of the european union (eu) or the european free trade association (efta) who did not obtain their professional qualification in switzerland and who wish to work in switzerland on a self-employed basis or as a posted worker for the purpose of providing a service must, before commencing their professional activities in switzerland, fulfil a compulsory registration requirement in accordance with legislation governing the compulsory registration and verification of professional qualifications for service providers in regulated professions.section 5 procedure art. 18 granting a licence 1 the applicant for the licence must submit the application in writing to the cantonal authorities of the applicant's place of residence or registered office. if the person is resident or has a registered office abroad, the application must be submitted to the cantonal authorities at the primary place of business.2 the application must contain the information and documents set out in annex 1.3 cantons may require that their own application form be used.4 the authority shall review the application and the accompanying documents within 10 days of submission. if the application is deficient or incomplete, the authority shall reject it and set a deadline for its correction or completion. if this deadline is not met, the application is considered to be withdrawn.5 the authority shall decide on the application within 10 days of the point in time at which the application is available in a complete and correct form.6 article 8 paragraph 2 and article 9 paragraph 1 of the ordinance also apply by analogy to aspirant mountain guides, rock climbing instructors, hiking guides and whitewater sports guides. 7 in all other respects the procedure is governed by cantonal procedural law.art. 19 renewing a licence 1 in order to renew a licence, holders of an individual licence for activities defined in article 3 paragraph 1 letters a-h and k must:a.prove that since the granting or last renewal of the licence, they have participated in further training of at least two days' duration offered or recognised by one of the professional organisations on the subject of safety and risk management and covering topics referred to in article 2 of the act;b.have professional indemnity insurance in accordance with article 13 of the act. 2 in order to have their licences renewed in accordance with article 6 of the act, businesses must:a.prove they have valid certification; if the certification expires during the three-year certification cycle in accordance with the standard en iso/iec 17021-1:201515, the licence is extended to the end of the certification cycle free of charge, on presentation of a successful monitoring audit;b.have professional indemnity insurance in accordance with article 13 of the act.3 in all other respects article 18 applies to the procedure.15 the standard may be viewed free of charge and obtained for a fee from the swiss association for standardisation, sulzerallee 70, 8404 winterthur; www.snv.ch.art. 20 reporting of changes licence holders are obliged to inform the competent cantonal authority within 30 days of the following changes:a.changes to the information in annex 1;b.non-extension/non-renewal of certification;c.changes in conjunction with the holder's professional indemnity insurance in accordance with article 13 of the act and article 24. art. 21 list of licences 1 a list of the licences awarded under articles 4-10 is published on the internet by the federal office of sport (fospo).2 this list contains the following data:a.last name and first name or company name of the licence holder;b.postal address;c.type of licence;d.date of expiry of licence;e.website of licence holder if the holder has made this information available voluntarily.3 data is entered in this list by the responsible cantonal authority.4 fospo and the responsible cantonal authority may edit the data.5 the data may be used only for the purpose foreseen in article 12 of the act.art. 22 measures in the event of a failure to observe provisions 1 the cantonal authority responsible for granting the licence shall take the necessary measures if it determines that the provisions of the act or this ordinance are not being observed, i.e. if:a.the conditions for granting the licence are no longer met;b.the licence holder no longer has professional indemnity insurance;c.the duty to provide information has been violated.2 if it is expected that the deficiency can be remedied, the authority shall set an appropriate deadline for remedying it. this deadline may be extended in justifiable cases.3 if there is no prospect of remedying the deficiency and it would be irresponsible to continue to offer the activity, the authority shall prohibit the licence holder from offering the activity and shall withdraw the licence.4 cantonal law enforcement authorities which determine that the provisions of the act or this ordinance have not been observed are required to report this to the cantonal authority responsible for the licence.art. 23 fees 1 the following fees are charged:a.for granting and renewing a licence: maximum chf 100;b.for withdrawing a licence: maximum chf 200.2 if the review of documents or the withdrawal of a licence necessitates an extraordinary amount of work, a fee of up to chf 100 per hour shall be charged. every half hour commenced is charged as a full half hour.3 expenses, in particular the costs of expert opinions, and fees charged by seri for the recognition of foreign qualifications shall be calculated separately and invoiced in addition to the basic fee schedule.4 in all other respects, the provisions of the general fees ordinance of 8 september 200416 apply.16 sr 172.041.1chapter 3 insurance and duty to provide information art. 24 compulsory insurance 1 the minimum cover provided by the licence holder's professional indemnity insurance as outlined in article 13 of the act must amount to chf 5 million annually.2 the following security is considered to be equivalent to professional indemnity insurance:a.a surety or bank guarantee declaration for the sum of chf 5 million;b.a blocked bank account holding chf 5 million.3 the insurance company or bank must be licensed by or registered with the responsible supervisory authority.4 article 13 of the act also applies to aspirant mountain guides, rock climbing instructors, mountain leaders and whitewater sports guides. art. 25 duty to provide information persons who hold licences under the act must inform their clients of their insurance cover or the equivalent surety or guarantee:a.in their contracts and their general terms and conditions;b.in booking confirmations and on tickets;c.on their websites or in their online information.chapter 4 cantonal variant inventory art. 26 cantons may list tours and downhill ski runs on their territory in an inventory which describes the training necessary for offering the respective tour or downhill ski run.chapter 5 applicability of criminal provisions of the act art. 27 article 15 of the act also applies to aspirant mountain guides, rock climbing instructors, mountain leaders and whitewater sports guides. chapter 6 final provisions art. 28 revocation of another decree the high-risk activities ordinance of 30 november 201217 is revoked.17 [as 2013 447, 2014 2767]art. 29 transitional provisions 1 licences issued under previous laws remain valid until the expiry of their period of validity.2 providers who are certified in accordance with article 6 of the act at the time when the ordinance comes into force may apply for a licence under the previous law until the end of the certification cycle. 3 certificates of competence obtained under previous laws and entered by the safety in adventures foundation on the list of training courses of 30 november 201818 meet the requirements of article 13 paragraph 1 letter c.18 the list of training courses (in german, french and italian only) may be viewed free of charge at: www.baspo.admin.ch > aktuell > themen (dossiers) > gesetz ber risikoaktivitten > merkbltter und links.art. 30 commencement this ordinance comes into force on 1 may 2019.annex 119 19 the correction of 7 april 2020 concerns the italian text only (as 2020 1191).(art. 18 para. 2 and 20 letter a)information and documents required in the licence procedure 1. information and documents required of natural persons 1 the application must contain the following information:a.last name, first name(s);b.date of birth;c.home town, or in the case of foreigners: place of birth;d.residential and business addresses.2 the application must be accompanied by the following documents:a.copy of the permanent residence permit, residence permit or current travel document, together with a visa where applicable;b.an extract from the commercial register which is no older than two months if the person has an entry in the commercial register; in the case of persons resident abroad, a certificate of registration in the corresponding foreign register should be submitted;c.for mountain guides, climbing instructors, snow sports instructors, mountain leaders and whitewater sports guides: a copy of the professional diploma or proof of training recognised as equivalent; d.for aspiring mountain guides: a copy of the diploma or certificate from the swiss mountain guide association aspirant course, an ifmga aspirant course or a foreign aspirant course recognised as equivalent by fospo;e.for mountain guides and aspiring mountain guides who are applying for a canyoning licence under article 4 paragraph 3 and article 5 paragraph 3: a copy of the certificate of additional training recognised by the swiss mountain guide association or the ifmga;f.for climbing instructors who are applying for a licence for the use of vie ferrate under article 6 paragraph 4: a copy of the certificate of additional training issued by or recognised by the swiss rock guides association;g.for mountain leaders who are applying for a licence for alpine hikes under article 8 paragraph 4: a copy of the certificate of additional training recognised by the berufsverband schweizer wanderleiter (association of swiss mountain leaders).2. information and documents required of private legal entities and sole proprietorships 1 the application must contain the following information:a.name;b.headquarters and registered office of any branches in switzerland;c.business address;d.name of responsible person.2 the application must be accompanied by the following documents:a.in the case of private legal entities with a registered office in switzerland: an extract from the commercial register which is not older than two months;b.in the case of private legal entities with a registered office abroad: a certificate of registration in the corresponding foreign register;c.valid certification in accordance with article 13.annex 2 (art. 3 para. 1 letters b-e, 7 para. 1 letter a, 8 para. 1 letter a and 4 letter a)difficulty levels for ski tours and snowshoe tours, off-piste skiing and alpine hiking the difficulty levels in the following scales20 apply with respect to this ordinance: 1.swiss alpine club (sac) alpine tour and hiking scale of 5 september 2012;2.swiss alpine club (sac) ski tour scale of september 2012;3.swiss alpine club (sac) snowshoe tour scale of september 2012.20 the scales may be viewed free of charge on the fospo website (in german, french and italian only) at: www.baspo.admin.ch > aktuell > themen (dossiers) > gesetz ber risikoaktivitten > merkbltter und links.annex 3 (art. 3 para. 1 letters j and k)whitewater difficulty levels whitewater i: easy viewclearwaterregular currents, regular waves, small swellsriverbedno serious obstacleswhitewater ii: moderately difficult viewpassage clearwaterirregular currents, irregular waves, mid-sized swells, weak breaking waves, eddies and reversalsriverbedsimple obstacles in the current, small dropswhitewater iii: difficult viewpassage easy to recognisewaterhigh, irregular waves, larger swells, breaking waves, eddies and reversalsriverbedsingle exposed boulders, drops, other obstacles in currentwhitewater iv: very difficult viewpassage not obviously recognisable; scouting is generally necessarywaterhigh, long-lasting swells, strong breaking waves, eddies and reversalsriverbedcurrent obstructed by offset boulders, higher drops with backflowwhitewater v: extremely difficult viewscouting is absolutely essentialwaterextreme swells, extreme breaking waves, eddies and reversalsriverbedextreme obstructions, high drops with difficult approaches or exitswhitewater vi: practically impassable generally not passable, possibly passable at specific water levelsannex 4 (art. 4 para. 2 letter a, 6 para. 3 and 7 para. 2 letter a)licences issued under previous laws 1. mountain guides 1.graubnden mountain guide licence acquired before 26 november 2000;2.bern mountain guide licence acquired before 1 january 2001;3.valais mountain guide licence acquired before 1 january 2001.2. climbing instructors swiss mountain guide association climbing instructor diploma acquired before 31 december 2011.3. snow sports instructors 1.graubnden ski instructor licence acquired before 26 november 2000;2.graubnden snowboard instructor licence acquired before 26 november 2000;3.graubnden cross-country ski instructor licence acquired before 26 november 2000;4.bern ski instructor licence acquired before 1 july 1999;5.valais ski instructor diploma acquired before 31 december 2003;6.vaud ski instructor licence acquired before 25 september 1996.annex 5 (art. 13 para. 1 letter b)risk analysis templates 1. in relation to certification, reference should be made to the following risk analysis templates of the institution as defined in article 1621 (available in german and french only): a.mountaineering, dated 31 august 2018;b.canyoning, dated 31 august 2018;c.river rafting, dated 31 august 2018;d.whitewater sports , dated 31 august 2018;e.bungee jumping, dated 31 august 2018.2. certification may be based on a different risk analysis, provided that an equivalent standard of safety is guaranteed.21 the risk analysis templates may be viewed (in german and french only) free of charge at: www.baspo.admin.ch > aktuell > themen (dossiers) > gesetz ber risikoaktivitten > merkbltter und links.

941.10english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal act on currency and payment instruments(cpia)of 22 december 1999 (status as of 1 january 2020)the federal assembly of the swiss confederation,based on articles 99, 122 paragraph 1 and 123 paragraph 1 of the federal constitution1, and having considered the dispatch of the federal council of 26 may 19992,decrees:1 sr 1012 bbl 1999 7258section 1 currency and legal tender art. 1 currency unit the swiss currency unit is the swiss franc. it is divided into 100 centimes.art. 2 legal tender the following payment instruments are considered to be legal tender:a.the coins issued by the confederation;b.the banknotes issued by the swiss national bank;c.swiss franc sight deposits at the swiss national bank.art. 3 obligation to accept 1 everyone is obliged to accept up to 100 swiss regular issue coins in payment. regular issue coins, commemorative coins and bullion coins are accepted at nominal value without restriction by the swiss national bank and the public cash offices of the confederation.2 everyone must accept swiss banknotes in payment without restriction.3 swiss franc sight deposits at the swiss national bank must be accepted in payment without restriction by any person holding an account there.section 2 coinage system art. 4 regular issue coinage 1 the confederation may operate a federal mint.2 the confederation shall mint and issue regular issue coins in order to meet demand for payment transactions.3 the federal council shall decide which regular issue coins are to be minted, put into circulation or withdrawn from circulation.4 the federal council shall decide on the design and the features of regular issue coins. it shall determine the denominations in agreement with the swiss national bank.5 the federal council shall regulate in an ordinance the exchange of coins by public cash offices of the confederation and the elimination of damaged, worn and counterfeit coins.33 amended by no i of the fa of 21 june 2019 (time limit for exchanging banknotes), in force since 1 jan. 2020 (as 2019 3769; bbl 2018 1097).art. 4a4 commercial services 1 the federal mint may provide commercial services to third parties provided these services:a.are closely connected with its main tasks;b.do not impede fulfilment of the main tasks; andc.do not require any significant additional material or human resources.2 commercial services shall be provided on the basis of a cost and performance accounting system at cost-covering prices as a minimum. the department responsible may authorise exceptions for certain services where there is no private sector competition.4 inserted by annex no 5 of the fa of 19 june 2015 (optimisation of the new accounting model), in force since 1 jan. 2016 (as 2015 4009; bbl 2014 9329).art. 5 provision of coinage 1 the national bank shall provide the required quantities of regular issue coins for payment transactions and shall take back without restriction the coins no longer needed against reimbursement of the nominal value.2 in order to guarantee the supply of cash, the national bank may issue regulations on the manner, place and time for the receipt and delivery of coins.3 destroyed, lost and counterfeit coins shall not be replaced.art. 6 commemorative coins and bullion coins 1 for numismatic requirements and investment purposes, the confederation may mint special quality regular issue coins, as well as commemorative coins and bullion coins. these coins may be issued above nominal value.2 the responsible government department5 shall decide on the nominal values, designs and features of commemorative coins and bullion coins. it shall also decide what commemorative coins and bullion coins are to be minted, issued and taken out of circulation.5 currently the federal department of finance.section 3 bank note system art. 7 issue of banknotes 1 the national bank shall issue banknotes commensurate with the demand for payment transactions. it shall determine their denominations and design.2 it shall take back without restriction the banknotes no longer needed against reimbursement of the nominal value.3 the national bank shall withdraw worn and damaged banknotes from circulation.4 in order to ensure cash distribution, the national bank may issue regulations on the manner, place and time for the receipt and delivery of banknotes.art. 8 replacement of banknotes 1 the national bank shall provide compensation for a damaged note, provided that its series and number are recognisable and the holder presents a part that is larger than half or proves that the missing part of the note has been destroyed. 2 the national bank shall not provide any compensation for destroyed, lost or counterfeit notes. art. 9 recall 1 the national bank may recall note denominations, types and series.2 the public cash offices of the confederation shall accept the recalled notes in payment at their nominal value for a period of six months following the first notice of recall.3 notwithstanding paragraph 4 and subject to article 8, the national bank is required to exchange at nominal value recalled notes that were issued from 1976 as part of the sixth banknote series or as a subsequent series.64 the equivalent value of recalled notes that are not returned for exchange shall be allocated after 25 years from the first notice of the recall as follows:a.one fifth of 90 per cent of the equivalent value shall go to the swiss fund for aid in cases of uninsurable damage by natural forces and of the remaining four fifths of the 90 per cent of equivalent value, one third goes to the confederation and two thirds to the cantons;b.10 per cent of the equivalent value shall be retained by the national bank in order to meet the exchange obligation under paragraph 3.76 amended by no i of the fa of 21 june 2019 (time limit for exchanging banknotes), in force since 1 jan. 2020 (as 2019 3769; bbl 2018 1097).7 amended by no i of the fa of 21 june 2019 (time limit for exchanging banknotes), in force since 1 jan. 2020 (as 2019 3769; bbl 2018 1097).section 4 sight deposits at the swiss national bank art. 10 in accordance with the national bank act (nba) of 23 december 19538, the national bank shall specify the conditions under which institutions offering payment transaction services may maintain swiss franc sight deposits.8 [as 1954 599, 1979 983, 1993 399, 1997 2252, 1998 2847 annex no 7, 2000 1144 annex no 4, 2004 297 no i 6. as 2004 1985 annex no i 2]. see now the fa of 3 oct. 2003 (sr 951.11).section 5 criminal provisions art. 11 1 any person who issues or puts into circulation coins or banknotes denominated in swiss francs in contravention of the provisions contained in article 99 of the federal constitution and in this act shall be liable to a custodial sentence of up to three years or to a monetary penalty.92 offences shall be subject to federal jurisdiction/.9 amended by art. 333 of the criminal code (sr 311.0) in the wording of the fa of 13 dec. 2002, in force since 1 jan. 2007 (as 2006 3459; bbl 1999 1979).section 6 referendum and commencement art. 12 1 this act is subject to an optional referendum.2 the federal council shall specify the commencement date.commencement date: 1 may 20001010 fcd of 12 april 2000.annex repeal and amendment of current legislation 1. the federal act of 18 december 197011 on the coinage system is repealed.2.-4. .1211 [as 1971 360, 1997 2755]12 the amendments may be consulted under as 2000 1144.

941.31english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal act on the control of the trade in precious metals and precious metal articles (precious metals control act, pmca)1of 20 june 1933 (status as of 1 january 2022) 1 amended by art. 75 no 2 of the trademark protection act of 28 aug. 1992, in force since 1 april 1993 (as 1993 274; bbl 1991 i 1).the federal assembly of the swiss confederation,based on articles 31bis paragraph 2, 31sexies and 34ter letter gof the federal constitution2,3and having examined the federal council dispatch dated 8 june 19314decrees:2 [bs 1 3; as 1981 1244]3 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).4 bbl 1931 i 888asection 1 definitions precious metal, precious metal articles and multi-metal articles art. 15 1 precious metals under this act are gold, silver, platinum and palladium.2 melt products are ingots, slabs, bars and granules produced by melting or recasting precious metal or melt material.3 melt material means:precious metals obtained through the extraction of raw materials or refining;waste products from the processing of precious metals or alloys thereof which are usable for reclaiming precious metal;material containing precious metal which is usable for reclaiming precious metal.4 precious metal articles are articles wholly comprised of precious metals with a legal standard of fineness, or articles made of precious metals with a legal standard of fineness in combination with a non metallic material. this does not include coins made of precious metals.5 multi-metal articles are articles made of a combination of precious metal with a legal standard of fineness and base metals.5 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).plated articles. imitations art. 26 1 plated articles are articles for which a layer of precious metal is fixed or plated to a substrate of another material.2 the minimum requirements for precious metal layers are set out in annex 1 hereto. the federal council shall specify the error tolerance and may adjust the provisions in the annex in line with international developments.3 imitations are:articles made of precious metals that are below the minimum legal standard of fineness or do not satisfy the other material conditions for precious metal articles;articles that qualify as multi-metal articles or plated articles but which are not marked as such or do not satisfy the material conditions for these categories of articles.6 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).section 2 fineness legal standards of fineness7 7 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).art. 3 1 fineness refers to the purity of precious metal contained in a unit of weight of a metal alloy, measured in parts per thousand.2 the legal standards of fineness for precious metal articles and multi-metal articles are set out in annex 2 hereto. the federal council may adjust these provisions in line with international developments.88 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).art. 49 9 repealed by no i of the fa of 17 june 1994, with effect from 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).error tolerance art. 5 the federal council10 shall define the extent to which and the circumstances in which error tolerances may be allowed for deviations from the standard of fineness.10 expression in accordance with no ii of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033). this amendment has been made throughout the text.section 3 trade in finished articles marking of goods; accuracy art. 611 where the act or the ordinance prescribes or authorises marks on goods, these must refer to the composition of the article. it is prohibited to apply a mark that is likely to be misleading to precious metal articles, multi-metal articles, plated articles or imitations or to items likely to be confused with these.11 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).precious metal articles; fineness mark art. 712 1 precious metal articles may only be placed on the market with a legal fineness mark.2 all parts of a precious metal article must at least meet the specified fineness. the central office for precious metals control (central office) may make exceptions on technical grounds.3 in addition to the fineness mark, articles of platinum or palladium must also bear a reference to the type of precious metal used.12 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).multi-metal articles; marking and appearance art. 7a13 1 multi-metal articles may be traded as such provided that they are marked accordingly and satisfy the material conditions.2 the actual composition must be clear from the mark. the precious metal parts must be clearly marked with the legal fineness in parts per thousand, the other metal parts with the type of metal used.3 the different metals must be visible from the exterior and differ in colour. multi-metal articles must not have the appearance of plated articles.13 inserted by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).plated articles and imitations; marking art. 814 1 plated articles may be traded as such provided that they are marked accordingly and satisfy the material conditions.2 plated articles must bear quality marks which must not leave any doubt as to their plated nature.3 imitations with precious metal coatings may be marked as gilded, silvered, platinised or palladised articles.4 plated articles and imitations must not bear any fineness marks.14 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).other marks and exceptions art. 8a15 1 the federal council may prescribe or authorise other marks for precious metal articles, multi-metal articles, plated articles and imitations.2 the federal council may provide for exceptions to the legally prescribed marks for special, i.e. technical and medical, purposes.3 the central office may issue more specific provisions on the type and form of the prescribed and authorised marks.15 inserted by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).material requirements; more specific provisions art. 8b16 1 the federal council shall issue detailed provisions on the requirements for precious metal articles, multi-metal articles and plated articles.2 it may authorise the central office to specify the technical details.16 inserted by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).responsibility mark a. obligation art. 9 1 in addition to the prescribed marks, precious metal articles, multi-metal articles and plated articles must also bear a responsibility mark.172 manufacturers who do not themselves produce the articles that they use may have their trademark stamped as a responsibility mark on the articles manufactured for them. articles 10 to 12 apply in the case of these marks.3 for watch-cases, members of manufacturer associations may use a collective responsibility mark with a serial number.184 an indication of the standard of fineness may not be applied unless a responsibility mark is applied at the same time.17 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).18 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).b. composition art. 1019 1 the responsibility mark is a symbol which in itself identifies the owner of the mark. it may consist of letters, figures, words, graphic representations or artistic forms, individually or in combination. the mark should not be likely to be confused with previously registered marks or with the official hallmarks.2 the imprint of the responsibility mark on the article must be clear and indelible.19 amended by art. 75 no 2 of the trademark protection act of 28 aug. 1992, in force since 1 april 1993 (as 1993 274; bbl 1991 i 1).c. application for registration art. 11 1 the responsibility mark must be submitted in writing to the central office20 for registration. the application must include the owner's place of residence and registered office and a precise description of the type of business as well as the evidence needed to prove the mark's compliance with legal requirements.2 an owner of a mark who is not listed in the swiss commercial register or is not resident in switzerland may be asked to provide collateral. this collateral serves as a guarantee for all claims under this act.3 the registration fee is payable on submission of the application.20 expression in accordance with no ii of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033). this amendment has been made throughout the text.d. registration art. 12 1 the central office shall maintain a register of all responsibility marks that fulfil the legal requirements. the applicant shall be notified of the registration decision by registered letter, which, in the case of refusal, contains information on the right of appeal against the decision.1bis registration applies for a period of 20 years from the date of registration. before expiry of this period, it may be extended for a further 20 years at a time on payment of the relevant fee.212 if, subsequently, the legal requirements for registration of a responsibility mark no longer apply, or if the registration period expires before an application for extension is submitted, the responsibility mark shall be deleted from the register.22 a mark may also be deleted from the register if the owner uses it in contravention of this act. deletion shall be ordered by the central office and the owner of the mark shall be notified by registered letter, which contains information on the right of appeal.3 .2321 inserted by art. 75 no 2 of the trademark protection act 28 aug. 1992, in force since 1 april 1993 (as 1993 274; bbl 1991 i 1).22 amended by art. 75 no 2 of the trademark protection act 28 aug. 1992, in force since 1 april 1993 (as 1993 274; bbl 1991 i 1).23 repealed by annex no 135 of the administrative court act of 17 june 2005, with effect from 1 jan. 2007 (as 2006 2197; bbl 2001 4202).controlling and hallmarking a. precondition art. 1324 1 watch-cases made of precious metal are subject to an official control before being placed on the market. the control must be applied for by the manufacturer or the party who places the watch-case on the market.2 for all other precious metal articles and for multi-metal articles, the owner of the articles may apply for an official control.24 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).b. purpose art. 14 the official control covers the accuracy and the permissibility of the marks stamped on the articles.c. officials hallmarks art. 1525 1 the accuracy of the fineness and responsibility marks stamped on the precious metal articles and multi-metal articles is certified by stamping the official hallmark.2 hallmarks bear the unique identification of the assay office conducting the official control.25 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).d. procedure art. 16 the official control is applied for by written application to the relevant assay office. only articles bearing a legal fineness mark and the responsibility mark may be controlled. the official control is certified by the official hallmark.e. objection art. 17 1 if the article submitted for controlling does not satisfy the legal minimum fineness or if the fineness mark stamped on the article does not match the actual fineness, the assay office shall refuse to grant its official hallmark and shall notify the central office, which shall order a second opinion.2 depending on the outcome of the second opinion, the central office shall either authorise the official hallmarking or it shall have the articles seized and shall file a criminal complaint.3 if the objection is justified but no offence appears to have been committed, the central office shall take the steps necessary for the further processing of the articles in question, which may not be placed on the market in switzerland. the costs thereby incurred are borne by the party submitting the article for controlling. the central office may order the destruction of the articles.f. fees. right of retention. appeal art. 18 1 for all articles submitted for an official control, a fee (control or hallmark fee) must be paid irrespective of the outcome of the control.2 for collection of the fees and expenses to be paid, a right of retention applies to the goods submitted for official control. in the event of dispute, claims are ruled upon by the central office. .2626 sentence repealed by annex no 135 of the administrative court act of 17 june 2005, with effect from 1 jan. 2007 (as 2006 2197; bbl 2001 4202).g. enforcement provisions art. 19 the federal council shall regulate the details of the procedure to be followed by the assay offices, the shape and composition of the official hallmarks, the means of notification of the official hallmark in switzerland and abroad, the running of the controls and the amount of the fees, which must not be of fiscal character.import art. 20 1 articles manufactured abroad and governed by this act may only be placed on the domestic market if they comply with the provisions of this act. the requirement for the official controlling of the watch-cases mentioned in article 13 paragraph 1 is extended to imported finished watches with such cases.272 the federal council may provide for exceptions for special articles.283 the articles governed by this act may be subject to comprehensive or random testing on import. if such testing reveals a that an offence has been committed, the article must be seized and forwarded to the central office so that it may file a criminal complaint. if the article does not meet the statutory requirements but no offence has been committed, it shall be returned across the border.294 watch-cases and watches subject to mandatory official controlling must be forwarded by the customs office conducting the import assessment to the appropriate assay office.305 in the case of travel samples which are imported by sales representatives in observance of the federal act of 1 october 192531 on customs and commercial treaties but which do not remain in switzerland, the provisions may be relaxed if a reciprocity agreement exists with the country of origin.27 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).28 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).29 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).30 amended by annex no 19 of the customs act of 18 march 2005, in force since 1 may 2007 (as 2007 1411; bbl 2004 567).31 [bs 6 465; as 1956 587, 1959 1343 art. 11 no iii, 1973 644, 1974 1857 annex no 7, 1980 1793 no i 1, 1992 1670 no iii, 1994 1634 no i 3, 1995 1816, 1996 3371 annex 2 no 2, 1997 2465 annex no 13, 2000 1300 art. 92 1891 no vi 6, 2002 248 no i 1 art. 41, 2004 4763 annex no ii 1, 2006 2197 annex no 50. as 2007 1411 art. 131 para.1]. see now: customs act of 18 march 2005 (sr 631.0).export art. 2132 1 precious metal articles, multi-metal articles, plated articles and imitations intended for export must bear the prescribed marks; in addition, watch-cases made of precious metal must also bear the prescribed official hallmark.2 however, domestic manufacturers may, of their own accord, provide such articles with marks that are customary or prescribed in the destination country.3 the federal council shall determine the requirements to be observed and the symbols used that the assay offices are permitted to use to confirm a standard of fineness as prescribed by the destination country. the federal council may define relaxed provisions for watch-cases that are verifiably exported directly to countries which stipulate mandatory controlling of watch-cases.32 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).transit art. 22 1 goods in direct transit may undergo an official control. article 20 paragraph 3 applies correspondingly.332 however, the provisions of this act apply to those articles that do not enter the domestic market and remain under customs supervision, but which are forwarded abroad with swiss transport papers duty unpaid.3 for the removal of articles from customs or bonded warehouses, art. 20, 21 and 22 paragraph 2 apply correspondingly.3433 amended by art. 75 no 2 of the trademark protection act of 28 aug. 1992, in force since 1 april 1993 (as 1993 274; bbl 1991 i 1).34 amended by annex no 19 of the customs act of 18 march 2005, in force since 1 may 2007 (as 2007 1411; bbl 2004 567).reporting of suspicious articles art. 22a35 if the central office suspects that imported, exported or transit articles unjustifiably bear or imitate a responsibility mark, maker's or assayer's mark that is not their own or that the provisions for the protection of intellectual property are violated in any other way, it shall notify the aggrieved party. the articles may be retained.35 inserted by art. 75 no 2 of the trademark protection act of 28 aug. 1992 (as 1993 274; bbl 1991 i 1). amended by annex no 6 of the fa of 22 june 2007, in force since 1 july 2008 (as 2008 2551; bbl 2006 1).hawking ban art. 2336 the hawking of articles subject to this act is prohibited. this ban also applies to the taking of orders by retail sales representatives.36 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).section 4 manufacture of melt products37 37 amended by no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, in force since 1 june 2008 (as 2008 2265; bbl 2007 315). manufacture of melt products 1. melter's licence art. 2438 authorisation is required for the commercial manufacture of melt products.38 amended by no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, in force since 1 june 2008 (as 2008 2265; bbl 2007 315).a. requirements art. 2539 1 individuals, commercial enterprises and cooperatives established under the code of obligations40 as well as comparable foreign enterprises may apply for a melter's licence.412 individuals must be entered in the swiss commercial register and have their place of residence in switzerland. they must be of good standing and offer proof of irreproachable business operations.3 commercial enterprises and cooperatives as well as swiss branches of foreign enterprises must be entered in the swiss commercial register. the persons entrusted with the administration and business management of the enterprises companies and cooperatives must be of good standing and offer proof of irreproachable business operations.39 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).40 sr 22041 amended by no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, in force since 1 june 2008 (as 2008 2265; bbl 2007 315).b. granting. renewal. withdrawal art. 26 1 the melter's licence shall on application be granted by the central office for a period of four years. on expiry of this period, the licence may be renewed provided that the applicant satisfies the statutory requirements.422 if a licence holder no longer satisfies any one of these requirements or has repeatedly violated the obligations assumed, the licence shall be automatically withdrawn by the issuing authority on a temporary or permanent basis.3 notice of the granting or withdrawal of a melter's licence shall be given in the swiss official gazette of commerce.434 .4442 amended by no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, in force since 1 june 2008 (as 2008 2265; bbl 2007 315).43 amended by no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, in force since 1 june 2008 (as 2008 2265; bbl 2007 315).44 repealed by annex no 135 of the administrative court act of 17 june 2005, with effect from 1 jan. 2007 (as 2006 2197; bbl 2001 4202).art. 2745 45 repealed by no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, with effect from 1 june 2008 (as 2008 2265; bbl 2007 315).2. . art. 2846 46 repealed by no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, with effect from 1 june 2008 (as 2008 2265; bbl 2007 315).art. 2947 47 repealed by no i of the fa of 17 june 1994, with effect from 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).a. . art. 3048 48 repealed by no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, with effect from 1 june 2008 (as 2008 2265; bbl 2007 315).b. obligations of the licence holder. marking art. 31 1 each melt product must be inscribed with the licence holder's mark. the die used for the mark must be deposited with the central office and may not be changed without the approval of this body. notice of the deposit of the die must be published in the swiss official gazette of commerce.2 the federal council shall specify the obligations of the holder of a melter's licence.determination of the fineness of melt products a. competence. purpose art. 32 1 only assay offices or trade assayers may determine the fineness of melt products.2 the control must determine the actual fineness of the melt product.b. procedure art. 33 1 the controlling agency shall first establish that a mark has been stamped in accordance with article 31. if not, the melt product shall be seized and the party requesting the determination reported. the case shall at the same time be referred to the central office, which shall ask the applicant to provide proof of origin of the melt product. if such proof cannot be furnished, or if there is any indication that an offence has been committed, the central office shall file a criminal complaint.2 if the melt product has been stamped, the control shall be conducted. once determined, the melt product is stamped with the mark of the assay office or trade assayer; the actual fineness must be specified at the same time.approval procedure. fees art. 34 1 the federal council shall regulate the details of the procedure for granting, renewing and withdrawing melter's licences and for fineness determinations. it may also issue regulations on the recognition of foreign official fineness determinations.492 the federal council shall regulate the fees to be paid for the official duties set out in paragraph 1. article 18 paragraph 2 applies correspondingly.49 amended by no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, in force since 1 june 2008 (as 2008 2265; bbl 2007 315).section 5 organisation central office a. reporting line art. 35 1 the central office is affiliated to the federal department of finance50 for the implementation of this act. it may be incorporated into an existing administrative unit within the department.2 the federal council shall regulate the organisation of the central office.50 name in accordance with art. 1 of the unpublished fcd of 23 april 1980 on the adaptation of federal law enactments to the new names of the departments and offices. this amendment has been made throughout the text.b. duties art. 36 1 the central office shall supervise the trade in precious metals and precious metal articles.2 in particular, it shall deal with the registration of responsibility marks and supervise the official controlling and hallmarking of precious metal articles. it is responsible for granting melter's licences and for supervising the determination of the fineness of melt products.51 it shall supervise the administration of the assay offices and the trade assayers. it shall issue the diplomas for sworn assayers52 and the assayer licence as trade assayers.51 version of second sentence in accordance with no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, with effect from 1 june 2008 (as 2008 2265; bbl 2007 315).52 expression in accordance with no ii of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033). this amendment has been made throughout the text.assay offices a. establishment, dissolution art. 37 1 the assay offices for precious metal articles shall be established by the cantons or by the communes or business associations authorised to do so by the cantons. establishment requires the approval of the federal department of finance. it may also order the dissolution of an assay office if its facilities and management do not comply with the existing regulations or if there is no further need for its existence. the cost of establishing and operating an assay office shall be borne by the authorities or associations authorised to establish it. these shall receive the fees charged by the assay office.2 in agreement with the appropriate cantonal government, the department may establish federal assay offices if this is necessary in the country's economic interests. in this case, the participating business sectors may be called on to contribute to the costs of establishment and any operating deficit of the assay offices. these assay offices report directly to the central office. the fees they receive flow into the federal budget.3 the organisation, fees, accounting and operations of all assay offices are regulated by the federal council.b. duties art. 38 1 the assay offices deal with the official controlling and hallmarking of precious metal articles. they may also determine the fineness of melt products. assay offices may be assigned a limited geographical area in which to operate. they are authorised to control the precious metal articles and melt products made in that area. the central office may make exceptions under certain circumstances. the assay offices are prohibited from trading in melt material and melt products or performing any melting on behalf of third parties. under certain circumstances, however, the federal department of finance may authorise them to carry out such melting.2 the assay offices shall support the central office in its supervision of enforcement of this act. in particular, they shall report to it all offences that come to their attention and take the necessary measures to establish the facts by themselves or as instructed by the central office or the police authorities.3 officers of the assay offices are bound to secrecy concerning all observations made in the course of their work or which, by virtue of their nature, are confidential.4 for losses incurred through incorrect execution of the duties entrusted to the assay offices, the confederation shall be liable in the case of federal assay offices, and the canton in all other cases, to the extent that the bodies at fault cannot bear the costs themselves.official sworn assayers a. diploma art. 39 1 officers of the assay offices responsible for controlling the precious metal articles and multi-metal articles to be officially hallmarked and for determination of the fineness of melt products must hold a federal diploma as sworn assayers.53 this shall be issued by the central office on their passing the diploma examination. the assayer thus qualified shall swear an oath or make solemn promise before the central office to faithfully discharge the official duties of the profession.2 the requirements for the acquisition of the federal diploma are determined by the federal council.53 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).b. obligations. responsibility art. 40 1 it is the duty of sworn assayers to comply with the provisions of this act, the implementing provisions and the directives of the central office and avoid anything that could encourage others to commit an offence. specifically, they may only perform fineness tests on melt products when the statutory requirements therefor have been met in each case and must immediately report all offences and administrative infringements under this act that come to their attention. article 38 paragraph 3 applies correspondingly.2 the central office shall supervise the work done by the sworn assayers. it may withdraw the diploma in the event of serious violations of the duties incumbent upon the holder of an assayer diploma or on account of proven incompetence. .543 sworn assayers are liable for all losses or damage caused by the incorrect or negligent execution of their work. article 38 paragraph 4 also applies.54 sentenced repealed by annex no 135 of the administrative court act of 17 june 2005, with effect from 1 jan. 2007 (as 2006 2197; bbl 2001 4202).trade assayers a. operating licence. duties art. 41 trade assayers must hold an assayer licence as trade assayer issued by the central office. this licence shall only be granted to assayers who hold a federal assayer's diploma, are resident in switzerland and are of good character. trade assayers are permitted to acquire a melter's licence.55 trade assayers shall swear an oath or make a solemn promise before the central office to faithfully discharge the official duties of their profession. they are authorised to ascertain the fineness of melt products and receive by way of remuneration the fees provided for in the implementing ordinance. they are not authorised to perform the official assaying and hallmarking of precious metal articles.55 version of the third sentence in accordance with no i 5 of the fa of 21 dec. 2007 on the removal and simplification of licensing procedures, in force since 1 june 2008 (as 2008 2265; bbl 2007 315).b. obligations. responsibility art. 42 1 it is the duty of trade assayers to keep a proper account of the determinations of fineness that they perform and all sums received in return. for the purposes of official investigations, the central office and the police authorities may inspect the books and enquire about specific entries. the bookkeeping rules shall be drawn up by the federal council.2 article 40 applies correspondingly. the withdrawal of an assayer's diploma means the withdrawal of the assayer licence as trade assayer.additional authorisation for trading in banking precious metals art. 42bis 56 1 trade assayers who themselves or through a group company trade on a commercial basis in banking precious metals require authorisation from and are subject to supervision of a financial market supervisory authority in accordance with article 61 paragraphs 1, 2 and 4 of the financial institutions act of 15 june 201857 (finia).2 if a company trades in banking precious metals of a trade assayer belonging to its group company, it also requires authorisation in accordance with paragraph 1.3 the provisions on the authorisation conditions for portfolio managers as defined in article 17 paragraph 1 of the finia apply by analogy. 56 inserted by annex no ii 11 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).57 sr 954.1section 6 appeals art. 4358 1 orders issued by the assay offices and by trade assayers may be contested by way of appeal to the central office.2 and 3 .5958 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).59 repealed by annex no 135 of the administrative court act of 17 june 2005, with effect from 1 jan. 2007 (as 2006 2197; bbl 2001 4202).section 7 criminal provisions60 60 as of 1 jan. 2007, the penalties and the prescriptive periods are to be interpreted and converted in accordance with art. 333 para. 2 to 6 of the swiss criminal code (sr 311.0) in the version of the fa of 13 dec. 2002 (as 2006 3459). 1. offences61 61 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).a. fraud62 62 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).art. 44 1 any person who submits articles for hallmarking or, for the purpose of sale, makes, commissions or imports, supplies or offers to supply articles under a mark that is liable to be misleading or that is prohibited under this act, being articles that do not meet the prescribed standard of fineness as precious metal articles or articles not meeting the provisions of this act, as multi-metal, plated or imitations, any person who stamps on precious metal articles or multi-metal articles a mark purporting to represent a higher fineness than actually exists, shall, if acting with intent, be liable to a term of imprisonment or to a fine not exceeding chf 100,000.632 if the offender acts professionally, he or she shall be liable to a term of imprisonment of at least one month.3 if the offender acts through negligence, he or she shall be liable to a fine not exceeding chf 50,000.64 excusable errors committed in the course of the manufacturing process are not classified as negligence.63 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).64 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).b. counterfeiting and falsification of stamps art. 4565 1 any person who counterfeits or falsifies swiss, foreign or international stamps (hallmarks or symbols), any person who uses such marks,any person who produces, procures or supplies to third parties devices for counterfeiting or falsification of such marks, shall, if acting with intent, be liable to a term of imprisonment or to a fine not exceeding chf 100,000.2 if the offender acts through negligence, he or she shall be liable to a fine not exceeding chf 50,000.3 article 246 of the swiss criminal code66 does not apply.65 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).66 sr 311.0c. improper use of stamps art. 4667 1 any person who intentionally makes improper use of official swiss, foreign or international stamps shall be liable to a term of imprisonment or to a fine not exceeding chf 100,000.2 if offender acts through negligence, he or she shall be liable to a fine not exceeding chf 50,000.67 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).d. stamp requirements, violation; misuse of marks and symbols; alteration of hallmarks art. 4768 1 any person who places on the market precious metal articles without a fineness mark or without a responsibility mark, melt products without a fineness mark or without a melter's or assayer's mark, or watch-cases without a hallmark,any person who issues or places on the market articles as multi-metal articles or plated articles without the required mark or without a responsibility mark,any person who, without authorisation, imitates or uses a responsibility mark or a melter's or assayer's mark that is not their own,any person who places on the market precious metal articles or melt products on which the fineness mark or the imprint of a hallmark has been altered or removed,shall, if acting with intent, be liable to a term of imprisonment or to a fine not exceeding chf 100,000.2 if the offender acts through negligence, he or she shall be liable to a fine not exceeding chf 50,000.68 amended by no i of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).e. acts without a licence art. 4869 any person who performs acts requiring one of the aforementioned permits without holding a melter's licence or an assayer licence as trade assayer shall be liable to a fine.69 amended by no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, in force since 1 june 2008 (as 2008 2265; bbl 2007 315).f. offences70 in hawking and in the acquisition of melt material 70 expression in accordance with no ii of the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033). this amendment has been made throughout the text.art. 49 any person who contravenes the hawking ban in articles 23 and 28,any person who violates the provisions on the acquisition of melt material for their own use,shall be liable to a fine .71.71 amounts deleted by art. 75 no 2 of the trademark protection act of 28 aug. 1992 (as 1993 274; bbl 1991 i 1).g. unauthorised reproduction of articles art. 50 1 officers of the central office or an assay office who make or commission a reproduction of an article submitted to the office shall be liable to a fine .72.2 article 40 paragraph 2 is reserved.72 amounts deleted by art. 75 no 2 of the trademark protection act of 28 aug. 1992 (as 1993 274; bbl 1991 i 1).2. offences in the course of business of legal entities and corporations art. 51 if offences are committed in the course of business of a legal entity or of a general or limited partnership, the criminal provisions apply to those persons who have or should have acted as governing officers, partners or employees. however, the legal entity or corporation is jointly and severally liable together with the convicted individuals for the payment of any fines imposed or costs awarded.3. confiscation art. 52 1 stamping devices used in violation of this act shall be forfeited.2 in the event of a conviction for fraud in terms of article 44, the court may order the confiscation of the articles involved in the commission of the offence. the articles in question must be destroyed. subject to the provisions of the federal act of 19 march 200473 on the division of forfeited assets, the proceeds from the sale of the metal shall be forfeited to the confederation.7473 sr 312.474 amended by annex no 5 of the fa of 19 march 2004 on the division of forfeited assets, in force since 1 aug. 2004 (as 2004 3503; bbl 2002 441).4. federal criminal law, application art. 53 unless otherwise stipulated in this act, the general provisions of the federal act of 4 february 185375 on federal criminal law apply.75 [as iii 404, vi 312 art. 5, 19 253, 28 129 art. 227 para.1 no 6; bs 3 303 art. 342 para. 2 no 3, 4 766 art. 61, 7 754 art. 69 no 4 867 art. 48. sr 3 203 art. 398 para.2 let. a]. today: the general provisions of the swiss criminal code (art. 334 scc - sr 311.0).5. criminal proceedings art. 54 1 and 2 .763 the central office and the assay offices must report any offences that come to their attention to the competent prosecuting authority. .7776 repealed (art. 342 para. 1 federal criminal justice act - bs 3 303; bbl 1929 ii 575). today: the criminal procedure code of 5 oct. 2007 (sr 312.0).77 second sentence repealed by annex 1 no ii 32 of the criminal procedure ordinance of 5 oct. 2007, with effect from 1 jan. 2011 (as 2010 1881; bbl 2006 1085).6. administrative offences a. criminal liability art. 5578 any person who, with intent or negligence, contravenes a provision of this act or of an implementing ordinance or of a general directive issued on the basis of such provisions or an individual order directed at him or her that makes reference to the penalty under this article shall be liable to a fine not exceeding chf 2000.78 amended by no 20 of the annex to the administrative criminal law act, in force since 1 jan. 1975 (as 1974 1857; bbl 1971 i 993).b. applicable law and prosecuting authority art. 5679 1 the general provisions of the federal act of 22 march 197480 on administrative criminal law (art. 2-13) apply.2 offences within the meaning of article 55 shall be prosecuted and judged by the central office in accordance with the federal act of 22 march 1974 on administrative criminal law. the assay offices are obliged to report to the central office any administrative offences that come to their attention. the sworn assayers and trade assayers are subject to the same obligation.79 amended by no 20 of the annex to administrative criminal law act, in force since 1 jan. 1975 (as 1974 1857; bbl 1971 i 993).80 sr 313.0section 8 transitional and final provisions art. 57 transitional provisions 1 domestic articles that are already manufactured at the time of this act coming into force and which satisfy the previously applicable provisions but not the provisions of this act may be submitted to an assay office within one year for the application of a transitional stamp. this transitional stamp shall entitles the owner of the article to sell it for a further three years. more precise provisions in this respect shall be drawn up by the federal council.2 .8181 repealed by no i 5 of the fa of 21 dec. 2007 on the abolition and simplification of licensing procedures, with effect from 1 june 2008 (as 2008 2265; bbl 2007 315).repeal of existing enactments art. 58 1 on commencement of this act, all previous enactments that are contradictory to the provisions hereof are repealed.2 in particular, the federal act of 23 december 188082 on the assaying and guarantee of the fineness of gold and silver articles and the supplementary act of 21 december 188683 as well as the federal act of 17 june 188684 on the trade in gold and silver waste products are repealed.82 [as 5 363, 10 45]83 [as 10 45]84 [as 9 266]commencement and execution art. 59 1 the federal council shall determine the date of commencement of this act.2 it shall issues the regulations required for the execution hereof.commencement date: 1 july 19348585 fcd of 8 may 1934 (as 50 345).final provision to the amendment of 17 june 199486 86 as 1995 3102; bbl 1993 ii 1033articles that were manufactured before the commencement of the amendment of 17 june 1994 and which satisfy the previous but not the new provisions may be placed on the market on a commercial basis for a maximum of one year after commencement of this amendment.final provision to the amendment of 15 june 201887 87 as 2018 5247, 2019 4631; bbl 2015 8901. amended by annex 1 no 3 of the fa of 19 march 2021, in force since 1 jan. 2022 (as 2021 656; bbl 2019 5451).1 trade assayers and group companies that, at the time of entry into force of the amendment of 15 june 2018, have a licence from finma in accordance with article 14 of the amla88 in the version of 1 january 200989 must appoint an audit firm licensed by the federal audit oversight authority in accordance with article 9a of the federal act of 16 december 200590 on the licensing and oversight of auditors to conduct an audit in accordance with article 24 of the finmasa91.2 trade assayers and group companies that, at the time of entry into force of the amendment of 15 june 2018, are affiliated to a recognised self-regulatory organisation in accordance with article 24 of the amla shall remain subject to its supervision.88 sr 955.089 as 2008 520790 sr 221.30291 sr 956.1annex 192 92 inserted by the fa of 17 june 1994 (as 1995 3102; bbl 1993 ii 1033). revised in accordance with no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2217).(art. 2 para. 2)minimum requirements of precious metals layers for plated articles 1. thickness: - platings of gold, platinum and palladium: 5 micrometers- platings of silver: 10 micrometers- gold-capped (coiffe or) watch-cases and additional parts: 200 micrometers2. fineness: - gold: 585 parts per thousand- platinum: 850 parts per thousand- palladium: 500 parts per thousand- silver: 800 parts per thousandannex 293 93 inserted by the fa of 17 june 1994, in force since 1 aug. 1995 (as 1995 3102; bbl 1993 ii 1033).(art. 3 para. 2)legal standards of fineness for precious metals articles and multi-metal articles 1. the legal standards of fineness are: - for gold:999 parts per thousand916 parts per thousand750 parts per thousand585 parts per thousand375 parts per thousand- for silver:999 parts per thousand925 parts per thousand800 parts per thousand- for platinum:999 parts per thousand950 parts per thousand900 parts per thousand850 parts per thousand- for palladium:999 parts per thousand950 parts per thousand500 parts per thousand2. for medals, the following standards of fineness also apply: - for gold:minimum999 parts per thousand986 parts per thousand900 parts per thousand- for silver:minimum999 parts per thousand958 parts per thousand900 parts per thousand835 parts per thousand- for platinum:minimum999 parts per thousand- for palladium:minimum999 parts per thousand

941.311english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon the control of trade in precious metals and articles of precious metals(precious metals control ordinance, pmco)1of 8 may 1934 (status as of 1 september 2021)1 amended by no i of the o of 17 feb. 1993, in force since 1 april 1993 (as 1993 984).the swiss federal council,based on article 59 of the federal act of 20 june 19332 on the control of the trade in precious metals and precious metal articles (hereinafter the act),decrees:2 sr 941.31section 1 organisation of official bodies i. federal council art. 1 the federal council is the supreme body in all matters concerning the control of trade in precious metals and precious metal articles. specifically, its duties are to:a. appoint the officers of the federal central office for precious metals control (hereinafter the central office) in accordance with article 4 of the public officials regulations i of 24 october 19303;b. approve the reports of the federal department of finance4;c. issue directives to the federal department of finance, where the latter does not make orders independently under the act;d.5 .e.6 .3 [bs 1 610; as 1948 367, 1949 i 133 832, ii 1730. as 1952 659 art. 76 para. 2]. see today: the federal personnel act of 24 march 2000 (sr 172.220.1).4 name in accordance with art. 1 of the unpublished fcd of 23 april 1980 on the adaptation of federal legislation to the new names of the departments and offices. this amendment has been made throughout the text.5 let. d concerned the now repealed para. 1 and 2 of art. 54 of the act.6 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).ii. department of finance art. 2 the federal department of finance is responsible for the direct business management. specifically, its duties are to:a. appraise, submit motions for the attention of the federal council and to execute the decrees of the federal council;b. supervise the administration of the central office;c. report to the federal council;d. decide on the establishment of federal assay offices and determine the contribution fee paid by the business sectors involved towards the establishment and operating costs (art. 6);e. approve the establishment of assay offices by cantons, communal authorities or associations (art. 7);f. decide on the dissolution of cantonal and federal assay offices (art. 9);g. receive the reports of the central office and issue the required directives to this body (art. 4 let. a);h. approve the settlement of fees flowing into the federal coffers (art. 4 let. n);i. select the officers of the central office in accordance with article 4 of the public officials regulations i of 24 october 19307.7 [bs 1 610; as 1948 367, 1949 i 133 832, ii 1730. as 1952 659 art. 76 para 2]. see today: the federal personnel act of 24 march 2000 (sr 172.220.1).iii. central office 1 .organisation art. 3 the central office is affiliated to the directorate general of customs. .88 second sentence repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).2. duties art. 4 the central office is responsible for all business matters involved in supervising the trade in precious metals and precious metal articles. specifically, its duties are to:9a. submit motions and report to the federal department of finance and execute the instructions of the department;b.10 supervise the management of the assay offices and of sworn trade assayers (art. 18, 19, 33 and 34); approve the budgets and annual accounts of the assay offices (art. 19 para. 3);c.11 register the responsibility marks (art. 69-75);d.12 supervise the official controlling and hallmarking of precious metal articles and multi-metal articles (art. 81-123);e.13 arrange and supervise the diploma examination for sworn assayers and also issue and withdraw diplomas (art. 22 and 25);f. issue and withdraw assayer licences as trade assayers (art. 29 and 34);g.14 issue and withdraw melter's licences (art. 165, 166a and 166);h. supervise the determinations of the fineness of melt products (art. 173-178);i.15 register and store documents sent by the assay offices, by sworn trade assayers and by holders of melter's licences as well as other correspondence;k.16 procure new official stamps/hallmarks and destroy those which have become unusable17 (art. 113 and 114);l.18 supervise the domestic market (art. 15 para. 2);m.19 rule on appeals against orders of assay offices and trade assayers;n.20 keep accounts for the fees flowing into the federal coffers.9 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).10 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).11 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).12 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).13 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).14 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).15 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).16 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).17 the terms stamp and hallmark have the same meaning here.18 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).19 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).20 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 521 21 repealed by no 1 of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).iv. assay offices 1. organisation a. establishment aa. federal assay offices art. 6 1 federal assay offices shall be established if and when necessary in the country's economic interests, particularly where a cantonal assay office does not exist. a federal assay office may be established for an area covering several cantons, or parts of various cantons may be included in its sphere of operation. establishment is effected by a decision of the federal department of finance.2 before establishment, opinions must be sought from the relevant cantonal governments and the business associations involved, which shall also receive precise details of the financial requirements that are made of them in the event of establishment. the department may request payment of collateral to secure these financial requirements.3 the department shall determine the organisation of the federal assay offices. the officers and sworn assayers22 are employees of the customs administration and are subject to its official regulations.22 expression in accordance with no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113). this amendment has been made throughout the text.bb. cantonal assay offices art. 7 1 cantonal assay offices are those established by a canton or by the communes or business associations authorised by a canton to do so. where a canton authorises a commune or a business association to establish an assay office, it has the duty to supervise the general management thereof. the central office is solely authorised to supervise the technical activities of the assay office and to issue technical directives concerning implementation of the act and its ordinances.2 prior to the establishment of an assay office, a draft of the office's organisational by-laws must be presented to the federal department of finance by way of the cantonal government. if the assay office is not established by the canton itself, details must be given on the procurement of the working capital required. the canton shall appoint a supervisory board for each assay office. a representative of the central office must sit on each supervisory board.3 the assay office may not commence operations until its establishment has been approved by the federal department of finance.4 the set-up and operating expenses of cantonal assay offices are borne by the establishing canton, communes or associations. the canton shall be liable for any deficit in operating expenses that may occur if the commune or association that set up the assay office is not in a position to cover it.b. staff of assay offices art. 8 1 the number and position of officers working at federal assay offices shall be determined by the federal department of finance. specifically, the latter shall appoint the senior staff, in response to the proposal of the directorate general of customs, and appoint the official sworn assayers.2 cantonal assay offices must have a sufficient number of officers to ensure the prompt execution of the functions of the office. the central office shall determine the required number of sworn assayers.3 the sworn assayers working at the assay offices, whose duty is to conduct the official assaying and hallmarking of precious metal articles and ascertain the fineness of melt products, must hold a federal diploma as a sworn assayer.4 officers of cantonal assay offices are selected as prescribed by the cantons, communes or associations. such selection requires the approval of the federal department of finance.5 the determination of the remuneration of officers of the cantonal assay offices is subject to approval by the federal department of finance, as are the rules drawn up by the cantons, communes or associations on the sureties to be paid by the agencies of the assay offices they establish.c. dissolution of assay offices art. 923 1 the relevant cantonal government or the business associations concerned must be notified of the intention to close an assay office. in the case of a cantonal assay office, sufficient notice must be given before dissolution.2 where a cantonal assay office is to be closed because the facilities and management no longer meet existing requirements, the canton, or the communes or business associations concerned, must be given sufficient time to remedy the situation.23 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 10-1324 24 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).2. duties a. content art. 14 1 the assay offices must perform their duties in accordance with the statutory provisions and the directives that they receive from the central office.2 they shall take charge of the official controlling and hallmarking of precious metal articles (art. 13-17 of the act) and determination of the fineness of melt material and melt products submitted by private customers (art. 32 of the act). melting on behalf of third parties is only permitted with the special authorisation of the federal department of finance.3 in particular cases, the central office may entrust the assay office with the performance of tests and analyses with regard to violations of the law.4 if the assay office becomes aware of an offence or violation of its own accord, it must draw up the provisional findings required and then submit the file to the central office. the latter shall decide on any further measures to be taken.b. determination of scope of authority art. 1525 1 the central office shall assign the federal and cantonal assay offices a specific geographical scope of operation. in the case of cantonal assay offices, the scope of operation shall, as a rule, not extend beyond the boundary of the canton in question.2 the assay offices verify in the place of domicile of manufacturers, suppliers and dealers in their scope whether the articles governed by the act satisfy its conditions.25 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).3. operations art. 16 1 the assay offices shall be assigned suitable premises for their offices and laboratories. they shall also be provided with the required equipment, tools, materials and technical documentation. the central office shall issue the directives required in this respect.2 the official stamps given to the assay offices must always be kept under lock and key, and it must be ensured that they are used only by persons authorised to do so.3 the hours during which the offices of the assay offices are open shall be determined in agreement with the central office and publicised.4 the working hours of the officers of cantonal assay offices shall be regulated by directive of the federal department of finance.4. official stamps art. 17 1 the central office shall provide the assay offices with the official stamps required for the hallmarking of precious metal articles (art. 113 and 114).2 article 30 applies to the appearance of the stamps to confirm the fineness on melt products.5. controls a. controls and books art. 18 1 the assay office shall maintain a business log, which continuously records the arrival of articles to be processed, the processing itself and the return of the articles. each job is given a control number.2 .263 the assay office must keep accounts of its income and expenditures.4 the official registers, books and forms to be used by the assay offices are drawn up by the central office and sold to the assay offices at cost price.26 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).b. verification art. 19 1 the assay offices shall provide the central office with a monthly and quarterly summary of the checks they have conducted and their books, using the official form.2 the central office shall conduct regular checks of the assay offices' facilities, controls and books.3 cantonal assay offices must submit, before 1 december of each year, a budget for the income and expenses expected for the following year and the procurement of working capital, using the official form (three copies) by way of the appropriate cantonal authority. the budget must be presented to the central office for approval. observations made by the central office shall be brought to the attention of the relevant cantonal authority, which shall take charge of remedying the deficiencies identified.v. officially sworn assayers 1. assayer's diploma27 27 expression in accordance with no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113). this amendment has been made throughout the text.a. content art. 20 1 only holders of the federal diploma may be hired as officially sworn assayers with an assay office.2 the assayer's diploma shall be issued by the central office to candidates who pass the federal assayer's diploma examination28, provided that they meet the personal requirements.28 expression in accordance with no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113). this amendment has been made throughout the text.b. personal requirements art. 2129 1 candidates for the federal assayer's diploma must be at least 20 years old and be of good standing. good standing is to be proven by means of an extract from the swiss register of criminal convictions.302 the candidate must have undergone a corresponding training programme with a federal or cantonal assay office or trade assayer and must also have attended the centralised courses at the central office.31 3 the federal department of finance shall regulate the entry conditions for the training programme and issue directives on the content and duration of the training and of the central courses as well as on the examination requirements.4 the central office shall determine the curriculum and the programmes for the central courses and the examinations.29 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).30 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).31 amended by no i of the o of 6 nov. 2019 on fees for precious metal control, in force from 1 jan. 2020 (as 2019 3771).c. examination aa. examination board art. 22 1 the federal assayer's diploma examination is administered by a board of three members. this board comprises a senior employee of the central office as its chairman, an expert in the field and a sworn assayer.32 the latter two members of the board are appointed by the federal council for a term of three years33.2 the examination board meets when convened by its chairman.3 .3432 second sentence amended by art. 17 of the o of 6 nov. 2019 on fees for precious metal control, in force from 1 jan. 2020 (as 2019 3771).33 today: four years (art. 8g para. 1; sr 172.31)34 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).bb. examination process art. 2335 1 the federal assayer's diploma examinations are conducted as required on the order of the central office.2 an application to take the examination must be made in writing to the central office. the application fee must be paid at the same time. if the entry conditions are met, the central office shall invite the candidate to take the examination.35 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).cc. results of the examination art. 24 1 the examination board shall decide on the results after completion of the examination and shall notify the central office and the candidate thereof.2 candidates who have not passed the examination may apply to take it again. after three failed examinations, no further attempts may be made.d. swearing in and awarding of the diploma art. 25 1 based on the recommendation of the examination board, the central office shall issue the federal assayer's diploma and swear in the candidate, who shall swear an oath or make a solemn promise to faithfully discharge the official duties of the profession.2 .3636 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).2. duties of the profession art. 26 1 the official sworn assayers must perform their duties in accordance with the legal provisions, the associated implementing provisions and the specific instructions for the job.2 in particular, they may only conduct determinations of the fineness of melt products if the applicable conditions are met in each specific case.3 they are bound to secrecy concerning all observations made in the course of their work or which are confidential in nature.4 they must immediately notify the head of the assay office of any offences against the provisions of the act that may come to their attention in the course of their work.art. 2737 37 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).vi. trade assayers 1. definition of their work38 38 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 28 1 trade assayers are authorised to conduct determinations of the fineness of melt material and melt products on behalf of third parties.392 they are not permitted to conduct official controlling or hallmarking of precious metal articles.403 for the acquisition of a melter's licence, the provisions of articles 165-165c apply.4139 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).40 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).41 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).2. operating licence art. 2942 1 an assayer licence from the central office is required to operate as a trade assayer. a company may be issued with an assayer licence as a trade assayer if it employs at least one sworn assayer.2 the assayer licence as trade assayer must be applied for in writing from the central office.3 if the requirements are met, the central office shall issue the assayer licence and give notice of this in the swiss official gazette of commerce.4 the central office shall maintain a register of the holders of such licences and shall periodically publish its content.42 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).3. marking art. 30 1 the trade assayer must have a mark which he strikes on the melt products assayed by him (art. 173-176).2 the mark shall comprise the holder's name, in full or abbreviated form, framed and accompanied by the word assayer. if the trade assayer also holds a melter's licence (art. 30 para. 1 of the act), he may register a combined assayer/melter's mark.433 for the registration of an assayer's or assayer/melter's mark, the same provisions apply as for the registration of a responsibility mark as set out in section 4.444 notice of the approved mark shall be given in the swiss official gazette of commerce at the same time as the operating licence.43 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).44 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).4. duties of the profession art. 31 1 in conducting determinations of the fineness, the trade assayer must comply with the provisions of the act and the ordinance and the specific directives issued by the central office.2 if the trade assayer becomes aware of any offences against the act in the course of his work, he must immediately bring this to the attention of the central office. if he suspects that a different offence has been committed, he must file a criminal complaint with the competent police or judicial authority.5. . art. 3245 45 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).6. registration art. 3346 1 trade assayers must register the documents and the accounts, results and observations concerning their fineness tests.2 these documents must be securely archived for a period of ten years.46 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).7. responsibility and supervision art. 34 1 the trade assayer shall be liable for all losses or damage resulting from incorrect or negligent performance of his work. the confederation shall not be held liable in any case. claims for damages must be filed with the competent civil courts.2 in cases of serious breaches of the duties incumbent on the trade assayer or of proven incompetence, the central office may withdraw an operating licence that it has previously issued. before doing so, it must grant the trade assayer in question an opportunity to make a formal response; this must be submitted in writing with the necessary evidence. notice of withdrawal shall be given in writing and shall specify the reasons therefor. .47 once final, notice of the withdrawal of an operating licence shall be given in the swiss official gazette of commerce.3 the central office must inspect trade assayers' business premises, work, register and accounts maintenance and storage of articles.4847 fourth sentence repealed by no iv 82 of the o of 22 aug. 2007 on the formal adjustment of federal law, with effect from 1 jan. 2008 (as 2007 4477).48 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).section 249 definitions of provisions on article categories and fineness50 49 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).50 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).alloys and fineness art. 35 1 a metal alloy within the meaning of article 3 paragraph 1 of the act is a solid combination of a precious metal with other metals. products made of homogeneous mixtures of precious metals with other substances and products manufactured using other methods such as electroforming or powder metallurgy are classified as alloys.2 objects that have a precious-metal or precious-metal-alloy layer produced by electrolysis which is sufficiently thick and resistant to be self-supporting when separated from the substrate are classified as precious metal articles made by electroforming.3 for articles made by electroforming, the fineness of the melted object must at least correspond to the applied fineness mark.waste products art. 35a51 waste products from the processing of precious metals or their alloys within the meaning of article 1 paragraph 3 letter b of the act are defined as:a. filings, turnings, cuttings, polishing waste, waste from silvering, gilding, platinisation and palladisation, ashes, refuse, unprocessed and pre-processed pieces no longer in use, waste from ingots, slabs, wire, rondelles, etc., waste from plating manufacture;b. precious metal waste stemming from dental technology;c. precious metal waste and scrap from all other trades and industries.51 inserted by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).solders art. 36 1 in principle, solders must consist of the same metal and an alloy of the same fineness as the article itself.2 the central office may permit the use of solders of an alloy with a lower fineness or of another material where this is necessary for technical reasons (art. 7 para. 2 of the act).3 in the case of solders under paragraph 2, a tolerance not exceeding ten parts per thousand is permitted on the fully melted object.filled-in objects art. 37 1 precious metal articles and precious metal parts of multi-metal articles must not contain inside any metals or substances that differ from the precious metal of the main mass.2 the central office may provide for exceptions for technical reasons (art. 7 para. 2 of the act).watch-cases art. 38 watch-cases within the meaning of the act are defined as all surroundings of watch mechanisms. the central office shall decide whether and which types of surroundings of watch mechanisms must be classified as watch-cases within the meaning of the act.coins, medals art. 39 1 coins are defined as pieces of metal that have been issued as a means of payment by the entity authorised to mint coins or on its behalf and whose weight, fineness and nominal value are specified by law.2 coins that are out of circulation are classified as coins.3 medals within the meaning of annex 2 to the act are metal collector pieces that resemble coins but have no market value. small bars designed to be used as jewellery items are classified as medals if they have been manufactured by assayers/melters recognised by the central office.mixed articles art. 40 mixed articles are articles that have been manufactured from different precious metals with a legal standard of fineness.multi-metal articles art. 41 the central office shall regulate the technical details concerning the requirements for multi-metal articles.mechanisms and other components art. 42 precious metal articles may have mechanisms and other components made of other materials if this is necessary for technical reasons. the central office shall specify the details.plated articles art. 43 1 with plated articles, the precious metal layer must be applied by a mechanical, electroplating, chemical or physical method at least on the surface that determines the article's appearance or function.2 the precious metal layer must be of the thickness prescribed in annex 1 to the act over the entire surface in accordance with paragraph 1, with the exception of those points that cannot be touched by a sphere measuring 5 mm in diameter.3 a coiffe or within the meaning of annex 1 to the act is a gold cap at least 200 microns thick that is inseparably attached to watch-cases and additional parts, specifically watch straps.4 the permissible minimum tolerance for the thickness of the precious metal layer is 20 percent.5 the mean fineness of the precious metal coating must not fall below the minimum fineness in accordance with annex 1 to the act.6 the central office shall determine the test and measurement method to be used.surface coatings and colour combinations art. 44 the central office issues the required provisions on:a. the permissible surface coatings for precious metal articles, multi-metal articles and plated articles;b. the colour combinations of metal alloys in the case of mixed articles and multi-metal articles.section 352 fineness marks, other marks and stamps 52 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113). exceptions art. 45 1 the following items need not be marked:a. precious metal articles for scientific or technical use or for medical or dentistry purposes;b. articles that are over 50 years old;c. musical instruments;d. works of art destined for public collections.2 any quality indications on the articles mentioned in paragraph 1 or on the associated advertising material must match the actual composition of the articles.precious metal articles art. 46 1 precious metal articles must bear the legal standard of fineness in parts per thousand, struck in arabic numerals.2 the fineness mark must be applied in a visible, legible and indelible manner and measure at least 0.5 mm in height.3 if an article comprises parts made of different alloys of the same precious metal, the fineness mark must refer to the lowest standard of fineness used. an exception is made for medals and small bars mounted on a stand made of a lower-quality alloy; in this case, a fineness mark is applied to each part correspondingly.4 additional marks, particularly the number of carats in the case of gold alloys or the term sterling for silver articles with a standard of fineness of 0.925, are permissible provided that they correspond to the actual composition of the articles.5 fineness marks on platinum and palladium articles must also show the complete or abbreviated name of the metal in question, such as pt or pd.6 fully gilded or gold-plated silver articles must be marked as silver.mixed articles art. 47 1 if the precious metals of a mixed article can be distinguished by their colour, the fineness marks must be applied to each precious metal.2 if, for technical or aesthetic reasons, the mark cannot be struck on one part, it may be applied to the other part.3 if the precious metals cannot be distinguished by their colour, only the fineness mark for the lowest-value precious metal may be applied. the order in which precious metals are valued is from silver to palladium, and then from gold to platinum.4 the central office shall regulate the details.multi-metal articles art. 48 1 for multi-metal articles, the parts made of precious metal and the parts made of non-precious metal must be marked separately:a. with the fineness mark and the responsibility mark on the precious metal parts;b. with the type of metal or the word metal on the parts made of base metal.2 if, for technical or aesthetic reasons, one part cannot be marked, the mark can be applied to the other part.3 the central office shall regulate the details.plated articles art. 4953 1 plated articles may be marked as follows:a. with the word plaqu, together with the type of production, the following letters being used:1. l for laminated coating,3. g for electrolytic plating; andb. with a responsibility mark.2 the mark under paragraph 2 may be supplemented by the name of the coating metal, the thickness of the layer in micrometres and the word microns in full or abbreviated form.3 the marks may be struck on an unplated part if, for technical or aesthetic reasons, they cannot be applied on the plated part.4 gold plated watch-cases and accessory parts may be also marked as follows: a. with two letters that indicate the type of plating, the following letters being used:1. gr for laminated coating,2. gp for all other types of coating,3. gc for gold capped or coiffe or;b. with digits that specify the thickness of the plating in micrometres; andc. with a responsibility mark.5 the central office shall issue directives on the permissibility of other marks or the marking of partially plated articles.53 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).prohibited marks on plated articles and imitations art. 50 1 for plated articles and imitations, the following marks are prohibited:a. fineness marks;b. marks providing information on the proportion or the weight of the precious metal used;c. marks together with the name of precious metals or other information likely to be misleading as to the actual value or the actual composition of the article.2 for imitations, information on the layer thickness is also prohibited.tableware and cutlery art. 51 tableware and cutlery may be marked with the silver content. the central office shall issue the relevant regulations.supplies and semi-finished products art. 5254 1 loose components (supplies) and incomplete articles or parts (semi-finished products) may be given a fineness mark and a responsibility mark. the person who assembles or completes the product is responsible for ensuring that the mark corresponds to the composition of the articles.2 semi-finished products are products destined for the manufacture of articles such as slabs, wires, tubes, profile sections and pre-processed pieces in a legal standard of fineness.54 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).art. 53-57 repealedsection 455 responsibility mark 55 amended by no i of the o of 17 feb. 1993, in force since 1 april 1993 (as 1993 984). responsibility art. 5856 1 in applying the responsibility mark or having such a mark applied, the owner of the mark becomes responsible for the correctness of the marks on the objects.2 the assayer/melter's mark provided for in article 30 is permitted as a responsibility mark.3 the assay offices may apply their mark, as per no. 2 of the annex, to articles instead of a responsibility mark if:a. the articles were made by private individuals who do not have their own responsibility marks;b. the articles do not have any responsibility marks, are destined for sale by public auction, and have been submitted by official institutions such as pawn brokers, lost property offices or debt collection offices.4 these marks may also be used for the correction of contested articles in the supervision of the domestic market.56 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).distinctiveness art. 59 1 the mark must differ from other responsibility marks already registered:a. in the combination of letters or digits;b. in the type or form of lettering;c. by adding, removing or modifying the surrounding shapes;d. in the graphical representation.2 the difference must be detectable at a magnification of 2.5x.collective responsibility mark art. 60 1 for watch-cases, several manufacturers may use a collective responsibility mark.2 they must set out the use of the collective responsibility mark in a regulatory document.3 the regulatory document must be approved by the central office.form of the collective responsibility mark art. 61 1 the collective responsibility mark shall consist of a specific identifying symbol.2 each manufacturer shall use a personal control number.3 in the mark itself, the symbol must surround the number.origin of the right to the mark art. 62 the right to the mark originates on entry in the register.priority art. 63 the right to the mark belongs to the person who was first to submit the reproduction of the responsibility mark to the central office.grounds for rejection art. 64 the following may not be registered as responsibility marks:a. symbols that do not meet the requirements set out in the act or in the ordinance;b. symbols that do not sufficiently differ from other symbols already registered;c. symbols that are in the public domain;d. symbols that offend against public order, common decency, federal law or state treaties;e. misleading symbols;f. official swiss, foreign or international assay marks or hallmarks.application for registration art. 65 1 to apply for registration of a mark, the following documents must be submitted to the central office:a. the registration application;b. a reproduction of the mark.2 for the application, the official forms for this purpose must be used.registration application art. 66 1 the registration application for individual marks shall comprise:a. the applicant's first and last names or company name;b. the place of registration and residence;c. the type of business;d. the date and the signature of the applicant or a representative.2 the registration application for collective responsibility marks shall comprise:a. the regulatory document;b. the list of the individual manufacturers with the first and last names or company name, personal control number and place of registration and residence;c. the date and the signature of the applicant or a representative.3 the registration application must be accompanied by:a. a extract from the commercial register less than one year old or, if the applicant is not entered in the commercial register, a proof of residence certificate less than one year old;b. a power of attorney if the applicant is represented by another party.reproduction of the mark art. 67 the registration application must be accompanied by:a. 10 black and white reproducible images of the mark, whereby the length of the mark image in each direction must be no less than 15 mm and no more than 30 mm;b. a small metal sheet with several imprints of the mark.examination of the application art. 68 1 the central office shall check to ensure that the application meets the requirements for registration.2 if there is an error in the application, the central office shall grant a deadline for rectification of the fault.3 if the error is not rectified by the given deadline, the central office shall either issue a further deadline or reject the application.registration art. 69 1 the central office shall enter the responsibility mark into the register if:there are no grounds for objection;the documents submitted are complete and correct;the registration fee has been paid.2 the central office shall issues the owner of the mark with a registration certificate. this serves as a certificate to use the responsibility mark.extension of registration art. 70 1 the registration period may be extended for a further 20 years in return for payment of a fee before expiry of the current period of validity.2 the central office shall send the owner of the mark or his representative a written reminder in advance that the period of validity is about to expire.obligation to notify and automatic instigation of an investigation art. 71 1 the owner of the mark must notify the central office of any changes concerning entries in the register.2 if the central office learns that a change has not been reported, it shall set the owner of the mark a deadline for reporting the change. if the deadline passes without a result, the central office shall conduct the necessary investigations ex officio.modifications and deletions art. 72 1 the central office shall enter modifications and delete entries in the register.2 the central office shall grant the owner of the mark an opportunity to make a formal statement before modifying entries in the register on the basis of investigations automatically instigated.3 changes made to the register are subject to a fee.register of responsibility marks art. 73 1 the central office maintains a register of the responsibility marks.2 this register shall contain the following information:the owner's first and last names or company name as well as their place of registration and residence;the type of business;the control number;the reproduction of the mark;the submission date;the registration date;modifications and deletions.3 the register of responsibility marks shall be open to the public.4 the assay offices shall keep a copy of the register.archiving of files art. 74 1 the central office shall maintain a dossier with all documents concerning the marks.2 it keeps the files from applications for a period of five years following deletion of the entry.3 it keeps the files from applications not resulting in registration for a period of five years.publication art. 75 1 notice shall be given of each registered responsibility mark in the swiss official gazette of commerce.2 the notice shall include the control number, a reproduction of the mark, the owner's details and the date of registration.3 in the case of collective responsibility marks, the numbers of the individual participants shall also be published.4 modifications and deletions shall also be published.art. 76-80 repealedsection 5 official controlling and hallmarking i. purpose of the official assay art. 81 1 the official control serves to ascertain whether precious metal articles and multi-metal articles have the legal standards of fineness and meet the other material requirements and whether they bear the prescribed marks and stamps.572 if the legal requirements have been met, this is certified by stamping the official hallmark.57 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).ii. the official assay 1. mandatory art. 82 1 watch-cases made of precious metal may not be placed on the market before undergoing official controlling and hallmarking.58 this provision also applies to watch-cases that are destined for export and have a standard of fineness required under the legislation of the destination country.2 watch-cases are deemed to be placed on the market as soon as they have left the manufacturing plant of the case manufacturer.3 in accordance with article 13 paragraph 1 of the act, the case manufacturer must apply for the official control to the assay office of its business area.4 for watch-cases in an unworked or finished condition that are to be sent directly to states that require the mandatory controlling of watch-cases, the official hallmarking may be dispensed with, subject to the provisions of article 138. based on the foreign statutory provisions, the central office shall stipulate the cases in which the aforesaid precondition applies and bring this to the attention of interested parties with appropriate presentation of guidelines with periodic updates. these guidelines shall also be forwarded to the customs offices responsible for export clearance.5958 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).59 amended by annex 4 number 62 of the customs ordinance of 1 nov. 2006, in force since 1 may 2007 (as 2007 1469).2. hallmarking of multi-metal articles art. 8360 only those multi-metal articles bearing a fineness mark and a responsibility mark on their precious metal parts may be given the official hallmark.60 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).iii. control procedure 1. introduction a. request art. 8461 the request for official hallmarking shall include a precise list of the articles submitted.61 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).b. enclosure of the article art. 85 1 the article to be controlled, in a clean condition, shall be enclosed with the request.2 if the consignment contains articles of different types, these must be arranged for testing by type and by fineness.3 watch-cases must be presented open for official hallmarking.624 the articles must be presented in full for official hallmarking. if only parts of an article are officially hallmarked, the applicant shall sign to accept liability that the finished objects meet the statutory requirements.635 if possible, the articles are presented in a manufacturing stage at which the risks of damage are kept to a minimum. they must be sufficiently along the manufacturing process that no changes may be made to either the stamped hallmark or the article itself in the finishing stages.6462 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).63 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).64 inserted by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 8665 65 repealed by no 1 of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).2. formal verification art. 8766 1 the assay office shall check to ensure that the articles presented correspond to the details in the application and their marking complies with the provisions.2 if so, the request is registered.3 if the articles do not correspond to the details of the request or if they are not correctly marked, the assay office shall refuse to carry out the official hallmarking.66 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 88-9067 67 repealed by no 1 of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).3. material verification a. . art. 9168 1 the determination of the fineness covers all parts of the article.2 the central office shall decide on the testing methods to be used.68 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 9269 69 repealed by no 1 of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).b. method of sampling art. 9370 for the analytical sample, the required amount of material is either scraped or cut from the articles. the sample is taken from clean material, without any surface coating, solder, residue or any other substances.70 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 9471 71 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).c. return of material72 72 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 95 1 the cornets and the beads remaining in the pan as well as all other waste products from the sampling process must be returned with the tested articles.2 where the samples have been taken correctly, no compensation shall be payable for any loss in weight.d. touchstone testing73 73 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 96 1 objects with fragile ornamentation, jewellery work, enamel or decorations for which the removal of a sufficient amount of metal for analytical testing is not advisable may be tested using a touchstone.2 watch-cases and other precious metal articles for which touchstone testing does not produce a conclusive result shall undergo analytical testing.e. certified material art. 9774 1 a written agreement may be made with the manufacturer on the conformity assessment of certified material.2 the central office shall issue directives on the general conditions for agreements.75 74 repealed by no i of the o of 19 june 1995 (as 1995 3113). amended by art. 21 of the o of 17 aug. 2005 on fees for precious metal control (as 2005 4317).75 inserted by art. 17 of the o of 6 nov. 2019 on fees for precious metal control, in force from 1 jan. 2020 (as 2019 3771).iv. objection procedure 1. principle art. 98 1 if the article submitted for verification does not satisfy the statutory minimum fineness or if the fineness mark stamped on the article does not match the actual fineness, the official hallmarking shall be deferred and an objection raised. the same shall apply where an objection is raised to a responsibility mark.2 the applicant shall receive provisional notification of this measure.3 if the objection concerns only individual pieces of the articles submitted, official hallmarking shall proceed for the remaining pieces.2. report to central office art. 9976 1 the assay office shall send the central office a report on the reason for and extent of the objection.2 the central office shall determine the circumstances in which the assay office must also send it the contested articles.76 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).3. procedure of the central office in the case of an objection to the fineness a. ordering of a second opinion art. 100 1 the central office shall order the verification of the articles submitted to it in a second opinion (art. 17 para. 1 of the act).2 the second-opinion test shall be conducted by the agencies of the central office or, exceptionally, by another assay office.7777 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).b. type of verification art. 10178 1 for the second opinion, article 93 and 95 are applicable.2 the central office shall decide on the methods of analysis to be used.78 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).c. article found to comply art. 102 1 if the second opinion determines that the article is of the legally prescribed fineness or that the mark affixed to the article corresponds to the legal fineness of the article, the central office shall order its hallmarking.2 the article shall be returned to the assay office, which must proceed with the hallmarking without any further testing.3 .7979 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).d. confirmation of an offence art. 103 1 if the objection by the assay office turns out to be justified and if an offence has been committed in accordance with article 44 of the act, the central office shall seize the article and file a criminal complaint.2 the applicant shall be notified of these measures in writing.e. justification of the objection without an offence being committed aa. procedure art. 104 1 if there is no indication that an offence has been committed, despite the objection to the article being justified, the central office shall order the refusal of the official hallmarking. at the same time, it shall arrange for the necessary measures to be taken to prevent the disputed articles from being placed on the market.2 the applicant shall be notified of these orders and arrangements in writing.bb. safeguarding measures art. 105 1 as a rule, the contested articles must be made unusable. if the objection concerns only individual parts, only these are made unusable.2 the objects that have been made unusable are returned to the applicant.803 this provision has effect subject to the provision on the responsibility of the officers and sworn assayers in the case of unjustified destruction of articles.80 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).4. procedure of the central office in the case of an objection to the responsibility mark art. 106 1 if an objection is raised to the responsibility mark, the central office shall conduct an investigation.2 if the objection is found to be justified and if an offence has been committed in accordance with article 47 of the act, the article shall be seized and a criminal complaint filed.3 if it cannot be assumed that an offence has been committed, despite the objection to the responsibility mark, the central office shall impose a fixed penalty on the applicant and order him to affix the correct responsibility mark. the article shall be returned to the applicant unstamped for this purpose.5. expenses art. 10781 1 in the case of a justified objection, the applicant must pay the testing fee and expenses incurred.2 the central office's testing fees and expenses shall be collected by the assay office along with its own charges.81 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).v. stamping 1. procedure art. 108 1 if the result of the control does not raise any objection, or if any such objection is found to be unjustified by the second opinion, the assay office must proceed with the hallmarking.2 this is performed by stamping the official hallmark in accordance with the following provisions.3 if the article's size or shape poses difficulties for affixing the hallmark, the assay office must seek further instructions from the central office.2. hallmark a. type art. 10982 1 the appearance and size of the official hallmarks are specified in number 1 of the annex.2 the assay offices' distinctive symbols are specified in number 3 of the annex.82 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 110-11283 83 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).b. delivery of the official hallmark84 84 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 113 1 the official hallmarks shall be procured by the central office and delivered to the assay offices. the cantonal assay offices shall pay the cost price.852 the original hallmarks and dies used to apply the hallmark shall be stored under lock and key by the central office.3 the central office shall conduct a manufacturing check and verifies the hallmarks given to each assay office.85 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).c. storage of the hallmarks at the assay office and replacement art. 11486 1 the assay offices shall store the hallmarks in a safe place under lock and key.2 damaged hallmarks must be returned to the central office for destruction. the central office shall provide a replacement. hallmarks that no longer produce a perfect imprint may be withdrawn.86 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).d. periodic inspection of the hallmarks at the assay offices art. 115 1 the central office must arrange for an inventory and inspection of the assay offices' hallmarks to be carried out periodically. the manner in which the hallmarks are stored and used shall also be inspected.2 .8787 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).art. 11688 88 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).3. application of the hallmarks onto objects art. 11789 1 the assay office shall affix the official hallmark as close as possible to the fineness mark and the responsibility mark.2 at least one official hallmark must be visible on the exterior of the stamped object. the central office may designate the position at which the official hallmark has to be applied.3 if, for a watch-case, all marks are applied on the inside, at least a fineness mark must be visible on the exterior.89 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).4. agreement art. 117a90 1 a written agreement may be made with the manufacturer whereby the latter may have the hallmark affixed at its place of business with its own infrastructure by itself or its own staff.2 the hallmarking shall be carried out under the supervision of the assay office.3 the central office shall issue directives on the general conditions for agreements.91 90 inserted by art. 21 of the o of 17 aug. 2005 on fees for precious metal control (as 2005 4317).91 inserted by art. 17 of the o of 6 nov. 2019 on fees for precious metal control, in force from 1 jan. 2020 (as 2019 3771).vi. procedure for returning the article art. 11892 after hallmarking, the assay office shall return the article to the applicant in return for payment of the fees and expenses.92 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 119-12093 93 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).vii. renewal of hallmarks 1. when replacing individual parts of the hallmarked article art. 12194 1 if individual parts of the article on which the assay office has applied its mark are subsequently to be replaced, an application must be made for a new controlling and hallmarking procedure.2 the replaced pieces must be presented to the assay office for removal of the hallmark.3 to renew the hallmark, the fee charged is half of the fee for a new stamp. if pieces are replaced as a result of a manufacturing error, and evidence to this effect exists, the hallmark shall be applied free of charge.4 the central office shall regulate the hallmarking of unmachined parts of precious metal articles and multi-metal articles and the procedure for subsequent submission of additional parts or finished articles for official hallmarking.94 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).2. replacement of a damaged hallmark art. 122 1 if stamped hallmarks are removed or damaged in the finishing and polishing process, a new hallmark must be obtained from the same assay office that applied the original one.2 if the new pieces to be hallmarked can be proven to correspond to those that were previously stamped, the new hallmark shall be applied without any further testing of the article. if this cannot be proven, the article shall be controlled once again.3 the provisions of article 84-120 apply correspondingly.4 no fee shall be charged for a new hallmark if the article is not controlled.viii. retention of documents art. 12395 the assay office shall retain all documents concerning the official controlling and hallmarking for a period of five years. these shall be given the control number of the job in question.95 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 124-12596 96 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).section 6 import, export and transit i. import 1. permissibility art. 12697 1 precious metal articles, multi-metal articles, plated articles and imitations manufactured abroad may be placed on the market in switzerland only if they comply with the provisions of the act.2 watch-cases of precious metals and finished watches with such cases may not be placed on the market in switzerland until they have been officially controlled and hallmarked.3 this provision has effect subject to the following state treaties:convention of 15 november 197298 on the control and marking of articles of precious metals;agreement of 14 february 197299 between the swiss confederation and the republic of austria on the reciprocal recognition of official hallmarks on watch-cases of precious metals;exchange of letters of 30 october 1935100 between switzerland and spain on the hallmarking of precious metals;d.101 agreement of 19 june 2018102 between the swiss federal council and the government of the republic of france on the reciprocal recognition of official hallmarks on precious metal and multi-metal articles;agreement of 15 january 1970103 between the swiss confederation and the republic of italy on the reciprocal recognition of stamps on precious metal articles;f.104 agreement of 14 december 2011105 between the swiss federal council and the government of the russian federation on the reciprocal recognition of official hallmarks on watch industry products made of precious metals.97 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).98 sr 0.941.3199 sr 0.941.316.3100 sr 0.941.333.2101 amended by no i of the o of 18 april 2018, in force since 1 sept. 2021 (as 2021 472).102 sr 0.941.334.91103 sr 0.941.345.4104 inserted by no i of the o of 2 nov. 2011, in force since 2 aug. 2013 (as 2013 2345).105 sr 0.941.366.5art. 127106 106 repealed by no 1 of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).2. exceptions art. 128107 even if they do not meet the provisions of the act, the following articles are permitted for import:articles for the diplomatic corps;personal property transferred when moving residence and acquired by inheritance;personal effects;gifts, souvenirs, etc., addressed to private individuals by private individuals or sent on behalf of private individuals;e.108 articles imported as part of the tourist trade, destined exclusively for the personal use of the importer or as a gift;f. awards obtained abroad;g. staff loyalty gifts from firms.107 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).108 amended by annex 4 no 62 of the customs ordinance of 1 nov. 2006, in force since 1 may 2007 (as 2007 1469).3. procedure a. clearance offices art. 129109 the directorate general of customs shall decide on the customs offices through which articles governed by the act may be imported.109 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).b. import declaration art. 130110 1 articles governed by the act must be declared on import and reported to the relevant assay office.2 watch-cases and watches requiring official hallmarking must be presented to the relevant assay office, together with a hallmark request.110 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).c. clearance art. 131111 1 the assay offices may conduct the necessary analytical tests when controlling articles on import. articles 43 paragraph 6 and 91-96 are applicable.2 if an offence is established in the course of such testing, the article shall be seized and forwarded to the central office for the filing of a criminal complaint.3 if the articles do not comply with the provisions but no offence has been committed, they shall be returned on payment of the expenses incurred in the objection procedure.4 articles that comply with the provisions shall be released immediately and free of charge for forwarding to the recipient.111 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 132-133112 112 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).4. temporary import art. 134113 samples of articles imported temporarily within the meaning of article 20 paragraph 5 of the act are not required to comply with the legal provisions. a deposit may be payable as collateral to ensure that they are subsequently exported or brought into order.113 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).ii. export 1. marking the article art. 135114 1 articles destined for export may only be given the marks that are prescribed or customary in the destination country if their composition actually matches such marks.2 to confirm fineness marks that comply with the provisions of the destination country (art. 21 para. 3 of the act), the official hallmark as per number 1 of the annex is used.114 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).2. procedure a. customs offices art. 136115 the directorate general of customs shall decide which customs offices are to be used for exporting the articles governed by the act.115 amended by annex 4 no 62 of the customs ordinance of 1 nov. 2006, in force since 1 may 2007 (as 2007 1469).b. export declaration art. 137116 the articles governed by the act must be declared on export and reported to the relevant assay office.116 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).c. export of unstamped watch-cases art. 138117 1 watch-cases that are sent abroad temporarily in accordance with article 82 paragraph 4 for assaying and hallmarking are cleared with a free-pass certificate.2 a deposit may be payable as collateral to ensure that the articles are re-imported.117 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).d. clearance art. 139118 article 131 applies to the export control of articles governed by the act.118 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).iii. transit 1. applicability of the legal provisions concerning import art. 140 1 .1192 articles imported from abroad that are not placed on the open market in switzerland and have been held under customs supervision, but which are to be forwarded unassessed to another country with swiss transport papers, may only be released for export if they meet the applicable requirements (art. 126-128) for import into switzerland (art. 22 para. 2 of the act).1203 to determine their existence, the procedure provided for in art. 129-132 applies correspondingly.119 repealed by no i of the o of 17 feb. 1993, with effect from 1 apr. 1995 (as 1993 984).120 amended by annex 4 no 62 of the customs ordinance of 1 nov. 2006, in force since 1 may 2007 (as 2007 1469).2. treatment of articles in storage art. 141 1 if articles imported from abroad are stored in a open customs warehouse or in a bonded warehouse, the fineness marks, responsibility marks and stamps required for export in accordance with article 6-9 of the act may be applied, or an official assaying and hallmarking be arranged, while in storage.1212 the provisions of art. 129-132 apply correspondingly.121 amended by annex 4 no 62 of the customs ordinance of 1 nov. 2006, in force since 1 may 2007 (as 2007 1469).section 7 . art. 142-144122 122 repealed by no i of the o of 26 may 2010, with effect from 1 july 2010 (as 2010 2219).art. 144a and 144b123 123 inserted by no i of the o of 19 june 1995 (as 1995 3113). repealed by no i of the o of 26 may, with effect from 1 july 2010 (as 2010 2219).art. 145 and 146124 124 repealed by no i of the o of 26 may 2010, with effect from 1 july 2010 (as 2010 2219).art. 147125 125 repealed no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).art. 148-152126 126 repealed by no i of the o of 26 may 2010, with effect from 1 july 2010 (as 2010 2219).art. 153127 127 repealed no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).art. 154-161128 128 repealed by no i of the o of 26 may 2010, with effect from 1 july 2010 (as 2010 2219).art. 162-163129 129 repealed no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).section 8 manufacture of melt products i. definition of commercial activity art. 164130 1 the manufacture of melt products for the purpose of reselling or on behalf of third parties in return for payment is deemed commercial.2 the manufacture of melt products for one's own use is not deemed commercial.130 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).ii. melter's licence 1. application art. 165131 a melter's licence must be applied for in writing from the central office.131 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).2. personal requirement art. 165a132 good standing in accordance with article 25 paragraphs 2 and 3 of the act must be proven by means of an extract from the swiss register of criminal convictions.132 inserted by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).3. supporting documents art. 165b133 1 individuals must enclose the following with their applications:a. an attestation of place of residence, issued by the communal authorities;b. an extract from their entry in the swiss commercial register;c. an extract from the swiss register of criminal convictions; andd. an attestation from the relevant communal or cantonal authorities showing that the facilities and premises being used for precious metal melting comply with environmental and fire-prevention regulations.2 commercial enterprises and cooperatives as well as the swiss branches of foreign companies must enclose the following with their applications:a. an extract from their entry in the swiss commercial register;b. an extract from the swiss register of criminal convictions for the members of management and for those persons in charge of transactions with melt material and melt products; andc. an attestation from the relevant communal or cantonal authorities showing that the facilities and premises being used for precious metal melting comply with environmental and fire-prevention regulations.133 inserted by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).4. decision on the application art. 165c134 1 the central office shall ensure that the conditions for issuing a melter's licence are met. it may call on assay offices to conduct investigations in this respect.2 if the conditions are met, the central office shall issue the melter's licence.134 inserted by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).5. renewal of the licence art. 166135 for the renewal of the licence, the central office may request the same supporting documents as for granting the licence.135 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).6. withdrawal of the licence art. 166a136 1 if any one of the requirements for issuing a melter's licence, as set out in article 25 of the act, is no longer met, or if the holder has repeatedly breached his obligations under articles 168-168c, the central office shall withdraw the melter's licence.2 the assay offices are obliged to immediately report any such facts to the central office, together with any documentary evidence they may have (certificates, witness statements, etc.).3 the central office shall notify the licence holder in writing of the reasons for withdrawal and fix a reasonable deadline for submitting a written formal response.4 once this has been received, it shall order the required inspection measures and make its decision, which it shall forward to the licence holder in writing.136 inserted by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).7. publication art. 166b137 in the notice of the granting or withdrawal of a melter's licence in the swiss official gazette of commerce, specific mention must be made of the name of the licence holder and, in the case of commercial enterprises and cooperatives, details of the management bodies and business premises.137 inserted by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).art. 167138 138 repealed by no i of the o of 26 may 2010, with effect from 1 july 2010 (as 2010 2219).iii. compliance with the licence 1. general obligations art. 168139 1 in carrying out its business activities, the holder of a melter's licence must strictly follow the provisions of the act, the associated implementing provisions and the special directives of the central office and do all in its power to avoid anything that could encourage an offence by third parties.2 the holder is obliged to refer to the fact that it holds a melter's licence on company nameplates, letterheads, in newspaper advertisements and on the internet.139 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).2. acceptance of melt material art. 168a140 1 the holder of a melter's licence is permitted to accept melt material only from persons who can prove their lawful acquisition.2 the licence holder must verify the customer's identity by means of valid documentation such as a passport or identity card.3 if there is any doubt concerning the origin of the goods or if the offer originates from unknown parties, it is the licence holder's duty to clarify in detail the origin of the melt material.4 in relation to the requirement of the holder of a melter's licence to report any offences against cantonal criminal laws that come to his attention, the provisions of the cantonal laws apply. any offences against federal provisions that come to its attention must be reported to the central office or to the relevant assay office or the nearest customs office. in addition, the provisions of the anti-money laundering act of 10 october 1997141 apply.5 if there is any suspicion that the articles on offer have been unlawfully acquired, the relevant police authorities must be informed immediately and their instructions obtained.140 inserted by no i of the o of 19 june 1995 (as 1995 3113). amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).141 sr 955.03. organisational measures art. 168b142 1 the licence holder shall take the necessary organisational measures in its firm to prevent the melting of melt material of unlawful origin. it shall oversee the performance of controls and ensure the existence of appropriate internal supervision and appropriate staff training.2 if, in application of article 168a paragraph 3, there is an obligation to clarify the origin of the article in more detail, the article shall be stored in an unaltered state by the licence holder until the case has been clarified.3 the documents on business transactions in melt material and melt products must be stored for a period of ten years.142 inserted by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).iv. bookkeeping art. 168c143 1 the holder of a melter's licence must keep records of his purchases of melt material and melt products.2 the bookkeeping must include at least the following details:the customer's name and address;the proof of identification prescribed in article 168a paragraph 2;the goods acceptance date;a precise description of the article, if necessary its composition, and its marking in the case of melt products;the weight at the time of acceptance;the weight after melting;completion of the transaction.3 the provisions set out in article 33 also apply in the case of trade assayers who hold a melter's licence.4 the above provisions do not affect the obligation to keep commercial accounts as stipulated in the code of obligations144.143 inserted by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).144 sr 220v. supervision art. 168d145 1 the central office shall maintain a register of the holders of melter's licences and periodically publish the content of this.2 the central office shall oversee the operations of holders of melter's licences. it may delegate this task to assay offices.3 the supervisory bodies must be permitted to inspect the business documents, commercial accounts and goods storage.145 inserted by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).vi. melter's mark146 146 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).art. 169147 1 the melter's mark comprises the holder's name, in full or abbreviated form, framed and accompanied by the word melter. if the melter also holds an assayer licence, he can apply for a combined assayer/melter's mark.2 for the application of the melter's mark, the same provisions apply as for the application of a responsibility mark as set out in section 4. the melter's mark is valid for the same length of time as the melter's licence.3 the application to register a melter's mark must be submitted at the same time as the application for the melter's licence. the applicant may apply to register two or more melter's marks.147 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).art. 170148 148 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).vii. individual melter's licence 1. licence149 149 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).art. 171150 1 manufacturers who themselves melt down their manufacturing waste for sale must hold an individual melter's licence. they may not perform melting for third parties.2 melt products destined for assaying or for sale which originate from holders of an individual melter's licence must be stamped with the individual melter's mark.150 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).2. individual melter's mark151 151 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).art. 172152 1 the individual melter's mark may not contain the word melter.2 the image of the individual melter's mark may correspond to that of the responsibility mark. the mark image applied to the melt products must measure at least 5 mm on its shortest side.3 for the registration of the individual melter's mark, the same provisions apply as for the registration of a responsibility mark as set out in section 4.4 the individual melter's mark is valid for a period of 20 years; for holders of a responsibility mark, its validity is limited for the same period as the corresponding responsibility mark.152 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).viii. determination of the fineness of melt products153 153 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).1. requirement art. 173 1 melt products destined for resale must be tested for their fineness and, as proof thereof, bear the stamp of an assay office (number 4 of the annex) or a sworn trade assayer.1542 the holder of the melter's licence may only apply the fineness mark himself if he also holds an assayer licence as trade assayer.154 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).2 means of testing art. 174 1 the purpose of such testing is to determine the actual fineness of the melt product (art. 32 para. 2 of the act).1552 for the manner in which the test is conducted, articles 91, 93 and 95 apply correspondingly.1563 the fineness determined must be stated in parts per thousand and fractions thereof.4 the fineness determined is stamped on each tested piece provided that the dimensions of the piece permit this. the mark of the assay office or of the trade assayer must also be applied.155 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).156 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).3. test method a. test of origin art. 175157 1 when melt products are submitted to an assay office or a trade assayer for testing, the articles must be immediately recorded in the business control or accounting system. the person submitting the article is given a receipt.2 the assayer checks whether the melt products are marked as set out in articles 169 and 171. if this is not the case, or if there is any reason to assume that the melt product has been acquired unlawfully, the test is postponed. the case must be reported to the central office together with a report and any more specific details. the central office shall conduct the necessary investigations and instigates criminal proceedings (art. 181) if necessary.3 if there is any suspicion that the articles submitted for testing have been unlawfully acquired, the relevant police authorities must be informed immediately and further instructions obtained.157 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).b. determination of the fineness and return art. 176 1 if the origin of the article does not raise any objection, or if, after examination, the central office declares an objection to be unfounded, the determination of the fineness shall be carried out.2 the assaying and stamping shall be carried out in accordance with article 174.3 .158158 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).c. second opinion art. 177159 1 if the owner of the melt product does not agree with the stamped fineness mark, he may request a second opinion from the central office.2 the second-opinion test is carried out in accordance with articles 100 and 101.3 if the second opinion reveals that the fineness mark stamped on the melt material is incorrect, the central office shall return the article to the office that conducted the original determination of the fineness with an order to make the corresponding change.4 if the determination of the fineness turns out to be correct, the person submitting the article shall be informed and receive the article against payment of the relevant fees.5 if the fineness mark has to be corrected, the office that applied it bears the costs of the second opinion.159 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).4. recognition of foreign determinations of the fineness art. 178160 1 determinations of the fineness made abroad on melt products are only recognised in switzerland if they have been made by recognised assayer/melters or if the melt products constitute banking precious metals.2 banking precious metals are:ingots and granules of gold with a minimum fineness of 995 parts per thousand;ingots and granules of silver with a minimum fineness of 999 parts per thousand;ingots and sponges of platinum or palladium with a minimum fineness of 999.5 parts per thousand.3 ingots must comply with standard practice on the international precious metal market in terms of shape, size, weight and marks. they must have at least a fineness mark and the stamp of a recognised assayer/melter.4 gold and silver granules and platinum and palladium sponges require packaging that is sealed by a recognised assayer/melter.5 the central office shall publish the list of recognised foreign assayer/melters.160 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).section 9 criminal proceedings i. filing a criminal complaint in the case of an offence 1. by holders of melter's licences and trade assayers161 161 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).art. 179 1 holders of melter's licences and sworn trade assayers are obliged to report to the nearest assay office any offence against the provisions of the act that comes to their attention.1622 their report must contain as much detail as possible and refer to any evidence that may exist. they are given printed forms for the reporting of offences.3 any offences against other criminal laws must be reported to the competent cantonal police and judicial authorities.162 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).2. by assay offices and customs offices163 163 amended by annex 4 no 62 of the customs ordinance of 1 nov. 2006, in force since 1 mai 2007 (as 2007 1469).art. 180 1 the assay offices are obliged to report to the central office any offence against the provisions of the act that comes to their attention. article 179 applies correspondingly.2 complaints filed by holders of a melter's licence and by sworn trade assayers are verified by the assay office, supplemented as far as possible, and forwarded to the central office.1643 the obligation to report offences within the meaning of paragraph 1 also applies to customs offices.165164 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).165 amended by annex 4 no 62 of the customs ordinance of 1 nov. 2006, in force since 1 may 2007 (as 2007 1469).ii. determining and investigating offences art. 181 1 if the central office receives a report of an offence against the provisions of the act, it shall take the necessary investigative measures. if these find that an offence has been committed in accordance with the act, the central office shall file a criminal complaint with the competent prosecuting authority.2 the central office shall proceed similarly if it is made aware of offences against other criminal laws.art. 182166 166 repealed by the o of 25 nov. 1974, with effect from 1 jan. 1975 (as 1974 1984).section 10 appeals i. requirements art. 183 1 .1672 an appeal is not permissible against the decisions of assay offices and trade assayers that also hold melter's licences in relation to melting carried out for third parties or the actions of holders of a melter's licence. disputes in such cases shall be settled by the competent civil courts by way of civil proceedings.168167 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).168 amended by no i of the o of 26 may 2010, in force since 1 july 2010 (as 2010 2219).ii. . art. 184-185169 169 repealed by no i of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).section 11 fees170 170 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113). i. fees art. 186171 1 the central office and the assay offices shall charge fees for their services and orders.2 the trade assayers charge fees for conducting fineness tests.3 the fees are based on the ordinance of 17 august 2005172 on fees for precious metal controls.1734 the cantonal assay offices and trade assayers shall keep the fees they charge.171 amended by no i of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).172 [as 2005 4317, 2010 2219 ii. as 2019 3771 art. 16]. now the o of 6 nov. 2010 (sr 941.319).173 amended by art. 21 of the o of 17 aug. 2005 on fees for precious metal controls (as 2005 4317).art. 187-189174 174 repealed by no 1 of the o of 19 june 1995, with effect from 1 aug. 1995 (as 1995 3113).ii. commencement and repeal of previous provisions art. 190 1 this ordinance comes into force on 1 july 1934.2 at this point, all enactments in contradiction hereto shall be repealed, specifically the following decrees and regulations:implementing ordinance of 15 november 1892175 on the control and guarantee of the fineness of gold and silver articles;federal council decree of 25 november 1892176 on the organisation and powers of the federal office for gold and silver articles;federal council decree of 8 june 1896177 on the stamping of watch-cases destined for russia;federal council decree of 23 october 1906178 on the control of gold watch-cases with a fineness of 14 carats destined for austria-hungary;federal council decree of 10 february 1914179 on the control of platinum articles;federal council decree of 8 september 1916180 on the implementation of article 1 of the federal act on the control and guarantee of the fineness of gold and silver articles;federal council decree of 2 february 1917181 on the mandatory control of platinum articles;federal council decree of 16 june 1917182 on the control of gold, silver and platinum articles presented for import;federal council decree of 2 july 1918183 on fees for assaying and controlling gold, silver and platinum articles;federal council decree of 31 march 1924184 on the optional hallmarking of gold watch-cases below the legal standard of fineness;federal council decree of 15 february 1929185 on fees for stamping gold, silver and platinum articles manufactured abroad presented for import;federal council decree of 2 july 1929186 on gold-plated or doubl articles;federal council decree of 29 november 1932187 on gold-plated or doubl watch-cases;implementing ordinance of 29 october 1886188 to the federal act of 17 june 1886 on the trade in gold and silver waste and scrap;federal council decree of 13 march 1916189 on the trade in gold, silver and platinum waste and scrap.175 [as 13 146, 15 462, 24 11 184]176 [as 13 174]177 [as 15 462]178 [as 22 639]179 [as 30 56]180 [as 32 333]181 [as 33 35]182 [as 33 378]183 [as 34 713]184 [as 40 101]185 [as 45 38]186 [as 45 321]187 [as 48 712]188 [as 9 291, 37 19]189 [as 32 85]final provision of 19 june 1995190 190 as 1995 3113precious metal articles that satisfy the new conditions but are still stamped with the old official hallmark may continue to be placed on the market.annex i191 191 repealed by art. 22 of the o of 4 nov. 1981 on fees for precious metal controls, with effect from 1 jan. 1982 (as 1981 1806).annex ii192 192 amended by no ii of the o of 19 june 1995, in force since 1 aug. 1995 (as 1995 3113).official hallmarks, assay offices mark, distinctive symbols of the assay offices, assayer's mark of the assay offices number 1 official national hallmark (guarantee stamp)number 2 assay office marknumber 3 distinctive symbols of the assay officesnumber 4 assayer's mark of the assay officesnumber 1image of the official national hallmark (guarantee stamp) (art. 109 para. 1)large hallmark:dimensions:height: 1.6 mmwidth: 2 mmsmall hallmark:dimensions:height: 0.8 mmwidth: 1 mmnote:the official national hallmark (head of a st. bernard dog) bears the distinctive symbol of the assay office, which is positioned at the spot marked with an x.number 2image of the assay offices mark (art. 58 para. 3)dimensions:side length: 0.8 mmnote:the mark bears the distinctive symbol of the assay office, which is positioned at the spot marked with an x.number 3distinctive symbols of the assay offices (art. 109 para. 2)central office and biel/bienne bbasel chiasso tgeneva and geneva airport gla chaux-de-fonds clausanne vle locle lle noiremont jneuchtel nromanshorn rschaffhausen szurich and zurich airport znumber 4image of the assayer's mark of the assay offices (art. 173)examples:federal assay offices:cantonal assay offices:

941.319 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon the fees for precious metal control(pmc-feeo)of 6 november 2019 (status as of 21 january 2020)the swiss federal council,based on article 18 paragraph 1, 19, 34 paragraph 2 and 37 paragraph 3 of the federal act of 20 june 19331 on the control of the trade in precious metals and precious metal articles (precious metals control act, pmca) and article 46a of the government and administration organisation act of 21 march 19972,ordains:1 sr 941.312 sr 172.010section 1 general provisions art. 1 subject matter this ordinance governs the fees for precious metal analysis, namely:a.fees for the services and decisions of the central office for precious metals control, the federal assay offices and the cantonal assay offices;b.fees for assays of fineness carried out by trade assayers in accordance with article 41 of the precious metals control act;c. fees for services provided by the central office.art. 2 fees liability anyone who requests a service or decision in accordance with article 1 letter a must pay a fee.art. 3 applicability of the general fees ordinance unless otherwise stipulated in this ordinance, the provisions of the general fees ordinance of 8 september 20043 apply.3 sr 172.041.1art. 4 fees 1 the fees are calculated in accordance with the rates specified in the annex.2 for services and decisions for which no rate is specified in the annex, the fee is based on time spent (art. 14).3 fees are periodically adjusted to the services actually performed and to technological developments.section 2 official analysis and hallmarking art. 5 principles the fees for the official swiss hallmarking of watch-cases and other precious metal articles and mixed metal articles comprise:a.the fee for conformity testing;b.the hallmarking fee.art. 6 fee for conformity testing 1 for conformity testing of watch-cases and other precious metal articles and mixed metal articles, the fees specified in the annex apply.2 for objects comprised of a combination of several precious metals, the rates for each individual metal are added together.3 certified material means precious metals and precious metal alloys whose fineness before production is confirmed with a conformity certificate that is issued or recognised by one of the bodies under article 1 letter a.art. 7 hallmarking fees 1 for applying the hallmark on precious metal and mixed metal watch-cases or other articles, the fees specified in the annex apply.2 a single mark is:a.the official swiss hallmark; orb.the international hallmark in accordance with the convention of 15 november 19724 on the control and marking of articles of precious metals.3 a double mark is the combined swiss/international hallmark. the double mark is applied as a single unit. the fee for a double mark is charged even if individual marks are applied separately and by the manufacturer itself.4 sr 0.941.31art. 8 acceptance fee 1 if a series of fewer than ten objects is submitted for official hallmarking, an acceptance fee as specified in the annex will be charged.2 the acceptance fee is not charged if the official hallmarks are applied by the applicant itself. art 9 official hallmarking agreements 1 for the conclusion of an agreement in accordance with article 97 paragraph 2 and article 117a paragraph 3 of the ordinance on the control of the trade in precious metals and precious metal articles of 8 may 19345 (pmco), the fees specified in the annex apply:a.for creating the dossier and reviewing the application;b.for the audits carried out during the term of the agreement in accordance with article 97 of the pmco or for its renewal;c.for the additional audit in the case of a request for an agreement in accordance with article 117a of the pmco.2 the fees specified in paragraph 1 are payable before the conclusion or renewal of the agreement.3 the fee for onsite supervision based on article 117a paragraph 2 of the pmco is based on time spent (art. 14).4 the central office charges an annual fee for the accreditation of suppliers and testing laboratories for certified material in accordance with the annex. 5 sr 941.311section 3 fees for fineness assays art. 10 assay of the fineness of samples 1 a sample is defined as an object, a piece or any type of specimen taken from the same material which does not correspond to a parcel or a melted product.2 for assaying the fineness of samples, the fees specified in the annex apply.3 the fee covers the number of analyses necessary to assay the fineness of the sample.4 reduced-scope fineness assays include analyses for conformity with the legal standard of fineness on a single analysed metal.5 the fee for assaying the fineness is doubled in the case of arbitration analysis.6 for assays of fineness that cannot be carried out using standardised testing methods, the fees are based on time spent.art. 11 assay of the fineness of melted products 1 for assaying the fineness of melted products, the fees specified in the annex apply.2 for the assay and marking of each melted product, an additional fee is charged as specified in the annex.art. 12 fees for conversion into analysable form for the conversion into analysable form of material, solutions, salts and other materials which, due to their composition, require prior chemical and physical digestion, further fees as specified in the annex are charged in addition to the fees set out in articles 10 and 11.section 4 other flat-rate fees art. 13 1 other flat-rate fees apply for:a.licences; b.registrations of responsibility marks; c.awarding of diplomas;d.ongoing supervision of trade assayers, melters and the cantonal assay offices;e.courses for precious metal assayers from industry or the cantonal assay offices;f.conformity testing of new coatings and materials.2 the fees are calculated in accordance with the rates specified in the annex.section 5 hourly fees art. 14 1 for services, in particular expert opinions and decisions, for which no rate is specified in the annex, a fee of chf 90 to 135 per hour is charged.2 the exact fee within the range given in paragraph 1 is determined on the basis of the expertise required.3 hours may be divided into quarters of an hour. each fraction of a quarter of an hour is counted as one full quarter of an hour.section 6 compensation for services provided by the central office art. 15 1 the cantonal assay offices pay an annual fee to the central office.2 this consists of a fixed sum and a variable amount depending on the gross turnover generated by the fees charged in accordance with articles 5 to 9.3 the compensation is governed by an administrative service level agreement.section 7 final provisions art. 16 repeal of existing legislation the ordinance of 17 august 20056 on the fees for precious metal control is repealed.6 [as 2005 4317, 2010 2219 n. ii]art. 17 amendment of existing legislation .77 the modifications may be consulted under as 2019 3771. art. 18 commencement this ordinance comes into force on 1 january 2020.annex8 8 the correction of 21 jan. 2020 concerns the italian text only (as 2020 253).1. conformity testing (art. 6), per object made of gold, silver, platinum or palladium: chf1.1 made of certified material1.301.2 made of uncertified material1.902. hallmarking (art. 7) feeper single markper double markmechanical chflaserchfmechanical chflaserchf2.1 by the assay office1.003.001.303.802.2 by the manufacturer0.800.801.101.103. acceptance fee (art. 8) chffee for series of less than ten objects20.004. official hallmarking agreements (art. 9 paras. 1 and 4) chf4.1 non-recurring fee for creating a dossier 500.004.2 additional fee for conducting an audit2000.004.3 non-recurring fee for additional audits in accordance with article 117a of the pmco 250.004.4 annual fee for accreditation of suppliers and testing laboratories for certified material2000.005. assay of fineness of objects or samples (art. 10) goldchfsilverchfplatinumchfpalladiumchf5.1 fee for reduced-scope fineness assay 80.0055.00170.00170.005.2 fee for fineness assay105.0080.00210.00210.006. assay of fineness of melted products (art. 11) goldchfsilverchfplatinumchfpalladiumchf6.1 fee for fineness assay105.0080.00210.00210.00chf6.2 fee for assay and marking of a melted product50.007. conversion into analysable form (art. 12) fee per parcel sampledchf7.1 fee for pre-ground material that is to be broken down by lead (or other metal) melting300.007.2 fee for clean solutions and salts100.007.3 fee for contaminated solutions and salts normally destined for refining or recovery300.007.4 fee for breaking down materials not listed in this table120.008. other flat-rate fees (art. 13) chf8.1 issue or renewal of a melter's licence with a melter's mark1000.008.2 non-recurring fee for issue of an additional melter's mark 200.008.3 issue or renewal of individual melter's licence with individual melter's mark 200.008.4 non-recurring fee for issue of a trade assayer's licence1500.008.5 registration or renewal of an individual responsibility mark 800.008.6 registration or renewal of a collective responsibility mark:1.per mark and 800.002.per participant 200.008.7 modifications and cancellations of licences and marks in accordance with sections 8.1 to 8.6 -.-8.8 exam registration fee for the federal diploma for sworn assayers 150.008.9 issue of the federal diploma for sworn assayers 600.008.10 annual fees for ongoing supervision:1trade assayers, includes activities as a melter if applicable5000.002melters1000.003cantonal assay offices5000.008.11 course fees for assayers from industry or a cantonal assay office, per person and day 500.008.12 conformity testing of new coatings and materials is charged according to time spent.

944.0 english is not an official language of the swiss confederation. this translation is provided for information purposes only, has no legal force and may not be relied on in legal proceedings.federal act on information for consumers (consumer information act, consumia)of 5 october 1990 (status as of 1 january 2013)the federal assembly of the swiss confederation,on the basis of article 31sexies paragraph 1 of the federal constitution1,2 and having considered the federal council dispatch dated 7 may 19863,decrees:1 [bs 1 3; as 1981 1244]. the said provision is now art. 97 of the cst. of 18 april 1999 (sr 101).2 amended by annex no ii 10 of the therapeutic products act of 15 dec. 2000, in force since 1 jan. 2002 (as 2001 2790; bbl 1999 3453).3 bbl 1986 ii 354section 1 purpose art. 1 this act has the aim of encouraging the provision of objective information to consumers by means of:a. regulations on declarations relating to goods and services;b. financial assistance to consumer organisations.section 2 declarations relating to goods and services art. 2 principles 1 where it is in consumers' interests, the following shall be declared in a form that enables a comparison to be made:a. the essential characteristics of the goods offered for sale or use;b. the essential content of services designated by the federal council.2 any person who places such goods on the market or offers such services is required to make a declaration.3 foreign declarations must be recognised if they enable a comparison to be made with swiss declarations.4 trade and manufacturing secrecy shall be preserved.5 labelling obligations in accordance with other federal provisions are reserved.46 declarations shall be made in the official languages of the confederation.4 amended by annex no ii 10 of the therapeutic products act of 15 dec. 2000, in force since 1 jan. 2002 (as 2001 2790; bbl 1999 3453).art. 3 agreements under private law the business and consumer organisations concerned shall agree which goods must be declared. they shall also agree on the requirements for the form and content of the declarations related to these goods and the services designated by the federal council. in doing so, they shall take account of international standards and the principle of non-discrimination.art. 4 federal council ordinances the federal council may after consulting the business and consumer organisations concerned regulate the declaration procedure by ordinance if:a. no agreement has been reached within a reasonable time; orb. an agreement is not being fulfilled satisfactorily.section 3 financial assistance to consumer organisations art. 5 principles 1 the confederation may grant financial assistance to consumer organisations whose activities are of nationwide importance and which, in accordance with their articles of association, are devoted exclusively to consumer protection. the financial assistance may not exceed 50 per cent of the eligible costs, within the limits of the approved credits, of:a. providing objective and accurate information on printed or in electronic media;b. conducting comparison tests on the essential and clearly ascertainable characteristics of goods and on the essential content of services;c. negotiating agreements on declarations.2 the confederation may also grant financial assistance under paragraph 1 letter a to other organisations whose activities are of national importance and which, in accordance with their articles of association, are devoted to consumer protection.art. 6 financial assistance for conducting comparison tests 1 the confederation shall grant financial assistance for conducting comparison tests only if the consumer organisation in all its testing activities:a. bases its selection of the test subjects and the conduct of the tests on the consumers' need for information;b. conducts the tests in accordance with scientific principles;c. ensures that the tests are conducted in a technically competent, professional and impartial manner;d. grants the suppliers concerned a right of reply.2 the competent federal authority shall ensure the coordination of the test activities of consumer organisations seeking financial assistance.art. 7 independence in conducting tests any organisation that receives financial assistance for conducting comparison tests in accordance with article 5 paragraph 1 letter b must be sufficiently independent to guarantee the objective conduct of the tests.section 4 obligation to provide information art. 8 1 organisations that claim financial assistance must provide the competent administrative unit with all the required information and permit the inspection of documents.2 the business and consumer organisations concerned and the suppliers of goods and services must provide the competent administrative unit with all the information required to implement the federal council regulations on declarations relating to goods and services (art. 4).section 5 federal commission for consumer affairs art. 9 1 the federal council shall establish a federal commission for consumer affairs in which consumers, businesses and academia are represented.2 the commission shall advise the federal council and the departments on matters affecting consumers.3 the commission shall promote the resolution of consumer issues in a spirit of partnership.section 6 procedures and criminal provisions art. 10 legal remedies legal remedies are governed by the provisions on the administration of federal justice.art. 11 offences 1 any person who wilfully commits any of the following acts shall be liable to a fine:a. failure to comply with a federal council regulation on declarations relating to goods and services (art. 4), where such failure carries a criminal penalty;b. failure to comply with the obligation to provide information under article 8 paragraph 2.2 if the offender acts through negligence, the fine shall not exceed 2000 francs.3 in particularly minor cases, no penalty need be imposed.art. 12 relationship with the federal act on administrative criminal law 1 the federal act of 22 march 19745 on administrative criminal law applies to the prosecution and adjudication of the offences.2 the administrative unit responsible for prosecution and judgment is the federal department of economic affairs, education and research6.5 sr 313.06 term in accordance with no i 34 of the o of 15 june 2012 (restructuring of the departments), in force since 1 jan. 2013 (as 2012 3655).section 7 final provisions art. 13 implementation 1 the federal council shall implement this act. it shall issue the implementing provisions.2 it may consult the business and consumer organisations concerned on the implementation of the regulations.art. 14 referendum and commencement 1 this act is subject to an optional referendum.2 the federal council shall determine the commencement date.commencement date: 1 may 19927 7 fcd of 1 april 1992.

944.021.1 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.eaer ordinance on the declaration for timber and timber productsof 7 june 2010 (status as of 1 january 2017)the federal department of economic affairs education and research (eaer1),based on articles 1 paragraph 2 and 2 paragraph 2 the ordinance of 4 june 20102 on the declaration for timber and timber products,ordains:1 the name of this administrative unit was amended in application of art. 16 para. 3 of the publications ordinance of 17 nov. 2004 (as 2004 4937) on 1 jan. 2013. the amendment has been made throughout the text.2 sr 944.021art. 1 timber and timber products subject to declaration the duty to declare applies to timber and timber products specified in the annex.art. 2 reference system for the declaration of timber species the reference system for the declaration of the timber species comprises:a.the commercial timber list of the swiss timber trade centre3; andb.standard sn en 13556:20034.3 the list may be inspected under: www.konsum.admin.ch.4 the text of this standard may be obtained from the swiss information centre for technical rules (switec), brglistrasse 29, 8400 winterthur; www.snv.chart. 3 commencement this ordinance comes into force on 1 october 2010.annex5 5 revised in accordance with no i of the eaer ordinance of 2 dec. 2011 (as 2011 6267) and of 18 oct. 2016, in force since 1 jan. 2017 (as 2016 3853).(art. 1)timber and timber products subject to declaration customs tariff numberproduct designation4401 without 4401.3100 4401.3900 and 4401.4000fuel wood, in logs, in billets, in twigs, in faggots or in similar forms; wood in chips or particles4402wood charcoal (including shell or nut charcoal), whether or not agglomerated4403wood in the rough, whether or not stripped of bark or sapwood, or roughly cut at two or four sides4404hoopwood, split poles, piles, pickets and stakes of wood, pointed but not sawn lengthwise, wooden sticks, roughly trimmed but not turned, bent or otherwise worked, suitable for the manufacture of walking sticks, umbrellas, tool handles and the like, chipwood, woodstrips, woodbands and the like4406railway or tramway sleepers of wood, and the like4407wood sawn or chipped lengthwise, sliced or peeled, whether or not planed, sanded or end-jointed, of a thickness exceeding 6mm. 4409wood (including strips and friezes for parquet flooring, not assembled) continuously shaped (tongued, grooved, rebated, chamfered, v-jointed, beaded, moulded, rounded or the like) along any of its edges, ends or faces, whether or not planed, sanded or end-jointed4414wooden frames for paintings, photographs , mirrors or similar objects, made of solid wood4416casks, barrels, vats, tubs and other coopers' products and parts thereof, made of solid wood4418.5000shingles and shakes4418.6000posts and beams made of solid wood9401.6900seats with main components made of solid wood9403.3000 9403.4000 9403.5000 9403.6000other furniture with main components made of solid wood

944.3english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton package travelof 18 june 1993 (status as of 20 august 2021)the federal assembly of the swiss confederation,based on articles 31sexies and 64 of the federal constitution1,and having considered the federal council dispatch of 24 february 19932,decrees:1 sr 1012 bbl 1993 i 805section 1 definitions art. 1 package travel 1 package travel means the pre-arranged combination of not fewer than two of the following when sold or offered for sale at an inclusive price and when the service covers a period of more than twenty-four hours or includes overnight accommodation:a. transport;b. accommodation;c. other tourist services not ancillary to transport or accommodation and accounting for a significant proportion of the package.2 this act also applies if various components of the same package have been billed separately.art. 2 organiser, retailer and consumer 1 organiser3 means any person who, other than occasionally, organises packages and sells or offers them for sale, whether directly or through a retailer.2 retailer4 means any person who sells or offers for sale the package put together by the organiser.3 consumer5 means:a. any person who takes or agrees to take a package;b. any person on whose behalf or for whose benefit a package has been purchased or an agreement to purchase has been entered into;c. any person to whom the booking relating to a package tour has been transferred in accordance with article 17.3 footnote relevant to german version only.4 footnote relevant to german version only.5 footnote relevant to german version only.section 2 brochures art. 3 the organiser or retailer who publishes a brochure is bound by the particulars contained therein; these particulars may only be changed thereafter:a. by mutual agreement of the parties to the contract;b. if the brochure has expressly made reference to the possibility of modification, and provided that such modifications have been clearly communicated to the consumer prior to the conclusion of the contract.section 3 information for the consumer art. 4 before conclusion of the contract 1 the organiser or the retailer must communicate all the terms and conditions of the contract to the consumer in writing before the contract is concluded.2 the terms of the contract may also be brought to the consumer's attention in another appropriate form, provided that they are confirmed to him in writing before the contract is concluded. the obligation to confirm in writing does not apply if compliance would prevent the conclusion of the contract.3 where it is relevant for the package, the organiser or the retailer shall provide the consumer, in writing or any other appropriate form, with general information on:a. passport and visa requirements applicable to nationals of the states of the ec and the efta, and in particular on the periods for obtaining them;b. health formalities required for the journey and the stay.4 nationals of any other states are entitled to such information according to paragraph 3 letter a above, if they request the same immediately.art. 5 before the start of the journey the organiser or retailer shall provide the consumer, in writing or any other appropriate form, with the following information in good time before the start of the journey:a. the times and places of intermediate stops and transport connections;b. the seat to be occupied by the traveller;c. the name, address and telephone number of the organiser's or retailer's local representative or, failing that, of local agencies on whose assistance a consumer in difficulty could call; where even no such agencies exist, the consumer must in any case be provided with an emergency telephone number or any other information that will enable him to contact the organiser or the retailer;d. in the case of journeys or stays abroad by minors, information enabling direct contact to be established with the child or the person responsible at the child's place of stay;e. information on the optional conclusion of an insurance policy to cover the cost of cancellation by the consumer or the cost of assistance, including repatriation, in the event of accident or illness.section 4 content of the contract art. 6 1 irrespective of the kind of services agreed, the following elements must be included in the contract:a. the name and address of the organiser, and, where applicable, the retailer;b. the date, time and location of the beginning and the end of the travel arrangement;c. the special requirements of the consumer that have been accepted by the organiser or the retailer;d. whether a minimum number of persons is required for the package to take place and, if so, the latest date for informing the consumer of cancellation;e. the price of the package as well as the payment schedule and method of payment;f. periods within which the consumer must make any complaint concerning failure to perform or improper performance of the contract;g. the name and address of the insurer, where appropriate.2 depending on the particular package agreed on, the following elements must be included in the contract as well:a. the travel destination and, where periods of stay are involved, the relevant periods with dates; b. the itinerary;c. the means, characteristics and categories of transport to be used;d. the number of meals included in the total price agreed for the package;e. the location, the tourist category or degree of comfort of the accommodation as well as its main features and its compliance with the rules of the host state concerned;f. the visits, excursions or other services which are included in the total price agreed for the package;g. the requirements for a price revision under article 7;h. details of any dues, taxes or fees chargeable for certain services, such as landing, embarkation or disembarkation fees at ports and airports, and tourist taxes, where such costs are not included in the package.section 5 price increases art. 7 the price laid down in the contract may only be increased where:a. the contract expressly provides for that possibility and states precisely how the revised price is to be calculated;b. it takes place at least three weeks prior to the departure date; andc. it is based solely on an increase in transportation costs, including the cost of fuel, on an increase in dues chargeable for certain services, such as landing taxes or embarkation or disembarkation fees at ports and airports, or on modifications to the exchange rates applied to the particular package.section 6 significant changes to the contract art. 8 definition 1 any significant change of an essential contract term by the organiser before the start of the journey is considered an essential change to the contract itself.2 a price increase exceeding ten percent is considered an essential change to the contract.art. 9 obligation to inform the organiser shall notify the consumer as quickly as possible of any essential change to the contract as well as its effects on the total package price.art. 10 consumer rights 1 the consumer may accept an essential change to the contract or withdraw from the contract without penalty.2 he must give notice of his withdrawal from the contract to the organiser or the retailer as soon as possible.3 if the consumer withdraws from the contract he or she is entitled to either:a. take a substitute package of equivalent or higher quality where the organiser or retailer is able to offer him such a substitute;b. take a substitute package of lower quality as well as the refund of the difference in price; orc. be repaid all sums paid by him under the contract in the quickest possible manner.4 a claim for damages due to non-performance of the contract remains reserved.section 7 cancellation of the package art. 11 1 where, for whatever cause not imputable to the consumer, the organiser cancels the package before the agreed date of departure, the consumer is entitled to the rights under article 10.2 the consumer is not, however, entitled to claim for damages for non-performance of the contract:a. if the cancellation is on the grounds that the number of persons enrolled for the package is less than the minimum number required and the consumer is informed of the cancellation, in writing, within the period indicated in the contract; orb. if the cancellation is due to force majeure. overbooking is not considered a case of force majeure.section 8 non-performance and improper performance of the contract art. 12 complaints 1 the consumer must communicate any failure in the performance of the contract which he or she perceives on the spot to the supplier of the services concerned and to the organiser or the retailer in writing or any other appropriate form at the earliest opportunity.2 in cases of complaint, the organiser, the retailer or his local representative must make prompt efforts to find appropriate solutions.art. 13 alternative arrangements 1 where, after departure, a significant proportion of the services contracted for is not provided or the organiser perceives that it will be unable to procure a significant proportion of the services to be provided, the organiser shall:a. make suitable alternative arrangements for the continuation of the package;b. compensate the consumer for the loss suffered; the quantum of damages corresponds to the difference between the services offered and those supplied.2 if it is impossible to make such arrangements or these are not accepted by the consumer for good reasons, the organiser must provide the consumer with equivalent transport back to the place of departure, or to another return-point to which the consumer has agreed.6 in addition, the organiser must compensate the consumer for the loss suffered therefrom.3 the measures under this article do not justify any extra charge to the consumer.6 the correction of the federal drafting committee of 20 august 2021 concerns the italian text only (ru 2021 496).art. 14 liability; principle 1 the organiser or the retailer party to the contract is liable to the consumer for the proper performance of the obligations arising from the contract, irrespective of whether such obligations must be performed by that organiser or retailer himself or by other suppliers of services.2 the organiser and the retailer have a right of recourse against other suppliers of services.3 in the matter of damages arising from the non-performance or improper performance of the contract, the limits of compensation provided for in international conventions remain reserved.art. 15 exceptions 1 the organiser or the retailer are not liable to the consumer where the non-performance or improper performance of the contract is due to:a. failures attributable to the consumer;b. unforeseeable or unavoidable failures attributable to a third party unconnected with the provision of the services contracted for;c. a case of force majeure or an event which the organiser, the retailer or the supplier of services, even with all due care, could not foresee or forestall.2 in the cases referred to in paragraph 1 letter b, the organiser or the retailer party to the contract is required to give prompt assistance to a consumer in difficulty.art. 16 limitation and exclusion of liability 1 any limitation of liability by means of a contractual clause for personal injury arising from the non-performance or improper performance of the contract is excluded.2 in the matter of other damages, liability may be reduced to double the amount of the total price of the package by means of a contractual clause, save for damages caused wilfully or through gross negligence.section 9 assignment of the booking art. 17 1 where the consumer is prevented from proceeding with the package, he or she may assign his or her booking to a person who satisfies all the conditions applicable to the package, provided that he or she has first given the organiser or the retailer reasonable notice of his or her intention before departure.2 this person and the consumer shall be jointly and severally liable to the organiser or the retailer party to the contract for payment of the price and for any additional costs arising from such transfer.section 10 security art. 18 1 the organiser or the retailer party to the contract shall provide security for the refund of money paid over and for the repatriation of the consumer in the event of their insolvency or bankruptcy.2 on request, the organiser or the retailer must provide evidence of the security to the consumer. if it fails to do so, the consumer may withdraw from the contract.3 the withdrawal must be communicated to the organiser or the retailer in writing before the departure date.section 11 mandatory law art. 19 any deviation from this act to the disadvantage of the consumer is prohibited unless explicitly provided for therein.section 12 referendum and commencement art. 20 1 this act is subject to an optional referendum.2 the federal council determines the date on which this act comes into force.commencement date: 1 july 199477 fcd of 30 nov. 1993.

946.15 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceon the organisation of the national contact pointfor the oecd guidelines for multinational enterprises and on its advisory board(ncpo-oecd)of 1 may 2013 (status as of 1 june 2013)the swiss federal council,on the basis of articles 55, 57 and 57c paragraph 2 of the government and administration organisation act of 21 march 19971,ordains:1 sr 172.010section 1 national contact point for the oecd guidelines for multinational enterprises art. 1 tasks 1 the national contact point for the oecd2 guidelines for multinational enterprises (ncp) promotes in terms of clause i.11 of the oecd guidelines of 25 may 20113 for multinational enterprises (oecd guidelines) the implementation of the guidelines by international enterprises that have their registered office or a permanent establishment in switzerland.2 it has the following tasks in particular:a.it promotes awareness and the dissemination of the oecd guidelines.b.it accepts submissions raising specific instances regarding possible violations by companies of the oecd guidelines and mediates between the parties.c.it responds to enquiries about the oecd guidelines.2 organisation for economic co-operation and development3 oecd declaration of 25 may 2011; www.oecd.org > topics > industry and entrepreneurship > guidelines for multinational enterprises; a german translation is available in the report of 11 january 2012 on foreign economic policy 2011, bbl 2012 827, here 938.art. 2 responsibility the state secretariat for economic affairs (seco) runs the ncp.art. 3 submissions raising specific instances 1 submissions raising specific instances regarding possible violations of the oecd guidelines may be raised by individual persons or groups.2 they must be submitted in writing.art. 4 procedure for dealing with submissions raising specific instances 1 the ncp shall issue instructions on dealing with submissions raising specific instances, taking account of the procedural guidance of the oecd guidelines.2 the ncp shall set up a working group within the federal administration to deal with a submission raising a specific instance. the working group shall include representatives of the offices of the federal administration that are affected by the specific instance.section 2 federal advisory board to the national contact point for the oecd guidelines for multinational enterprises art. 5 status the federal advisory board to the national contact point for the oecd guidelines for multinational enterprises (ncp advisory board) is a standing administrative committee as defined in article 8a paragraph 2 of the government and the administration organisation ordinance of 25 november 19984 (gaoo).4 sr 172.010.1art. 6 tasks 1 the ncp advisory board advises the ncp on its strategic orientation and on the application of the oecd guidelines and the ncp procedural instructions.2 it shall encourage a dialogue between interest groups and contribute to the effective implementation of the oecd guidelines.art. 7 composition and appointment 1 the ncp advisory board has 14 members. it shall comprise:a.the director of seco and three further members of the federal administration;b.two representatives each from employers' federations, trade unions, trade associations, non-governmental organisations and academia.2 the ncp advisory board shall be jointly chaired by the director of seco and one additional member of the ncp advisory board in accordance with paragraph 1 letter b.3 the federal council shall appoint the members of the ncp advisory board and its joint-chairpersons on the proposal of the federal department of economic affairs, education and research (eaer).art. 8 meetings 1 the ncp advisory board meets twice a year. if required, further meetings shall be held.2 the meetings are convened by the joint-chairpersons.3 the ncp advisory board may invite ncp staff and additional specialists from within and outside the federal administration to attend the meetings.art. 9 non-public nature and provision of information 1 the discussions of the ncp advisory board are not held in public.2 the ncp advisory board shall publish a brief statement on its discussions following each meeting. it shall report on its activities in the ncp annual report.art. 10 remuneration and department responsible for costs 1 the remuneration paid to the members of the ncp advisory board is governed by the gaoo5.2 the costs of the ncp advisory board are borne by the eaer.5 sr 172.010.1art. 11 secretariat the seco runs the secretariat to the ncp advisory board.section 3 final provisions art. 12 amendment of current legislation. .66 the amendment may be consulted under as 2013 1313.art. 13 commencement this ordinance comes into force on 1 june 2013.

950.1english is not an official language of the swiss confederation. this translation is provided for information purposes only, has no legal force and may not be relied on in legal proceedings.federal act on financial services(financial services act, finsa)of 15 june 2018 (status as of 1 august 2021)the federal assembly of the swiss confederation,based on articles 95, 97, 98 and 122 paragraph 1 of the federal constitution1,and having considered the federal council dispatch of 4 november 20152,decrees:1 sr 1012 bbl 2015 8901title 1 general provisions art. 1 purpose and subject matter 1 this act seeks to protect the clients of financial service providers and to establish comparable conditions for the provision of financial services by financial service providers, and thus contributes to enhancing the reputation and competitiveness of switzerland's financial centre.2 to this end, it establishes the requirements for honesty, diligence and transparency in the provision of financial services and governs the offering of financial instruments. art. 2 scope of application 1 this act applies to all of the following, irrespective of their legal form:a. financial service providers;b. client advisers; c. producers and providers of financial instruments.2 this act does not apply to:a. the swiss national bank;b. the bank for international settlements;c. occupational pension schemes and other institutions whose purpose is to serve occupational pensions (occupational pension schemes), as well as employer-sponsored foundations (employer-sponsored welfare funds); employers who manage the assets of their occupational pension schemes; employer and employee associations which manage the assets of their association schemes; d. the following, provided their activities are subject to the insurance supervision act of 17 december 20043 (isa): 1. insurance companies,2. insurance intermediaries,3. ombudsman's offices;e. public insurance institutions in accordance with article 67 paragraph 1 of the federal act of 25 june 19824 on occupational old age, survivors' and invalidity pension provision.3 sr 961.014 sr 831.40art. 3 definitions for the purposes of this act:a. financial instruments are: 1. equity securities:- securities in the form of shares including share-like securities allowing for participation or voting rights, such as participation certificates and dividend rights certificates- securities which, on conversion or exercise of the rights evidenced by them, enable the acquisition of equity securities, as set forth above, as soon as they have been registered for conversion,2. debt instruments: securities not classified as equity securities,3. units in collective investment schemes in accordance with articles 7 and 119 of the collective investment schemes act of 23 june 20065 (cisa), 4. structured products, i.e. capital-protected products, capped return products and certificates,5.6 derivatives in accordance with article 2 letter c of the financial market infrastructure act of 19 june 20157 (finmia), 6. deposits whose redemption value or interest is risk- or price-dependent, excluding those whose interest is linked to an interest rate index,7. bonds: units in an overall loan subject to uniform conditions;b.8 securities are standardised certificated and uncertificated securities, in particular uncertificated securities in accordance with article 973c of the code of obligations (co)9 and ledger-based securities in accordance with article 973d of the co, as well as derivatives and intermediated securities, which are suitable for mass trading; c. financial services are any of the following activities carried out for clients: 1. acquisition or disposal of financial instruments, 2. receipt and transmission of orders in relation to financial instruments, 3. administration of financial instruments (portfolio management), 4. provision of personal recommendations on transactions with financial instruments (investment advice), 5. granting of loans to finance transactions with financial instruments; d. financial service providers are persons who provide financial services on a commercial basis in switzerland or for clients in switzerland, with the criterion of a commercial basis being satisfied if there is an independent economic activity pursued on a permanent, for-profit basis;e. client advisers are natural persons who perform financial services on behalf of a financial service provider or in their own capacity as financial service providers; f. issuers are persons who issue or intend to issue securities;g. an offer is any invitation to acquire a financial instrument that contains sufficient information on the terms of the offer and the financial instrument itself;h. a public offer is an offer to the public; i. producers are persons who produce a financial instrument or modify an existing financial instrument, including its risk and return profile or the costs associated with investing in the financial instrument.5 sr 951.316 amended by no i 4 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).7 sr 958.18 amended by no i 4 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).9 sr 220art. 4 client segmentation 1 financial service providers shall assign the persons for whom they provide financial services to one of the following segments: a. retail clients;b. professional clients;c. institutional clients.2 retail clients are clients who are not professional clients.3 professional clients10 are: a. financial intermediaries as defined in the banking act of 8 november 193411 (banka), the financial institutions act of 15 june 201812 (finia) and the cisa13; b. insurance companies as defined in the isa14; c. foreign clients subject to prudential supervision as the persons listed under a and b above; d. central banks; e. public entities with professional treasury operations; f. occupational pension schemes with professional treasury operations and other occupational pension institutions providing professional treasury operations;g. companies with professional treasury operations;h. large companies;i. private investment structures with professional treasury operations created for high-net-worth retail clients.4 institutional clients15 are professional clients as defined in paragraph 3 letters a to d as well as national and supranational public entities with professional treasury operations. 5 a large company is a company which exceeds two of the following parameters:balance sheet total of chf 20 million;turnover of chf 40 million;equity of chf 2 million. 6 companies of a group that receive a financial service from another company from the same group are not deemed to be clients.7 financial service providers may refrain from client segmentation if they treat all clients as retail clients.10 as professional clients are primarily legal entities, they are referred to herein as it.11 sr 952.012 sr 954.113 sr 951.3114 sr 961.0115 as institutional clients are primarily legal entities, they are referred to as it.art. 5 opting out and opting in 1 high-net-worth retail clients and private investment structures created for them may declare that they wish to be treated as professional clients (opting out). 2 any person who can credibly declare that they satisfy the criteria under a and b below will be deemed high-net-worth within the meaning of paragraph 1:a. on the basis of training, education and professional experience or on the basis of comparable experience in the financial sector, they possess the necessary knowledge to understand the risks associated with the investments and have at their disposal assets of at least chf 500,000; orb. they have at their disposal assets of at least chf 2 million.3 professional clients within the meaning of article 4 paragraph 3 letters f and g may declare that they wish to be treated as institutional clients.4 swiss and foreign collective investment schemes and their management companies which are not already deemed to be institutional clients within the meaning of article 4 paragraph 3 letter a or c in conjunction with article 4 paragraph 4 may declare that they wish to be treated as institutional clients.5 professional clients who are not institutional clients within the meaning of article 4 paragraph 4 may declare that they wish to be treated as retail clients (opting in). 6 institutional clients may declare that they wish to be treated only as professional clients.7 before providing any financial services, financial service providers shall inform those of their clients who are not classified as retail clients of the possibility of opting in.8 the declarations in paragraphs 1 to 6 must be made in writing or in another form demonstrable via text.title 2 requirements for the provision of financial services chapter 1 required knowledge art. 6 client advisers must have sufficient knowledge of the code of conduct set out in this act and the necessary expertise required to perform their activities.chapter 2 code of conduct section 1 principle art. 7 1 financial service providers must comply with the supervisory duties set out under this title when providing financial services.2 the specific provisions of other pieces of legislation are reserved.section 2 duty to provide information art. 8 content and form of information 1 financial service providers shall inform their clients of the following: a. their name and address;b. their field of activity and supervisory status; c. the possibility of initiating mediation proceedings before a recognised ombudsman in accordance with title 5; andd. the general risks associated with financial instruments.2 they shall also provide information on:a. the financial service personally recommended and the associated risks and costs; b. the business affiliations with third parties in connection with the financial service offered; c. the market offer taken into account when selecting the financial instruments.3 where financial instruments are personally recommended, financial service providers shall also make the key information document available to the retail client insofar as such a document must be produced for the financial instrument recommended (articles 58 and 59). in the case of a compound financial instrument, a key information document shall be made available for said instrument only. 4 no key information document need be made available if the service is provided exclusively in the execution or transmission of client orders, unless a key information document has already been produced for the financial instrument. 5 when personally recommending financial instruments for which a prospectus is required (articles 35 to 37), financial service providers shall make this prospectus available to their retail client free of charge upon request.6 advertising must be indicated as such.art. 9 timing and form of information 1 financial service providers shall inform their clients before the signing of the contract or provision of the service.2 financial service providers shall make the key information document available free of charge to their retail clients before the signing or conclusion of the contract. where consultation takes place without the client being physically present, the key information document may be made available after conclusion of the transaction if the client so consents. financial service providers shall document said consent.3 the information may be made available to clients in standardised form on paper or electronically.section 3 appropriateness and suitability of financial services art. 10 duty to review financial service providers that provide investment advice or portfolio management services shall perform an appropriateness or suitability review.art. 11 assessment of appropriateness a financial service provider that provides investment advice for individual transactions without taking account of the entire client portfolio must enquire about its clients' knowledge and experience and must check whether financial instruments are appropriate for its clients before recommending them.art. 12 assessment of suitability a financial service provider that provides investment advice taking account of the client portfolio or portfolio management must enquire about its clients' financial situation and investment objectives as well as their knowledge and experience. this knowledge and experience relates to the financial service and not to the individual transactions. art. 13 exemption from the duty to review 1 where solely executing or transmitting client orders, financial service providers are not obliged to perform an appropriateness or suitability assessment. 2 they shall notify the clients before providing the service described in paragraph 1 that an appropriateness or suitability assessment will not be performed.3 in the case of professional clients, they may assume that these clients have the required level of knowledge and experience and can financially bear the investment risks associated with the financial service.art. 14 non-assessable or lacking appropriateness or suitability 1 if the information received by the financial service provider is insufficient for assessing the appropriateness or suitability of a financial instrument, it shall inform the client before providing the service that it cannot perform this assessment.2 if the financial service provider is of the opinion that a financial instrument is not appropriate or suitable for its clients, it shall advise them against it before providing it. 3 a lack of knowledge and experience may be compensated for by providing clients with information.section 4 documentation and rendering of account art. 15 documentation 1 financial service providers shall document in an appropriate manner:a. the financial services agreed with clients and the information collected about them;b. the notification described in article 13 paragraph 2 or the fact that they advised the clients in accordance with article 14 against availing of the service;c. the financial services provided for clients.2 when providing investment advice, they shall also document clients' needs and the grounds for each recommendation leading to the acquisition or disposal of a financial instrument.art. 16 rendering of account 1 if so requested, financial service providers shall provide their clients with a copy of the documentation mentioned in article 15 or shall make it accessible to them in another appropriate manner.2 moreover, at the clients' request, they shall render account of:a. the financial services agreed and provided;b. the composition, valuation and development of the portfolio; c. the costs associated with the financial services.3 the federal council shall regulate the minimum content of the information specified in paragraph 2. section 5 transparency and care in client orders art. 17 handling of client orders 1 financial service providers shall uphold the principles of good faith and equal treatment when handling client orders. 2 the federal council shall regulate how the principles under paragraph 1 are to be upheld, specifically regarding the procedures and systems for processing client orders.art. 18 best execution of client orders 1 financial service providers shall ensure in the execution of their clients' orders that the best possible outcome is achieved in terms of cost, timing and quality. 2 regarding cost, they shall consider not only the price of the financial instrument but also the expenses incurred in the execution of the order and the compensation from third parties mentioned in article 26 paragraph 3. 3 if they employ staff to execute client orders, financial service providers shall issue internal directives on the execution of client orders which are commensurate with the number of such staff members and the structure of operations.art. 19 use of clients' financial instruments 1 financial service providers may borrow financial instruments from clients' portfolios as a counterparty or act as an agent for such transactions only if the clients have given their prior and express consent to these transactions in writing or in another form demonstrable via text in an agreement that is separate from the general terms and conditions. 2 the clients' consent is valid only if: a. they have been clearly informed of the risks associated with such transactions; b. they are entitled to equalisation payments for the proceeds due from the financial instruments borrowed; and c. they are compensated for the financial instruments borrowed. 3 short selling with the financial instruments of retail clients is not permitted.section 6 institutional and professional clients art. 20 1 the provisions of this chapter do not apply to transactions involving institutional clients. 2 professional clients may expressly release financial service providers from applying the code of conduct set out in articles 8, 9, 15 and 16.chapter 3 organisation section 1 organisational measures art. 21 appropriate organisation financial service providers shall ensure that they fulfil their duties under this act through internal regulations and an appropriate organisation of operations.art. 22 staff 1 financial service providers shall ensure that their staff possess the necessary skills, knowledge and experience to perform their work.2 financial service providers not subject to supervision in accordance with article 3 of the financial market supervision act of 22 june 200716 (finmasa) must also ensure that only persons listed in the register of advisers (article 29) act as client advisers for them.16 sr 956.1art. 23 involvement of third parties 1 financial service providers may appoint third parties for the provision of financial services. 2 they shall appoint only persons who possess the necessary skills, knowledge and experience for their work and have the required authorisations and register entries for this activity, and shall carefully instruct and supervise the appointed persons. art. 24 chain of providers 1 financial service providers that mandate another financial service provider to provide a financial service for clients remain liable for the completeness and accuracy of the client information and for fulfilling the duties set out in articles 8 to 16.2 if the mandated financial service provider has reasonable grounds to suspect that the client information is incorrect or that the duties under articles 8 to 16 were not fulfilled by the mandating financial service provider, it shall provide its service only after it has ensured the completeness and accuracy of the information and compliance with the code of conduct.section 2 conflicts of interest art. 25 organisational precautions 1 financial service providers shall take appropriate organisational measures to prevent conflicts of interest that could arise through the provision of financial services or any disadvantages for clients as a result of conflicts of interest. 2 if disadvantages for clients cannot be excluded, this possibility must be disclosed to them.3 the federal council shall regulate the details in this respect; in particular, it shall designate forms of conduct that are always impermissible on account of conflicts of interest.art. 26 compensation from third parties 1 financial service providers may accept compensation from third parties in association with the provision of financial services only if they: a. have expressly informed the clients of such compensation in advance and the latter relinquish such compensation; orb. pass the compensation on to the clients in full. 2 the information for the clients must contain the type and scope of the compensation and must be given to them before provision of the financial service or conclusion of the contract. if the amount cannot be determined in advance, the financial service provider shall inform its clients of the calculation parameters and the ranges. if so requested, the financial service providers shall disclose the amounts effectively received.3 compensation is defined as payments from third parties accruing to the financial service provider in association with the provision of a financial service, such as brokerage fees, commissions, discounts or other financial benefits.art. 27 staff transactions 1 financial service providers shall take measures to prevent staff from misusing for own-account transactions any information made available to them only by virtue of their function.2 they shall issue an internal directive on the required monitoring measures.chapter 4 register of advisers art. 28 duty to register 1 client advisers of swiss financial service providers not subject to supervision in accordance with article 3 finmasa17 as well as client advisers of foreign financial service providers may carry out their activity in switzerland only if they are entered in a register of advisers. 2 the federal council may exempt prudentially supervised client advisers of foreign financial service providers from the duty to register if the services they provide in switzerland are exclusively for professional or institutional clients within the meaning of article 4.3 it may make the exception under paragraph 2 dependent on a reciprocal right being granted.17 sr 956.1art. 29 registration conditions 1 client advisers are entered in the register of advisers if they prove that they:a. satisfy the requirements set out in article 6;b. have taken out professional indemnity insurance or that equivalent collateral exists; and c.18 are themselves affiliated to an ombudsman (art. 74) in their capacity as a financial service provider, or that the financial service provider for which they work is affiliated to an ombudsman, where a duty to affiliate exists (art. 77).2 client advisers shall not be entered in the register of advisers if they: have been convicted of criminal offences in accordance with articles 89 to 92 of this act or article 86 isa19 or of property offences under articles 137 to 172ter of the swiss criminal code20; orb. have been prohibited from performing the registrable activity in accordance with article 33a finmasa21 or from practising a profession in accordance with article 33 finmasa.3 if client advisers are employed as staff by a financial service provider, the condition set out in paragraph 1 letter b may be fulfilled by the latter.18 amended by no i 4 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).19 sr 961.0120 sr 311.021 sr 956.1art. 30 contents the register of advisers shall contain at least the following details on client advisers:a. surname and forenames;b. name or company name and address of the financial service provider for which they work;c. function and position of the client adviser within the organisation;d. fields of activity;e. basic training and continuing professional development completed;f. ombudsman's office to which they themselves in their capacity as financial service providers or the financial service provider for which they work are affiliated;g. date of the register entry.art. 31 registration body 1 the registration body shall keep the register of advisers. it requires a licence from the swiss financial market supervisory authority (finma). 2 finma may grant a licence to two or more registration bodies provided this is objectively justified.3 the registration body must be organised so as to guarantee the independent fulfilment of its tasks.4 the registration body and the persons responsible for its management must provide the guarantee of irreproachable business conduct. furthermore, the persons responsible for its management must enjoy a good reputation and have the specialist qualifications required for their function.5 if the registration body no longer fulfils the requirements under this act, finma shall order the measures necessary to remedy the deficiencies. if, within a reasonable period, the registration body fails to remedy the deficiencies preventing it from fulfilling its tasks, finma shall withdraw its licence to register client advisers.6 if a private body is not available as a registration body, the federal council shall designate a body for this task.art. 32 keeping of the register and notification duty 1 the registration body shall decide which advisers are registered and deregistered as advisers and shall issue the necessary rulings. 2 registered client advisers and the financial service provider for which they work must notify the registration body of all changes in the facts underlying their registration.3 the competent supervisory authorities shall notify the registration body if they: a. prohibit any registered client advisers from performing an activity or practising a profession as defined in article 29 paragraph 2 letter b;b. learn of a criminal conviction against registered client advisers in accordance with article 29 paragraph 2 letter a. 4 if the registration body learns that a client adviser no longer meets a condition for registration, it shall deregister that client adviser.5 the contents of the register of advisers shall be public and may be consulted online.art. 33 fees 1 the registration body shall charge fees to cover the expenses incurred in its rulings and services. 2 the federal council shall regulate the details. this regulation is based on article 46a of the government and administration organisation act of 21 march 199722.22 sr 172.010art. 34 procedure the procedure for registration entries is based on the administrative procedure act of 20 december 196823.23 sr 172.021title 3 offering of financial instruments chapter 1 prospectus for securities section 1 general art. 35 duty to publish a prospectus 1 any person in switzerland who makes a public offer for the acquisition of securities or any person who seeks the admission of securities to trading on a trading venue in accordance with article 26 letter a of the finmia24 must first publish a prospectus.25 1bis articles 35 to 57 and 64 to 69 apply by analogy to the admission of dlt securities in accordance with article 2 letter bbis of the finmia to trading on a dlt trading facility in accordance with article 73a of the finmia.26 2 if the issuer of the securities does not participate in the public offer, it is not obliged to cooperate with the preparation of the prospectus.24 sr 958.125 amended by no i 4 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).26 inserted by no i 4 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 36 exemptions by type of offer 1 a prospectus does not need to be published if the public offer:a. is addressed solely at investors classified as professional clients;b. is addressed at fewer than 500 investors;c. is addressed at investors acquiring securities to the value of at least chf 100,000;d. has a minimum denomination per unit of chf 100,000;e. does not exceed a total value of chf 8 million over a 12-month period.2 each public offer for the resale of securities that were previously the subject of an offer in accordance with paragraph 1 is regarded as a separate offer.3 in the absence of indications to the contrary, the offeror may, for the purposes of this provision, assume that professional and institutional clients have not declared that they wish to be treated as retail clients.4 a financial service provider need not publish a prospectus for securities offered publicly at a later stage:as long as a valid prospectus exists; and b. if the issuer or the persons who have assumed responsibility for the prospectus have consented to its use.5 taking account of recognised international standards and legal developments abroad, the federal council may adjust the number of investors and the amounts specified under paragraph 1 letters b to e.art. 37 exemptions by type of securities 1 a prospectus need not be published if the following types of securities are offered publicly:equity securities issued outside the scope of a capital increase in exchange for previously issued equity securities of the same class; b. equity securities issued or delivered on the conversion or exchange of financial instruments of the same issuer or corporate group; c. equity securities issued or delivered following the exercise of a right linked to financial instruments of the same issuer or corporate group;d. securities offered for exchange in connection with a takeover, provided that information exists that is equivalent in terms of content to a prospectus; e. securities offered or allocated in connection with a merger, division, conversion or transfer of assets, provided that information that is equivalent in terms of content to a prospectus exists;f. equity securities that are distributed as dividends to holders of equity securities of the same class, provided that information exists on the number and type of equity securities and on the reasons for and details of the offer;g. securities that employers or affiliated companies offer or allocate to current or former members of the board of directors or management board or their employees;h. securities issued by or with an unlimited and irrevocable guarantee from the confederation or cantons, from an international or supranational public entity, from the swiss national bank or from foreign central banks;i. securities issued by non-profit institutions for raising funds for non-commercial purposes;j. medium-term notes;k. securities with a term of less than one year (money market instruments);l. derivatives that are not offered in the form of an issue.2 taking account of recognised international standards and legal developments abroad, the federal council may provide for exemptions from the duty to publish a prospectus for further types of publicly issued securities.art. 38 exemptions for admission to trading 1 a prospectus need not be published if the following types of securities are admitted to trading:a. equity securities that over a period of 12 months account for less than 20% of the number of equity securities of the same category already admitted to trading on the same trading venue;b. equity securities issued upon the conversion or exchange of financial instruments or following the exercise of rights linked to financial instruments, provided they are equity securities of the same category as those already admitted to trading;c. securities admitted to trading on a foreign trading venue whose regulation, supervision and transparency are acknowledged as being appropriate by the domestic trading venue or whose transparency for investors is ensured in another manner;d. securities for which admission is sought for a trading segment open exclusively to professional clients trading for their own account or for the account solely of professional clients.2 exemptions from the duty to publish a prospectus in accordance with articles 36 and 37 also apply by analogy to admission to trading.art. 39 information beyond the scope of the duty to publish a prospectus in the absence of a duty to publish a prospectus, offerors or issuers shall treat investors alike when sending them essential information on a public offer. section 2 requirements art. 40 contents 1 the prospectus shall contain the essential information for the investor's decision on:a. the issuer and the guarantor and security provider, specifically: 1. the board of directors, management board, auditors and other governing bodies,2. the most recent semi-annual or annual accounts or, where these are not yet available, information on assets and liabilities,3. the business situation,4. the main prospects, risks and litigation;b. the securities to be offered publicly or admitted to trading on a trading venue, specifically the associated rights, obligations and risks for investors;c. the offer, specifically the type of placement and the estimated net proceeds of the issue.2 the information shall be provided in one of the official languages of the swiss confederation or in english.3 the prospectus shall also contain a clearly understandable summary of the essential information.4 if the final issue price and the issue volume cannot be stated in the prospectus, it must then indicate the maximum issue price and the criteria and conditions used to determine the issue volume. the information on the final issue price and on the issue volume shall be filed with and published by the reviewing body.5 in the case of offers for which an exception in accordance with article 51 paragraph 2 is requested, the prospectus shall mention that this has not yet been reviewed.art. 41 exemptions 1 the reviewing body may provide that information need not be included in the prospectus if:disclosure would be seriously detrimental to the issuer and omission would not mislead investors with regard to facts and circumstances that are essential to an informed assessment of the quality of the issuer and the characteristics of the securities;b. the information in question is only of minor importance and has no bearing on the assessment of the business situation and the main prospects, risks and litigation of the issuer or of the guarantor and security provider; orc. the information concerns securities traded on a trading venue, and the issuer's periodic reporting over the preceding three years complied with the applicable financial reporting requirements.2 the reviewing body may to a limited degree provide for further exemptions insofar as the interests of investors remain protected.art. 42 inclusion by reference the prospectus may contain references to previously or simultaneously published documents in all sections apart from the summary.art. 43 summary 1 the summary should facilitate a comparison with similar securities. 2 the summary must clearly state that: a. it is regarded as an introduction to the prospectus; b. the investment decision must be based not on the summary but on the information contained in the entire prospectus;c. liability for the summary is limited to cases where the information contained therein is misleading, inaccurate or inconsistent when read together with the other parts of the prospectus.art. 44 structure 1 the prospectus may consist of a stand-alone document or several individual documents. 2 if it consists of two or more individual documents, it may be broken down into:a. a registration document with information about the issuer;b. a securities note with information on the securities to be offered publicly or admitted to trading on a trading venue;c. the summary.art. 45 base prospectus 1 for debt instruments issued in an offer programme or issued in a continuous or repeated manner by banks in accordance with the banka27 or securities firms in accordance with the finia28, the prospectus may be drafted in the form of a base prospectus. 2 the base prospectus shall contain all the information available at the time of publication on the issuer, the guarantor and security provider and the securities, but not the final terms.3 the final terms shall be included at least in a version with indicative information at the time of the public offer. at the end of the subscription period, they shall be published in a definitive version and filed with the reviewing body.4 approval of the final terms is not necessary.27 sr 952.028 sr 954.1art. 46 supplementary provisions taking account of the specific characteristics of the issuers and securities, the federal council shall issue supplementary provisions on:a. the format of the prospectus and the base prospectus, the summary, the final terms and the supplements;b. the content of the summary;c. the minimum information to be contained in the prospectus;d. the documents to which reference may be made.section 3 relaxation of requirements art. 47 1 the federal council may grant a relaxation of the duty to publish a prospectus and supplements to issuers that have not exceeded two of the following volumes in the preceding financial year:a. balance sheet total of chf 20 million;b. turnover of chf 40 million;c. 250 ftes on average for the year.2 it may also grant a relaxation of the requirements particularly to: a. issuers with low market capitalisation on a trading venue;b. issues of subscription rights;c. issuers that regularly offer securities publicly or whose securities are admitted to trading on a foreign trading venue whose regulation, supervision and transparency are acknowledged as being appropriate by a domestic trading venue.3 it shall grant a relaxation of the requirements uniformly and, in particular, with respect to:a. the type of securities issued;b. the issue volume; c. the market environment;d. the investors' specific requirements for transparent information;e. the business activities and the size of the issuers.section 4 collective investment schemes art. 48 open-ended collective investment schemes 1 for open-ended collective investment schemes as defined in title 2 of the cisa29, the fund management company (article 32 finia30) and the investment company with variable capital (sicav) (article 13 paragraph 2 letter b cisa) shall produce a prospectus.2 the prospectus shall include the fund regulations in cases where interested persons are not notified as to where such regulations may be separately obtained prior to an agreement being concluded or prior to subscription. 3 the federal council shall determine which information must be set out in the prospectus apart from the fund regulations.4 the prospectus and its amendments shall be submitted to finma without delay.29 sr 951.3130 sr 954.1art. 49 closed-ended collective investment schemes 1 a limited partnership for collective investment under article 98 cisa31 shall produce a prospectus.2 specifically, this shall contain the information contained in the partnership agreement in accordance with article 102 paragraph 1 letter h cisa. 3 for the prospectus of an investment company with fixed capital (sicaf) in accordance with article 110 cisa, article 48 applies by analogy. 31 sr 951.31art. 50 exemptions finma may exempt collective investment schemes under the cisa32 from all or some of the provisions of this chapter provided that they are open only to qualified investors in accordance with article 10 paragraphs 3 and 3ter cisa and the protective purpose of the law is not thereby affected.32 sr 951.31section 5 review of the prospectus art. 51 duty 1 the prospectus must be submitted to the reviewing body prior to publication. the reviewing body shall check that it is complete, coherent and understandable.2 the federal council may designate securities whose prospectus must be reviewed only after publication if a bank in accordance with the banka33 or a securities firm in accordance with the finia34 confirms that the most important information on the issuers and the securities is known at the time of publication.3 prospectuses for collective investment schemes do not have to be reviewed; the foregoing does not apply to the approval requirement for the documentation of foreign collective investment schemes under article 15 paragraph 1 letter e and article 120 cisa35.33 sr 952.034 sr 954.135 sr 951.31art. 52 reviewing body 1 the reviewing body requires a licence from finma. finma may grant a licence to two or more reviewing bodies provided this is objectively justified.2 the reviewing body must be organised so as to guarantee the independent fulfilment of its tasks.3 the reviewing body and the persons responsible for its management must provide the guarantee of irreproachable business conduct. furthermore, the persons responsible for its management must enjoy a good reputation and have the specialist qualifications required for their function.4 if the reviewing body no longer fulfils the requirements under this act, finma shall order the measures necessary to remedy the deficiencies. if, within a reasonable period, the reviewing body fails to remedy the deficiencies preventing it from fulfilling its tasks, finma shall withdraw its licence. 5 if a private body is not available as a reviewing body, the federal council shall designate a body for this task.art. 53 procedure and deadlines 1 the procedure followed by the reviewing body is based on the administrative procedure act of 20 december 196836.2 the reviewing body shall check prospectuses as soon as they are received.3 if it ascertains that a prospectus does not meet the statutory requirements, within ten calendar days from the time of receipt it shall notify the submitter of the prospectus accordingly, with reasons, and ask the latter to make the improvements necessary. 4 within ten calendar days of receiving the rectified prospectus the reviewing body shall decide on whether to approve it. 5 this period is 20 calendar days for new issuers.6 if the reviewing body fails to issue its decision within the time frames set out in paragraphs 4 and 5, this shall not constitute approval of the prospectus.36 sr 172.021art. 54 foreign prospectuses 1 the reviewing body may approve a prospectus produced under foreign legislation if:it was produced in accordance with international standards established by international organisations of securities regulators; andb. the duty to inform, including with regard to providing financial information, is equivalent to the requirements set out in this act; audited individual financial statements are not required.2 it may provide that prospectuses approved in certain jurisdictions are considered approved in switzerland too. 3 it shall publish a list of countries whose prospectus approval is recognised in switzerland.art. 55 validity 1 prospectuses shall be valid for 12 months after approval for public offers or admission to trading on a trading venue of securities of the same category and the same issuer.2 prospectuses for debt instruments issued by a bank in accordance with the banka37 or a securities firm in accordance with the finia38 in an offer programme shall be valid until none of the debt instruments in question is issued in a continuous or repeated manner any more.37 sr 952.038 sr 954.1art. 56 supplements 1 a supplement to the prospectus must be produced if any new facts arise or are established between the time of approval of the prospectus and final completion of a public offer or opening of trading on a trading venue which could have a significant influence on the assessment of securities. 2 the supplement must be reported to the reviewing body immediately upon occurrence or establishment of the new fact. 3 the reviewing body shall decide whether to approve the supplement within a maximum of seven calendar days. thereafter, the supplement shall be published immediately. the information contained in the supplement must be added to the summaries. 4 the reviewing body shall maintain a list of facts which by their nature are not subject to approval. supplements on such facts have to be published at the same time as they are reported to the reviewing body.5 if a new fact in accordance with paragraph 1 arises during a public offer, the offer period shall end no sooner than two days after publication of the supplement. investors may withdraw their subscriptions or acquisition pledges up to the end of the subscription or offer period.art. 57 fees 1 the reviewing body shall charge fees to cover the expenses incurred in its rulings and services. 2 the federal council shall regulate the fees. this regulation is based on article 46a of the government and administration organisation act of 21 march 199739.39 sr 172.010chapter 2 key information document for financial instruments art. 58 duty 1 where a financial instrument is offered to retail clients, the producer must first produce a key information document. 2 it is not required to prepare a key information document for financial instruments which may be acquired for retail clients solely within the scope of a portfolio management agreement.3 the federal council may designate qualified third parties to whom the preparation of the key information document may be assigned. the producer shall remain liable for the completeness and accuracy of the details in the key information document, as well as for compliance with the duties set out in chapters 2 to 4 (articles 58 to 68).4 if financial instruments are offered to retail clients on the basis of indicative details, at least a draft version of the key information document with the relevant indicative information is to be prepared.art. 59 exemptions 1 persons who offer securities in the form of shares, including share-like securities allowing for participation rights, such as participation certificates, dividend rights certificates and non-derivative debt instruments, are not obliged to prepare a key information document.2 documents prepared in accordance with foreign legislation that are equivalent to the key information document may be used instead of a key information document.art. 60 contents 1 the key information document shall contain the information essential for investors to make a well-founded investment decision and a comparison of different financial instruments.2 in particular, the information shall include:a. the name of the financial instrument and the identity of the producer;b. the type and characteristics of the financial instrument;c. the risk/return profile of the financial instrument, specifying the maximum loss the investor could incur on the invested capital;d. the costs of the financial instrument;e. the minimum holding period and the tradability of the financial instrument;f. information on the authorisations and approvals associated with the financial instrument.art. 61 requirements 1 the key information document must be easy to understand.2 it is a stand-alone document that must be clearly distinguishable from advertising materials.art. 62 changes 1 the producer shall regularly check the information contained in the key information document and revise it in the event of material changes.2 the checking and revision of the information contained in the key information document may be assigned to qualified third parties. the producer shall remain liable for the completeness and accuracy of the details in the key information document, as well as for compliance with the duties set out in chapters 2 to 4 (articles 58 to 68).art. 63 supplementary provisions the federal council shall issue supplementary provisions on the key information document. it shall regulate in particular:a. its content;b. its scope, language and layout; c. details on how it is to be made available;d. the equivalence of foreign documents with the key information document in accordance with article 59 paragraph 2.chapter 3 publication art. 64 prospectus for securities 1 the offeror of securities or the person requesting their admission to trading must:a. file the prospectus with the reviewing body after it has been approved;b. publish the prospectus no later than the beginning of the public offer or admission of the securities in question to trading. 2 if a class of equity securities of an issuer is being admitted to trading on a trading venue for the first time, the prospectus must be made available at least six working days before the end of the offer. 3 the prospectus may be published:a. in one or more newspapers with a distribution corresponding to the issue or in the swiss official gazette of commerce;b. through free-of-charge distribution in printed form at the issuer's registered office or from the office involved in the issue; c. in electronic form on the website of the issuer, the guarantor and security provider, the trading venue or the office involved in the issue; or d. in electronic form on the website of the reviewing body. 4 if the prospectus is published electronically, a paper version must also be made available free of charge upon request.5 the reviewing body shall place the approved prospectuses on a list and make this list available for 12 months. 6 if the prospectus is prepared in two or more individual documents or if it is incorporated by reference, the information and documents constituting the prospectus may be published separately. the individual documents shall be made available to the investors free of charge. each individual document must indicate where to obtain the other individual documents that, together with said document, constitute the complete prospectus. 7 the text and format of the prospectus and supplements that are published or made available to the public must at all times correspond to the version filed with the reviewing body.art. 65 prospectus for collective investment schemes 1 the prospectus for a collective investment scheme must be published no later than the beginning of the public offer.2 for publication, article 64 paragraphs 3, 4 and 6 apply by analogy.art. 66 key information document 1 if a financial instrument for which a key information document has to be prepared is offered publicly, the key information document must be published no later than the beginning of the public offer.2 article 64 paragraphs 3 and 4 apply by analogy.art. 67 changes to the rights associated with securities 1 the issuer shall announce changes to the rights associated with securities sufficiently early to ensure that investors can exercise their rights.2 the content and scope of the publication shall otherwise be based on the issuing conditions. article 64 paragraphs 3 and 4 apply by analogy.3 special statutory provisions remain reserved.chapter 4 advertising art. 68 1 advertising for financial instruments must be clearly indicated as such. 2 advertising must mention the prospectus and the key information document for the financial instrument in question, as well as where these can be obtained. 3 advertising and other information on financial instruments intended for investors must correspond to the details given in the prospectus and the key information document. chapter 5 liability art. 69 1 any person who fails to exercise due care and thereby furnishes information that is inaccurate, misleading or in violation of statutory requirements in prospectuses, key information documents or similar communications is liable to the acquirer of a financial instrument for the resultant losses. 2 with regard to information in summaries, liability is limited to cases where such information is misleading, inaccurate or inconsistent when read together with the other parts of the prospectus.3 with regard to false or misleading information on main prospects, liability is limited to cases where such information was provided or distributed against better knowledge or without reference to the uncertainty regarding future developments.chapter 6 offering of structured products and creation of in-house funds art. 70 structured products 1 structured products may be offered in or from switzerland to retail clients with whom there is no permanent portfolio management or investment advice relationship only if these are issued, guaranteed or secured in an equivalent manner by:a. a bank as defined in the banka40;b. an insurance company as defined in the isa41;c. a securities firm as defined in the finia42;d. a foreign institution that is subject to equivalent prudential supervision.2 the issuing of structured products to retail clients by special purpose entities is permitted if: a. these products are offered by: 1. financial intermediaries as defined in the banka, the finia and the cisa43,2. insurance companies as defined in the isa,3. a foreign institution that is subject to equivalent supervision, andb. collateral corresponding to the requirements under paragraph 1 is guaranteed.3 the federal council shall regulate the requirements for such collateral.40 sr 952.041 sr 961.0142 sr 954.143 sr 951.31art. 71 in-house funds 1 in-house funds of a contractual nature for the purpose of collectively managing the assets of existing clients may be created by banks as defined in the banka44 and securities firms in accordance with the finia45 only if said banks and securities firms meet the following conditions:a. they manage clients' participation in the in-house funds exclusively on the basis of a permanent portfolio management or investment advice relationship;b. they do not issue any unit certificates for this;c. they do not offer participation to the public and they undertake no advertising for this.2 a key information document in accordance with articles 58 to 63 must be prepared for in-house funds. 3 the creation and dissolution of in-house funds must be notified to the auditors appointed under the relevant supervisory law. 4 in the event of bankruptcy of the bank or securities firm, assets and rights that form part of in-house funds shall be segregated in favour of the investors.44 sr 952.045 sr 954.1title 4 provision of documents art. 72 entitlement 1 clients are entitled at all times to receive a copy of their file and all other documents concerning them that the financial service provider has prepared within the context of their business relationship. 2 with the client's consent, documents may be provided in electronic form.art. 73 procedure 1 any person who wishes to assert their right must submit a corresponding request in writing or in another form demonstrable via text. 2 the financial service provider shall provide the client with a copy of the documents in question free of charge within 30 days after receipt of such request.3 if it fails to comply with such a request, the client may apply to the court. 4 a refusal by the financial service provider to supply the requested documents may be taken into account by the competent court in any subsequent legal dispute when deciding on procedural costs. title 5 ombudsman's offices chapter 1 mediation art. 74 principle disputes regarding legal claims between the client and the financial service provider should be settled by an ombudsman in mediation proceedings if possible.art. 75 procedure 1 the proceedings before the ombudsman must be straightforward, fair, quick, impartial and inexpensive or free of charge for the client.2 the proceedings are confidential. the statements made by the parties within the framework of mediation proceedings and the correspondence between a party and the ombudsman may not be used in other proceedings. 3 the parties are not entitled to view the ombudsman's correspondence with the other party.4 a mediation request is permissible at any time if:a. it was submitted in accordance with the ombudsman's rules of procedure or using the form provided by the ombudsman;b. the client credibly proves that they previously informed the financial service provider of their point of view and attempted to reach an agreement;c. it is not obviously vexatious, and mediation proceedings have not already been conducted in the same matter; andd. the case is not being or has not been dealt with by a conciliation authority or by a court, court of arbitration or administrative authority.5 the proceedings are conducted in the official language of the swiss confederation chosen by the client unless the parties make alternative arrangements that comply with the ombudsman's rules of procedure.6 the ombudsman shall freely assess the cases submitted to him and is not subject to any directives.7 the ombudsman shall take the appropriate measures for mediation unless there appears to be no prospect of success from the outset.8 if an agreement is not reached or there appears to be no prospect of such, the ombudsman may give the parties his own factual and legal assessment of the dispute based on the information available and include it in the notification of conclusion of proceedings.art. 76 interdependence with conciliation proceedings and other proceedings 1 filing a mediation request with an ombudsman does not rule out civil action and does not prevent such from being initiated.2 after bringing proceedings before an ombudsman, the plaintiff may unilaterally waive conciliation proceedings under the civil procedure code46.3 the ombudsman shall terminate proceedings once a conciliation authority, a court, a court of arbitration or an administrative authority begins dealing with the case.46 sr 272chapter 2 duties of financial service providers art. 7747 duty to affiliate financial service providers that do not provide financial services exclusively to institutional or professional clients in accordance with article 4 paragraphs 3 and 4 must affiliate to an ombudsman at the latest on commencing their activity.47 amended by no i 4 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).art. 78 duty to participate 1 financial service providers that are affected by a mediation request to an ombudsman for dispute resolution must participate in the proceedings. 2 they must respond promptly to summonses, requests for comments, and any enquiries from ombudsman's offices.art. 79 duty to provide information 1 financial service providers shall inform their clients about the possibility of mediation proceedings through an ombudsman:a. on entering into a business relationship in accordance with the duty to provide information under article 8 paragraph 1 letter c;b. in the event of the rejection of a legal claim asserted by a client; andc. at any time upon request.2 the information shall be given in an appropriate form and contain the name and address of the ombudsman's office to which the financial service provider is affiliated.art. 80 financial participation financial service providers shall make financial contributions to the ombudsman's office to which they are affiliated. based on the volume of work caused, the contributions are in accordance with the ombudsman office's schedule of contributions and costs.chapter 3 admission and exclusion art. 81 admission an ombudsman's office is obliged to admit a financial service provider if it fulfils the admission conditions. art. 82 exclusion financial service providers that repeatedly fail to comply with the duties in accordance with articles 78 to 80 shall be excluded by the ombudsman's office.art. 83 duty to inform the ombudsman's office shall inform the supervisory authorities as well as the registration body about the financial service providers it has admitted, those refused admission and those excluded. chapter 4 recognition and publication art. 84 recognition 1 ombudsman's offices must be recognised by the federal department of finance (fdf).2 organisations meeting the following conditions shall be recognised as ombudsman's offices:a. they and the persons charged by them with mediation are organisationally and financially independent, perform their task impartially, transparently and efficiently, and do not accept directives;b. they ensure that the persons charged by them with mediation have the necessary specialist skills; c. they have organisational regulations that ensure the proper functioning of the ombudsman's office and specify the admission conditions;d. they have procedural rules governing the procedure under article 75;e. they have a schedule of contributions and costs in accordance with article 80.3 the fdf shall publish a list of ombudsman's offices.4 if individual financial service providers have no possibility of being affiliated to an ombudsman's office, the fdf may require an ombudsman's office to admit these financial service providers. where two or more financial service providers have no appropriate ombudsman's office available to them, the federal council may create such an office.art. 85 review of recognition 1 changes which concern the fulfilment of the conditions for recognition laid down in article 84 must be submitted to the fdf for approval.2 if an ombudsman's office no longer fulfils the conditions for recognition, the fdf shall set an appropriate period for rectification.3 if the necessary rectifications are not made within this period, the fdf shall withdraw its recognition.art. 86 reporting ombudsman's offices shall publish an activity report annually.title 6 supervision and exchange of information art. 87 supervision 1 the competent supervisory authority shall monitor the compliance of financial service providers under its supervision with the requirements for the provision of financial services and the offering of financial instruments. 2 within the scope of the supervisory instruments available to it, it may issue orders to prevent or remedy breaches of the requirements. 3 contentious civil matters between different financial service providers or between financial service providers and clients are settled by the competent court or court of arbitration. art. 88 exchange of information finma, the supervisory organisation, the registration body, the reviewing body, the ombudsman's office and the fdf may exchange information not in the public domain which they require to fulfil their tasks.title 7 criminal provisions art. 89 violation of the code of conduct a fine not exceeding chf 100,000 shall be imposed on any person who wilfully:a. provides false information or withholds material facts when complying with the duties to provide information under article 8;b. seriously violates the duties to assess appropriateness and suitability under articles 10 to 14; c. violates the provisions on the disclosure of compensation paid by third parties under article 26.art. 90 violation of the regulations on prospectuses and key information documents 1 a fine not exceeding chf 500,000 shall be imposed on any person who wilfully:a. provides false information or withholds material facts in the prospectus or key information document in accordance with title 3;b. fails to publish the prospectus or the key information document under title 3 by the beginning of the public offer at the latest.2 a fine not exceeding chf 100,000 shall be imposed on any person who wilfully fails to make the key information document available prior to subscription or conclusion of the contract.art. 91 unauthorised offering of financial instruments a fine not exceeding chf 500,000 shall be imposed on any person who wilfully:a. offers retail clients structured products without complying with the conditions set out in article 70;b. creates an in-house fund without complying with the conditions set out in article 71.art. 92 exemptions articles 89 to 91 do not apply to persons and entities subject to supervision in accordance with article 3 finmasa48 and to persons working for them.48 sr 956.1title 8 final provisions art. 93 implementing provisions the federal council shall issue the implementing provisions.art. 94 amendment of other legislation the amendment of other legislative instruments is set out in the annex.art. 95 transitional provisions 1 the federal council may make provision for a transitional period for fulfilment of the requirements set out in article 6.2 the client advisers in accordance with article 28 must report to the registration body for entry in the register within six months of this act coming into force.3 financial service providers must be affiliated to an ombudsman's office in accordance with article 74 within six months of this act coming into force.4 the provisions of title 3 of this act will come into force two years after this act comes into force:a. in the case of securities for which a public offer was made or a request was made for admission to trading on a trading venue before entry into force;b. in the case of financial instruments that were offered to retail clients before entry into force.5 the federal council may extend the time frame under paragraph 4 for securities if this is warranted by a delay in the reviewing body commencing operations.art. 96 referendum and commencement 1 this act is subject to an optional referendum.2 the federal council shall determine the commencement date.3 this act shall only come into force with the finia49.commencement date: 1 january 20205049 sr 954.150 o of 6 nov. 2019 on the final commencement of the financial institutions act (as 2019 4631).annex (art. 94)amendment of other legislative instruments the legislative instruments below are amended as follows:.5151 the amendments may be consulted under as 2019 4417.

951.11english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal act on the swiss national bank(national bank act, nba)of 3 october 2003 (status as of 1 august 2021)the federal assembly of the swiss confederation,based on articles 99, 100 and 123 of the federal constitution1,and having examined the dispatch of the federal council dated 26 june 20022,resolves:1 sr 1012 bbl 2002 6097chapter 1 general provisions art. 1 legal status and name 1 the central bank of the swiss confederation is a joint-stock company incorporated by special act.2 it shall bear the names:schweizerische nationalbankbanque nationale suissebanca nazionale svizzerabanca naziunala svizraswiss national bank.art. 2 subsidiary application of the code of obligations unless otherwise provided by this act, the provisions of the code of obligations (co)3 relating to joint-stock companies apply.3 sr 220art. 3 head offices, branches, agencies and representative offices 1 the national bank shall have its head offices in berne and zurich.2 to the extent required by the country's supply of money, the national bank shall maintain branches and agencies.3 it may set up representative offices for observing the economy and for maintaining relations in the regions.art. 4 exclusive right to issue banknotes the national bank shall have the exclusive right to issue swiss banknotes.art. 5 tasks 1 the national bank shall pursue a monetary policy serving the interests of the country as a whole. it shall ensure price stability. in so doing, it shall take due account of economic developments.2 within this framework, it shall have the following tasks:a. it shall provide the swiss franc money market with liquidity.b. it shall ensure the supply and distribution of cash.c. it shall facilitate and secure the operation of cashless payment systems.d. it shall manage the currency reserves.e. it shall contribute to the stability of the financial system.3 it shall participate in international monetary cooperation. for this purpose, it shall work jointly with the federal council in accordance with the relevant federal legislation.4 it shall provide banking services to the confederation. in so doing, it shall act on behalf of the competent federal authorities.art. 6 independence in fulfilling its monetary tasks according to article 5 paragraphs 1 and 2, the national bank and the members of the bank's bodies shall not be permitted to seek or accept instructions either from the federal council or from the federal assembly or any other body.art. 7 accountability and information 1 the national bank shall regularly discuss with the federal council the economic situation, monetary policy and topical issues of federal economic policy. the federal council and the national bank shall inform each other of their intentions before taking decisions of major importance for economic and monetary policy. the national bank's annual report and annual accounts shall be submitted to the federal council for approval before being approved by the general meeting of shareholders.2 the national bank shall render account of the fulfilment of its tasks pursuant to article 5 to the federal assembly annually in the form of a report. it shall regularly report on the economic situation as well as its monetary policy to the competent committees of the federal assembly.3 it shall regularly inform the public about its monetary policy and shall announce its monetary policy intentions.4 it shall publish its annual report. furthermore, it shall publish quarterly reports on the development of the real economy and the monetary situation; it shall also publish data relevant to monetary policy on a weekly basis.art. 8 exemption from taxation 1 the national bank shall be exempt from direct federal taxes.2 the national bank shall not be subject to taxation by the cantons. cantonal and communal fees shall remain reserved.chapter 2 scope of business art. 9 transactions with financial market participants 1 in performing its monetary tasks pursuant to article 5 paragraphs 1 and 2, the national bank may:a. maintain interest-bearing and non-interest-bearing accounts for banks and other financial market participants, and take assets into custody;b. open accounts with banks and other financial market participants;c. buy and sell, in the financial markets, swiss franc or foreign currency denominated receivables and securities as well as precious metals and claims on precious metals (spot or forward) or enter into lending operations therewith;d. issue and repurchase interest-bearing bonds of its own (spot and forward) as well as create derivatives on receivables, securities and precious metals according to letter c;e. enter into credit transactions with banks and other financial market participants on condition that sufficient collateral is provided for the loans;f. hold and manage the assets designated in this article.2 it shall lay down the general terms and conditions for transactions in accordance with paragraph 1.art. 10 transactions with other central banks and international organisations the national bank may enter into relations with foreign central banks and international organisations and effect with them any form of banking transaction, including raising and granting credits in swiss francs, foreign currencies and international payment instruments.art. 11 transactions on behalf of the confederation 1 the national bank may provide banking services to the confederation. these shall be provided for an adequate consideration. however, the services shall be provided free of charge if they facilitate the implementation of monetary policy. the details shall be laid down in agreements concluded between the respective federal offices and the national bank.2 the national bank may not grant the confederation loans or overdraft facilities; nor shall it be permitted to buy government bonds from new issues. it may permit intraday account overdrafts against sufficient collateral.art. 12 participations and membership rights to the extent necessary for performing its tasks, the national bank may participate in the capital of companies and other legal entities and acquire membership rights in such companies and entities.art. 13 transactions for its own operation in addition to transactions related to its statutory tasks, the national bank may enter into transactions serving its own operation as well as effecting banking transactions for its staff and its pension fund.chapter 3 monetary policy powers section 1 statistics art. 14 collection of statistical data 1 for the purpose of fulfilling its statutory tasks and observing developments in the financial markets, the national bank shall collect the necessary statistical data.2 in collecting statistical data, it shall cooperate with the competent federal offices, in particular with the swiss federal statistical office and the swiss financial market supervisory authority (finma), the competent authorities of foreign countries and with international organisations.44 amended by annex no 13 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).art. 15 duty to provide information 1 banks, financial market infrastructures, financial institutions as defined in article 2 paragraph 1 of the financial institutions act of 15 june 20185, and authorised parties in accordance with article 13 paragraph 2 of the collective investment schemes act of 23 june 20066 must provide the national bank with statistical data relating to their activities.72 to the extent necessary for an analysis of financial market developments, for an overview of payment transactions, for drawing up the balance of payments or for statistics on foreign assets, the national bank may collect statistical data on the business activities from other natural persons or legal entities, including entities for the issuing of payment instruments or for the processing, clearing and settlement of payment transactions, insurance companies, occupational pension institutions and investment and holding companies.83 the national bank shall lay down in an ordinance what data are to be provided and with what frequency; furthermore, it shall lay down the organisation and procedure after having consulted the reporting institutions.5 sr 954.16 sr 951.317 amended by annex no ii 12 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).8 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 16 confidentiality 1 the national bank must maintain confidentiality with respect to the data collected.2 it shall publish the data collected in the form of statistics. for purposes of confidentiality, the data shall be aggregated.3 the national bank may communicate the data collected in aggregated form to the authorities and organisations listed in article 14 paragraph 2.4 the national bank may exchange the data collected with the competent supervisory authorities of the swiss financial market.5 in other respects, the federal act of 19 june 19929 on data protection applies.9 sr 235.1section 1a10 stability of the financial system 10 inserted by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483). art. 16a 1 financial market participants are obliged, upon request, to provide all necessary information and surrender any documents to the national bank which the latter requires to fulfil its task in accordance with article 5 paragraph 2 letter e. in particular, they must provide information on their:a. assessment of market developments and identification of relevant risk factors;b. exposure to risk factors to be determined by the national bank;c. resilience to disruptions affecting the stability of the financial system.2 the national bank shall inform finma about its intention to request information and documents. it shall refrain from procuring information and documents if the information is already available elsewhere or can easily be obtained, namely from finma.3 it shall inform the affected financial market participants about:a. the purpose of the procurement of the information;b. the type and scope of the information and documents requested;c. the envisaged use of the information and documents.4 it shall inform finma about the outcome of its information procurement.section 2 minimum reserves art. 17 purpose and scope of application 1 in order to facilitate the smooth functioning of the money market, the banks shall hold minimum reserves.2 the national bank may issue an ordinance to subject issuers of electronic money and other issuers of payment instruments to the minimum reserve requirement if their activities threaten to substantially interfere with the implementation of monetary policy.art. 18 features 1 the national bank shall fix the rate for minimum reserves which the banks must hold on average for a specific period of time. minimum reserves shall consist of swiss franc denominated coins, banknotes and sight deposit accounts which the banks hold with the national bank.2 the rate for minimum reserves shall not exceed four percent of the banks' short-term liabilities denominated in swiss francs. short-term liabilities are deemed to be sight liabilities and liabilities with a residual maturity not exceeding three months as well as liabilities arising from customer deposits that are repayable on demand (excluding tied-up pension fund monies). to the extent permitted by the purpose of this act, individual categories of liabilities can be partially or fully exempt from the reserve requirement.113 the national bank shall apply the provisions on minimum reserves mutatis mutandis to banking groups with collective liquidity management. it may request groups of banks to hold minimum reserves on a consolidated basis.4 the banks shall regularly provide evidence to the national bank that they are holding the required level of minimum reserves.5 the national bank shall lay down the details in an ordinance after having consulted the competent supervisory authority for the swiss financial market.11 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).section 312 oversight of systemically important financial market infrastructures 12 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 19 principle 1 in order to protect the stability of the financial system, the national bank shall oversee systemically important central counterparties, central securities depositories, payment systems and dlt trading facilities in accordance with article 22 (systemically important financial market infrastructures) of the financial market infrastructure act of 19 june 201513 (finmia).142 the oversight shall also extend to systemically important financial market infrastructures domiciled abroad if these:a. have substantial parts of their operation or leading participants in switzerland; orb. clear or settle significant transaction volumes in swiss francs.13 sr 958.114 amended by no i 5 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 20 modalities and instruments 1 central counterparties, central securities depositories, payment systems and dlt trading facilities in accordance with article 73a finmia15 shall provide the national bank, upon request, with all of the information and documents it requires to identify risks for the stability of the financial system at an early stage and to assess systemic importance.162 systemically important financial market infrastructures and their audit firms must give the national bank all of the information and documents it requires to fulfil its tasks. moreover, they must immediately notify the national bank of all incidents that are of substantial importance for oversight.3 in the case of systemically important financial market infrastructures, the national bank may carry out audits directly or have them conducted by audit firms mandated by financial market infrastructures in accordance with article 84 finmia17.4 if an audit firm is appointed, the financial market infrastructure must provide it with all of the information it requires to fulfil its tasks.5 the national bank shall set out the details in an ordinance.15 sr 958.116 amended by no i 5 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).17 sr 958.1art. 21 cooperation with foreign authorities for the purpose of overseeing systemically important financial market infrastructures, the national bank may:a. cooperate with foreign supervisory or oversight authorities and request information from them;b. transmit non-public information regarding systemically important financial market infrastructures to foreign supervisory or oversight authorities, provided that these authorities:1. use such information exclusively for directly supervising or overseeing such financial market infrastructures or their participants, and2. are bound by official or professional secrecy.section 4 review and sanctions art. 22 review of compliance with the duties to provide information and to hold minimum reserves 1 the national bank shall require the audit firms and the competent supervisory organisations to examine compliance with the duty to provide information and, in the case of banks, the duty to hold minimum reserves and shall report their findings to the national bank. if the audit firms and the competent supervisory organisations ascertain any violation, in particular if incorrect information has been provided or if the duty to hold minimum reserves has been breached, they shall notify the national bank and the competent supervisory authority.182 the national bank may itself review, or may have audit firms or supervisory organisations review, whether the duty to provide information and the duty to hold minimum reserves have been duly observed. should any violation of these provisions be ascertained, the party required to provide information or to hold minimum reserves shall bear the costs of the review.193 the national bank shall file a complaint with the federal department of finance (the department) if the duty to provide information or the duty to hold minimum reserves has been breached, or if a review ordered or carried out by the national bank has been obstructed.18 amended by annex no ii 12 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).19 amended by annex no ii 12 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 23 administrative sanctions 1 any bank that fails to hold the required amount of minimum reserves must pay the national bank interest on the shortfall for the period during which the required minimum reserve ratio has not been observed. the national bank shall set the relevant interest rate, which may be up to five percentage points above the money market rate for interbank credits for the same period.2 if the national bank notices that a systemically important financial market infrastructure does not comply with the special requirements in accordance with article 23 finmia20, it shall bring this to the attention of finma as well as the other competent swiss or foreign supervisory or oversight authorities. it shall observe the conditions set out in article 21 letter b of this act in doing so.213 furthermore, the national bank may:a. refuse to open a sight deposit account for the financial market infrastructure, or terminate an existing sight deposit account;b. in the event of a refusal to comply with an enforceable order, publish this order in the swiss official gazette of commerce (schweizerisches handelsamtsblatt) or bring it to the attention of the public in any other manner, provided such measure has been preceded by a warning.2220 sr 958.121 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).22 inserted by annex no. 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 24 criminal provisions 1 any person who wilfully:a. fails to provide the national bank with the information or the evidence required under chapter 3 of this act, or fails to comply with formal requirements, or provides incomplete or inaccurate information or evidence;b. prevents a review ordered or carried out by the national bank;shall be liable to a fine not exceeding 200,000 swiss francs.232 if the offending party acts through negligence, the penalty shall be a fine not exceeding 100,000 swiss francs.3 the department shall prosecute and adjudicate such offences in accordance with the provisions of the federal act of 22 march 197424 on administrative criminal law.3bis the ascertainment of the criminally liable persons may be dispensed with and instead the business operation may be ordered to pay the fine (art. 7 of the administrative criminal law act of 22 march 1974) where:a. the ascertainment of the persons who are criminally liable under article 6 of the administrative criminal law act of 22 march 1974 requires investigative measures that are disproportionate in comparison with the penalty incurred; andb. a fine of a maximum of chf 50,000 is under consideration for the violations of the criminal provisions of this act or the financial market acts in accordance with article 1 of financial market supervision act of 22 june 200725.264 the right to prosecute offences is subject to a seven-year prescriptive period.2723 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).24 sr 313.025 sr 956.126 inserted by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).27 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).chapter 4 company law provisions section 1 structure of the joint-stock company art. 25 share capital, shares 1 the share capital of the national bank amounts to 25 million swiss francs. it is divided into 100,000 registered shares with a nominal value of 250 swiss francs each. the shares are fully paid up.2 in lieu of individual shares the national bank may issue certificates covering several shares. in addition, it may dispense with the printing and the delivery of share certificates. the bank council shall regulate the details.art. 26 share register, limitation of transferability 1 the national bank shall recognise as shareholders only persons who are listed in the share register. the bank council shall regulate the details of the registration.2 a shareholder's registration is limited to a maximum of 100 shares. this limitation shall not apply to swiss public-law corporations and institutions or to cantonal banks pursuant to article 3a of the federal act of 8 november 193428 on banks and savings banks.3 registration shall be refused if the transferee, contrary to a request by the national bank, does not explicitly declare that he or she has purchased and is holding the shares in his or her own name and for his or her own account.28 sr 952.0art. 2729 listing rules if the shares of the national bank are listed on a swiss stock exchange, the competent bodies shall take account of the special nature of the national bank when applying the listing rules, in particular the provisions on the content and the frequency of financial reporting and those on ad hoc publicity.29 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 28 notifications the invitation to the general meeting of shareholders and notifications to shareholders shall be communicated by letter to the addresses listed in the share register and by a one-off publication in the swiss official gazette of commerce.section 2 determination and distribution of profits art. 2930 annual accounts the annual accounts of the national bank, consisting of the income statement, the balance sheet and the notes to the accounts, shall generally be drawn up in accordance with the provisions of title thirty-two of the co31 on commercial accounting and financial reporting. derogations may be made from the provisions of the co to the extent required by the special nature of the national bank. in particular, the national bank does not have to prepare a cash flow statement.30 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).31 sr 220art. 30 determination of profits 1 the national bank shall set up provisions permitting it to maintain the currency reserves at a level necessary for monetary policy. in so doing, it shall take into account the development of the swiss economy.2 the remaining earnings are deemed to be distributable profit.art. 31 distribution of profits 1 a dividend not exceeding six percent of the share capital shall be paid from the net profit.2 one-third of any net profit remaining after the distribution of a dividend shall accrue to the confederation and two-thirds to the cantons. the department and the national bank shall, for a specified period of time, agree on the amount of the annual profit distribution with the aim of smoothing these distributions in the medium term. the cantons shall be informed in advance.3 the net profit accruing to the cantons shall be distributed in proportion to their resident population. the federal council shall regulate the details after having consulted the cantons.3232 amended by no ii 33 of the federal act of 6 oct. 2006 on the new system of financial equalisation and division of tasks between the confederation and the cantons (nfe), in force since 1 jan. 2008 (as 2007 5779 5817; bbl 2005 6029).art. 32 liquidation 1 the swiss national bank as a joint-stock company may be liquidated by means of a federal act. this act shall also regulate the liquidation procedure.2 in the event of the liquidation of the national bank, the shareholders shall receive in cash the nominal value of their shares as well as reasonable interest for the period of time since the decision to liquidate the national bank became effective. the shareholders shall not have any additional rights to the assets of the national bank. any remaining assets shall become the property of the new central bank.chapter 5 organisation section 1 corporate bodies art. 33 the corporate bodies of the national bank shall be the general meeting of shareholders, the bank council, the governing board and the audit board.section 2 general meeting of shareholders art. 34 schedule 1 the ordinary shareholders' meeting shall take place every year no later than at the end of june.2 extraordinary shareholders' meetings shall be held whenever the bank council so decides or at the request of the audit board, or if shareholders jointly representing at least ten percent of the share capital submit a written request stating the agenda and their proposals.art. 35 invitation, agenda 1 the president of the bank council shall convene the shareholders' meeting in writing no later than 20 days before the day of assembly.2 the invitation shall state the items on the agenda as well as the bank council's proposals. agenda items with proposals submitted by shareholders shall also be announced. shareholder proposals must be signed by at least 20 shareholders and must be submitted to the president in writing in due time before the invitation is sent out.3 no decisions shall be passed with respect to proposals on agenda items which have not been announced in the invitation.art. 36 powers the shareholders' meeting shall have the following powers:a. it shall elect five members of the bank council.b. it shall elect the audit board.c. it shall approve the annual report and the annual accounts.d. it shall decide on the allocation of the net profit.e. it shall decide on the discharge of the bank council.f. it may make proposals concerning amendments to this act or the liquidation of the national bank to the federal council for submission to the federal assembly.art. 37 participation 1 any shareholder listed in the share register shall be eligible to attend the shareholders' meeting.2 any shareholder may authorise another shareholder in writing to represent him or her at the shareholders' meeting.art. 38 resolutions 1 the shareholders' meeting shall pass its resolutions and perform elections by an absolute majority of the voting stock present. in case of a tie, the chairperson shall have the casting vote.2 balloting shall be open. it shall be secret if the chairperson so orders or at the request of at least 20 shareholders present.section 3 bank council art. 39 election and term of office 1 the bank council shall consist of eleven members. the federal council shall elect six members, the shareholders' meeting five.2 the federal council shall appoint the president and the vice president.3 the term of office shall be four years.4 the members of the bank council shall be eligible for re-election. the full term of office of a member shall not exceed twelve years.art. 40 requirements 1 to be eligible for election as members of the bank council, persons must have swiss citizenship, an impeccable reputation and a recognised knowledge of the fields of banking and financial services, business administration, economic policy, or an academic field. they need not be shareholders.2 the different parts of the country and language regions shall be adequately represented in the bank council.art. 41 resignation, removal from office and election of a substitute 1 members of the bank council may resign at any time by giving three months' notice. the resignation shall be submitted to the president of the bank council.2 the members elected by the federal council shall be replaced as soon as possible; the members elected by the shareholders' meeting shall be replaced at the next shareholders' meeting. the new members shall be elected for the remainder of the term.3 the federal council may remove from office any member elected by it if said member no longer fulfils the requirements for exercising the office or has committed a grave offence. the federal council shall elect a substitute according to paragraph 2.art. 42 tasks 1 the bank council shall oversee and control the conduct of business by the national bank, notably regarding compliance with the act, regulations and directives.2 in particular, it shall perform the following tasks:a. it shall lay down the internal organisation of the national bank; notably, it shall issue the organisation regulations and submit these to the federal council for approval.b. it shall decide on the opening or closing of branches, agencies and representative offices.c. it may set up advisory councils at the bank offices for observing the economic situation in the regions.d. it shall approve the level of provisions.e. it shall oversee the investment of assets and risk management. f. it shall approve the annual report and the annual accounts for submission to the federal council and the shareholders' meeting.g. it shall prepare the shareholders' meeting and implement its resolutions.h. it shall draw up the proposals for the election of the members of the governing board and their deputies and may submit petitions for the removal of any such elected persons to the federal council.i. it shall appoint the members of the management at the head offices, branches and representative offices; they shall be employed on the basis of private-law employment contracts.j. it shall lay down the remuneration of its members and the salaries of the members of the governing board in a set of regulations. article 6a paragraphs 1-6 of the federal personnel act of 24 march 200033 shall apply mutatis mutandis.k. it shall lay down the principles for the salaries of staff members in salary regulations.l. it shall lay down the rules on the legally binding authority to sign on behalf of the national bank in a set of regulations.3 the bank council shall pass decisions in all matters not allocated to another body by statute or the organisation regulations.33 sr 172.220.1section 4 governing board art. 43 election and term of office 1 the governing board shall consist of three members, to whom deputies shall be assigned.2 the members of the governing board and their deputies shall be appointed by the federal council on the recommendation of the bank council. their term of office shall be six years. re-election is possible.3 the federal council shall designate the chairperson and the vice-chairperson of the governing board.art. 44 requirements 1 persons with an impeccable reputation and a recognised knowledge of monetary, banking and financial issues can be elected as members of the governing board. they must, moreover, hold swiss citizenship and be resident in switzerland.2 they may not exercise any other business activity nor hold a federal or cantonal office. the bank council may authorise exceptions in cases where a mandate is in the bank's interest.3 the requirements contained in this article shall also apply to the deputies of the members of the governing board.art. 45 removal from office and election of a substitute 1 a member of the governing board or a deputy can be removed from office by the federal council following a proposal by the bank council during his or her term of office if said person no longer fulfils the requirements for exercising this office or has committed a grave offence.2 in such a case, the federal council shall elect a substitute according to article 43. the substitute member shall be elected for the remainder of the current term.art. 46 tasks 1 the governing board is the supreme management and executive body. it shall represent the national bank vis--vis the public and fulfil the accountability obligation pursuant to article 7.2 in particular, it shall perform the following tasks:a. it shall take conceptional and operational monetary policy decisions.b. it shall decide on the composition of the required currency reserves including the proportion of gold.c. it shall decide on the investment of assets.d. it shall exercise the monetary policy powers according to chapter 3.e. it shall perform the tasks relating to international monetary cooperation.f. it shall decide on the salaries of the staff at the head offices, branches and representative offices; staff are hired on the basis of private-law employment contracts.g. it shall confer authority to sign and limited commitment authority on employees.3 the allocation of the tasks shall be determined by the organisation regulations.section 5 audit board art. 47 election and requirements 1 the shareholders' meeting shall elect the audit board. it may consist of one or more natural persons or legal entities. the auditors shall be elected for a term of one year. re-election is possible.2 the auditors must meet special professional requirements pursuant to article 727b co34, and they must be independent of the bank council, the governing board and the controlling shareholders.34 sr 220art. 48 tasks 1 the audit board shall examine whether the bookkeeping and the annual accounts as well as the proposal for the allocation of the net profit comply with the statutory requirements.2 the audit board shall be entitled to inspect at any time all aspects of the national bank's business. the bank shall hold all the usual documents at its disposal and provide any information necessary for fulfilling the auditing obligation.section 6 secrecy, processing of personal data, exchange of information and liability35 35 amended by art. 28 no 3 of the covid-19 credit guarantees act of 18 dec. 2020, in force from 19 dec. 2020 to 31 dec. 2032 (as 2020 5831; bbl 2020 8477 8819).art. 49 secrecy 1 the members of the bank bodies, the employees and the agents of the national bank shall be bound by official and professional secrecy.2 official and professional secrecy must be kept even after a person has ceased to be a member of a bank body or an employee of the bank.3 any person who violates official or professional secrecy shall be liable to a custodial sentence not exceeding three years or a fine.364 any person who discloses a secret with the written consent of his or her superior shall not be liable to prosecution.36 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 49a37 processing of personal data in order to fulfil its statutory tasks, the national bank may process personal data, including sensitive personal data.37 inserted by art. 28 no 3 of the covid-19 credit guarantees act of 18 dec. 2020, in force from 19 dec. 2020 to 31 dec. 2032 (as 2020 5831; bbl 2020 8477 8819).art. 5038 cooperation with domestic authorities 1 the national bank is authorised to provide the competent swiss financial market supervisory authorities with non-public information which they need to fulfil their tasks.2 it may also exchange non-public information on certain financial market participants with the department if this helps maintain the stability of the financial system.38 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 50a39 cooperation with foreign central banks 1 the national bank may cooperate with foreign central banks and the bank for international settlements (bis) in order to perform its tasks in accordance with article 5.2 it may transmit non-public information on certain financial market participants to foreign central banks and the bis only if:a. this information is used exclusively to fulfil tasks that correspond to those of the national bank;b. confidentiality is ensured.39 inserted by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 50b40 cooperation with international organisations and bodies 1 in order to fulfil its tasks in accordance with article 5, the national bank may participate in multilateral initiatives of international organisations and bodies which give rise to the exchange of information.2 in the case of multilateral initiatives which have far-reaching implications for the swiss financial centre, participation in the exchange of information shall take place in agreement with the department.3 when participating, the national bank may transmit non-public information to international organisations and bodies only if confidentiality is ensured.4 the national bank shall agree the precise intended use and any further dissemination with the international organisations and bodies. paragraph 3 remains reserved.40 inserted by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 51 liability 1 liability of the national bank, its bodies and employees shall be governed by the federal act of 14 march 195841 on the liability of the federal government, the members of its authorities and its public officials.2 to the extent that the national bank, its bodies and employees act in a private-law capacity, liability shall be governed by private law.41 sr 170.32chapter 6 procedure and legal remedies art. 52 orders 1 the national bank shall issue its decisions pursuant to articles 15, 16a, 18, 20, 22 and 23 of this act, article 8 of the banking act of 8 november 193442 and articles 23 and 25 finmia43 in the form of an order.442 final and conclusive orders on the payment of sums of money shall be equivalent to court judgments enforceable in terms of article 80 of the federal act of 11 april 188945 on debt collection and bankruptcy.42 sr 952.043 sr 958.144 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).45 sr 281.1art. 5346 legal remedies47 1 the contesting of national bank orders is governed by the provisions on the administration of federal justice.481bis the national bank is entitled to appeal to the federal supreme court.492 an action may be brought before the federal supreme court in the event of disputes between the confederation and the cantons regarding the agreement on the distribution of profits pursuant to article 31.46 amended by annex no 142 of the administrative court act of 17 june 2005, in force since 1 jan. 2007 (as 2006 2197 1069; bbl 2001 4202).47 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).48 amended by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).49 inserted by annex no 8 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 54 jurisdiction of the civil courts private-law disputes between the national bank and third parties are subject to the jurisdiction of the civil courts.chapter 7 final provisions section 1 repeal and amendment of existing legislation art. 55 the existing legislation that is repealed or amended is listed in the annex.section 2 transitional provisions art. 56 and 5750 50 repealed by annex no 8 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 58 .51 1 claims entered in the federal debt register at the time of its abolition shall be converted into bonds of the respective issue by the swiss national bank, and shall be held in safekeeping free of charge for the last registered creditor.2 claims which are converted into bonds when this act comes into force shall be entered in the balance sheet in accordance with the act heretofore in effect. the bonds may be entered in the balance sheet by the last registered creditor at cost price. if the acquisition cost is higher than the redemption value, the difference must be written off at least in annual amounts distributed equally over the entire term. if the acquisition cost is lower, the difference may be settled in even annual payments at the most.51 repealed by annex no 8 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).section 3 referendum and commencement art. 59 1 this act is subject to the optional referendum.2 the federal council shall decide on the commencement date.commencement date:52 annex no ii 5 article 4: 1 january 2005all other provisions: 1 may 200452 fcd of 24 march 2004.annex (art.55)repeal and amendment of existing legislation ithe following enactments are repealed:1. federal act of 21 september 193953 on the federal debt register2. national bank act of 23 december 1953543. decree of the federal parliament of 26 june 193055 on the participation of the swiss national bank in the bank for international settlements4. decree of the federal parliament of 28 november 199656 on the renewal of the swiss national bank's note-issuing privilegeiithe enactments below are amended as follows:.5753 [bs 6 10]54 [as 1954 599, 1979 983, 1993 399, 1997 2252, 1998 2847 annex no 7, 2000 1144 annex no 4]55 [bs 6 100]56 [bbl 1997 i 821]57 the amendments may be consulted under as 2004 1985.

951.131english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceto the federal act on the swiss national bank(national bank ordinance, nbo)of 18 march 2004 (status as of 1 january 2021)the swiss national bank (snb),based on articles 15 paragraph 3, 17 paragraph 2, 18 paragraph 5, 20 paragraph 31 and 23 paragraph 1 of the federal act on the swiss national bank of 3 october 20032 (nba),ordains:1 since 1 jan. 2016: art. 20 para. 5.2 sr 951.11 chapter 1 common provisions art. 1 objective this ordinance governs:a. the conduct of statistical surveys by the national bank;b. the obligation of the banks to hold minimum reserves;c.3 the oversight of systemically important financial market infrastructures.3 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 2 definitions 1 in this ordinance:a. bank means any person or company in possession of a licence pursuant to article 3 of the federal act on banks and savings banks of 8 november 19344;b.5 securities firm means any company pursuant to article 41 of the financial institutions act of 15 june 20186;c.7 fund management company means any company pursuant to article 32 of the financial institutions act;d.8 representative of a foreign collective investment scheme means any person or company pursuant to article 123 of the collective investment schemes act of 23 june 20069;e.10 insurance company means any institution pursuant to article 2 of the federal act of 17 december 200411 on the oversight of insurance companies;f. occupational pension scheme means any pension scheme that is inscribed, pursuant to article 48 of the federal act of 25 june 198212 on occupational old age, survivors and invalidity insurance, in the occupational pensions register held by the supervisory authority;g. investment and holding company means any legal entity, company or public law institution, whose principal object is the ongoing administration of participations, and which meets the requirements laid down in the annex to this ordinance;h.13 systemically important financial market infrastructure means a payment system, a central securities depository or a central counterparty pursuant to article 22 paragraph 1 of the financial market infrastructure act of 19 june 201514 (finmia);i.15 payment system means an entity pursuant to article 81 finmia;j.16 .k.17 central securities depository means an entity pursuant to article 61 paragraph 1 finmia;l.18 central counterparty means an entity pursuant to article 48 finmia;m.19 operator means a central securities depository as well as any person or company operating a payment system or central counterparty;n.20 indirect participant means any person pursuant to article 2 letter e finmia;o.21 operational risk means the risk that, as a result of inadequate or failed internal procedures or systems, human error or external events, the functioning of the financial market infrastructure is impaired or financial losses are incurred;p.22 general business risk means the risk that the operator of a financial market infrastructure will incur losses that are not directly linked to the default of a participant or to other credit and liquidity risks. general business risk also includes the risk of financial losses arising from operational or strategic risks; q.23 capital means common equity tier 1 (cet1) capital pursuant to articles 21-26 of the capital adequacy ordinance of 1 june 201224;r.25 net liquidity means readily available assets, minus short-term liabilities;s.26 extreme but plausible market conditions are determined on the basis of the largest price fluctuations which have been observed over the last 30 years, or which are considered possible in the future.2 the national bank shall define further terms in the annex to this ordinance and in the reporting forms.3 the definitions used in the regulations of the swiss financial market supervisory authority (finma) on bank accounting27 shall also apply.284 sr 952.05 amended by no i of the snb o of 31 oct. 2019, in force since 1 jan. 2020 (as 2019 3909).6 sr 954.17 amended by no i of the snb o of 31 oct. 2019, in force since 1 jan. 2020 (as 2019 3909).8 amended by no i of the snb o of 31 oct. 2019, in force since 1 jan. 2020 (as 2019 3909).9 sr 951.3110 amended by no i of the snb o of 10 june 2013, in force since 1 july 2013 (as 2013 1987).11 sr 961.0112 sr 831.4013 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).14 sr 958.115 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).16 repealed by no i of the snb o of 26 nov. 2015, with effect from 1 jan. 2016 (as 2015 5307).17 inserted by no i of the snb o of 10 june 2013 (as 2013 1987). amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).18 inserted by no i of the snb o of 10 june 2013 (as 2013 1987). amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).19 inserted by no i of the snb o of 10 june 2013 (as 2013 1987). amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).20 inserted by no i of the snb o of 10 june 2013 (as 2013 1987). amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).21 inserted by no i of the snb o of 10 june 2013, in force since 1 july 2013 (as 2013 1987).22 inserted by no i of the snb o of 10 june 2013, in force since 1 july 2013 (as 2013 1987).23 inserted by no i of the snb o of 10 june 2013 (as 2013 1987). amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).24 sr 952.0325 inserted by no i of the snb o of 10 june 2013, in force since 1 july 2013 (as 2013 1987).26 inserted by no i of the snb o of 10 june 2013, in force since 1 july 2013 (as 2013 1987).27 finma accounting o of 31 oct. 2019 (sr 952.024.1), as well as finma circular 2020/1 'accounting - banks' of 31 oct. 2019.28 amended by no i of the snb o of 2 july 2020, in force since 1 jan. 2021 (as 2020 4627).chapter 2 statistical surveys section 1 scope of application art. 3 subject the swiss national bank conducts the required statistical surveys:a. to fulfil its monetary policy tasks;b.29 to fulfil its oversight tasks with respect to systemically important financial market infrastructures;c. within the context of its contribution to the stability of the swiss financial system;d. on behalf of international organisations of which switzerland is a member;e. for drawing up the balance of payments and the statistics on the international investment position.29 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 4 principles of data collection 1 the national bank shall limit the number and type of surveys to what is strictly necessary. in particular, it shall ensure that the burden on the institutions obliged to provide information for the collection of statistical data is kept to a minimum.2 it shall conduct a survey among all institutions obliged to provide information (full sample survey) if the data that can be gained by conducting a survey among a part of these institutions (partial sample survey) are not representative or pertinent.3 it shall not collect statistical data in cases where it can draw on existing, sufficiently pertinent, statistics or if it can procure data of a comparable quality by other means within the available time.4 it can totally or partially release certain groups of institutions required to provide statistical information from their obligation.art. 5 statistical surveys 1 the annex to this ordinance lays down the following for each survey:a. name of survey;b. coverage;c. whether it is to be conducted as a partial sample survey or a full sample survey;d. reporting institutions;e. whether, in the case of an institution divided into several organisationally independent units, the survey covers the domestic office (including domestic branches), the entire parent company (including foreign branches) or the entire group (including branches and subsidiaries in switzerland and abroad);f. the intervals at which it is conducted (frequency);g. the deadline for submitting the data (submission deadline); andh. any other procedures.2 if, in order to fulfil a statutory task, the national bank urgently requires the data of a particular survey, it shall fix, for a limited period of time, a submission deadline and frequency deviating from the annex for such survey.3 .3030 repealed by no i of the snb o of 10 june 2013, with effect from 1 july 2013 (as 2013 1987).art. 6 supplementary surveys 1 if, in order to fulfil a statutory task, the national bank urgently requires additional data, it shall conduct supplementary surveys or, within the context of existing surveys, solicit data not provided for in the annex to this ordinance. the supplementary surveys must be limited to what is strictly necessary in terms of content and time.2 the national bank advises the respective reporting institutions of:a. the coverage;b. the purpose and the procedure of the survey;c. the envisaged use of the data;d. the envisaged data protection measures.3 at the request of a reporting institution, the national bank issues an order on the obligation to provide information and the coverage and extent according to article 52 nba.art. 7 consultation of the reporting institutions the national bank shall give the reporting institutions and their associations an opportunity to express an opinion before amending this ordinance with a view to:a. determining or changing the organisation and the procedure of a survey;b. introducing a new survey or significantly extending an existing survey.section 2 conduct of surveys art. 8 participation of the reporting institutions 1 the reporting institutions are invited by the national bank to participate in the survey.2 they are required to provide the information truthfully, within the deadline, free of charge and in the prescribed form.art. 9 calling in third persons 1 if the national bank calls in third persons to conduct surveys, these shall, in particular, be contractually obliged as follows:a. to use the data supplied to them or collected by them in the course of their mandate solely for the exercise of this mandate;b. not to combine the survey conducted on behalf of the national bank with any other surveys;c. after completion of the mandate, to return all the data to the national bank and to delete electronically saved data.2 any exception from these obligations shall require the written permission of the national bank.3 third persons must provide evidence of the fact that they have taken the necessary technical and organisational measures for the processing of these data according to the ordinance of 14 june 199331 on the federal act on data protection.31 sr 235.11art. 10 form of reporting 1 the national bank issues technical instructions on the form of reporting.2 in particular, it specifies which data are to be provided entirely or partially in electronic form.art. 11 confidentiality and data protection 1 all institutions entrusted with conducting surveys shall be obliged to treat the collected data confidentially. they shall take all due care that the data collected are stored in a safe place.2 the information provided by the reporting institutions is stored in accordance with the federal act on archiving of 26 june 199832.32 sr 152.1chapter 3 minimum reserves art. 12 scope of application 1 solely banks are obliged to hold minimum reserves. 2 bank groups with collective liquidity management shall fulfil the minimum reserve requirement at group level.art. 13 eligible assets the following swiss franc denominated assets of the banks are eligible as minimum reserves:a. coins in circulation (excluding commemorative coins and bullion coins)100 percentb. banknotes100 percentc. sight deposits at the national bank100 percentart. 1433 relevant liabilities 1 the following swiss franc denominated liabilities of the banks count towards the calculation of the minimum reserves:a. liabilities arising from money market instruments which cannot be attributed to either banks or customers, and which mature within three months;b. liabilities vis--vis banks payable on sight or maturing within three months;c. 20 percent of liabilities arising from customer time deposits (excluding tied pension fund monies);d. liabilities arising from customer deposits payable on sight or maturing within three months (including call money);e. liabilities arising from medium-term bank-issued notes maturing within three months;f.34 .1bis liabilities vis--vis banks which are themselves subject to minimum reserve requirements based on articles 17 and 18 nba are not counted in the calculation.2 .353 the terms used in paragraph 1 letters a-e refer to finma's accounting regulations36.374 liabilities towards the national bank are not counted in the calculation of the minimum reserves.3833 amended by no i of the snb o of 7 may 2014, in force since 1 jan. 2015 (as 2014 3023).34 repealed by no i of the snb o of 31 oct. 2019, with effect from 1 jan. 2020 (as 2019 3909).35 repealed by no i of the snb o of 31 oct. 2019, with effect from 1 jan. 2020 (as 2019 3909).36 finma accounting o of 31 oct. ober 2019 (sr 952.024.1), as well as finma circular 2020/1 'accounting - banks' of 31 oct. 2019.37 inserted by no i of the snb o of 2 july 2020, in force since 1 jan. 2021 (as 2020 4627).38 inserted by no i of the snb o of 2 july 2020, in force since 1 jan. 2021 (as 2020 4627).art. 15 level of minimum reserve and fulfilment of minimum reserve requirement 1 the required minimum reserve amounts to 2.5 percent of the average of the liabilities at the end of the three months preceding the reporting period.2 the minimum reserve requirement must be fulfilled, on an average of the respective reporting period, from the 20th of one month until the 19th of the following month.3 the average according to paragraph 2 will be calculated based on the relation between total daily assets available at the close of business according to article 13, on the one hand, and the number of calendar days in the reporting period, on the other hand. for saturdays, sundays and public holidays, the assets of the last preceding business day are to be entered.art. 16 accountability by the end of the month of the terminated reporting period, the banks shall report to the national bank whether the minimum reserve obligation has been fulfilled. the national bank shall determine the form and manner of reporting in guidelines.art. 17 interest obligation 1 if a bank fails to fulfil the minimum reserve requirement for a reporting period that has ended, it shall pay interest on the shortfall to the national bank for the number of days of the respective reporting period. the interest rate shall exceed by four percentage points the overnight rate for swiss franc deposits payable on average in the respective reporting period. the saron (fixing at close of trading) serves as the basis. in the event of non-fulfilment, an amount of at least chf 500 is payable.392 the national bank shall order the bank to pay the interest amount by the end of the second month following the end of the reporting period. should the bank disagree with the payment of interest it may, within 30 days, demand the issuance of a contestable order pursuant to the terms of article 52 nba.39 amended by no i of the snb o of 3 sept. 2009, in force since 1 jan. 2010 (as 2009 6373).chapter 4 oversight of systemically important financial market infrastructures40 40 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).section 141 determination of systemically important financial market infrastructures and business processes 41 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 18 disclosure obligation 1 the disclosure obligation specified in article 20 paragraph 1 nba applies to:a. payment systems which settle payments in excess of chf 25 billion (gross) per financial year;b. central securities depositories;c. central counterparties.2 the disclosure obligation already applies prior to the payment system, central securities depository or central counterparty starting operations; however, it applies to payment systems only if it is to be expected that the value of payments stated in paragraph 1 letter a will be attained in the first year after the system starts operations.art. 19 procedure 1 the national bank shall issue an order designating systemically important financial market infrastructures and their systemically important business processes pursuant to article 22 finmia42.2 the national bank shall request from the operator the necessary information and documentation, and set the deadline and the format for their submission.3 before designating a financial market infrastructure as systemically important and determining its systemically important business processes, the national bank shall provide the operator with the opportunity to express an opinion. if the operator is a financial market infrastructure subject to authorisation in accordance with article 4 finmia, the national bank shall consult finma.42 sr 958.1art. 20 criteria for systemically important financial market infrastructures in determining whether a payment system, central securities depository or central counterparty is important for the stability of the swiss financial system in accordance with article 22 paragraph 1 finmia43, the national bank shall, in particular, take the following factors into account:a. the transactions that are cleared or settled through the financial market infrastructure, and in particular whether they are foreign exchange, money market, capital market or derivatives transactions, or are transactions that serve to implement monetary policy;b. the transaction volumes and amounts cleared or settled through the financial market infrastructure;c. the currencies in which transactions are cleared or settled through the financial market infrastructure;d. the number, nominal value and currency of issue of the financial instruments held in central custody or under management by the financial market infrastructure;e. the participants of the financial market infrastructure;f. the financial market infrastructure's links with other financial market infrastructures;g. the possibility of the financial market infrastructure's participants switching at short notice to another financial market infrastructure or to an alternative clearing and settlement arrangement in order to clear and settle transactions, and the associated risks;h. the credit and liquidity risks associated with the operation of the financial market infrastructure.43 sr 958.1art. 20a and 21 repealedsection 244 special requirements for systemically important financial market infrastructures45 44 amended by no i of the snb o of 10 june 2013, in force since 1 july 2013 (as 2013 1987).45 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 21a46 applicability of special requirements 1 for systemically important financial market infrastructures which are not subject to finma authorisation and supervision pursuant to article 4 finmia47, the following special requirements shall apply. 2 for systemically important financial market infrastructures which are subject to finma authorisation and supervision pursuant to article 4 finmia, the requirements specified in article 23, article 24 paragraphs 4 to 6, article 24a, article 25c, article 27 paragraphs 1 and 2, articles 28-28d, article 29, article 30 paragraphs 1 and 3, articles 32-32c, and article 34, as well as section 3, with the exception of article 36 paragraph 1 letter h, shall apply.46 inserted by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).47 sr 958.1art. 22 governance and organisation 1 the operator shall have appropriate corporate governance rules and procedures in place. these include, in particular:a. an organisational structure and framework which define the tasks, responsibilities, powers and reporting duties of the board of directors, the senior management and the internal audit function;b. a risk management framework for the identification, measurement, management and monitoring of risk;c. a system of internal controls which, inter alia, ensures compliance with statutory, regulatory and internal company rules and regulations (compliance function).2 the operator shall have mechanisms in place that allow participants' needs with regard to services provided by the financial market infrastructure to be surveyed.3 and 4 .4848 repealed by no i of the snb o of 26 nov. 2015, with effect from 1 jan. 2016 (as 2015 5307).art. 22a board of directors, senior management and internal audit 1 the members of the board of directors and senior management shall have an impeccable reputation and shall possess the experience and skills to perform their mandate. the board of directors shall have its performance regularly assessed.2 the board of directors shall also contain non-executive directors.3 the board of directors shall specify the basic risk management principles. it shall approve the plans specified in article 26 and article 31 paragraph 4, as well as the business continuity strategy and plans specified in article 32b paragraph 4.4 the internal audit function shall be independent of the senior management and shall report to the board of directors or one of its committees. it shall be equipped with sufficient resources and shall have unlimited right of review as well as unrestricted access to all documentation, data carriers and information processing systems.5 .4949 repealed by no i of the snb o of 26 nov. 2015, with effect from 1 jan. 2016 (as 2015 5307).art. 22b documentation and retention 1 the operator shall keep records on the main services provided and activities performed and shall retain all records for a period of ten years.2 and 3 .5050 repealed by no i of the snb o of 26 nov. 2015, with effect from 1 jan. 2016 (as 2015 5307).art. 23 contractual framework 1 the contractual framework of the financial market infrastructure shall define, in particular:a. the participation requirements as well as the criteria for the suspension and exclusion of a participant;b. the rights and obligations of the operator and the participants;c. the rules and procedures for the operation of the financial market infrastructure;d. the rules and procedures in the event of a participant's default;e. the reciprocal rights and obligations arising from links with other financial market infrastructures;f. the obligations regarding the delivery of physical instruments or commodities.2 the operator shall regularly review the effectiveness and enforceability of the contractual framework in all relevant jurisdictions and shall take the necessary measures to limit any legal risks.art. 23a transparency 1 the operator shall publicly disclose key aspects of all information relating to the financial market infrastructure on a regular basis, in particular:a. the design and operation of the financial market infrastructure;b. the operator's organisational structure;c. the rights and obligations of the participants;d. the participation requirements as well as the criteria for the suspension and exclusion of a participant;e. the rules and procedures in the event of a participant's default;f.51 .g. the aggregate transaction volumes and amounts;h.52 .i. the prices and fees charged by the financial market infrastructure for the services it offers, including its conditions for discounts.2 the operator shall publish information in accordance with the standards set by the relevant international bodies.51 repealed by no i of the snb o of 26 nov. 2015, with effect from 1 jan. 2016 (as 2015 5307).52 repealed by no i of the snb o of 26 nov. 2015, with effect from 1 jan. 2016 (as 2015 5307).art. 24 access and exclusion 1 the operator shall grant non-discriminatory and open access to its services.2 the operator may restrict access provided that this increases the safety or efficiency of the financial market infrastructure, and that such an effect cannot be brought about by any other means. in particular, the operator may make participation conditional upon fulfilment of operational, technical, financial and legal requirements.3 if an operator restricts access for reasons of efficiency, the national bank shall consult the competition commission as part of its assessment.4 the operator shall monitor compliance with the participation requirements on an ongoing basis.5 the operator shall define the criteria and procedure for the suspension and exclusion of participants that no longer fulfil the participation requirements.6 the operator shall immediately notify the participant of its suspension or exclusion.art. 24a default of a participant 1 the operator shall have appropriate rules and procedures for managing the default of a participant and for minimising credit and liquidity risks for the financial market infrastructure and its participants. these rules and procedures shall enable the operator to meet its obligations when due.2 in particular, the rules and procedures shall define:a. the sequence in which the operator uses collateral and other financial resources to cover losses (default waterfall);b. how the operator allocates losses that are not covered by collateral and other financial resources;c. how the operator deals with liquidity shortfalls;d. how the operator replenishes collateral and other financial resources that were deployed to cover losses or to bridge liquidity shortfalls following the default of a participant.3 the operator shall review and test these rules and procedures at least annually.art. 24b53 53 repealed by no i of the snb o of 26 nov. 2015, with effect from 1 jan. 2016 (as 2015 5307).art. 25 means of payment 1 where possible and practicable, the financial market infrastructure shall settle payments by transferring sight deposits at a central bank.2 alternatively, the financial market infrastructure shall use a means of payment with no or only low credit and liquidity risks. the operator shall minimise and monitor these risks on an ongoing basis.art. 25a finality 1 the rules of the financial market infrastructure shall determine the point in time after which:a. a participant's payment order is unconditional and irrevocable;b. a payment is settled.542 the financial market infrastructure shall settle payments and securities transfers in real time, but at the latest by the end of the value day.54 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 25b55 exchange-of-value settlement the operator of a financial market infrastructure shall enable the participants to eliminate their principal risk by ensuring that for transactions involving the settlement of two linked obligations, the settlement of one obligation occurs if and only if the settlement of the other obligation is guaranteed.55 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 25c56 central securities depositories 1 a central securities depository shall have appropriate rules, procedures and controls for minimising the risks associated with the safekeeping and transfer of securities.2 a central securities depository shall enable its participants to hold the securities in an immobilised or dematerialised form by recording them in a securities account.56 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 26 recovery and orderly wind-down of systemically important business processes 1 the operator shall identify scenarios that might jeopardise its viability as a going concern, and shall prepare a plan to ensure:a. the recovery or orderly wind-down of systemically important business processes in the event of impending insolvency or other scenarios jeopardising its viability as a going concern;b. the orderly wind-down of systemically important business processes in the event of a voluntary cessation of business.2 the plan shall, in particular, describe the measures to be taken by the operator as well as the resources required to implement these measures. the plan shall take into account the length of time required for the participants to connect to an alternative financial market infrastructure.art. 27 risk management principles 1 the operator shall have a concept for the integrated identification, measurement, management and monitoring of key risks, especially legal, credit, liquidity, business and operational risks.572 in defining the procedures and tools to manage credit and liquidity risks, the operator shall take into account their impact on the participants and the financial system. in particular, it shall aim to prevent procyclical effects.3 the operator shall provide tools and incentives for the participants to continuously manage and contain the risks arising for themselves or for the financial market infrastructure.57 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 28 management of credit risk 1 the operator shall identify, measure, manage and monitor its credit risk through the use of appropriate procedures and tools.2 the operator shall have sufficient collateral, as specified in article 28a, to cover current and potential credit exposures to each participant with a high level of confidence. it shall regularly assess compliance with this requirement.art. 28a collateral 1 to cover risk exposures, the operator shall only accept liquid collateral with low credit and market risks.2 the operator shall value collateral prudently. it shall apply haircuts which are also appropriate under extreme but plausible market conditions and validate them regularly.3 the operator shall avoid concentration risk in the collateral. in order to diversify the collateral, it shall define concentration limits and monitor compliance with these limits. the operator shall also ensure that no participants post collateral whose value will be substantially reduced in the event of their default.584 the operator shall ensure that it can access the collateral in a timely manner. this applies, in particular, to collateral which is:a. held in custody abroad;b. issued by foreign issuers; orc. denominated in foreign currency.58 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 28b financial resources and default waterfall of central counterparties 1 a central counterparty shall limit its credit exposure to its participants by collecting collateral as specified in article 28a in the form of initial margin, variation margin and default fund contributions.2 a central counterparty shall mark the participants' collateral and positions to market, and shall collect margin (initial and variation margin) at least once daily when predefined thresholds are exceeded. in addition, it shall have the authority and capability to make intraday margin calls.3 the margin and the default fund contributions shall cover current and potential credit exposures under a wide range of scenarios. these scenarios shall include, but not be limited to, the default of the participant or group of participants as well as the default of the two participants or two groups of participants against which a central counterparty has the largest potential credit exposure under extreme but plausible market conditions. a group of participants consists of all participants affiliated to the same parent company.4 in order to cover any losses from a participant's default, a central counterparty shall use collateral and capital in the following sequence:a. margin of the defaulting participant;b. default fund contributions of the defaulting participant;c. dedicated capital of the central counterparty, which needs to be substantial relative to the central counterparty's total capital;d. default fund contributions of the non-defaulting participants.art. 28c calculating a central counterparty's margin 1 the initial margin of a participant shall cover the potential credit exposure arising from its default for a central counterparty due to expected price movements over an appropriate time horizon with a confidence level of at least 99%. the confidence level for over-the-counter derivatives must be at least 99.5% unless they show the same risk characteristics as exchange-traded derivatives.592 the appropriate time horizon pursuant to paragraph 1 corresponds to the period from the last variation margin payment up to the expected close-out or hedging of positions in the event of a participant's default. this horizon shall be at least two business days. for over-the-counter derivatives, the horizon shall be at least five business days, unless they show the same risk characteristics as exchange-traded derivatives.603 a central counterparty shall base its initial margin calculation on price movements in the financial instruments underlying the positions over at least the previous 12 months. it may choose other and additional periods if these result in higher initial margin.4 if a central counterparty nets the positions of a participant when calculating that participant's initial margin, then the assumptions applied with regard to the correlations in the financial instruments underlying these positions shall also be appropriate under extreme but plausible market conditions.5 the variation margin shall cover the current credit exposure arising from realised price movements, taking into account the predefined thresholds.59 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).60 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 28d risk control at central counterparties 1 a central counterparty shall assess:a. by means of daily back tests, whether the initial margin meets the requirements specified in article 28c paragraph 1;b. by means of daily stress tests, whether the margin and the default fund contributions meet the requirements specified in article 28b paragraph 3;c. on a monthly basis, how initial margin changes when the assumptions and parameters underlying its calculation vary;d. on a monthly basis, the scenarios, models, assumptions and parameters underlying the stress tests;e. at least annually and in a comprehensive manner, its credit risk management model and the implementation thereof.2 in the event that a central counterparty identifies shortcomings when performing the tests specified in paragraph 1, it shall make adjustments so as to meet the requirements.art. 29 management of liquidity risk 1 the operator shall identify, measure, manage and monitor its liquidity risk through the use of appropriate procedures and tools.2 the operator shall have sufficient liquid resources to effect its payment obligations in all currencies when due, under a wide range of stress scenarios. as regards these liquid resources, the operator shall apply haircuts which are also appropriate under extreme but plausible market conditions.3 when selecting stress scenarios, the operator shall, in particular, take into account the following stress events under extreme but plausible market conditions:a. the default of the participant or group of participants which would generate the largest aggregate payment obligation for the financial market infrastructure;b. additionally, for a central counterparty, the default of the two participants or two groups of participants which would generate the largest aggregate payment obligation for the central counterparty;c. the default of the largest liquidity provider in each of the five currencies in which the financial market infrastructure has the largest payment obligations.4 liquid resources in a currency, as specified in paragraph 2, comprise cash, credit lines and collateral in accordance with article 50 paragraph 1 and article 58 paragraph 1 of the financial market infrastructure ordinance of 25 november 201561 (finmio).625 the operator shall diversify its liquidity providers and avoid concentration risk for collateral and assets in accordance with article 50 paragraph 1 letters d and e finmio as well as article 58 paragraph 1 letters d and e finmio.636 the operator shall assess:a. by means of daily stress tests, whether the requirement specified in paragraph 2 is met;b. at least on a quarterly basis, the creditworthiness of the liquidity providers and their ability to meet their obligations.61 sr 958.1162 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).63 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 30 management of custody and investment risks 1 the operator shall identify, measure, manage and monitor its custody and investment risks through the use of appropriate procedures and tools.2 if the operator places own assets or collateral and assets of participants in the custody of a third party, it shall minimise the associated risks. in particular, it shall place the collateral and assets concerned with creditworthy and, wherever possible, supervised financial institutions, and shall take measures to ensure that, if necessary, it can access the collateral and assets immediately.3 the operator's investment strategy shall be consistent with its risk management strategy and allow only liquid investments with minimal credit and market risks. the operator shall avoid risk concentrations and disclose the investment strategy vis--vis its participants, in particular regarding the possible re-use of the collateral they have provided.art. 31 management of general business risk 1 the operator shall identify, measure, manage and monitor its general business risk through the use of appropriate procedures and tools.2 in order to cover losses from general business risk, the operator shall hold capital and net liquidity. such capital and net liquidity shall be sufficient to ensure the implementation of the plan specified in article 26, and shall in any case be sufficient to cover current operating expenses for at least six months.3 collateral and other dedicated financial resources which are used to cover losses from participant defaults or from other credit or liquidity risks in accordance with articles 28 and 29 must not be used to satisfy the requirement specified in paragraph 2.644 the operator shall have a plan to raise additional capital in case the requirement specified in paragraph 2 is no longer fulfilled.64 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 32 management of operational risk the operator shall identify, measure, manage and monitor its operational risk through the use of appropriate procedures and tools, particularly in order to ensure information security and business continuity, taking into account recognised standards.art. 32a information security 1 the operator shall apply a company-wide approach and maintain an appropriate organisational structure with regard to planning, implementing, monitoring and improving the management of tasks and activities relating to information security (information security management).2 the operator shall set appropriate targets with regard to the availability, integrity, confidentiality, auditability, authenticity, accountability and non-repudiation of information, particularly data in connection with transactions that are cleared or settled via the financial market infrastructure (information security objectives).3 the operator shall take organisational and technical measures to ensure that the information security objectives are met during normal operations, during development and maintenance activities, and in times of increased transaction volumes. in particular, it shall take precautions enabling it to:a. identify, analyse and evaluate internal and external threats to information security and, if necessary, implement appropriate protective measures;b. ensure the physical security of the data processing facilities;c. ensure the secure and continuous operation of the data processing facilities;d. control, record and evaluate access to information and to the data processing facilities;e. protect data from loss, leakage, unauthorised access, and other processing risks such as negligence, fraud, poor administration and inadequate recordkeeping;f. ensure the secure storage and transmission of sensitive data;g. ensure the correct and complete processing of transactions;h. record and check transactions at all key stages of processing, in particular regarding input to and output from the data processing system;i. record and monitor interventions in the data processing system, such as software and parameter changes;j.65 record, evaluate and rectify processing errors and system disruptions promptly and in standardised form and prevent them from recurring.4 the operator shall regularly monitor the appropriateness of, and compliance with, the information security objectives specified in paragraph 2.65 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 32b business continuity 1 the operator shall apply a company-wide approach to maintaining or recovering business processes, in particular those business processes which are systemically important, in a timely manner in the event of damage or disruption.2 the operator shall define the necessary resources (premises, staff, technical facilities, data, external service providers) for the individual business areas and assess the impact of any complete or partial loss or disruption of each of these resources with regard to business processes, in particular systemically important business processes (business impact analysis). the assessment shall include any interdependency among business areas and any dependency on external service providers.3 based on the business impact analysis, the operator shall define the maximum acceptable time before business processes are recovered, as well as the required degree of recovery (recovery objectives) and the associated resource requirements. the maximum acceptable time for recovery in the case of systemically important business processes, even in the event of major damage or disruption (e.g. non-availability of a business-critical building including staff), shall be two hours.4 the operator shall define the procedure by which it aims to meet the recovery objectives specified in paragraph 3 (business continuity strategy), and shall draw up plans that describe in detail the action to be taken and the persons responsible (business continuity plans).5 subsequent to any major modifications but at least once a year, the operator shall review and test the business continuity plans with regard to their implementation and effectiveness, and to ensure that they are up to date. such tests shall, if necessary, also involve participants and important service providers.art. 32c data centres 1 the operator shall have at least two data centres that meet high standards, particularly with regard to physical security, fire protection, power supply, cooling systems and telecommunications infrastructure.2 the operator shall decide on the location of the data centres based on a risk analysis, and ensure that the data centres have different risk profiles and provide protection even in the event of a major incident adversely affecting a large geographical area.3 the data centres and precautions taken to ensure their operation shall be appropriate for the fulfilment of the information security and recovery objectives specified in articles 32a and 32b. if one of the data centres becomes inoperable, the operator shall ensure that, in particular, systemically important business processes can be continued within two hours at another data centre without the loss of any processing steps confirmed to participants.art. 32d66 outsourcing 1 if the operator outsources significant services, it shall select its service providers with care and instruct them appropriately.2 the operator shall integrate the outsourced services into its internal control system and monitor the performance of the service provider on an ongoing basis.3 the operator shall, with regard to any outsourced services, remain responsible for compliance with the special requirements specified in this chapter.4 the outsourcing contract shall, in particular, specify:a. the services to be rendered by the service provider;b. the possibilities for the national bank, the operator or a mandated external party to examine - in full and without hindrance - the services outsourced to the service provider.66 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 33 management of risk from indirect participation if the financial market infrastructure has indirect participants and these are visible to the operator, the latter shall identify, measure, manage and monitor the risks to the financial market infrastructure arising from indirect participants.art. 34 management of risk from links between financial market infrastructures 1 the operator shall identify, measure, manage and monitor risks arising from links to other financial market infrastructures.2 if a central securities depository establishes a link with another central securities depository:a. the central securities depository shall use appropriate collateralisation measures to cover, with a high confidence level, the credit risk arising out of the granting of credit to the other central securities depository;b. the central securities depository shall permit the re-use of securities provisionally received from the other central securities depository only after the original transfer is unconditional and irrevocable;c. the central securities depository shall, in the case of indirect links, identify, measure, manage and monitor the risks arising due to intermediary financial institutions.d. the central securities depository shall, on a daily basis, match the holdings in its sub-custody with those it holds at other central securities depositories and custodians;e. the central securities depository shall make the settlement of transactions between the participants of linked central securities depositories possible on a delivery versus payment basis where practicable.673 if a central counterparty enters into a link with another central counterparty, it shall cover the resulting current and potential credit exposure with a high confidence level through the collection of collateral as specified in article 28a from the other central counterparty.67 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).section 3 assessment of compliance with special requirements68 68 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307). art. 3569 obligation to provide information the operator shall provide the national bank or any third party designated by the latter with all the information and documentation that it requires for the assessment of compliance with the special requirements specified in this chapter.69 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 3670 reporting obligations 1 the operator shall submit the following documentation and information to the national bank:a. the annual report;b. the contractual framework;c. the organisational principles;d. the minutes of the board of directors' meetings;e. the internal and external auditors' reports;f. information on the participants;g. data on the clearing and settlement of payments and financial instruments and the central custody of securities;h. the plan specified in article 26, to ensure the recovery or orderly wind-down of systemically important business processes, and the plan specified in article 31 paragraph 4, to raise additional capital;i. the results of the risk controls specified in articles 27-32a, 33 and 34; j. information on the availability of the data processing system, as well as on system failures and disruptions, including their causes and the action taken (operating statistics and production report);k. the business impact analysis, the business continuity strategy and the business continuity plans specified in article 32b paragraphs 2-4;l. the results of the tests of the business continuity plans specified in article 32b paragraph 5;m. a report on the course of the exclusion procedure in the case of default of a participant;n.71 a report on compliance with the special requirements specified in this chapter.2 the operator shall inform the national bank in good time about any significant planned changes with regard to:a. the ownership structure;b. the corporate objectives, corporate strategy and services offered;c. the corporate governance and organisation pursuant to article 22;d. the means of payment used;e. the requirements for participation in the financial market infrastructure;f. the risk management, in particular the procedures and tools for managing credit and liquidity risks;g. the management of operational risk, in particular the business continuity strategy and the organisational and technical measures taken to achieve the information security objectives;h. agreements with third parties whose services are important for the operation of the financial market infrastructure.3 the operator shall inform the national bank immediately about:a. significant legal disputes;b.72 events that significantly impair the achievement of the information security objectives specified in article 32a and the business continuity objectives specified in article 32b;c. any non-compliance with the requirements regarding the management of credit and liquidity risks in accordance with articles 28, 28b, 28c, 28d and 29.4 the operator shall inform the national bank, finma and other responsible supervisory authorities immediately of any suspension or exclusion of a participant.5 the national bank shall, in consultation with the operator, define the frequency, deadlines and formats for the submission of the documents and the provision of the information specified in paragraphs 1-4.70 amended by no i of the snb o of 10 june 2013, in force since 1 july 2013 (as 2013 1987).71 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).72 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 3773 on-site assessments 1 in order to assess compliance with the special requirements specified in this chapter, the national bank may undertake on-site assessments of the financial market infrastructure or charge a third party with the performance of such assessments.742 the operator shall have the adequacy and effectiveness of its risk management reviewed regularly by a qualified internal or external body. the national bank may set requirements regarding the scope and depth of the assessments.3 the operator shall have the adequacy and effectiveness of the procedures and tools used for the management of operational risk reviewed annually by a qualified external body. the national bank shall, in consultation with the operator, define the scope and depth of the assessments.73 amended by no i of the snb o of 10 june 2013, in force since 1 july 2013 (as 2013 1987).74 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).art. 3875 procedure in cases of non-compliance with the special requirements 1 if a financial market infrastructure does not satisfy the special requirements specified in this chapter, the national bank shall issue a recommendation to the operator.2 the national bank shall issue an order if the operator fails to comply with a corresponding recommendation as specified in paragraph 1.3 before issuing the recommendation specified in paragraph 1 or the order specified in paragraph 2, the national bank shall provide the operator with the opportunity to express an opinion. if the financial market infrastructure is subject to authorisation and supervision by finma pursuant to article 4 finmia76, the national bank shall first consult finma.75 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).76 sr 958.1art. 3977 77 repealed by no i of the snb o of 26 nov. 2015, with effect from 1 jan. 2016 (as 2015 5307).chapter 5 audit art. 4078 1 the audit companies shall check whether the statistical reporting obligations and the minimum reserve requirements are fulfilled and shall submit a separate report to the national bank.2 the audit shall, as a rule, be conducted at the same time as the audit specified in article 24 of the financial market supervision act of 22 june 200779. duplication should be avoided as far as possible. however, the report should be submitted to the national bank no later than six months after the annual accounts have been drawn up.78 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).79 sr 956.1chapter 6 final provisions art. 4180 transitional provisions 1 for financial market infrastructures which are subject to finma authorisation and supervision, the special requirements in accordance with articles 21a-34 and the obligations in accordance with article 36 shall apply only after the licence granted in accordance with article 25 finmia81 has entered into force. until such time, the relevant requirements and obligations as laid out in the existing legislation shall apply. 2 for financial market infrastructures which are not subject to finma authorisation and supervision, the special requirements in accordance with articles 22-34 and the obligations in accordance with article 36 shall apply as soon as the amended national bank ordinance of 26 november 2015 enters into force.80 amended by no i of the snb o of 26 nov. 2015, in force since 1 jan. 2016 (as 2015 5307).81 sr 958.1art. 42 commencement this ordinance comes into force on 1 may 2004.annex82 82 amended by no ii of the snb o of 3 sept. 2009 (as 2009 6373). revised in accordance with no i of the snb o of 23 june 2011 (as 2011 5043), no ii of the snb o of 10 june 2013 (as 2013 1987), of 7 may 2014 (as 2014 3023), the corrections of 24 feb. 2015 (as 2015 643), of 10 march 2015 (as 2015 767), no ii of teh snb o of 26 nov. 2015 (as 2015 5307), no i of the snb o of 8 june 2017 (as 2017 6495), the correction of 30 jan. 2018 (as 2018 527), no ii of the snb o of 31 oct. 2019 (as 2019 3909) and of 2 july 2020, in force since 1 jan. 2020 (as 2020 4627).(art. 5 para. 1)surveys name of survey:comprehensive monthly balance sheetcoverage:balance sheet positions and fiduciary business based on the bank accounting regulations of the federal council83 and finma84; breakdown by residual maturity, by currency (swiss francs, us dollars, euros, yen), by domicile or residence of customers in switzerland or abroad, and by economic sector; on-balance sheet monetary claims and liabilities arising from repo transactions and from cash collateral for lending and other transactions; loans granted in cooperation with banks abroad - these loans are recorded in the foreign bank's balance sheettype of survey:partial sample surveyreporting institutions:banks whose balance sheet total and fiduciary business combined exceed chf 500 million breakdown by economic sector: banks whose domestic assets exceed chf 1.5 billionreporting entity:bank office; parent companyfrequency:monthlysubmission deadline after survey date:17 daysspecial provisions:-name of survey:selected balance sheet positions for monetary aggregate statisticscoverage:those balance sheet positions that permit monetary aggregates to be estimated at an early stagetype of survey:partial sample surveyreporting institutions:banks whose total m3-relevant balance sheet positions exceed chf 3 billionreporting entity:bank officefrequency:monthlysubmission deadline after survey date:10 daysspecial provisions:-name of survey:comprehensive year-end statisticscoverage:balance sheet positions and off-balance sheet business based on the bank accounting guidelines of the federal council85 and finma86; breakdown by residual maturity, by currency (swiss francs, us dollars, euros, yen), and by domicile or residence of customers in switzerland or abroad; profit and loss account and supplementary information; country breakdown of assets and liabilities and of fiduciary business; on-balance-sheet monetary claims and liabilities arising from repo transactions and from cash collateral for lending and other transactionstype of survey:full sample surveypartial sample survey for the country breakdownreporting institutions:all bankscountry breakdown: banks that are required to participate in the locational banking statisticsreporting entity:parent company; bank office and group for individual subsectionsfrequency:annuallysubmission deadline after survey date:3 monthsspecial provisions:-name of survey:credit volume statisticscoverage:lending activities (credit limits, utilisation, value adjustments, write-downs) and impaired receivables; broken down into mortgage loans and claims against customers (secured and unsecured), by residual maturity, by economic sector, by domicile or residence of customers in switzerland or abroad, and by the size of the borrower's companytype of survey:partial sample surveyreporting institutions:banks whose loans to domestic non-banks exceed chf 280 millionreporting entity:bank officefrequency:monthlysubmission deadline after survey date:20 daysspecial provisions:-name of survey:survey on loan qualitycoverage:information on loan quality (probability of default and expected loss) and loan volume; breakdown by economic sector, and by domicile or residence of customers in switzerland or abroadtype of survey:partial sample surveyreporting institutions:banks whose loans to domestic non-banks exceed chf 15 billionreporting entity:groupfrequency:quarterlysubmission deadline after survey date:2 monthsspecial provisions:-name of survey:lending rate statisticscoverage:form of credit, amount of loan, collateral, rating, interest rate, interest rate fixing, commission, term of credit and mode of repayment as well as characteristics of the borrower; all transactions based on new loan agreements shall be reported separatelytype of survey:partial sample surveyreporting institutions:banks whose loans to non-financial domestic companies exceed chf 2 billionreporting entity:bank officefrequency:monthlysubmission deadline after survey date:1 monthspecial provisions:-name of survey:bank lending surveycoverage:information on changes in lending criteria, lending conditions and demand for loans; breakdown of borrowers into companies (and by company size) and private households, by type of lending, by residual maturity, and by domicile or residence of customers in switzerland or abroad.information on market interest rates in price-setting; broken down into different market rates or interest rate curves, and by type of loantype of survey:partial sample surveyreporting institutions:banks whose loans to domestic non-banks exceed chf 8 billionsurvey on bank lending abroad: swiss-controlled banks whose loans to non-banks abroad exceed chf 10 billionreporting entity:bank officesurvey on bank lending abroad: groupfrequency:quarterly; every 2 yearssubmission deadline after survey date:20 daysspecial provisions:-name of survey:new mortgagescoverage:newly approved mortgage loans financing real estate in switzerland for the three following business trans-actions: (i) financing the purchase of real estate, (ii) refinanc-ing a loan with another lender or (iii) financing the construction of real estate. information on a loan's general characteristics (e.g. borrower, type of business transaction, credit limit, usage, collateral, income), the characteristics of the individual tranches (e.g. interest rate product, interest rate, interest rate and capital commitment) and the characteristics of the individual property (e.g. type, location, value, net rent)type of survey:partial sample surveyreporting institutions:banks whose domestic mortgage lending volume ex-ceeds chf 6 billionreporting entity:bank officefrequency:quarterlysubmission deadline after survey date:40 daysspecial provisions:-name of survey:interest rate statisticscoverage:published end-of-month interest rates for new trans- actions; interest rates for variable mortgages, fixed mortgages, mortgages tied to money market interest rates and consumer credits; interest rates for customer deposits (break-down by product characteristic), time deposits and cash bondstype of survey:partial sample surveyreporting institutions:banks whose total swiss-franc denominated customer deposits and cash bonds in switzerland exceed chf 500 million (excluding private bankers who do not actively seek deposits from the public)reporting entity:bank officefrequency:monthlysubmission deadline after survey date:10 daysspecial provisions:-name of survey:breakdown of selected balance sheet items, by interest ratecoverage:selected balance sheet positions broken down by interest rate and by domicile or residence of counterparty in switzerland or abroadtype of survey:partial sample surveyreporting institutions:banks whose swiss franc denominated liabilities arising from customer deposits exceed chf 4 billion or whose swiss franc denominated liabilities towards banks exceed chf 1.3 billionreporting entity:parent companyfrequency:quarterlysubmission deadline after survey date:1 monthspecial provisions:-name of survey:securities holdingscoverage:securities held in open customer custody accounts; breakdown by category of securities (in particular money market instruments, medium-term bank-issued notes, bonds, shares, units in collective investment schemes, structured products), by origin of the issuer (resident or non-resident) and by currency; breakdown of custody account holders by economic sector and by domicile or residence in switzerland or abroad; stock of borrowed securitiestype of survey:partial sample survey; full sample surveyreporting institutions:banks, central securities depositories and central counterparties with total securities in customer custody accounts exceeding chf 4.3 billion report on a monthly basis; all other banks, central securities depositories and central counterparties report once a yearreporting entity:bank officefrequency:monthly; annuallysubmission deadline after survey date:monthly reporting: 25 daysannual reporting: 3 monthsspecial provisions:-name of survey:securities turnovercoverage:turnover in open customer custody accounts from purchase and sales transactions; breakdown of custody account holders by domicile or residence in switzerland or abroad; breakdown of turnover by securities category (in particular money market instruments, medium-term bank-issued notes, bonds, shares, units in collective investment schemes, structured products), by origin of issuer (resident or non-resident) and by currencytype of survey:partial sample surveyreporting institutions:banks, central securities depositories and central counterparties that are required to participate in the monthly securities holdings statisticsreporting entity:bank officefrequency:quarterlysubmission deadline after survey date:25 daysspecial provisions:-name of survey:collective investment schemes statisticscoverage:assets and changes in the assets of collective investment schemes; value of the units issued and reimbursed respectively by the collective investment schemes; breakdown of assets by switzerland and other countries, by currency and by investment category (money market instruments, claims from repurchase transactions, bonds, shares and other equity securities, units in other collective investment schemes, structured products, land and buildings, other securities); breakdown of liabilities into switzerland and abroad; breakdown of collective investment schemes by legal form and by the legal type of open-ended collective investment schemes; income statementtype of survey:full sample surveyreporting institutions:fund management companies of swiss funds and swiss companies offering collective investment schemes in accordance with article 13 paragraph 2 of the collective investment schemes act of 23 june 200687reporting entity:-frequency:quarterlysubmission deadline after survey date:20 daysspecial provisions:-name of survey:solvency risk of counterparties in the interbank sectorcoverage:recording of the ten or twenty largest claims and liabilities positions vis--vis other banks or bank groups in switzerland and abroadtype of survey:full sample surveyreporting institutions:all banks or bank groupsreporting entity:groupfrequency:quarterlysubmission deadline after survey date:6 weeksspecial provisions:if the conditions set forth in article 5 paragraph 2 nbo are fulfilled, the deadline may be shortened to 24 hoursname of survey:fsb survey on granular institution-to-aggregate assets and liabilitiescoverage:country breakdown of items on the assets and liabilities sides of the balance sheet, as well as off-balance-sheet items, financial derivatives and foreign exchange derivatives; breakdown by economic sector, currency and residual maturity; information on different reporting levels. the survey follows the recommendations of the financial stability boardtype of survey:partial sample surveyreporting institutions:global systemically important banks in accordance with definition of the financial stability boardreporting entity:groupfrequency:quarterlysubmission deadline after survey date:2 monthsspecial provisions:-name of survey:imf coordinated portfolio investment surveycoverage:recording of the stock of securities of non-resident issuers in the open custody accounts of resident customers; breakdown by category of securities (money market instruments, bonds, shares, units in collective investment schemes, structured products and other securities) and by country of origin of the issuertype of survey:partial sample surveyreporting institutions:banks, central securities depositories and central counterparties with total reportable securities holdings exceeding chf 1.8 billionreporting entity:bank officefrequency:quarterlysubmission deadline after survey date:25 daysspecial provisions:-name of survey:bis locational banking statisticscoverage:country breakdown of items on the assets and liabilities sides of the balance sheet, as well as off-balance-sheet items; recording of local claims and liabilities of subsidiaries and branches; breakdown by economic sector, residual maturity and collateral. the survey follows the requirements of the bank for international settlements (bis)type of survey:partial sample surveyreporting institutions:banks which are required to report for the bis locational banking statistics, and which are either swiss-controlled or whose foreign parent company has no banking licencereporting entity:groupfrequency:quarterlysubmission deadline after survey date:2 monthsspecial provisions:-name of survey:bis locational banking statisticscoverage:country breakdown of the assets and liabilities sides of the balance sheet, as well as fiduciary transactions; breakdown by economic sector, currency and residual maturity. the survey follows the requirements of the bank for international settlementstype of survey:partial sample surveyreporting institutions:banks for which the sum of assets and fiduciary assets abroad or the sum of liabilities and fiduciary liabilities abroad exceeds chf 1 billionreporting entity:bank officefrequency:quarterlysubmission deadline after survey date:25 daysspecial provisions:-name of survey:bis otc derivatives statisticscoverage:foreign exchange and derivatives transactions according to the requirements of the bank for inter-national settlements; amounts outstanding; turnovertype of survey:partial sample surveyreporting institutions:half-yearly statistics: two largest bank groupsevery three years: banks with contract volumes of open derivative financial instruments exceeding chf 8 billion (for turnover) and chf 30 billion (for amounts outstanding)reporting entity:bank office (turnover); group (amounts outstanding)frequency:turnover: every three yearsamounts outstanding: semi-annually and every three yearssubmission deadline after survey date:1 month (turnover); 2 months (amounts outstanding)special provisions:-name of survey:current account surveycoverage:cross-border trade in goods (excluding foreign trade according to the statistics of the federal customs administration) and services, merchanting, trade related to manufacturing services on physical inputs and production abroad, cross-border labour income and investment income, and transfers according to the guidelines of the international monetary fund and the european union (eu) requirements under the agreement of 26 october 200488 between the swiss confederation and the european community on cooperation in the field of statistics. breakdown by country, type of transaction and economic sectortype of survey:partial sample surveyreporting institutions:legal entities and companies where the transaction value per reporting item exceeds chf 100,000reporting entity:-frequency:quarterly or annuallysubmission deadline after survey date:quarterly reporting: 1 monthannual reporting: 3 monthsspecial provisions:the reporting obligation is also fulfilled if the bank involved in the payment transactions reports the transactionname of survey:survey on cross-border capital linkagescoverage:cross-border capital flows (transactions), capital stocks (foreign assets and liabilities) and investment income according to the guidelines of the inter-national monetary fund (imf) and the european union (eu) requirements under the agreement of 26 october 200489 between the swiss confederation and the european community on cooperation in the field of statistics. breakdown by country, size of stocks and economic sector. the survey covers both intragroup relations (direct investment) and relations with third partiestype of survey:partial sample surveyreporting institutions:legal entities and companies where the transaction value exceeds chf 1 million per reporting item, or where the foreign assets or liabilities at the time of the survey exceed chf 10 million per reporting itemreporting entity:-frequency:quarterly or annuallysubmission deadline after survey date:quarterly reporting: 1 monthannual reporting: 3 monthsspecial provisions:the reporting obligation is also fulfilled if the bank entrusted with the payment transactions or the custody of the foreign assets reports the itemname of survey:cashless payment transactions - payment systemscoverage:amount and number of settled transactions, broken down by currency; number of direct participantstype of survey:partial sample surveyreporting institutions:payment systems operators settling payments that exceed chf 100 million (gross) per financial year (excluding so-called in-house payment systems)reporting entity:-frequency:monthlysubmission deadline after survey date:1 monthspecial provisions:-name of survey:cashless payment transactions - payment cards and other payment instrumentscoverage:data on payment cards and other payment instruments, broken down into credit cards, debit cards and e-money: amount and number of transactions breakdown by location of transaction (domestics and foreign), by type of transaction (card present and card not present transactions for the purchase of goods and services; cash withdrawals) by card origin (domestic and foreign), and by business activity of the merchant (industry breakdown); number of cards; number of terminals; for e-money only: float and loading (amount of electronically stored monetary value)type of survey:partial sample surveyreporting institutions:issuers and acquirers (excluding atm acquirers) of credit cards settling payments that exceed chf 100 million (gross) per financial yearissuers and acquirers (excluding atm acquirers) of debit cards settling payments that exceed chf 100 million (gross) per financial yearissuers and acquirers (excluding atm acquirers) of e-money settling payments that exceed chf 50 million (gross) per financial yearreporting entity:-frequency:monthlysubmission deadline after survey date:1 monthspecial provisions:-name of survey:customer payment transactionscoverage:customer payments initiated at or received by banks within a given month. divided into incoming and outgoing payments, and then subdivided by type of order. payments are broken down into domestic payments and those involving a bank domiciled abroad, and also by currency. specific cash withdrawals and deposits, as well as data on bank infrastructure.type of survey:partial sample surveyreporting institutions:banks whose annual number of transactions in swiss interbank clearing exceeds 5 millionreporting entity:bank officefrequency:monthlysubmission deadline after survey date:1 monthspecial provisions:-name of survey:automated teller machines (atms)coverage:number of atmstype of survey:full sample surveyreporting institutions:operators of atm networksreporting entity:-frequency:monthlysubmission deadline after survey date:1 monthspecial provisions:-83 chap. 4, art. 25-42 of the banking o of 30 april 2014 (sr 952.02). 84 finma accounting o of 31 oct. 2019 (sr 952.024.1), as well as finma circular 2020/1 'accounting - banks' of 31 oct. 2019.85 chap. 4, art. 25-42 of the banking o of 30 april 2014 (sr 952.02).86 finma accounting o of 31 oct. 2019 (sr 952.024.1), as well as finma circular 2020/1 'accounting - banks' of 31 oct. 2019.87 sr 951.3188 sr 0.431.026.8189 sr 0.431.026.81

951.31english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal act on collective investment schemes(collective investment schemes act, cisa)of 23 june 2006 (status as of 1 january 2020) the federal assembly of the swiss confederation,based on articles 98 paragraphs 1 and 2 and 122 paragraph 1 of the federal constitution1, and having considered the federal council dispatch of 23 september 20052,decrees:1as 2006 5379 sr 1012 bbl 2005 6395title 1 general provisions chapter 1 aim and scope of application art. 1 aim this act aims to protect investors and to ensure transparency and the proper functioning of the market for collective investment schemes.art. 2 scope of application 1 this act governs the following, irrespective of their legal status:a.3collective investment schemes and persons who are responsible for the safekeeping of assets held in them;b.4foreign collective investment schemes which are offered in switzerland;c.-e.5.f.persons who represent foreign collective investment schemes in switzerland.62 the following are not governed by this act:a.institutions and ancillary institutions in the occupational pensions sector, in- cluding investment foundations;b.social security institutions and compensation funds;c.public authorities and institutions;d.operating companies which are engaged in business activities;e.companies which by way of a majority of the votes or by any another way bring together one or more companies to form a group under single man- agement (holding companies);f.investment clubs whose members are in a position to manage their financial interests themselves;g.associations and foundations as defined in the swiss civil code7;h.8.2bis .93 investment companies in the form of a swiss company limited by shares are not governed by this act, provided they are listed on a swiss exchange, or provided that:10a.11only shareholders as defined in article 10 paragraphs 3 and 3ter are entitled to participate in them; andb.their shares are registered.124 .133 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).4 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).5 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).6 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).7 sr 2108 inserted by no i of the fa of 28 sept. 2012 (as 2013 585; bbl 2012 3639). repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).9 inserted by no i of the fa of 28 sept. 2012 (as 2013 585; bbl 2012 3639). repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).10 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).11 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).12 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).13 repealed by no i of the fa of 28 sept. 2012, with effect from 1 march 2013 (as 2013 585; bbl 2012 3639).art. 3-614 14 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).chapter 2 collective investment schemes art. 7 definition 1 collective investment schemes are assets raised from investors for the purpose of collective investment, and which are managed for the account of such investors. the investment requirements of the investors are met on an equal basis.2 collective investment schemes may be open or closed-ended.3 the federal council may stipulate a minimum number of investors in accordance with the legal status and target group. it may authorise collective investment schemes for a single qualified investor (single investor fund) in accordance with article 10 paragraph 3 in conjunction with article 4 paragraph 3 letters b, e and f of the financial services act of 15 june 201815 (finsa).16 174 in the case of single investor funds, the fund management company and the in- vestment company with variable capital (sicav) may delegate the investment decisions to the single investor. finma may exempt them from the duty to subject themselves to supervision recognised under article 31 paragraph 3 and article 36 paragraph 3, respectively.185 collective investment schemes must have their registered office and head office in switzerland.1915 sr 950.116 second sentence amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).17 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639)18 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639)19 inserted by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).art. 8 open-ended collective investment schemes 1 open-ended collective investment schemes may be in the form of a contractual fund (art. 25 et seq.) or sicav (art. 36 et seq.).2 with open-ended collective investment schemes, investors have either a direct or indirect legal entitlement, at the expense of the collective assets, to redeem their units at the net asset value.3 each open-ended collective investment scheme has its own fund regulations. in the case of contractual funds this is the collective investment contract (fund contract), and in the case of sicavs it is the articles of association and the investment regulations.art. 9 closed-ended collective investment schemes 1 closed-ended collective investment schemes may be in the form of a limited partnership for collective capital investments (art. 98 et seq.) or an investment company with fixed capital (sicaf, art. 110 et seq.).2 in the case of closed-ended collective investment schemes, investors have neither a direct nor an indirect legal entitlement at the expense of the collective assets to the redemption of their units at the net asset value.3 limited partnerships for collective investment are based on a company agreement.4 sicafs are based on articles of association and issue a set of investment regulations.art. 10 investors 1 investors are natural and legal persons, as well as general and limited partnerships, which hold units in collective investment schemes.2 collective investment schemes are open to all investors, except where this act, the fund regulations or the articles of association restrict investor eligibility to qualified investors.3 qualified investors within the meaning of this act are professional clients as defined in article 4 paragraphs 3-5 or article 5 paragraphs 1 and 4 finsa20:213bis .223ter qualified investors also include retail clients for whom a financial intermediary in accordance with article 4 paragraph 3 letter a finsa or a foreign financial intermediary that is subject to equivalent prudential supervision provides portfolio management or investment advice in accordance with article 3 letter c items 3 and 4 finsa within the scope of a permanent portfolio management or investment advice relationship, provided they have not declared that they do not wish to be treated as such. such declaration must be made in writing or in another form demonstrable via text.234 .245 the finma may fully or partially exempt collective investment schemes from certain provisions of the financial market acts within the meaning of article 1 paragraph 1 of the financial market supervision act of 22 june 200725 (finmasa), provided that they are exclusively open towards qualified investors and that the protective purpose of this act is not impaired, specifically from the provisions concerning:26a.27.b.28.c.the requirement to produce a semi-annual report;d.the requirement to provide investors with the right to terminate their invest- ment at any time;e.the requirement to issue and redeem units in cash;f.risk diversification.20 sr 950.121 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).22 inserted by no i of the fa of 28 sept. 2012 (as 2013 585; bbl 2012 3639). repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).23 inserted by no i of the fa of 28 sept. 2012 (as 2013 585; bbl 2012 3639). amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).24 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).25 sr 956.126 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).27 repealed by no i of the fa of 28 sept. 2012, with effect from 1 june 2013 (as 2013 585; bbl 2012 3639).28 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).art. 11 units units are claims against the fund management company conferring entitlement to the assets and income of the investment fund or interests in the investment company.art. 12 protection against confusion or deception 1 the designation collective investment scheme must not provide any grounds for confusion or deception, in particular in relation to the investments.2 designations such as investment fund, investment company with variable capital, sicav, limited partnership for collective investment, investment company with fixed capital and sicaf may only be used for the relevant collective investment schemes governed by this act.2929 amended by no iii of the fa of 25 sept. 2015 (law on business names), in force since 1 july 2016 (as 2016 1507; bbl 2014 9305).chapter 3 authorisation and approval section 1 general art. 13 duty to obtain authorisation 1 any party who establishes or operates a collective investment scheme or is responsible for the safekeeping of the assets held in it requires authorisation from finma.302 the following must apply for authorisation:a.31.b.sicavs;c.limited partnerships for collective investment;d.sicafs;e.32the custodian bank;f. und g.33 .h.representatives of foreign collective investment schemes.3 representatives who are already subject to other equivalent official supervision may be granted exemption from the duty to obtain authorisation by the federal council.344 .355 the persons cited in paragraph 2 letters b-d may only be entered in the commercial register once authorisation has been granted by finma.3630 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).31 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).32 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).33 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).34 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).35 repealed by no i of the fa of 28 sept. 2012, with effect from 1 march 2013 (as 2013 585; bbl 2012 3639).36 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 14 authorisation requirements 1 authorisation is granted if:a.37the persons under article 13 paragraph 2 and the persons responsible for the administration and management provide the guarantee of irreproachable business conduct; abis.38the persons responsible for the administration and management enjoy a good reputation and possess the specialist qualifications required for the function;b.the significant equity holders have a good reputation and do not exert their influence to the detriment of prudent and sound business practice;c.compliance with the duties stemming from this act is assured by internal regulations and an appropriate organisational structure;d.sufficient financial guarantees are available;e.the additional authorisation conditions listed in the relevant provisions of the act are met.1bis insofar as the financial guarantees are used to meet minimal capital requirements, the federal council may stipulate higher capital requirements than required by the code of obligations39.401ter the federal council may stipulate additional authorisation conditions if this is consistent with recognised international standards.412 .423 the following are deemed to be significant equity holders, provided they directly or indirectly control at least 10 percent of the capital or votes in the persons specified in article 13 paragraph 2 or can materially influence their business activities in another way:a.natural and legal persons;b.general and limited partnerships;c.financially related parties which meet this criterion on a combined basis.4337 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).38 inserted by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).39 sr 22040 inserted by annex no 14 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).41 inserted by no i of the fa of 28 sept. 2012 (as 2013 585; bbl 2012 3639). amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).42 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).43 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 15 duty to obtain approval 1 the following documents are required for obtaining the approval of finma:a.for investment fund, the collective investment contract (art. 25);b.for sicavs, the articles of association and investment regulations;c.for limited partnerships for collective investment, the company agreement;d.sicafs, the articles of association and investment regulations;e.44the relevant documents of foreign collective investment schemes which are offered to non-qualified investors.2 if an investment fund or sicav is structured as an open-ended collective invest- ment scheme with subfunds (art. 92 et seq.), each subfund or category of shares requires individual approval.44 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 16 change in circumstances if there is a change in the circumstances underlying the authorisation or approval, finma's authorisation or approval must be sought prior to the continuation of activity.art. 17 simplified authorisation and approval procedure the federal council may specify a simplified authorisation and approval procedure process for collective investment schemes.section 2 . art. 18-18c45 45 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901)section 3 . art. 1946 46 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).chapter 4 protection of investors' interests47 47 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901). art. 20 principles 1 persons who manage or represent collective investment schemes or hold the assets of these schemes in safekeeping, as well as their agents must fulfil the following duties in particular:48a.duty of loyalty: they act independently and exclusively in the interests of the investors;b.due diligence: they implement the organisational measures that are necessary for irreproachable business conduct;c.49duty to provide information: they shall render account of the collective investment schemes which they manage and represent and the assets of these schemes which they hold in safekeeping, and provide information on all of the fees and costs incurred directly or indirectly by investors as well as compensation from third parties, particularly commissions, discounts or other financial benefits.2 .503 persons who manage or represent collective investment schemes or hold their assets in safekeeping, as well as their agents, shall take all necessary precautions to ensure that all duties in relation to all their business activities are performed properly.5148 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).49 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).50 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).51 inserted by no i of the fa of 28 sept. 2012 (ru 2013 585; bbl 2012 3639). amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).art. 21 investments 1 persons who manage or represent collective investment schemes or hold their assets in safekeeping, as well as their agents shall pursue an investment policy that at all times corresponds with the investment characteristics of the collective investment scheme as set out in the relevant documents.522 in respect of the purchase and sale of assets and rights on their own behalf as well as that of third parties, they are only entitled to receive the fees specified in the relevant documents. compensation in accordance with article 26 finsa53 must be credited to the collective investment scheme.54 3 assets acquired for their own account may only be purchased at market price, while any sale of own-account assets must also be at market price.52 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).53 sr 950.154 second sentence amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).art. 2255 55 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).art. 23 exercising membership and creditors' rights 1 the membership and creditors' rights associated with the investments must be exercised independently and exclusively in the interests of the investors.2 article 685d paragraph 2 of the code of obligations56 does not apply to investment funds.3 if a fund management company manages several investment funds, the level of the participation with respect to the percentage limit set out in article 685d paragraph 1 of the code of obligations is calculated individually for each investment fund.4 paragraph 3 also applies to each subfund of an open-ended collective investment scheme as defined in article 92 et seq.56 sr 220art. 2457 57 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).title 2 open-ended collective investment schemes chapter 1 the contractual fund section 1 definition art. 25 1 the contractual fund (investment fund) is based on a collective investment agree- ment (fund contract) under which the fund management company commits itself to:a.involving investors in accordance with the number and type of units which they have acquired in the investment fund;b.managing the fund's assets in accordance with the provisions of the fund contract at its own discretion and for its own account.2 the custodian bank is a party to the contract in accordance with the tasks conferred on it by the law and by the fund contract.3 the investment fund must have the stipulated minimum assets. the federal coun- cil determines the level thereof, and the period in which it must be accumulated.section 2 the fund contract art. 26 content 1 the fund management company draws up the fund contract and, with the consent of the custodian bank, submits it to finma for approval.2 the fund contract sets out the rights and duties of the investors, the fund manage- ment company and the custodian bank.3 the federal council determines the minimum contents.5858 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 27 amendments to the fund contract 1 amendments to the fund contract must be submitted by the fund management company, with the consent of the custodian bank, to finma.2 if the fund management company amends the fund contract, it must publish a summary of the significant amendments in advance, in which reference is made to the locations where the full wording of the contractual amendments may be obtained free of charge.3 these publications must inform investors of their right to lodge objections with finma within 30 days of their publication. the procedure is based on the federal act on administrative procedure of 20 december 196859. investors must further- more be made aware that they may request the repayment of their units in cash, while observing the contractual or regulatory notice period.604 finma publishes its decision in the media of publication.59 sr 172.02160 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (ru 2013 585; bbl 2012 3639).section 3 . art. 28-3561 61 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).chapter 2 investment company with variable capital section 1 general provisions art. 36 definition and duties62 1 sicav is a company:a.whose capital and number of shares are not specified in advance;b.whose capital is divided into company and investor shares;c.for whose liabilities only the company's assets are liable;d.whose sole object is collective capital investment.2 a sicav shall have a minimum level of assets. the federal council determines the level and the period within which it must be accumulated.3 the sicav may delegate investment decisions only to persons who hold the authorisation required for this activity. articles 14 and 35 of the financial institutions act of 15 june 201863 (finia) apply mutatis mutandis.64 62 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).63 sr 954.164 inserted by by no i of the fa of 28 sept. 2012 (as 2013 585; bbl 2012 3639). amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 37 formation 1 the formation of a sicav is based on the provisions of the code of obligations65 regarding the formation of companies limited by shares, with the exception of the provisions regarding contributions in kind, acquisitions in kind and special privileges.2 the federal council specifies the minimum investment amount for a sicav on its formation.663 .6765 sr 22066 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).67 repealed by no i of the fa of 28 sept. 2012, with effect from 1 march 2013 (as 2013 585; bbl 2012 3639).art. 38 company name 1 the company name must contain a description of the legal status or the abbrevia- tion thereof (sicav).2 in all other respects, the provisions of the code of obligations68 regarding the name of companies limited by shares apply.68 sr 220art. 39 capital adequacy 1 there must be an appropriate relationship between the holdings of the company shareholders and the total assets of the sicav. the federal council regulates this relationship.2 in special cases, finma may grant a relaxation of the requirements or may order a tightening thereof.art. 40 shares 1 the company shares are registered.2 the company and investor shares have no nominal value and must be fully paid up in cash.3 the shares are freely transferable. the articles of association may restrict investor eligibility to qualified investors if the shares of the sicav are not listed on an exchange. if the sicav withholds its consent to a transfer of the shares, article 82 applies.4 the articles of association may specify different categories of shares, to which different rights are assigned.5 the issuing of participation certificates, dividend right certificates and preference shares is prohibited.art. 41 company shareholders 1 the company shareholders contribute the minimum holding necessary for the formation of the sicav.2 they resolve the dissolution of the sicav and its subfunds in accordance with article 96 paragraphs 2 and 3.693 in all other respects, the provisions regarding the rights of the shareholders (art. 46 et seq.) apply.4 the rights and duties of the company shareholders pass to the purchaser on the transfer of the shares.69 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 42 issue and redemption of shares 1 unless the law and articles of association provide otherwise, a sicav may at any time issue new shares at the net asset value and must, if requested by a shareholder, at any time redeem issued shares at the net asset value. this requires neither an amendment to the articles of association nor an entry in the commercial register.2 a sicav may not hold treasury shares, whether directly or indirectly.3 the shareholders have no entitlement to the portion of newly issued shares corresponding to their previous holding. in the case of real estate funds, this is subject to article 66 paragraph 1.4 in all other respects, the issue and redemption of shares is conducted in accordance with articles 78-82.art. 43 articles of association 1 the articles of association must contain provisions concerning: a.the company name and its registered office;b.the objects;c.the minimum investment amount;d.the convening of general meetings;e.the executive and governing bodies;f.the media of publication.2 to be effective, the articles of association must include provisions on the following:a.the term;b.the restriction of shareholder eligibility to qualified investors and associated limitation of the transferability of shares (art. 40, para. 3);c.the categories of shares and rights associated therewith;d.the delegation of management and representation, and the attendant procedural details (art. 51);e.the passing of resolutions by means of correspondence.art. 44 investment regulations a sicav shall produce a set of investment regulations. its contents are based on the provisions regarding the fund contract, unless the law and articles of association provide otherwise.art. 44a70 custodian bank 1 the sicav must appoint a custodian bank in accordance with articles 72-74.2 finma may grant exemptions from this duty if justified, provided:a.the sicav is exclusively open to qualified investors;b.one or more institutions which are subject to equivalent supervision execute the transactions related to settlement and specialise in such transactions (prime broker); andc.it is ensured that the prime broker or the foreign supervisory authority responsible for the prime broker will provide finma with all the information and documents that it requires to carry out its duties.70 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 4571 relationship with the financial market infrastructure act the provisions on public takeover offers (arts. 125 to 141 of the financial market infrastructure act of 19 june 201572) do not apply to sicavs.71 amended by annex no 9 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).72 sr 958.1section 2 shareholders' rights and obligations73 73 amended by no i 6 of the fa of 12 dec. 2014 on the implementation of the revised recommendations 2012 of the financial action task force, in force since 1 july 2015 (as 2015 1389; bbl 2014 605). art. 46 membership rights 1 any person recognised as a shareholder by the sicav may exercise membership rights.2 the shareholders may represent their shares at a general meeting in person or be represented by a third party. unless the articles of association provide otherwise, the third party need not be a shareholder.3 a sicav shall keep a register of the shares, in which the names and addresses of company shareholders are recorded. it shall also keep a register under article 697l of the code of obligations74 of the beneficial owners of the shares held by company shareholders.754 the articles of association may specify that the company shareholders and investor shareholders are both entitled to at least one seat on the board of directors in the case of self-managed as well as externally managed sicavs.7674 sr 22075 second sentence inserted by no i 6 of the fa of 12 dec. 2014 on the implementation of the revised recommendations 2012 of the financial action task force, in force since 1 july 2015 (as 2015 1389; bbl 2014 605).76 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 46a77 company shareholders' obligation to give notice 1 company shareholders whose shares are not listed on a stock exchange are subject to the obligation to give notice under article 697j of the code of obligations78.2 the consequences of failure to comply with obligation to give notice are governed by article 697m of the code of obligations.77 inserted by no i 6 of the fa of 12 dec. 2014 on the implementation of the revised recommendations 2012 of the financial action task force, in force since 1 july 2015 (as 2015 1389; bbl 2014 605).78 sr 220art. 4779 voting rights 1 each share carries one vote.2 the federal council may authorise finma to order the splitting or merging of shares in a share class.79 amended by annex no 14 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).art. 48 inspection rights inspection rights are based on the provisions of the code of obligations80 regarding the shareholders' inspection rights unless this act provides otherwise.80 sr 220art. 49 other rights in all other respects, articles 78 et seq. apply.section 3 organisation art. 50 general meeting 1 the supreme governing body of the sicav is the general meeting of shareholders.2 the general meeting is held every year within four months of the close of the business year.3 unless otherwise provided for by the federal council, in all other respects, the provisions of the code of obligations81 regarding the general meetings of companies limited by shares apply.8281 sr 22082 amended by annex no 14 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).art. 51 board of directors 1 the board of directors consists of at least three but no more than seven members.2 the articles of association may authorise the board of directors to transfer management and representation in full or in part to individual members or third parties in accordance with the organizational regulations.3 the persons holding executive powers at the sicav and custodian bank must be independent of the other party.4 the board of directors fulfils the duties associated with the offering of financial instruments under title 3 of the finsa83.845 the administration of a sicav may be delegated only to an authorised fund management company in accordance with article 32 finia85 that has authorisation.866 unless otherwise provided for by the federal council, in all other respects, the provisions of the code of obligations87 regarding the board of directors of companies limited by shares apply.8883 sr 950.184 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).85 sr 954.186 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).87 sr 22088 amended by annex no 14 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).art. 52 audit company a sicav shall appoint an audit company (art. 126 et seq.).chapter 3 types of open-ended collective investment schemes and investment regulations section 1 securities funds art. 53 definition securities funds are open-ended collective investment schemes which invest their assets in securities and comply with the laws of the european communities.art. 54 permitted investments 1 securities funds may invest in transferable securities issued on a large scale and in non-securitised rights having the same function (uncertified securities) and which are traded on a stock exchange or another regulated market that is open to the public, in addition to other liquid financial assets.2 the fund management company may also hold a limited volume of other securities and rights, as well as adequate liquidity.art. 55 investment techniques 1 the fund management company and the sicav may employ the following in- vestment techniques for the purpose of efficient management:a.securities lending;b.repurchase agreements;c.borrowing of funds, though only on a temporary basis and up to a certain percentage;d.pledging or transferring the ownership of collateral, however, only up to a certain percentage.2 the federal council may permit other investment techniques such as short selling and the granting of loans.3 it defines the percentage limits. finma regulates the details.art. 56 use of derivatives 1 the fund management company and the sicav may conduct transactions in derivatives provided:a.such transactions do not result in a change to the investment characteristics of the securities fund;b.they have an appropriate organisational structure and adequate risk management;c.the persons entrusted with processing and monitoring are qualified to do so, and can at all times comprehend and track the effect of the derivatives used.2 the overall exposure to transactions involving derivatives may not exceed a certain percentage of the fund's net assets. exposure to transactions involving derivatives must be calculated in relation to the statutory and regulatory limits, specifically with regard to risk diversification.3 the federal council determines the percentage rate. finma regulates the details.art. 57 risk diversification 1 in relation to their investments, the fund management company and sicav must comply with the principles of risk diversification. as a rule, they may invest only a certain percentage of the fund's assets in the same debt issuer or company.2 the voting rights acquired through the purchase of securities or rights in a single debt issuer or company may not exceed a certain percentage.3 the federal council decides the percentage rates. finma regulates the details.section 2 real estate funds art. 58 definition real estate funds are open-ended collective investment schemes which invest their assets in real estate.art. 59 permitted investments 1 real estate funds may invest their assets in:a.property, including fixtures and fittings;b.investments in and claims on real estate companies whose sole objective is the purchase and sale and/or the rental and lease of their own property, provided that at least two thirds of their capital and voting rights are incorporated in the investment fund;c.units in other real estate investment funds and listed real estate investment companies amounting to no more than 25% of the fund's total assets;d.foreign real estate securities whose value can be adequately valued.2 co-ownership of property is permitted only if the fund management company or the sicav can exert a dominant influence.art. 60 securing liabilities in order to secure their liabilities, the fund management company and sicav must maintain an adequate proportion of the fund's assets in short-term fixed-interest securities or in funds available at short notice.art. 61 use of derivatives the fund management company and sicav may conduct derivative transactions provided they comply with the investment policy. the provisions concerning the use of derivatives for securities funds (art. 56) shall apply accordingly.art. 62 risk diversification investments must be diversified by type of property, purpose of use, age, building fabric and location.art. 63 special duties 1 the fund management company shall bear responsibility with regard to the investors for ensuring that the real estate companies belonging to the real estate fund comply with this act and with the fund regulations.2 the fund management company, custodian bank and its agents, as well as closely related natural and legal persons, may not acquire real estate assets from real estate funds or assign any such assets to them.3 a sicav may not acquire any real estate assets from the company shareholders, their agents, or closely connected natural or legal persons, nor may it assign such assets to them.4 if justified, individual situations may arise where finma may grant an exemption from the ban on transactions with closely related persons as defined in paragraphs 2 and 3 if this is in the interest of the investors. the federal council regulates the exemption criteria.8989 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 64 valuation experts90 1 the fund management company and the sicav shall appoint at least two natural persons or one legal person as valuation experts. appointments require the approval of finma.912 approval is granted if the valuation experts:92a.possess the necessary qualifications;b.are independent;c.93.3 the valuation experts must conduct their valuations with the due diligence and expertise required of a valuation expert.944 finma may make recognition dependent on the conclusion of professional indemnity insurance or on the evidence of financial guarantees.955 it may stipulate additional requirements for the valuation experts and describe the valuation methods to be adopted.9690 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).91 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).92 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).93 repealed by no i of the fa of 28 sept. 2012, with effect from 1 march 2013 (as 2013 585; bbl 2012 3639).94 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).95 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).96 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 65 special powers 1 the fund management company and the sicav may commission the construction of buildings provided the fund regulations explicitly permit the purchase of building land and the execution of construction projects.2 they may pledge land and cede the rights of lien as collateral; however, the en- cumbrance may not exceed on average a certain percentage of the market value of all real estate assets.3 the federal council defines the percentage rate. finma regulates the details.art. 66 issue and redemption of units 1 the fund management company and the sicav must offer new units first to existing investors.2 the investors may request the redemption of their units at the end of a financial year provided they give twelve months' prior notice.art. 67 trading the fund management company and the sicav ensure that real estate fund units are regularly traded via a bank or a securities dealer on a stock exchange or over the counter.section 3 other funds for traditional and alternative investments art. 68 definition other funds for traditional and alternative investments are open-ended collective investment schemes that are neither securities funds nor real estate funds.art. 69 permitted investments 1 in particular, investments in securities, precious metals, real estate, commodities, derivatives, units of other collective investment schemes, as well as other assets and rights, are permitted for other funds for traditional and alternative investments.2 the following investments in particular may be conducted for these funds:a.those that have only limited marketability;b.those that are subject to strong price fluctuations;c.those that exhibit limited risk diversification;d.those that are difficult to value.art. 70 other funds for traditional investments 1 other funds for traditional investments include open-ended collective investment schemes which in terms of their investments, investment techniques and investment restrictions exhibit a risk profile that is typical for traditional investments.2 other funds for traditional investments are subject to the provisions concerning the use of investment techniques and derivatives for securities funds.art. 71 other funds for alternative investments 1 other funds for alternative investments include open-ended collective investment schemes whose investments, structure, investment techniques (short-selling, borrowing of funds, etc.) and investment restrictions exhibit a risk profile that is typical for alternative investments.2 leverage is permitted only up to a certain percentage of the fund's net assets. the federal council determines the percentage rate. finma regulates the details.3 reference must be made in the fund name and in the prospectus and key information document in accordance with title 3 of the finsa97, as well as in advertising material, to the special risks involved in alternative investments.984 .995 finma may allow the transaction-related settlement services of a directly invest- ing other fund for alternative investments to be provided by a regulated institution specializing in such transactions (prime broker). it may specify which monitoring functions must be undertaken by the fund management company and the sicav.97 sr 950.198 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).99 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).chapter 4 common provisions section 1 custodian bank art. 72 organisation 1 the custodian bank must be a bank pursuant to the federal act on banks and savings banks of 8 november 1934100 and have an appropriate organisational structure to act as custodian bank to collective investment schemes.1012 in addition to the persons entrusted with the management, the persons entrusted with the tasks of custodian bank activity must also comply with the requirements laid down in article 14 paragraph 1 letter a.100 sr 952.0101 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 73 duties 1 the custodian bank is responsible for the safekeeping of the investment fund's assets, the issue and redemption of units, as well as payment transfers on behalf of the investment fund.2 it may transfer the responsibility for the safekeeping of the investment fund's assets to third-party custodians and central securities depositories in switzerland or abroad, provided this is in the interest of efficient safekeeping. investors must be informed in the prospectus and key information document in accordance with title 3 of the finsa102 about the risks associated with such transfers.1032bis financial instruments may only be transferred (paragraph 2) to regulated third-party custodians and central securities depositories. this does not apply to mandatory safekeeping at a location where the transfer to regulated third-party custodians and collective securities depositories is not possible, in particular due to mandatory legal provisions or to the investment product's modalities. investors must be informed in the product documentation of safekeeping by non-regulated third-party custodians or collective securities depositories.1043 the custodian bank ensures that the fund management company or the sicav complies with this act and with the fund regulations. it verifies whether:105a.the calculation of the net asset value and of the issue and redemption prices of the units is in compliance with this act and with the fund regulations;b.the investment decisions are in compliance with this act and with the fund regulations;c.the income is appropriated in accordance with the fund regulations.4 the federal council regulates the requirements for acting as a custodian bank and may specify parameters for the protection of the securities investments.106102 sr 950.1103 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).104 inserted by no i of the fa of 28 sept. 2012 (as 2013 585; bbl 2012 3639). amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).105 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).106 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 74 change of custodian bank 1 in the case of investment funds, the provisions concerning a change of fund management company (art. 39 finia107) also apply accordingly to a change of custodian bank.1082 in the case of a sicav, a change of custodian bank requires a contract in writing or in another form demonstrable via text, and must be approved in advance by finma.1093 finma shall publish its decision in the media of publication.107 sr 954.1108 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).109 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).section 2 . art. 75-77110 110 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).section 3 position of investors art. 78 purchase and redemption 1 on concluding a contract, or subscribing and paying in cash, investors acquire:a.in the case of an investment fund, a claim against the fund management company to participate in the assets and income of the investment fund in accordance with the fund units they acquire;b.in the case of a sicav, an interest in the company and its unappropriated net earnings in accordance with the shares they acquire.2 they are, in principle, entitled at all times to request the redemption of their units and payment of the redemption amount in cash. unit certificates must be returned for cancellation purposes.3 in the case of collective investment schemes with various unit classes, the federal council regulates the details.4 finma may allow a derogation from the duty to make payments in and out of the fund in cash.5 in the case of collective investment schemes with subfunds, the asset entitlements are based on article 93 paragraph 2 and article 94 paragraph 2.art. 79 exceptions from the right to redeem at any time 1 in accordance with the investment provisions (art. 54 et seq., art. 59 et seq. and art. 69 et seq.), the federal council may in the case of collective investment schemes whose value is difficult to ascertain, or which have limited marketability, specify exemptions from the right to redeem at any time.2 however, it may only suspend the right to redeem at any time for a maximum period of five years.art. 80 issue and redemption price the issue and redemption prices of the units are based on the net asset value per unit on the day of valuation, plus or minus any fees and expenses.art. 81 deferred repayment 1 the federal council determines in which instances the fund regulations may specify a limited deferment of the repayment of the units in the interest of all investors.2 finma may in exceptional instances grant limited deferment for the repayment of the units in the interest of all investors.art. 82 enforced redemption the federal council enforces redemption if:a.this is necessary to safeguard the reputation of the financial market, and specifically to combat money laundering;b.the investor no longer meets the statutory, regulatory or contractual requirements, or the requirements set out in the articles of association, for participation in a collective investment scheme.art. 83 calculation and publication of the net asset value 1 the net asset value of an open-ended collective investment scheme is calculated at the market value as of the end of the financial year, and on each day on which units are issued or redeemed.2 the net asset value per unit represents the market value of the fund's assets, less all the fund's liabilities, divided by the number of units in circulation.3 finma may permit a method of calculating the net asset value(s) that differs from that specified in paragraph 2, provided such method meets international standards and the protective purpose of this act is not impaired as a result.4 the fund management company and the sicav publish the net asset values at regular intervals.art. 84 right to information 1 the fund management company and the sicav shall on request supply investors with information concerning the basis for the calculation of the net asset value per unit.2 if investors express an interest in more detailed information on specific business transactions effected by the fund management company or the sicav, such as the exercising of membership and creditors' rights, or on risk management, they must be given such information at any time.1113 the investors may request at the courts of the registered office of the fund management company or the sicav that the audit company or another expert investigate the matter which requires clarification and furnish the investors with a report.111 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 85 claim for reimbursement if the open-ended collective investment scheme is unlawfully denied asset entitlements or benefits are withheld from it, the investors may claim compensation from the open-ended collective investment scheme concerned.art. 86 representative of the investors 1 the investors may request that the courts appoint a representative if they wish to pursue a claim for damages in favour of the open-ended collective investment scheme.2 the court shall give notice of the appointment in the media of publication of the open-ended collective investment scheme.3 the representative has the same rights as the investors.4 if the representative files an action for damages in favour of the open-ended collective investment scheme, the investors may no longer exercise their individual right to file such an action.5 unless the court decides otherwise, the expenses incurred by the representative are paid by the investment fund.section 4 accounting, valuation and financial statements art. 87 accounting duty separate books of account must be kept for each open-ended collective investment scheme. unless this act or the implementing regulations provide otherwise, article 662 et seq. of the code of obligations112 apply.112 sr 220. today, art. 957 et seq.art. 88 valuation at market value 1 investments which are listed on a stock exchange or another regulated market open to the public shall be valued at the prices paid on the main market.2 other investments for which no current price is available must be valued at the price that would probably be obtained in a diligent sale at the time of valuation.art. 89 annual and semi-annual report 1 an annual report shall be published for each open-ended collective investment scheme within four months of the close of the financial year; it shall contain the following data in particular:a.the annual accounts consisting of a statement of net assets or the balance sheet and the profit and loss account, together with information concerning the appropriation of net income and the disclosure of expenses;b.the number of units redeemed and newly issued during the financial year, as well as the final balance of the issued units;c.the inventory of the fund's assets at market value and the resulting value (net asset value) of a fund unit as of the last day of the financial year;d.the valuation principles as well as the principles used for the calculation of the net asset value;e.a breakdown of the buy and sell transactions;f.the names of persons and companies to which duties have been entrusted;g.information relating to matters of particular economic or legal significance, specifically:1.amendments to the fund regulations,2.material questions concerning interpretation of this act and the fund regulations,3.a change of fund management company and custodian bank,4.113changes concerning the executive officers at the fund management company, sicav or asset manager of collective investment schemes,5.legal disputes;h.the performance of the open-ended collective investment scheme, possibly benchmarking it with comparable investments;i.a brief report by the audit company regarding the information mentioned above, as well as the items set out in article 90 in the case of real estate funds.2 the statement of net assets of the investment fund and the balance sheet of the sicav must be prepared on the basis of market values.3 a semi-annual report must be issued within two months after the end of the first half of the financial year. the report contains an unaudited statement of net assets or unaudited balance sheet and income statement, as well as information as per paragraph 1 letters b, c and e.4 the annual and semi-annual reports shall be filed with finma the latest at the time of publication.5 these are made available for inspection free of charge to interested parties for ten years.113 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 90 annual accounts and annual report of real estate funds 1 the annual accounts of a real estate fund consist of a consolidated statement of net assets or balance sheet and profit and loss account of the real estate fund and the associated real estate companies. article 89 applies accordingly.2 the statement of net assets must show property assets at market value.3 the inventory of the fund's assets must state the purchase price and estimated market values of the individual property assets.4 in addition to the information required as per article 89, the annual report and the annual accounts shall contain the particulars of the valuation expert, the valuation methods and the capitalisation and discounting rates applied.art. 91 supervisory requirements finma issues additional regulations concerning the duty to maintain books of account, valuation, financial statements and publication requirements.section 5 open-ended collective investment schemes with subfunds art. 92 definition in the case of an open-ended collective investment scheme with subfunds (umbrella fund), each subfund constitutes a collective investment scheme in its own right and has its own net asset value.art. 93 umbrella funds 1 in the case of an umbrella fund, investors are only entitled to the income and assets of the respective subfund in which they are participating.2 each subfund is liable only for its own liabilities.art. 94 sicav with subfunds 1 investors are only entitled to participate in the assets and income of the respective subfund in accordance with the number of shares they hold.2 each subfund under paragraph 1 is liable only for its own liabilities.114114 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).section 6 restructuring and dissolution art. 95115 restructuring 1 the following restructurings of open-ended collective investment schemes are permitted:a.a merger through the transfer of assets and liabilities;b.a conversion to a different legal status of a collective investment scheme;c.in the case of sicavs: the transfer of assets in accordance with articles 69-77 of the mergers act of 3 october 2003116.2 a restructuring in accordance with paragraph 1 letters b and c may only be entered in the commercial register following finma's approval in accordance with article 15.115 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).116 sr 221.301art. 96 dissolution 1 an investment fund is dissolved:a.if it was formed for an unlimited period: on notice by the fund management company or the custodian bank;b.if it was formed for a fixed period: on expiry of such period;c.by order of finma:1.if it was formed for a fixed period: based on reasonable cause, at the re- quest of the fund management company or the custodian bank,2.if the minimum assets fall below the required amount,3.in the cases specified in article 13 paragraph 3 et seq.2 a sicav is dissolved:a.if it was formed for an unlimited period: by resolution of the company shareholders, provided such resolution is carried by at least two thirds of the company shares;b.if it was formed for a fixed period: on expiry of such period;c.by order of finma:1.if it was formed for a fixed period: based on reasonable cause, by reso- lution of the company shareholders, provided such resolution is carried by at least two thirds of the company shares,2.if the minimum assets fall below the stipulated amount,3.in the cases specified in article 133 et seq.;d.in the other cases specified by the act.3 for the dissolution of subfunds, paragraphs 1 and 2 apply accordingly.4 the fund management company and the sicav shall notify finma of the disso- lution forthwith, and shall announce the dissolution in the media of publication.art. 97 consequences of dissolution 1 following its dissolution, an investment fund or sicav may neither issue nor redeem any units.2 in the case of an investment fund, investors have a claim to a proportionate share of the proceeds of liquidation.3 in the case of a sicav, investors have the right to a proportionate share of the proceeds of the liquidation. the rights of company shareholders are subordinate. in all other respects, articles 737 et seq. of the code of obligations117 apply.117 sr 220title 3 closed-ended collective investment schemes chapter 1 the limited partnership for collective investment art. 98 definition 1 a limited partnership for collective investment is a partnership whose sole object is collective investment. at least one member bears unlimited liability (general partner), while the other members (limited partners) are liable only up to a specified amount (limited partner's contribution).2 general partners must be companies limited by shares with their registered office in switzerland. companies limited by shares without authorisation as managers of collective assets may only be active as a general partner in one limited partnership for collective investment.1182bis the conditions for obtaining an authorisation as defined in article 14 also apply to the general partners.1193 limited partners must be qualified investors as defined in article 10 paragraph 3 or 3ter.120118 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).119 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).120 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 99 relationship to the code of obligations unless this act provides otherwise, the provisions of the code of obligations121 concerning limited partnerships apply.121 sr 220art. 100 commercial register 1 the partnership exists on being entered in the commercial register.2 notification of the facts to be entered or any amendments thereto must be signed by all general partners in the commercial register or submitted in writing together with notarised signatures.art. 101122 partnership name the partnership name must contain a description of the legal status or its permitted abbreviation.122 amended by no iii of the fa of 25 sept. 2015 (law on business names), in force since 1 july 2016 (as 2016 1507; bbl 2014 9305).art. 102 partnership agreement and prospectus 1 the partnership agreement must contain provisions regarding:a.the partnership name and its registered office;b.the object;c.the company name and the registered office of the general partners;d.total limited partners' contributions;e.the duration; f.the conditions of the limited partners' joining and departing;g.the maintenance of a register of limited partners;h.the investments, investment policy, investment restrictions, risk diversification, the risks associated with investment, and the investment techniques;i.the delegation of management and representation;j.the appointment of a custodian bank and a paying agent.2 the partnership agreement must be in writing.3 .123123 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).art. 103 investments 1 the partnership conducts investments in risk capital.2 the federal council may also permit other investments.art. 104 non-competition clause 1 the limited partners are entitled without the consent of the general partners to conduct other business transactions for their own account and on behalf of third parties and to participate in other companies.2 unless the partnership agreement provides otherwise, the general partners may without the consent of the limited partners conduct other business transactions for their own account and on behalf of third parties and participate in other companies, provided this is disclosed and the interests of the limited partnership for collective investment are not impaired as a consequence.art. 105 joining and departure of limited partners 1 where specified by the partnership agreement, the general partner may decide on the joining and departure of limited partners.2 this is subject to the provisions of the code of obligations124 regarding the exclusion of owners of the limited partnership.3 the federal council may prescribe compulsory exclusion. this shall be based on article 82.124 sr 220art. 106 inspection and information 1 the limited partners are entitled to inspect the business accounts of the partnership at any time. business confidentiality with regard to the companies in which the limited partnership invests shall be preserved.2 the limited partners are entitled to obtain information about the business performance of the partnership at least once every quarter.art. 107 audit company the partnership shall appoint an audit company (art. 126 et seq.).art. 108 financial statements 1 with respect to the financial statements of the partnership and the valuation of the assets, article 88 et seq. apply accordingly.2 internationally recognised standards must be observed.art. 109 dissolution the partnership is dissolved:a.by resolution of the owners;b.for the reasons set forth in this act and in the partnership agreement;c.by order of finma in the cases specified in article 133 et seq.chapter 2 the investment company with fixed capital art. 110 definition 1 sicaf is a company limited by shares pursuant to the code of obligations125 (art. 620 et seq. co):a.the sole object of which is the investment of collective capital;b.the shareholders of which are not required to be qualified pursuant to article 10 paragraph 3; andc.which is not listed on a swiss stock exchange.2 there must be an appropriate relationship between a sicaf's equity and its total assets. the federal council defines this relationship.126125 sr 220126 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 111 company name 1 the company name must contain the designation of its legal status or the abbreviation thereof (sicaf).2 in all other respects, the provisions of the code of obligations127 regarding the name of companies limited by shares apply.127 sr 220art. 112 relationship with the code of obligations unless this act provides otherwise, the provisions of the code of obligations128 concerning companies limited by shares apply.128 sr 220 art. 113 shares 1 the share capital is fully paid up.2 the issuing of voting shares, participation certificates, dividend right certificates and preference shares is prohibited.3 the federal council may specify compulsory redemption. this is laid down in article 82.art. 114129 custodian bank the sicaf must appoint a custodian bank in accordance with articles 72-74.129 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 115 investment policy and investment restrictions 1 a sicaf defines the investments, investment policy, investment restrictions, risk diversification, together with the risks associated with the investments, in the articles of association and in the investment regulations.2 the investments are subject to article 69; articles 64, 70 and 71 apply according- ly.3 resolutions to amend the investment regulations must be passed by a majority of votes at the general meeting.art. 116130 130 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).art. 117 financial statements with respect to the financial statements, article 89 paragraph 1 letters a and c-i, paragraphs 2-4 and article 90 apply accordingly in addition to the statutory provisions concerning accounting standards.art. 118 audit company a sicaf shall appoint an audit company (art. 126 et seq.).title 4 foreign collective investment schemes chapter 1 definition and approval art. 119 definition 1 the following are considered foreign open-ended collective investment schemes:a.assets that were accumulated on the basis of a fund contract or another agreement with similar effect for the purpose of collective investment and are managed by a fund management company with its registered office and main administrative office abroad;b.companies and schemes with their registered office and main administrative office located abroad whose purpose is collective capital investment and whose investors have a legal right with regard to the company itself, or with regard to a closely associated company, to the redemption of their units at the net asset value.2 closed-end collective investment schemes are deemed to be companies and schemes with their registered office and main administrative office located abroad whose purpose is collective capital investment and whose investors have no legal right with regard to the company itself, or with regard to a closely connected company, to the redemption of their units at the net asset value.art. 120 duty to obtain approval 1 foreign collective investment schemes must be approved by finma before they can be offered in switzerland to non-qualified investors. the representative shall submit the documents requiring approval to finma.1312 approval is granted if:a.132the collective investment scheme, fund management company or company, asset manager of the collective investment scheme and depository are sub- ject to public supervision intended to protect investors;b.133with regard to organization, investor rights and investment policy, the fund management company or company and the depository are subject to regula- tions which are equivalent to the provisions of this act;c.the designation of the collective investment scheme does not provide grounds for confusion or deception;d.134a representative and a paying agent are appointed for the offer of units in switzerland;e.135there is an agreement on cooperation and the exchange of information between finma and the foreign supervisory authorities relevant to the offer.2bis the representative and the paying agent may only end their mandate with finma's prior approval.1363 the federal council may specify a simplified, fast-track approval procedure for foreign collective investment schemes provided such investments have already been approved by a foreign supervisory authority, such arrangement being reciprocal.4 foreign collective investment schemes which are offered in switzerland to qualified investors in accordance with article 5 paragraph 1 finsa137 do not require approval but must meet the conditions pursuant to paragraph 2 letters c and d at all times.1385 employee share participation schemes in the form of foreign collective investment schemes that are offered exclusively to employees do not require approval.139131 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).132 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).133 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).134 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).135 inserted by no i of the fa of 28 sept. 2012 (as 2013 585; bbl 2012 3639). amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).136 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).137 sr 950.1138 inserted by no i of the fa of 28 sept. 2012 (as 2013 585; bbl 2012 3639). amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).139 inserted by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 121 paying agent 1 the paying agent must be a bank pursuant to the federal act on banks and savings banks of 8 november 1934140.2 the investors may request the issue and redemption of the units from the paying agent.140 sr 952.0art. 122 international treaties assuming the mutual recognition of regulations and measures of an equivalent standard, the federal council may conclude international treaties which specify that collective investment schemes from the signatory countries merely have a duty to register rather than the duty to obtain approval.chapter 2 representatives of foreign collective investment schemes art. 123 mandate 1 foreign collective investment schemes may be offered in switzerland to non-qualified investors and to qualified investors in switzerland in accordance with article 5 paragraph 1 finsa141 only if the fund management company or the company has first appointed a representative to undertake the duties specified in article 124, subject to the provisions of article 122.1422 the fund management and the investment scheme company undertake to provide the representative with the information the latter may require for the performance of its tasks.141 sr 950.1142 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 124 duties 1 the representative represents the foreign collective investment scheme with regard to investors and finma. the representative's powers of representation may not be restricted.2 the representative observes the statutory obligations to report, publish and inform, as well as the codes of conduct of industry bodies which have been declared to be the minimum standard by finma. the representative's identity must be disclosed in every publication.art. 125 place of performance and place of jurisdiction143 1 the place of performance for units of the foreign collective investment schemes offered in switzerland is the registered office of the representative.1442 it shall continue to be the registered office of the representative after the revocation of authorisation or following the dissolution of the foreign collective investment scheme.3 the place of jurisdiction is:a.the registered office of the representative; orb.the registered office or place of residence of the investor.145143 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).144 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).145 inserted by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).title 5 audit146 and supervision 146 term in accordance with annex no 14 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829). this change has been made throughout the text. chapter 1 audit art. 126 appointment 1 the following persons must appoint an audit company licensed by federal audit oversight authority under article 9a paragraph 1 of the auditor oversight act of 16 december 2005147 to carry out an audit under article 24 of the finmasa148:149a.150.fund management companies for the investment funds they manage;b.sicavs;c.limited partnerships for collective investment;d.sicafs;e.151.f.representatives of foreign collective investment schemes.2 .1523 the same audit company must audit the sicav and any fund management company that it appoints pursuant to article 51 paragraph 5. finma may grant exemptions.1534 .1545 the persons named in paragraph 1, managed investment funds and any real estate companies belonging to real estate funds or real estate investment companies must have their annual accounts and if applicable their consolidated accounts audited by a state supervised audit firm in accordance with the principles of the code of obligations155 on the ordinary audit.1566 the federal council shall regulate the details. it may authorise finma to issue implementing provisions on matters of limited scope, and in particular on largely technical matters.157147 sr 221.302148 sr 956.1149 amended by annex no 4 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1 jan. 2015 (as 2014 4073; bbl 2013 6857).150 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).151 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).152 repealed by annex no 14 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).153 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).154 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).155 sr 220156 inserted by annex no 4 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1 jan. 2015 (as 2014 4073; bbl 2013 6857).157 inserted by annex no 4 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1 jan. 2015 (as 2014 4073; bbl 2013 6857).art. 127-129158 158 repealed by annex no 4 of the fa of 20 june 2014 (consolidation of oversight through audit companies), with effect from 1 jan. 2015 (as 2014 4073; bbl 2013 6857).art. 130159 duty to provide information 1 the valuation experts and real estate companies belonging to the collective in vestment scheme shall provide the audit company with full access to the accounting records, the accounting vouchers, the records and to the reports of the valuation experts; moreover, they shall supply them with all the information needed to perform the audit function.2 the audit company of the custodian bank and the audit company of the other licensees cooperate with each other.159 amended by annex no 14 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).art. 131160 160 repealed by annex no 14 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).chapter 2 supervision art. 132161 supervision 1 finma issues the necessary authorisations and approvals pursuant to this act and supervises compliance with the statutory, contractual and regulatory provisions as well as the provisions of the articles of association.2 it does not review the expediency of the business decisions taken by the licensees.161 amended by annex no 14 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).art. 133162 supervisory instruments 1 in the event of infringements of the contractual or regulatory provisions or of the provisions of the articles of association, the supervisory instruments pursuant to articles 30-35 and 37 of the finmasa163 apply mutatis mutandis.1642 article 37 of finmasa also applies mutatis mutandis to approval under the present act.3 if the investors' rights appear to be endangered, finma may order the licensees to provide the necessary collateral.4 if an enforceable order issued by finma is not complied with after prior warning within the deadline that has been set, finma may itself carry out the required actions at the expense of the negligent party.162 amended by annex no 14 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).163 sr 956.1164 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 134165 liquidation licensees from which authorisation has been withdrawn or collective investment schemes from which approval has been withdrawn may be liquidated by finma. the federal council regulates the details.165 amended by annex no 14 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).art. 135 measures in the case of non-authorised or non-approved activity 1 where persons operate without any authorisation or approval, finma may order that the collective investment scheme be dissolved.2 to safeguard the interests of investors, finma may order that the collective investment scheme be changed to another legal status.art. 136 other measures 1 in justified cases, finma may, in accordance with article 64, appoint valuation experts to value the assets of real estate funds or real estate investment companies.2 it may dismiss the valuation experts appointed by the real estate fund or by the real estate investment company.art. 137166 initiation of bankruptcy proceedings 1 where there is justified concern that an authorised parties as defined in article 13 paragraph 2 letters b-d is excessively indebted or has serious liquidity problems and there is no prospect of restructuring or restructuring has failed, finma shall withdraw authorisation from the financial institution, initiate bankruptcy proceedings and make this public.1672 the provisions on composition proceedings (art. 293-336 of the federal act of 11 april 1889168 on debt enforcement and bankruptcy, deba), on a stay of proceedings for companies (art. 725 and 725a of the code of obligations169) and on notification of the court (art. 728c para. 3 of the code of obligations) do not apply to the licensee referred to in paragraph 1.3 finma appoints one or more bankruptcy liquidators. these are subject to supervi- sory control by finma and shall provide finma with a report if requested.170166 amended by annex no 3 of the fa of 18 march 2011 (securing investments), in force since 1 sept. 2011 (as 2011 3919; bbl 2010 3993).167 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).168 sr 281.1169 sr 220170 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 138171 conduct of bankruptcy proceedings 1 the bankruptcy order has the effect of a commencement of bankruptcy proceedings pursuant to articles 197-220 deba172.2 the bankruptcy proceedings are conducted in accordance with articles 221-270 deba. articles 138a-138c remain subject to reservation.3 finma may issue different rulings and orders.171 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).172 sr 281.1art. 138a173 creditors' meetings and creditors' committees 1 the bankruptcy liquidator may apply to finma for the following:a.to constitute a creditors' meeting and determine its powers as well as the necessary attendance and voting quorums necessary to pass resolutions;b.to designate a creditors' committee and determine its composition and powers.2 in the case of a sicav with subfunds as defined in article 94, a creditors' meeting or creditors' committee may be established for each subfund.3 finma is under no obligation to follow the proposals of the bankruptcy liquidator.173 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 138b174 distribution and closure of the proceedings 1 if all assets have been realised and all processes relating to the calculation of assets and liabilities have been completed, the bankruptcy liquidators shall draw up the final distribution list as well as the final accounts and forward these to finma for approval. processes arising from the assignment of legal claims under article 260 deba175 shall be disregarded.1762 the approval decision, together with the distribution list and final accounts, shall be made available for inspection for 30 days. notice of this availability for inspection shall be published in the swiss official gazette of commerce and on finma's website; advance notification shall be given to each of the creditors, stating their share, as well as to the owners if need be.1773 finma issues the necessary orders for the closure of the proceedings. it announces the closure publicly.174 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).175 sr 281.1176 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).177 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 138c178 foreign insolvency proceedings articles 37f and 37g of the federal act on banks and savings banks of 8 november 1934179 apply to recognising foreign bankruptcy decrees and insolvency measures, as well as for coordination with foreign insolvency proceedings.178 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).179 sr 952.0art. 138d180 appeals 1 in bankruptcy proceedings, creditors and owners of an authorised party covered by article 137 paragraph 1 may appeal only against realisation actions and against approval of the distribution list and the final accounts. appeals pursuant to article 17 deba181 shall be excluded.2 the timeframe for filing an appeal against approval of the distribution list and the final accounts commences the day after they have been made available for inspection.3 appeals in bankruptcy proceedings have no suspensive effect. the instructing judge can restore the suspensive effect on request.180 inserted by annex no 9 of the financial market infrastructure act of 19 june 2015 (as 2015 5339; bbl 2014 7483). amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).181 sr 281.1art. 139182 duty to provide information 1 persons who perform a role in the context of this act must provide finma with all the information and documents that it requires to carry out its duties.2 finma may order licensees to provide it with the information it requires to carry out its duties.183182 amended by annex no 14 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).183 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).art. 140184 184 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 141185 185 repealed by annex no 9 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 142186 186 repealed by annex no 14 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).art. 143187 187 repealed by annex no 9 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 144 collection and reporting of data188 1 finma is authorised to collect data concerning licensees' business activities and the trend of collective investment schemes in order to maintain market transparency or to execute its supervisory function. it may appoint third parties to collect this information or order licensees to submit this data themselves.1892 third parties appointed to collect data must treat such data as confidential.3 the statistical reporting duties vis--vis the swiss national bank, as specified in the swiss national bank act of 3 october 2003190, together with the right of finma and the swiss national bank to exchange data are reserved.188 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).189 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).190 sr 951.11title 6 liability and criminal provisions chapter 1 liability art. 145 principle 1 any person who breaches their duties is liable to the company, the individual investors and the company's creditors for the losses resulting therefrom, unless they prove that they are not at fault. any person involved in the establishment, management, portfolio management, auditing or liquidation of any of the following financial institutions may be held liable:191a.the fund management company;b.the sicav;c.the limited partnership for collective investment;d.the sicaf;e.the custodian bank;f.192the manager of collective assets;g.the representative of foreign collective investment schemes;h.the audit company;i.the liquidator.2 liability as defined in paragraph 1 also applies to the valuation expert and the representative of the investors.1933 any person who assigns the fulfilment of a task to a third party is liable for the losses caused by that third party unless they prove that they applied the degree of due diligence with regard to the selection, instruction and monitoring required in the given circumstances. the federal council may regulate the requirements for monitoring, subject to article 68 paragraph 3 finia194.195 1964 the liability of the executive and governing bodies of the fund management com- pany, sicav and sicaf is based on the provisions of the code of obligations197 governing companies limited by shares.5 the liability of a limited partnership for collective investment is based on the provisions of the code of obligations governing limited partnerships.191 second sentence amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).192 amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).193 amended by annex no 14 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).194 sr 954.1195 third sentence amended by annex no ii 13 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).196 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639).197 sr 220art. 146 joint and several liability and recourse 1 if more than one person is liable to pay compensation, each of them is liable jointly and severally to the extent that the loss is attributable directly to them by reason of their fault and the circumstances.2 the claimant may file a claim for the overall loss against more than one party jointly, and may request that in the same proceedings the court determine each individual defendant's liability to pay compensation.3 the court, taking all circumstances into consideration, determines recourse among the parties.art. 147198 prescription 1 the right to claim damages prescribes five years from the date on which the person suffering damage became aware of the damage and of the identity of the person liable for it, but not later than three years after the redemption of a unit and in any event not later than ten years after the date on which the harmful conduct took place or ceased.2 if the person liable has committed a criminal offence through his or her harmful conduct, then notwithstanding the foregoing paragraphs the right to damages or satisfaction prescribes at the earliest when the right to prosecute the offence becomes time-barred. if the right to prosecute is no longer liable to become time-barred because a first instance criminal judgment has been issued, the right to claim damages or satisfaction prescribes at the earliest three years after notice of the judgment is given.198 amended by annex no 28 of the fa of 15 june 2018 (revision of the law on prescription), in force since 1 jan. 2020 (as 2018 5343; bbl 2014 235).chapter 2 criminal provisions art. 148 felonies and misdemeanours199 1 any person who wilfully does any of the following is liable to a custodial sentence not exceeding three years or to a monetary penalty:200a.201.b.establishes a collective investment scheme without approval or authorisation;c.202.d.203offers domestic and foreign collective investment schemes that have not been approved to non-qualified investors;e.fails to maintain the books of account in an orderly manner or does not ar- chive company books of account, records and documents as prescribed;f.204in annual report or semi-annual report:1.provides false information or withholds material facts,2.does not provide all the mandatory information;g.205with respect to the annual report or semi-annual report:1.fails to produce them or fails to produce them in an orderly manner,2.fails to publish it or fails to publish it by the specified deadline;h.provides false information to the audit company, the investigating officer, the administrative receiver, the liquidator or finma or refuses to provide the requested information;i.206.j.as valuation experts, commit a gross breach of the duties assigned to them;k.207.l.208.1bis .2092 where the offender acts through negligence, the penalty is a fine not exceeding chf 250,000.3 .210199 amended by no i 1 of the fa of 12 dec. 2014 on expanding the offence of breach of professional confidentiality, in force since 1 july 2015 (as 2015 1535; bbl 2014 6231 6241).200 amended by no i 1 of the fa of 12 dec. 2014 on expanding the offence of breach of professional confidentiality, in force since 1 july 2015 (as 2015 1535; bbl 2014 6231 6241).201 repealed by annex no 14 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).202 repealed by annex no 14 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).203 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).204 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).205 amended by annex no 3 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).206 repealed by annex no 14 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).207 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).208 inserted by no i 1 of the fa of 12 dec. 2014 on expanding the offence of breach of professional confidentiality (as 2015 1535; bbl 2014 6231 6241). repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).209 inserted by no i 1 of the fa of 12 dec. 2014 on expanding the offence of breach of professional confidentiality (as 2015 1535; bbl 2014 6231 6241). repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).210 repealed by annex no 9 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 149 contraventions 1 any person who wilfully does any of the following is liable to a fine not exceeding chf 500,000:a.commits a breach of the provision concerning the protection against confusion or deception (art. 12);b.provides non-permissible, false or misleading information in advertising material for a collective investment scheme;c.211.d.fails to file the required notification with finma, the swiss national bank or investors, or provides false information therein;e.212.f.213fails to keep the share register in terms of article 46 paragraph 3 correctly.2 .2143 .2154 .216211 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).212 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).213 inserted by no i 6 of the fa of 12 dec. 2014 on the implementation of the revised recommendations 2012 of the financial action task force, in force since 1 july 2015 (as 2015 1389; bbl 2014 605).214 repealed by annex no 3 of the financial services act of 15 june 2018, with effect from 1 jan. 2020 (as 2019 4417; bbl 2015 8901).215 repealed by annex no 9 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).216 repealed by annex no 14 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).art. 150217 217 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 151218 218 repealed by annex no 14 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).title 7 final provisions219 219 amended by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639). chapter 1 implementation; repeal and amendment of existing legislation220 220 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639). art. 152221 implementation 1 the federal council issues the implementing provisions.2 when issuing subordinate legislation, the federal council and finma shall observe the key requirements of the law of the european communities.221 amended by annex no 14 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207 5205; bbl 2006 2829).art. 153 repeal and amendment of existing legislation the repeal and amendment of the existing legislation are set out in the annex.chapter 2 . art. 154-158222 222 repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).chapter 3 . art. 158a-158e223 223 inserted by no i of the fa of 28 sept. 2012 (as 2013 585; bbl 2012 3639). repealed by annex no ii 13 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901)chapter 4 referendum and commencement224 224 inserted by no i of the fa of 28 sept. 2012, in force since 1 march 2013 (as 2013 585; bbl 2012 3639). art. 159 .225 1 this act is subject to an optional referendum.2 the federal council determines its commencement date.commencement date: 1 january 2007226225 repealed by no i of the fa of 28 sept. 2012, with effect from 1 march 2013 (as 2013 585; bbl 2012 3639).226 fcd of 22 nov. 2006.annex (art. 153)amendment of existing legislation ithe investment funds act of 18 march 1994227 is repealed.iithe following federal acts are amended as follows:.228227 [as 1994 2523, 2000 2355 annex no 27, 2004 1985 annex no ii 4]228 the amendments may be consulted under as 2006 5379.

951.312english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinance of the swiss financial market supervisory authorityon collective investment schemes(finma collective investment schemes ordinance, ciso-finma)of 27 august 2014 (status as of 1 january 2021)the swiss financial market supervisory authority (finma),based on articles 55 paragraph 3, 56 paragraph 3, 71 paragraph 2, 91 and 128 paragraph 2 of the collective investment schemes act of 23 june 20061 (cisa),decrees:1 sr 951.31title 1 collective investment schemes chapter 1 securities funds section 1 securities lending (art. 55 para. 1 let. a cisa; art. 76 ciso2)art. 1 definition securities lending means: a legally binding transaction in which the fund management company or investment company with variable capital (sicav), acting as lender, undertakes to temporarily transfer to the borrower ownership of specific securities, and where:a.the borrower is obliged to return to the lender securities of the same type, quantity and quality at the end of the securities lending period and to transfer any income earned during that period to the lender; andb.the lender bears the price risk of the securities for the duration of the securities lending.art. 2 principles 1 the fund management company or sicav may lend securities in its own name and for its own account to a borrower (principal).2 the fund management company or sicav may also appoint an intermediary to put the securities at the disposal of the borrower either on a fiduciary basis (agent) or directly (finder), in accordance with the provisions of this section.3 the fund management company or sicav shall conclude a standardised framework agreement governing securities lending with each borrower or intermediary in accordance with article 7.art. 3 authorised borrowers and intermediaries 1 the fund management company or sicav shall conduct securities lending transactions exclusively with first-class supervised borrowers and intermediaries which are specialised in transactions of this type, such as banks, brokers and insurance companies, as well as licensed and recognised central counterparty clearing houses and central securities depositories that guarantee the proper execution of such transactions.2 the fund management company or sicav must obtain the custodian bank's written consent should the latter not be participating in the securities lending transaction as either borrower or intermediary.3 the custodian bank may only withhold its consent if there is no guarantee that it can meet its statutory and contractual duties with regard to settlement, safekeeping, provision of information, and control.art. 4 securities eligible for lending 1 the fund management company or sicav may lend all types of securities that are traded on an exchange or other regulated market open to the public.2 it may not lend securities acquired under a reverse repo transaction.art. 5 termination dates and notice periods 1 it must be possible to terminate individual transactions and the standardised framework agreement for the securities lending transaction at any time.2 where the observation of a notice period has been agreed, that period may not exceed seven banking days.art. 6 scope and duration 1 if the fund management company or sicav is required to observe a notice period before it may again have legal control of the loaned securities, it may not lend more than 50 percent of the eligible holding of a particular security.2 if, however, the borrower or intermediary provides a contractual guarantee to the fund management company or sicav that the latter may again legally dispose of the loaned securities on the same or following banking day, the fund management company or sicav may lend the entire eligible holding of a particular security.art. 7 minimum contents of the standardised framework agreement 1 the standardised framework agreement must meet the relevant international standards.2 the standardised framework agreement must indicate those securities funds whose securities are in principle eligible for securities lending, in addition to the securities which are excluded from securities lending.3 the fund management company or sicav shall stipulate in the standardised framework agreement with the borrower or intermediary that they:a.pledge or transfer collateral to the fund management company or sicav for the purposes of guaranteeing restitution in accordance with article 51;b.are liable vis--vis the fund management company or sicav for:1.the prompt, unconditional payment of any income accruing during the securities lending period, 2.the assertion of other proprietary rights such as conversion and subscription rights, and 3.the contractually agreed return of securities of the same type, quantity and quality;c.assign all securities available for the securities lending transaction to the individual lenders on the basis of objective and transparent criteria.4 the framework agreement should also set out: a.agreement of an appropriate collateral value that at all times should amount to at least 100 percent of the market value of the loaned securities; b.the loaned securities are excluded from the claims of the borrower or intermediary.art. 8 special duties of the custodian bank the custodian bank has the following special duties in connection with the settlement of the securities lending transaction:a.it shall inform the fund management company or sicav on a regular basis of the lending transactions conducted.b.it shall, at least once a month, account for any income earned on the securities lending.c.it shall ensure that the securities lending transactions are settled in a secure manner, in line with the agreements and, in particular, it shall monitor compliance with the requirements relating to collateral.d.in addition, it shall carry out the administrative duties assigned to it under the safe-custody regulations during the term of the lending transaction and assert all rights associated with the loaned securities, unless such duties have been ceded under the terms of the standardised framework agreement.art. 9 inventory and statement of net assets, or balance sheet, inclusion in investment limits 1 loaned securities must be denoted as being lent in the securities fund's inventory and must continue to be included in the statement of net assets, or the balance sheet.2 loaned securities must continue to be taken into account when ensuring compliance with the statutory and regulatory investment restrictions.2 collective investment schemes ordinance of 22 nov. 2006 (sr 951.311).section 2 securities repurchase agreements (repo, reverse repo) (art. 55 para. 1 let. b cisa; art. 76 ciso3)art. 10 definitions the terms below are defined as follows:a.securities repurchase agreement means a repo (or sale and repurchase agreement) and reverse repo (or reverse sale and repurchase agreement);b.repo means a legally binding transaction in which one party (the borrower or repo seller) temporarily transfers ownership of securities to another party (the repo buyer), and where:1.the repo buyer undertakes to return to the repo seller securities of the same type, quantity and quality at the end of the repo term together with any income earned during such term,2.during the term of the repurchase agreement, the price risk associated with the securities shall be borne by the repo seller; c.reverse repo means a repo from the perspective of the lender;d.repo interest means the difference between the selling price and purchase price of the securities.art. 11 principles 1 the fund management company or sicav may conclude repurchase agreements in its own name and for its own account with a counterparty (principal).2 it may appoint an intermediary to conclude repurchase agreements with a counterparty either indirectly on a fiduciary basis (agent) or directly (finder), in accordance with the provisions of this section.3 the fund management company or sicav shall conclude a standardised framework agreement governing repurchase agreements with each counterparty or intermediary in accordance with article 17.art. 12 authorised counterparties and intermediaries 1 the fund management company or sicav shall conduct repurchase agreements exclusively with first-class supervised counterparties and intermediaries that specialise in these types of transactions, such as banks, brokers and insurance companies, as well as licensed and recognised central counterparty clearing houses and central securities depositories that can guarantee the execution of transactions in a due and proper manner.2 the fund management company or sicav must obtain the written consent of the custodian bank if the latter is not to be involved in the repurchase agreement as either counterparty or intermediary. 3 the custodian bank may only deny its consent if there is no guarantee that it can meet its statutory and contractual duties with regard to settlement, safekeeping, provision of information, and control.art. 13 securities eligible for repurchase agreements 1 for repo transactions, the fund management company or sicav may use all types of securities that are traded on a stock exchange or other regulated market open to the public.2 for repo purposes, it may not use securities acquired under a reverse repo.art. 14 termination dates and notice periods 1 it must be possible to terminate individual transactions and the standardised framework agreement for the repurchase transaction at any time.2 where the observation of a notice period has been agreed, such period may not exceed seven banking days.art. 15 scope and duration of the repo 1 if the fund management company or sicav must observe a notice period before it can again have legal control of the securities under the repurchase agreement, it may not use more than 50 percent of its holdings of a particular security eligible for repo transactions.2 if, however, the counterparty or intermediary provides the fund management company or sicav with a contractual guarantee that the latter may again have legal control of the securities under the repurchase agreement on the same or following banking day, its entire holding of a particular security eligible for repo transactions may be used.art. 16 securing claims for money and securities 1 in order to secure claims for money and securities arising from repurchase agreements, the claims and obligations must be valued daily at the current market price, taking account of accrued interest and the income due to the borrower, and the difference must be marked to market daily.2 compensation must be in cash or in securities. the latter must be comparable in type and quality to the securities used for the repurchase agreement.art. 17 minimum contents of the standardised framework agreement 1 the standardised framework agreement must meet the relevant international standards.2 the standardised framework agreement must indicate both the securities funds for which repurchase agreements may in principle be conducted and the securities which are excluded from the repurchase agreement.3 the fund management company or sicav shall stipulate in the standardised framework agreement with the counterparty or intermediary that:a.the lender is liable vis--vis the borrower for:1.the prompt, unconditional payment of any income accruing during the repurchase agreement and the compensating payments to be made pursuant to article 16, 2.the assertion of other proprietary rights such as conversion and subscription rights, and3.the contractually agreed return of securities of the same type, quantity and quality;b.the borrower is liable vis--vis the lender for:1.the prompt, unconditional payment of any compensating payments to be made during the term of the repurchase agreement pursuant to article 16, and 2.the repurchase of the securities under the repo transaction in compliance with the terms of the agreement;c.claims for money and securities arising from repurchase agreements may not be netted with claims of the counterparty or intermediary.art. 18 special duties of the custodian bank the custodian bank has the following special duties in relation to the settlement of the repurchase transaction:a.it ensures that the repurchase transaction is settled in a secure and contractually agreed manner.b.it ensures that fluctuations in the value of the securities used in repo transactions are compensated for in cash or securities (marked to market).c.for the duration of the repurchase transaction it shall, in addition, carry out the administrative duties assigned to it under the safe-custody regulations and assert all rights associated with the securities used in the repo transaction, unless such duties have been ceded under the standardised framework agreement.art. 19 raising loans via repo agreements 1 pursuant to article 77 paragraph 2 ciso4, a repurchase agreement represents the raising of a loan by the securities fund.2 the money obligations arising from repos, together with all other loans taken, must comply with the statutory and regulatory limits on borrowing.3 if, when conducting a repo transaction, the fund management company or sicav uses the money received to acquire securities of the same type, quality, credit rating and maturity in conjunction with the conclusion of a reverse repo, this is not deemed to be taking a loan.4 sr 951.311art. 20 distinction between reverse repos and the granting of loans 1 pursuant to article 77 paragraph 1 letter a ciso5, reverse repos do not represent the granting of a loan.2 pursuant to article 75 ciso, money claims in connection with the conclusion of reverse repos are deemed liquid assets.5 sr 951.311art. 21 inclusion in investment limits 1 securities sold through repos must continue to be taken into account when ensuring compliance with the statutory and regulatory investment restrictions.2 money claims acquired through reverse repos must continue to be taken into account when ensuring compliance with the statutory and regulatory investment restrictions.art. 22 inventory, statement of net assets, or balance sheet and profit and loss account 1 securities sold through repos must be denoted as being used in repo in the inventory of the securities fund's assets and must continue to be included in the statement of net assets, or the balance sheet.2 money obligations arising from repos must be disclosed in the statement of net assets, or the balance sheet, under liabilities from repurchase agreements at the value assigned on the calculation date based on the assumption of a linear development in value.3 in the case of repos, repo interest must be disclosed in the profit and loss account under interest payable.4 securities purchased through reverse repos are not included in the inventory of the securities fund's assets, nor in the statement of net assets, or the balance sheet.5 money claims arising from reverse repos must be disclosed in the statement of net assets, or the balance sheet, under claims from repurchase agreements at the value assigned on the calculation date based on the assumption of a linear development in value.6 in the case of reverse repos, repo interest must be disclosed in the profit and loss account under income from reverse repos.3 sr 951.311section 3 derivative financial instruments (art. 56 para. 3 cisa; art. 72 ciso6)art. 23 definitions the terms below are defined as follows:a.basic type of derivative:1.a call or put option, the expiration value of which is linearly dependent on the positive or negative difference between the market value of the underlying and the strike price and is zero if the difference is preceded by the opposite algebraic sign, 2.a credit default swap (cds), 3.a swap, the payments of which are dependent on the value of the underlying or on an absolute amount in both a linear and a path-independent manner, 4.a future or forward transaction the value of which is linearly dependent on the value of the underlying;b.exposure-increasing: derivative exposure, the financial effect of which is similar to the purchase of an underlying (e.g. the purchase of a call option, purchase of a future, sale of a put option, exchanging of variable for fixed interest payments or the conclusion of a credit default swap as protection seller);c.exposure-reducing: a derivative exposure the financial effect of which is similar to the sale of an underlying (in particular, the sale of a call option, sale of a future, purchase of a put option, exchanging of fixed for variable interest payments or the conclusion of a credit default swap as secured party);d.exotic derivative means a derivative with a mode of operation that cannot be described as a basic form of derivative or a combination of basic forms of derivatives (for instance, a path-dependent option, an option with several factors or an option with contract modifications);e.contract size: number of underlying securities or nominal value of a derivative contract;f.contract value:1.in the case of a swap, the product of the nominal value of the underlying and the contract size,2.in the case of all other derivatives, the product of the underlying's market value and the contract size;g.otc (over the counter): the conclusion of transactions off an exchange or any other regulated market which is open to the public;h.synthetic liquidity: underlyings whose market risk and potential credit risk are hedged with derivatives that have a symmetric payment profile;i.overall exposure: exposure to the fund's net assets, the net overall exposure to derivatives and investment techniques under article 55 cisa, including short-selling; j.gross overall exposure to derivatives: total amount of capital requirements eligible from derivatives, including derivative components;k.net overall exposure to derivatives: total amount of capital requirements eligible from derivatives, including derivative components, taking account of permissible netting, hedging transactions and other rules set out in articles 35 and 36;l.leverage: effect of derivatives, derivative components investment techniques, including short-selling on the fund's net assets, by building up over-proportionally high positions in an underlying when compared to the capital invested.art. 24 principles derivatives may be used only where, even in exceptional market conditions, the effect of using derivatives does not result in a deviation from the investment objectives set out in the fund regulations, prospectus and important information for investors, or in a change in the investment character of the securities fund.art. 25 umbrella funds the provisions in this section apply to the individual securities funds or, in the case of an umbrella fund, to each individual sub-fund.art. 26 structured products, derivative components and warrants 1 in order to comply with the statutory and regulatory provisions for risk diversification, the underlying and the issue of a structured product must be taken into account.2 if a structured product has one or more derivative components, these must be treated in accordance with the provisions in this section.3 to establish the amount eligible for the overall exposure and the risk diversification requirements, the structured product is to be broken down into its components, if it has leverage. the components are to be considered individually. the breakdown is to be documented.4 if structured products that cannot be broken down are used as a not negligible part of the fund's assets, the model approach as a risk measurement procedure is to be applied.5 derivative components of a financial instrument must be taken into account in compliance with statutory and regulatory risk diversification provisions, and are eligible for the overall exposure to derivatives. 6 warrants must be treated as derivatives in accordance with the provisions of this section. an option belonging to a warrant bond is deemed a warrant.art. 27 credit derivatives 1 as defined in article 77 paragraph 1 letter a ciso7, an exposure-increasing credit derivative is not deemed a guarantee.2 the debtor of reference of a credit derivative must have outstanding equity or debt securities or rights to equity or debts that are traded on an exchange or another regulated market open to the public.7 sr 951.311art. 28 exotic derivatives 1 the fund management company or sicav may only use an exotic derivative if:a.it can calculate the minimum and the maximum delta across the entire price spectrum of the underlyings; and b.it understands the derivative's mode of operation, as well as the factors that influence its pricing.2 in the case of securities funds, where the commitment approach ii is applied, the exotic derivative must be weighted according to its maximum possible delta (absolute value) when converted to its underlying equivalent pursuant to article 35 paragraph 2. 3 the risk assessment model used risk must be capable of reflecting the exotic derivative in accordance with its risk.4 if the maximum delta of the exotic derivative is positive, it must be weighted by such maximum delta in order to comply with the statutory and regulatory maximum limits. if the minimum delta is negative, it must be weighted by this minimum delta in order to comply with the regulatory minimum limits.art. 29 conclusion of the contract 1 the fund management company or sicav shall conclude derivative transactions on an exchange or other regulated market which is open to the public.2 transactions with otc derivatives (otc transactions) are permitted, provided the conditions stipulated in articles 30 and 31 are met.art. 30 otc transactions 1 otc transactions may only be concluded on the basis of a standardised framework agreement which complies with the pertinent international standards.2 the counterparty must:a.be a regulated financial intermediary specialised in such types of transactions;b.ensure proper execution of the contract; and c.meet the credit rating requirements stipulated in article 31 paragraph 1.3 it must be possible to reliably and verifiably value an otc derivative on a daily basis and to sell or close out the derivative at market value at any time.4 if the market price for an otc derivative is not available, it must be possible at all times to determine the price at any time using appropriate valuation models that are recognised in practice, based on the market value of the underlyings from which the derivative was derived;5 before concluding a contract for a derivative under paragraph 4, specific offers must be obtained from at least two potential counterparties. the contract is to be concluded with the counterparty providing the most favourable offer in terms of price. a deviation from this principle is possible for reasons relating to risk diversification, or where other parts of the contract such as credit rating or the range of services offered by the counterparties in another offer seem are more advantageous overall for the investors.6 if it is in the investors' best interests, obtaining offers from at least two potential counterparties may be dispensed with. the reasons for doing so must be clearly documented.7 the conclusion of the transaction and pricing must be clearly documented.art. 31 credit rating 1 in the case of otc transactions, the counterparty or its guarantor shall have a high credit rating.2 this requirement does not apply to the custodian bank of the securities fund.art. 32 valuation 1 derivatives for which market prices are available shall be valued at the current prices paid on the main market. prices are to be obtained from an external source specialising in this type of transaction and which operates independently of the fund management company or sicav and its agents.2 if no current market price is available for derivatives, it must be possible to determine the price at any time using appropriate valuation models that are recognised in practice, based on the market value of the underlyings. valuations are to be documented clearly.art. 33 risk measurement procedure 1 the fund management company or sicav shall apply commitment approach i or ii, or the model approach.2 the model approach requires the approval of finma.3 the fund management company or sicav shall align the risk assessment process selected with the investment objectives.4 the model approach must be used where:a.the overall exposure of the securities fund using commitment approach i or ii cannot be appropriately recorded and measured;b.a not negligible amount is being invested in exotic derivatives; orc.complex investment strategies of a not negligible amount are being used.art. 34 commitment approach i 1 for a securities fund applying commitment approach i, only basic derivative types are permitted. they may only be used where account is taken of the necessary coverage set out in this article and their use does not result in a leverage effect on the fund's assets nor does it involve short-selling.2 exposure-reducing derivatives must at all times be covered by the relevant underlyings. if the delta has been calculated, it may be taken into account when calculating the necessary underlyings. article 44 paragraph 3 also applies mutatis mutandis.3 covering with other investments is permitted if the exposure-reducing derivative is indexed by an independent external office. the index must be representative of the underlyings and there must be an adequate correlation between the index and such investments.4 the underlying equivalents (art. 35 para. 2) of exposure-increasing derivatives must at all times be covered by highly liquid assets.5 the following assets are considered highly liquid:a.liquid assets as defined in article 75 ciso8;b.money market instruments as defined in article 74 ciso;c.collective investment schemes which invest exclusively in liquid assets or money market instruments;d.debt securities and rights with a time remaining till maturity of maximum twelve months and the issuer or guarantor have a high credit rating;e.synthetic liquidity;f.credit limits accorded to, but not used by, the securities fund, in line with the statutory and regulatory maximum investment limits;g.withholding tax credits as confirmed by the swiss federal tax administration.6 account can be taken of permitted netting rules and hedging transactions under article 36 paragraphs 1, 2 and 4. covered hedging transactions by interest derivatives are permitted. convertible bonds do not have to be taken into account when calculating the overall exposure to derivatives.8 sr 951.311art. 35 commitment approach ii: determination of the overall exposure 1 to establish the overall exposure of a securities fund using commitment approach ii, the fund management company shall determine the individual conversion amounts of the respective derivatives and derivative components as well as the conversion amounts arising from investment techniques.2 in the case of basic types of derivatives, the conversion amount for the overall exposure arising from derivatives is normally the underlying equivalent, based on the market value of the underlying assets of the derivatives. the underlying equivalents are calculated in accordance with annex 1. the nominal value or the forward price of futures contracts calculated on each trading day may be taken as the basis, if the result is a more conservative calculation.3 the conversion amount for the overall exposure is the basic commitment from the net fund assets and the sum of the following absolute values:a.conversion amounts of the individual derivatives and derivative components pursuant to annex 1 that are not included in netting pursuant to article 36;b.conversion amounts after permitted netting pursuant to article 36; andc.conversion amounts from permitted investment techniques.4 the following transactions may be disregarded when determining the conversion amount for the overall exposure arising from derivatives pursuant to paragraph 3:a.swaps by means of which the performance of the underlyings directly held by the securities fund is swapped with the performance of other underlyings (total return swaps), provided that:1.the market risk of the swapped underlyings is completely eliminated from the securities fund so that these assets have no impact on the change in the value of the securities fund, and 2.the swap does not grant option rights or contain leverage or other additional market risks that exceed those of a direct investment in the relevant underlyings;b.derivatives to which corresponding highly liquid assets are assigned so that the combination of derivative and highly liquid assets is equivalent to a direct investment in the underlying asset and neither an additional market risk nor leverage is generated. the highly liquid assets used to cover the derivative position may not be used for more than one combination simultaneously.5 securities lending and repurchase transactions must be taken into account when calculating the overall exposure if these generate leverage on the fund assets through the reinvestment of collateral. where collateral is reinvested in financial assets that provide a return in excess of the risk-free interest rate, the amount received must be included when determining the overall exposure if cash collateral is held.art. 36 commitment approach ii: rules on netting and hedging transactions 1 counter positions in derivatives based on the same underlying as well as counter positions in derivatives and in investments in the same underlying may be netted, irrespective of the maturity date of the derivatives, provided that:a.the derivative transaction was concluded with the sole purpose of eliminating the risks associated with the derivatives or investments acquired;b.no material risks are disregarded in the process; andc.the conversion amount of the derivatives is determined pursuant to article 35.2 if the derivatives in hedging transactions do not relate to the same underlying as the asset that is to be hedged, the following additional conditions must be met for netting:a.the derivative transaction is not based on an investment strategy that serves to generate a profit.b.the derivative results in a demonstrable reduction in the risk of the securities fund.c.the general and special risks of the derivative are balanced out. d.the derivatives, underlyings or assets that are to be netted relate to the same class of financial instruments.e.the hedging strategy remains effective even under exceptional market conditions.3 where interest rate derivatives are predominantly used, the amount to be included in the overall exposure arising from derivatives can be determined using internationally recognised duration-netting rules provided that:a.the rules result in a correct determination of the risk profile of the securities fund; b.the material risks are taken into account;c.the use of these rules does not generate an unjustified level of leverage;d.no interest rate arbitrage strategies are pursued; ande.the leverage of the securities fund is not increased either by applying these rules or through investments in short-term positions.4 notwithstanding paragraph 2, derivatives that are used solely for currency hedging purposes and do not result in leverage or contain additional market risks may be netted when calculating the overall exposure arising from derivatives.art. 37 commitment approach ii: documentation requirements all calculations under articles 35 and 36 must be clearly documented.art. 38 model approach: principles of value-at-risk (var) 1 applying the model approach, the fund management company or sicav shall estimate the risks for a securities fund as value-at-risk (var).2 the model must be fully documented. the documentation must in particular provide information about the specification of the risk assessment model, back-testing and stress tests.3 the fund management company or sicav shall verify the suitability of the model on a periodic basis, but at least once a year. the results must be clearly documented.4 the var of a securities fund may at no time exceed twice the var of the benchmark portfolio of such securities fund (relative var limits)5 when using the model approach, the fund management or the sicav must ensure a periodical calculation of the gross overall exposure to derivatives of the securities fund in question.art. 39 model approach: calculation of var 1 the var may be determined using variance/covariance models, historical simulations and monte-carlo simulations. when selecting the model, the investment strategy is to be taken into account.2 the var must be calculated daily on the basis of the previous day's positions using the following parameters:a.a 99th percentile, one-tailed confidence interval;b.a holding period of 20 trading days;c.an effective historical observation period of at least one year (250 bank working days).3 the var factors in interest rate risk, currency risk, share price risk and commodity risks. the following must also be taken into account:a.gamma and vega risks in the case of option positions;b.specific risks in the form of residual risks;c.event, default and liquidity risks as part of stress tests.4 the calculations must be clearly documented.5 variance from the confidence interval, the holding period or the observation period is possible owing to exceptional market circumstances, and must have the prior approval of finma.art. 40 model approach: benchmark portfolio 1 the benchmark portfolio of a securities fund is assets without any leverage and generally without any derivatives.2 the composition of the benchmark portfolio corresponds to the information in the fund regulations, prospectus and information necessary for the securities fund's investors, specifically concerning its investment objectives, investment policy and limits.3 it must be reviewed periodically, but at least once a quarter. the respective composition and any changes thereto must be documented clearly.4 where a benchmark, such as an equity index for benchmark portfolios, is defined in the fund regulations or in the prospectus and information necessary for the securities fund's investors, it may be used for calculating the var of the benchmark portfolios. the benchmark must be:a.derivative-free and not have any leverage;b.calculated by an independent, external office; andc.representative of the investment objectives, investment policy and limits of the securities fund.5 the benchmark portfolio may include derivatives, where:a.according to the fund regulations or prospectus, the securities fund is implementing a long/short strategy, and in the benchmark portfolio the short exposure is shown as derivatives;b.according to the fund regulations or prospectus, the securities fund is implementing a currency hedge investment policy and a currency hedge benchmark portfolio is used as a benchmark.6 if it is not possible to construct a representative benchmark portfolio on the basis of the specific investment objectives and investment policy of a securities fund, a var limit may be agreed upon with finma (absolute var limit). this must be stated in the prospectus.art. 41 model approach: reviewing the risk assessment model 1 in the case of a securities fund, the forecast quality of the risk assessment model must be examined by comparing the actual changes in the value of its net assets during the course of a trading day with the relevant one-day var (back-testing).2 the comparison must be documented clearly.3 the sample to be used must be compiled from the previous 250 observations.4 if back-testing shows the risk assessment model to be impracticable, the audit company and finma must be notified forthwith.5 if back-testing produces more than six anomalies, the practicability of the risk assessment model must be examined in depth and the audit company and finma notified forthwith.6 if the model is impracticable, finma may demand a swift rectification of any shortcomings of the model and order tighter restrictions on the risk.art. 42 model approach: stress tests 1 in the case of securities funds, extreme market circumstances must be simulated periodically, but at least monthly (stress tests).2 stress tests must also be conducted where significant changes to the results of the stress test owing to changes in the value or the composition of the securities fund's assets, or to changes in the market circumstances cannot be excluded. 3 stress tests include all risk factors which may have a material influence on the market value of the securities fund. special attention must be paid to risk factors which are not or only insufficiently taken into account by the risk assessment model.4 the results of the conducted stress tests and any necessary resulting measures must be clearly documentedart. 43 model approach: changes under the model approach 1 finma may allow variances from the requirements stipulated in articles 39- 43.2 it may permit the use of other risk assessment models, provided they afford an appropriate degree of protection.3 if changes are made to the risk assessment model, back-testing or stress tests, these changes must be submitted to finma for approval in advance.art. 44 cover for a physical delivery obligation of an underlying 1 if the fund management company or sicav enters into a physical delivery obligation in respect of a derivative, this derivative must be covered by the corresponding underlyings.2 cover of such an obligation with other investments is permitted if the investments and the underlyings are highly liquid and, if delivery is requested, they may be purchased or sold at any time.3 the fund management company or sicav must have unrestricted access to these underlyings or investments at all times.art. 45 covering a payment obligation 1 if the fund management company or sicav enters into a payment obligation in respect of a derivative, this payment obligation must at all times be covered by highly liquid assets as defined in article 34 paragraph 5.2 in the case of securities funds applying commitment approach ii or the model approach, the following shall additionally be recognised as cover:a.debt securities and rights the remaining time to maturity of which is more than twelve months and whose issuer or guarantor has a high credit rating;b.shares traded on an exchange or another regulated market open to the public.3 it must be possible at all times to turn collateral as defined in paragraph 2 into liquid assets within seven banking days.4 shares may only be included as cover at market value less a security margin. this security margin must take account of the volatility of the corresponding share and must amount to at least 15 percent.5 if an investment may require an additional payment, it is deemed an obligation to pay.art. 46 general provisions for inclusion of investment restrictions 1 in complying with the statutory and regulatory investment restrictions on determining maximum and minimum limits, the following must be taken into account:a.investments, including derivatives, in accordance with article 70 ciso9;b.liquid assets as defined in article 75 ciso;c.claims against counterparties arising from otc transactions.2 pursuant to article 82 ciso, exceptions may be made for index funds.3 any overrun of an investment limit due to a change in the delta must be rectified within three banking days; the rectification must ensure that the investors' interests remain safeguarded.9 sr 951.311art. 47 inclusion of derivatives 1 in complying with the statutory and regulatory maximum and minimum limits, and in particular the regulations on risk diversification, underlying equivalents as set out in annex 1 are decisive. 2 a minimum limit may be temporarily undercut with exposure-reducing derivatives purchased as part of a hedging strategy if the interests of investors remain safeguarded.3 derivative components are to be taken into account with the capital requirement under article 35. art. 48 inclusion of claims against counterparties at the maximum limits 1 claims against counterparties arising from derivative transactions must be calculated on the basis of the current positive replacement values.2 positive and negative replacement values arising from transactions in derivatives with the same counterparty may be netted if a netting agreement exists that meets the current legal requirements and is legally enforceable.3 claims arising from derivative transactions against a central counterparty of an exchange or another regulated market open to the public must not be taken into account if:a.such a unit is subject to an appropriate supervisory body; andb.the derivatives and collateral are subject to daily marking to market and daily margining.art. 49 disclosure 1 if the use of derivatives is permitted for the management of a securities fund, such derivatives must be described in the fund regulations and the prospectus.2 the prospectus must indicate whether the derivatives are used as part of the investment strategy or solely to hedge investment positions. in addition, the prospectus must explain how the use of derivatives affects the risk profile of the securities fund.3 the fund regulations and prospectus must state which risk assessment process is applied to the securities fund. the risk assessment process must also be described in the prospectus. if the model approach is used, the gross overall exposure to derivatives must be shown. if the relative var approach is used, the benchmark portfolio must be disclosed in the prospectus. 4 if a securities fund exhibits increased volatility or leverage due to the use of derivatives, special reference must be made to this in the prospectus and advertising material.5 reference must be made to the counterparty risks of derivatives in the prospectus.6 sr 951.311section 4 management of collateral (art. 76 para. 2 and art. 80 para. 4 ciso10)art. 50 scope of application assets received as collateral as part of investment techniques or otc transactions must satisfy the requirements of this section.art. 51 requirements for collateral only collateral that meets the following requirements may be accepted:a.it is highly liquid and is traded at a transparent price on an exchange or other regulated market open to the public. it can be disposed of at short notice at a price close to the valuation undertaken prior to sale.b.it is valued at least on each trading day. where price volatility is high, suitable conservative security margins must be applied.c.it is not issued by the counterparty or by a company that belongs to or is dependent on the counterparty's group.d.the credit quality of the issuer is high.art. 52 management of collateral the fund management company, sicav or their agents must comply with the following duties and requirements when managing the collateral:a.they must diversify the collateral appropriately in terms of countries, markets and issuers. appropriate diversification of issuers is deemed to have been achieved if the collateral of a single issuer held does not correspond to more than 20 percent of the net asset value. deviation from this rule is permitted if the collateral meets the requirements of article 83 paragraph 1 ciso11 or the approval conditions set out in article 83 paragraph 2 ciso are met. if collateral is provided by more than one counterparty, an aggregate perspective must be ensured.b.they must be able to obtain power of disposal over, and authority to dispose of, the collateral received at any time in the event of default by the counterparty, without involving the counterparty or obtaining its consent.c.they may not re-lend, re-pledge, sell or reinvest collateral pledged or transferred to them or use it as part of a repurchase transaction or to hedge obligations arising from derivative financial instruments. they may only use cash collateral received in the corresponding currency as liquid assets or invest it in high-quality government bonds and directly or indirectly in short-term money market instruments or use it as a reverse repo.d.if they accept collateral representing more than 30 percent of the fund assets, they must ensure that the liquidity risks can be captured and monitored appropriately. regular stress tests must be carried out that take account of both normal and exceptional liquidity conditions. the controls carried out must be documented.e.they must take account of the risks associated with the management of collateral in their risk management process.f.they must be in a position to attribute any uncovered claims remaining after the realisation of collateral to the securities funds whose assets were the subject of the underlying transactions.11 sr 951.311art. 53 collateral strategy 1 the fund management company, sicav and their agents must have in place a collateral strategy that:a.provides for appropriate security margins; b.is geared to all types of assets received as collateral; and c.takes account of characteristics of the collateral such as volatility and the default risk of the issuer.2 they must document the collateral strategy.art. 54 safekeeping of collateral 1 the collateral received must be kept at the custodian bank.2 safekeeping by a supervised third-party custodian on behalf of the fund management company is permitted provided that:a.ownership of the collateral is not transferred; andb.the third-party custodian is independent of the counterparty.3 in the case of collateral delivered to a counterparty, a custodian appointed by the latter, or a central counterparty, the custodian bank must ensure that transactions are settled in a secure manner and in line with the agreements.art. 55 prospectus the prospectus of the securities fund must contain appropriate information on the collateral strategy, in particular details of:a.the permitted types of collateral;b.the required level of collateralisation;c.the determination of security margins;d.the investment strategy and the risks in the event that cash collateral is reinvested.10 sr 951.311section 5 master-feeder structures (art. 73a ciso12)art. 56 principle in principle, the investors in a master fund are its feeder funds. other investors may be accepted provided the fund management company or sicav informs them in advance of the fact that they are investing in a master fund and ensures that the other investors receive equal treatment with the feeder funds.art. 57 requirements for the documents of a feeder fund 1 in addition to the information set out in articles 35a and 62b ciso13, the fund contract or investment regulations of a feeder fund or feeder sub-fund shall in particular contain the following:a.a statement that the fund is a feeder fund which invests at least 85 percent of its assets in a specific master fund;b.the name of the master fund;c.the investment objective and the investment policy of the master fund;d.the nature, amount and method of calculation of all remuneration as well as incidental costs that result from the investment in the master fund and that are permitted to be charged to the fund assets or the investors;e.a statement that the fund contract or investment regulations, the prospectus, the key investor information document, as well as the annual and semi-annual reports of the master fund may be obtained free of charge;f.a statement that the feeder fund may continue to exist after the dissolution of the master fund or after merger, conversion or transfer of the assets of the master fund up until the application is approved pursuant to article 63 or 64.2 in addition to the information set out in article 106 ciso, the prospectus of a feeder fund shall in particular contain the following:a.a statement that the fund is a feeder fund which invests at least 85 percent of its assets in a specific master fund;b.a description of the master fund including the investment strategy and risk profile;c.a summary of the most important content of the agreements on cooperation and duties of disclosure concluded in accordance with articles 58, 61 and 62;d.the location from which further information about the master fund and the agreements on cooperation and duties of disclosure concluded may be obtained free of charge.3 the annual report of the feeder fund shall indicate the location from which the annual and semi-annual reports of the master fund may be obtained free of charge.4 the marketing documents and the key investor information document on the feeder fund shall include a statement that it is a feeder fund which invests at least 85 percent of its assets in a specific master fund. 13 sr 951.311art. 58 joint duties of the master and feeder fund / their fund management companies 1 the master fund shall provide the feeder fund with all the documents and information it needs to fulfil its duties. to this end, they shall conclude an agreement on cooperation and duties of disclosure. 2 the agreement on cooperation and duties of disclosure shall, as a minimum, govern the following points:a.the principles regarding the transfer of the relevant documents and further information by the master fund to the feeder fund;b.the master fund's duty of disclosure to the feeder fund regarding the delegation of tasks to third parties;c.the violations of statutory and contractual provisions which the master fund is required to report to the feeder fund and the form and timing of such reports;d.the duty of the master fund to inform the feeder fund of the overall exposure arising from derivative financial instruments;e.the master fund's duty of disclosure to the feeder fund if it concludes additional agreements regarding the exchange of information with third parties;f.the ways in which the feeder fund may invest in the master fund as well as details of the costs and expenses to be borne by the feeder fund;g.the principles and arrangements for implementing the measures set out in paragraph 4;h.the arrangements for reporting the deferral of issues and redemptions and for reporting errors in the setting of prices by the master fund;i.the principles for reconciling the audit reports of the master fund and feeder fund.3 if the master fund and feeder fund are managed by the same fund management company or sicav, the agreement on cooperation and duties of disclosure may be replaced by internal regulations. these must contain measures to prevent conflicts of interest. in all other respects, the internal regulations must meet the requirements set out in paragraph 2 letters f-i.4 the master fund and feeder fund shall take measures to coordinate the schedules for calculating and publishing the net asset value in order to prevent market timing and possibilities for arbitrage.art. 59 duties of the master fund / its fund management company 1 the master fund shall inform finma without delay of the identity of every feeder fund that invests in its units.2 it shall not charge the feeder fund an issue or redemption commission for investments in its units.3 it shall ensure that all information required by law or contract is made available in a timely manner to the feeder fund, its custodian bank and the audit company as well as finma. in so doing, it shall comply with its statutory and contractual obligations regarding the disclosure of data and data protection.art. 60 duties of the feeder fund / its fund management company 1 the feeder fund shall provide its custodian bank with all the information regarding the master fund that it needs in order to fulfil its task.2 it shall take effective measures to monitor the activities of the master fund.3 when calculating its overall exposure in accordance with article 72 paragraph 3 ciso14, it shall take account of the overall exposure of the master fund in proportion to the feeder fund's investments in the master fund.4 if the feeder fund, its fund management company or another person acting on behalf of the feeder fund or its fund management company receives a pecuniary benefit in connection with the investment in units of the master fund, this shall be credited to the assets of the feeder fund.14 sr 951.311art. 61 duties of the custodian bank 1 if the master fund's custodian bank identifies irregularities in the master fund that may have a negative impact on the feeder fund, it shall notify its audit company and the feeder fund / the feeder fund's fund management company and custodian bank. this includes, inter alia, the following events:a.errors in the calculation of the net asset value of the master fund;b.errors in transactions, in the settlement of purchases and sales or of orders to issue or redeem units of the master fund by the feeder fund;c.errors in the distribution or reinvestment of income from the master fund;d.violations of statutory provisions or of the investment objectives, limits, policy or strategy of the master fund described in the fund contracts or investment regulations, the prospectus or the key investor information document.2 if the master fund and feeder fund have different custodian banks, the latter shall, with the approval of the master fund and feeder fund, conclude an agreement on cooperation and duties of disclosure to ensure the fulfilment of their duties. this agreement shall, as a minimum, contain the following points:a.a description of the documents and categories of information that the two custodian banks exchange on a regular basis, including the arrangements for and timing of such exchanges;b.the principles regarding the handling of operational issues, including the calculation of the net asset value, protection against market timing, and the processing of orders of the feeder fund;c.the arrangements for the reporting of violations of statutory and contractual provisions by the master fund;d.other points that are necessary for the cooperation between the custodian banks. 3 when exchanging data, the custodian banks shall comply with their statutory and contractual obligations regarding the disclosure of data and data protection.art. 62 duties of the audit company 1 in its short-form report for the feeder fund, the audit company shall take account of the short-form report for the master fund. if the master fund and feeder fund have different accounting years, the master fund shall compile an interim financial statement as of the reporting date of the feeder fund. based on this, the audit company shall compile an ad-hoc short-form report for the master fund as of the reporting date of the feeder fund.2 in its short-form report for the feeder fund, the audit company shall mention any deviations from the standard wording contained in the short-form report for the master fund as well as any other material information, together with any influence on the feeder fund.3 if the master fund and feeder fund have different audit companies, the latter shall conclude an agreement on cooperation and duties of disclosure to ensure the fulfilment of their duties. this shall contain, as a minimum:a.a description of the documents and categories of information that the two audit companies exchange on a regular basis, including the arrangements for and timing of such exchanges;b.the coordination of the role of the audit companies in the process of compiling the annual financial statements for the master fund and feeder fund;c.a statement of the information that must be included in the audit report for the master fund in accordance with paragraph 2;d.other arrangements governing the cooperation between the audit companies as well as the compilation and transfer of the short-form and ad-hoc reports.art. 63 dissolution of the master fund 1 following the announcement of the dissolution of the master fund, the feeder fund shall without delay defer repayments. within one month following the announcement of the dissolution of the master fund, it shall submit to finma a report / an application regarding:a.the dissolution of the master fund;b.an amendment to the fund contract or investment regulations due to the change of master fund; or c.an amendment to the fund contract or investment regulations due to the conversion into a non-feeder fund.2 the liquidation proceeds of the master fund may not be paid out before the applications set out in paragraph 1 letters b and c have been approved unless they are reinvested solely for the purpose of efficient liquidity management until the time of approval.art. 64 merger, conversion and transfer of assets 1 if the master fund decides on a merger, conversion or transfer of assets, the feeder fund must, within a month of the announcement being made by the master fund, notify finma whether it:a.is dissolving itself;b.intends to retain the same master fund;c.is switching to another master fund; ord.is converting itself into a non-feeder fund.2 simultaneously with the notification, the feeder fund shall submit to finma any necessary application for approval of amendments to the fund contract or investment regulations.3 if the merger, conversion or transfer of assets of the master fund takes place before the application pursuant to paragraph 1 letters c and d has been approved, the feeder fund may only return the units of the master fund if the proceeds received are reinvested for the sole purpose of efficient liquidity management until the amendments enter into force. 12 sr 951.311chapter 2 other funds art. 65 1 the provisions for securities funds relating to securities lending (arts. 1-9), securities repurchase agreements (arts. 10-22), derivatives (arts. 23-49), collateral management (arts. 50-55) and master-feeder structures (arts. 56-64) apply to other funds, mutatis mutandis.2 the above must be read subject to articles 100 and 101 ciso15.3 finma may permit deviations from these provisions (art. 101 ciso).15 sr 951.311title 2 institutions chapter 116 duties of representatives of foreign collective investment schemes 16 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).(art. 128a para. 2 and 131 ff. ciso17)art. 66 publication duties 1 representatives of foreign collective investment schemes shall publish the issue and redemption prices and if applicable the asset value with the indication excluding commission.together in the organs of publication named in the prospectus on every issue and redemption of units, but at least twice each month.2 in the case of collective investment schemes for which the right to redeem at any time pursuant to article 109 paragraph 3 ciso18 has been restricted, publication in accordance with paragraph 1 is required at least once each month. the weeks and weekdays on which publication takes place must be indicated in the prospectus.3 notice of the amendment of documents given to investors in the foreign collective investment scheme's home country must at the same time be published in switzerland.18 sr 951.311art. 66a obligation to give notice 1 the representative of foreign collective investment schemes must in particular give notice to finma if:a.collective investment schemes or sub-funds are combined or liquidated or their legal form is changed;b.a collective investment scheme or a sub-fund is not launched or the offer in switzerland is not taken up or is cancelled;c.the redemption of units in a foreign collective investment scheme that it represents is postponed or if the management company decides to reduce redemption requests on a pro rata basis (gating);d.a foreign supervisory authority has taken measures against the collective investment scheme, and in particular if it has withdrawn approval.2 in the event of a change of paying agent or the termination of agency agreements, finma's approval for the termination of the mandate must be obtained in advance (art. 120 para. 2bis cisa).art. 66b obligation to give notice on cancellation or amendment of the professional indemnity insurance representatives of foreign collective investment schemes must give immediate notice to finma of the cancellation or amendment of the professional indemnity insurance.17 sr 951.311chapter 2 risk management and risk control (art. 14 cisa; art. 12a ciso19)art. 6720 articles 8-14 der finma financial institutions ordinance of 4 november 202021 apply by analogy to risk management and risk control for the sicav.20 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).21 sr 954.111art. 68-7122 22 repealed by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, with effect from 1 jan. 2021 (as 2020 5327).19 sr 951.311chapter 323 sicav 23 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327). (art. 33 para. 1 ciso24)art. 72 the self-managed sicav shall ensure that the valuation of investments is separated from the function concerned with investment decisions (portfolio management), both functionally and in terms of personnel.24 sr 951.311chapter 4 . art. 73-7625 25 repealed by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, with effect from 1 jan. 2021 (as 2020 5327).chapter 5 custodian bank (art. 14, 72 f. cisa; art. 102a ff. ciso26)art. 77 organisation 1 the custodian bank shall ensure that its premises, staff and functions are independent of the fund management company or sicav.2 where tasks are delegated to the custodian bank by the fund management company or the sicav, measures must be put in place to ensure that no conflicts of interest arise. managerial independence between the delegating fund management company or sicav and/or its agents, on the one hand, and those entrusted with the tasks of the custodian bank in accordance with article 73 cisa must be ensured. where conflicts of interest are unavoidable, they must be disclosed to the investors.3 those entrusted with the tasks of the custodian bank in accordance with article 73 cisa may not simultaneously perform tasks delegated by the fund management company or sicav.art. 78 control function 1 in order to carry out its control tasks in accordance with article 73 paragraph 3 letters a and b cisa, the custodian bank shall assess the risks in connection with the nature, scope and complexity of the strategy of the collective investment scheme in order to develop control processes that are appropriate to the collective investment scheme and the assets in which it invests.2 the custodian bank shall issue appropriate internal guidelines to this effect setting out, as a minimum:a.how it organises its control function, in particular what roles there are and who is responsible for what;b.the control processes in accordance with which the controls, including those carried out when transferring safekeeping to a third-party custodian or collective securities depository within the meaning of article 105a ciso27, are to be carried out;c.the control plan and the control processes, in particular the methods, data basis and frequency of controls;d.the escalation processes that are triggered when irregularities are identified, in particular the process steps, deadlines, contacts with the fund management company or sicav and other relevant parties, procedures for defining measures and duties of disclosure;e.the custodian bank's reporting on its control activities to the governing bodies, in particular the frequency, form and content thereof as well as any further addressees.3 in respect of the fund management company, the custodian bank has the right and duty to intervene to prevent investments that are not permitted. if, in the exercise of its control function, it becomes aware of such investments, it shall restore compliance with the law by, for example, arranging for the investments to be reversed.27 sr 951.31126 sr 951.311title 3 accounting, valuation, financial statements and duty to publish chapter 1 accounting section 1 general provisions art. 79 principles (arts. 87 and 91 cisa)1 unless the cisa and this ordinance provide otherwise, the provisions set out in the code of obligations28 (co) in accordance with article 87 cisa apply in respect of accounting.2 accounting must comply with the statutory requirements for the annual and semi-annual reports (art. 89 ff. cisa) and be conducted in such a way that the accounts provide a true and fair view of the financial situation and income.3 transactions, including off-balance-sheet transactions, must be recognised immediately after conclusion of the contract. concluded transactions that have not yet been executed must be accounted for by using the closing date principle.4 the accounting must take account of the tax law requirements.28 sr 220art. 80 unit of account (arts. 26 para. 3 and 108 cisa; art. 35a para. 1 let. o ciso29)1 a foreign currency may be designated as the unit of account for:a.an investment fund or its sub-funds in the fund regulations;b.the sub-funds of a sicav in the investment regulations;c.a limited partnership for collective investment in the partnership agreement.2 in its investment regulations, a sicav must also specify the currency which will serve as the unit of account for the overall accounts (art. 98), as well as the conversion process.3 if a foreign currency is used in accounting, the values must not also be given in the local currency.29 sr 951.311section 2 open-ended collective investment schemes art. 81 sub-funds and unit classes (arts. 92-94 cisa and art. 112 ciso30)311 in the case of collective investment schemes which include sub-funds, the provisions of this title apply to each individual sub-fund.2 the sub-funds must be presented separately in the annual and semi-annual reports.3 the accounting year ends on the same date for all sub-funds.4 in the case of unit classes, the net asset value must be disclosed for each class.30 sr 951.31131 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).art. 82 control of units and unit certificates (arts. 11 and 73 para. 1 cisa)1 the custodian bank shall record the issue and redemption of units, including fractions thereof, on a continuous basis. it shall record the following details:a.the date of issue or redemption;b.the number of units issued or redeemed;c.the gross amount paid by the investor or net payment made to the investor;d.the fees and incidental costs in relation to the issue or redemption;e.the amount credited or debited to the collective investment scheme;f.the net asset value of the unit.2 in the case of registered units, the identity of the investor must also be recorded.3 the custodian bank shall record the issue and redemption of unit certificates separately.art. 83 real estate funds (arts. 59 para. 1 let. b, 83 cisa; arts. 86 para. 3 let. b and 93 ciso32)1 the real estate fund and real estate companies owned by it must close their accounts on the same day. finma may grant exemptions provided consolidated financial statements are produced.2 the calculation of the net asset value must take account of taxes (income and real estate gains tax and, if applicable, real estate transfer tax) incurred in connection with any liquidation of the real estate fund.3 depreciation of buildings, including fixtures, may be charged to the profit and loss account provided it is economically reasonable.32 sr 951.311chapter 2 valuation section 1 general provisions art. 84 investments (arts. 88 and 89 para. 2 cisa)1 investments are valued at market value (art. 88 cisa).2 in the notes to the statement of net assets, or balance sheet and profit and loss account (arts. 94 and 95), the investments are to be summarised in a table according to the following three valuation categories: a.trading of investments listed in a stock exchange or in another regulated market open to the public and valued according to the prices in the primary market (art. 88 para 1 cisa);b.investments that are not priced according to let. a whose value is based on market-observed parameters;c.investments whose value cannot be based on market-observed parameters and are valued with suitable valuation models taking account of the current market circumstances. art. 85 private equity (arts. 88 para. 2 and 108 cisa)1 private equity investments are valued in accordance with recognised international standards, provided the valuation is not governed by this ordinance.2 the standards applied must be described in detail in the prospectus or regulations.art. 8633 real estate fund (arts. 88 and 90 cisa)building land and buildings under construction must be recognised at market price in the statement of net assets. the fund management or sicav provides an estimation of buildings under construction recognised at market price at the closing of the financial year. 33 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).section 2 open-ended collective investment schemes (art. 88 para. 2 cisa)art. 87 1 the tangible and intangible assets of the company shareholders of a sicav must be valued at acquisition or production cost less any economically necessary depreciation.2 the valuation principles for the tangible and intangible assets must be disclosed under additional information. if they are amended, the restated data for the previous year must also be disclosed for information purposes.3 the other assets of a sicav shall be valued in accordance with articles 84 to 86.section 3 closed-ended collective investment schemes art. 88 limited partnership for collective investment (arts. 88 para. 2 and 108 cisa)articles 84-87 apply mutatis mutandis to the valuation process.art. 89 investment company with fixed capital (sicaf) (art. 117 cisa)1 the valuation methods applied to prepare the single entity financial statements (art. 109 para. 1) shall be in accordance with the provisions of accounting. in addition, the market values of the investments must be indicated for information purposes.2 the valuation methods applied to prepare the consolidated financial statements (art. 109 para. 2) are as stipulated in the ordinance in accordance with internationally recognised accounting standards of 21 november 201234 (vasr).34 sr 221.432chapter 3 general provisions on accountability art. 90 private equity (arts. 88 and 108 cisa)1 the valuation methods applied (art. 85) must be disclosed in the annual and semi-annual reports.2 if an investment is recognised below cost, this fact must be disclosed.3 in the case of collective investment schemes which can invest more than 10 percent of their assets in private equity, the following minimum information on the individual private equity investments, classified by type and phase of development, must be provided if they account for more than 2 percent of the assets of the collective investment scheme:a.description of the investment (name, registered office, purpose, capital stock and equity stake);b.description of the business activity and any significant developments;c.information on the board of directors and executive board;d.categorisation by development phase (such as seed, early stage or buyout);e.scope of commitments entered into.art. 91 subsidiary companies (art. 90 para. 1 cisa; art. 68 ciso35)1 if subsidiary companies are used to implement the investment policy, a transparent substance-over-form approach must be applied to the accounts (such as in the statement of net assets, or the balance sheet and profit and loss account, inventory, buy and sell transactions).2 the companies must be consolidated in accordance with a vasr36 standard. therefore, the accounting principles applied to them must be for consolidation purposes.35 sr 951.31136 sr 221.432chapter 4 accounting for open-ended collective investment schemes section 1 annual accounts art. 92 sicavs (art. 36 para. 1b cisa; arts. 68, 70, 86 and 99 ciso37)1 the annual accounts of a sicav comprise the annual accounts relating to the individual pools of investor assets (sub-funds) and the annual accounts relating to the shareholders' assets, and the overall accounts of the sicav.2 the annual accounts disclose the permitted investments pursuant to articles 70, 86 and 99 ciso in respect of the investors' assets.3 in respect of the shareholders' assets, the annual accounts disclose the following: permitted investments within the meaning of paragraph 2 and the movable, immovable and intangible assets essential for immediate business operations of the sicav;the permitted liabilities.4 short-term liabilities and liabilities secured by mortgage, entered into in connection with the sicav's immediate business operations, are permitted.5 the annual accounts relating to one or more selected pools of investor assets may only be published together with the overall accounts of the sicav.6 the annual accounts form part of the annual report, which replace the business report under the co38. a management report and a cash flow statement are not required.37 sr 951.31138 sr 220art. 93 minimum breakdown of statement of net assets, or the balance sheet and profit and loss account for investment funds and sicavs (art. 91 cisa)the statement of net assets, or the balance sheet and profit and loss account for investment funds and sub-funds must be published in the annual and semi-annual reports, whereby a minimum breakdown under articles 93-98 must be ensured.art. 94 securities funds (arts. 53-57 and 89 cisa; arts. 70-85 ciso39)for securities funds, the statement of net assets, or the balance sheet and profit and loss account, have the minimum structure set out in annex 2.39 sr 951.311art. 95 real estate funds (arts. 58-67 and 89 cisa; arts. 86-98 ciso40)for real estate funds, the statement of net assets, or the balance sheet and profit and loss account, have the minimum structure set out in annex 3.40 sr 951.311art. 96 other funds (arts. 68-71 and 89 cisa; arts. 99-102 ciso41)the provisions on the minimum breakdown for securities funds (art. 94) apply mutatis mutandis to other funds. they also include the investments permitted for other funds.41 sr 951.311art. 97 minimum breakdown of balance sheet and profit and loss account relating to the shareholders' assets (art. 53 ff. cisa; art. 68 ciso42)1 the shareholders' assets must be broken down into:a.investments;b.business assets. 2 for the breakdown of investments, articles 94-96 apply.3 for the breakdown of the business assets, articles 959 and 959a co43 apply mutatis mutandis. 4 for the notes, article 959c co apply mutatis mutandis. in addition, the valuation principles for the tangible and intangible assets of the company shareholders must be disclosed. the notes must also provide information on the risk assessment process.5 company shareholders and shareholder associations with aligned voting rights holding 5 percent or more of the shares must be listed in the annual report as follows:a.name or company;b.place of residence or domicile;c.percentage of shares held.42 sr 951.31143 sr 220art. 98 overall accounts of a sicav (art. 91 cisa)1 the overall accounts of a sicav consist of the balance sheet, profit and loss account and the notes pursuant to the co44 and include the investors' assets and the shareholders' assets.2 for the purpose of preparing the balance sheet and profit and loss account, the positions constituting the investors' assets must be aggregated. classification is in accordance with articles 94-96.3 the shareholders' assets must be disclosed separately in the balance sheet and profit and loss account. items are broken down mutatis mutandis in accordance with articles 94-96 in the case of investments, and article 959, 959a and 959b co in the case of business assets.4 the overall accounts of a sicav must be structured into investors' assets, the shareholders' assets and the overall assets of the sicav.5 the information stated in article 97 paragraph 5 must also be disclosed in the overall financial statement.44 sr 220section 2 further information art. 99 inventory of the collective investment scheme (art. 89 para. 1 let. c cisa)1 as a minimum, the inventory must be broken down by type of investment such as securities, bank credit balances, money market instruments, derivative financial instruments, precious metals and commodities and, within such types of investment, in accordance with the investment policy by industry, geographical location, type of security (annex 2 let. 1.4) and currencies.2 the total amount and the percentage of the overall assets of the collective investment scheme must be indicated for each group or subgroup.3 the share in the overall assets of the collective investment scheme must be indicated for each individual value disclosed in the inventory.4 securities must also be broken down as follows:a.traded on an official stock exchange;b.traded on another regulated market open to the public;c.as defined in article 70 paragraph 3 ciso45;d.as defined in article 71 paragraph 2 ciso;e.securities that do not correspond to categories a-d above.5 the valuation category must be indicated for each value recognised in the inventory in accordance with article 84 paragraph 2.6 in relation to the securities listed in paragraph 3, only the subtotal per category need be indicated and each item denoted accordingly.45 sr 951.311art. 100 inventory of real estate funds (arts. 89 para. 1 let. c and 90 cisa)1 as a minimum, the inventory must be broken down into:a.residential buildings;b.commercially used properties;c.mixed-use properties;d.building land, including properties for demolition, and buildings under construction;e.units in other real estate funds and real estate investment companies;f.mortgages and other advances secured by mortgage.2 for property in buildings with development rights and condominiums, the circumstances for each property and the total for each item in paragraph 1 letters a-d are to be indicated in the inventory. 3 the inventory must include information on each item of land and buildings:a.address;b.purchase price;c.estimated market value;d.gross income generated.4 any investments in short-term fixed-interest securities, real estate certificates or derivatives must also be disclosed.5 any mortgages and other liabilities secured by mortgage outstanding at the end of the year, as well as loans and advances must be listed stating their interest terms and maturity periods.6 a list of the real estate companies owned must be published for each real estate fund, including an indication of the equity stake (voting rights/capital).7 the items in the inventory must be indicated in accordance with the three valuation categories under article 84 paragraph 2. if all the investment property have the same valuation category, they can be put together and summarised under the total property portfolio.art. 101 itemisation of buy, sell and other transactions (art. 89 para. 1 let. e cisa)1 all changes in the composition of the collective investment scheme, in particular buy, sell, off-balance-sheet exposures, bonus shares, subscription rights and splits, must be disclosed in the annual report. the individual assets must be described in precise terms.2 in the case of real estate funds, each property acquired or sold must be listed individually. the agreed price must be disclosed at the request of any investor.3 in the case of real estate funds, transactions between collective investment schemes which are managed by the same or an associated fund management company or sicav must be disclosed separately.4 mortgages and advances secured by mortgage which have been granted over the course of the financial year and redeemed prior to the end of that financial year must be listed, including interest terms and maturity periods.5 mortgages and other liabilities secured by mortgage, as well as loans and advances which have been taken up and repaid within the financial year, must be listed, including interest terms and maturity periods, or summarised per category with an average maturity period and an average interest rate.art. 102 changes in the fund's net assets (art. 89 cisa)1 for each collective investment scheme, any changes in the fund's net assets must be itemised and contain at least:a.the fund's net assets at the beginning of the reporting year;b.distributions;c.balance from unit transactions;d.overall net income;e.the fund's net assets at the end of the reporting year.2 the unit statistics for the reporting year must also be disclosed (art. 89 para. 1 let. b cisa).art. 103 figures from previous years (art. 91 cisa)1 in the annual and semi-annual reports, the previous year's figures must also be disclosed in the statement of net assets, or the balance sheet and profit and loss account.2 the fund's net assets and the net asset value per unit for the past three reporting years must also be itemised in the annual report. the key date shall be the last day of the reporting year.section 3 appropriation of net income and distributions art. 104 appropriation of net income (art. 89 para. 1 let. a cisa)1 the appropriation of net income has the following minimum structure:a.net income for the accounting year;b.capital gains generated during the accounting year intended for distribution;c.capital gains from previous accounting years earmarked for distribution;d.balance brought forward from the previous year;e.net income available for distribution;f.net income earmarked for distribution to investors;g.net income retained for reinvestment;h.balance brought forward to new account.2 no reserves may be created.art. 105 distributions (art. 91 cisa)1 interim distributions of net income are only permitted if specified in the fund regulations.2 capital gains may only be distributed if the following conditions are met:a.the fund regulations must provide for the distribution.b.the capital gains must be realised.c.they do not constitute interim distributions.3 the distribution of capital gains is also permitted if there are capital losses from previous years.4 no share in profit may be disbursed.section 4 duty to publish art. 106 publication of issue and redemption prices, or of net asset value (arts. 26 para. 3, 79, 80, 83 para. 4 cisa; art. 35a para. 1 let. 1 and 39 ciso46)1 the issue and redemption price, or net asset value, must be published in the print media or electronic platforms cited in the prospectus each time units are issued and redeemed.2 prices for securities funds and other funds must also be published at least twice a month.3 prices of the following collective investment schemes must be published at least once a month:a.real estate funds;b.collective investment schemes for which the right to redeem at any time is restricted pursuant to article 109 paragraph 3 ciso.4 the weeks and weekdays on which publication takes place pursuant to paragraphs 2 and 3 must be stated in the prospectus.5 if the net asset value is published, it must be flagged exclusive of commission.46 sr 951.311art. 10747 47 repealed by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, with effect from 1 jan. 2021 (as 2020 5327).chapter 5 accounting for closed-ended collective investment schemes art. 108 limited partnership for collective investment (art. 108 cisa)1 accounting shall be based on the provisions relating to open-ended collective investment schemes mutatis mutandis.2 participations which are held purely for investment purposes may not be consolidated, irrespective of the percentage of votes and capital held in the company concerned.art. 109 sicafs (art. 117 cisa)1 the accounting methods applied to individual financial statements shall in principle be based on the provisions of the open-ended collective investment schemes.2 the duty to consolidate under the co48 is not applied. consolidation may be effected in accordance with a recognised vasr49 standard.48 sr 22049 sr 221.432title 4 audits and audit reports chapter 1 audits art. 11050 separation of financial and regulatory audits (art. 126 cisa; art. 24 finmasa51)audits shall be separated into a financial audit and a regulatory audit.50 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).51 financial market supervision act of 22 june 2007 (sr 956.1).art. 111 financial audit (art. 126 paras. 5 and 6 cisa; art. 137 ciso52)1 for a financial audit of collective investment schemes, the information is audited in accordance with articles 89 paragraph 1 letters a-h and 90 cisa.1bis the audit of the management or management company of the collective investment scheme and compliance with the statutory, contractual and regulatory provisions that do not relate to the annual accounts is a matter for the regulatory audit of the fund management company.532 the financial audit, general partners of a limited partnership for collective investment and representatives of foreign collective investment schemes is conducted in accordance with article 728-731a co54.553 finma may allow exceptions for representatives of foreign collective investment schemes.52 sr 951.31153 inserted by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).54 sr 22055 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).art. 112 regulatory audit (art. 126 paras. 1-3 cisa; art. 24 finmasa56 and 2-8 fmao57)581 the regulatory audit comprises the examination of the licensee's compliance with the regulatory provisions applied under article 13 paragraph 2 letters b-d and h cisa including collective investment schemes.592 for audit scope is to include the general partner of a limited partnership for collective investment.3 the regulatory audit in relation to collective investment schemes also examines the prospectus and basic information sheet.604 .6156 sr 956.157 financial market auditing ordinance of 15 oct. 2008 (sr 956.161).58 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).59 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).60 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).61 repealed by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, with effect from 1 jan. 2021 (as 2020 5327).chapter 2 audit reports art. 113 type of reports (art. 126 cisa; art. 24 finmasa62; art. 137 ciso63; arts. 9-12 fmao64)the audit company shall produce:a.reports on the regulatory audit of the licensees and the collective investment schemes, as well as the representatives of foreign collective investment schemes not requiring authorisation (regulatory audit);b.audit reports on the annual accounts audit under article 126 paragraph 5 cisa (financial audit);c.brief reports on the audits of collective investment schemes (financial audit).62 sr 956.163 sr 951.31164 sr 956.161art. 114 financial audit report (art. 126 para. 1-3 cisa; art. 24 finmasa65 and 9-12-fmao66)671 the audit company shall produce the report on the regulatory audit.682 in the case of a fund management company, the report also covers the investment funds that it manages.693 the audit reports for a limited partnership for collective investment also include the general partner. 4 the audit reports for licensees and investment funds are to be shown to the ultimate management and those responsible for supervision and control. the audit reports must be discussed at a meeting of such a governing body, and minutes thereof shall be taken.65 sr 956.166 sr 956.16167 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).68 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).69 amended by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).art. 115 financial audit (art. 126 paras. 5 and 6 cisa; art. 137 ciso70)1 the provisions set out for regular audits under the co71 apply mutatis mutandis to financial reports on a financial report. 2 the audit company produces short-form reports on a timely basis prior to the publication of the annual reports. they must be signed by the responsible lead auditor and an authorised signatory of the audit company.3 reports must be provided for each of the collective investment schemes with a sub-fund.70 sr 951.31171 sr 220art. 116 short-form report (art. 126 paras. 5-6 cisa; art. 24 finmasa72; art. 137 ciso73; arts 9-12 fmao74)1 the brief report expresses an opinion on the adherence to the statutory, contractual and regulatory provisions for the annual accounts, as well as the provisions laid down in the articles of association, and on the audits of the information required by article 89 paragraph 1 letters a-h cisa, and additionally in the case of real estate funds on those audits pursuant to article 90 cisa.2 in relation to a sicav or sicaf, the short-form report may also include the reports of the statutory audit company pursuant to article 728 co75. 3 finma may declare a standard confirmation of the audit industry organisation to be generally binding. 72 sr 956.173 sr 951.31174 sr 956.16175 sr 2204a. titel76 form of submission 76 inserted by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327). (art. 142 ciso77)art. 116a 1 the documents in accordance with article 142 paragraph 1 ciso78 must be submitted in electronic form using the templates provided by finma.2 finma may permit exceptions to electronic submission.78 sr 951.31177 sr 951.311title 5 final and transitional provisions art. 117 repeal of another decree the finma collective investment schemes ordinance of 21 december 200679 is repealed.79 [as 2007 301, 2008 5613 n. i 1]art. 11880 80 repealed by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, with effect from 1 jan. 2021 (as 2020 5327).art. 119 commencement this ordinance comes into force on 1 january 2015.annex 1 (art. 35 para. 2)inclusion of derivatives / underlying equivalents 1. in principle, underlying equivalents are determined in accordance with the following, non-exhaustive list of derivatives. the following points apply in general:1.1 the reference currency of the securities fund must be used on the basis of the current exchange rates.1.2 in the case of a currency derivative consisting of two contract legs where both are not required to be fulfilled in the reference currency of the securities fund, both contract legs must be included.1.3 if delta is not calculated, a delta of one must be employed.2. basic types of derivatives are, specifically:2.1 futures:2.1.1 bond future: number of contracts x contract size x market value of the cheapest deliverable reference bond2.1.2 interest rate future: number of contracts x contract size2.1.3 currency future: number of contracts x contract size2.1.4 equity future: number of contracts x contract size x market price of the underlying share2.1.5 index future: number of contracts x contract size x index level2.2 options (buy/sell position; call/put options):2.2.1 bond option: number of contracts x contract size x market price of the underlying bond x delta2.2.2 equity option: number of contracts x contract size x market price of the underlying share x delta2.2.3 interest rate option: contract value x delta2.2.4 currency option: contract value of the currency leg(s) x delta2.2.5 index option: number of contracts x contract size x index level x delta2.2.6 options on futures: number of contracts x contract size x market value of the underlying x delta2.2.7 warrants and subscription rights: number of shares/bonds x market value of the underlying x delta2.3 swaps:2.3.1 interest rate swaps: contract value2.3.2 currency swaps: nominal value of currency leg(s)2.3.3 cross-currency interest rate swaps: nominal value of currency leg(s)2.3.4 total return swap: market value of the underlying asset2.3.5 complex total return swap: cumulative market value of both legs of the total return swap2.3.6 single name credit default swaps:a.protection seller: the higher of the market value of the underlying asset or the nominal value of the credit default swapb.protection buyer: market value of the underlying asset2.3.7 contracts for differences: number of shares/bonds x market value of the underlying asset2.4 forwards:2.4.1 fx forwards: nominal value of currency leg(s)2.4.2 forward rate agreements: nominal value2.5 leveraged exposure to indices or indices with embedded leverage:in the case of derivatives providing leveraged exposure to an underlying index, or indices that embed leveraged exposure, the conversion amounts of the corresponding assets must also be determined and included in the calculation.3. financial instruments with a derivative component are, specifically:3.1 convertible bonds: number of underlying assets x market value of the underlying assets x delta3.2 credit linked notes: market value of the underlying asset3.3 partially paid securities: number of shares/bonds x market value of the underlying assets3.4 warrants and subscription rights: number of shares/bonds x market value of the underlying x delta4. barrier optionsnumber of contracts x contract size x market price of the underlying asset x deltaannex 2 (art. 94)minimum structure of the statement of net assets / balance sheet and profit and loss account of securities funds 1. statement of net assets and balance sheet1.1 due from banks, including fiduciary deposits with third-party banks, broken down into:1.1.1 sight deposits1.1.2 time deposits1.2 money market instruments1.3 claims from repurchase agreements1.4 securities, including those on loan and under repurchase agreements, broken down into:1.4.1 bonds, convertible bonds, warrant bonds and other debt securities and rights1.4.2 structured products1.4.3 shares and other equity securities and rights1.4.4 units in other collective investment schemes1.5 other investments1.6 derivative financial instruments1.7 other assets1.8 total fund assets, less1.9 liabilities from repurchase agreements1.10 loans1.11 other liabilities1.12 net fund assets1.13 number of units outstanding1.14 net asset value per unit2. profit and loss account2.1 income from bank assets2.2 income from money market instruments2.3 income from reverse repos 2.4 income from securities lending2.5 income from securities, broken down by:2.5.1 bonds, convertible bonds, warrant bonds and other debt securities and rights2.5.2 structured products2.5.3 shares and other equity securities and rights, including income from bonus shares2.5.4 units of other collective investment schemes2.6 income from other investments2.7 other income2.8 current net income paid in on issued units2.9 total income less:2.10 interest paid2.11 auditing expenses2.12 remunerations to the following in accordance with the fund regulations:2.12.1 the fund management company2.12.2 the company shareholders2.12.3 the custodian bank2.12.4 the asset manager2.12.5 other third parties2.13 other expenses2.14 current net income paid out on redeemed units2.15 net income2.16 realised capital gains and losses2.17 realised net income2.18 unrealised capital gains and losses2.19 total net income3. notes3.1 derivatives:3.1.1 if applying commitment approach i: as amount and as a percentage of net fund assets a.total exposure-increasing positions (underlying equivalent)b.total exposure-reducing positions (underlying equivalent)3.1.2 if applying commitment approach ii: as amount and as a percentage of net fund assetsa.gross overall exposure arising from derivativesb.net overall exposure arising from derivatives c.commitment arising from securities lending and repurchase agreements3.1.3 if applying the model approach:a.value-at-risk limit on closing date as a percentage of the fund's net assetsb.value-at-risk on closing date as a percentage of the fund's net assetsc.value-at-risk (average as a percentage of the fund's net assets)d.back-testing: number of outliers e.gross overall exposure arising from derivatives 3.1.4 identity of contracting partners for otc transactions 3.2 security, issuer, number / nominal value of the securities lent as at the balance sheet date3.3 security, issuer, number / nominal value of the securities under repurchase agreement as at the balance sheet date3.4 balance of account for income retained for reinvestment3.5 information on expenses:3.5.1 information on actual rates of remuneration if maximum rates are indicated in the fund regulations3.5.2 indication and explanation of performance in accordance with industry standards3.5.3 total expense ratio (ter) in accordance with industry standards3.6 information concerning soft commission agreements3.7 principles applied to value and calculate the net asset value3.8 direct and indirect operating expenses arising from securities lending and repurchase agreements as well as the borrowers, counterparties and intermediaries involved3.9 for index-replicating collective investment schemes: information on the level of the tracking error3.10 nature and amount of collateral receivedannex 381 81 revised by annex no 1 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327.(art. 95)minimum structure of the statement of net assets / balance sheet and profit and loss account of real estate funds 1. statement of net assets and balance sheet1.1 cash on hand, postal check and bank sight deposits, including fiduciary deposits with third-party banks1.2 bank time deposits, including fiduciary investments with third-party banks1.3 short-term fixed-income securities, broken down into:1.3.1 collateral for construction projects (art. 90 ciso82)1.3.2 other (art. 89 ciso)1.4 real estate, broken down into:1.4.1 residential property 1.4.2 commercial property 1.4.3 mixed-use property 1.4.4 building land, including properties for demolition, and buildings under construction1.4.5 mortgages and other advances secured by mortgage1.4.6 units in other real estate funds and real estate investment companies1.5 derivative financial instruments1.6 other assets1.7 total fund assets, less:1.8 short-term liabilities, broken down into:1.8.1 short-term interest-bearing mortgages and other liabilities secured by mortgage1.8.2 short-term loans and advances subject to interest1.8.3 short-term other liabilities1.9 long-term liabilities, broken down into:1.9.1 long-term mortgages subject to interest and other liabilities secured by mortgage1.9.2 long-term loans and advances subject to interest 1.9.3 long-term other liabilities1.10 units of minority shareholders in real estate companies1.11 net fund assets before estimated liquidation taxes1.12 estimated liquidation taxes1.13 net fund assets1.14 number of units outstanding1.15 net asset value per unit2. profit and loss account2.1 income from bank and postal accounts2.2 income from short-term, fixed-interest securities2.3 rental income (gross income received)2.4 capitalised interest on building loans2.5 other income2.6 current net income paid in on issued units2.7 total income less:2.8 mortgage interest and interest from liabilities secured by mortgage2.9 other interest paid2.10 repairs and maintenance2.11 property management, broken down into:2.11.1 property expenses2.11.2 general and administrative expenses2.12 appraisals and auditing expenses2.13 depreciation of land and buildings2.14 provisions for future repairs2.15 remunerations to the following in accordance with the fund regulations:2.15.1 the fund management company2.15.2 the company shareholders2.15.3 the custodian bank2.15.4 the real estate manager2.15.5 other third parties2.16 other expenses2.17 current net income paid out on redeemed units2.18 interests of minority shareholders in real estate companies2.19 net income2.20 realised capital gains and losses2.21 realised net income2.22 unrealised capital gains and losses including liquidation taxes2.23 total net income3. notes3.1 balance of depreciation account for land and buildings3.2 balance of provisions account for future repairs3.3 balance of account for income retained for reinvestment3.4 number of units scheduled for redemption at the end of the next accounting year3.5 ratios in accordance with industry standards:3.6.1 rent default rate3.6.2 borrowing ratio3.6.3 dividend yield3.6.4 pay-out ratio3.6.5 operating profit margin3.6.6 fund operating expense ratio3.6.7 return on equity3.6.8 premium or discount3.6.9 performance3.6.10 investment return3.7 information on derivatives (annex 2 is applicable, mutatis mutandis)3.8 principles for the valuation of fund assets (method of estimation and quantitative information on the assumptions in the estimation model) and calculation of the net asset value 3.9 information on actual rates of remuneration if maximum rates are indicated in the fund regulations3.10 total amount of contractual payment obligations after the balance sheet date for property purchases, construction orders and investments in property.3.11 long-term liabilities, broken down into maturing within one to five years, and after five years.82 sr 951.311

952.03 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinance on the capital adequacy and risk diversification of banks and securities firms1(capital adequacy ordinance, cao)of 1 june 2012 (status as of 1 august 2021)1 amended by annex 1 no ii 10 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633).the swiss federal council,based on article 3 paragraph 2 letter b, article 3g, article 4 paragraphs 2 and 4, article 4bis paragraph 2, article 10 paragraph 4 letter a and article 56 of the banking act of 8 november 19342 (banka) and on articles 46 paragraph 3 and 72 of the financial institutions act of 15 june 20183 (finia),4ordains:2 sr 952.03 sr 954.14 amended by annex 1 no ii 10 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633).title 1 general provisions chapter 1 purpose, scope and definitions art. 1 principles 1 to protect creditors and the stability of the financial system, banks and account-holding securities firms must mitigate their risks appropriately and hold adequate capital commensurate with their business activities and risks.52 they shall provide capital backing for credit risks, market risks, non-counterparty risks and operational risks.5 amended by annex 1 no ii 10 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633).art. 2 subject matter 1 this ordinance governs:a. eligible capital;b. the risks to be backed with capital and the level of capital backing;c. risk diversification, i.e. the limits for risk concentrations and the treatment of intra-group exposures;d. the special requirements for systemically important banks.2 the swiss financial market supervisory authority (finma) may issue technical implementing provisions.art. 36 scope this ordinance applies to banks in accordance with the banka and account-holding securities firms pursuant to the finia (hereinafter banks).6 amended by annex 1 no ii 10 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633).art. 4 definitions in this ordinance:a. regulated stock exchange means an institution that is appropriately regulated and supervised according to internationally recognised standards whose purpose is to enable the simultaneous purchase and sale of securities among several securities firms7 and that also ensures this by means of sufficient market liquidity;b. main index means an index comprising all securities traded on a regulated stock exchange (total market index) or a selection of key securities on such an exchange, or an index comprising the key securities of various regulated stock exchanges;c. regulated entity means an entity active in the financial sector that must comply with appropriate capital adequacy requirements, particularly with regard to business risks, and that is regulated according to internationally recognised standards and supervised by a banking, securities or insurance supervisory authority;d. equity security means a security representing a financial interest in the share capital of an entity;e. equity instrument means equity securities that qualify as common equity tier 1 capital or additional tier 1 capital, as well as debt instruments that qualify as additional tier 1 capital or tier 2 capital;f. corresponding deduction approach means the corresponding deduction approach described in the basel committee's minimum standards;g. qualifying interest rate instrument means an interest rate instrument that has:1. a rating of between 1 and 4 from at least two recognised rating agencies,2. a rating of between 1 and 4 from one recognised rating agency, provided it does not have a lower rating from another finma-recognised rating agency,3. no rating from a recognised rating agency, but has a yield to maturity and residual maturity comparable to those of securities with a rating of between 1 and 4, provided that the issuer's securities are traded on a regulated stock exchange or on a market where at least three market makers independent of each other normally quote rates on a daily basis that are published regularly, or4. no rating from a recognised rating agency (external rating), but has an internal bank rating (internal rating) corresponding to a rating of between 1 and 4, provided that the issuer's securities are traded on a regulated stock exchange or on a market where at least three market makers independent of each other normally quote rates on a daily basis that are published regularly;h. basel minimum standards means those documents of the basel committee on banking supervision (bcbs) that are relevant for calculating capital adequacy requirements.87 term in accordance with annex 1 no ii 10 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633). this amendment has been made throughout the text.8 the current basel minimum standards may be obtained from the bank for international settlements at centralbahnplatz 2, 4002 basel, or viewed online at www.bis.org/bcbsart. 5 trading book 1 banks may keep a trading book of exposures in financial instruments and commodities held with the intent to trade or to hedge other exposures.2 they may allocate exposures to the trading book only if:a. they are unencumbered by contractual agreements regarding their tradability; orb. they can be fully hedged at all times.3 an intent to trade exists if the bank intends to:a. hold the exposures for the short term;b. benefit from short-term fluctuations in market prices; orc. realise arbitrage gains.4 the exposures must be valued frequently and accurately. the trading book must be actively managed.art. 6 rating agencies 1 finma may recognise a rating agency if:a. its rating methodology and ratings are objective;b. the agency and its rating procedure are independent;c. it makes its ratings and the underlying information available;d. it discloses its rating methodology, its code of conduct, the basis for its remuneration and the main characteristics of its ratings;e. it has sufficient resources; andf. the agency and its ratings are credible.2 finma shall publish a list of recognised rating agencies.3 if it finds that a recognised rating agency no longer meets the recognition requirements, it shall withdraw such recognition.chapter 2 consolidation art. 7 consolidation requirement 1 the capital adequacy and risk diversification requirements must be met not only at the level of the individual entity, but also at the level of the financial group and financial conglomerate (consolidation requirement).2 consolidation shall include all group companies operating in the financial sector as described in article 4 in conjunction with article 22 of the banking ordinance of 30 april 20149 (banko), with the following exceptions:10a. subject to article 12, financial interests in the insurance sector shall be consolidated only within the framework of the risk diversification requirements;b. there shall be no collective investment consolidation requirement concerning the management of collective investments on behalf of investors or the holding of the initial capital of investment companies.3 if the bank holds equity instruments in an unconsolidated company in accordance with paragraph 2 letter a, these shall be subject to the corresponding deduction approach.4 if the bank holds equity instruments in an unconsolidated company in accordance with paragraph 2 letter b, these shall be subject to the corresponding deduction approach without reference to a threshold.9 sr 952.0210 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).art. 8 consolidation types and options available to the bank 1 majority interests in companies subject to consolidation must be fully consolidated.2 in the case of financial interests held jointly with a second shareholder or partner where each holds 50% of the voting rights (joint ventures), the bank may choose full consolidation, proportionate consolidation or the corresponding deduction approach.3 in the case of minority interests of at least 20% in companies subject to consolidation over which the bank exerts a controlling influence directly or indirectly with other shareholders, the bank may opt for proportionate consolidation or the corresponding deduction approach. 4 the corresponding deduction approach shall be applied for all other minority interests.5 with proportionate consolidation, the eligible and required capital, as well as the risk concentrations, must be taken into account in proportion to the financial interest in question.6 financial interests accounted for using the corresponding deduction approach shall not be included in risk diversification.7 the corresponding deduction approach under paragraphs 2 and 3 shall be applied without reference to a thresholdart. 9 alternative treatment with the consent of the audit firm 1 with the audit firm's consent, the following financial interests may be treated as exempt from the consolidation requirement:a. financial interests in companies which, due to their size and business activities, are insignificant for compliance with the capital adequacy requirements;b. significant group companies held for less than a year.2 financial interests conferring more than 50% of the voting rights may exceptionally be consolidated on a proportionate basis with the audit firm's consent if it is contractually stipulated that:a. the support for the company subject to consolidation is limited to the bank's proportionate share; andb. the other shareholders or partners are obliged to provide support to the extent of their proportionate share and are legally and financially capable of fulfilling that obligation.3 financial interests that are exempt from the consolidation requirement in accordance with paragraph 1 shall be subject to the corresponding deduction approach without reference to a thresholdart. 10 special provisions 1 in special cases, finma may fully or partially exempt a bank from fulfilling the capital adequacy and risk diversification requirements at the level of the individual entity, in particular if the conditions under article 17 of the banko11 are met.122 in the context of the capital adequacy requirements to be met at the level of the financial group or financial conglomerate, finma may impose additional requirements regarding the adequate capitalisation of a company which is at the head of a financial group or financial conglomerate and which is not supervised as an individual entity.3 in special cases, finma may permit a bank to consolidate group companies operating in the financial sector at the level of the individual entity (solo consolidation) due to their particularly close relationship with the bank.11 sr 952.0212 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).art. 11 subordinate financial groups 1 the consolidation requirement shall apply to every financial group, even if a superordinate financial group or such a financial conglomerate is already supervised by finma.2 finma may exempt a subordinate financial group from the consolidation requirement in special cases, particularly if:a. its group companies operate exclusively in switzerland; andb. the superordinate financial group or such a financial conglomerate is itself subject to appropriate consolidated supervision by a financial market supervisory authority.art. 12 captives for operational risks subject to approval by finma, group companies with the sole purpose of insuring intra-group operational risks may be fully consolidated at financial group level in the same way as group companies operating in the financial sector and, if appropriate, solo consolidation may be used (art. 10 para. 3).art. 13 financial interests outside the financial sector the upper limits for qualified financial interests of a bank in a company outside the financial sector under article 4 paragraph 4 of the banka do not apply if:a. such financial interests are acquired temporarily as part of a corporate restructuring or bail-out;b. securities are acquired for the standard underwriting period; orc. the difference between the carrying value and the upper limits applicable to these financial interests is fully backed by freely disposable eligible capital.chapter 3 demonstration and disclosure of adequate capital art. 14 capital adequacy reporting 1 banks shall provide quarterly evidence that they have adequate capital. finma shall determine what the capital adequacy reporting must include.2 capital adequacy reports on a consolidated basis must be submitted every six months.3 the reports must be submitted to the swiss national bank within six weeks of the end of the quarter or half-year.art. 15 calculation basis when calculating the eligible and required capital for capital adequacy reporting, the bank shall rely on the financial statements prepared in accordance with the accounting standards prescribed by finma. finma shall regulate the exceptions to this principle.art. 16 disclosure 1 the banks shall publish information in appropriate form on their risks and capital. the calculation of eligible capital must be derived from the financial statements in a comprehensible manner.2 private bankers who do not actively seek deposits from the public are exempt from this obligation.3 finma shall issue technical implementing provisions. in particular, it shall define which information must be disclosed in addition to the annual financial statements or interim financial statements.chapter 4 simplified application art. 17 1 the banks may opt for simplified application of individual provisions of this ordinance and of finma's technical implementing provisions that flesh them out if:a. they thereby avoid disproportionate efforts;b. they ensure risk management that is appropriate with regard to their business activities; andc. the ratio of minimum capital to the bank's eligible capital is at least maintained as a result.2 they shall ensure that these requirements are met and shall document the type of simplification.title 2 eligible capital chapter 1 general art. 18 capital components 1 eligible capital consists of core capital (tier 1 capital; t1) and supplementary capital (tier 2 capital; t2).2 core capital is composed of common equity tier 1 (cet1) capital and additional tier 1 (at1) capital.art. 19 loss absorption 1 the loss absorbtion principles for the capital components are as follows:a. cet1 capital shall absorb losses ahead of at1 capital;b. at1 capital shall absorb losses ahead of tier 2 capital.2 if individual instruments of the same capital component (excluding cet1) are not to absorb losses in the same way, this must be specified in the articles of association or when the instrument is issued.art. 20 common capital requirements 1 capital must be fully paid up or generated internally to the extent of its recognition.2 at the time of issuance, it may not:a. be directly or indirectly financed by loans granted by the bank to third parties;b. be offset against the bank's receivables;c. be secured by bank assets.3 it must be subordinate to the senior claims of all other creditors in the event of liquidation, bankruptcy or restructuring.4 capital instruments that provide for conditional conversion or write-off not only for the point of non-viability (art. 29) shall be recognised as capital components in the same way as corresponds to their characteristics prior to conversion or write-down. this shall be without prejudice to:a.13 recognition to cover the capital buffer requirement under article 43 paragraph 1 and annex 8; as well asb. the provisions for the convertible capital of systemically important banks pursuant to title 5.13 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2018 (as 2017 7625)chapter 2 calculation section 1 common equity tier 1 (cet1) capital art. 21 eligible elements 1 the following shall be eligible as cet1 capital:a. paid-up share capital;b. disclosed reserves;c. reserves for general banking risks after deduction of deferred taxes, where a corresponding provision has not been created;d. retained earnings;e.14 the profit for the current business year after deducting the estimated earnings distribution, subject to the existence of a full income statement in accordance with finma's implementing provisions based on article 42 of the banko15 that has been audited according to finma's guidelines or of a full income statement in accordance with an international standard recognised by finma that has been audited according to finma's guidelines.2 minority interests in fully consolidated regulated entities shall be eligible to the extent that they are eligible in these entities themselves. capital surpluses attributable to minorities, calculated on the basis of requirements that include capital buffers and additional capital, are not eligible.14 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).15 sr 952.02art. 22 eligibility of share capital 1 share capital shall be eligible as cet1 capital if:a. it meets the requirements set out in article 20;b. it was directly issued in accordance with the resolution or authorisation of the owners;c. it does not constitute a liability for the company;d. it is shown clearly and separately in the balance sheet in accordance with the applicable accounting standards;e. it is perpetual and not subject to any provision to the contrary in the bank's articles of association or contractual obligations;f. distributions to the owners are carried out from distributable reserves without any obligations or privileges; andg. owners do not have any privileges or preferential claims to proceeds in the event of liquidation.2 preferred stock and participation capital shall be eligible as cet1 if:a. they meet the criteria under paragraph 1;b. they can be used as collateral in the same way as share capital in the form of cet1 capital; andc. the issuer (as a company limited by shares) has not listed its ordinary shares on a regulated stock exchange.163 finma shall take account of the bank's legal form and the characteristics of its share capital when assessing whether the criteria under paragraph 1 and paragraph 2 letter b are met.16 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).art. 23 types of share capital 1 depending on a bank's legal form, the share capital shall consist of equity, nominal, cooperative or endowment capital and the limited-partner contribution in the case of banks in the form of partnerships (private bankers).2 finma may issue technical implementing provisions on the regulatory recognition of banks' share capital.art. 24 endowment capital of banks under public law if cantonal legislation or the articles of association of banks under public law provide for a maturity date for their endowment capital, this capital may be recognised as cet1 capital if the maturity: a. serves the purpose of being able to redefine the conditions; andb. does not lead to the repayment of the endowment capital.art. 25 capital contributions of private bankers 1 private bankers may recognise capital contributions as cet1 capital if:a. their amount is specified in the partnership agreement to be approved by finma;b. they bear interest or entitle the contributor to a share in profits only if sufficient profit is available at the end of the financial year; andc. they are liable for losses in the same way as a limited-partner contribution.2 capital contributions may be reduced only in a process that involves all partners with unlimited liability.3 cet1 capital may be decreased by a reduction in capital contributions only to the extent that the remaining capital meets the requirements under article 41.art. 26 cooperative capital 1 if the articles of association provide for the redemption of cooperative capital share certificates, the cooperative capital may be recognised as cet1 capital if the articles of association specify that the redemption:a. may be rejected by the governing bodies at any time without giving reasons; andb. is carried out only to the extent that the bank's remaining capital meets the requirements under article 41.2 a restriction on the claim to the liquidation proceeds must:a. affect all share certificate holders equally; andb. be provided for in the articles of association.3 a share in the liquidation proceeds may be foregone only in favour of:a. a public or tax-exempt private institution; orb.17 a central organisation within the meaning of article 17 of the banko18 if the bank to be liquidated belongs to this central organisation.4 articles of association may not guarantee distributions for holders of share certificates, even if they set a ceiling.17 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).18 sr 952.02section 2 additional tier 1 (at1) capital art. 27 eligibility 1 a capital instrument shall be eligible as at1 capital if:a. it meets the requirements under articles 20 and 29;b. it is open-ended and, at the time of issuance, the bank does not raise expectations of repayment or the corresponding approval of the supervisory authority;c. the bank is entitled to repay the capital no earlier than five years after issuance;d. the bank indicates at the time of issuance that the supervisory authority will consent to repayment only if: 1. the remaining capital continues to meet the requirements under article 41, or2. sufficient capital that is at least equivalent is issued to replace it;e. it does not have any characteristics which would in any way complicate an increase in the bank's share capital;f. distributions by the bank to the capital providers are made solely on a discretionary basis and only if distributable reserves are available; andg. it is excluded that distributions to the capital providers may be increased during the term as a result of issuer-specific credit risk. 2 equity securities shall be eligible as at1 capital if they meet the criteria under paragraph 1.3 liabilities that meet the criteria under paragraph 1 shall be eligible as at1 capital if, in the event of a contractually defined event (trigger) occurring, but no later than when cet1 capital falls below 5.125%, they cease to exist by virtue of: a. a write-down; orb. conversion to cet1 capital.4 the terms and conditions of issue of a conditional write-off capital instrument may grant the capital provider a deferred conditional right to participate in an improvement in the bank's financial situation. this may not substantially impair the strengthening of the bank's capital base at the time of the write-down.5 before a capital instrument is issued, finma shall approve:a. the contractually defined trigger event under paragraph 3; andb. the extent to which a right to participate in an improvement under paragraph 4 is permissible.6 article 21 paragraph 2 concerning the eligibility of minority interests in fully consolidated regulated entities applies by analogy.art. 28 availability in the financial group at1 capital issued by a non-operating special purpose entity shall be recognised on a consolidated basis if it is directly and unrestrictedly transferred in the same or higher quality to the group parent company or an operating entity of the bank.art. 29 point of non-viability (ponv) 1 the terms and conditions of issue or the articles of association must make provision for at1 capital to contribute to the bank's restructuring by means of a complete write-off or conversion at the point of non-viability. in this case, creditors' claims must be written off in full.2 the conversion to cet1 capital or the write-down must take place at the latest:a. before recourse to public sector assistance; orb. when finma orders this to avoid insolvency.3 in the case of equity securities that are recognised as at1 capital and do not have a loss absorption mechanism in accordance with paragraph 1, the contract or the articles of association must make provision for the irrevocable waiver of any privileges with respect to the share capital that qualifies as cet1 capital at the point of non-viability.section 3 supplementary (tier 2) capital art. 30 eligibility 1 a capital instrument shall be eligible as tier 2 capital if:a. it meets the requirements under article 20 and article 29 paragraphs 1 and 2;b. it has an original maturity of at least five years and the terms and conditions of issue do not contain any repayment incentives for the bank;c. the bank is entitled to repay the capital no earlier than five years after issuance;d. the bank indicates at the time of issuance that the supervisory authority will consent to early repayment only if:1. the remaining capital continues to meet the requirements under article 41, or2. sufficient capital that is at least equivalent is issued to replace it; ande. it is excluded that distributions to the capital providers may be increased during the term as a result of issuer-specific credit risk.2 in the last five years prior to final maturity, the recognition of tier 2 capital instruments shall decrease by 20% of the nominal amount each year. they shall not be recognised at all in the last year.3 article 21 paragraph 2, article 28 and article 29 paragraphs 1 and 2 apply by analogy.4 finma shall define in technical implementing provisions the criteria for the recognition of additional tier 2 capital components, in particular:a. banks under public law;b. the capital contributions made by partners with unlimited liability to private bankers which do not meet the criteria under article 25; andc. hidden reserves.section 4 adjustments art. 31 general 1 the adjustments to eligible capital shall be calculated in the same manner for both individual entities and consolidated financial groups.2 the carrying value shall be the relevant amount for an adjustment. anticipated taxation effects may be taken into account to reduce the adjustment only if:a. the tax liability expires automatically together with the corresponding item; orb. this is expressly provided for in this ordinance or in finma's technical implementing provisions.3 finma's technical implementing provisions may provide for adjustments for banks that prepare their financial statements in accordance with internationally recognised accounting standards.art. 31a19 changes in the fair value of own liabilities as a result of a change in the bank's credit risk 1 when calculating cet1 capital, all unrealised gains and losses on own liabilities that are attributable to fair value changes caused by changes in the bank's credit risk must be neutralised.2 in addition, all valuation adjustments concerning derivative liabilities that arise from the bank's own credit risk must be neutralised.3 valuation adjustments arising from the bank's own credit risk may not be netted against valuation adjustments arising from counterparties' credit risk.19 inserted by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).art. 32 deductions from cet1 capital the following must be deducted in full from cet1 capital:a. any loss carried forward and the loss for the current financial year;b. any uncovered valuation adjustment and provisioning requirements for the current financial year;c. goodwill, including any goodwill included in the valuation of significant interests in financial sector entities outside the scope of consolidation, and intangible assets other than mortgage servicing rights (msr);d. deferred tax assets (dtas) that depend on future profitability, whereby offsetting against corresponding deferred tax liabilities within the same geographical and material tax jurisdiction is permitted, with the exception of dtas due to temporary differences;e. for banks using the irb approach20 (art. 77), the amount by which the expected losses calculated using this approach exceed the value adjustments according to the basel minimum standards;f. any gain on sale related to securitisation transactions;g. defined benefit pension fund assets recognised on the balance sheet in accordance with the relevant requirements of the basel minimum standards;h. the net long positions under article 52 in own equity securities that are part of cet1 capital, held directly or indirectly by the bank, both on and off the trading book, provided that they have not already been recognised in the income statement;i. qualified financial interests in the capital of another financial sector entity, where such entity also has a stake in the capital of the bank (reciprocal cross-holdings);j.21 in the context of the individual entity calculation, if finma does not permit risk weighting in accordance with sections 1.6 or 1.7 of annex 4: the net long positions of the directly held financial interests in financial sector entities subject to consolidated reporting, calculated in accordance with article 52;k. deductions resulting from a deduction option chosen by the bank within the framework of the consolidation provisions under article 7 paragraph 4, article 8 paragraphs 2 and 3 and article 9 paragraphs 1 and 3.20 internal ratings-based approach21 amended by no i of the o of 21 nov. 2018, in force since 1 jan. 2019 (as 2018 5241).art. 33 corresponding deduction approach 1 if the bank holds equity instruments of a financial sector entity, the deductions shall be made using the corresponding deduction approach. the value of these instruments shall be deducted from the bank's capital component that corresponds to the component at the level of the third-party entity.1bis bail-in bonds issued by internationally active systemically important banks in accordance with article 126a paragraph 1 or corresponding regulations in foreign jurisdictions shall be treated as tier 2 capital instruments for the requirements of this section.222 if the bank does not hold any capital for the deduction in the corresponding eligible capital component, or if such capital is insufficient, the deduction shall be made from the next higher capital component.22 inserted by no i of the o of 21 nov. 2018 (as 2018 5241). amended by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).art. 34 deductions of positions in own equity instruments outside cet1 capital 1 the bank's own direct or indirect net long positions in at1 capital and tier 2 capital instruments, calculated in accordance with article 52, must be deducted using the corresponding deduction approach.2 with the corresponding deduction approach in accordance with paragraph 1 for tier 2 capital instruments, the restricted recognition under article 30 paragraph 2 (amortisation) shall not apply to securities of the same issue, and nominal values may be netted against each other.art. 35 threshold deductions 1 in the case of threshold deductions, the amount that exceeds the threshold shall be deducted. to determine the threshold, a bank's positions are to be measured against a predefined percentage of its own cet1 capital in accordance with the requirements of the basel minimum standards.2 threshold 1 shall amount to 10% of cet1 capital after all adjustments under article 31 paragraph 3 and article 32 letters a to i and k.3 threshold 2 shall amount to 10% of cet1 capital after all adjustments under article 31 paragraph 3 and article 32, including any deductions from cet1 capital as a result of the threshold 1 calculation (in accordance with art. 37 paras. 1 and 2).4 threshold 3 shall be determined such that, after the application of all regulatory adjustments, including any deductions at this threshold level in accordance with article 40 paragraph 1, the amount of the three positions that remains recognised does not exceed 15% of cet1 capital.2323 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).art. 36 applicable deduction approach for equity instruments 1 whether the deduction approach under article 37 or that under article 38 applies to a bank's equity holdings in a financial sector entity shall depend on the percentage of direct or indirect equity securities holdings in such an entity calculated in accordance with article 52, as well as other forms of investment in such securities which synthetically embody the same risk (securities held).242 equity instruments which the bank holds in the form of at1 capital or tier 2 capital in companies whose equity securities must be deducted in full from cet1 capital in accordance with article 32 letters i to k shall be subject to the procedure under article 38 paragraph 1.24 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).art. 37 equity securities in financial sector entities up to 10% 1 a bank that holds no more than 10% equity securities in a financial sector entity in the form of cet1 capital shall deduct from its own capital components the total carrying value of all equity instruments held in all such financial sector entities that exceeds threshold 1. this shall apply even if the bank only holds equity instruments in a financial sector entity that do not constitute cet1 capital.252 when applying the corresponding deduction approach, the amount to be deducted under paragraph 1 shall be in proportion to the equity instruments held by the bank in the relevant financial sector entities before the deduction.2bis in addition to the threshold 1 limit under paragraph 1, a bank may hold bail-in bonds in accordance with article 33 paragraph 1bis up to 5% of cet1 capital without deducting them from its own capital components. finma may issue corresponding implementing provisions.263 the portion of the aggregate carrying values under paragraph 1 that is below the threshold shall be risk-weighted. the risk weight for each capital component shall be based on its allocation to the banking and trading book before the deduction.25 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).26 inserted by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).art. 38 equity securities in financial sector entities over 10% 1 a bank that holds more than 10% equity securities in a financial sector entity in the form of cet1 capital shall apply the corresponding deduction approach to all at1 capital and tier 2 capital instruments of such entities without a threshold. the corresponding deduction approach without thresholds shall also apply to bail-in bonds of internationally active systemically important banks under article 33 paragraph 1bis.272 it must deduct from its cet1 capital the amount by which the total carrying value of all directly or indirectly held shares in the cet1 capital of such entities outside the scope of consolidation exceeds threshold 2, both at the level of the individual entity and on a consolidated basis.3 the amount calculated in accordance with paragraph 2 that is below the threshold shall be treated in accordance with article 40.27 amended by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).art. 39 further threshold 2 deductions 1 the bank must separately deduct from its cet1 capital the following amounts that exceed threshold 2:a. mortgage servicing rights; andb. deferred tax assets (dtas) due to temporary differences.2 amounts below the threshold shall be treated in accordance with article 40.art. 40 threshold 3 deductions 1 the carrying values resulting from the calculations under article 38 paragraphs 2 and 3 and article 39 that are below threshold 2 shall be aggregated and measured against threshold 3. the bank must deduct the amount that exceeds threshold 3 from its cet1 capital.2 the bank shall apply a risk weight of 250% to each amount below threshold 3.title 3 required capital chapter 1 general art. 41 composition required capital shall be composed of the following:a. minimum capital;b. the capital buffer;c.28 the countercyclical buffer;cbis.29 the countercyclical buffer add-on; andd. additional capital.28 amended by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).29 inserted by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).art. 42 minimum capital 1 after the deductions in accordance with articles 31 to 40, banks must hold total capital representing 8.0% of the risk-weighted exposures as minimum capital. at least 4.5% of the risk-weighted exposures must be backed by cet1 capital and at least 6.0% by tier 1 capital.302 the risk-weighted exposures shall be composed of:a. the exposures weighted according to their credit risk (art. 49) and the weighted exposures from unsettled transactions (art. 76);b. the non-counterparty risks weighted in accordance with article 79;c. the minimum capital requirement for market risk (arts. 80 to 88) multiplied by a factor of 12.5;d. the minimum capital requirement for operational risk (arts. 89 to 94) multiplied by a factor of 12.5;e. the minimum capital requirement for risks arising from guarantee commitments to central counterparties (art. 70) multiplied by a factor of 12.5;f. the minimum capital requirement for the credit valuation adjustment risk due to the counterparty credit risk of derivatives (art. 55) multiplied by a factor of 12.5.3 a bank must inform finma and its audit firm as soon as its capital falls below the minimum required under paragraph 1.4 a bank that holds less than the minimum capital required under paragraphs 1 and 2 shall be deemed non-compliant with the capital adequacy requirements within the meaning of article 25 paragraph 1 of the banka.30 amended by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).art. 43 capital buffer 1 in addition to the minimum capital, banks shall permanently maintain a capital buffer representing the amount of the total capital ratio in accordance with the requirements of annex 8. the more stringent special requirements for systemically important banks under title 5 remain reserved.312 banks whose capital buffer temporarily falls below the requirements due to exceptional, unforeseeable circumstances such as a crisis in the international or swiss financial system shall not be deemed to be non-compliant with the capital adequacy requirements.3 in the event of a shortfall, finma shall set a bank-specific deadline for restoring the capital buffer.31 amended by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).art. 44 countercyclical buffer 1 the swiss national bank may request the federal council to oblige banks to hold a countercyclical capital buffer in the form of cet1 capital of a maximum of 2.5% of their risk-weighted exposures in switzerland if this is necessary to:a. strengthen the banking sector's resilience to the risks of excessive credit growth; orb. counteract excessive credit growth.2 the swiss national bank shall consult finma before submitting the request and simultaneously inform the federal department of finance. if the federal council approves the request, this ordinance shall be supplemented with a corresponding annex.3 the countercyclical buffer may be restricted to certain credit exposures. it shall be removed or adjusted in line with the changed circumstances if the criteria for its imposition no longer apply. the procedure shall be based on paragraphs 1 and 2.4 article 43 paragraphs 2 and 3 shall apply by analogy to the countercyclical buffer.art. 44a32 countercyclical buffer add-on 1 banks with total assets of at least chf 250 billion including total foreign exposure of at least chf 10 billion, or with a total foreign exposure of at least chf 25 billion, shall be obliged to hold a countercyclical buffer add-on in the form of cet1 capital.2 for such banks, the level of the countercyclical buffer add-on shall correspond to the weighted average level of the countercyclical buffers which, according to the list published by the basel committee, apply in the member countries where a bank's relevant private sector claims are located, but it shall not exceed 2.5% of the risk-weighted exposures. claims vis--vis banks and the public sector shall not be deemed to be private sector claims.3 the weighting of the ratios for each member country shall correspond to the total capital requirement for credit exposures to the private sector in that country, divided by the bank's total capital requirement for credit exposures to the private sector.4 the relevant level of the countercyclical buffer add-on for switzerland shall correspond to the countercyclical buffer stipulated for all exposures in accordance with article 44. a buffer under article 44 is eligible to be recognised for the countercyclical buffer add-on.5 a countercyclical buffer restricted to certain credit exposures in accordance with article 44 paragraph 3 shall not be recognised for the countercyclical buffer add-on.6 article 43 paragraphs 2 and 3 apply by analogy.32 inserted by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).art. 4533 additional capital in special circumstances, finma may require certain banks to hold additional capital if the minimum capital under article 42 and the capital buffer under article 43 do not provide sufficient security, particularly in relation to:a. their business activities; b. their risk exposures;c. their business strategy;d. the quality of risk management; ore. the state of the art of the techniques used.33 amended by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).art. 4634 leverage ratio 1 after the deductions in accordance with articles 31 to 40, banks must hold tier 1 capital amounting to 3% of the unweighted exposures (total exposure).2 the total exposure shall be the denominator of the leverage ratio calculated in accordance with the requirements of the basel minimum standards. finma shall issue technical implementing provisions based on the basel committee's minimum standards.34 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2018 (as 2017 7625).art. 47 parallel calculations when using model-based approaches for banks that determine their required capital using model-based approaches that are subject to approval (irb, epe modelling method35, market risk model approach or ama36), finma may require a parallel calculation of the required capital using a standardised approach that it deems appropriate.35 expected positive exposure modelling method36 advanced measurement approachchapter 1a37 simplifications for particularly liquid and well-capitalised banks in categories 4 and 5 37 inserted by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).art. 47a simplifications banks in categories 4 and 5 under annex 3 to the banko38 may apply to finma to be exempted from compliance with the provisions on required capital under articles 41 to 46.38 sr 952.02art. 47b prerequisites 1 banks in categories 4 and 5 may take advantage of the simplifications if they meet the following prerequisites at all times at the level of both the individual entity and the financial group:a. the required capital corresponds to a simplified leverage ratio of at least 8%.b. the average liquidity ratio is at least 110%.c. the refinancing ratio is at least 100%.2 the simplified leverage ratio is the quotient of:a. tier 1 capital; andb. the sum of all balance sheet assets, less goodwill and financial interests, plus all off-balance sheet items.3 the average liquidity ratio is the quotient of:a. the average of the last twelve month-end holdings of high-quality liquid assets (hqla) in accordance with article 15 of the liquidity ordinance of 30 november 201239 (liqo); andb. the average value for the last twelve months of the net cash outflow at month-end in accordance with article 16 of the liqo which can be expected over a 30-day horizon under the stress scenario for the liquidity coverage ratio (lcr).4 the refinancing ratio is the quotient of:a. the sum of amounts due in respect of client deposits, medium-term notes, bonds with a residual maturity of more than one year, mortgage bond loans with a residual maturity of more than one year and net assets/equity; andb. claims against customers and mortgage claims.5 finma may issue technical implementing provisions concerning paragraphs 2 to 4.39 sr 952.06art. 47c rejection of application finma may reject the application for simplifications if:a. the prerequisites under articles 47a and 47b are not met;b. it has taken supervisory measures against the bank in question, proceedings have been initiated under article 30 of the financial market supervision act of 22 june 200740 (finmasa) or the bank has not taken measures to restore compliance in accordance with article 31 of the finmasa in the following areas:1. the code of conduct under the financial services act of 15 june 201841,2. market rules of conduct under the financial market infrastructure act of 19 june 201542,3. anti-money laundering and terrorist financing under the anti-money laundering act of 10 october 199743,4. cross-border transactions; c. interest rate risk management is insufficient or the interest rate risk is disproportionately high in relation to tier 1 capital, net interest income or risk-bearing capacity, taking all risks into account.40 sr 956.141 sr 950.142 sr 958.143 sr 955.0art. 47d prerequisites no longer met 1 banks that no longer meet the prerequisites under article 47b must notify finma immediately. 2 if finma finds that a bank is no longer in category 4 or 5 or that there is a reason for rejection in accordance with article 47c, it shall inform the bank accordingly.3 in the event of notifications in accordance with paragraphs 1 and 2, finma shall grant the bank a deadline for restoring compliance with the prerequisites. this deadline shall generally be one year, but it may be shortened or extended in justified individual cases. if the prerequisites are not met at the end of this period, the simplifications under article 47a may no longer be availed of.art. 47e waiver of simplifications banks that no longer wish to avail themselves of the simplifications under article 47a shall notify finma and the audit firm accordingly.chapter 2 credit risk section 1 general art. 48 definition 1 in the context of the calculation of required capital, credit risk refers to the risk of loss resulting from:a. a counterparty's failure to meet its contractual obligations; orb. a reduction in the value of financial instruments issued by a third party, namely equity securities, interest rate instruments or units of collective investment schemes.2 in the case of derivatives, repo and repo-like transactions, counterparty credit risk means the credit risk vis--vis the counterparty, and not the credit risk of the financial instruments underlying the transactions.4444 inserted by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625).art. 49 risk-weighted exposures 1 exposures shall be risk-weighted if they carry a credit risk and no deduction from capital is provided for under articles 31 to 40.2 the following shall be deemed to be exposures:a. receivables, including claims arising from guarantee credits not recognised under assets;b. claims in connection with securitisations;c. other off-balance sheet transactions converted into their credit equivalent;d. net exposures in equity securities and interest rate instruments not in the trading book;e. net exposures in equity securities and interest rate instruments in the trading book, provided the de minimis approach (art. 82 para. 1 lit. a) is applied;f. net exposures in own securities and qualified participations in the trading book.3 any exposure to a group of affiliated counterparties as described in article 109 that is not broken down by counterparty shall be risk-weighted according to the highest of the risk weights assigned to the individual counterparties in the group.art. 50 approaches 1 one of the following approaches shall be used to calculate the minimum capital requirement for credit risk in accordance with article 42 paragraph 2 letter a:a. the bis sa45 (arts. 63-75); orb. the irb (art. 77).2 the irb and bis sa may be combined.3 use of the irb requires approval from finma, which shall define the approval criteria.4 finma shall issue technical implementing provisions on credit risks and securitisations.45 international standardised approach.section 2 calculation of exposures art. 51 net exposures 1 net exposures shall be calculated as follows:physical holdings plus securities lending claims minus securities borrowing commitments+ unsettled spot and forward purchases (including financial futures and swaps)./. unsettled spot and forward sales (including financial futures and swaps)+ firm commitments to underwrite securities less sub-participations and firm subscriptions, provided these eliminate the bank's price risk+ exercise rights from purchased calls, delta-weighted./. delivery obligations from written calls, delta-weighted+ underwriting obligations from written puts, delta-weighted./. exercise rights from purchased puts, delta-weighted2 amounts for individual value adjustments and provisions recognised as liabilities shall be deducted from net exposures.3 positive net exposures shall be referred to as net long positions, and the absolute amounts of negative net exposures shall be referred to as net short positions.art. 52 net exposures for equity instruments of companies active in the financial sector 1 the net exposures for equity instruments of companies active in the financial sector shall be calculated as follows, taking into account the additional requirements set out in paragraphs 2 and 3:physical holdings plus synthetic positions, as well as securities lending claims minus securities borrowing commitments+ unsettled spot and forward purchases (including financial futures and swaps)./. unsettled spot and forward sales (including financial futures and swaps)./. underwriting positions held for five business days or less+ exercise rights from purchased calls, delta-weighted./. delivery obligations from written calls, delta-weighted+ underwriting obligations from written puts, delta-weighted./. exercise rights from purchased puts, delta-weighted2 in the case of direct holdings of instruments that are equity instruments or through which equity instruments are held indirectly or synthetically, other than own equity instruments, long and short positions in equity instruments may be netted only if:46a. the long and short positions relate to the same equity instrument; andb. the maturity of the short position either matches the maturity of the long position or has a residual maturity of at least one year.3 in the case of own equity instruments, the following net exposures must be determined for each component (cet1, at1 and t2) and deducted from the corresponding component in accordance with articles 32 to 34:a. net exposures in own equity instruments held directly or synthetically, whereby long and short positions may be netted only if they relate to the same equity instrument and the short position does not involve counterparty risk;b. net exposures in own equity instruments held indirectly via a financial instrument such as an index or an option on an index, whereby long and short positions may be netted only if they relate to the same underlying instrument; the short position's counterparty risk must have capital backing.46 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).art. 53 exposures in off-balance sheet transactions 1 off-balance sheet transactions shall be converted into a credit equivalent using credit conversion factors. this shall constitute the risk-weighted exposure.2 banks using the irb approach shall calculate the credit equivalent for contingent funding obligations and irrevocable commitments in accordance with the bis sa rules where the irb does not contain a corresponding provision.art. 54 contingent funding obligations and irrevocable commitments 1 in the case of contingent funding obligations and irrevocable commitments, the credit equivalent under the bis sa shall be calculated by multiplying the nominal or present value of the transaction in question with its credit conversion factor as set out in annex 1.2 contingent funding obligations where the bank has ceded sub-participations may be treated as direct claims against the respective sub-participants in the amount of the sub-participation.art. 55 credit valuation adjustment risk for derivatives 1 the banks must use minimum capital to cover not only the credit default risks of derivatives counterparties under articles 50 and 56, but also the risk of market value losses due to valuation adjustments of derivatives based on the counterparty credit risk.2 finma shall regulate the calculation method for the corresponding minimum capital depending on the calculation methods chosen for credit equivalents (art. 56) and market risk (art. 82). it shall base it on the basel minimum standards.3 finma shall provide a conservative, simplified calculation method for banks that have chosen neither a model approach in accordance with article 56 nor a model approach in accordance with article 82.art. 56 calculation methods for derivatives 1 credit equivalents for derivatives may be calculated using the following methods:a. the standardised approach;b. the expected positive exposure modelling method (epe modelling method).472 use of the epe modelling method requires approval from finma, which shall define the approval criteria.3 finma shall specify how the credit equivalent is to be calculated in the event of statutory or contractual netting in accordance with article 61 involving more than two parties.4 these calculation methods shall apply to all derivatives, irrespective of whether they are traded on an exchange or concluded over the counter.47 amended by no i of the o of 23 nov. 2016, in force since 1 jan. 2017 (as 2016 4683).art. 5748 standardised approach 1 to calculate the credit equivalents of derivatives using the standardised approach, the sum of the regulatory replacement cost and the amount for potential future exposure shall be multiplied by a factor of 1.4.2 finma shall issue technical implementing provisions in accordance with the basel minimum standards.48 amended by no i of the o of 23 nov. 2016, in force since 1 jan. 2017 (as 2016 4683).art. 5849 49 repealed by no i of the o of 23 nov. 2016, with effect from 1 jan. 2017 (as 2016 4683).art. 59 epe modelling method 1 finma shall determine how the credit equivalent of derivatives is to be calculated using the epe modelling method based on the basel minimum standards. 2 the credit equivalents are multiplied by the epe factor. finma shall determine the epe factor in each individual case. it shall be at least 1.2.art. 60 interest rate instruments and equity securities 1 if the interest rate instruments or equity securities are equity instruments of an entity active in the financial sector, the net exposure shall be determined in accordance with article 52.2 in the case of interest rate instruments and equity securities of the same issuer which are not in the trading book and which have the same risk weight, the net exposure shall be calculated in accordance with article 51.3 the carrying value of the physical holding shall be used for exposures not in the trading book.4 paragraphs 1 and 2 shall also apply to interest rate instruments and equity securities in the trading book, provided the de minimis approach (art. 82 para. 1 lit. a) is applied.art. 61 risk mitigation measures 1 the following risk mitigation measures may be taken into account when calculating exposures:a. statutory and contractual netting;b. guarantees;c. credit derivatives; andd. other collateral.2 upon request, the banks must demonstrate to the audit firm or to finma that these risk mitigation measures are legally enforceable in the jurisdictions concerned.3 finma shall flesh out these risk mitigation measures.art. 62 secured transactions 1 a bank may choose one the following approaches to take account of collateral under article 61 paragraph 1 letter d:a. the simplified approach;b. the comprehensive approach.2 with the simplified approach, the collateralised exposure components shall be assigned to the collateral provider's exposure class.3 with the comprehensive approach, the exposure shall be netted against the collateralised exposure component. the net exposure shall remain in the original exposure class.4 finma shall flesh out these approaches.5 when calculating the credit equivalents in accordance with articles 56 to 59, all eligible collateral provided by the bank and received by the bank to secure derivatives must be taken into account.5050 inserted by no i of the o of 23 nov. 2016, in force since 1 jan. 2017 (as 2016 4683).section 3 exposure classes and their weightings according to the bis sa art. 63 exposure classes 1 the banks shall assign the individual exposures to exposure classes.2 the individual exposures in the following exposure classes may be risk-weighted using external ratings:a. central governments and central banks;b. public sector entities;c. the bank for international settlements (bis), the international monetary fund (imf) and multilateral development banks;d. banks and securities firms;e. community bodies;f. stock exchanges and clearing houses;g. corporates.3 external ratings may not be used for the following exposure classes:a. private individuals and small businesses (retail exposures);b. domestic pfandbrief bonds;c. direct and indirect mortgage-backed positions;d. subordinated exposures;e. past-due exposures;f.51 equity securities;fbis.52 units of managed collective investment schemes;g. other exposures.51 amended by no i of the o of 23 nov. 2016, in force since 1 jan. 2017 (as 2016 4683).52 inserted by no i of the o of 23 nov. 2016, in force since 1 jan. 2017 (as 2016 4683).art. 64 use of external ratings 1 banks using the bis sa may risk-weight exposures with ratings from rating agencies, provided such agencies are recognised by finma for this purpose.2 finma shall assign the ratings of recognised rating agencies to individual rating categories and determine the risk weight for the individual categories.3 the use of external ratings must be based on a concrete, institution-specific concept, which must be adhered to consistently.4 if a bank risk-weights exposures based on external rating agencies' ratings, it must generally use external ratings to risk-weight all exposures other than those in the corporates exposure class. if it also uses external ratings to risk-weight exposures in the corporates exposure class, it must generally risk-weight all exposures in this class according to external ratings.5 if a bank does not use external ratings to risk-weight exposures, or if no rating from a recognised rating agency is available to risk-weight an exposure, the weights of the unrated rating category must be used.art. 65 use of external ratings at group level the ratings used in the companies to be consolidated may be used at group level.art. 66 calculation of the exposures to be risk-weighted 1 for bis sa purposes, exposures within exposure classes under article 63 paragraph 2 shall be risk-weighted in accordance with annex 2.2 exposures within the exposure classes under article 63 paragraph 3 letters a to e and g shall be risk-weighted in accordance with annex 3.3 exposures within the exposure class under article 63 paragraph 3 letter f shall be risk-weighted in accordance with annex 4.3bis exposures within the exposure class under article 63 paragraph 3 letter fbis shall be risk-weighted in accordance with finma's technical implementation provisions. finma shall use the basel minimum standards as a basis.534 net exposures in interest rate instruments under article 60 shall be allocated to the issuer's exposure class and risk-weighted accordingly.5 in the case of exposures in the form of equity instruments of entities active in the financial sector, the weighting under paragraphs 3 and 4 shall refer to the portion of the net exposure in accordance with article 52 that was not deducted from capital under the corresponding deduction approach (art. 33).53 inserted by no i of the o of 23 nov. 2016, in force since 1 jan. 2017 (as 2016 4683).art. 67 local currency exposures to central governments or central banks where the supervisory authority of a country other than switzerland provides for a lower risk weight than that stipulated in article 66 paragraph 1 for local currency exposures to the central government or central bank of that country, banks may apply a similar weight to such exposures, provided that such exposures are refinanced in the local currency of that country and that the banking supervision of that country is appropriate. this similar weight shall refer to the portion of such exposure that is refinanced in the local currency.art. 68 banks and securities firms 1 securities firms may be assigned to the banks and securities firms exposure class (art. 63 para. 2 letter d) only if they are subject to supervision that is equivalent to that of banks.2 netted exposures arising from off-balance sheet transactions shall be allocated to the time band of the shortest netted exposures.3 with the exception of short-term self-liquidating trade letters of credit, exposures to banks without an external rating may not be assigned a risk weight that is lower than the risk weight for exposures to the banks' country of domicile.5454 inserted by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).art. 69 stock exchanges and clearing houses 1 clearing houses are institutions through which the contractual obligations of traded contracts are settled.2 the risk weights of 0% or 2% under annex 2 shall apply for credit risks only if a regulated central counterparty interposes itself directly in the transaction between two market participants and an appropriate and comprehensive collateralisation system is established as the basis for the performance of the functions of that central counterparty.3 this collateralisation system shall be considered appropriate and comprehensive particularly if:a. the contracts are marked to market daily and there are daily margin calls;b. the changes in value expected the next day are collateralised on an ongoing basis with a high level of confidence; andc. unexpected losses are hedged.4 finma shall regulate the additional criteria for central counterparties in connection with derivatives, repo and repo-like transactions in accordance with the basel minimum standards.art. 70 credit risks and guarantee commitments to central counterparties 1 for banks that act as a clearing member of a central counterparty for exchange-traded or over-the-counter derivatives and for repos or repo-like transactions, finma shall define the method for determining the minimum capital required for risks arising from explicit and implicit guarantee commitments to the central counterparty. finma shall use the basel minimum standards as a basis.2 central counterparties are clearing houses that act as a contracting party between the counterparties to contracts and guarantee the performance of the contracts throughout their term.3 clearing members are authorised to enter into a direct transaction with the central counterparty as a party, irrespective of whether they do so on their own behalf or as intermediaries between the central counterparty and other market participants.art. 71 exposures to unrated companies if a bank uses ratings to risk-weight exposures to companies, unrated exposures shall be assigned the risk weight of 100% or that of the relevant central government if that is higher than 100%.art. 72 direct and indirect mortgage-backed exposures 1 residential real estate shall be deemed to be real estate occupied or rented out by the borrower personally.2 construction loans and loans for building land shall be allocated to the real estate categories set out in annex 3 according to the future use of the financed property.3 the risk weight of 35% for foreign residential real estate shall apply only if appropriate risk management that is equivalent to that for swiss residential real estate can be ensured for this foreign real estate.4 pledged pension assets and pledged pension benefit entitlements in accordance with article 30b of the federal act of 25 june 198255 on occupational old age, survivors' and invalidity pension provision (opa) and article 4 of the ordinance of 13 november 198556 on tax relief on contributions to recognised pension schemes shall be included in the borrower's capital when calculating the relevant exposure for risk weighting in accordance with annex 3, provided that: a. the pledge exists as additional security for a mortgage-backed claim;b. the real estate in question is used by the borrower personally; andc. the minimum requirements under paragraph 5 are met.5 the risk weight for mortgage-backed exposures in accordance with annex 3 shall be 100% if the credit transaction does not meet the requirements of one of the self-regulation standards recognised as a minimum standard by finma in accordance with article 7 paragraph 3 of the financial market supervision act of 22 june 200757. the minimum requirements shall provide for:a. an appropriate minimum share of capital to be supplied by the borrower for the financing; such share must not originate from a pledge or an advance withdrawal pursuant to articles 30b or 30c of the opa;b. appropriate repayment of the loan in terms of timeframe and amount.55 sr 831.4056 sr 831.461.357 sr 956.1art. 73 equity securities net exposures in equity securities shall be risk-weighted in accordance with annex 4. this shall not apply to portions of net exposures which:a. are to be deducted from the capital components under articles 31 to 40; orb. are to be risk-weighted in accordance with article 40 paragraph 2.art. 74 lombard loans within the corresponding exposure class, lombard loans can be weighted individually according to the simplified approach (art. 62 para. 1 lit. a) or the comprehensive approach (art. 62 para. 1 lit. b).art. 75 loan, repo and repo-like transactions in securities within the corresponding exposure class for the individual transactions, loan, repo and repo-like transactions in securities can be treated according to the simplified approach, the comprehensive approach or the epe modelling method.art. 76 exposures arising from unsettled transactions 1 positive replacement values of exposures arising from unsettled foreign exchange, securities and commodities transactions which carry a risk of loss owing to late or failed settlement (exposures arising from unsettled transactions) and are settled through a payment system or securities settlement system according to the payment-versus-settlement or payment-versus-payment principle shall be weighted as follows:number of business days afteragreed settlement daterisk weight 5-15 100%16-30 625%31-45 937.5%46 or more1,250%2 for exposures arising from unsettled transactions that are settled in another manner, the treatment shall be as follows:a. the bank that has delivered shall treat the transaction as a credit until receipt of the corresponding receivable. if the exposures are not materially significant, a risk weight of 100% may be applied instead of a ratings-based risk weight.b. if the corresponding receivable has not been received five business days after the agreed settlement date, a 1,250% weight shall be assigned to the delivered asset and any positive replacement value.3 repos, reverse repos and securities lending and borrowing shall be treated exclusively as set out in article 75.section 4 irb approach art. 77 1 banks using the internal ratings-based approach (irb) to calculate risk-weighted exposures and required capital for credit risk may choose between:a. simplified, or foundation irb (f-irb58); orb. advanced irb (a-irb59).2 finma shall flesh out the calculation details, based on the basel minimum standards.3 in the absence of a rule, the provisions of the bis sa apply by analogy.58 footnote not relevant to english text.59 footnote not relevant to english text.chapter 3 non-counterparty risks art. 78 definition the term non-counterparty risks refers to the risk of loss owing to valuation changes or a liquidation of non-counterparty assets such as real estate and other fixed assets.art. 79 weighting 1 to calculate the charge for non-counterparty risk, a 100% weight shall be assigned to the following exposures:a. real estate;b. other fixed assets and depreciable items recognised on the balance sheet as other assets, unless they can be deducted from cet1 capital in accordance with article 32 letter c.2 a 0% weight shall be assigned to the asset balance of the compensation account.chapter 4 market risk section 1 general art. 80 principle 1 a capital charge shall apply to the market risk of interest rate instruments and equity securities in the trading book, and of foreign exchange, gold and commodities exposures for the whole bank.2 finma shall issue technical implementing provisions on market risk.art. 81 definition the term market risk refers to the risk of losses arising from movements in the value of an exposure caused by changes in, and the volatility of, price-relevant factors such as share or commodity prices, exchange rates and interest rates.art. 82 calculation approaches 1 the minimum capital requirement for market risk may be calculated using the following approaches:a. the de minimis approach;b. the standardised approach; orc. the market risk model approach. 2 when more than one of these approaches is used, the minimum capital requirement shall be derived from the sum of the minimum capital amounts calculated according to these approaches.section 2 de minimis approach art. 83 1 banks that do not exceed certain thresholds may use articles 66 to 76 to calculate the minimum capital requirement for interest rate instruments and equity securities in the trading book. in so doing, they shall apply the provisions of the same approach as that used to calculate the credit risk capital requirement.2 finma shall set the thresholds.section 3 standardised approach for market risk art. 84 interest rate instruments in the trading book 1 the minimum capital requirement for specific risk in interest rate instruments shall be derived by multiplying the net exposure for each issue by the rates in annex 5.2 finma shall issue technical implementing provisions on calculating the minimum capital requirement for specific risk in interest rate instruments from securitisations broken down into risk buckets.3 the minimum capital requirement for general market risk in interest rate instruments comprises the sum of the values calculated for each currency using either the maturity method or the duration method.art. 85 equity instruments in the trading book 1 the minimum capital requirement for specific risk in equity instruments shall amount to 8% of the sum of the net exposures per issuer.2 the minimum capital requirement for general market risk in equity instruments shall amount to 8% of the sum of the net exposures per national market.art. 86 foreign exchange exposures the minimum capital requirement for market risk in foreign exchange exposures shall amount to 8% of the sum of net long positions or the sum of net short positions, whichever is higher.art. 87 gold and commodity exposures 1 the minimum capital requirement for market risk in gold exposures shall amount to 8% of the net exposure.2 the minimum capital requirement for commodity risk shall be determined using either the maturity band method or the simplified method.section 4 model-based approach for market risk art. 88 1 use of the model-based approach for market risk requires approval by finma, which shall define the approval criteria.2 finma shall flesh out the details for calculating minimum capital under the model-based approach for market risk, based on the basel committee's minimum standards.3 it shall define the multipliers provided for under the model-based approach in each individual case. in so doing, it shall take account of the approval criteria and the forecast accuracy of the institution-specific risk aggregation model. the multipliers shall be at least 3.0 in each case.chapter 5 operational risk section 1 general art. 89 definition the term operational risk refers to the risk of loss resulting from the inappropriateness or failure of internal procedures, people or systems, or from external events. this includes legal risk, but not strategic risk or reputational risk.art. 90 calculation approaches 1 banks may choose between the following approaches when determining the minimum capital requirement for operational risk:a. the basic indicator approach;b. the standardised approach;c. institution-specific approaches (ama).2 use of an institution-specific approach requires approval by finma.3 finma shall issue technical implementing provisions on the approaches.art. 91 income indicator 1 banks that determine their minimum capital requirement for operational risk according to either the basic indicator approach or the standardised approach must calculate an income indicator for each of the previous three years. this comprises the sum of the following items in the income statement:a.60 gross income from interest business;b. income from commission business and services;c.61 income from trading and the fair value option;d. income from participating interests not subject to consolidated reporting; ande. income from real estate.2 all income from outsourcing agreements in which the bank itself acts as service provider must be included as components of the income indicator.3 if the bank acts as the contracting authority of an outsourced service, the corresponding expenses may be deducted from the income indicator only if the outsourcing occurs within the same financial group and is included in consolidated reporting.4 when determining the income indicator, banks may use internationally recognised accounting standards instead of the swiss accounting standards, subject to finma approval.60 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).61 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).section 2 approaches art. 92 basic indicator approach 1 minimum capital shall amount to 15% of the average of the income indicators for the previous three years. only years in which the income indicator was positive should be taken into account.2 finma may make the use of the basic indicator approach contingent on additional qualitative risk management requirements.art. 93 standardised approach 1 minimum capital shall be calculated as follows:a. for each business line and each of the previous three years, an income indicator shall be determined and multiplied by the rate under paragraph 2.b. the resulting numerical values shall be added for each year. negative numerical values from individual business lines can be offset against positive values from other business lines.c. the minimum capital corresponds to the three-year average amount. for the purposes of obtaining the average, any negative totals are set to zero.2 activities shall be assigned to the following business lines and multiplied by the following rates:a. corporate finance/advice 18%b. trading 18%c. retail client business 12%d. corporate client business 15%e. payment transactions/securities settlement 18%f. custody and fiduciary business 15% g. institutional asset management 12%h. securities commission business 12%3 finma may make the use of the standardised approach contingent on additional qualitative risk management requirements.art. 94 institution-specific approaches (ama) 1 banks may use an institution-specific approach to determine the minimum capital.2 finma shall issue the required approval if the bank has a model that allows it to quantify operational risks by using internal and external loss data, scenario analyses and the key factors in the business environment and the internal control system.title 4 risk diversification chapter 1 general provisions section 1 subject matter art. 9562 risk concentrations and other large credit risk exposures 1 a risk concentration exists when the total exposure to a counterparty or group of affiliated counterparties equals or exceeds 10% of the bank's adjusted eligible tier 1 capital under articles 31 to 40.2 banks must identify and monitor risk concentrations and other large credit risk exposures to an individual counterparty or group of affiliated counterparties, and comply with associated reporting obligations.62 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625).art. 9663 recordable exposures and total exposure 1 for the purposes of identifying and monitoring risk concentrations, all on- and off-balance sheet items in the banking book and trading book that carry a credit risk exposure or counterparty credit risk exposure to an individual counterparty or group of affiliated counterparties must be recorded.2 the recorded exposures must be aggregated to form a total exposure.3 the following do not need to be included in the calculation of the total exposure:a. exposures that can be deducted from tier 1 capital in accordance with articles 31 to 40: the amount of the deduction;b. intraday exposures to banks.4 exposures that are assigned a 1,250% risk weight in the minimum capital calculation must be included in the total exposure.5 the total exposure to a group of affiliated counterparties is the sum of total exposures to the individual counterparties.63 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625).section 2 upper limits on risk concentrations art. 9764 upper limit on individual risk concentrations 1 risk concentrations may not exceed 25% of adjusted eligible tier 1 capital under articles 31 to 40.2 this limit does not apply to:a. exposures to central banks and central governments;b. exposures with an explicit guarantee from counterparties under letter a;c. exposures secured by financial collateral from counterparties under letter a;d. exposures to qualifying central counterparties resulting from clearing services.3 the exposures shall be calculated in accordance with article 119 paragraph 3.64 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625).art. 9865 upper limit on risk concentrations with banks and securities firms in a departure from article 97 paragraph 1, as regards banks in categories 4 and 5 under annex 3 of the banko66, the upper limit on individual risk concentrations with banks and securities firms, where these are not designated as systemically important banks or financial groups in accordance with article 8 paragraph 3 of the banka or article 136 paragraph 2 letter b, shall be: 100% of the adjusted eligible tier 1 capital under articles 31 to 40.65 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625).66 sr 952.02art. 9967 upper limit breaches 1 the upper limit on risk concentrations may not be breached, except in the cases specified in paragraphs 2 and 3.2 a limit breach is permitted if this is related to the settlement of client payment transactions and lasts for no more than five business days.3 a limit breach is also permitted if this results solely from the affiliation of previously independent counterparties or the affiliation of a bank with other financial entities.4 the amount by which the limit may be breached owing to an affiliation under paragraph 3 may not be actively increased further. the breach must be rectified within two years of the affiliation acquiring legal force.67 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625).section 368 reporting obligations relating to risk concentrations and other large credit risk exposures 68 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625).art. 100 reporting risk concentrations and other large credit exposures 1 the bank shall report all outstanding risk concentrations and other large credit exposures to its body responsible for overall management, supervision and control:a. quarterly on an individual entity basis;b. semi-annually on a consolidated basis.2 the reports must be submitted to the statutory banking audit firm and the swiss national bank within six weeks of the end of the quarter or half-year, using the form prescribed by finma.3 the following reference dates apply for the reports:a. total exposure: last day of the current quarter and half-year;b. tier 1 capital: last day of the current or preceding quarter and half-year.4 specifically, the following must be reported:a. all risk concentrations;b. all exposures amounting to at least 10% of eligible tier 1 capital, without applying the risk mitigation under article 119 paragraph 1;c. all total exposures for which there is no upper limit and which amount to at least 10% of eligible tier 1 capital.5 in addition, each year the twenty largest total exposures must be reported, irrespective of whether or not they constitute risk concentrations, excluding total exposures to central banks and central governments.6 for the exposures under paragraphs 4 and 5, values both before and after applying the risk mitigation under article 119 paragraph 1 must be reported.7 if a risk concentration involves a member of the management or holder of a qualified participation under article 3 paragraph 2 letter cbis of the banka or a related person or company, the risk concentration must be reported under the collective heading management business.8 if a risk concentration involves a group company, the risk concentration must be reported under the collective heading group business. the components of the group business item that are exempted from the upper limit in accordance with article 111a paragraph 1 and article 112 paragraph d must also be reported.9 the audit firm shall assess the internal controls carried out by the bank to ensure correct risk identification and reporting, and shall examine the trend of risks.art. 101 reporting of unauthorised breaches if the bank observes that a risk concentration has breached the upper limit without the existence of an exception under article 99, it must inform its audit firm and finma immediately and rectify the breach within a period to be approved by finma. limit breaches caused by the use of the settlement date principle and arising out of transactions having a settlement date within the next two business days shall be exempt from the reporting duty.art. 102 reporting of intra-group exposures the bank must report intra-group exposures under article 111a on a quarterly basis and submit the report to the audit firm, the swiss national bank and the body responsible for overall management, supervision and control, together with the report on outstanding risk concentrations under article 100. a distinction must be made between group companies in accordance with article 111a paragraphs 1 and 3.section 4 calculation principles art. 103 firm commitments to underwrite securities the issuer-specific exposures for firm commitments to underwrite securities must be calculated as follows:a. sub-participations and firm subscriptions may be deducted from firm commitments to underwrite debt and equity securities, provided this eliminates the bank's associated market risk;b. the resulting amount must be multiplied by one of the following credit conversion factors:1. 0.05 as of the day on which the firm commitment to underwrite is irrevocably entered into,2. 0.1 on the issue's payment date,3. 0.25 on the second and third business day after the issue's payment date,4. 0.5 on the fourth business day after the issue's payment date,5. 0.75 on the fifth business day after the issue's payment date,6. 1 as of the sixth business day after the issue's payment date.arts. 104 and 10569 69 repealed by no i of the o of 22 nov. 2017, with effect from 1 jan. 2019 (as 2017 7625).art. 106 exposures arising from unsettled transactions transactions that remain unsettled after five business days (art. 76) must be included in the total exposure figure at their full exposure value.arts. 107 and 10870 70 repealed by no i of the o of 22 nov. 2017, with effect from 1 jan. 2019 (as 2017 7625).art. 10971 groups of affiliated counterparties 1 a group of affiliated counterparties comprises:a. counterparties between which there is a control relationship or economic dependence;b. counterparties that are held as financial interests by the same person, or are directly or indirectly controlled by them; orc. counterparties that form a consortium.2 groups of affiliated counterparties must be treated as one entity.3 if the total exposure to a single counterparty exceeds 5% of eligible tier 1 capital, it must be verified, within three months and at appropriate intervals thereafter, whether counterparties are economically dependent on each other.4 central counterparties do not constitute a group of affiliated counterparties if the exposures to them are related to clearing services.5 legally independent public enterprises together with their controlling public sector entity do not constitute a group of affiliated counterparties if:a. the public sector entity is not legally liable for the enterprise's obligations; orb. the enterprise in question is a bank.71 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625).art. 110 exposures to a consortium 1 exposures to a consortium shall be allocated to the individual consortium members according to their participating interest.2 in the case of joint and several liability, the bank must recognise the entire exposure to the consortium member to which it assigned the highest credit rating during the lending decision.art. 111 exposures of group companies from the perspective of each bank in the financial group or financial conglomerate, group companies constitute a group of affiliated counterparties.art. 111a72 intra-group exposures 1 if a bank is part of a financial group or financial conglomerate subject to appropriate consolidated supervision, intra-group exposures to group companies fully integrated into the consolidated capital and risk diversification may be exempted from the upper limit under article 97 if the group companies:a. are individually subject to appropriate supervision; orb. act as counterparty only to group companies that are individually subject to appropriate supervision.2 finma is authorised to issue implementing provisions to appropriately restrict the exclusion of intra-group exposures under paragraph 1.3 intra-group exposures to other group companies shall be subject, on an aggregate basis, to the regular limit of 25% of the adjusted eligible tier 1 capital under articles 31 to 40.72 inserted by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625).section 5 easing and tightening of requirements art. 11273 1 finma shall regulate the extent to which the risk diversification requirements may be relaxed for banks in categories 4 and 5 under annex 3 of the banko74.2 in special cases, it may also relax or tighten the risk diversification requirements. specifically, it may:a. set lower reporting limits or upper limits for individual total exposure figures;b. impose upper limits on a bank's direct and indirect real estate holdings;c. subject to prior request, allow the upper limit to be breached temporarily;d. declare that the exemption from the upper limit under article 111a paragraph 1 does not apply to some or all group companies, or extend the exemption to cover individual group companies that do not meet the criteria under article 111a paragraph 1;e. exempt individual group companies that do not operate in the financial sector from inclusion in the aggregate exposure under article 111a paragraphs 1 and 3;f. declare that financial interests excluded from consolidation under article 9 paragraph 1 are exempt from inclusion in the aggregate exposure under article 111a paragraphs 1 and 3.g. lower or raise the applicable weighting rates for a specific counterparty;h. set a different deadline to that in article 99 paragraph 4;i. in special circumstances for which the bank must provide justification, allow the parties concerned to not be considered as a group of affiliated counterparties, even if they meet the criteria under article 109 paragraph 1;j. allow counterparties to not be considered as a group of affiliated counterparties, provided the bank demonstrates that a counterparty can absorb the financial problems or the default of an economically closely interconnected counterparty and find other business partners or fund providers within a reasonable period.73 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625).74 sr 952.02chapter 275 calculation of total exposure 75 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625). section 1 weighting art. 113 1 counterparty exposures shall be assigned a risk weight of 100% as a rule.2 the following exposures are to be weighted differently to paragraph 1:a. exposures to cantons rated 1 or 2: 20%;b. exposures in domestic pfandbrief bonds issued in accordance with the mortgage bond act of 25 june 193076: 10%;c. exposures in covered bonds under article 118 paragraph 1 letter c: at least 20%.76 sr 211.423.4section 2 addition art. 114 when calculating the total counterparty exposure, the associated exposures in the trading book and those in the banking book must be added together. short positions in the trading book may not be offset against long positions in the banking book.section 3 general exposure calculation art. 115 risk weighting, derivatives, loan, repo and repo-like transactions in securities and other instruments with counterparty credit risk exposure 1 the counterparty credit risk exposure for derivatives in the banking and trading books must be calculated in accordance with article 57.2 for non-linear derivatives in the trading book, the exposure shall additionally include the credit risk exposure of the underlying assets, assuming complete loss of value.3 the exposures for loan, repo and repo-like transactions with securities in the banking and trading books must be calculated using either the simplified or the comprehensive approach for calculating minimum capital; model-based approaches are not permitted. finma shall issue the implementing provisions.art. 116 other balance sheet items for balance sheet items in the banking book that are not covered by article 115, the carrying value in the accounts shall apply. individual value adjustments and individual provisions for balance sheet items may be deducted. alternatively, the bank may also use the gross value without deducting individual value adjustments and value changes.art. 117 off-balance sheet items 1 off-balance sheet items in the banking book shall be converted to their credit equivalent using the credit conversion factors under annex 1. individual value adjustments and individual provisions for off-balance sheet items may be deducted. for exposures under annex 1 no. 1.3, a credit conversion factor of 0.1 shall be applied instead of 0.0.2 for irrevocable loan commitments as part of a syndicated loan, the following credit conversion factors shall be applied:a. 0.1 from the time at which the bank provides the commitment, up to the time of acceptance and confirmation by the counterparty;b. 0.5 from the time at which the counterparty accepts the bank's commitment, up to the start of the syndication phase;c. 0.5 for the non-syndicated portion during the syndication phase, and 1 for the planned equity contribution;d. 1.0 for the entire non-syndicated portion after 90 days (residual risk).art. 118 finma's implementing provisions on calculating the different exposures 1 finma shall regulate the calculation of:a. exposures in the trading book;b. exposures to central counterparties;c. exposures in covered bonds;d. exposures in collective investment schemes, securitisations and other investment structures;e. other exposures.2 it shall base these provisions on the basel committee's minimum standards.section 4 risk mitigation art. 119 off-balance sheet transactions 1 the following may be included in the total exposure calculation:a. netting;b. guarantees;c. credit derivatives;d. collateral recognised under the bis sa.2 upon request, the banks must demonstrate to the audit firm or to finma that these risk mitigation instruments are legally enforceable in the jurisdictions concerned.3 finma shall issue technical implementing provisions based on the basel committee's minimum standards.arts. 120-123 repealedtitle 5 provisions for systemically important banks chapter 1 general provisions art. 12477 principle 1 in addition to the requirements applicable to all banks concerning capital and risk diversification under titles 2 to 4 of this ordinance, the special requirements of this title shall apply to systemically important banks.2 the amount of the special requirements shall be defined for the highest level of the financial group.3 the special requirements must be met by the entities listed below, at the level of the financial group, the level of each individual entity licensed under the banka78 and the level of each securities firm licensed under the finia:a. entities performing systemically important functions;b. the highest entity in a financial group, where the consolidation scope includes an entity under letter a;c. entities at the head of significant subordinate financial groups, where their consolidation scope includes an entity under letter a; andd. entities which, owing to their core function or their relative size, are significant for the financial group.794 in individual cases, finma may exempt entities which perform systemically important functions but whose direct share in the financial group's domestic systemically important functions does not exceed 5% in total, or whose significance for the continued performance of the financial group's systemically important functions is otherwise minor.8077 amended by no i of the o of 21 nov. 2018, in force since 1 jan. 2019 (as 2018 5241).78 sr 952.079 amended by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).80 inserted by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).art. 124a81 internationally active and non-internationally active systemically important banks 1 internationally active systemically important banks are those designated as global systemically important banks by the financial stability board.2 where a systemically important bank no longer qualifies as internationally active under paragraph 1, finma may continue to designate it as such if this is necessary owing to the scale of its activities abroad.3 other systemically important banks shall not be deemed to be internationally active.81 inserted by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).art. 12582 82 repealed by no i of the o of 21 nov. 2018, with effect from 1 jan. 2019 (as 2018 5241).art. 125a83 83 inserted by no i of the o of 11 may 2016 (as 2016 1725). repealed by no i of the o of 22 nov. 2017, with effect from 1 jan. 2018 (as 2017 7625).chapter 2 convertible capital and bail-in bonds84 84 amended by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725). art. 126 convertible capital85 1 convertible capital shall be deemed to be capital within the meaning of article 11 paragraph 1 letter b in conjunction with article 13 of the banka and capital from write-down bonds in accordance with article 11 paragraph 2 of the banka that meets the criteria in this chapter.2 convertible capital shall be issued to investors outside the financial group by:a. the group parent company;b. a group company specially established for this purpose by financial groups and bank-dominated financial conglomerates; orc. another group company licensed by finma.85 amended by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).art. 126a86 bail-in bonds 1 bail-in bonds may be recognised as additional loss-absorbing funds under chapter 4 only if they:87a. are fully paid up;b. are issued by a swiss entity;c. are subject to swiss law and jurisdiction; if justified, finma may grant exemptions if it can be demonstrated that a conversion or write-off ordered by finma is enforceable in the jurisdictions concerned;d. are issued by the group parent company or, with finma approval and in accordance with international standards, are issued by a group company exclusively established for this purpose, provided it is ensured that the bonds can be used to absorb losses during restructuring;e. are legally or contractually subordinate to the issuer's other obligations, or structurally subordinate to the obligations of other group companies;f. do not contain an option for early termination by the creditors;g. cannot be offset or secured or guaranteed in a way that restricts their bail-in capacity;h. their terms and conditions contain a binding and irrevocable clause stating that creditors declare themselves in agreement with any potential conversion or write-off ordered by the supervisory authority during restructuring;i. do not contain derivatives transactions and, with the exception of hedging transactions, are not linked to derivatives transactions;j. were not purchased using either direct or indirect funding from the issuing bank or one of its group companies;k.88 were issued with the approval of finma or are part of a finma-approved annual issuance programme and may be redeemed before maturity only with finma approval, provided this would not cause the level of additional loss-absorbing funds to fall below the quantitative requirements.2 finma may deem loans that meet the criteria under paragraph 1 to be equivalent to bail-in bonds.3 the redemption/repayment of bail-in bonds or loans under paragraphs 1 and 2 that were issued with finma approval and are to be redeemed/repaid before their maturity/due date without finma approval must be reported to finma.8986 inserted by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).87 amended by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).88 amended by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).89 amended by no i of the o of 21 nov. 2018, in force since 1 jan. 2019 (as 2018 5241).art. 126b90 intra-group bail-in bonds 1 swiss entities of systemically important banks may recognise intra-group bail-in bonds as additional loss-absorbing funds under chapter 4 at a level below group parent company if these funds:a. meet the criteria under article 126a paragraph 1 letters a to c and f to i;b. are contractually subordinated to the issuer's other obligations;c. may be redeemed before maturity only with finma approval, provided this would not cause the level of additional loss-absorbing funds to fall below the quantitative requirements.2 finma may deem loans that meet the criteria under paragraph 1 to be equivalent to bail-in bonds.3 the debt instruments under paragraph 1 may be recognised in the amount of the receivable, provided they have a residual maturity of at least one year.90 inserted by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).art. 127 eligibility of convertible capital91 1 convertible capital may be recognised in the amount of certain capital components to the extent that it contributes to loss absorption when a trigger event occurs. the loss absorption must take the following forms:a. write-off as the result of a debt waiver;b. conversion into cet1 capital of the bank.2 finma shall grant the approval under article 11 paragraph 4 of the banka only if the bank demonstrates that the effects under the banka and its implementing ordinances will occur and that the requirements under corporate and capital market legislation are met.3 the convertible capital must meet at least the criteria for tier 2 capital within the meaning of article 30 of this ordinance.91 amended by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).art. 127a92 eligibility of bail-in bonds 1 bail-in bonds meeting the criteria under article 126a may be recognised as additional loss-absorbing funds under chapter 4 in the amount of the receivable, provided they have a residual maturity of at least one year.932 the maturities of the loss-absorbing funds shall be staggered so as to ensure that the requirements concerning the level of these funds can be met, even in the event of temporarily impaired borrowing conditions. a maximum of 25% of the requirements concerning additional loss-absorbing funds may be met with assets with a residual maturity between one and two years.943 where tier 2 capital in accordance with article 30 paragraph 2 is excluded as regulatory capital for a period of five years up to one year before final maturity, it can be recognised in the same way as bail-in bonds in accordance with international standards, provided it is ensured that these instruments will absorb losses ahead of bail-in bonds.4 systemically important banks may not hold at their own risk convertible or debt-reducing capital instruments of other banks, nor bail-in bonds of other swiss banks or foreign systemically important banks governed by swiss law or corresponding regulations in foreign jurisdictions. the following are exempt:a. exposures relating to the provision of bid and offer prices as a market maker, and short-term exposures relating to underwriting activities; andb. the holding of bail-in bonds under articles 37 and 38 in the bank's trading book, provided these bail-in bonds are resold within 30 business days of their purchase.9592 inserted by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).93 amended by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).94 amended by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).95 amended by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).chapter 396 going-concern capital of the bank 96 amended by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725). art. 128 principle 1 systemically important banks must hold sufficient capital to continue operating even in the event of major losses.2 required capital shall be calculated according to:a. the leverage ratio; andb. the share in risk-weighted assets (rwa ratio).art. 129 total capital requirement 1 the total capital requirement is made up of a base requirement plus surcharges for market share and bank size as measured by total exposure.2 the base requirement shall amount to:a. 4.5% for the leverage ratio;b. 12.86% for the rwa ratio.3 for the purpose of determining the surcharges, finma shall periodically allocate the banks to buckets according to their market share and total exposure. the relevant values and the surcharges are set down in annex 9. the surcharges shall be determined annually at the end of the second quarter.4 market share is determined using whichever is the higher of the average market share in domestic lending business and the market share in domestic deposit-taking business based on the swiss national bank's statistical surveys on the reporting date at the end of the previous calendar year.5 the fdf shall regularly review the values and surcharges set down in annex 9 against system stability and the competitiveness of the systemically important banks, and shall apply to the federal council for any adjustments.9797 inserted by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).art. 130 minimum capital and the capital buffer 1 systemically important banks shall permanently hold minimum capital amounting to:a. 3% for the leverage ratio;b. 8% for the rwa ratio.2 in addition, they must hold a capital buffer up to the amount of the total requirement.3 the capital buffer should be complied with at all times. temporary shortfalls are permitted in the event of bank losses.4 if there is a temporary shortfall in the capital buffer, the bank must demonstrate what measures will be taken to restore it and by what deadline. finma shall approve the deadline. if the capital requirements are not met after the deadline has expired, finma may order the necessary measures.art. 131 capital quality to meet the requirements, the capital must be of at least the following quality:a. leverage ratio requirements:1. minimum capital: cet1 capital; to meet the minimum capital requirement, up to 1.5% may be used as at1 capital in the form of convertible capital that is triggered if the eligible cet1 capital falls below 7% of the rwa ratio (high-trigger convertible capital),2. capital buffer: cet1 capital;b. rwa ratio requirement:1. minimum capital: cet1 capital; up to 3.5% may be used as at 1 capital in the form of high-trigger convertible capital to comply with the minimum capital requirement,2. capital buffer: cet1 capital; up to 0.8% may be used as at1 capital in the form of high-trigger convertible capital to comply with the capital buffer.art. 131a countercyclical buffer in addition to the capital requirements as a measure of risk-weighted exposures under this title, the countercyclical buffer under articles 44 and 44a must be complied with.art. 131b additional capital in special circumstances, finma may require individual banks to hold additional capital according to the criteria under article 45, or may set higher quality requirements.chapter 498 additional loss-absorbing funds 98 originally before art. 133. amended by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725). art. 13299 principle 1 systemically important banks must permanently hold additional funds to ensure resolution in accordance with sections 11 and 12 of the banka.2 the requirement concerning these additional funds is based on the total requirement comprising the base requirements and surcharges under article 129. it shall amount to:a. for an internationally active systemically important bank:1 for entities performing systemically important functions (art. 124 para. 3 lit. a): 62% of the total requirement at the level of the financial group and the individual entity,2 at the level of the highest entity in a financial group (art. 124 para. 3 lit. b) and significant subordinate financial groups (art. 124 para. 3 lit. c), unless the requirements under no. 1 apply: 100% of the total requirement minus the rebate under article 133,3 at the level of the individual entity under article 124 paragraph 3 letters c or d, the sum of:- the nominal amounts of additional loss-absorbing funds passed on to subsidiaries- 100% of the total requirement minus the rebate under article 133, except for financial interests subject to the consolidation requirement, including similarly recorded regulatory capital, and except for exposures from intra-group relationships, and- 30% of the consolidated requirements applicable to that entity;b. for a non-internationally active systemically important bank: 40% of the total requirement.1003 the additional funds must be held in the form of bail-in bonds meeting the criteria under article 126a. this is without prejudice to paragraphs 4 to 7 and article 132a.4 if a systemically important bank holds the additional funds in the form of cet1 capital or convertible capital that meets the requirements concerning at1 capital, the requirements under paragraph 2 shall be reduced by a factor of 0.5 for the amount of additional funds thus held. the requirements may be reduced by a maximum of one third.5 if an internationally active systemically important bank holds the additional funds in the form of capital under paragraph 4, these funds shall receive preferential treatment within the meaning of paragraph 4, up to a maximum of 2% for the leverage ratio and up to a maximum of 5.8% for the rwa ratio. the requirements concerning loss-absorbing capacity according to financial stability board recommendations101 must be complied with.6 capital held by a bank to meet the requirements under this chapter must not simultaneously be used to meet the requirements under articles 128 to 131b.7 if a bank has previously held capital to meet the requirements in this chapter, it may use now use it to meet the requirements under articles 128 to 131b only insofar as the requirements of this article continue to be met with the remaining funds.99 amended by no i of the o of 21 nov. 2018, in force since 1 jan. 2019 (as 2018 5241).100 amended by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).101 total loss-absorbing capacity term sheet of 9 november 2015art. 132a102 banks with a state guarantee or similar mechanism if a non-internationally active systemically important bank benefits from an explicit state guarantee or similar mechanism, the requirement under article 132 paragraph 2 letter b, in the amount of the guarantee:a. shall be deemed to be met up to a maximum of half the required 40%;b. shall be deemed to be fully met if, in a crisis situation, the corresponding funds are available to finma irrevocably and rapidly; finma shall decide whether these criteria are met on a case-by-case basis.102 inserted by no i of the o of 21 nov. 2018, in force since 1 jan. 2019 (as 2018 5241).art. 133 rebates for internationally active systemically important banks103 1 finma shall determine the rebate for measures to improve the overall resolvability of the financial group under articles 65 and 66 of the banko104 after consultation with the swiss national bank:a. based on the effectiveness of the measures to improve the overall resolvability of the financial group; andb. taking into account the interactions between the various rebate groups.2 for entities under article 124 paragraph 3 letters b to d, the level of the additional capital requirement taking account of the rebates and the reduced requirements owing to the preferential treatment of convertible capital under article 132 paragraph 4 must not fall below 3.75% for the leverage ratio and 10% for the rwa ratio.1053 the reduction may not result in:a.106 a shortfall with regard to the international standards, after the inclusion of cet1 capital or convertible capital under article 132 paragraph 4 has been taken into account;b. the implementability of the contingency plan being jeopardised.4 no rebates are granted for demonstrating that the contingency plan ensures the continued operation of systemically important functions in the event of impending insolvency under article 9 paragraph 2 letter d of the banka.5 finma may consult foreign supervisory and insolvency authorities regarding the bank's proposed measures and may take their evaluation into account when assessing the improvement in the financial group's overall resolvability with respect to the rebates on additional funds.103 amended by no i of the o of 21 nov. 2018, in force since 1 jan. 2019 (as 2018 5241).104 sr 952.02105 amended by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).106 amended by no i of the o of 21 nov. 2018, in force since 1 jan. 2019 (as 2018 5241).arts. 134 and 135 repealedchapter 5 special risk diversification requirements art. 136107 risk concentrations 1 a risk concentration may not exceed 25% of the adjusted eligible tier 1 capital under articles 31 to 40 which is not used to meet the additional loss-absorbing capital requirements.2 a risk concentration may not exceed 15% of the tier 1 capital under paragraph 1 in the case of:a. exposures to other systemically important banks under article 8 paragraph 3 of the banka;b. exposures to foreign systemically important banks that have been designated as global systemically important banks by the financial stability board.3 the upper limit under paragraph 2 must be complied with at the latest twelve months after:a. the designation of a bank as systemically important under article 8 paragraph 3 of the banka;b. the designation of a foreign bank as a global systemically important bank under paragraph 2 letter b.4 furthermore, article 99 applies by analogy.107 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2019 (as 2017 7625).title 6 transitional and final provisions chapter 1 transitional provisions section 1 transitional provisions of 1 june 2012108 108 inserted by attachment no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725). arts. 137 and 138109 109 repealed by no i of the o of 22 nov 2017, with effect from 1 jan 2019 (as 2017 7625).art. 139 entry into force of the capital adequacy requirement for exchange-traded derivatives and credit risk exposures to central counterparties finma shall set the starting date for compliance with the new provisions of the basel minimum standards on exchange-traded derivatives (art. 56 para. 4) and credit risk exposures to central counterparties (arts. 69 and 70).art. 140 eligible capital 1 capital instruments comprising at1 capital and tier 2 capital which were issued after 12 september 2010 and which do not meet the relevant new eligibility criteria for regulatory capital shall no longer qualify as capital from 1 january 2013. paragraph 3 is reserved.2 capital instruments which were issued before 12 september 2010 may be recognised subject to phasing out over a ten-year horizon in accordance with article 141 and shall no longer qualify as capital from 1 january 2022 at the latest.3 capital instruments comprising at1 capital and tier 2 capital which were issued between 12 september 2010 and 31 december 2011, and for which only the contractual provisions on impending insolvency (art. 29) are missing, may be recognised subject to phasing out in accordance with article 141.art. 141 eligibility of tier 1 capital and tier 2 capital under existing legislation 1 participation capital and other tier 1 capital components under existing legislation which now no longer qualify as cet1 capital or at1 capital and were issued before 12 september 2010 may be recognised over a maximum ten-year horizon in accordance with the provisions of paragraphs 6 and 7. this does not include participation capital of banks which are not organised as corporations; the participation capital of such banks may continue to be recognised as cet1 capital under the same mechanism.2 tier 2 capital under existing legislation which was issued before 12 september 2010 and does not qualify as tier 2 capital under this ordinance, may be recognised as tier 2 capital subject to phasing out in accordance with paragraph 1.3 with the entry into force of this ordinance, between 1 january 2013 and 31 december 2022 at the latest, regulatory capital shall be divided into the following components:a. cet1 capital as measured by the new provisions;b. at1 capital as measured by the new provisions;c. tier 1 capital under existing legislation: in accordance with paragraph 1;d. tier 2 capital as measured by the new provisions;e. tier 2 capital under existing legislation: in accordance with paragraph 2.4 until 31 december 2021 at the latest, the components under paragraph 3 letters b and c shall constitute at1 capital, and the components under letters d and e tier 2 capital.5 at the time of entry into force of this ordinance, all capital components under paragraphs 1 and 2 shall be quantified and added together for each category.6 the amounts determined in accordance with paragraph 5 on 1 january 2013 shall be reduced by 10% annually, starting on 1 january 2013. they shall constitute the upper limit for the maximum eligible capital components under existing legislation in the year concerned. they may be recognised only to the extent that the bank has outstanding capital instruments of the corresponding quality.7 if an existing capital instrument can no longer be recognised as at1 capital as a result of the phased reduction under paragraph 6, it may instead be recognised as tier 2 capital in the same amounts as have been derecognised from at1 capital, provided it meets the new criteria for tier 2 capital.art. 142 introductory phase for corrections 1 deductions that were not provided for under existing legislation shall be made from cet1 capital over a five-year horizon in increments of 20% annually, as follows:a. 20% of the relevant amount from 1 january 2014;b. 40% of the relevant amount from 1 january 2015;c. 60% of the relevant amount from 1 january 2016;d. 80% of the relevant amount from 1 january 2017; ande. 100% of the relevant amount from 1 january 2018.2 the portion of exposures under paragraph 1 that is not subject to deductions shall be recognised in required capital in accordance with the risk weighting under existing legislation.3 full or partial deductions from existing tier 1 capital under existing legislation shall be gradually changed over to deductions from cet1 capital using the increments in paragraph 1.4 for the portion of exposures under paragraph 3 that is not subject to a deduction, the deductions under existing legislation shall be continued over a five-year horizon in decrements of 20% annually, as follows:a. 100% of the relevant amount from 1 january 2013;b. 80% of the relevant amount from 1 january 2014;c. 60% of the relevant amount from 1 january 2015;d. 40% of the relevant amount from 1 january 2016;e. 20% of the relevant amount from 1 january 2017.5 the additional deduction under paragraph 4 shall be eliminated completely from 1 january 2018.6 up to 31 december 2017, threshold 3 (art. 35 para.4) shall be 15% of cet1 capital after taking account of all regulatory adjustments except the deduction from threshold 3.1107 new deductions from at1 capital or from tier 2 capital shall be made using the same phased procedure as in paragraphs 1 to 5.110 amended by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).arts. 143-147111 111 repealed by no i of the o of 11 may 2016, with effect from 1 july 2016 (as 2016 1725).art. 148112 112 repealed by no i of the o of 22 nov. 2017, with effect from 1 jan. 2019 (as 2017 7625).art. 148a113 113 inserted by annex 2 no 4 of the banking ordinance of 30 april 2014 (as 2014 1269). repealed by no i of the o of 11 may 2016, with effect from 1 july 2016 (as 2016 1725).section 2114 transitional provisions to the amendment of 11 may 2016 114 inserted by no i of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725). art. 148b capital quality 1 as regards required capital quality under article 131, instruments shall be recognised as follows:a: high-trigger convertible capital qualifying as tier 2 capital which is held at the time this amendment enters into force: recognised as high-trigger convertible capital in the form of at1 capital for the period of its maturity or up to the time of the first capital call, but at the latest until 31 december 2019;b. low-trigger convertible capital qualifying as at1 capital which is held at the time this amendment enters into force: recognised as high-trigger convertible capital in the form of at1 capital up to the time of the first capital call;c. convertible capital that no longer qualifies under letter a: recognised as funds used to meet the requirements under articles 132 and 133 up to one year before final maturity;d. convertible capital that no longer qualifies under letter b: recognised as funds used to meet the requirements under articles 132 and 133 up to the time of any termination by the bank.2 as regards required capital quality under article 131, convertible capital with a 5% trigger and issued before the entry into force of the amendment on 1 july 2016 shall be recognised as follows:a: where it qualifies as tier 2 capital: recognised as high-trigger convertible capital in the form of at1 capital for the period of its maturity or up to the time of the first capital call, but at the latest until 31 december 2019;b. where it qualifies as at1 capital: recognised as high-trigger convertible capital in the form of at1 capital up to the time of the first capital call;c. where it no longer qualifies under letters a and b: recognised as funds used to meet the requirements under articles 132 and 133 up to one year before final maturity.art. 148c going-concern capital of the bank 1 with the entry into force of the amendment on 1 july 2016, the requirement under article 129 shall be 3% for the leverage ratio and 10.75% for the rwa ratio. a maximum of 0.70% of at1 capital in the form of high-trigger convertible capital may be recognised for the leverage ratio, and a maximum of 2.625% for the rwa ratio.2 in 2017, the requirement under article 129 shall be 3.5% for the leverage ratio and 12.0% for the rwa ratio. a maximum of 0.9% of at1 capital in the form of high-trigger convertible capital may be recognised for the leverage ratio, and a maximum of 3% for the rwa ratio.3 in 2018, the requirement under article 129 shall be 4.0% for the leverage ratio and 12.86% for the rwa ratio. a maximum of 1.1% of at1 capital in the form of high-trigger convertible capital may be recognised for the leverage ratio, and a maximum of 3.4% for the rwa ratio.4 in 2019, the base requirement under article 129 must be met for the leverage ratio, and the base requirement under article 129 plus half the surcharges for market share and total exposure must be met for the rwa ratio. a maximum of 1.3% of at1 capital in the form of high-trigger convertible capital may be recognised for the leverage ratio, and a maximum of 3.9% for the rwa ratio.art. 148d additional loss-absorbing funds 1 with the entry into force of the amendment on 1 july 2016, the requirement under article 132 shall be 1.0% for the leverage ratio and 3.5% for the rwa ratio.2 in 2017, the requirement under article 132 shall be 1.875% for the leverage ratio and 5.84% for the rwa ratio, plus a quarter of the surcharges for market share and total exposure.3 in 2018, the requirement under article 132 shall be 2.75% for the leverage ratio and 8.18% for the rwa ratio, plus half the surcharges for market share and total exposure.4 in 2019, the requirement under article 132 shall be 3.625% for the leverage ratio and 10.52% for the rwa ratio, plus three quarters of the surcharges for market share and total exposure.5 the reduction in requirements in accordance with paragraphs 1 to 4 as a result of a rebate under article 133 remains reserved.art. 148e bail-in bonds issued before the entry into force of the amendment of 11 may 2016 1 finma shall retroactively approve the bail-in bonds issued by internationally active banks as defined in article 124a before the entry into force of the amendment on 1 july 2016, subject to the criteria under article 126a being met.2 up to 31 december 2012, bail-in bonds issued by a special purpose entity may also be approved.art. 148f extended countercyclical buffer measured in terms of weighted exposures, the maximum extended countercyclical buffer may amount to:a. with the entry into force of the amendment on 1 july 2016: 0.625%;b. in 2017: 1.25%;c. in 2018: 1.875%.section 3115 transitional provision to the amendment of 23 november 2016 115 inserted by no i of the o of 23 nov. 2016, in force since 1 jan. 2017 (as 2016 4683).art. 148g116 1 for the purposes of determining the capital requirement, the credit equivalents of derivatives must be calculated in accordance with articles 56 to 59 at the latest 36 months after the entry into force of the amendment of 23 november 2016.2 the exposures in the exposure class under article 63 paragraph 3 letter fbis must be weighted in accordance with article 66 paragraph 3bis at the latest 36 months after the entry into force of the amendment of 23 november 2016.3 up to 31 december 2019, the conversion of derivatives into their credit equivalent within the scope of title 4 may also be carried out using the market valuation method or the standardised method in accordance with articles 56 to 58 in the version of 1 july 2016.117 finma may extend this deadline.116 amended by no i of the o of 22 nov. 2017, in force since 1 jan. 2018 (as 2017 7625).117 as 2012 5441section 4118 transitional provision to the amendment of 22 november 2017 118 inserted by no i of the o of 22 nov. 2017, in force since 1 jan. 2018 (as 2017 7625).art. 148h banks which expect or suspect that, from 1 january 2019, they will impermissibly breach the upper limit on risk concentrations (arts. 97 to 99) shall report this to finma within three months after the entry into force of the amendment of 22 november 2017.section 5119 transitional provision to the amendment of 21 november 2018 119 inserted by no i of the o of 21 nov. 2018, in force since 1 jan. 2019 (as 2018 5241).art. 148i treatment of participations individual transitional rules on the treatment of participations that were set by finma before the entry into force of the amendment of 21 november 2018 shall take precedence over the provisions of article 32 paragraph j and annex 4.art. 148j additional funds for non-internationally active systemically important banks the requirement under article 132 paragraph 2 letter b shall amount to:a. in 2019: 0.21% for the leverage ratio and 0.64% for the rwa ratio;b. in 2020: 0.42% for the leverage ratio and 1.28% for the rwa ratio;c. in 2021: 0.63% for the leverage ratio and 1.92% for the rwa ratio;d. in 2022: 0.84% for the leverage ratio and 2.56% for the rwa ratio;e. in 2023: 1.05% for the leverage ratio and 3.2% for the rwa ratio;f. in 2024: 1.26% for the leverage ratio and 3.84% for the rwa ratio;g. in 2025: 1.5% for the leverage ratio and 4.5% for the rwa ratio, plus half the surcharges for market share and total exposure.section 6120 transitional provisions to the amendment of 27 november 2019 120 inserted by no i of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).art. 148k calculation methods for derivatives 1 up to 31 december 2021, banks in categories 4 and 5 under annex 3 of the banko121 may also use the market valuation method in accordance with article 57 in the version of 1 july 2016122 to convert derivatives into their credit equivalents within the scope of titles 3 and 4.1bis the deadline in accordance with paragraph shall be extended to 31 december 2023.1232 this also applies to banks in category 3 under annex 3 of the banko which do not have significant derivatives exposures. finma shall issue technical implementing provisions.121 sr 952.02122 as 2012 5441123 inserted by no i 6 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).art. 148l additional funds for internationally active systemically important banks the requirement under article 132 paragraph 2 letter a number 3 third indent shall amount to:a. in 2020: 0%;b. in 2021: 5%;c. in 2022: 10%;d. in 2023: 20%.art. 148m rebates for internationally active systemically important banks in 2020 and 2021, the requirements under article 133 paragraph 2 may not fall below 3% for the leverage ratio and 8.6% for the rwa ratio.chapter 2 final provisions art. 149 repeal of existing legislation the capital adequacy ordinance of 29 september 2006124 is repealed.124 [as 2006 4307, 2008 5363 annex no 8, 2009 6101, 2010 5429 and 2012 3539]art. 150 amendment of existing legislation the amendment of existing legislation is regulated in annex 6.art. 151 commencement 1 this ordinance enters into force on 1 january 2013, subject to paragraphs 2 and 3.2 article 43 enters into force on 1 january 2016.3 the entry into force of the provisions of title 5, with the exception of articles 126 and 127, is conditional on approval by the federal assembly.125125 approved by the fa on 18 sept. 2012 (bbl 2012 8395).annex 1126 126 revised by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269). the correction of 10 may 2016 relates to the french text only (as 2016 1359).(art. 54 para. 1)credit conversion factors when using the bis standardised approach no.contingent funding obligations and irrevocable commitmentscredit conversion factorsbis sa1.loan commitments1.1with firm commitment and agreed original maturity of less than one year0.201.2with firm commitment and agreed original maturity of one year or more0.501.3that are unconditionally cancellable at any time, or provide for automatic cancellation due to deterioration in the borrower's creditworthiness0.002.builder warranties for construction work in switzerland and abroad0.503.self-liquidating guarantees from goods trade transactions0.203.1short-term self-liquidating trade letters of credit, e.g. documentary credits collateralised by the underlying shipment0.204.initial and variation margin obligations4.1on equity securities not recorded as participations in the balance sheet1.004.2on equity securities that are not participations subject to consolidated reporting1.004.3on equity securities that are not participations subject to consolidated reporting or equity securities in the insurance sector1.005.warranties5.1transaction-related contingent liabilities, e.g. performance bonds, bid bonds, warranties and standby letters of credit related to particular transactions0.505.2note issuance facilities (nifs) and revolving underwriting facilities (rufs)0.506.other contingent liabilities1.006.1direct credit substitutes, e.g. general guarantees of indebtedness including standby letters of credit serving as financial guarantees for loans and securities, and acceptances including endorsements with the character of acceptances1.006.2other contingent liabilities1.00comments:other contingent liabilities (under no. 6.2) contain, in particular:1. - sale and repurchase agreements and asset sales with recourse, where the credit risk remains with the bank [paragraph 83(ii) of the basel ii framework];- lending of securities and posting of securities as collateral, including instances where these arise out of repo-style transactions, e.g. repurchase/reverse repurchase and securities lending/borrowing transactions [paragraph 84 of the basel minimum standards];- forward asset purchases, forward forward deposits and partly paid shares and securities which represent commitments with certain drawdown [paragraph 84(i) of the basel ii framework];2. where there is an undertaking to provide a commitment on an off-balance sheet item, banks may use the lower of the two applicable credit conversion factors [paragraph 86 of the basel ii framework].annex 2127 127 revised by annex 2 no 4 of the banking ordinance of 30 april 2014, in force since 1 jan. 2015 (as 2014 1269).(art. 66 para. 1)exposure classes under the bis sa when using external ratings and their risk weights no.exposure classes (bis sa) for which external ratings can be usedrating category1234567unratedfixed1.central governments and central banks1.1central governments and central banks0%0%20%50%100%100%150%100%-1.2confederation and swiss national bank, where the asset is denominated and refinanced in domestic currency--------0%2.public sector entities2.1public sector entities20%20%50%100%100%150%150%100%-2.2unrated public sector entities, where they have tax-collecting powers or where their obligations have a full and unlimited guarantee from a public body--------50%2.3unrated cantons--------20%3.bis, imf and multilateral development banks3.1multilateral development banks20%20%50%50%100%100%150%50%-3.2bank for international settlements (bis), international monetary fund (imf), certain multilateral development banks designated by finma--------0%4.banks and securities firms4.1banks and securities firms, original asset maturity < 3 months20%20%20%20%50%50%150%20%-4.2banks and securities firms, original asset maturity > 3 months20%20%50%50%100%100%150%50%-5.community bodies5.1banks' community bodies recognised by finma20%20%50%100%100%150%150%100%-5.2payment obligations to the agency of the deposit protection scheme--------20%6.stock exchanges, clearing houses and central counterparties6.1stock exchanges, clearing houses and central counterparties20%20%50%100%100%150%150%100%-6.2central counterparties, where credit risks are directly linked to the central counterparty's guarantee of payment performance for exchange-traded or over-the-counter contracts (especially derivatives, repos or repo-like transactions for which the central counterparty guarantees performance of the obligation over the entire maturity).--------2%6.3stock exchanges and clearing houses, where credit risks are directly linked to the central counterparty's guarantee of payment performance for transactions for which the central counterparty guarantees only the settlement (especially spot transactions).--------0%7.corporates20%20%50%100%100%150%150%100%-annex 3128 128 the correction of 9 april 2019 concerns the italian text only (as 2019 1203).(art. 66 para. 2)exposure classes under the bis sa without the use of external ratings and their risk weights exposure classes (bis sa) without external ratingsrisk weightbis sa1.private individuals and small businesses (retail)1.1retail exposures, where the total value of the exposures under article 49 paragraph 1 to a counterparty, excluding residential mortgage-backed securities, does not exceed chf 1.5 million and 1% of all retail exposures75%1.2other retail exposures100%2.mortgage bonds (pfandbrief bonds)2.1domestic pfandbrief bonds20%3.direct and indirect mortgage-backed exposures3.1residential real estate in switzerland and abroad, up to two thirds of the market value35%3.2residential real estate in switzerland and abroad, over two thirds and up to 80% of the market value75%3.3residential real estate in switzerland and abroad, over 80% of the market value100%3.4other real estate and buildings100%4.subordinated exposures4.1subordinated exposures to public sector entities with a maximum risk weight under annex 2 (bis sa) of 50%are weighted in the same way as unsubordinated exposures4.2other subordinated exposures5.past-due exposures5.1the exposures under 3.1, corrected for individual value adjustments; mortgage-backed exposures under 3.2 to 3.4 shall be deemed unsecured100%5.2the unsecured exposure components, corrected for individual value adjustments, where the individual value adjustments amount to at least 20% of the outstanding amount100%5.3the unsecured exposure components, corrected for individual value adjustments, where the individual value adjustments amount to less than 20% of the outstanding amount150%6.other exposures6.1liquid assets, excluding exposures under annex 2 no. 6.20%6.2credit equivalents from initial and variation margin obligations100%6.3other exposures (incl. accruals and deferrals)100%annex 4129 129 revised by no i of the o of 23 nov. 2016 (as 2016 4683) and no ii of the o of 21 nov. 2018, in force since 1 jan. 2019 (as 2018 5241).(art. 32 let. j and 66 para. 3)risk weighting of equity securities and units of collective investment schemes under the bis sa exposure class: equity securities and units of collective investment schemesrisk weightbis sa1.1equity securities held as financial investments or - where the bank applies the de minimis approach - in the trading booktraded on a regulated stock exchangeyes100%no 150%1.2.1.3.1.4participations outside the banking, financial and insurance sectorstraded on a regulated stock exchangeyes100%no150%1.5participations in the banking, financial and insurance sectors, where these are not deducted from cet1 or at1 capital or weighted at 250% in accordance with article 40 paragraph 2150%1.6as part of the individual entity calculation: the net long positions of direct or indirect participations calculated in accordance with article 52 in companies subject to consolidated financial reporting, with registered office:in switzerland: 250%abroad: 400%1.7as part of the individual entity calculation: the net long positions of direct or indirect regulatory capital instruments calculated in accordance with article 52 in companies subject to consolidated financial reporting, with registered office:in switzerland: 250%abroad: 400%annex 5 (art. 84 para. 1)rates for calculating the minimum capital requirement for specific risk in interest rate instruments according to the standardised approach for market risk categoryrating categoryratecentral governments andcentral banks1 or 2 0.00%3 or 4 0.25% (residual maturity < 6 months) 1.00% (residual maturity > 6 months and < 24 months) 1.60% (residual maturity > 24 months)5 or 6 8.00%712.00%unrated 8.00%eligible interest rate instruments (art. 4 lit. g) 0.25% (residual maturity < 6 months) 1.00% (residual maturity > 6 months and < 24 months 1.60% (residual maturity > 24 months)other5 8.00%6 or 712.00%unrated 8.00%annex 6 (art. 150)amendment of existing legislation .130130 the amendment may be consulted under as 2012 5441.annex 7131 131 inserted by no i of the o of 13 feb. 2013 (as 2013 693). repealed by no i of the o of 27 march 2020, with effect from 28 march 2020 (as 2020 1105).annex 8132 132 inserted by no ii of the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).(art. 43 para. 1)minimum capital, capital buffer and total capital ratio (in % of risk-weighted exposures)category under annex 3 of the banko1331 and 2345minimum capital8.0%- of which cet14.5%- of which at1 or higher1.5%- of which t2 or higher2.0%capital buffer 4.8% 4.0% 3.2% 2.5%- of which cet1 3.7% 3.3% 2.9% 2.5%- of which at1 or higher 0.5% 0.3% 0.1%-- of which t2 or higher 0.6% 0.4% 0.2%-total capital ratio12.8%12.0%11.2%10.5%133 sr 952.02annex 9134 134 inserted by no ii of the o of 11 may 2016 (as 2016 1725). revised by no ii of the o of 27 nov. 2019, in force since 1 jan. 2020 (as 2019 4623).(art. 129)surcharges 1 surcharges for market share 1.1 market share of up to 27% bucketmarket sharelr surchargerwa ratio surchargem1< 12% 0%0%m2< 17% 0.125%0.36%m3< 22% 0.25%0.72%m4< 27% 0.375%1.08%1.2 market share of 27% or more for every additional 5 percentage points of market share, the requirement increases by 0.125 percentage points for the leverage ratio and by 0.36 percentage points for the rwa ratio.2 surcharges for total exposure 2.1 total exposure of up to chf 1,341 billion bucket total exposure lr surcharge rwa ratio surcharge g1 < chf 697 billion0% 0% g2 < chf 912 billion0.125% 0.36% g3 < chf 1,127 billion0.25% 0.72% g4< chf 1,341 billion0.375% 1.08% 2.2 total exposure exceeding chf 1,341 billion for every additional chf 215 billion of total exposure, the requirement increases by 0.125 percentage points for the leverage ratio and by 0.36 percentage points for the rwa ratio.

952.05 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceof the swiss financial market supervisory authority on the insolvency of banks and securities firms1(finma banking insolvency ordinance, bio-finma)of 30 august 2012 (status as of 1 january 2021)1 term in accordance with annex no 3 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327). this amendment has been made throughout the text.the swiss financial market supervisory authority (finma),based on articles 28 paragraph 2 and 34 paragraph 3 of the banking act of 8 november 19342 (banka), article 67 of the financial institutions act of 15 june 20183 (finia), and article 42 of the mortgage bond act of 25 june 19304 (mba),5decrees:2 sr 952.0 3 sr 954.14 sr 211.423.45 amended by annex no 3 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).chapter 1 general provisions art. 1 object this ordinance defines restructuring proceedings and bankruptcy proceedings under articles 28-37g banka.art. 2 scope of application 1 in this ordinance, banks are:6a.banks under the banka;b.7securities firms and fund management companies under the finia;c.central mortgage bond institutions under the mba.2 the provisions on bank restructuring (arts. 40-57) do not apply to individuals and legal entities operating without the requisite licence. finma may declare them applicable where there is sufficient public interest.6 amended by annex no 3 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).7 amended by annex no 3 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).art. 3 universality 1 if bankruptcy proceedings or restructuring proceedings are opened, they cover all realisable assets in a bank's possession at the time in question, regardless of whether they are located in switzerland or abroad.2 all swiss and foreign creditors of the bank and its foreign branches are equally entitled to participate in bankruptcy proceedings or restructuring proceedings opened in switzerland and enjoy the same privileges.3 the assets of a branch of a foreign bank operating in switzerland include all assets in switzerland and abroad that are constituted by parties acting on behalf of that branch.art. 4 public notices and communications 1 public notices are published in the swiss official gazette of commerce and on the finma website.2 communications are sent directly to creditors whose name and address are known. if it simplifies the proceedings, finma may require creditors domiciled or residing abroad to appoint an authorised person for service in switzerland. for reasons of urgency or to simplify the procedure, direct communications may be dispensed with.3 with regard to deadlines and the legal consequences associated with a public notice, publication in the swiss official gazette of commerce is the deciding factor.art. 5 inspection of documents 1 any person making a credible claim that their financial interests are directly affected by the restructuring or the bankruptcy is entitled to inspect documents relating to the restructuring or the bankruptcy, although professional confidentiality in accordance with article 47 banka and article 69 finia must be observed wherever possible.82 the right to inspect documents may be restricted to specific stages of the proceedings, or it may be limited or refused where opposing interests take precedence.3 any person granted the right to inspect documents may only use the information received through inspecting documents to protect their own immediate financial interests.4 the right to inspect documents may be made dependent on a declaration which states the information inspected may only be used to protect the individual's own immediate financial interests. in the event of any failure to comply, reference may be made in advance to the criminal penalties under article 48 of the financial market supervision act of 22 june 20079 and article 292 of the swiss criminal code10.5 the restructuring agent or bankruptcy administrator and, following completion of the restructuring proceedings or bankruptcy proceedings, finma shall decide on the right to inspect documents.8 amended by annex no 3 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).9 sr 956.110 sr 311.0art. 6 complaints to finma 1 any person whose interests are adversely affected by a decision, an act or an omission by a person who was entrusted with tasks in accordance with this ordinance may make a complaint to finma.2 any decisions made by these persons are not regarded as rulings and the complainants are not deemed to be parties within the meaning of the federal act of 20 december 196811 on administrative procedure.3 finma shall assess the facts reported, take the necessary measures and issue a ruling if required. 11 sr 172.021art. 7 insolvency venue 1 the insolvency venue is the location of the registered office of the bank or the swiss branch of a foreign bank.2 if a bank has more than one registered office or a foreign bank has more than one swiss branch, there will only be one insolvency venue. this venue shall be determined by finma.3 in the case of individuals, the insolvency venue is the person's business domicile at the time the bankruptcy proceedings or restructuring proceedings are opened.art. 8 book claims and liabilities the bank's claims and liabilities are deemed to be book claims and liabilities where the bank's books are kept properly and the bankruptcy liquidator is genuinely able to discern that the claim or liability exists and the extent to which they exist.art. 9 coordination finma and the restructuring agent or bankruptcy liquidator shall coordinate their actions as far as possible with authorities and governing bodies in switzerland and abroad.art. 10 recognition of foreign bankruptcy decrees and measures 1 where finma recognises a foreign bankruptcy decree or a foreign insolvency measure in accordance with article 37g banka, the provisions of this ordinance apply to the assets located in switzerland.2 even if there are no reciprocal rights, finma may meet recognition requests where this is in the interests of the creditors affected.3 it shall determine one insolvency venue in switzerland and the privileged creditors under article 37g paragraph 4 banka.4 it shall give public notice of the recognition and the circle of creditors.chapter 2 bankruptcy section 1 procedure art. 11 publication and notice to creditors 1 finma shall inform the bank of the bankruptcy order and give public notice of it together with notice to creditors.2 public notice shall be given of the following details in particular:a.the bank's name as well as its registered office and branches;b.the date and time of the opening of bankruptcy proceedings;c.the bankruptcy venue;d.the name and address of the bankruptcy liquidator;e.a notice to creditors and persons who have claims to assets held with the bank instructing them to register their claims, together with proof of the same, with the bankruptcy liquidator within a specific deadline;f.a reference to claims that qualify as registered under article 26;g.a reference to the surrender and reporting obligations under articles 17-19.3 the bankruptcy liquidator may provide known creditors with a copy of the notice.art. 12 appointing a bankruptcy liquidator 1 finma shall issue a ruling appointing a bankruptcy liquidator unless it is to carry out the liquidator's duties itself.2 where finma appoints a bankruptcy liquidator, it must ensure when making its choice that the liquidator has sufficient time and expertise to perform the mandate diligently, efficiently and effectively and is not subject to any conflict of interests that might compromise his or her ability to perform the mandate.3 it specifies the details of the task, in particular regarding the bankruptcy liquidator's costs, reporting and control.art. 13 the bankruptcy liquidator's tasks and powers the bankruptcy liquidator conducts the proceedings. in particular, he or she must:a.create the technical and administrative conditions for conducting the bankruptcy;b.secure and realise the bankruptcy assets;c.put in place the executive management required for the bankruptcy proceedings;d.represent the bankruptcy assets and other authorities before the courts;e.ensure, in conjunction with the agency of the deposit protection scheme, that the deposits protected under article 37h banka are identified and paid out.art. 14 assembly of creditors 1 if the bankruptcy liquidator deems it necessary to convene an assembly of creditors, he or she shall submit a request to this effect to finma. the latter shall stipulate the powers of the assembly of creditors as well as the quorum and voting majority requirements.2 all creditors are entitled to attend or be represented at the assembly. in cases of doubt, the bankruptcy liquidator decides on admission.3 the bankruptcy liquidator chairs the hearing and reports on the bank's assets and the progress of the proceedings.4 the creditors may pass resolutions by circular vote. creditors who do not expressly reject the bankruptcy liquidator's proposal within the specified deadline are regarded as being in agreement with it.art. 15 committee of creditors 1 finma decides, at the request of the bankruptcy liquidator, on the appointment, composition, tasks and powers of a committee of creditors.2 if the agency of the deposit protection scheme has paid out a substantial amount of privileged assets under article 37h banka, it must nominate a person to represent its interests on the committee of creditors.3 finma determines the chair, the voting procedure and the compensation of the individual members.section 2 bankruptcy assets art. 16 inventory 1 the bankruptcy liquidator draws up an inventory of the bankruptcy assets.2 the inventory is drawn up in accordance with articles 221 to 229 of the federal act of 11 april 188912 on debt enforcement and bankruptcy (deba), unless this ordinance provides otherwise.3 the assets held in custody that are to be segregated under article 37d banka and investment funds that are to be segregated under article 40 finia must be recorded in the inventory at their market value at the time the bankruptcy proceedings were opened. the inventory shall refer to the following claims that conflict with segregation:a.bank claims against the depositors;b.claims by the fund management company against the investment fund.134 the bankruptcy liquidator shall submit a request to finma for the measures required to secure the bankruptcy assets.5 he or she shall forward the inventory to the banker or a person selected by the bank's owners to act as the bank's agent. this person must confirm that the inventory is complete and correct. their confirmation must be recorded in the inventory.12 sr 281.113 amended by annex no 3 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).art. 17 surrender and reporting obligation 1 the bank's debtors and persons who have taken possession of the bank's assets through a pledge or for any other reason must report to the bankruptcy liquidator within the deadline specified in article 11 paragraph 2 letter e and release the assets to him or her.2 claims for which the right to offset has been asserted must still be reported.3 any existing pre-emptive right lapses in the event of an unjustifiable failure to report or surrender.art. 18 exceptions to the obligation to surrender 1 securities and other financial instruments serving as collateral need not be surrendered provided the legal conditions for the collateral recipient to take responsibility for their realisation are met.2 however, these assets must be reported, together with proof of the right to realise them, to the bankruptcy liquidator, who shall make a note of them in the inventory.3 the collateral recipient must agree a settlement with the bankruptcy liquidator over the proceeds from the realisation of these assets. any surplus accrues to the bankruptcy assets.art. 19 exceptions to the obligation to report finma may waive the requirement for debtors to be reported in respect of book claims.art. 20 segregation 1 the bankruptcy liquidator checks the surrender of assets claimed by third parties.2 if he or she believes a surrender claim to be justified, the bankruptcy liquidator shall offer the creditors the opportunity to demand assignment of their right to object under article 260 paras. 1 and 2 deba14 and set a reasonable deadline for this purpose.3 if he or she believes a surrender claim to be unjustified, or if creditors have demanded assignment of their right to object, the bankruptcy liquidator shall set the person making the claim a deadline for filing an action before the court at the bankruptcy venue. if the deadline is allowed to expire, the surrender claim is regarded as waived.4 in the case of assignment, the action must be filed against the assignee creditors. the bankruptcy liquidator shall provide the third party with the details of the assignee creditors when setting the deadline.14 sr 281.1art. 20a15 segregation in the bankruptcy of a fund management company 1 if the continuation of an investment fund is in the interests of the investors, the bankruptcy liquidator shall request finma to transfer the investment fund concerned with all its rights and obligations to another fund management company.2 if no other fund management company is prepared to take over the investment fund, the bankruptcy liquidator shall request finma to liquidate the investment fund concerned as part of the bankruptcy of the fund management company.15 inserted by annex no 3 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).art. 21 assets due, bankruptcy estate and contestation 1 claims falling due to the bankruptcy assets are collected by the bankruptcy liquidator, through debt enforcement if necessary.2 the bankruptcy liquidator shall check claims on the part of the bankruptcy assets for movable assets in the custody or co-custody of a third party or land entered in the land register in the name of a third party.3 he or she shall also check if legal transactions under articles 285 to 292 deba16 may be contested. the duration of any prior restructuring proceedings or any prior order for protective measures under article 26 paragraph 1 letters e-h banka are not taken into account in the deadlines under articles 286 to 288 deba.4 if the bankruptcy liquidator intends to pursue a contested claim in accordance with paragraph 2 or 3 through the actions process, he or she shall obtain approval and appropriate instructions from finma.5 if the bankruptcy liquidator does not file a claim, he or she shall give the creditors the opportunity to demand assignment within the meaning of article 260 paragraphs 1 and 2 deba or to realise the claims in question and any other entitlements under article 31.6 if he or she gives the creditors the opportunity to demand assignment, he or she shall set them an appropriate deadline.7 realisation in accordance with article 31 is not permitted in the case of contested claims under paragraph 3 or responsibility claims under article 39 banka.16 sr 281.1art. 22 continuation of ongoing proceedings under civil and administrative law 1 the bankruptcy liquidator shall assess claims on the part of the bankruptcy assets that are already the subject of proceedings under civil and administrative law at the time the bankruptcy proceedings are opened and submit a request to finma for the continuation of these proceedings.2 if finma rejects a request for continuation, the bankruptcy liquidator shall give the creditors the opportunity to demand assignment of their right to continue proceedings within the meaning of article 260 paragraphs 1 and 2 deba17 and set a reasonable deadline for this purpose.17 sr 281.1art. 23 discontinuation due to lack of assets 1 if the bankruptcy assets are not sufficient to continue the bankruptcy proceedings, the bankruptcy liquidator shall submit a request to finma to discontinue the proceedings.2 finma shall continue the proceedings in exceptional cases, in particular where there is a special interest in doing so, even if the bankruptcy assets are not sufficient.3 if finma intends to discontinue proceedings, it shall give public notice of this fact, stating that it will continue them if a creditor can provide security for the costs of the proceedings not covered by the bankruptcy assets within a specified deadline. finma shall set the deadline as well as the type and amount of the security.4 if the required security is not provided within the deadline, all pledgees may demand realisation of the assets pledged in their favour by finma within a deadline specified by the latter. finma shall instruct a bankruptcy liquidator to proceed with the realisation.5 in the case of legal entities, finma shall order the realisation of assets that are not subject to a demand for realisation from a pledgee within the specified deadline. any proceeds remaining after the realisation costs and any encumbrances attached to individual assets are covered go to the federal government once the costs incurred by finma have been covered.6 where bankruptcy proceedings against individuals are discontinued, the debt enforcement procedure is governed by article 230 paragraphs 3 and 4 deba18.18 sr 281.1section 3 bankruptcy liabilities art. 24 groups of creditors 1 where a joint claim against the bank exists, the group shall be treated as a creditor in its own right, separate from its individual members.2 solidary claims shall be attributed to the solidary creditors in equal shares, provided the bank has no setting-off right. the shares are treated as claims on the part of each individual solidary creditor.art. 25 privileged deposits 1 under article 37a banka privileged deposits are:a.client claims arising from banking or securities dealing operations that are booked or should be booked as liabilities from client deposits in the balance-sheet;b.medium-term notes booked as medium-term notes in the balance sheet that are deposited at the bank in the depositor's name.192 within the meaning of article 37a banka privileged deposits are not:a.bearer claims;b.medium-term notes that are not held at the bank;c.contractual and non-contractual compensation claims such as compensation claims for custody assets no longer at the bank's disposal in accordance with article 37d banka.3 claims on the part of bank foundations under article 5 paragraph 2 of the ordinance of 13 november 198520 on tax-deductible contributions to recognised forms of retirement provision and on the part of vested benefits foundations under article 19 paragraph 2 of the vested benefits ordinance of 3 october 199421 qualify as deposits belonging to the individual pension fund members and policy holders. however, these claims shall be paid out to the respective bank foundation or vested benefits foundation.19 amended by no i of the finma ordinance of 27 march 2014, in force since 1 jan. 2015 (as 2014 1309).20 sr 831.461.321 sr 831.425art. 26 verification of claims 1 the bankruptcy liquidator shall verify the claims registered and those to be considered by law. he or she may make enquiries personally and ask the creditors to provide additional proof.2 the following claims shall be considered by law:a.land register claims, complete with accrued interest; andb.book claims under article 8.3 the bankruptcy liquidator obtains a statement of claims that are not book claims from the banker or from a person selected by the bank's owners to act as the bank's agent. art. 27 schedule of claims 1 the bankruptcy liquidator shall decide whether, to what extent and with what rank claims are recognised and shall draw up the schedule of claims.2 if the bankruptcy assets include land, he or she shall draw up a schedule of the encumbrances on that land such as rights of lien, easements, land charges and priority notices. this schedule shall form part of the schedule of claims.3 the bankruptcy liquidator may with finma's consent draw up a separate schedule of claims for claims secured by a registered pledge if systemic risks can only be restricted by doing so.art. 28 claims subject to proceedings under civil and administrative law 1 claims that are already the subject of proceedings under civil or administrative law at the time the bankruptcy proceedings are opened in switzerland must initially be marked in the schedule of claims pro memoria.2 if the bankruptcy liquidator opts not to continue the proceedings under civil and administrative law, he or she shall give the creditors the opportunity to demand assignment in accordance with article 260 paragraph 1 deba22.3 unless proceedings under civil and administrative law are continued by the bankruptcy assets or by individual assignee creditors, the claim is deemed to be recognised, and the creditors no longer have any right to contest it via an action to contest the schedule of claims.4 where proceedings are continued by individual assignee creditors, the amount by which the success of these proceedings reduces the subordinated creditors' share of the bankruptcy assets serves to satisfy the assignee creditors up to the full coverage of their collocated claims as well as the cost of the proceedings. any surplus accrues to the bankruptcy assets.22 sr 281.1art. 29 inspection of the schedule of claims 1 the creditors may inspect the schedule of claims under article 5 for a period of at least 20 days.2 the bankruptcy liquidator shall give public notice of when and how the schedule of claims may be inspected.3 he or she may provide for inspection at the bankruptcy office in the bankruptcy venue.4 the bankruptcy liquidator shall inform every creditor whose claim was not collocated as registered or as a book or land register claim why the claim was rejected in full or in part.art. 30 actions to contest the schedule of claims 1 actions to contest the schedule of claims are governed by article 250 deba23.2 the deadline for actions runs from the point when the schedule of claims may first be inspected.23 sr 281.1section 4 realisation art. 31 type of realisation 1 the bankruptcy liquidator shall decide on the type and timing of realisation and shall carry it out.2 pledged assets may not be realised by means other than a public auction except with the pledgees' consent.3 assets may be realised without delay if they:a.are subject to rapid depreciation;b.generate unreasonably high administrative costs;c.are traded on a representative market; or d.are of insignificant value.art. 32 public auction 1 public auctions are held in accordance with articles 257-259 deba24 unless this ordinance specifies otherwise.2 the bankruptcy liquidator shall conduct the auction. he or she may set a reserve price for the first auction in the terms and conditions.3 he or she shall give public notice that the terms and conditions may be inspected. he or she may provide for inspection at the bankruptcy or debt enforcement office at the bankruptcy venue.24 sr 281.1art. 33 assignment of legal claims 1 in the certificate of assignment pertaining to a legal claim on the part of the bankruptcy assets within the meaning of article 260 deba25, the bankruptcy liquidator shall specify the deadline within which the assignee creditors must assert their claim before the court. if the deadline is allowed to expire, the assignment lapses.2 the assignee creditors shall report without delay the outcome of their assertion to the bankruptcy liquidator and, following completion of the bankruptcy proceedings, to finma.3 where no creditor demands assignment or the deadline expires without the claim being asserted, the bankruptcy liquidator and, following completion of the bankruptcy proceedings, finma shall decide on any further realisation of the legal claims in question.25 sr 281.1art. 34 contestation of realisation actions 1 the bankruptcy liquidator shall periodically draw up a realisation plan containing information on the bankruptcy assets awaiting realisation and the nature of their realisation.2 realisation actions that may proceed without delay in accordance with article 31 need not be included in the realisation plan.3 the assignment of legal claims under article 33 does not constitute a realisation action.4 the bankruptcy liquidator forwards the realisation plan to the creditors and sets them a deadline within which they may demand a contestable ruling from finma on individual realisation actions contained therein.section 5 distribution art. 35 bankruptcy liabilities the following liabilities are covered first from the bankruptcy assets in the order listed:a.liabilities under article 37 banka and under article 43 of this ordinance;b.liabilities incurred by the bankruptcy assets during the proceedings;c.all costs incurred through the opening and conduct of the bankruptcy proceedings;d.liabilities towards a third-party custodian under article 17 paragraph 3 of the book entry securities act of 3 october 200826.26 sr 957.1art. 36 distribution 1 the bankruptcy liquidator may provide for provisional distributions. he or she shall draw up a provisional distribution list for this purpose and forward it to finma for approval.2 if all assets have been realised and all processes relating to the calculation of assets and liabilities have been completed, the bankruptcy liquidator shall draw up the final distribution list as well as the final accounts and forward these to finma for approval. the proceedings conducted by individual creditors under article 260 deba27 may be disregarded.3 once the distribution list has been approved, the bankruptcy liquidator shall pay out to the creditors.4 no payout is made for claims:a.whose existence or amount has not been definitively established;b.whose beneficiaries are not definitively known;c.that are partially covered by collateral outside switzerland or under article 18 that has not been realised; ord.that are likely to be partially covered by a pending settlement in foreign foreclosure proceedings connected to the bank bankruptcy.5 if a separate schedule of claims is drawn up in accordance with article 27 paragraph 3, the bankruptcy liquidator may with finma's consent carry out the distribution once this ordinance has entered into force, and independently of the entry into force of the schedule of claims regarding the remaining claims.27 sr 281.1art. 37 certificate of loss 1 creditors may demand a certificate of loss under article 265 deba28 for the amount of their claim that remains outstanding from the bankruptcy liquidator and, following completion of the bankruptcy proceedings, from finma against payment of a flat fee.2 the bankruptcy liquidator shall inform the creditors of this option when paying out their share.28 sr 281.1art. 38 depositing 1 subject to the rules on dormant assets, finma shall issue the necessary instructions for depositing the shares not yet paid out as well as the segregated custody assets not yet surrendered.2 deposited assets that become free or are not withdrawn after 10 years shall be realised and distributed in accordance with article 39 unless special legislation provides otherwise.art. 39 assets discovered after the fact 1 if assets or other legal claims that have not previously been included in the bankruptcy assets are discovered within 10 years of the bankruptcy proceedings being completed, finma shall appoint a bankruptcy liquidator to restart the bankruptcy proceedings without further formalities.2 assets discovered after the fact or legal claims shall be distributed to creditors who suffered a loss and for whom the bankruptcy liquidator has the details needed to make the payout. the bankruptcy liquidator may ask creditors to provide up-to-date details, stating that these are required in connection with their claim. he or she shall set a reasonable deadline for this purpose.3 where it is clear that the costs incurred through restarting the bankruptcy proceedings will not be covered or will only be marginally exceeded by the expected proceeds from realising the assets discovered after the fact, finma may refrain from restarting the proceedings. in such cases, it shall pass the assets discovered after the fact to the federal government.chapter 3 restructuring section 1 procedure art. 40 prerequisites 1 the prospect of restructuring the bank or continuing individual banking services is justified if, at the time of the decision, there is sufficient evidence that:a.the creditors are likely to fare better from the restructuring than from the bankruptcy; andb.the restructuring plan is feasible in terms of time and scope.2 there is no automatic entitlement to opening restructuring proceedings.art. 41 opening 1 finma opens the restructuring proceedings with a ruling.2 it shall give public notice of the opening immediately.3 in its opening ruling, it shall specify whether existing protective measures under article 26 banka are to be maintained or altered, or replaced by new ones.4 when it opens the restructuring proceedings, it may also already approve the restructuring plan.art. 42 restructuring agent 1 finma shall issue a ruling appointing a restructuring agent, unless it is to carry out these duties itself.2 where finma appoints a restructuring agent, it must ensure when making its choice that the agent has sufficient time and expertise to carry out the mandate diligently, efficiently and effectively and is not subject to any conflict of interests that might compromise its ability to perform the mandate.3 it shall determine the restructuring agent's powers and whether he or she is authorised to act in place of the bank's governing bodies. during the duration of the restructuring proceedings, he or she may in particular make commitments pertaining to the restructuring to be honoured by the bank.4 finma shall specify the details of the task, in particular with regard to the restructuring agent's costs, reporting and control.art. 43 liabilities during the restructuring proceedings during the restructuring proceedings, liabilities into which the bank enters with the restructuring agent's consent shall, in the event that restructuring fails, be satisfied before all other claims in the ensuing bankruptcy proceedings.art. 44 restructuring plan 1 the restructuring plan shall set out the basic elements of the restructuring, the bank's future capital structure and business model after the restructuring, and explains how it fulfils the conditions for approval under article 31 paragraph 1 banka.2 the restructuring plan shall also provide information on the following elements:a.future compliance with the licensing requirements;b.the bank's assets and liabilities;c.the bank's future organisation and management and, if the bank is part of a banking group or a banking conglomerate, the future organisation of the group or conglomerate;d.whether and how the restructuring plan affects the rights of the bank's creditors as well as the owners;e.whether the bank's right to contest legal acts and assert civil responsibility claims under article 32 banka are excluded;f.which current members of the bank's governing bodies are to retain responsibility for its management, and why this is in the interests of the bank, its creditors and its owners;g.the severance settlements for departing members of governing bodies;h.those transactions which require an entry in the commercial register or in the land register; andi.the provisions in sections 3 and 4 of this chapter which are to be applied to a specific restructuring case.3 finma may request that the restructuring plan provide information on additional elements.section 2 approval of the restructuring plan art. 45 approval 1 finma shall approve the restructuring plan with a ruling if the conditions stipulated in the banka and this ordinance are met.2 it shall give public notice of the approval and the basic features of the restructuring plan, stating how the affected creditors and owners can inspect the plan.3 if the restructuring plan orders the transfer of land, the granting of in rem rights and obligations over land or changes in the share capital, these orders shall have direct effect with the approval of the restructuring plan. the required entries in the land register, the commercial register or in any other register shall be made as soon as possible.2929 the correction of 6 sept. 2016, concerns french text only (as 2016 3099).art. 46 rejection by creditors 1 where the restructuring plan provides for an intervention into creditors' rights, finma sets the creditors a deadline at the latest with the approval of the restructuring plan within which they can reject it. the deadline is of at least ten working days. the transfer of liabilities and contractual relationships and the change of debtor involved do not infringe upon the rights of the creditors.2 creditors wishing to reject the plan must do so in writing. they must give their name and address as well as the amount of their claim at the time of opening the restructuring proceedings, and the reasons for it. the rejection letter must be sent to the restructuring agent.section 3 corporate actions art. 47 general provisions 1 if the restructuring plan allows corporate actions in accordance with this section, it is necessary to ensure that:a.the creditors' interests take precedence over the interests of the owners and the hierarchy of creditors is respected;b.the provisions of the swiss code of obligations30 apply mutatis mutandis.2 where granting pre-emption rights may endanger the restructuring, they may be denied to the owners. 30 sr 220art. 48 principles for converting debt capital into equity capital 1 if the restructuring plan provides for the conversion of debt capital into equity capital then:a.sufficient debt capital must be converted into equity capital to ensure that the bank holds the required capital to continue its business activities after the restructuring is completed;b.share capital must be completely written down before converting debt capital into equity capital;c.debt capital may be converted into equity capital only if the debt instruments issued by the bank which are part of additional core capital or supplementary capital have already been converted into equity capital, in particular contingent convertible bonds; d.the following order of rank shall be observed when converting debt capital into equity capital where claims of the next rank are only converted if the conversion of claims of the previous rank does not suffice to meet the capital adequacy requirements in accordance with letter a:1.subordinated claims without capital adequacy eligibility,2.other claims not excluded from the conversion, with the exception of deposits, and3.deposits, in so far as they are not privileged. art. 49 convertibility of claims all debt capital may be converted into equity capital. the following are excluded:a.privileged claims in classes 1 and 2 according to article 219 paragraph 4 deba31 and article 37a paragraph 1-5 banka to the extent that they are classed as preferential; andb.secured claims to the extent that they are secured and offsettable claims to the extent that they are offsettable, if the creditor can credibly demonstrate the existence, amount and fact that the claim is object of a relevant agreement, or this is evident from the bank's books.31 sr 281.1art. 50 reduction in claims in addition to or instead of converting debt capital into equity capital, finma may order a partial or full reduction in claims. article 48 letters a-c and article 49 apply equally.section 4 continuation of certain banking services art. 51 continuation of banking services 1 where the restructuring plan provides for individual banking services or groups of services to be continued and for certain bank assets or contractual relationships to be transferred to another legal entity, including a bridge bank, it must in particular:a.name the legal entity or entities to which such banking services and assets are to be transferred;b.describe the assets, liabilities and contractual relationships to be transferred and the compensation to be provided for them;c.describe the banking services that are to be continued and transferred;d.list the corporate actions undertaken and, where banking services are to be transferred to a bridge bank, describe how assets and liabilities will be shared between the bank and the bridge bank;e.stipulate an obligation on the bank's part to take any action necessary to ensure that all of the assets and objects to be transferred, including in particular those located abroad or subject to foreign law, can be transferred to the other legal entity;f.explain whether compensation is to be paid, how such compensation is to be calculated and whether a maximum compensation amount is to be imposed; g.explain whether systems and applications will be used jointly by the bank and the other legal entity and, if banking services are to be continued by a bridge bank, how the latter will be guaranteed access to payment transaction and financial market infrastructure and how it will be able to use this; h.describe how to preserve the legal and economic connections between assets, liabilities and contractual relationships, thereby ensuring that only the following can be transferred:1.all claims and liabilities on the bank's part vis--vis a counterparty or several counterparties that can be offset, in particular those that are subject to a netting agreement,2.secured claims and liabilities together with their collateral, and3.structured financing arrangements or comparable capital market agreements to which the bank is a party, together with all rights and obligations pertaining to them.2 as soon as the approved restructuring plan is enforceable, or in the case of a systemically important bank once the restructuring plan has been approved, all transferred assets or contractual relationships, together with all rights and obligations pertaining to them at the time of the approval of the restructuring plan, pass to the new legal entity or entities.art. 52 bridge bank 1 the bridge bank serves to ensure the temporary continuation of individual banking services transferred to it.2 finma shall grant the bridge bank a licence with a fixed term of two years. it may deviate from the licensing requirements when granting it. the licence may be extended.chapter 432 protecting systems and financial market infrastructure 32 amended by annex 2 no ii 1 of the finma financial market infrastructure ordinance of 3 dec. 2015, in force since 1 jan. 2016 (as 2015 5509). art. 53 repealedart. 54 binding nature of instructions to a central counterparty, a central custodian or a payment system 1 the following measures may restrict the legally binding nature of an instruction within the meaning of article 89 paragraph 2 of the financial market infrastructure act of 19 june 201533 (finmia):a.the opening of bankruptcy proceedings under articles 33-37g banka; andb.protective measures under article 26 paragraph 1 letters f-h banka.2 in its ruling, finma shall expressly order the time from when the measures under paragraph 1 apply.33 sr 958.1art. 55 netting agreements netting agreements under article 27 paragraph 1 banka include the following in particular: a.netting provisions in bilateral agreements or in framework agreements;b.offsetting and netting provisions as well as default agreements of central counterparties, central custodians or payment systems under article 89 paragraph 1 finmia34.34 sr 958.1chapter 5 stay on early termination rights35 35 amended by no i of the finma ordinance of 9 march 2017, in force since 1 april 2017 (as 2017 1675). art. 5636 contracts 1 the requirement set out in article 12 para. 2bis of the banking ordinance of 30 april 201437 (bo) applies to:a.contracts for the purchase, sale, lending or repurchase agreements relating to certificated securities, uncertificated securities or intermediated securities and corresponding transactions involving indices containing these underlying assets, as well as options in relation to such underlying assets;b.contracts for the purchase and sale with future delivery, lending or repurchase agreements relating to commodities and corresponding transactions involving indices containing these underlying assets, as well as options in relation to such underlying assets;c.contracts for the purchase, sale or transfer of commodities, services, rights or interest at a future date and at a predetermined price (futures contracts);d.contracts for swap transactions relating to interest, foreign exchange, currencies and commodities as well as to certificated securities, uncertificated securities, intermediated securities, the weather, emissions or inflation, and corresponding transactions involving indices containing these underlyings, including credit derivatives and interest rate options; e.interbank borrowing agreements;f.other contracts with the same effect as those listed under letters a-e;g.contracts in accordance with letters a-f in the form of master agreements;h.contracts in accordance with letters a-g entered into by foreign group entities guaranteed or otherwise secured by a bank or securities firm domiciled in switzerland.2 the requirement set out in article 12 para. 2bis bo does not apply to:a.contracts which provide for the termination or exercise of rights pursuant to article 30a para. 1 ba which are neither directly nor indirectly triggered by actions taken by finma in accordance with the eleventh section of the banking act;b.contracts which are concluded or settled directly or indirectly through a financial market infrastructure or organised trading facility;c.contracts with central banks;d.contracts of group entities which are not active in the financial services sector;e.contracts with counterparties that are not companies within the meaning of article 77 of the financial market infrastructure ordinance of 25 november 201538;f.contracts relating to the placement of financial instruments in the market;g.amendments to existing contracts which become effective pursuant to their terms and conditions and without further action by the parties.36 amended by no i of the finma ordinance of 9 march 2017, in force since 1 april 2017 (as 2017 1675).37 sr 952.0238 sr 958.11art. 5739 39 repealed by annex 2 no ii 1 of the finma financial market infrastructure ordinance of 3 dec. 2015, with effect from 1 jan. 2016 (as 2015 5509).chapter 6 completion of proceedings art. 58 concluding report 1 the bankruptcy liquidator or the restructuring agent shall report to finma, summarising the progress of the bankruptcy proceedings or the restructuring proceedings.2 the bankruptcy liquidator's concluding report shall also contain the following information:a. details of the completion of all processes relating to the calculation of the assets and liabilities;b. details of the status of the legal claims assigned to creditors under article 260 deba40; andc. a list of the shares not yet paid out as well as the segregated custody assets not yet surrendered, complete with an explanation as to why no payout or surrender has been possible to date.3 finma shall give public notice that the bankruptcy proceedings or the restructuring proceedings have been completed.40 sr 281.1art. 59 document archiving 1 finma shall determine how the insolvency and business documentation is to be archived following completion of the bankruptcy proceedings or the restructuring proceedings.2 the insolvency documentation and the remaining business documentation shall be destroyed on finma's instructions 10 years after completion of the bankruptcy proceedings or the restructuring proceedings.3 any special legislation providing otherwise for the archiving of individual documents applies notwithstanding.chapter 7 final provisions art. 60 repeal and amendment of prior legislation 1 the finma bankruptcy ordinance of 30 june 200541 is repealed.2 .4241 [as 2005 3539, 2008 5613 no i 3, 2009 1769]42 the amendment may be consulted under as 2012 5573.art. 61 transitional provisions the provisions of this ordinance apply to proceedings pending in court when this ordinance comes into force.art. 61a43 transitional provisions to the amendment of 9 march 2017 1 the requirements set out in article 12 para. 2bis bo44 in conjunction with article 56 must be met: a.within twelve months of this amendment coming into effect for the conclusion or amendment of contracts with banks and securities firms or with counterparties who would qualify as such if they were domiciled in switzerland;b.within 18 months of this amendment coming into effect for the conclusion or amendment of contracts with other counterparties.2 finma may extend the implementation deadline for individual institutions where this is justified.43 inserted by no i of the finma ordinance of 9 march 2017, in force since 1 april 2017 (as 2017 1675).44 sr 952.02art. 62 commencement this ordinance comes into force on 1 november 2012.

954.1english is not an official language of the swiss confederation. this translation is provided for information purposes only, has no legal force and may not be relied on in legal proceedings.federal act on financial institutions(financial institutions act, finia)of 15 june 2018 (status as of 1 august 2021)the federal assembly of the swiss confederation,based on articles 95 and 98 paragraphs 1 and 2 of the federal constitution1,and having considered the federal council dispatch of 4 november 20152,decrees:1 sr 1012 bbl 2015 8901chapter 1 general provisions section 1 subject matter, purpose and scope of application art. 1 subject matter and purpose 1 this act governs the requirements for acting as a financial institution.2 its purpose is to protect the investors and clients of financial institutions and ensure the proper functioning of the financial market.art. 2 scope of application 1 financial institutions within the meaning of this act are as follows, irrespective of their legal form:a. portfolio managers (article 17 paragraph 1); b. trustees (article 17 paragraph 2);c. managers of collective assets (article 24);d. fund management companies (article 32);e. securities firms (article 41).2 this act does not apply to: a. persons who manage solely the assets of persons with whom they have business or family ties;b. persons who manage assets solely within the context of employee participation schemes;c. lawyers, notaries and their auxiliaries insofar as their activity is subject to professional confidentiality in accordance with article 321 of the swiss criminal code3 or article 13 of the lawyers act of 23 june 20004, as well as the legal entities into which these persons are organised;d. persons who manage assets within the framework of a legally regulated mandate;e. the swiss national bank and the bank for international settlements;f. occupational pension schemes and other occupational pension institutions (occupational pension schemes), employer-sponsored foundations (employer-sponsored welfare funds); employers who manage the assets of their occupational pension schemes; employer and employee associations which manage the assets of their association schemes;g. social security institutions and compensation funds;h. insurance companies as defined in the insurance supervision act of 17 december 20045;i public insurance institutions in accordance with article 67 paragraph 1 of the federal act of 25 june 19826 on occupational old age, survivors' and invalidity pension provision;j. banks pursuant to the banking act of 8 november 19347 (banka). 3 sr 311.04 sr 935.615 sr 961.016 sr 831.407 sr 952.0art. 3 commerciality within the meaning of the present act, the criterion of a commercial basis is deemed satisfied by an independent economic activity pursued on a permanent, for-profit basis.art. 4 group parent companies and significant group companies 1 the following are subject to the insolvency law measures under article 67 paragraph 1 provided they are not subject to the bankruptcy jurisdiction of the swiss financial market supervisory authority (finma) within the scope of the supervision of the individual institution:a. group parent companies of a financial group or financial conglomerate which have their registered office in switzerland;b. those group companies which have their registered office in switzerland and perform significant functions for activities which require authorisation (significant group companies).2 the federal council shall set the criteria for assessing significance.3 finma shall identify significant group companies and keep a publicly accessible list of said companies.section 2 common provisions art. 5 duty to obtain authorisation 1 financial institutions under article 2 paragraph 1 require authorisation from finma. 2 they may be entered in the commercial register only after authorisation has been granted.3 financial institutions in accordance with article 2 paragraph 1 letter c that are already subject to other equivalent official supervision in switzerland are exempt from the duty to obtain authorisation.art. 6 authorisation chain 1 authorisation to operate as a bank within the meaning of the banka8 also authorises an entity to operate as a securities firm, a manager of collective assets, a portfolio manager and a trustee.2 authorisation to operate as a securities firm under article 41 letter a also authorises an entity to operate as a manager of collective assets, a portfolio manager and a trustee.93 authorisation to operate as a fund management company also authorises an entity to operate as a manager of collective assets and a portfolio manager.4 authorisation to operate as a manager of collective assets also authorises an entity to operate as a portfolio manager. 8 sr 952.09 amended by no i 7 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 7 authorisation conditions 1 any party that meets the conditions set out in this section and the specific conditions that apply to individual financial institutions is entitled to authorisation.2 portfolio managers and trustees submitting an application for authorisation are required to provide proof that they are subject to supervision by a supervisory organisation in accordance with article 43a of the financial market supervision act of 22 june 200710 (finmasa).3 the federal council may define additional authorisation conditions if this is necessary for implementing recognised international standards.10 sr 956.1art. 8 change in facts 1 the financial institution shall notify finma of any changes in the facts on which its authorisation is based. 2 if the changes are of material significance, the financial institution must obtain prior authorisation from the supervisory authority in order to pursue its activity.art. 9 organisation 1 the financial institution must establish appropriate corporate management rules and be organised in such a way that it can fulfil its statutory duties. 2 it shall identify, measure, control and monitor its risks, including legal and reputational risks, and organise effective internal controls. 3 the federal council shall set the minimum organisational requirements to be satisfied by financial institutions, taking into account their different business activities and sizes as well as the risks.art. 10 place of management 1 the financial institution must effectively be managed from switzerland. general directives and decisions within the context of group supervision are excluded if the financial institution forms part of a financial group that is subject to appropriate consolidated supervision by foreign supervisory authorities.2 the persons entrusted with managing the financial institution must be resident in a place from which they may effectively exercise such management.art. 11 guarantee of irreproachable business conduct 1 the financial institution and the persons responsible for its administration and management must provide a guarantee of irreproachable business conduct.2 moreover, the persons responsible for the administration and management of the financial institution must enjoy a good reputation and have the specialist qualifications required for their functions. 3 qualified participants in a financial institution must also enjoy a good reputation and ensure that their influence is not detrimental to prudent and sound business activity.4 persons who directly or indirectly hold at least 10% of the share capital or votes or who can significantly influence its business activity in another manner are deemed to be qualified participants in a financial institution.5 each person must notify finma before directly or indirectly acquiring or disposing of a qualified participation in accordance with paragraph 4 in a financial institution. this mandatory notification also applies if a qualified participation is increased or reduced in such a way as to reach, exceed or fall below the thresholds of 20%, 33% or 50% of the share capital or votes.6 the financial institution shall notify finma of the persons who meet the conditions of paragraph 5 as soon as it becomes aware of the same.7 portfolio managers and trustees are exempt from the requirements of paragraphs 5 and 6.8 qualified participants in portfolio managers and trustees are permitted to perform management dutiesart. 12 public offer of securities on the primary market persons operating primarily in the financial sector may perform the following activities only if they have authorisation as a securities firm as defined in this act or as a bank in accordance with the banka11:a. underwriting securities issued by third parties and offering these to the public on a primary market on a commercial basis; b. creating derivatives in the form of securities and offering these to the public on the primary market on a commercial basis.11 sr 952.0art. 13 protection against confusion and deception 1 the name of the financial institution must not lead to confusion or deception.2 the terms portfolio manager, trustee, manager of collective assets, fund management company or securities firm may be used, alone or in compound terms, in the company name, in the description of its business purpose or in commercial documents only if the corresponding authorisation has been obtained. the foregoing is without prejudice to article 52 paragraph 3 and article 58 paragraph 3.art. 14 delegation of tasks 1 financial institutions may delegate a task solely to third parties that possess the necessary skills, knowledge and experience and that have the required authorisations. they shall carefully instruct and supervise the appointed third parties.2 finma may make the delegation of investment decisions to a person located abroad subject to an agreement on cooperation and information exchange between finma and the competent foreign supervisory authority, in particular if such an agreement is required under the other country's legislation.art. 15 international business a financial institution must notify finma before: a. establishing, acquiring or closing a foreign subsidiary, branch or representation;b. acquiring or surrendering a qualified participation in a foreign company.art. 1612 ombudsman financial institutions that provide financial services under article 3 letter c of the financial services act of 15 june 201813 (finsa) must affiliate to an ombudsman as stipulated in the provisions of title 5 of the finsa at the latest on assuming their activity.12 amended by no i 7 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).13 sr 950.1chapter 2 financial institutions section 1 portfolio managers and trustees art. 17 definitions 1 a portfolio manager is a person mandated to manage assets on a commercial basis in the name of and on behalf of clients within the meaning of article 3 letter c items 1 to 4 finsa14. 2 a trustee is a person who on a commercial basis manages or holds a separate fund for the benefit of the beneficiaries or for a specified purpose based on the instrument creating a trust within the meaning of the hague convention of 1 july 198515 on the law applicable to trusts and on their recognition.14 sr 950.115 sr 0.221.371art. 18 legal form 1 portfolio managers and trustees which have their registered office or place of residence in switzerland must have one of the following legal forms: a. sole proprietorship; b. commercial enterprise;c. cooperative.2 portfolio managers and trustees must be listed in the commercial register. art. 19 tasks 1 the portfolio manager manages individual portfolios.2 the trustee manages the separate fund, ensures its value is maintained and employs it for the specified purposes.3 portfolio managers and trustees may also provide the following services in particular:a. investment advice;b. portfolio analysis;c. offering of financial instruments.art. 20 qualified managers 1 the management body of a portfolio manager or trustee entity must consist of at least two qualified persons. 2 the management body may consist of only one qualified person subject to proof that continuation of business operations on a going concern basis is guaranteed. 3 a person is deemed qualified to manage business operations if they have received appropriate training in the activities of a portfolio manager or trustee and at the time of assuming management duties has had sufficient professional experience in portfolio management for third parties or within the framework of trusts. the federal council shall regulate the details. art. 21 risk management and internal control 1 portfolio managers and trustees must have an appropriately defined risk management system in place as well as an effective internal control structure to ensure, among other requirements, compliance with legal and internal provisions.2 the tasks of risk management and internal control may be carried out by a qualified manager or delegated to one or more suitably qualified employees or to a qualified external entity.3 persons who carry out the tasks of risk management and internal control may not be involved in the activities which they supervise.art. 22 minimum capital and collateral 1 the minimum capital of portfolio managers and trustees must amount to chf 100,000 and be paid up in cash. the minimum capital requirement must be complied with at all times.2 portfolio managers and trustees must have adequate collateral or take out professional liability insurance. 3 the federal council shall set the amount of collateral and the sum to be insured under professional liability insurance. art. 23 own funds 1 portfolio managers and trustees must have sufficient own funds.2 own funds must at all times amount to at least one quarter of the fixed costs reported in the most recent annual financial statement and no more than chf 10 million. section 2 managers of collective assets art. 24 definition 1 a manager of collective assets is a person who manages assets on a commercial basis in the name and on behalf of:a. collective investment schemes;b. occupational pension schemes. 2 portfolio managers within the meaning of article 17 paragraph 1 are:a. managers of collective assets in accordance with paragraph 1 letter a whose investors are qualified within the meaning of article 10 paragraph 3 or 3ter of the collective investment schemes act of 23 june 200616 and fulfil one of the following conditions:1. the assets of collective investment schemes under their management, including the assets acquired through the use of leveraged finance, amount in total to no more than chf 100 million.2. the assets of collective investment schemes under their management do not exceed chf 500 million in total and do not include leveraged financial instruments. the collective investment schemes give no right to redemption in the first five years after making the first investment.b. managers of collective assets in accordance with paragraph 1 letter b who manage the assets of occupational pension schemes totalling no more than chf 100 million and in the mandatory segment manage no more than 20% of the assets of an individual occupational pension scheme.3 portfolio managers in accordance with paragraph 2 may request authorisation as managers of collective assets provided this is required by the state where the collective investment scheme is established or offered or where the occupational pension scheme is managed. the federal council shall regulate the details.16 sr 951.31art. 25 legal form managers of collective assets who have their registered office in switzerland must have the legal form of a commercial enterprise.art. 26 tasks 1 managers of collective assets are responsible for the portfolio and risk management of the assets entrusted to them.2 in addition, managers of collective assets may conduct fund business, in particular, for foreign collective investment schemes. if the foreign country's law requires an agreement on cooperation and information exchange between finma and the foreign supervisory authorities of relevance for the fund business, they may perform this business only where such an agreement exists.3 managers of collective assets may also perform administrative activities within the scope of these tasks.art. 27 delegation of tasks 1 managers of collective assets may delegate tasks to third parties, provided this is in the interests of efficient management.2 any person who delegates the management of the assets of an occupational pension scheme or collective investment scheme to a manager of collective assets remains responsible for adhering to the relevant investment guidelines.art. 28 minimum capital and collateral 1 managers of collective assets must possess the required minimum capital. this must be fully paid up.2 finma may permit managers of collective assets in the form of partnerships to provide appropriate collateral instead of minimum capital.3 the federal council shall regulate the amount of the minimum capital and of the collateral. it may furthermore make the granting of authorisation contingent upon possession of professional liability insurance. art. 29 own funds 1 managers of collective assets must possess an appropriate level of own funds.2 the federal council shall set the amount of own funds based on the business activity and the risks.art. 30 group and conglomerate supervision where a financial group is dominated by a manager of collective assets or a financial conglomerate is dominated by a manager of collective assets, finma may make these subject to group or conglomerate supervision, provided this is in accordance with recognised international standards.art. 31 change of manager of collective assets a manager of collective assets shall give advance notice of the assumption of its rights and obligations by another manager of collective assets to the relevant supervisory authority for the collective investment scheme or occupational pension scheme. section 3 fund management companies art. 32 definition a fund management company is an entity that manages investment funds independently in its own name and for the account of investors.art. 33 legal form and organisation 1 the fund management company must be a company limited by shares that has its registered office and head office in switzerland.2 the share capital shall be divided into registered shares.3 the persons managing the fund management company and the custodian bank must be independent of each other's company.4 the main purpose of the fund management company is to conduct the fund business; this consists of the offering of units in the investment fund and its management and administration.art. 34 tasks in addition to conducting activities in accordance with the present act, the fund management company may perform the following other services, in particular:a. the safekeeping and technical management of collective investment schemes;b. the administration of an investment company with variable capital (sicav).art. 35 delegation of tasks 1 the fund management company may not delegate the management of the investment fund to third parties. however, it may delegate investment decisions as well as specific tasks to third parties, provided this is in the interests of efficient management.2 in the case of collective investment schemes for which the facilitated offering of shares exists in the european union based on a treaty, investment decisions may not be delegated to either the custodian bank or any other companies whose interests may conflict with those of the manager of collective assets or the fund management company or the investors.art. 36 minimum capital 1 the fund management company must possess the required minimum capital. this must be fully paid up.2 the federal council shall regulate the amount of the minimum capital. art. 37 own funds 1 there must be an appropriate ratio between the fund management company's own funds and the overall assets of the collective investment schemes under its management. the federal council shall specify this ratio.2 in special cases, finma may ease the requirements, provided this does not adversely affect the protective purpose of this act, or it may order more stringent requirements.3 the fund management company may not invest the prescribed level of its own funds in fund units that it has issued itself or lend its own funds to its shareholders or any natural or legal person with whom they have business or family ties. the holding of liquid funds with the custodian bank shall not constitute a loan.art. 38 rights 1 the fund management company is entitled to:a. receive the fees stipulated in the fund contract;b. an exemption from any liabilities which may have arisen in the course of the proper execution of its tasks;c. receive reimbursement of the expenses incurred in connection with such liabilities.2 these payments are made from the assets of the investment fund. investors are not held personally liable.art. 39 change of fund management company 1 the rights and duties of the fund management company may be transferred to another fund management company.2 in order to be effective, the transfer agreement between the outgoing and incoming fund management company must be made in writing or in another form demonstrable via text and must have the consent of the custodian bank and the approval of finma.3 prior to approval by finma, the outgoing fund management company shall publish the proposed transfer in the publication media.4 the investors must be informed in these publications of their right to lodge objections with finma within 30 days of publication. the procedure is based on the administrative procedure act of 20 december 196817.5 finma shall approve the change of fund management company if the legal requirements are met and the continuation of the investment fund is in the interest of the investors.6 it shall publish the decision in the publication media.17 sr 172.021art. 40 segregation of the fund assets 1 in the event of the bankruptcy of the fund management company, assets and rights belonging to the investment fund shall be segregated in favour of the investors. the foregoing is without prejudice to the fund management company's claims under article 38.2 debts incurred by the fund management company that do not result from the fund contract may not be set off against claims belonging to the investment fund.section 4 securities firms art. 41 definition a securities firm is an entity that, on a commercial basis:a. trades in securities in its own name for the account of clients;b. trades in securities for its own account on a short-term basis, operates primarily on the financial market and: 1. could thereby jeopardise the proper functioning of the financial market, or2. is a member of a trading venue, or3.18 operates an organised trading facility under article 42 of the financial market infrastructure act of 19 june 201519; orc. trades in securities for its own account on a short-term basis and publicly quotes prices for individual securities upon request or on an ongoing basis (market maker). 18 inserted by no i 7 of the fa of 26 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).19 sr 958.1art. 42 legal form a securities firm that has its registered office in switzerland must have the legal form of a commercial enterprise.art. 43 foreign-controlled securities firms the provisions of the banka20 on foreign-controlled banks apply by analogy.20 sr 952.0art. 44 tasks 1 in particular, the securities firm may:a. hold accounts for settling securities trade within the context of its activity under article 41 for clients, either itself or with third parties; b. act as custodian of clients' securities, either itself or in its own name with third parties; c. underwrite securities issued by third parties as a firm commitment or on commission and offer these to the public on the primary market on a commercial basis; d. create derivatives itself on a commercial basis, which it offers to the public on the primary market on its own behalf or that of another party. 2 it may accept deposits from the public on a commercial basis within the context of its activity under paragraph 1 letter a. 3 the federal council may regulate the use of deposits from the public.art. 45 minimum capital and collateral 1 securities firms must possess the required minimum capital. this must be fully paid up.2 finma may permit securities firms in the form of partnerships to post appropriate collateral instead of the minimum capital.3 the federal council shall regulate the amount of the minimum capital and of the collateral.art. 46 own funds, liquidity and risk diversification 1 securities firms must have sufficient own funds and liquidity individually and on a consolidated basis. 2 they must diversify their risks appropriately. 3 the federal council shall regulate the risk diversification requirements. it shall set the amount of own funds and liquidity based on the business activity and the risks. 4 where there are legitimate grounds for so doing, finma may ease the requirements, provided this does not adversely affect the protective purpose of the law, or it may order more stringent requirements.5 finma may issue implementing regulations. art. 47 additional capital the provisions of the banka21 on additional capital apply by analogy.21 sr 952.0art. 48 accounting the provisions of the banka22 on accounting apply by analogy.22 sr 952.0art. 49 group and conglomerate supervision 1 two or more companies are deemed to be a financial group dominated by a securities firm if:a. at least one of them operates as a securities firm;b. they operate primarily in the financial sector; andc. they form an economic unit or other circumstances suggest that one or more of the companies under individual supervision is de jure or de facto obliged to provide assistance to group companies.2 a financial conglomerate dominated by a securities firm is a financial group as defined in paragraph 1 operating primarily in the field of securities trading and comprising at least one insurance company of considerable economic significance.3 the provisions of the banka23 on financial groups and financial conglomerates apply by analogy.23 sr 952.0art. 50 record-keeping duty the securities firm must keep a record of the orders and transactions it conducts together with all the details necessary for their traceability and for the supervision of its activity.art. 51 reporting duty 1 the securities firm must report all of the information necessary for transparent securities trading.2 finma shall regulate which information is to be reported to whom and in what form.3 provided this is required for the purposes of the act, the federal council may also impose the reporting duty in accordance with paragraph 1 on persons and companies that buy and sell securities on a commercial basis but without the involvement of a securities firm. any such company must instruct an audit firm licensed by the federal audit oversight authority (faoa) in accordance with article 9a paragraph 1 of the auditor oversight act of 16 december 200524 (aoa) to audit compliance with this reporting duty and must inform finma.24 sr 221.302section 5 branches art. 52 duty to obtain authorisation 1 authorisation from finma is required by financial institutions that have their registered office abroad (foreign financial institutions) and that wish to establish a branch in switzerland that employs persons who perform any of the following activities in the name of the foreign financial institution on a permanent commercial basis in switzerland or from switzerland:a. asset management or trustee activities;b. portfolio management for collective investment schemes or occupational pension schemes;c. securities trading;d. conclusion of transactions; or e. client account management.2 foreign fund management companies may not establish branches in switzerland. 3 the federal council may sign international treaties allowing financial institutions from the treaty states to open a branch without requiring authorisation from finma if both sides recognise the equivalent nature of the respective regulation of financial institutions' activity and the supervisory measures.art. 53 authorisation conditions finma shall grant the foreign financial institution authorisation to establish a branch if:a. the foreign financial institution:1. is sufficiently organised and has adequate financial resources and qualified personnel to operate a branch in switzerland,2. is subject to appropriate supervision that includes the branch, and3. proves that the business name of the branch can be entered in the commercial register;b. the competent foreign supervisory authorities:1. do not raise any objections to the establishment of a branch,2. undertake to notify finma immediately if any circumstances arise that could seriously prejudice the interests of the investors or clients, and3. provide finma with administrative assistance;c. the branch: 1. fulfils the conditions set out in articles 9 to 11 and has a set of regulations that accurately describes the scope of business and provides for an administrative or operational organisation corresponding to its business activity, and2. fulfils the additional authorisation conditions under articles 54 to 57.art. 54 requirement of reciprocity finma may make the granting of authorisation to establish a branch of a foreign financial institution additionally contingent upon a guarantee of reciprocity with the states in which the foreign financial institution or the foreigners with qualified participations have their place of residence or registered office. art. 55 financial groups and financial conglomerates where a foreign financial institution is part of a financial group or financial conglomerate, finma may make the granting of authorisation contingent upon it being subject to appropriate consolidated supervision by foreign supervisory authorities.art. 56 collateral finma may make the granting of authorisation to establish a branch of a foreign portfolio manager, a foreign trustee or a foreign manager of collective assets additionally contingent upon the posting of collateral if so required for the protection of investors or clients.art. 57 exemptions the federal council may make provision for exempting branches of foreign financial institutions from certain provisions of this act. section 6 representations art. 58 duty to obtain authorisation 1 foreign financial institutions require authorisation from finma if they employ persons in switzerland who work for them on a permanent and commercial basis in switzerland or from switzerland in another manner than that set out in article 52 paragraph 1, specifically where these persons forward client orders to them or represent them for marketing or other purposes.2 foreign fund management companies may not establish representations in switzerland. 3 the federal council may sign international treaties allowing financial institutions from the treaty states to open a representation without requiring authorisation from finma if both sides recognise the equivalent nature of the respective regulation of financial institutions' activity and the supervisory measures.art. 59 authorisation conditions 1 finma shall grant the foreign financial institution authorisation to establish a representation if:a. the foreign financial institution is subject to appropriate supervision;b. the competent foreign supervisory authorities do not raise any objections to the establishment of the representation;c. the persons entrusted with its management provide a guarantee of irreproachable business conduct.2 finma may make authorisation additionally contingent upon the granting of reciprocity by the state in which the foreign financial institution has its registered office.art. 60 exemptions the federal council may make provision for exempting representations of foreign financial institutions from certain provisions of this act.chapter 3 supervision art. 61 competence 1 portfolio managers and trustees are supervised by finma in consultation with a supervisory organisation under finmasa25, subject to consolidated supervision by finma in accordance with articles 30 and 49 of the present act or article 1 paragraph 1 finmasa.2 ongoing supervision of portfolio managers and trustees will be performed by finma-approved supervisory organisations.3 managers of collective assets, fund management companies and securities firms are supervised by finma.4 where no supervisory organisation exists in accordance with paragraph 1, supervision is performed by finma. 25 sr 956.1art. 62 auditing of portfolio managers and trustees 1 portfolio managers and trustees must appoint an audit firm in accordance with article 43k paragraph 1 finmasa26 to perform an annual audit, provided that this audit is not conducted by the respective supervisory organisation itself.2 the supervisory organisation may increase the audit frequency to a maximum of four years taking account of the activity of those supervised and the associated risks.3 in the years without a periodic audit, portfolio managers and trustees shall submit to the supervisory organisation a report on their business activity's compliance with the legislative provisions. this report may be delivered in a standardised format.26 sr 956.1 art. 63 auditing of managers of collective assets, fund management companies, securities firms, financial groups and financial conglomerates 1 the managers of collective assets, fund management companies, securities firms, financial groups and financial conglomerates must:a. appoint an audit firm licensed by the faoa under article 9a paragraph 1 aoa27 to carry out an annual audit under article 24 finmasa28;b. have their annual accounts, and if applicable their consolidated accounts, audited by an audit company subject to state oversight in accordance with the ordinary auditing principles set out in the swiss code of obligations29 (co). 2 finma may establish an audit frequency of several years for the audit in accordance with paragraph 1 letter a taking account of the activity of those supervised and the associated risks.3 in the years without a periodic audit, financial institutions in accordance with paragraph 1 shall submit a report to finma on their business activity's compliance with the legislative provisions. this report may be delivered in a standardised format.4 the fund management company shall appoint the same audit firm for itself and for the investment funds it manages. 5 finma may itself conduct audits directly.27 sr 221.30228 sr 956.129 sr 220art. 64 duty to provide information and to report in the case of delegation of significant functions 1 if a financial institution delegates significant functions to other persons, these shall be subject to the duty to provide information and to report in accordance with article 29 finmasa30.2 finma may conduct audits of these persons at any time.30 sr 956.1art. 65 suspension of voting rights in order to enforce article 11 paragraphs 3 and 5, finma may suspend the voting rights attached to equities or shares held by qualified participants.art. 66 liquidation 1 if finma withdraws authorisation from a financial institution, this shall result in liquidation in the case of legal entities and general and limited partnerships and in deletion from the commercial register in the case of sole proprietorships. 2 finma shall designate the liquidator and oversee its activity. 3 the provisions under insolvency law are reserved.art. 67 measures under insolvency law 1 the provisions of the banka31 on measures in case of the risk of insolvency and bankruptcy apply by analogy to fund management companies and securities firms.2 the provisions of the banka on the protection of deposits and dormant assets apply by analogy to securities firms under article 41 letter a.3231 sr 952.032 amended by no i 7 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).chapter 4 liability and criminal law provisions section 1 liability art. 68 1 the liability of the financial institutions and their bodies is based on the provisions of the co33.2 where a financial institution delegates performance of a task to a third party, it remains liable for any losses caused by the latter unless it proves that it took the due care required in that party's selection, instruction and monitoring. the federal council may set out the requirements for such monitoring.3 the fund management company remains liable for the actions of persons to whom it has delegated tasks in accordance with article 35 paragraph 1 as if it had performed those tasks itself.33 sr 220section 2 criminal provisions art. 69 violation of professional confidentiality 1 a custodial sentence not exceeding three years or a monetary penalty shall be imposed on any person who wilfully:a. discloses a secret entrusted to them in their capacity as a director or officer, employee, agent or liquidator of a financial institution or of which they have become aware in said capacity;b. attempts to induce a violation of professional secrecy;c. discloses to other persons a secret disclosed to them in violation of letter a or exploits such a secret for their own benefit or for the benefit of others.2 a custodial sentence not exceeding five years or a monetary penalty shall be imposed on any person who obtains a pecuniary advantage for themselves or another person through an action as detailed in paragraph 1 letter a or c.3 a fine not exceeding chf 250,000 shall be imposed on persons who commit the foregoing acts through negligence.4 any person who violates professional confidentiality remains liable to prosecution after termination of the official or employment relationship or exercise of the profession.5 the federal and cantonal provisions relating to the duty to testify and the duty to provide information to the authorities are reserved.6 the cantons are responsible for the prosecution and adjudication of acts under this provision.art. 70 violation of the provisions on protection against confusion and deception and notification duties a fine not exceeding chf 500,000 shall be imposed on any person who wilfully:a. violates the provision on protection against confusion and deception (article 13);b. fails to provide finma with the prescribed notifications in accordance with articles 11 and 15, or does so incorrectly or too late.art. 71 violation of the record-keeping and reporting duties a fine not exceeding chf 500,000 shall be imposed on any person who wilfully:a. violates the record-keeping duty set out in article 50;b. violates the reporting duty in accordance with article 51.chapter 5 final provisions art. 72 implementing provisions the federal council shall issue the implementing provisions.art. 73 repeal and amendment of other legislative instruments the repeal and amendment of other legislative instruments are set out in the annex.art. 74 transitional provisions 1 financial institutions that already possess authorisation by virtue of a financial market act pursuant to article 1 paragraph 1 finmasa34 for the corresponding activity at the time of this act coming into force are not required to obtain new authorisation. they must fulfil the requirements of this act within one year of its coming into force.2 financial institutions that under prior law are not subject to an authorisation requirement but are newly subject to an authorisation requirement at the time of this act coming into force shall report to finma within six months of this act coming into force. they must satisfy the requirements of this act and submit an authorisation application within three years of the act coming into force. they may continue to perform their activity until a decision has been made concerning authorisation, provided that they are affiliated to a self-regulatory organisation in accordance with article 24 of the anti-money laundering act of 10 october 199735 (amla) and are supervised by said organisation with regard to compliance with the corresponding duties.3 portfolio managers and trustees that assume their activity within one year of this act coming into force must report immediately to finma and after assuming their activity must satisfy authorisation conditions with the exception of article 7 paragraph 2. no later than one year after finma has authorised a supervisory organisation in accordance with article 43a finmasa, they must affiliate to such an organisation and submit an application for authorisation. they may perform their activity until a decision has been made concerning authorisation, provided that they are affiliated to a self-regulatory organisation in accordance with article 24 amla and are supervised by said organisation with regard to compliance with the corresponding duties.4 in special cases, finma may extend the deadlines under paragraphs 1 and 2.34 sr 956.135 sr 955.0art. 74a36 coordination with the amendment of the anti-money laundering act within the context of the gambling act of 29 september 2017 .3736 inserted by the correction made by the federal assembly drafting committee of 24 sept. 2019 (as 2019 5065).37 the coordination provisions can be consulted under as 2019 5065 and as 2020 501. correction by federal assembly drafting committee of 31 jan. 2020, published on 18 febr. 2020 (as 2020 501).art. 75 referendum and commencement 1 this act is subject to an optional referendum.2 the federal council will determine the commencement date.3 this act shall only come into force with the finsa38.4 the federal council may implement the following provisions early:a. amendments to the federal act of 23 march 200139 on consumer credit (annex no. 2);b. article 9a paragraph 4bis aoa40 (annex no 3);c. articles 1a, 1b, 47 paragraph 1 letter a and 52a banka41 (annex no 14);d. article 2 paragraph 2 letter a amla42 (annex no 15);e. articles 4, 5 and 15 paragraph 2 letter a finmasa43 (annex no 16).5 article 15 paragraph 2 letter a finmasa shall apply until article 15 paragraph 2 letter abis finmasa (annex no 16) comes into force.commencement date: 1 january 20204438 sr 950.139 sr 221.214.140 sr 221.30241 sr 952.042 sr 955.043 sr 956.144 o of 6 nov. 2019 (as 2019 4631).annex (art. 73)repeal and amendment of other legislative instruments ithe stock exchange act of 24 march 199545 is repealediithe legislative instruments below are amended as follows:.4645 [as 1997 68 2044, 2005 5269 annex no ii 7, 2006 2197 annex no 146, 2008 5207 annex no 16, 2012 6679 annex no 8, 2013 1103, 2014 4073 annex no 6, 2015 1535 no i 3 5339 annex no 11]46 the amendments may be consulted under as 2018 5247.

954.11english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinance on financial institutions(financial institutions ordinance, finio)of 6 november 2019 (status as of 1 august 2021)the swiss federal council,based on the financial institutions act of 15 june 20181 (finia),ordains:1 sr 954.1chapter 1 general provisions section 1 subject matter and scope of application art. 1 subject matter (art. 1 and 72 finia)this ordinance governs:a. the authorisation conditions for financial institutions;b. the duties of the financial institutions;c. the supervision of the financial institutions.art. 2 scope of application (art. 2 finia)this ordinance applies to financial institutions operating in or from switzerland.art. 3 business ties (art. 2 para. 2 let. a finia)companies or units of a group are deemed to have business ties insofar as they provide financial services or services in the capacity of trustee for other companies or units of the same group.art. 4 family ties (art. 2 para. 2 let. a finia)1 the following persons are deemed to have family ties with one another:a. relatives by blood or by marriage in the direct line;b. relatives by blood or by marriage up to the fourth degree in the collateral line;c. spouses and registered partners;d. coheirs and legatees from succession until completion of the division of estate or allocation of the legacy;e. remaindermen and remainderwomen and residuary legatees in accordance with article 488 of the swiss civil code2 (cc);f. persons living in a permanent life partnership with a portfolio manager or trustee.2 family ties are deemed to exist insofar as portfolio managers manage assets or trustees manage in-house funds in favour of persons who have family ties with one another, if the portfolio managers or trustees are directly or indirectly controlled by:a. third parties who have family ties with these persons;b. a trust, a foundation or a similar legal construct set up by a person with family ties.3 paragraph 2 also applies insofar as, in addition to the persons with family ties, institutions with a public or not-for-profit purpose are also beneficiaries.2 sr 210art. 5 employee participation schemes (art. 2 para. 2 let. b finia)employee participation schemes are deemed to be plans which:a. represent a direct or indirect investment in the company of the employer or in another company which by virtue of a majority of votes or by some other means is under uniform management with the company of the employer (group); andb. are directed at employees who at the time of the offer are not under notice.art. 6 legally regulated mandates (art. 2 para. 2 let. d finia)legally regulated mandates are in particular:a. an advance care directive in accordance with articles 360-369 cc3;b. a representative deputyship to manage assets in accordance with article 395 cc;c. a general deputyship in accordance with article 398 cc;d. an executorship in accordance with articles 517 and 518 cc;e. an estate administration in accordance with articles 554 and 555 cc;f. an official liquidation in accordance with articles 593-596 cc;g. a representation of heirs in accordance with article 602 paragraph 3 cc;h. a bankruptcy administration in accordance with articles 237 paragraph 2 and article 240 of the federal act of 11 april 18894 on debt enforcement and bankruptcy (deba);i. an administrative receivership in accordance with article 295 deba;j. enforcement tasks under an ordinary composition agreement in accordance with article 314 paragraph 2 deba;k. an appointment as liquidator under a composition agreement with assignment of assets in accordance with article 317 deba;l. an appointment as investigating agent in accordance with article 36 of the financial market supervision act of 22 june 20075 (finmasa);m. a restructuring mandate in accordance with article 28 paragraph 3 of the banking act of 8 november 19346 (banka), article 67 paragraph 1 finia and article 88 paragraph 1 of the financial market infrastructure act of 19 june 20157 (finmia);n. a bankruptcy liquidation in accordance with article 33 paragraph 2 banka, article 67 paragraph 1 finia, article 137 paragraph 3 of the collective investment schemes act of 23 june 20068 (cisa), article 88 paragraph 1 finmia and article 53 paragraph 3 of the insurance supervision act of 17 december 20049 (isa);o. a liquidation in accordance with article 23quinquies paragraph 1 banka, article 66 paragraph 2 finia, article 134 cisa, article 87 paragraph 2 finmia and article 52 isa.3 sr 2104 sr 281.15 sr 956.16 sr 952.07 sr 958.18 sr 951.319 sr 961.01art. 7 exemption (art. 2 finia)where there are legitimate grounds for so doing, the swiss financial market supervisory authority (finma) may fully or partially exempt managers of collective assets from the provisions of the finia and the present ordinance if:a. the protective purpose of the finia is not impaired; andb. the management of collective assets has been delegated to them solely by the following persons:1. authorised parties in accordance with article 2 paragraph 1 letters c and d as well as paragraph 2 letters f-i finia,2. authorised parties in accordance with article 13 paragraph 2 letters b-d cisa10, or3. foreign companies which with regard to organisation and investor rights are subject to rules that are equivalent to the provisions of the finia and the cisa.10 sr 951.31art. 8 significant group companies (art. 4 para. 2 finia)the functions of a group company are significant with respect to the activities which require authorisation if they are necessary for the continuation of important business processes, in particular in the areas:a. liquidity management;b. treasury;c. risk management;d. master data administration and accounting;e. personnel;f. information technology;g. trading and settlement;h. legal and compliance.section 2 common provisions art. 9 authorisation application and duty to obtain authorisation (art. 5 and 7 finia)1 the financial institution shall submit an authorisation application to finma. the application shall contain all information and documents required to assess it, specifically information and documents on:a. the organisation, in particular on corporate governance and control as well as on risk management (articles 9, 20, 21 and 33 finia);b. the place of management (article 10 finia);c. the guarantee (article 11 finia);d. tasks and the delegation of such tasks (articles 14, 19, 26, 27, 34, 35 and 44 finia);e. minimum capital and collateral (articles 22, 28, 36 and 45 finia);f. capital (articles 23, 29, 37 and 46 finia);g. the ombudsman's office (article 16 finia);h. the supervisory organisation and the audit firm (articles 61-63 finia).2 insurance companies as defined in the isa11 are exempt from the duty to obtain authorisation as a manager of collective assets.3 exemption from the duty to obtain authorisation as a trustee from finma can be granted to trustees which act exclusively as trustees for trusts which were established by the same person or in favour of the same family and which are held and monitored by a financial institution which possesses authorisation in accordance with article 5 paragraph 1 or article 52 paragraph 1 finia.11 sr 961.01art. 10 change in facts (art. 8 para. 2 finia)changes of material significance for financial institutions in accordance with article 8 paragraph 2 finia are in particular:a. changes in organisational and partnership documents;b. changes in the persons responsible for administration and management;c. changes in minimum capital and capital adequacy, in particular falling short of minimum requirements;d. facts which are likely to call into question the good reputation or the guarantee of irreproachable business conduct on the part of the financial institution or of the persons entrusted with management tasks as well as of owners of a qualified participation, specifically the initiation of criminal proceedings;e. facts which call into question prudent and sound business activity on the part of the financial institution owing to the influence of owners of a qualified participation.art. 11 form for submission (art. 5, 7 and 8 finia)1 finma may determine the form for submission, specifically for the following documents:a. applications for authorisation from financial institutions and necessary documents;b. reports of changes in accordance with article 8 finia and necessary documents.2 it may designate a third party as recipient of submitted documents.art. 12 organisation (art. 9 finia)1 financial institutions must define their organisation in their organisational principles.2 they must describe their area of business in factually and geographically precise terms in the principal documents. the business area and its geographical extent must be commensurate with the financial possibilities as well as with the operational organisation.3 financial institutions must have personnel in place who are appropriately and suitably qualified to perform their business activities.4 risk management must encompass all business activities and be organised in such a way that all the main risks can be identified, assessed, controlled and monitored.art. 13 guarantee (art. 11 finia)1 the application for authorisation for a new financial institution must contain in particular the following information and documentation on the persons responsible for administration and management in accordance with article 11 paragraphs 1 and 2 finia as well as on the owners of a qualified participation in accordance with article 11 paragraph 3 finia:a. natural persons:1. details of nationality, place of residence, qualified participations in the financial institution or in other companies and pending court and administrative proceedings,2. a curriculum vitae signed by the relevant person,3. references,4. an extract from the register of convictions and the debt collection register or a corresponding attestation;b. companies:1. the articles of association, 2. an extract from the commercial register or a corresponding attestation,3. a description of business activities, the financial situation and, if applicable, the group structure,4. details of completed and pending court or administrative proceedings.2 the envisaged activity at the financial institution as well as the nature of the intended investments must also be taken into account when assessing the good reputation, the guarantee of irreproachable business conduct and the required specialist qualifications of the persons responsible for administration and management.3 owners of a qualified participation must make a declaration to finma stating whether they hold the participation in question for their own account or on a fiduciary basis for third parties, and whether they have granted options or similar rights with respect to this participation.4 securities firms must submit to finma within 60 days of the end of the financial year a list of all persons who hold a qualified participation in them. this list shall contain details on the identity and percentage holding of all qualified participants as at the relevant closing date, as well as any changes relative to the prior-year closing date. in addition, the information and documentation set out in paragraph 1 is to be submitted for any qualified participants being reported for the first time.5 persons connected through business ties or in any other manner who jointly hold at least 10% of the share capital or votes of the financial institution or persons jointly significantly influencing the business activities of the financial institution in another manner are deemed to be a qualified participant in accordance with article 11 paragraph 4 finia.art. 14 public offer of securities on the primary market (art. 12 finia)1 the question of what constitutes a public offer is determined on the basis of article 3 letters g and h of the financial services act of 15 june 201812 (finsa).2 offers to schemes and persons in accordance with article 65 paragraphs 2 and 3 are not deemed public.12 sr 950.1art. 15 delegation of tasks (art. 14 para. 1 finia)1 tasks in accordance with article 14 paragraph 1 finia are deemed delegated if financial institutions appoint a service provider to independently and permanently perform in full or in part a material task, thereby changing the circumstances underlying the authorisation.2 material tasks are deemed to be:a. for portfolio managers and trustees: tasks in accordance with article 19 finia;b. for managers of collective assets: tasks in accordance with article 26 finia;c. for fund management companies: tasks in accordance with article 32, article 33 paragraph 4 and article34 finia;d. for securities firms: tasks in accordance with articles 41 and 44 finia.art. 16 delegable tasks (art. 14 para. 1 finia)1 financial institutions may delegate to third parties only tasks in accordance with article 14 paragraph 1 finia which do not need to be within the decision-making remit of the body responsible for management or for governance, supervision and control.2 delegation must not impair the appropriateness of the operational organisation.3 the operational organisation is no longer deemed to be appropriate if a financial institution:a. does not have the necessary personnel resources and specialist knowledge to select, instruct and monitor the third party and manage the associated risks, orb. does not have the necessary rights to issue instructions to or control the third party.art. 17 delegation of tasks: responsibility and procedures (art. 14 para. 1 finia)1 the financial institutions remain responsible for the fulfilment of supervisory duties and when delegating tasks shall safeguard clients' interests.2 they shall agree with the third party in writing or in another form demonstrable via text which tasks are to be delegated. the following in particular are to be laid down in the agreement:a. the authorities and responsibilities;b. any powers of sub-delegation;c. the third party's duty to render account;d. the financial institutions' rights of control.3 financial institutions shall lay down in their organisational principles the tasks delegated as well as details of the possibility of sub-delegation.4 delegation is to be defined such that the financial institution, its internal auditors, the audit firm, the supervisory organisation and finma can inspect and review the delegated task.art. 18 international business (art. 15 finia)1 the notification which a financial institution is required to submit to finma before engaging in activities abroad must contain all the information and documents needed to assess such activities, specifically:a. a business plan describing in particular the nature of the planned transactions and the organisational structure;b. the name and address of the office abroad;c. the names of the persons responsible for administration and management;d. the auditing firm;e. the name and address of the supervisory authority in the foreign state in which the registered office or domicile is located.2 furthermore, the financial institution shall notify finma of:a. the discontinuation of business activities abroad;b. any material change in business activities abroad;c. a change in audit firm;d. a change in the supervisory authority in the foreign state in which the registered office or domicile is located.chapter 2 financial institutions section 1 portfolio managers and trustees art. 19 commerciality (art. 3 and 17 finia)1 portfolio managers and trustees are deemed to pursue their activities on a commercial basis and, within the meaning of anti-money laundering legislation, on a professional basis if they:a. thereby generate gross earnings of more than chf 50,000 per calendar year;b. establish business relationships with more than 20 contractual partners per calendar year, each of which relationships is not limited to a once-only activity, or they maintain at least 20 such relationships per calendar year; orc. have unlimited power of disposal over assets belonging to others, which assets exceed chf 5 million at any given time.2 activities for schemes and persons in accordance with article 2 paragraph 2 letters a, b, d and e finia are not factored into the assessment of commerciality.3 paragraphs 1 and 2 do not apply to portfolio managers in accordance with article 24 paragraph 2 finia.art. 20 additional authorisation (art. 6 finia)1 portfolio managers also wishing to act as trustees require additional authorisation for this.2 trustees also wishing to act as portfolio managers require additional authorisation for this.art. 21 entitlement to be subject to supervision by a supervisory organisation (art. 7 para. 2 finia)1 portfolio managers and trustees are entitled to be subject to supervision by a supervisory organisation if their internal rules and their operational organisation ensure that the supervisory requirements are satisfied.2 a supervisory organisation can make subjection to supervision dependent on portfolio managers and trustees being required to maintain special statutory professional confidentiality.art. 22 change in facts (art. 8 finia)1 portfolio managers and trustees shall notify the supervisory organisation of any changes in the facts on which its authorisation is based. the supervisory organisation shall periodically forward the changes to finma.2 if authorisation is required in accordance with article 8 paragraph 2 finia, finma will as part of its assessment hear the supervisory organisation.art. 23 organisation (art. 9 finia)1 two authorised signatories must sign jointly. article 20 paragraph 2 finia remains reserved.2 portfolio managers and trustees must be able to be represented by a person who has their place of residence in switzerland. this person must be a member of the body responsible for management or of the body responsible for governance, supervision and control in accordance with paragraph 3. article 20 paragraph 2 finia remains reserved.3 with reservation as to article 20 paragraph 2 finia, finma may require the portfolio manager or trustee to appoint a body responsible for governance, supervision and control the majority of whose members are not members of the body responsible for management if:a. it has ten or more full-time positions or annual gross earnings of more than chf 5 million; andb. the nature and scope of its activities so demand.art. 24 tasks (art. 19 finia)1 the portfolio manager shall ensure that the assets entrusted to it for management are held in safekeeping, segregated per client, with a bank pursuant to the banka13, a securities firm pursuant to the finia, a trading facility for distributed ledger technology securities (dlt trading facility) in accordance with the finmia14 or other institution that is subject to supervision equivalent to that in switzerland.152 it shall manage the assets on the basis of authorisation given in writing or in another form demonstrable via text. the authorisation must be limited to administrative acts. if the portfolio manager is entrusted with the provision of further services which require more far-reaching authorisations, it shall document the basis of these activities.3 portfolio managers shall take measures to avoid a break-off of contact with clients and to prevent client relationships from becoming dormant. if a business relationship becomes dormant, the portfolio manager shall take suitable steps to ensure that dormant assets are delivered to beneficiaries.4 paragraph 2 applies by analogy to trustees. moreover, trustees must, within the framework of the law applicable to the trust:a. act in the best possible interests of beneficiaries and with the required level of skill, care and diligence;b. take appropriate organisational precautions to avoid conflicts of interest or disadvantages for beneficiaries as a result of conflicts of interest.5 if the rendering of additional services increases the risks to which portfolio managers and trustees are exposed, this must be taken into account within the scope of supervision (articles 61 and 62 finia).13 sr 952.014 sr 958.115 amended by no i 7 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).art. 25 qualified managers (art. 20 finia)1 a qualified manager is deemed to satisfy the requirements for training and professional experience at the time of assuming management duties if she or he can furnish evidence of the following:a. five years of professional experience:1. in the case of portfolio managers, in portfolio management for third parties,2. in the case of trustees, within the framework of trusts; andb. training of at least 40 hours:1. in the case of portfolio managers, in portfolio management for third parties,2. in the case of trustees, within the framework of trusts.2 where there are legitimate grounds for so doing, finma may grant exemptions from these requirements.3 portfolio managers and trustees shall engage in regular continuing professional development to maintain the skills acquired.4 they shall take the necessary precautions to ensure the continuation of business operations in the event that the qualified manager is prevented from acting or dies. if third parties from outside the company are appointed, the clients must be informed accordingly. in all other respects, article 14 finia shall apply.art. 26 risk management and internal control (art. 9 and 21 finia)1 portfolio managers and trustees shall set out guidelines for the basic principles of risk management and define their risk tolerance.2 risk management and internal control are not required to be independent of revenue-based activities if the portfolio manager or trustee:a. is a company which has five or fewer full-time positions or annual gross earnings of less than chf 2 million; andb. adheres to a non-high-risk business model.3 the thresholds in accordance with paragraph 2 letter a must be achieved in two of three past business years or be provided for in the business planning.4 if the portfolio manager or trustee has a body responsible for governance, supervision and control in accordance with article 23 paragraph 3 and generates annual gross earnings of more than chf 10 million, finma may also require that internal auditors who are independent of management be appointed where the nature and scope of activity so dictate.art. 27 minimum capital (art. 22 para. 1 finia)1 the minimum capital requirements of companies limited by shares and of partnerships limited by shares must be met with share and participation capital, those of limited liability companies must be met with nominal capital, and those of cooperatives must be met with cooperative capital.2 the minimum capital requirements of partnerships and sole proprietorships must be met with:a. the capital accounts;b. the limited partnership contributions;c. the assets of partners with unlimited liability.3 the capital accounts and assets of partners with unlimited liability may only be counted towards the minimum capital requirement if a declaration is provided to the effect that:a. in the event of liquidation, bankruptcy or probate proceedings, such accounts and assets shall be subordinate to the claims of all other creditors; andb. the portfolio manager or trustee undertakes:1. neither to net such accounts and assets with its own claims nor to secure them with its own assets,2. without the prior consent of the supervisory organisation, not to reduce any of the capital components as defined in paragraph 2 letters a and c to the extent that the minimum capital requirement is no longer met.4 the declaration in accordance with paragraph 3 is irrevocable. it must be made in writing or in another form demonstrable via text and filed with the supervisory organisation.5 finma may permit partnerships and sole proprietorships to provide, instead of minimum capital, collateral in the form of a bank guarantee or a cash deposit in a blocked account with a bank, said collateral being equivalent to the minimum capital in accordance with article 22 paragraph 1 finia.art. 28 level of capital adequacy (art. 23 finia)1 the level of capital adequacy stipulated in article 23 finia must be maintained at all times.2 the following are fixed costs in accordance with article 23 paragraph 2 finia:a. personnel expenses;b. operating business expenses;c. depreciation of investment assets;d. expenses for valuation adjustments, provisions and losses.3 the portion of personnel expenses which is exclusively dependent on the business result or in relation to which no legal entitlement exists is to be deducted from personnel expenses.4 where there are legitimate grounds for so doing, finma may ease requirements.art. 29 qualifying capital (art. 23 finia)1 legal entities may count the following as qualifying capital:a. the paid-up share and participation capital in the case of a company limited by shares and a partnership limited by shares, the nominal capital in the case of a limited liability company and the cooperative capital in the case of a cooperative;b. the general statutory and other reserves;c. retained earnings;d. the net profit for the current financial year after deduction of the estimated share in the profit distribution, provided an audit review or an audit pursuant to the co16 of the interim or annual accounts confirms the assurances stipulated;e. hidden reserves, provided they are assigned to a separate account and designated as capital and their qualifiability as such is confirmed on the basis of the audit in accordance with article 62 finia.2 partnerships and sole proprietorships may count the following as qualifying capital:a. the capital accounts and assets of partners with unlimited liability if the conditions under article 27 paragraph 3 are satisfied;b. the limited partnership contribution.3 portfolio managers and trustees may also count as qualifying capital any loans granted to them, including bonds with a maturity of at least five years, if a declaration is provided to the effect that:a. in the event of liquidation, bankruptcy or probate proceedings, such loans shall be subordinate to the claims of all other creditors; andb. the portfolio manager or trustee undertakes neither to net such loans with its own claims nor to secure them with its own assets.4 the declaration in accordance with paragraph 3 is irrevocable. it must be made in writing or in another form demonstrable via text and filed with the supervisory organisation.16 sr 220art. 30 deductions applied when calculating the level of capital adequacy (art. 23 finia)the following shall be deducted when calculating the level of capital adequacy:a. the loss carried forward and the loss for the current financial year;b. any unsecured valuation adjustments and provisions for the current financial year;c. in the case of loans in accordance with article 29 paragraph 3: 20% of the original nominal amount per year for the last five years prior to repayment;d. intangible assets (including start-up and organisational costs as well as goodwill) with the exception of software;e. in the case of a company limited by shares and a partnership limited by shares: the shares which they hold in the company at their own risk;f. in the case of a limited liability company: the capital contribution which it holds in the company at its own risk;g. the carrying amount of participations.art. 31 collateral (art. 22 para. 2 and 23 finia)1 collateral is deemed to be appropriate if the applicable provisions on capital are complied with.2 insofar as it covers the risks entailed by the business model, professional indemnity insurance may be counted 50% towards qualifying capital.3 finma shall regulate the details of professional liability insurance, in particular with regard to term, notice period, the amount of insurance cover, the professional liability risks to be covered and the reporting duties.art. 32 accounting (art. 9, 22 and 23 finia)1 portfolio managers and trustees are subject to the accounting regulations of the co17. article 957 paragraphs 2 and 3 co are not applicable.2 where portfolio managers and trustees are subject to specific, more stringent accounting standards, such standards take precedence.17 sr 220art. 33 internal documentation (art. 9 finia)internal documentation of the portfolio managers and trustees must allow the audit firm, the supervisory organisation and finma to form a reliable picture of the business activities.section 2 managers of collective assets art. 34 calculation of thresholds (art. 24 para. 1 and 2 finia)1 the following apply to calculation of the thresholds for collective investment schemes managed by the manager of collective assets in accordance with article 24 paragraph 2 letter a finia:a. assets managed include all swiss and foreign collective investment schemes managed by the same manager irrespective of whether it manages them directly or via delegation or via a company with which it is connected through:1. a single management;2. a relationship of common control; or3. a significant direct or indirect participation.b. the value of the assets is calculated on at least a quarterly basis, under due consideration of any leverage effect.c. for collective investment schemes that were established more than 12 months previously, the threshold may be calculated on the basis of the average value of the assets over the last four quarters.d. the value of the collective investment schemes pursuant to article 24 paragraph 2 letter a item 2 finia is calculated on the basis of the capital commitments or the nominal value of the collective investment schemes concerned, provided the price of the investments underlying such schemes is not obtained through trading on a regulated market.2 the following apply to calculation of the thresholds for the assets of occupational pension schemes managed by the manager of collective assets within the meaning of article 24 paragraph 2 letter b finia:a. assets of the following occupational pension schemes shall be included:1. registered and non-registered occupational pension schemes;2. employer-sponsored welfare funds;3. investment foundations;4. pillar 3a foundations;5. vested benefits foundations.b. the manager shall calculate on a quarterly basis whether the threshold of chf 100 million has been reached.c. the occupational pension scheme shall calculate annually whether the threshold of 20% has been reached in the mandatory segment. it shall inform the manager of the value calculated.3 threshold values in accordance with article 24 paragraph 2 letters a and b finia shall not be added together.4 finma regulates the details for calculating the thresholds and the leverage effect in accordance with paragraphs 1 and 2.art. 35 procedure in the event that thresholds are exceeded (art. 24 para. 1 and 2 finia)1 if a manager exceeds a threshold in accordance with article 24 paragraph 2 finia, it shall notify finma to that effect within 10 days.2 the manager must submit to the latter an application for authorisation pursuant to article 24 paragraph 1 finia within 90 days if, during this period, they have not made changes to their business model which make a renewed exceeding of the thresholds appear unlikely.3 if changes are made to the business model within the meaning of paragraph 2 during an ongoing authorisation procedure, the authorisation procedure will be rendered unnecessary.art. 36 authorisation as manager of collective assets (art. 24 para. 3 finia)finma shall grant a portfolio manager in accordance with article 24 paragraph 2 finia authorisation in accordance with article 24 paragraph 3 finia if:a. it has its registered office in switzerland;b. the conditions of authorisation in accordance with article 24 paragraph 1 finia are satisfied; andc. swiss or applicable foreign law provides that the management of collective assets may only be delegated to a supervised manager of collective assets.art. 37 organisation (art. 9 finia)1 two authorised signatories must sign jointly.2 managers of collective assets must be able to be represented by a person who has their place of residence in switzerland. this person must be a member of the body responsible for management or of the body responsible for governance, supervision and control.3 the body responsible for management must comprise at least two persons.4 managers of collective assets must appoint a special body responsible for governance, supervision and control.5 where there are legitimate grounds for so doing, finma may allow departures from these requirements; it may grant exemptions in particular from the duty in accordance with paragraph 4 where the nature and scope of activity so dictate, in particular if the company has ten or fewer full-time positions or annual gross earnings of less than chf 5 million.art. 38 body responsible for governance, supervision and control (art. 9 finia)1 the majority of the members of the body responsible for governance, supervision and control may not be members of the body responsible for management.2 the chair may not at the same time hold the office of chair of the body responsible for management.3 at least one third of members must be independent of the persons who hold a qualified participation in the manager of collective assets and in companies of the same conglomerate or group. managers of collective assets which are part of a financial group subject to consolidated supervision by finma are exempted.4 where there are legitimate grounds for so doing, finma may allow departures from these requirements.art. 39 tasks (art. 26 finia)1 the receipt and transmission of orders in the name of and on behalf of clients in relation to financial instruments is deemed to be an administrative activity in accordance with article 26 paragraph 3 finia which a manager of collective assets can perform within the scope of its tasks in accordance with article 26 finia. article 35 finia remains reserved.2 a manager of collective assets which also offers personalised asset management in accordance with article 6 paragraph 4 in conjunction with article 17 paragraph 1 finia may not invest the investor's assets, whether in full or in part, in units of collective investment schemes that it manages, unless the client has given their general consent beforehand.3 if the rendering of additional services increases the risks to which managers of collective assets are exposed, this must be taken into account within the scope of supervision (articles 61 and 63 finia).art. 40 delegation of tasks (art. 14 and 27 finia)1 whether a delegation of investment decisions is deemed to have the necessary authorisation in accordance with article 14 paragraph 1 finia is determined in accordance with article 24 finia. foreign managers of collective assets must be subject to authorisation and supervision which is at least equivalent.2 where foreign law requires an agreement on cooperation and the exchange of information with the foreign supervisory authorities, investment decisions may only be delegated to managers of collective assets abroad if such an agreement is in place between finma and the foreign supervisory authorities relevant for the respective investment decisions.art. 41 risk management and internal control (art. 9 finia)1 managers of collective assets must have an appropriately defined risk management system in place as well as an effective internal control structure to ensure in particular compliance with legal and internal provisions.2 they shall set out guidelines for the basic principles of risk management and define their risk tolerance.3 they will keep the functions of risk management and compliance functionally and hierarchically separate from the operational business units, in particular from the function of investment decisions (portfolio management).4 the body responsible for the governance, supervision and control of the manager of collective assets is charged with establishing, securing and monitoring the internal control system (ics). this body also defines risk tolerance.5 the body responsible for management implements the corresponding requirements stipulated by the body for governance, supervision and control, it develops suitable guidelines, procedures and processes, and reports periodically to the body responsible for governance, supervision and control.6 paragraphs 4 and 5 do not apply to managers of collective assets which are granted an exemption in accordance with article 37 paragraph 5.7 if a body responsible for governance, supervision and control has been appointed in accordance with article 37 paragraph 4, finma may also require that internal auditors who are independent of management be appointed where the nature and scope of activity so dictate.8 where there are legitimate grounds for so doing, finma may depart from these requirements.9 finma shall regulate the details.art. 42 minimum capital (art. 28 para. 1 and 3 finia)1 the minimum capital of managers of collective assets must amount to at least chf 200,000 and be paid up in full. this amount must be maintained at all times.2 the minimum capital requirements of companies limited by shares and of partnerships limited by shares must be met with share and participation capital, those of limited liability companies must be met with nominal capital.3 the minimum capital requirements of partnerships must be met with:a. the capital accounts;b. the limited partnership contributions;c. the assets of partners with unlimited liability.4 the capital accounts and assets of partners with unlimited liability may only be counted towards the minimum capital requirement if a declaration is provided to the effect that:a. in the event of liquidation, bankruptcy or probate proceedings, such accounts and assets shall be subordinate to the claims of all other creditors; andb. the manager of collective assets undertakes:1. neither to net such accounts and assets with its own claims nor to secure them with its own assets,2. without the prior consent of the audit firm, not to reduce any of the capital components as defined in paragraph 3 letters a and c to the extent that the minimum capital requirement is no longer met.5 the declaration in accordance with paragraph 4 is irrevocable. it must be made in writing or in another form demonstrable via text and filed with the audit firm.6 if a manager of collective assets for foreign collective investment schemes conducts the fund business within the meaning of article 26 paragraph 2 finia, finma can stipulate a higher minimum capital requirement.art. 43 collateral (art. 28 para. 2 and 3 finia)1 finma may permit partnerships to provide, instead of minimum capital, collateral in the form of a bank guarantee or a cash deposit in a blocked account with a bank, said collateral being equivalent to the minimum capital in accordance with article 42.2 where there are legitimate grounds for so doing, finma may stipulate a different minimum amount.art. 44 level of capital adequacy (art. 29 finia)1 the capital stipulated in article 29 finia must be maintained at all times and amount to at least one quarter of the fixed costs reported in the most recent annual accounts and no more than chf 20 million, including capital in accordance with paragraph 2.2 managers of collective assets must:a. hold capital amounting to 0.01% of the total collective assets managed by the manager of collective assets; orb. take out professional liability insurance.3 finma shall regulate the details of professional liability insurance, in particular with regard to term, notice period, the amount of insurance cover, the professional liability risks to be covered and the reporting duties.4 fixed costs in accordance with paragraph 1 are:a. personnel expenses;b. operating business expenses;c. depreciation of investment assets;d. expenses for valuation adjustments, provisions and losses.5 the portion of personnel expenses which is exclusively dependent on the business result or in relation to which no legal entitlement exists is to be deducted from personnel expenses.6 where there are legitimate grounds for so doing, finma may ease requirements.art. 45 qualifying capital (art. 29 finia)1 legal entities may count the following as qualifying capital:a. the paid-up share and participation capital in the case of a company limited by shares and a partnership limited by shares, and the nominal capital in the case of a limited liability company;b. the general statutory and other reserves;c. retained earnings;d. the net profit for the current financial year after deduction of the estimated share in the profit distribution, provided an audit review or an audit pursuant to the co18 of the interim or annual accounts confirms the assurances stipulated;e. hidden reserves, provided they are assigned to a separate account and designated as own capital and their qualifiability as such is confirmed on the basis of the audit in accordance with article 63 finia.2 partnerships may count the following as qualifying capital:a. the capital accounts and assets of partners with unlimited liability if the conditions under article 42 paragraph 4 are satisfied;b. the limited partnership contribution.3 managers of collective assets may also count as qualifying capital any loans granted to them, including bonds with a maturity of at least five years, if a declaration is provided to the effect that:a. in the event of liquidation, bankruptcy or probate proceedings, such loans shall be subordinate to the claims of all other creditors; andb. they have undertaken neither to net such loans with their own claims nor to secure them with their own assets.4 the declaration in accordance with paragraph 3 is irrevocable. it must be made in writing or in another form demonstrable via text and filed with the audit firm.5 own capital in accordance with paragraphs 1 and 2 must amount to at least 50% of total capital required.18 sr 220art. 46 deductions applied when calculating the level of capital adequacy (art. 29 finia)the following shall be deducted when calculating the level of capital adequacy:a. the loss carried forward and the loss for the current financial year;b. any unsecured valuation adjustments and provisions for the current financial year;c. in the case of loans in accordance with article 45 paragraph 3: 20% of the original nominal amount per year for the last five years prior to repayment;d. intangible assets (including start-up and organisational costs as well as goodwill) with the exception of software;e. in the case of a company limited by shares and of a partnership limited by shares: the shares which they hold in the company at their own risk;f. in the case of a limited liability company: the capital contribution which it holds in the company at its own risk;g. the carrying amount of participations.art. 47 accounting and annual report (art. 9, 28 and 29 finia)1 managers of collective assets are subject to the accounting regulations of the co19. where managers of collective assets are subject to specific, more stringent accounting standards, such regulations take precedence.2 the manager of collective assets shall submit to finma the annual report and the full report for the body responsible for governance, supervision and control within 30 days of receiving approval from the body responsible for management. the manager of collective assets shall append to the annual report a list of the prescribed and available capital as at the balance sheet date.3 paragraph 2 does not apply to managers of collective assets which are granted an exemption in accordance with article 37 paragraph 5.19 sr 220art. 48 internal documentation (art. 9 finia)internal documentation of the managers of collective assets must allow the audit firm and finma to form a reliable picture of the business activities.section 3 fund management companies art. 49 independent management of investment funds (art. 32 finia)1 the independent management of investment funds in its own name and for the account of investors by the fund management company comprises in particular:a. decisions on the issue of units, on investments and on their valuation;b. calculation of the net asset value;c. determination of the issue and redemption prices as well as distributions of profit;d. assertion of all rights pertaining to the investment fund.2 institutions which engage solely in administration activities for externally managed sicavs pursuant to cisa20 manage investment funds independently and as fund management companies require authorisation in accordance with article 5 paragraph 1 in conjunction with article 32 finia.20 sr 951.31art. 50 head office in switzerland (art. 33 para. 1 finia)the head office of the fund management company is deemed to be in switzerland if the following conditions are met:a. the non-transferable and inalienable duties of the board of directors in accordance with article 716a co21 are performed in switzerland.b. for each of the investment funds managed by the fund management company, in minimum the following tasks are performed in switzerland: 1. decisions on the issue of units;2. decisions on investment policy and on the valuation of investments;3. valuation of investments;4. determination of issue and redemption prices;5. determination of distributions of profit;6. determination of the content of the prospectus and the key information document, of the annual or the semi-annual report, as well as of further publications intended for investors;7. keeping of accounts.21 sr 220art. 51 organisation (art. 9 and 33 finia)1 fund management companies shall as a rule have at least three full-time positions with authority to sign.2 two authorised signatories must sign jointly.3 the body responsible for management must comprise at least two persons.4 fund management companies must appoint a special body responsible for governance, supervision and control.5 where there are legitimate grounds for so doing, finma may allow relaxations of these requirements or it may impose more stringent requirements.art. 52 body responsible for governance, supervision and control (art. 9 and 33 finia)1 the body responsible for governance, supervision and control must comprise at least three members. 2 the majority of the members of this body may not also be members of the body responsible for management.3 the chair may not at the same time hold the office of chair of the body responsible for management.4 at least one third of members must be independent of the persons who hold a qualified participation in the fund management company and in companies of the same group. fund management companies which are part of a financial group subject to consolidated supervision by finma are exempted.5 where there are legitimate grounds for so doing, finma may allow relaxations of these requirements or it may impose more stringent requirements.art. 53 independence (art. 33 para. 3 finia)1 simultaneous membership of the body responsible for governance, supervision and control of the fund management company and that of the custodian bank is permitted.2 simultaneous membership of the body responsible for management of the fund management company and that of the custodian bank is not permitted.3 the majority of the members of the body responsible for governance, supervision and control of the fund management company must be independent of the persons at the custodian bank who are tasked with the duties in accordance with article 73 cisa22. persons at the custodian bank at management level tasked with duties in accordance with article 73 cisa are not deemed to be independent.4 none of the authorised signatories of the fund management company may at the same time be responsible at the custodian bank for duties in accordance with article 73 cisa.22 sr 951.31art. 54 conduct of fund business (art. 33 para. 4 finia)1 in addition to the tasks specified in articles 32 and 33 paragraph 4 finia as well as in accordance with article 49, fund business specifically entails:a. the representation of foreign collective investment schemes;b. the acquisition of participations in companies whose main purpose is the collective investment scheme business;c. the keeping of unit accounts.2 the fund management company may only perform these activities and any further services in accordance with article 34 finia if its articles of association so provide.3 article 26 paragraph 2 finia applies by analogy to the conduct of fund business for foreign collective investment schemes.art. 55 tasks (art. 34 finia)1 fund management companies shall keep their own assets separate from managed assets at all times.2 they shall ensure that the valuation of investments, portfolio management and trading and settlement are kept separate both functionally and in terms of personnel.3 a fund management company which also offers personalised asset management in accordance with article 6 paragraph 3 in conjunction with article 17 paragraph 1 finia may not invest the investor's assets, whether in full or in part, in units of collective investment schemes that it manages, unless the client has given their general consent beforehand.4 where there are legitimate grounds for so doing, finma may allow exemptions or it may order the separation of further functions.art. 56 delegation of tasks (art. 14 and 35 finia)1 whether a delegation of investment decisions is deemed to have the necessary authorisation in accordance with article 14 paragraph 1 finia is determined in accordance with article 24 finia. foreign managers of collective assets must be subject to authorisation and supervision which is at least equivalent.2 where foreign law requires an agreement on cooperation and the exchange of information with the foreign supervisory authorities, investment decisions may only be delegated to managers of collective assets abroad if such an agreement is in place between finma and the foreign supervisory authorities relevant for the respective investment decisions.art. 57 risk management and internal control (art. 9 finia)1 fund management companies must have an appropriately defined risk management system in place as well as an effective internal control structure to ensure in particular compliance with legal and internal provisions.2 they shall set out guidelines for the basic principles of risk management and define their risk tolerance.3 they will keep the functions of risk management and compliance functionally and hierarchically separate from the operational business units, in particular from portfolio management.4 the body responsible for the governance, supervision and control of the fund management company is charged with establishing, securing and monitoring the ics. this body also defines risk tolerance.5 the body responsible for management implements the corresponding requirements stipulated by the body for governance, supervision and control, it develops suitable guidelines, procedures and processes, and reports at appropriate intervals to the body responsible for governance, supervision and control.6 where the nature and scope of activity so justify, finma may require the appointment of internal auditors who are independent of management.7 where there are legitimate grounds for so doing, it may depart from these requirements.8 it shall regulate the details.art. 58 minimum capital (art. 36 finia)the minimum capital of fund management companies must amount to at least chf 1 million and be paid up in full. this amount must be maintained at all times.art. 59 level of capital adequacy (art. 37 finia)1 the level of capital adequacy stipulated in article 37 finia must be maintained at all times. they must amount to no more than chf 20 million, including the capital in accordance with paragraph 5.2 they will be calculated as follows in percentages of the total assets of the collective investment schemes managed by the fund management company:a. 1% for that portion of the total assets not exceeding chf 50 million;b. % for that portion of the total assets exceeding chf 50 million, but not exceeding chf 100 million;c. % for that portion of the total assets exceeding chf 100 million, but not exceeding chf 150 million;d. % for that portion of the total assets exceeding chf 150 million, but not exceeding chf 250 million;e. % for that portion of the total assets exceeding chf 250 million.3 where the fund management company renders further services in accordance with article 34 finia, the operational risks arising from such transactions are calculated using the basic indicator approach as defined in article 92 of the capital adequacy ordinance of 1 june 201223 (cao).4 if the fund management company is entrusted with the administration and portfolio management of the assets of a sicav, its total assets must be included in the calculation of capital in accordance with paragraph 2.5 if the fund management company is solely entrusted with the administration of a sicav, it must hold additional capital of 0.01% of the total assets of the sicav.23 sr 952.03art. 60 qualifying capital (art. 37 finia)1 fund management companies may count the following as qualifying capital:a. the paid-up share and participation capital;b. the general statutory and other reserves;c. retained earnings;d. the net profit for the current financial year after deduction of the estimated profit distribution, provided an audit review of the interim accounts including a complete income statement is available;e. hidden reserves, provided they are assigned to a separate account and designated as capital and their qualifiability as such is confirmed on the basis of the audit in accordance with article 63 finia.2 fund management companies may also count as qualifying capital any loans granted to them, including bonds with a maturity of at least five years, if a declaration is provided to the effect that:a. in the event of liquidation, bankruptcy or probate proceedings, such loans shall be subordinate to the claims of all other creditors; andb. the fund management company undertakes neither to net such loans with its own claims nor to secure them with its own assets.3 the declaration in accordance with paragraph 2 is irrevocable. it must be made in writing or in another form demonstrable via text and filed with the audit firm.4 capital in accordance with paragraph 1 must amount to at least 50% of total capital required.art. 61 deductions applied when calculating the level of capital adequacy (art. 37 finia)the following shall be deducted when calculating the level of capital adequacy:a. the loss carried forward and the loss for the current financial year;b. the unsecured valuation adjustments and provisions for the current financial year;c. in the case of loans in accordance with article 60 paragraph 2: 20% of the original nominal amount per year for the last five years prior to repayment;d. intangible assets (including start-up and organisational costs as well as goodwill) with the exception of software;e. own shares held by the fund management company at its own risk;g. the carrying amount of participations.art. 62 accounting and annual report (art. 9, 33, 36 und 37 finia)1 fund management companies are subject to the accounting regulations of the co24. where fund management companies are subject to specific, more stringent accounting standards, such regulations take precedence.2 the fund management company shall submit to finma the annual report and the full report for the body responsible for governance, supervision and control within 30 days of receiving approval from the body responsible for management. the fund management company shall append to the annual report a list of the prescribed and available capital as at the balance sheet date.24 sr 220art. 63 internal documentation (art. 9 and 33 finia)internal documentation of the fund management companies must allow the audit firm and finma to form a reliable picture of the business activities.art. 64 change of fund management company (art. 39 finia)article 27 cisa25 und article 41 of the collective investment schemes ordinance of 22 november 200626 apply by analogy to a change of fund management company.25 sr 951.3126 sr 951.311section 4 securities firms art. 65 commerciality (art. 3 and 41 finia)1 securities firms within the meaning of article 41 letter a finia are deemed to pursue their activities on a commercial basis if they directly or indirectly manage accounts or hold securities in safekeeping for more than 20 clients.2 the following are not deemed to be clients within the meaning of article 41 letter a finia:a. domestic and foreign banks and securities firms or other companies under state supervision;b. shareholders or partners holding a qualifying participation and persons with whom they have business or family ties;c. institutional investors with professional treasury operations.3 activities for schemes and persons in accordance with article 2 paragraph 2 letters a, b, d and e finia are not factored into the assessment of commerciality.4 the proper functioning of the financial market is deemed potentially jeopardised within the meaning of article 41 letter b item 1 finia if the total volume of executed trades in securities exceeds chf 5 billion per calendar year in switzerland.5 any party admitted as a direct participant of a trading venue is deemed to be operating as a member of a trading venue within the meaning of article 41 letter b item 2 finia.6 a securities firm shall publicly quote prices within the meaning of article 41 letter c finia if the prices according to article 3 letters g and h finsa27 are part of an offer to the public. offers to schemes and persons in accordance with paragraphs 2 and 3 are not deemed public.7 fund management companies are not deemed to be securities firms.27 sr 950.1art. 66 organisation (art. 9 finia)1 securities firms must be able to be represented by a person who has their place of residence in switzerland. this person must be a member of the body responsible for management or of the body responsible for governance, supervision and control.2 the body responsible for management must comprise at least two persons.3 firms trading for the account of clients and firms acting as market makers within the meaning of article 41 letters a and c finia must appoint a special body responsible for governance, supervision and control. its members may not be members of the body responsible for management.4 where there are legitimate grounds for so doing, finma may allow relaxations of these requirements or it may impose more stringent requirements.art. 67 tasks (art. 44 finia)1 within the frame of their tasks in accordance with article 44 finia, securities firms shall ensure an effective internal separation between the functions of trading, asset management and settlement. where there are legitimate grounds for so doing, finma may allow exemptions or it may order the separation of further functions.2 if they do not operate primarily in the financial sector, firms trading for the account of clients and firms acting as market makers within the meaning of article 41 letters a and c finia must keep securities trading activities legally separate.3 in all other respects, article 14 applies.art. 68 risk management and internal control (art. 9 finia)1 securities firms must have an appropriately defined risk management system in place as well as an effective internal control structure to ensure in particular compliance with legal and internal provisions.2 they shall set out guidelines for the basic principles of risk management and define their risk tolerance.3 they will keep the functions of risk management and compliance functionally and hierarchically separate from the operational business units, in particular from the function of trading.4 firms trading for the account of clients and firms acting as market makers within the meaning of article 41 letters a and c finia shall appoint internal auditors who are independent of management. internal auditors must be provided with sufficient resources and have unlimited audit rights.5 where there are legitimate grounds for so doing, finma may allow relaxations of these requirements or it may impose more stringent requirements.art. 69 minimum capital and collateral (art. 45 finia)1 the minimum capital of securities firms must amount to at least chf 1.5 million and be paid up in full. this amount must be maintained at all times.2 in the case of companies formed using a contribution in kind, the value of the assets contributed and the extent of liabilities must be verified by a licensed audit firm. this also applies to the conversion of an existing company into a securities firm.3 in the case of securities firms in the form of a partnership, capital is deemed to be:a. the capital accounts; andb. the assets of partners with unlimited liability.4 assets in accordance with paragraph 3 may only be counted towards the minimum capital requirement if a declaration is provided to the effect that:a. in the event of liquidation, bankruptcy or probate proceedings, such assets shall be subordinate to the claims of all other creditors; andb. the securities firm undertakes:1. neither to net such assets with its own claims nor to secure them with its own assets,2. without the prior consent of the audit firm, not to reduce any of the capital components to the extent that the minimum capital requirement is no longer met.5 the declaration in accordance with paragraph 4 is irrevocable. it must be made in writing or in another form demonstrable via text and filed with the audit firm.6 finma may allow securities firms in the form of a partnership to provide, instead of minimum capital in accordance with paragraphs 3 and 4, collateral of at least chf 1.5 million, for example in the form of a bank guarantee or a cash deposit in a blocked account with a bank.7 where there are legitimate grounds for so doing, finma can stipulate a higher minimum capital requirement.art. 70 capital and risk diversification (art. 46 finia)1 securities firms which themselves do not hold accounts in accordance with article 44 paragraph 1 letter a finia must maintain at all times capital amounting to at least one quarter of the fixed costs reported in the most recent annual accounts and no more than chf 20 million.2 fixed costs are deemed to be:a. personnel expenses;b. operating business expenses;c. depreciation of investment assets;d. expenses for valuation adjustments, provisions and losses.3 the portion of personnel expenses which is exclusively dependent on the business result or in relation to which no legal entitlement exists is to be deducted from personnel expenses.4 securities firms which themselves hold accounts in accordance with article 44 paragraph 1 letter a finia must comply with the provisions of the cao28.28 sr 952.03art. 70a29 eligible capital (art. 46 finia)1 securities firms may include the following as capital in accordance with article 70 paragraphs 1 to 3:paid-up share capital plus, in the case of partnerships, alternative capital instruments;disclosed reserves;retained earnings;the quarterly profits after deduction of the estimated profit distribution amount;subordinated bonds that are only repayable with the consent of finma.2 the capital under paragraph 1 letters a to c can be included in full.3 70% of the quarterly profits may be included after deducting the estimated profit distribution, subject to the existence of a complete income statement in accordance with finma's implementing provisions based on article 42 of the banking ordinance of 30 april 201430 or of a complete income statement in accordance with an international standard recognised by finma, even if the income statement has not been audited. where justified, finma can require an attestation.4 the following must be deducted in full from the eligible capital under paragraph 1 letters a to d:the loss carried forward and the loss for the current financial year;the value of any participations in the context of the individual entity calculation;goodwill, including any goodwill included in the valuation of significant interests in financial sector entities outside the scope of consolidation, and intangible assets;deferred tax assets (dtas) that depend on future profitability, whereby offsetting against corresponding deferred tax liabilities within the same geographical and material tax jurisdiction is permitted.5 if the capital under paragraph 1 letters a to d exceeds chf 1.5 million after the deductions under paragraph 4, 40% of the subordinated bonds may be included for the excess amount.29 inserted by no i 7 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).30 sr 952.02art. 71 liquidity (art. 46 finia)1 securities firms which themselves do not hold accounts in accordance with article 44 paragraph 1 letter a finia must invest their resources such that sufficient liquidity is guaranteed at all times.2 securities firms which themselves hold accounts in accordance with article 44 paragraph 1 letter a finia must comply with the provisions of the liquidity ordinance of 30 november 201231.31 sr 952.06art. 72 accounting (art. 45-48 finia)the provisions on accounting contained in the banking ordinance of 30 april 201432 apply by analogy.32 sr. 952.02art. 73 internal documentation (art. 9 finia)internal documentation of the securities firms must allow the audit firm and finma to form a reliable picture of the business activities.art. 74 record-keeping duty (art. 50 finia)1 the securities firm must keep a record of all orders received by it and all transactions in securities executed by it.2 the record-keeping duty also applies to orders and transactions in derivatives whose underlying instruments are securities admitted to trading on a trading venue or dlt trading facility33.3 it applies not only to transactions for own account, but also to transactions executed on behalf of clients.4 finma shall regulate which information is necessary and what form it is to be recorded in.33 term in accordance with no i 7 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400). this amendment has been taken into account only in the provisions mentioned in the as.art. 75 reporting duty (art. 51 finia)1 the securities firm shall report all transactions it executes involving securities admitted to trading on a trading venue or dlt trading facility. in particular, the following must be reported:a. the designation and number of the securities purchased or sold;b. the volume, date and time of the transaction;c. the price;d. the details necessary to identify the beneficial owner.2 the reporting duty also applies to transactions in derivatives whose underlying instruments are securities admitted to trading on a trading venue or dlt trading facility.3 it applies not only to transactions for own account, but also to transactions executed on behalf of clients.4 the following transactions executed abroad do not have to be reported:a. transactions in securities admitted to trading on a trading venue or dlt trading facility in switzerland and in derivatives with such securities as their underlying instruments, provided the information in question is communicated to the trading venue or dlt trading facility on the basis of an agreement in accordance with article 32 paragraph 3 finmia34 or within the framework of an exchange of information between finma and the competent foreign supervisory authority if:1. said transactions are executed by the branch of a swiss securities firm or by a foreign admitted participant, and2. the branch or the foreign participant is authorised to trade by the relevant foreign supervisory authority and is required to report in the corresponding state or in its state of domicile;b. transactions in foreign securities admitted to trading on a trading venue or dlt trading facility in switzerland and in derivatives with such securities as their underlying instruments, which transactions are executed on a recognised foreign trading venue or dlt trading facility.5 third parties may be involved in reporting.34 sr 958.1section 5 branches art. 76 foreign financial institutions (art. 52 para. 1 finia)1 a foreign financial institution is any company organised in accordance with foreign legislation and which:a. possesses authorisation abroad as a financial institution;b. in the company name, in the description of its business purpose or in commercial documents uses terms in accordance with article 13 paragraph 2 finia or a term of similar meaning; orc. operates a financial institution within the meaning of article 2 paragraph 1 finia.2 if the foreign financial institution is effectively managed from switzerland or if it executes its transactions exclusively or predominantly in or from switzerland, it must be organised in accordance with swiss legislation and be subject to the provisions governing domestic financial institutions.art. 77 duty to obtain authorisation and authorisation conditions (art. 52 para. 1 and 53 finia)1 the foreign financial institution must have:a. authorisation and supervision at least equivalent to the authorisation and supervision requested for the branch in switzerland;b. collateral which is comparable to that in accordance with:1. articles 22 and 23 finia in the case of foreign financial institutions which manage assets or act as a trustee (article 52 paragraph 1 letter a finia),2. articles 28, 29, 36 and 37 finia in the case of foreign financial institutions which perform fund business, portfolio management for collective investment schemes or portfolio management for occupational pension schemes (article 52 paragraph 1 letter b finia),3. articles 45-47 finia in the case of foreign financial institutions which trade securities, execute transactions or manage client accounts (article 52 paragraph 1 letters c-e finia).2 the branch must:a. comply with the standards of the finsa35 if it provides financial services in accordance with article 3 letter c finsa;b. comply with the conditions in accordance with article 20 finia in the case of foreign financial institutions which manage assets or act as a trustee (article 52 paragraph 1 letter a finia);c. be subject to supervision:1. in accordance with articles 61 and 62 finia in the case of foreign financial institutions which manage assets or act as a trustee,2. in accordance with articles 61 and 63 finia in the case of foreign financial institutions in accordance with article 52 paragraph 1 letters b-e finia.3 the foreign financial institution may only apply for entry of the branch in the commercial register when finma has granted said financial institution authorisation to establish the branch.35 sr 950.1art. 78 multiple branches (art. 52 para. 1 and 53 finia)1 if a foreign financial institution establishes multiple branches in switzerland, it must:a. obtain authorisation for each one;b. designate one among them which is responsible for relations:1. with finma and the supervisory organisation in the case of article 52 paragraph 1 letter a finia,2. with finma in the case of article 52 paragraph 1 letters b-e finia.2 these branches must jointly meet the conditions of the finia and the present ordinance. an audit report is sufficient.art. 79 annual and interim accounts of branches (art. 52 para. 1 and 53 finia)1 branches may draw up their annual and interim accounts in accordance with the provisions which apply to the foreign financial institution, provided they satisfy international standards of accounting.2 claims and liabilities must be stated separately:a. in respect of the foreign financial institution;b. in respect of companies active in the financial sector or real estate firms if:1. the foreign financial institution forms an economic unit with them, or2. it is to be assumed that the foreign financial institution is de jure or de facto obliged to provide assistance to group companies.3 paragraph 2 also applies to off-balance-sheet business.4 a branch shall send its annual and interim accounts:a. to the supervisory organisation for submission to finma in the case of article 52 paragraph 1 letter a finia;b. to finma in the case of article 52 paragraph 1 letters b-e finia.5 publication is not required.art. 80 audit report (art. 52 para. 1 and 53 finia)1 the audit firm shall send its audit report:a. to the supervisory organisation for submission to finma in the case of article 52 paragraph 1 letter a finia;b. to finma in the case of article 52 paragraph 1 letters b-e finia.2 it shall provide a copy to the branch manager responsible.3 the branch will send the copy of the audit report to the unit of the foreign financial institution which is responsible for the business activities of the branch.art. 81 closure of a branch (art. 52 para. 1 and 53 finia)the foreign financial institution shall obtain the approval of finma before closing a branch.section 636 representations 36 amended by no i 7 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400). (art. 58 para. 1 and 2 and 59 finia)art. 82 1 the representative office of a foreign financial institution that provides financial services in accordance with article 3 letter c of the finsa37 must:a. comply with the provisions of the finsa;b. enter its client advisers in a register of advisers in accordance with article 28 of the finsa if they do not exclusively provide their services in switzerland to professional or institutional clients in accordance with article 4 of the finsa. 2 the prohibition on establishing a representative office of a foreign fund management company in accordance with article 58 paragraph 2 of the finia38 applies exclusively to the office's activities in relation to the administration and management of investment funds.37 sr 950.138 sr 954.1chapter 3 supervision section 1 portfolio managers and trustees art. 83 domestic group companies (art. 61 para. 1 and 2 finia)1 for domestic portfolio managers and trustees which form part of a financial group finma can provide that ongoing supervision is performed exclusively within the framework of group supervision. this is conditional on the group company being closely integrated into the risk management, internal control and internal auditing structures of the financial group.2 finma shall publish a list of the group companies monitored by it in accordance with paragraph 1.art. 84 ongoing supervision (art. 61 para. 2 and 62 finia)1 the supervisory organisation shall verify on an ongoing basis whether the entities under its supervision specifically:a. satisfy the requirements of the finia;b. observe the duties pursuant to the anti-money laundering act of 10 october 199739 (amla);c. observe the duties pursuant to the finsa40 if they provide financial services in accordance with article 3 letter c finsa;d. observe the duties pursuant to the cisa41 if they perform activities falling under the cisa.2 finma shall provide the supervisory organisations with guidelines for auditing and supervision. in particular, it shall set down for the supervisory organisations a system of risk assessment as well as minimum requirements to be met by the supervision concept. it shall consult with the supervisory organisations beforehand.3 audit actions and their findings shall be recorded in audit reports. audit reports shall be published in an official language. exemptions through audit firms in accordance with article 43k finmasa42 require the consent of the supervisory organisation.4 if the supervisory organisation supervises a financial institution whose activity requires a higher authorisation level on exceeding thresholds, the supervisory organisation will monitor compliance with these thresholds and notify finma and the financial if they are exceeded.5 the issuance of rulings is reserved to finma. finma shall intervene in the ongoing supervision by the supervisory organisation if this is necessary to enforce the financial market acts in accordance with article 1 paragraph 1 finmasa.39 sr 955.040 sr 950.141 sr 951.3142 sr 956.1art. 85 coordination of supervisory activities (art. 5 and 62 finia)with respect to the supervision of portfolio managers and trustees, finma and the supervisory organisations will coordinate their supervisory activities in order to avoid duplication.art. 86 appointment of audit firms (art. 62 para. 1 finia)where the supervisory organisation does not itself conduct the audit of supervised entities, it will ensure that:a. the appointed audit firm is correctly mandated and authorised in accordance with article 43k finmasa43; b. the appointed audit firm implements the guidelines provided by finma;c. the areas audited and the corresponding depths of audit of risk assessments are commensurate with its supervision concept; andd. it is informed immediately of any irregularities.43 sr 956.1art. 87 audit frequency (art. 62 para. 2 and 3 finia)1 when defining the audit frequency and the intensity of supervision, the supervisory organisation shall be guided by the risks associated with the activity of those supervised and the risks associated with their organisation.2 in years in which no regular audit takes place, the supervisory authority shall collect standardised data on the risks associated with those supervised.3 it shall assess the self-declared data collected and take further measures where necessary.4 finma shall set down for, and in consultation with, the supervisory organisation guidelines for conducting an assessment in accordance with paragraphs 1-3.section 2 managers of collective assets, fund management companies, securities firms, financial groups and financial conglomerates art. 88 auditing (art. 61 para. 3 and 63 finia)1 the audit firm shall verify whether the entities under its supervision specifically:a. satisfy the requirements of the finia;b. observe the duties pursuant to the amla44;c. observe the duties pursuant to the finsa45 if it provides financial services in accordance with article 3 letter c finsa;d. observe the duties pursuant to the cisa46 if they perform activities falling under the cisa.2 supervised entities for which the audit firm submits an annual risk analysis are exempted from the duty to report on their business activity's compliance in accordance with article 63 paragraph 3 finia.44 sr 955.045 sr 950.146 sr 951.31art. 89 cooperation between audit firms (art. 63 finia)the audit firms of supervised entities which cooperate in accordance with article 14, 27 or 35 finia must themselves cooperate closely.section 3 measures under insolvency law (art. 67 finia)art. 90 article 24 banka47 applies by analogy to fund management companies and securities firms.47 sr 952.0chapter 4 final provisions art. 91 repeal and amendment of other legislative instruments (art. 73 finia)the repeal and amendment of other legislative instruments are set out in the annex.art. 92 transitional provisions for portfolio managers and trustees (art. 74 finia)1 portfolio managers and trustees which until entry into force of the finia were supervised by finma as financial intermediaries directly subordinated to it pursuant to the amla48 are no longer required to be affiliated to a self-regulatory organisation in accordance with article 24 amla if, within one year of entry into force of the finia, they:a. receive confirmation from a supervisory organisation that they are subject to supervision in accordance with article 7 paragraph 2 finia; andb. submit an authorisation application to finma.2 they shall submit a report on their business activity's compliance with the provisions of the amla:a. to the supervisory organisation prior to being subject to supervision in accordance with article 7 paragraph 2 finia; orb. to the self-regulatory organisation prior to affiliation accordance with article 14 amla.48 sr 955.0art. 93 further transitional provisions (art. 74 finia)1 article 5 paragraph 2 finia is not applicable to financial institutions which on entry into force of the finia are already entered in the commercial register.2 financial institutions which provide services in accordance with the finsa49 must be affiliated to the ombudsman's office within six months of the federal department of finance recognising or establishing for them an ombudsman's office in accordance with article 84 finsa. the period is deemed met on submission of the application.3 financial institutions that have their registered office abroad and by reason of a branch or representation in switzerland already hold authorisation are not required to submit a new application for authorisation. they must satisfy the legal requirements within one year of entry into force.4 financial institutions that have their registered office abroad and by reason of a branch or representation in switzerland are newly required to obtain authorisation pursuant to the finia shall report to finma within six months of entry into force. they must satisfy the legal requirements and submit an application for authorisation within three years of entry into force. they may continue their activities until a decision on authorisation is made.5 article 77 paragraph 3 is not applicable to branches which on entry into force of the finia are already entered in the commercial register.6 exemptions granted by finma based on article 18 paragraph 3 cisa50 in the version of 28 september 201251 to managers of collective investment schemes remain valid under article 7 of the present ordinance.49 sr 950.150 sr 951.3151 as 2013 585art. 94 commencement this ordinance enters into force on 1 january 2020. annex (art. 91)repeal and amendment of other legislative instruments ithe stock exchange ordinance of 2 december 199652 is repealed.iithe legislative instruments below are amended as follows:.5352 [as 1997 85 2044 art. 2, 2004 2781, 2005 4849 no iii, 2006 4307 annex 7 no 2, 2008 5363 annex no 9, 2012 5441 annex 6 no 3, 2013 1111, 2014 1269 annex 2 no 6 2321 annex 4 no 2 4295 annex no 4, 2015 5413 annex 1 no 12, 2017 3715 no iii]53 the amendments may be consulted under as 2019 4633.

955.0english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton combating money laundering andterrorist financing(anti-money laundering act, amla)1of 10 october 1997 (status as of 1 january 2022)1 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).the federal assembly of the swiss confederation,based on articles 95 and 98 of the federal constitution2,3and having considered the federal council dispatch dated 17 june 19964,decrees:2 sr 1013 amended by no i of the fa of 21 june 2013, in force since 1 nov. 2013 (as 2013 3493; bbl 2012 6941).4 bbl 1996 iii 1101chapter 1 general provisions art. 15 subject matter this act regulates the combating of money laundering as defined in article 305bis of the swiss criminal code6 (scc), the combating of terrorist financing as defined in article 260quinquies paragraph 1 scc, and the due diligence required in financial transactions.5 amended by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).6 sr 311.0art. 2 scope of application 1 this act applies to: a. financial intermediaries;b. natural persons and legal entities that deal in goods commercially and in doing so accept cash (dealers).72 financial intermediaries are:a.8 banks as defined in article 1a of the banking act of 8 november 19349 (banka) and the persons defined in article 1b banka;abis.10 portfolio managers and trustees as defined in article 2 paragraph 1 letters a and b of the financial institutions act of 15 june 201811 (finia), and trade assayers as defined in article 42bis of the precious metals control act of 20 june 193312;b.13 fund management companies as defined in article 2 paragraph 1 letter d finia;bbis.14 investment companies with variable capital, limited partnerships for collective investment and investment companies with fixed capital in accordance with the collective investment schemes act of 23 june 200615, as well as the managers of collective assets in accordance with article 2 paragraph 1 letter c finia;c.16 insurance institutions as defined in the insurance supervision act of 17 december 200417 that deal in direct life insurance or offer or distribute shares in collective investment schemes;d.18 securities firms in accordance with article 2 paragraph 1 letter e finia;dbis.19 central counterparties and central securities depositories in accordance with the financial market infrastructure act of 19 june 201520 (finmia);dter.21 payment systems that require authorisation from the swiss financial market supervisory authority (finma) in accordance with article 4 paragraph 2 finmia;dquater.22 trading facilities for dlt securities in accordance with article 73a finmia (dlt trading facilities);e.23 casinos as defined in the gambling act of 29 september 201724 (gambla);f.25 promoters of large-scale games under the gambla.3 financial intermediaries are also persons who on a professional basis accept or hold on deposit assets belonging to others or who assist in the investment or transfer of such assets; they include in particular persons who:a. carry out credit transactions (in particular in relation to consumer loans or mortgages, factoring, commercial financing or financial leasing);b. provide services related to payment transactions, in particular by carrying out electronic transfers on behalf of other persons, or who issue or manage means of payment such as credit cards and travellers' cheques;c. trade for their own account or for the account of others in banknotes and coins, money market instruments, foreign exchange, precious metals, commodities and securities (stocks and shares and value rights) as well as their derivatives;d.26 .e.27 .f. make investments as investment advisers;g. hold securities on deposit or manage securities.4 this act does not apply to:a. the swiss national bank;b. tax-exempt occupational pension institutions;c. persons who provide their services solely to tax-exempt occupational pension institutions;d. financial intermediaries within the meaning of paragraph 3 who provide their services solely to financial intermediaries within the meaning of paragraph 2 or to foreign financial intermediaries who are subject to equivalent supervision.7 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).8 amended by annex no ii 15 des financial institutions act of 15 june 2018, in force since 1 jan. 2019 (as 2018 5247; bbl 2015 8901).9 sr 952.010 inserted by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).11 sr 954.112 sr 941.3113 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).14 inserted by annex no ii 9 des collective investment schemes act of 23 june 2006 (as 2006 5379; bbl 2005 6395). amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).15 sr 951.3116 amended by annex no ii 9 of the collective investment schemes act of 23 june 2006, in force since 1 jan. 2007 (as 2006 5379; bbl 2005 6395).17 sr 961.0118 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).19 inserted by annex no 12 of the financial market infrastructure act of 19 june 2015 (as 2015 5339; bbl 2014 7483). amended by no i 8 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).20 sr 958.121 inserted by annex no 12 of the financial market infrastructure act of 19 june 2015 (as 2015 5339; bbl 2014 7483). amended by no i 8 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).22 inserted by no i 8 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).23 inserted by annex no 4 of the gambling act of 18 dec. 1998 (as 2000 677; bbl 1997 iii 145). amended by annex no ii 8 of the gambling act of 29 sept. 2017, in force since 1 jan. 2019 (as 2018 5103; bbl 2015 8387).24 sr 935.5125 inserted by annex no ii 8 of the gambling act of 29 sept. 2017, in force since 1 jan. 2019 (as 2018 5103; bbl 2015 8387).26 repealed by annex no ii 8 of the insurance supervision act of 17 dec. 2004, with effect from 1 jan. 2006 (as 2005 5269; bbl 2003 3789).27 repealed by annex no ii 15 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 2a28 definitions 1 politically exposed persons in terms of this act are:a. individuals who are or have been entrusted with prominent public functions by a foreign country, such as heads of state or of government, senior politicians at national level, senior government, judicial, military or political party officials at national level, and senior executives of state-owned corporations of national significance (foreign politically exposed persons);b. individuals who are or have been entrusted with prominent public functions at national level in switzerland in politics, government, the armed forces or the judiciary, or who are or have been senior executives of state-owned corporations of national significance (domestic politically exposed persons);c. individuals who are or have been entrusted with a prominent function by an intergovernmental organisation or international sports federations, such as secretaries general, directors, deputy directors and members of the board or individuals who have been entrusted with equivalent functions, (politically exposed persons in international organisations)2 the family members and close associates of politically exposed persons are individuals who are closely connected to persons under paragraph 1 either through their family or for social or professional reasons.3 the beneficial owners of an operating legal entity are the natural persons who ultimately control the legal entity in that they directly or indirectly, alone or in concert with third parties, hold at least 25 per cent of the capital or voting rights in the legal entity or otherwise control it. if the beneficial owners cannot be identified, the most senior member of the legal entity's executive body must be identified.4 domestic politically exposed persons are no longer regarded as being politically exposed in terms of this act when 18 months have elapsed since they relinquished their position. the general duties of due diligence for financial intermediaries are reserved.5 an international sports federation in terms of paragraph 1 letter c is the international olympic committee and the non-governmental organisations that it recognised that regulate one or more official sports at global level.28 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).chapter 2 duties29 29 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605). section 1 financial intermediaries duty of due diligence30 30 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605). art. 3 verification of the identity of the customer 1 when establishing a business relationship, the financial intermediary must verify the identity of the customer on the basis of a document of evidentiary value. where the customer is a legal entity, the financial intermediary must acknowledge the provisions regulating the power to bind the legal entity, and verify the identity of the persons who enter into the business relationship on behalf of the legal entity.312 in the case of cash transactions with a customer whose identity has not yet been identified, the duty to verify identity applies only if one transaction, or two or more transactions that appear to be connected, involve a considerable financial value.3 insurance institutions must verify the identity of the customer if the amount of a single premium, the regular premium or the total of the premiums involves a considerable financial value.4 if in cases under paragraphs 2 or 3 there is any suspicion of money laundering or terrorist financing, the identity of the customer must be verified even if the relevant amounts have not been reached.325 finma, the federal gaming board (fgb), the federal department of justice and police (fdjp), the federal customs administration (fca)33 and the self-regulatory organisations shall determine what constitutes a considerable financial value within the meaning of paragraphs 2 and 3 in their respective fields and adjust such values as required.3431 second sentence inserted by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).32 amended by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).33 now the federal office for customs and border security (focbs).34 amended by no i 8 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 435 establishing the identity of the beneficial owner 1 the financial intermediary must identify the beneficial owner with the due diligence required in the circumstances. if the customer is a listed company or a subsidiary over which a listed company has majority control, the identity of the beneficial owner need not be established.2 the financial intermediary must obtain a written declaration from the customer as to the identity of the individual who is the beneficial owner if:a. the customer is not the beneficial owner or if there is any doubt about the matter;b. the customer is a domiciliary company or an operating legal entity; orc. a cash transaction of considerable financial value in terms of article 3 paragraph 2 is being carried out.3 in the case of collective accounts or collective deposits, the financial intermediary must require the customer to provide a complete list of the beneficial owners and to give notice of any change to the list immediately. 35 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).art. 5 repetition of the verification of the identity of the customer or the establishment of the identity of the beneficial owner 1 if doubt arises in the course of the business relationship as to the identity of the customer or of the beneficial owner, the verification of identity or establishment of identity in terms of articles 3 and 4 respectively must be repeated.2 in the case of an insurance policy that may be surrendered, the insurance institution must also re-establish the identity of the beneficial owner if, in the event of a claim or the surrender of the policy, the person entitled to benefit is not the same person identified at the time that the insurance contract was concluded.art. 636 special duties of due diligence 1 the financial intermediary is required to ascertain the nature and purpose of the business relationship wanted by the customer. the extent of the information that must be obtained, the hierarchical level at which the decision to enter into or continue a business relationship must be taken and the regularity of checks are determined by the risk represented by the customer.2 the financial intermediary must clarify the economic background and the purpose of a transaction or of a business relationship if:a. the transaction or the business relationship appears unusual, unless its legality is clear;b.37 there are indications that assets are the proceeds of a felony or an aggravated tax misdemeanour under article 305bis number 1bis scc38 or are subject to the power of disposal of a criminal or terrorist organisation (art. 260ter scc) or serve the financing of terrorism (art. 260quinquies para. 1 scc);c. the transaction or the business relationship carries a higher risk;d.39 the data on a customer, a beneficial owner or an authorised signatory in a business relationship or transaction are identical or very similar to the data provided to the financial intermediary by finma under article 22a paragraph 2 letter a, by a supervisory organisation under article 22a paragraph 2 letter b, by a self-regulatory organisation under article 22a paragraph 2 letter c, or by the fgb40 under article 22a paragraph 3.3 business relationships with foreign politically exposed persons and their family members or close associates in terms of article 2a paragraph 2 are deemed in every case to be business relationships with a higher risk.4 business relationships with domestic politically exposed persons and politically exposed persons in international organisations and their family members or close associates in terms of article 2a paragraph 2 are deemed when combined with one or more further risk criteria to be business relationships with a higher risk.36 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).37 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).38 sr 311.039 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).40 name corrected by the federal assembly drafting committee on 31 jan. 2020, published on 18 feb. 2020 (as 2020 501). this modification has been made in the provisions mentioned in the asart. 7 duty to keep records 1 the financial intermediary must keep records of transactions carried out and of clarifications required under this act in such a manner that other specially qualified persons are able to make a reliable assessment of the transactions and business relationships and of compliance with the provisions of this act.2 the financial intermediary must retain the records in such a manner as to be able to respond within a reasonable time to any requests made by the prosecution authorities for information or for the seizure of assets.3 after the termination of the business relationship or after completion of the transaction, the financial intermediary must retain the records for a minimum of ten years.art. 7a41 assets of low value the financial intermediary may dispense with complying with the duties of due diligence (art. 3-7) if the business relationship only involves assets of low value and there is no suspicion of money laundering or terrorist financing.41 inserted by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).art. 8 organisational measures financial intermediaries must take the measures that are required to prevent money laundering and terrorist financing in their field of business.42 they must in particular ensure that their staff receive adequate training and that checks are carried out.42 amended by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).section 1a43 dealers' duties of due diligence 43 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605). art. 8a 1 dealers under article 2 paragraph 1 letter b must fulfil the following duties if they accept more than 100,000 francs in cash in the course of a commercial transaction:a. verification of the identity of the customer (art. 3 para. 1);b. establishing the identity of the beneficial owner (art. 4 para. 1 and 2 let. a and b);c. duty to keep records (art. 7).2 they must clarify the economic background and purpose of a transaction if:a. it appears unusual, unless its legality is clear;b.44 there are indications that assets are the proceeds of a felony or an aggravated tax misdemeanour under article 305bis number 1bis scc45 or are subject to the power of disposal of a criminal or terrorist organisation (art. 260ter scc) or serve the financing of terrorism (art. 260quinquies para. 1 scc).3 dealers are subject to the duties under paragraphs 1 and 2 even if the cash payment is made in two or more instalments and the individual instalments are less than 100,000 francs, but when added together exceed this amount.4 they are not subject to the duties if the payments that exceed 100,000 francs are made through a financial intermediary.5 the federal council shall specify the details of the duties under paragraphs 1 and 2 and stipulate how they are to be fulfilled.44 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).45 sr 311.0section 2 duties in the event of a suspicion of money laundering art. 9 duty to report 1 a financial intermediary must immediately file a report with the money laundering reporting office switzerland (the reporting office) as defined in article 23 if it:a. knows or has reasonable grounds to suspect that assets involved in the business relationship: 1.46 are connected to an offence in terms of article 260ter or 305bis scc47, 2.48 are the proceeds of a felony or an aggravated tax misdemeanour under article 305bis number 1bis scc,3.49 are subject to the power of disposal of a criminal or terrorist organisation, or 4. serve the financing of terrorism (art. 260quinquies para. 1 scc);b. terminates negotiations aimed at establishing a business relationship because of a reasonable suspicion as defined in letter a;c.50 knows or has reason to assume based on the clarifications carried out under article 6 paragraph 2 letter d that the data passed on by finma, the fgb, a supervisory organisation or a self-regulatory organisation relating to a person or organisation corresponds to the data of a customer, a beneficial owner or an authorised signatory in a business relationship or transaction.511bis a dealer must immediately file a report with the reporting office if it knows or has reasonable grounds to suspect that cash payments made in the course of a commercial transaction:a.52 are connected to an offence under article 260ter or 305bis scc;b. are the proceeds of a felony or an aggravated tax misdemeanour under article 305bis number 1bis scc;c.53 are subject to the power of disposal of a criminal organisation; or d.54 serve the financing of terrorism (art. 260quinquies para. 1 scc).551ter the name of the financial intermediary or dealer must appear in any report in accordance with paragraph 1. the identity of the financial intermediary's or dealer's staff who are in charge of the case may be made anonymous in the report, provided it is guaranteed that the reporting office and the competent prosecution authority are able to contact them without delay.562 lawyers and notaries are not subject to the duty to report insofar as they are bound in their activities by professional secrecy in terms of article 321 scc.46 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).47 sr 311.048 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).49 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).50 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force (as 2015 1389; bbl 2014 605) amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).51 amended by no i 4 of the fa of 3 oct. 2008 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).52 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).53 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).54 inserted by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).55 inserted by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force (as 2009 361; bbl 2007 6269). amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).56 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).art. 9a57 customer orders relating to the reported assets during the analysis conducted by the reporting office under article 23 paragraph 2, the financial intermediary shall execute customer orders relating to the assets reported under article 9 paragraph 1 letter a of this act or under article 305ter paragraph 2 scc58.57 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).58 sr 311.0art. 1059 freezing of assets 1 the financial intermediary shall freeze the assets entrusted to it that are related to the report under article 9 paragraph 1 letter a of this act or under article 305ter paragraph 2 scc60 as soon as the reporting office informs it that it has forwarded the report to the prosecution authority.1bis it shall without delay freeze the assets entrusted to it that are related to the report under article 9 paragraph 1 letter c.2 it shall continue to freeze the assets until it receives a ruling from the competent prosecution authority, but at most for five working days from the date on which the reporting office gives notice of forwarding the report under paragraph 1 or on which it filed the report with the reporting office under paragraph 1bis.59 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).60 sr 311.0art. 10a61 prohibition of information 1 the financial intermediary is prohibited from informing the persons concerned or third parties that it has filed a report under article 9 of this act or under article 305ter paragraph 2 scc62. the self-regulatory organisation to which the financial intermediary is affiliated is not regarded as a third party. the same applies to finma and the fgb in relation to the financial intermediaries under their supervision.632 if the financial intermediary itself is unable to freeze the assets, it may inform the financial intermediary that is able to do so and which is subject to this act.3 it may also inform another financial intermediary subject to this act that a report has been submitted under article 9, provided this is required in order to comply with duties under this act and provided both financial intermediaries:64a. provide joint services for one customer in connection with the management of that customer's assets on the basis of a contractual agreement to cooperate; orb. are part of the same corporate group.4 the financial intermediary who has been informed on the basis of paragraph 2 or 3 is subject to the prohibition of information in paragraph 1.5 the dealer is prohibited from informing the persons concerned or third parties that it has filed a report under article 9.656 the prohibition on providing information under paragraphs 1 and 5 does not apply to protecting personal interests in the context of a civil action or criminal or administrative proceedings.6661 inserted by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).62 sr 311.063 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).64 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).65 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).66 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).art. 1167 exclusion of criminal and civil liability 1 any person who in good faith files a report under article 9 of this act or who freezes assets in accordance with article 10 may not be prosecuted for a breach of official, profession or trade secrecy or be held liable for breach of contract.2 this exclusion of prosecution and liability also applies to financial intermediaries that file a report under article 305ter paragraph 2 scc68 or to self-regulatory organisations that file a report under article 27 paragraph 4.67 amended by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).68 sr 311.0section 369 provision of information 69 inserted by no i of the fa of 21 june 2013, in force since 1 nov. 2013 (as 2013 3493; bbl 2012 6941). art. 11a 1 if the reporting office requires additional information in order to analyse a report that it has received in accordance with article 9 of this act or article 305ter paragraph 2 scc70, the financial intermediary making the report must on request provide such information that is in its possession.2 if, based on this analysis, it becomes apparent that in addition to the financial intermediary making the report, other financial intermediaries are or were involved in a transaction or business relationship, the financial intermediaries involved must on request provide the reporting office with all related information that is in their possession.2bis if, on the basis of the analysis of information from a foreign reporting office, it becomes apparent that financial intermediaries subject to this act are or have been involved in a transaction or business relationship in connection with this information, the financial intermediaries involved must, on request, disclose to mros all related information to the extent that it is available to them.713 the reporting office shall specify a deadline for the provision of information by the financial intermediaries concerned under paragraphs 1-2bis.724 the financial intermediaries are subject to the prohibition of information under article 10a paragraph 1.5 the exclusion of criminal and civil liability under article 11 applies by analogy.70 sr 311.071 inserted by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).72 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).chapter 3 supervision section 1 general provisions art. 1273 responsibility the following bodies shall supervise compliance by financial intermediaries with the duties set out in chapter 2:74a.75 for financial intermediaries under article 2 paragraph 2 letters a to dquater, finma;b.76 for financial intermediaries under article 2 paragraph 2 letter e, the fgb;bbis.77 under article 2 paragraph 2 letter f: the intercantonal supervisory and executive authority under article 105 gambla78;c.79 for financial intermediaries under article 2 paragraph 3, the recognised self-regulatory organisations (art. 24).73 amended by annex no 17 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207; bbl 2006 2829).74 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).75 amended by no i 8 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).76 amended by annex no ii 8 of the gambling act of 29 sept. 2017, in force since 1 jan. 2019 (as 2018 5103; bbl 2015 8387).77 inserted by annex no ii 8 of the gambling act of 29 sept. 2017, in force since 1 jan. 2019 (as 2018 5103; bbl 2015 8387).78 sr 935.5179 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 1380 80 repealed by annex no 17 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207; bbl 2006 2829).art. 1481 licensing and affiliation requirement 1 financial intermediaries within the meaning of article 2 paragraph 3 must be affiliated to a self-regulatory organisation.2 a financial intermediary within the meaning of article 2 paragraph 3 is entitled to affiliate to a self-regulatory organisation if:a. the financial intermediary guarantees compliance with its duties in accordance with this act by means of its internal regulations and organisationb. the financial intermediary enjoys a good reputation and guarantees compliance with its duties in accordance with this actc. the persons responsible for its administration and management also meet the requirements of letter b; andd. its qualified participants enjoy a good reputation and guarantee that their influence is not detrimental to prudent and sound business operations.3 the self-regulatory organisation may make affiliation conditional on the financial intermediary operating in specific sectors.81 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 1582 dealers' duty to verify 1 dealers who must fulfil the duties of due diligence under article 8a shall appoint an audit firm to verify that they are complying with their duties under chapter two.2 auditors under article 5 or audit firms under article 6 of the auditor oversight act of 16 december 200583 which have the required technical expertise and experience may be appointed as the audit firm.3 the dealers are obliged to provide the audit firm with all the information and documents required to conduct the audit.4 the audit firm shall verify compliance with the duties under this act and prepare a report thereon for the attention of the responsible management bodies of the dealer audited.5 if a dealer fails to comply with its duty to report, the audit firm shall immediately file a report with the reporting office if it has reasonable grounds to suspect that:84a.85 an offence under article 260ter or 305bis scc86 has been committed;b. assets are the proceeds of a felony or an aggravated tax misdemeanour under article 305bis number 1bis scc;c.87 assets are subject to the power of disposal of a criminal or terrorist organisation; ord.88 assets serve the financing of terrorism (art. 260quinquies para. 1 scc).82 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605). 83 sr 221.30284 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).85 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).86 sr 311.087 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).88 inserted by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).section 289 duty to report of the supervisory authorities and the supervisory organisation90 89 amended by annex no 17 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207; bbl 2006 2829).90 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). art. 16 1 finma, the fgb, the intercantonal supervisory and executive authority under article 105 gambla91 and the supervisory organisation in accordance with article 43a of the financial market supervision act of 22 june 200792shall immediately submit a report to the reporting office if they have reasonable grounds to suspect that:93a.94 a criminal offence under article 260ter, 305bis or 305ter scc95 has been committed;b.96 assets are the proceeds of a felony or an aggravated tax misdemeanour under article 305bis number 1bis scc; c.97 assets are subject to the power of disposal of a criminal or terrorist organisation; ord.98 assets serve the financing of terrorism (art. 260quinquies para. 1 scc).2 this duty applies only if the financial intermediary or the self-regulatory organisation has not already submitted a report.3 the supervisory organisation shall submit a copy of the report to finma at the same time.9991 sr 935.5192 sr 956.193 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). corrected by the fa drafting committee on 31 jan. 2020, published on 18 feb. 2020 (as 2020 501).94 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).95 sr 311.096 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).97 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).98 inserted by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).99 inserted by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).section 3100 supervision of financial intermediaries under article 2 paragraph 2 100 amended by annex no 17 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207; bbl 2006 2829).art. 17101 in the absence of recognised self-regulation, the duties of due diligence defined in chapter 2 and their fulfilment shall be regulated by:a.102 finma for financial intermediaries under article 2 paragraph 2 letters a-dquater;b. the fgb for financial intermediaries under article 2 paragraph 2 letter e;c.103 the fdjp for financial intermediaries under article 2 paragraph 2 letter f.101 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). corrected by the federal assembly drafting committee on 24 sept. 2019 (as 2019 5065).102 amended by no i 8 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).103 amended by no i 8 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).section 3a supervision of financial intermediaries under article 2 paragraph 3104 104 inserted by annex no 17 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207; bbl 2006 2829).art. 18 duties of finma105 1 finma shall have the following duties in terms of its supervision of the financial intermediaries under article 2 paragraph 3:106a. it recognises the self-regulatory organisations or withdraws such recognition;b.107 it supervises the self-regulatory organisations;c. it approves the regulations issued by the self-regulatory organisations in accordance with article 25 and any amendments thereto;d. it ensures that the self-regulatory organisations enforce their regulations;e. and f.108 .2 .1093 in order to preserve professional secrecy, self-regulatory organisations shall arrange for inspections under this act (amla inspections) to be carried out on lawyers by lawyers and on notaries by notaries.1104 the lawyers and notaries instructed to carry out amla inspections must meet the following requirements:a. lawyer's or notary's practising certificate; b. guarantee of that inspections will be carried out properly; c. proof of the relevant knowledge of amla, practical experience and continuing professional development; d. independence from the member being checked.111105 amended by annex no 17 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207; bbl 2006 2829).106 amended by annex no 17 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207; bbl 2006 2829).107 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).108 repealed by annex no ii 15 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).109 repealed by annex no 7 of the fa of 20 june 2014 (consolidation of oversight of audit companies), with effect from 1 jan. 2015 (as 2014 4073; bbl 2013 6857).110 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).111 inserted by annex no 7 of the fa of 20 june 2014 (consolidation of oversight of audit companies), in force since 1 jan. 2015 (as 2014 4073; bbl 2013 6857).art. 18a112 public directory 1 finma shall maintain a directory of the financial intermediaries under article 2 paragraph 3 that are affiliated to a self-regulatory organisation. this directory shall be publicly accessible online.2 finma shall make the data available via remote access.112 inserted by annex no 17 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207; bbl 2006 2829).art. 19113 113 repealed by annex no 17 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207; bbl 2006 2829).art. 19a114 114 inserted by annex no 17 of the financial market supervision act of 22 june 2007 (as 2008 5207; bbl 2006 2829). repealed by annex no ii 15 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 19b115 115 inserted by annex no 17 of the financial market supervision act of 22 june 2007, (as 2008 5207; bbl 2006 2829). repealed by annex no 7 of the fa of 20 june 2014 (consolidation of oversight of audit companies), with effect from 1 jan. 2015 (as 2014 4073; bbl 2013 6857).art. 20116 116 repealed by annex no ii 15 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 21 and 22117 117 repealed by annex no 17 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207; bbl 2006 2829).section 3b118 passing on data on terrorist activities 118 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605). art. 22a 1 the federal department of finance (fdf) shall pass on to finma and the fgb data that it has received from another state and which has been published by that state on persons and organisations that have been placed on a list in the state concerned due to terrorist activities or their support for terrorist activities on the basis of resolution 1373 (2001)119 of the un security council.2 finma shall pass on the data received from the fdf to:a.120 the financial intermediaries under its supervision in accordance with article 2 paragraph 2 letters a and b-dquater;b.121 the supervisory organisations for the attention of the financial intermediaries in accordance with article 2 letter abis that are subject to their ongoing supervision;c. the self-regulatory organisations for the attention of the financial intermediaries affiliated to them.3 the duty to pass on data under paragraph 2 letter a also applies to the fgb.4 the fdf shall not pass any data on to finma or the fgb if, after consulting the federal department of foreign affairs, the federal department of justice and police, the federal department of defence, civil protection and sport and the federal department of economic affairs, education and research, it must assume that human rights or principles of the rule of law would be violated.119 > english > security council > security council resolutions > 2001 > 5/res/1373 (2001)120 amended by no i 8 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).121 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).section 4 money laundering reporting office switzerland (the reporting office) art. 23 1 the federal office of police122 shall manage the money laundering reporting office switzerland (the reporting office).2 the reporting office shall examine and analyse the reports received. if necessary, it shall obtain additional information in accordance with article 11a.123.3 it shall maintain its own data processing system in relation to money laundering.4 it must notify the responsible prosecution authority immediately if it has reasonable grounds to suspect that: a.124 an offence as defined in articles 260ter number 1, 305bis or 305ter scc125 has been committed;b.126 assets are the proceeds of a felony or an aggravated tax misdemeanour under article 305bis number 1bis scc;c.127 assets are subject to the power of disposal of a criminal or terrorist organisation; or d. assets serve the financing of terrorism (art. 260quinquies para. 1 scc).1285 the reporting office shall inform the financial intermediary concerned within 20 working days whether it will pass on the report under article 9 paragraph 1 letter a to a prosecution authority or not.1296 it shall inform the financial intermediary concerned whether it will pass the report under article 305ter paragraph 2 scc to a prosecution authority or not.130122 the title of this administrative entity has been amended in application of art. 16 para. 3 of the publication o of 17 nov. 2004 (as 2004 4937).123 amended by no i of the fa of 21 june 2013, in force since 1 nov. 2013 (as 2013 3493; bbl 2012 6941).124 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).125 sr 311.0126 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).127 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).128 amended by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).129 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).130 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).section 5 self-regulatory organisations art. 24 recognition 1 organisations are recognised as self-regulatory organisations if they:a. have regulations in accordance with article 25;b. supervise their affiliated financial intermediaries with regard to compliance with their duties in terms of chapter 2; andc. provide the guarantee of irreproachable business conduct and ensure that the persons and audit firms they instruct to carry out inspections:1311. possess the required specialist knowledge,2. provide the required guarantees that inspections will be carried out properly, and3. are independent of the management and administration of financial intermediaries being inspected;d.132 ensure that the audit firms they instruct to carry out inspections and lead auditors fulfil the requirements under article 24a.2 the self-regulatory organisations of the licensed transport undertakings under the public transport act of 20 march 2009133 must be independent of their respective managements.134art. 24a135 licensing of audit firms and lead auditors1 the self-regulatory organisation shall grant the audit firms and lead auditors the necessary licence and supervise their activity.2 the audit firm shall be licensed if:a. it is licensed as an auditor by the federal audit oversight authority in accordance with article 6 of the auditor oversight act of 16 december 2005136;b. it is adequately organised for this audit; andc. it does not perform any other activity requiring authorisation under the financial market acts in accordance with article 1 paragraph 1 of the financial market supervision act of 22 june 2007137 (finmasa).3 the lead auditor shall be licensed to lead audits in accordance with paragraph 1 if he or she:a. is licensed as an auditor by the federal audit oversight authority in accordance with article 5 of the auditor oversight act;b. has the necessary specialist knowledge and the necessary practical experience for performing audits in accordance with paragraph 1.4 article 17 of the auditor oversight act applies by analogy to the self-regulatory organisation's withdrawal of the licence granted to audit firms and lead auditors in accordance with paragraph 1, as well as to its issuing of a reprimand.131 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).132 inserted by annex no 7 of the fa of 20 june 2014 (consolidation of oversight of audit companies) (as 2014 4073; bbl 2013 6857). amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).133 sr 745.1134 amended by annex no ii 3 of the postal services organisation act of 17 dec. 2010, in force since 1 oct. 2012 (as 2012 5043; bbl 2009 5265).135 inserted by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).136 sr 221.302137 sr 956.1art. 25 regulations 1 self-regulatory organisations must issue regulations.2 the regulations shall specify the duties of diligence of their affiliated financial intermediaries within the meaning of chapter 2 and stipulate how these duties must be fulfilled.3 they shall further stipulate:a. the requirements for the affiliation and exclusion of financial intermediaries;b. how compliance with the duties in terms of chapter 2 is monitored;c. appropriate penalties.art. 26 lists 1 the self-regulatory organisations must maintain lists of their affiliated financial intermediaries and of persons to whom they refuse affiliation.2 they must notify finma of these lists and of any amendments thereto.138138 amended by annex no 17 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207; bbl 2006 2829).art. 26a139 swiss group companies 1 finma may provide for financial intermediaries in accordance with article 2 paragraph 3 that are swiss group companies of a financial intermediary in accordance with article 2 paragraph 2 letters a-dquater that proof of compliance with the obligations specified in chapter 2 may be provided in the audit report for the group.1402 finma shall publish a list of group companies in accordance with paragraph 1.139 inserted by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).140 amended by no i 8 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 27141 exchange of information and duty to notify 1 the self-regulatory organisations and finma may mutually exchange any information or documents that they require in order to fulfil their duties.2 the self-regulatory organisations shall notify finma of:a. terminations of memberships;b. decisions on the refusal of affiliation;c. decisions to exclude and the reasons therefor;d. the opening of sanctions proceedings that may end in exclusion.3 they shall provide finma with a report at least once each year on their activities in terms of this act together with a list of decisions on sanctions issued during the period covered by the report.4 they shall submit a report immediately to the reporting office if they have reasonable grounds to suspect that:a.142 a criminal offence under article 260ter or 305bis of the swiss criminal code143 has been committed;b.144 assets are the proceeds of a felony or an aggravated tax misdemeanour under article 305bis number 1bis scc; c.145 assets are subject to the power of disposal of a criminal or terrorist organisation; ord.146 assets serve the financing of terrorism (art. 260quinquies para. 1 scc).5 the duty under paragraph 4 does not apply if a report has already been filed by a financial intermediary affiliated to a self-regulatory organisation.141 amended by annex no 17 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207; bbl 2006 2829).142 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).143 sr 311.0144 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).145 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).146 inserted by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).art. 28147 withdrawal of recognition 1 finma shall not withdraw recognition from a self-regulatory organisation under article 37 of the financial market supervision act of 22 june 2007148 without prior warning.2 if a self-regulatory organisation has its recognition withdrawn, its affiliated financial intermediaries must submit a request for affiliation with another self-regulatory organisation within two months.1493 and 4 .150147 amended by annex no 17 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207; bbl 2006 2829).148 sr 956.1149 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).150 repealed by annex no ii 15 of the financial institutions act of 15 june 2018, with effect from 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).chapter 4 administrative assistance section 1 cooperation among domestic authorities art. 29 exchange of information among authorities151 1 finma, the fgb, the intercantonal supervisory and executive authority under article 105 gambla152 and the reporting office may provide each other with any information or documents required for the enforcement of this act.1532 the federal, cantonal and communal authorities shall if requested by the reporting office or the central offices of the federal criminal police pass on to the reporting office or the said central offices all the data required for the analyses in relation to combating money laundering, its predicate offences, organised crime or the financing of terrorism. the data includes in particular financial information and other sensitive personal data and personality profiles obtained in criminal, administrative criminal and administrative proceedings, including those from pending proceedings.1542bis the reporting office may provide, on a case by case basis, the authorities referred to in paragraph 2 with information in individual cases provided the authorities use the information exclusively for combating money laundering, its predicate offences, organised crime or the financing of terrorism. article 30 paragraphs 2-5 applies by analogy.1552ter the reporting office may only pass on information from foreign reporting offices with their express consent to the authorities referred to in paragraph 2 for the purposes mentioned in paragraph 2bis.1563 the reporting office shall inform finma, the fgb and the intercantonal supervisory and executive authority under article 105 gambla of the decisions of the cantonal prosecution authorities.157151 inserted by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).152 sr 935.51153 amended by annex no ii 8 of the gambling act of 29 sept. 2017, in force since 1 jan. 2019 (as 2018 5103; bbl 2015 8387).154 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).155 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).156 inserted by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).157 amended by annex no ii 8 of the gambling act of 29 sept. 2017, in force since 1 jan. 2019 (as 2018 5103; bbl 2015 8387).art. 29a158 prosecution authorities 1 the prosecution authorities shall notify the reporting office without delay of any pending proceedings connected with articles 260ter, 260quinquies paragraph 1, 305bis and 305ter paragraph 1 scc159.160 they shall provide the reporting office without delay with judgements and decisions on the closure of proceedings, including the grounds therefor.2 they shall also notify the reporting office without delay of rulings that they have issued on the basis of a report from the reporting office.3 they may provide finma, the fgb and the intercantonal supervisory and executive authority under article 105 gambla161 with any information and documents that they require in order to fulfil their duties, provided that this is not prejudicial to the criminal proceedings.1624 finma, the fgb and the intercantonal supervisory and executive authority under article 105 gambla shall coordinate any intervention in relation to a financial intermediary with the competent prosecution authorities.163 they shall consult with the competent prosecution authorities before passing on any information or documents received.158 inserted by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 feb. 2009 (as 2009 361; bbl 2007 6269).159 sr 311.0160 amended by annex no ii 6 of the fedd of 25 sept. 2020 on the approval and implementation of the council of europe convention on the prevention of terrorism and its additional protocol and the strengthening of criminal justice instruments for combating terrorism and organised crime, in force since 1 july 2021 (as 2021 360; bbl 2018 6427).161 sr 935.51162 amended by annex no ii 8 of the gambling act of 29 sept. 2017, in force since 1 jan. 2019 (as 2018 5103; bbl 2015 8387).163 amended by annex no ii 8 of the gambling act of 29 sept. 2017, in force since 1 jan. 2019 (as 2018 5103; bbl 2015 8387).section 2 cooperation with foreign authorities art. 30164 cooperation with foreign reporting offices 1 the reporting office may pass on the personal data and other information that are in its possession or that it may obtain under this act to a foreign reporting office provided that office:a. guarantees that it will use the information solely for the purpose of analysis in the context of combating money laundering and its predicate offences, organised crime or terrorist financing;b. guarantees that it will reciprocate on receipt of a similar request from switzerland;c. guarantees that official and professional secrecy will be preserved;d. guarantees that it will not pass on the information received to third parties without the express consent of the reporting office; ande. will comply with the conditions and restrictions imposed by the reporting office.2 it may pass on the following information in particular:a.165the name of the financial intermediary or the dealer, provided the anonymity is preserved of the person making the report or who has complied with a duty to provide information under this act;b. account holders, account numbers and account balances;c. beneficial owners; d. details of transactions.3 information is passed on in the form of a report.4 the reporting office may consent to information being passed on by the foreign reporting office to a third authority provided the latter guarantees that:a. it will use the information solely:1. for the purpose of analysis in the context of combating money laundering and its predicate offences, organised crime or terrorist financing, or 2. to institute criminal proceedings relating to money laundering and its predicate offences, organised crime or terrorist financing or to obtain evidence in response to a request for mutual assistance relating to such criminal proceedings;b. they will not use the information to prosecute offences that are not offences predicate to money laundering under swiss law;c. they will not use the information in evidence; and d. they will preserve official or professional secrecy.5 if the request to pass on the information to a foreign third authority concerns a matter that is the subject of criminal proceedings in switzerland, the reporting office shall first obtain the consent of the public prosecutor's office responsible for the proceedings.6 the reporting office is entitled to make more detailed arrangements on the modalities of cooperation with foreign reporting offices.164 amended by no i of the fa of 21 june 2013, in force since 1 nov. 2013 (as 2013 3493; bbl 2012 6941).165 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).art. 31166 refusal to provide information a request for information from a foreign reporting office shall not be granted if:a. the request has no connection with switzerland;b. the request requires the application of procedural compulsion or other measures or acts for which swiss law stipulates mutual assistance procedures or another procedure regulated in special legislation or an international treaty;c. national interests or public security and order will be prejudiced.166 amended by no i of the fa of 21 june 2013, in force since 1 nov. 2013 (as 2013 3493; bbl 2012 6941).art. 31a167 applicable provisions of the federal act of 7 october 1994 on central offices of the federal criminal police unless this act provides otherwise in relation to data processing and administrative assistance provided by the reporting office, the first and fourth sections of the federal act of 7 october 1994168 on the central offices of the federal criminal police apply by analogy.167 inserted by no i of the fa of 21 june 2013, in force since 1 nov. 2013 (as 2013 3493; bbl 2012 6941).168 sr 360art. 32 cooperation with foreign prosecution authorities169 1 the cooperation of the reporting office with foreign prosecution authorities is governed by article 13 paragraph 2 of the federal act of 7 october 1994170 on the central offices of the federal criminal police.2 .1713 the name of the person who made the report on behalf of the financial intermediary or the dealer or who complied with the duty to provide information under article 11a may not be passed on by the reporting office to foreign prosecution authorities.172169 amended by no i of the fa of 21 june 2013, in force since 1 nov. 2013 (as 2013 3493; bbl 2012 6941).170 sr 360171 repealed by no i of the fa of 21 june 2013, with effect from 1 nov. 2013 (as 2013 3493; bbl 2012 6941).172 inserted by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force (as 2009 361; bbl 2007 6269). amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).chapter 5 processing of personal data art. 33 principle the processing of personal data is governed by the federal act of 19 june 1992173 on data protection.173 sr 235.1art. 34 data collections in connection with the duty to report 1 financial intermediaries must maintain separate data collections containing all the documents connected with the report filed.2 data from these data collections may be passed on only to finma, the fgb, the intercantonal supervisory and executive authority under article 105 gambla174, the supervisory organisation, self-regulatory organisations, the reporting office and the prosecution authorities.1753 the right to information of persons concerned in accordance with article 8 of the federal act of 19 june 1992176 on data protection shall be suspended from the filing of a report under article 9 paragraph 1 of this act or under article 305ter paragraph 2 scc177 until the time when the reporting office informs the financial intermediary under article 23 paragraph 5 or 6 and for as long as assets are frozen in accordance with article 10.1784 the data must be destroyed five years after the report is filed.174 sr 935.51175 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). corrected by the federal assembly drafting committee on 31 jan. 2020, published on 18 feb. 2020 (as 2020 501).176 sr 235.1177 sr 311.0178 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).art. 35 processing by the reporting office 1 the processing of personal data by the reporting office is governed by the federal act of 7 october 1994179 on the central offices of the federal criminal police. the right of private individuals to information is governed by article 8 of the federal act of 13 june 2008180 on federal police information systems.1812 they may on pass on data from these data files to finma, the fgb, the intercantonal supervisory and executive authority under article 105 gambla182, self-regulatory organisations, the reporting office and prosecution authorities.183179 sr 360180 sr 361181 amended by annex 1 no 9 of the fa of 13 june 2008 on federal police information systems, in force since 5 dec. 2008 (as 2008 4989; bbl 2006 5061).182 sr 935.51183 amended by annex no ii 8 of the gambling act of 29 sept. 2017, in force since 1 jan. 2019 (as 2018 5103; bbl 2015 8387).art. 35a184 verification 1 in order to fulfil its duties, the reporting office may by means of a computerised access procedure verify whether a person reported or notified to it is listed in any of the following databases:a. the national police index;b. the central migration information system;c. the automated register of convictions;d. the state security information system;e. the person, file and case management system used in the field of mutual assistance in criminal matters.2 the right of access for further information is governed by the provisions applicable to the information system concerned.184 inserted by annex 1 no 9 of the fa of 13 june 2008 on federal police information systems, in force since 5 dec. 2008 (as 2008 4989; bbl 2006 5061).chapter 6 criminal provisions and procedure art. 36185 185 repealed by annex no 17 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207; bbl 2006 2829).art. 37186 violation of the duty to report 1 any person who fails to comply with the duty to report in terms of article 9 shall be liable to a fine not exceeding 500,000 francs.2 if the offender acts through negligence, he or she shall be liable to a fine not exceeding 150,000 francs.3 .187186 amended by annex no 17 of the financial market supervision act of 22 june 2007, in force since 1 jan. 2009 (as 2008 5207; bbl 2006 2829).187 repealed by annex no 12 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 38188 violation of the duty to verify 1 any dealer that wilfully violates its duty under article 15 to appoint an audit firm, shall be liable to a fine not exceeding 100,000 francs.2 if it acts through negligence, it shall be liable to a fine not exceeding 10,000 francs.188 amended by no i 7 of the fa of 12 dec. 2014 on the implementation of the 2012 revision of the recommendations of the financial action task force, in force since 1 jan. 2016 (as 2015 1389; bbl 2014 605).art. 39 and 40189 189 repealed by annex no 17 of the financial market supervision act of 22 june 2007, with effect from 1 jan. 2009 (as 2008 5207; bbl 2006 2829).chapter 7 final provisions art. 41190 implementation 1 the federal council shall issue the provisions required for the implementation of this act.2 it may authorise finma, the fgb, the fdjp and the fca191 to issue implementing provisions on matters of limited importance and in particular on matters of a primarily technical nature.192190 amended by no i 4 of the fa of 3 oct. 2008 on the implementation of the revised recommendations of the financial action task force, in force since 1 jan. 2010 (as 2009 361 6401; bbl 2007 6269).191 now the focbs.192 amended by no i 8 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 42193 transitional provision to the amendment of 15 june 2018 1 financial intermediaries as defined in article 2 paragraph 3 which at the time of the entry into force of the amendment to this act of 15 june 2018 have finma authorisation in accordance with article 14 must join a recognised self-regulatory organisation. they must submit their request within one year. they may continue to perform their activity until a decision has been made concerning their request.2 the final provisions of the pmca194 apply to trade assayers and group companies subject to the pmca.195193 amended by annex no ii 15 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).194 sr 941.31195 amended by no i of the fa of 19 march 2021, in force since 1 jan. 2022 (as 2021 656; bbl 2019 5451).art. 43 amendment of current legislation relevant to the french text onlyart. 44 referendum and commencement 1 this act is subject to an optional referendum.2 the federal council determines the date on which this act comes into force.commencement date: 1 april 1998196196 fcd of 16 march 1998.

956.1english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton the swiss financial market supervisory authority(financial market supervision act, finmasa)of 22 june 2007 (status as of 1 january 2022) 2021 656the federal assembly of the swiss confederation,based on articles 95 and 98 of the federal constitution1,and having considered the federal council dispatch dated 1 february 20062,decrees:1 sr 1012 bbl 2006 2829title 1 general provisions3 3 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). art. 1 subject matter 1 the confederation shall create an authority for the supervision of the financial markets in accordance with the following acts (the financial market acts):a. mortgage bond act of 25 june 19304;b. federal act on contracts of insurance of 2 april 19085;c. collective investment schemes act of 23 june 20066;d. banking act of 8 november 19347;e.8 financial institutions act of 15 june 20189;f. anti-money laundering act of 10 october 199710;g. insurance supervision act of 17 december 200411;h.12 financial market infrastructure act of 19 june 201513;i.14 financial services act of 15 june 201815.2 this act establishes the organisation and the supervisory instruments of this authority.4 sr 211.423.45 sr 221.229.16 sr 951.317 sr 952.08 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).9 sr 954.110 sr 955.011 sr 961.0112 inserted by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).13 sr 958.114 inserted by annex no 4 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).15 sr 950.1art. 2 relationship with the financial market acts 1 this act applies unless the financial market acts provide otherwise.2 international treaties concluded within the context of international withholding tax and their associated international agreements, specifically in relation to transnational audits and market access, take precedence over this act and financial market legislation.1616 inserted by art. 46 of the fa of 15 june 2012 on international withholding tax, in force since 20 dec. 2012 (as 2013 27; bbl 2012 4943).art. 3 supervised persons and entities the following are subject to financial market supervision:a. persons and entities that under the financial market acts require to be licensed recognised, or registered by the financial market supervisory authority; andb. collective capital investments;c.17 .17 repealed by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), with effect from 1 jan. 2015 (as 2014 4073; bbl 2013 6857).art. 418 objectives of financial market supervision in accordance with the financial market acts, financial market supervision has the objectives of protecting creditors, investors, and insured persons as well as ensuring the proper functioning of the financial market. it thus contributes to sustaining the reputation, competitiveness and sustainability of switzerland's financial centre.18 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2019 (as 2018 5247; bbl 2015 8901).title 2 financial market supervisory authority19 19 inserted by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). chapter 1 general provisions20 20 inserted by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). art. 521 legal form, seat and name 1 the authority that supervises the financial market is a public law institution with its own legal personality and official seat in bern.2 its name is the swiss financial market supervisory authority (finma).3 it organises itself according to the principles of good corporate governance and economic management. it keeps its own accounts.21 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2019 (as 2018 5247; bbl 2015 8901).art. 6 tasks 1 finma carries out its supervision according to the financial market acts and this act.2 it fulfils the international tasks that are related to its supervisory activity.art. 7 principles of regulation 1 finma exercises its regulatory powers by issuing: a. ordinances, where so provided in the financial market legislation; andb. circulars on the application of the financial market legislation.2 it issues ordinances and circulars only to the extent required for the purposes of supervision, limiting itself as far as possible to the definition of principles. in doing so, it takes account of overriding federal law and in particular of:22a. the costs that the supervised persons and entities incur due to regulation; b. the effect that regulation has on competition, innovative ability and the international competitiveness of switzerland's financial centre;c.23 the different sizes, complexities, structures, business activities and risks of the supervised persons and entities; andd. the international minimum standards.3 it supports self-regulation and may recognise and implement the same as a minimum standard within terms of its supervisory powers.4 it provides for a transparent regulatory process and the appropriate participation of the parties concerned.5 it issues guidelines on the implementation of these principles. in doing so, it acts in agreement with the federal department of finance (fdf)24.22 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).23 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).24 name in accordance with annex no 4 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901). this amendment has been made throughout the text.chapter 2 organisation section 1 management bodies and staff art. 8 management bodies the management bodies of finma are:a. the board of directors;b. the management board;c. the auditor.art. 9 board of directors 1 the board of directors is the strategic management body of finma. it has the following tasks:a. it determines the strategic objectives of finma and submits them to the federal council for approval.b. it decides on matters of substantial importance.c. it issues the ordinances delegated to finma and decides on the circulars.d. it supervises the management board.e. it establishes an internal audit unit and provides for internal controls.f. it draws up the annual report and submits it to the federal council for approval prior to publication.g. it appoints the chief executive officer, subject to approval by the federal council.h. it appoints the members of the management board.i. it issues the organisational regulations and the guidelines on information activities.j. it approves the budget.2 it comprises seven to nine expert members, who are independent of the supervised persons and entities. the board of directors is appointed for a term of office of four years; each member may be reappointed twice.3 the federal council appoints the board of directors. in doing so, it must ensure the appropriate representation of both genders. it appoints the chair and the vice-chair. it determines the level of remuneration. article 6a of the federal personnel act of 24 march 200025 applies by analogy.4 the chair may not carry out any other economic activity nor hold any federal or cantonal office unless this is in the interest of the fulfilment of the tasks of finma.5 the federal council removes members of the board of directors and approves the decision of the board of directors to terminate the employment of the chief executive officer if the requirements for holding office are no longer fulfilled.25 sr 172.220.1art. 10 management board 1 the management board is the operational management body. it is headed by a chief executive officer.2 it has the following tasks in particular:a. it issues rulings in accordance with the organisational regulations.b. it prepares the files and materials on which the board of directors bases its decisions and reports to it regularly, and in the case of special events immediately.c. it carries out all the tasks that are not assigned to another management body.3 the organisational regulations regulate the details.art. 11 supervision areas 1 finma is divided into supervision areas. the organisational regulations regulate the details.2 the federal council and the board of directors ensure the appropriate representation of the various supervision areas on the board of directors and the management board.art. 12 auditor the federal audit office is the external auditor and provides the board of directors and the federal council with a report on the result of its audit.art. 1326 staff 1 the employment of finma staff is governed by public law.2 article 6a of the federal personnel act of 24 march 200027 applies by analogy.3 the occupational pension scheme for the staff is governed by the legislation on the federal pension fund. 4 the board of directors regulates in an ordinance:a. the employment of personnel and in particular salaries, additional benefits, working hours, duty of loyalty and termination of employment;b. the composition, election and organisation of the joint committee for the finma pension fund.5 the board of directors shall submit the ordinance to the federal council for approval.art. 13a28 data processing1 finma shall process, in hard copy or in one or more information systems, the data on its employees necessary for performing the tasks in accordance with this act, particularly for:a. creating, executing and terminating an employment relationship;b. personnel and wage management;c. personnel development;d. performance appraisal; e. reintegration measures in the event of illness and accident.2 it may process the following data pertaining to its employees necessary for performing the tasks set out in paragraph 1, including sensitive personal data and personality profiles:a. personal details;b. state of health details with regard to working ability;c. performance and potential information, as well as data on personal and professional development;d. data required within the framework of participation in the implementation of social security law;e. case files and authorities' decisions associated with work.3 it shall issue implementing regulations with regard to:a. the architecture, organisation and operation of the information system(s);b. the processing of data, particularly gathering, storage, archiving and destruction;c. data processing authorisations;d. the data categories under paragraph 2;e. data protection and security.26 amended by annex no 4 of the fa of 14 dec. 2012, in force since 1 july 2013 (as 2013 1493; bbl 2011 6703).27 sr 172.220.128 inserted by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 14 official secrecy 1 the staff and the management bodies must observe secrecy on official matters.2 the duty of secrecy continues to apply after termination of employment or membership of a management body of finma.3 the staff and the individual members of the management bodies of finma may not without authorisation from finma disclose in evidentiary hearings and in court proceedings as parties, witnesses or expert witnesses matters that have come to their knowledge in the course of their duties and that relate to their official tasks.4 official secrecy applies to all finma agents (audit agents, investigating agents, restructuring agents, liquidators, administrators in bankruptcy).2929 amended by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).section 2 funding and financial budget art. 15 funding 1 finma levies fees for supervisory proceedings in individual cases and for services. in addition, it levies an annual supervision charge on the supervised persons and entities for each supervision area to cover the costs incurred by finma that are not covered by the fees.2 the supervision charge is assessed according to the following criteria:a.30 .abis.31 for supervised persons and entities under article 1a of the banking act of 8 november 193432, article 2 paragraph 1 letter e of the financial institutions act of 15 june 201833 and the mortgage bond act of 25 june 193034, on the basis of the balance sheet total and securities turnover; for supervised persons and entities under article 2 paragraph 1 letters c and d of the financial institutions act on the basis of the amount of assets managed, the gross earnings and the size of the undertaking; for supervised persons and entities under article 1b of the banking act, on the basis of the balance sheet total and the gross earnings.ater.35 for supervised persons and entities under the financial market infrastructure act of 19 june 201536, on the basis of the balance sheet total and securities turnover, or gross earnings if no securities are transacted.b. for supervised persons and entities under the collective investment schemes act of 23 june 200637, on the basis of the amount of assets managed, the gross earnings and the size of the undertaking.c. for insurance institutions under the insurance supervision act of 17 december 200438, on the basis of their share of the total premium income for all insurance institutions; for insurance agents under article 43 paragraph 1 of the insurance supervision act of 17 december 2004, on the basis of their number and the size of the undertaking.d.39 for self-regulatory organisations under the anti-money laundering act of 10 october 199740 (amla), on the basis of the gross earnings and number of members;e.41 for a supervisory organisation in accordance with title 3, the share accounted for by its supervised persons and entities with regard to the total number of supervised persons and entities of all supervisory organisations is decisive; the supervision fee also covers the costs that finma incurs that are caused by supervised persons and entities and which are not covered by other charges.3 the federal council may provide for the apportionment of the supervision fee into a fixed basic fee and a variable supplementary fee.4 it regulates the details, and in particular:a. the assessment principles;b. the supervision areas under paragraph 1; andc. the apportionment of the costs to be financed by the supervision charge among the supervision areas.30 obsolete. see art. 75 para. 5 of the financial institutions act of 15 june 2018 (sr 954.1).31 inserted by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).32 sr 952.033 sr 954.134 sr 211.423.435 originally: let. abis. inserted by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).36 sr 958.137 sr 951.3138 sr 961.0139 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).40 sr 955.041 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 16 reserves finma shall within a reasonable time form reserves for the exercise of its supervisory activity in an amount equivalent to one annual budget.art. 17 treasury 1 the federal finance administration manages the liquid assets of finma as part of its central treasury.2 it grants finma loans on market terms in order to guarantee its liquidity.3 the federal finance administration and finma determines the details of their cooperation by mutual agreement.art. 18 accounting 1 the financial statements of finma disclose in full its assets and liabilities, earnings and costs. 2 they follow the general principles of materiality, intelligibility, consistency and gross presentation and comply with the generally recognised standards.3 the accounting and valuation rules derived from the accounting standards must be disclosed.art. 19 liability 1 the liability of finma, its management bodies, its staff and finma agents is governed by the government liability act of 14 march 195842, subject to paragraph 2 below.432 finma and its agents are liable only if:a. they have committed a breach of fundamental duties; andb. loss or damage is not due to a breach of duty by a supervised person or entity.42 sr 170.3243 amended by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).art. 20 tax exemption 1 finma is exempt from any taxation by the confederation, the cantons or the communes.2 the federal legislation on:a. value added tax;b. withholding tax;c. stamp duties,is reserved.section 3 independence and supervision art. 21 1 finma carries out its supervisory activity autonomously and independently.2 at least once each year, it reviews the strategy for its supervisory activity and current issues of financial centre policy with the federal council.3 it deals with the federal council via the fdf.4 the national council and the council of states are responsible for its superintendence.section 4 information for the general public and data processing art. 22 information for the general public 1 finma informs the general public at least once each year about its supervisory activity and supervisory practices.2 it does not provide information on individual proceedings, unless there is a particular need to do so from a supervisory point of view and in particular if the information is necessary:a. for the protection of market participants or the supervised persons and entities;b. to correct false or misleading information; orc. to safeguard the reputation of switzerland's financial centre.3 where finma has provided information on individual proceedings, it must also provide immediate notice of the closure of the proceedings. this may be dispensed with at the request of the party concerned.4 finma takes account of the personality rights of those concerned in all its information activities. personal data may be published in electronic or printed form.art. 23 data processing and public directory 1 as part of its supervisory activity under this act and the financial market acts, finma processes personal data, including particularly sensitive personal data and personality profiles. it regulates the details.2 it maintains a directory of the supervised persons and entities. this directory is accessible to the public in electronic form.chapter 3 supervisory instruments section 1 audit art. 2444 principle 1 in accordance with the financial market acts (art. 1 para. 1), finma carries out the audit either itself or arranges for it to be carried out:a. by licensed audit companies appointed by the supervised persons and entities and der federal audit oversight authority under article 9a des auditor oversight act of 16 december 200545; orb. audit agents in accordance with article 24a.2 the audit relates in particular to the risks that supervised persons and entities may pass on to creditors, investors, insured persons or to the proper function of the financial markets. duplication of auditing work must be avoided as far as possible.3 article 730b paragraph 2 of the code of obligations46 applies by analogy to the preservation of confidentiality by audit companies.4 in relation to audits under paragraph 1 letter a, the federal council regulates the main aspects of the content and conduct of the audit and the form of the report. it may authorise finma to issue implementing provisions on technical matters.5 the supervised persons and entities bear the costs of the audit.44 amended by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).45 sr 221.30246 sr 220art. 24a47 audit agents 1 finma may instruct an independent and suitably qualified person to conduct audits of supervised persons and entities.2 it specifies the duties of the audit agent in the appointment order.3 the supervised persons and entities bear the agent's costs.47 inserted by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).art. 2548 duties of the audited supervised persons and entities 1 where an audit company is appointed or if finma appoints an audit agent, the supervised persons and entities must provide them with all information and documents that are required to carry out their tasks.2 the supervised person or entity must notify finma of its choice of audit company.48 amended by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).art. 2649 49 repealed by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), with effect from 1 jan. 2015 (as 2014 4073; bbl 2013 6857).art. 27 reporting and measures 1 the audit company provides finma with a report on its audits. the audit company provides the supreme management body of the audited supervised person or entity with a copy of the report.50 2 if it identifies violations of supervisory provisions or other irregularities, it shall give the audited supervised person or entity an appropriate period to restore compliance with the law. if the period is not complied with, it informs finma.3 in the case of serious violations of supervisory provisions or serious irregularities, the audit company notifies finma immediately.50 amended by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).art. 28 supervision of the audit companies 1 .512 finma and the federal audit oversight authority provide each other with all the information and documents that each need to enforce the relevant legislation.5251 repealed by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), with effect from 1 jan. 2015 (as 2014 4073; bbl 2013 6857).52 amended by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).art. 28a53 appointment and change of the audit company 1 two different audit companies must be instructed for the audit under the licensing procedure and the other audits.2 in justified cases, finma may require the supervised person or entity to change audit company.3 finma shall notify the federal audit oversight authority before ordering a change under paragraph 2.53 inserted by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).section 2 further supervisory instruments art. 29 duty to provide information and to report 1 the supervised persons and entities, their audit companies and auditors as well as persons or companies that are qualified investors or that have a substantial participation in the supervised persons and entities must provide finma with all information and documents that it requires to carry out its tasks.2 the supervised persons and entities and the audit companies that conduct audits of them must also immediately report to finma any incident that is of substantial importance to the supervision.5454 amended by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).art. 30 notice of the opening of proceedings where there are indications of violations of supervisory provisions and if finma opens proceedings, it notifies the parties of this.art. 31 restoration of compliance with the law 1 where a supervised person or entity violates the provisions of this act or of a financial market act or if there are any other irregularities, finma shall ensure the restoration of compliance with the law.2 where the rights of clients appear to be jeopardised, finma may require the supervised persons or entities to provide collateral.5555 inserted by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 32 declaratory ruling and substitute performance56 1 where the proceedings reveal that the supervised person or entity has seriously violated supervisory provisions, but there is no longer a need to order measures to restore compliance with the law, finma may issue a declaratory ruling.2 if an enforceable ruling from finma is not observed within the set deadline after a prior warning, finma may perform the required act itself or have it performed at the expense of the defaulting party.5756 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).57 inserted by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 33 prohibition from practising a profession 1 if finma detects a serious violation of supervisory provisions, it may prohibit the person responsible from acting in a management capacity at any person or entity subject to its supervision.2 the prohibition from practising a profession may be imposed for a period of up to five years.art. 33a58 prohibition from performing an activity1 where the following persons seriously violate the provisions of the financial market acts, the implementing provisions or in-house directives, finma may prohibit such persons from trading in financial instruments or acting as a client adviser for a fixed period, or permanently in the case of repeated offences:a. employees of a supervised entity responsible for trading in financial instruments;b. employees of a supervised entity acting as client advisers.2 if the prohibited activity also covers an activity in an area under the supervision of another supervisory authority, this authority is to be consulted and informed of the decision.58 inserted by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 34 publication of the supervisory ruling 1 where there is a serious violation of supervisory provisions, finma may publish in electronic or printed form its final ruling once it takes full legal effect, and disclose the relevant personal data.2 notice of publication must be contained in the ruling itself.art. 35 confiscation 1 finma may confiscate any profit that a supervised person or entity or a responsible person in a management position has made through a serious violation of the supervisory provisions.2 the foregoing provision applies by analogy if a supervised person or entity or a responsible person in a management position has prevented a loss through a serious violation of supervisory provisions.3 where the extent of the assets to be confiscated cannot be ascertained or requires a disproportionate effort to be ascertained, finma may make an estimate.4 the right to confiscate prescribes after seven years.5 criminal law confiscation under articles 70-72 of the criminal code59 takes precedence over confiscation under this provision.6 the confiscated assets go to the confederation unless they are paid to the parties suffering loss.59 sr 311.0art. 36 investigating agents 1 finma may appoint an independent and suitably-qualified person to investigate circumstances relevant for supervisory purposes at a supervised person or entity or to implement supervisory measures that it has ordered (an investigating agent).2 it specifies the duties of the investigating agent in the appointment order. it determines the extent to which the investigating agent may act in the place of the management bodies of the supervised person or entity.3 the supervised person or entity must allow the investigating agent access to its premises and provide him or her with all the information and documents that the investigating agent requires to fulfil his or her duties.4 the costs of the investigating agent are borne by the supervised person or entity. it must if so instructed by finma make an advance payment to cover costs.art. 37 revocation of licence, withdrawal of recognition60 1 finma shall revoke the licence of a supervised person or entity, or withdraw its recognition if it no longer fulfils the requirements for its activity or seriously violates the supervisory provisions.612 on revocation, withdrawal or cancellation, the supervised person or entity loses its right to carry out its activity. the other consequences of revocation, withdrawal or cancellation are governed by the applicable financial market acts.3 these consequences apply by analogy if a supervised person or entity carries out its activity without a licence, recognition, or registration.60 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).61 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).section 3 cooperation with domestic authorities art. 38 prosecution authorities 1 finma and the competent prosecution authority shall exchange the information that they require in the context of their collaboration and in order to fulfil their tasks. they shall use the information received exclusively to fulfil their respective tasks.622 they coordinate their investigations, as far as is practicable and required.3 where finma obtains knowledge of common law felonies and misdemeanours or of offences against this act or the financial market acts, it shall notify the competent prosecution authorities.62 amended by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 3963 other domestic authorities 1 finma is authorised to provide other domestic supervisory authorities and the swiss national bank with non-public information that they need to fulfil their tasks.1bis finma and the supervisory authority under the health insurance oversight act of 26 september 201464 shall coordinate their supervisory activities. they shall inform each other as soon as they become aware of events that are of significance to the other supervisory authority.652 finma may also exchange non-public information on certain financial market participants with the fdf where this helps maintain the stability of the financial system.6663 amended by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).64 sr 832.1265 inserted by annex no 4 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).66 amended by annex no 4 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).art. 40 grounds for refusal finma may refuse to disclose information that is not publicly accessible or to hand over files to prosecution authorities and other domestic authorities where:a. the information and the files solely serve the purpose of forming internal opinions;b. their disclosure or handover would prejudice ongoing proceedings or the fulfilment of its supervisory activity;c. it is not compatible with the aims of financial market supervision or with its purpose.art. 41 disputes at the request of any of the authorities concerned, the federal administrative court rules on disputes relating to the cooperation between finma on the one hand and prosecution authorities or other domestic authorities on the other.art. 41a67 communication of judgments1 the cantonal civil courts and the federal supreme court shall provide finma free of charge with a full copy of their judgment in relation to disputes between a supervised person or entity and creditors, investors or insured parties.2 finma shall forward to the supervisory organisation the judgments concerning the supervisory organisation's supervised persons and entities.67 inserted by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).section 4 cooperation with foreign bodies68 68 amended by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483). art. 4269 administrative assistance 1 in order to implement the financial market acts, finma may ask foreign financial market supervisory authorities to provide information.2 it may transmit non-public information to foreign financial market supervisory authorities only if:a. this information is used exclusively to implement financial market law, or is forwarded to other authorities, courts or bodies for this purpose;b. the requesting authorities are bound by official or professional secrecy, notwithstanding provisions on the public nature of proceedings and the notification of the general public about such proceedings.3 paragraphs 1 and 2 apply by analogy to the exchange of information between finma and foreign authorities, courts and bodies involved in the restructuring and resolution of authorised parties.4 the administrative assistance shall be carried out swiftly. finma shall observe the principle of proportionality. the transmission of information concerning persons who are manifestly uninvolved in the matter being investigated is not permitted.5 finma may, in agreement with the federal office of justice, authorise the forwarding of information to prosecution authorities for purposes other than those mentioned in paragraph 2 letter a, provided that mutual legal assistance in criminal matters is not excluded.69 amended by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 42a70 administrative assistance proceedings 1 if finma does not yet have the information to be transmitted, it may request it from the information holders. the persons called on to provide information may refuse to answer questions by virtue of article 16 of the administrative procedure act of 20 december 196871.2 subject to paragraphs 3 to 6, the administrative procedure act applies to information regarding individual clients which is to be transmitted by finma.3 finma may refuse the right of access to the correspondence with foreign authorities. article 28 of the administrative procedure act remains reserved.4 finma may exceptionally refrain from informing the clients concerned before transmitting the information if the purpose of the administrative assistance and the effective fulfilment of the requesting authority's tasks would be compromised by prior notification. in such cases, the clients concerned shall be informed afterwards.5 in the cases detailed in paragraph 4, finma shall inform the information holders and the authorities notified of the request about the postponement of notification. these may not provide information about the request until the clients in question have been informed.6 the decision of finma on the transmission of information to the foreign financial market supervisory authority may be challenged by the client before the federal administrative court within ten days. article 22a of the administrative procedure act does not apply. in the cases detailed in paragraph 4, the request may only cite a declaration of unlawfulness.70 inserted by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).71 sr 172.021art. 42b72 cooperation with international organisations and bodies 1 in order to fulfil its tasks in accordance with article 6, finma may participate in multilateral initiatives of international organisations and bodies which give rise to the exchange of information.2 in the case of multilateral initiatives which have far-reaching implications for the swiss financial centre, participation in the exchange of information shall take place in agreement with the fdf.3 when participating, finma may transmit non-public information to international organisations and bodies only if:a. this information is used exclusively to fulfil tasks associated with the development of and compliance with regulatory standards or to analyse systemic risks;b. confidentiality is ensured.4 finma shall agree the precise intended use and any forwarding of the information transmitted with the international organisations and bodies. paragraph 3 remains reserved.72 inserted by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 42c73 transmission of information by supervised parties 1 supervised parties may transmit non-public information to the foreign financial market supervisory authorities responsible for them and to other foreign entities responsible for supervision provided:a. the conditions set out in article 42 paragraph 2 are fulfilled;b. the rights of clients and third parties are preserved.2 furthermore, they may transmit non-public information related to the transactions of clients and supervised parties to foreign authorities and to entities acting on the authorities' behalf if the rights of clients and third parties are preserved.3 the transmission of information that is of substantial importance in accordance with article 29 paragraph 2 must be reported to finma beforehand. 4 finma may reserve administrative assistance channels. 5 it may make the transmission, publication or forwarding of files in the context of supervision subject to its approval if this is in the interest of its task fulfilment and is not in conflict with overriding private or public interests.73 inserted by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 43 cross-border audits 1 in order to implement the financial market acts, finma may itself carry out direct audits of supervised persons and entities abroad or have such audits carried out by audit agents.742 it may permit foreign financial market supervisory authorities to carry out direct audits of supervised parties provided:a. these authorities are responsible for the supervision of the audited supervised party as part of home country supervision or are responsible for supervising the activity of the audited supervised party in their territory; andb. the conditions for administrative assistance set out in article 42 paragraph 2 are fulfilled.753 information may be collected through cross-border direct audits only if it is required for the supervisory activity of the foreign financial market supervisory authority. this includes in particular information on whether an institution throughout its group structure:a. is appropriately organised;b. records, limits and monitors in an appropriate manner the risks inherent in its business operations;c. is managed by persons who guarantee proper business conduct;d. fulfils the own funds and risk diversification regulations on a consolidated basis; ande. properly complies with its reporting duties vis--vis the supervisory authorities.763bis if during direct audits in switzerland foreign financial market supervisory authorities wish to consult information linked directly or indirectly to the asset management, securities trading or deposit business for individual clients, finma shall collect this information itself and transmit it to the requesting authorities. the same applies to information which directly or indirectly relates to individual investors in collective investment schemes. article 42a applies.77 3ter finma may, for the purposes detailed in paragraph 3, allow the foreign financial market supervisory authority which is responsible for the consolidated supervision of the audited supervised party to consult a limited number of individual client dossiers. the dossiers must be selected randomly on the basis of predefined criteria.784 finma may accompany the foreign authorities responsible for financial market supervision on their direct audits in switzerland or arrange for them to be accompanied by an audit company or an audit agent. the supervised persons and entities concerned may request such accompaniment.795 establishments organised under swiss law must provide the foreign financial market supervisory authorities and finma with the information required to carry out the direct audits or the information that finma requires to provide the administrative assistance, and must permit the inspection of their books.6 establishments are defined as:a. subsidiaries, branch offices and representative offices of supervised persons and entities or of foreign institutions; andb. other companies, provided their activity is included by a financial market supervisory authority in the consolidated supervision.74 amended by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).75 amended by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).76 amended by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).77 inserted by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).78 inserted by annex no 13 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).79 amended by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).title 380 supervision of portfolio managers and trustees81 80 inserted by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).81 amended by annex 1 no 4 of the fa of 19 march 2021, in force since 1 jan. 2022 (as 2021 656; bbl 2019 5451).chapter 1 general provisions art. 43a supervisory organisation1 the ongoing supervision of portfolio managers and trustees under article 16 of the financial institutions act of 15 june 201882 is performed by one or more supervisory organisations with their registered office in switzerland.83 2 the supervisory organisation shall require authorisation from finma before commencing its supervisory activity and shall be supervised by finma. 3 the supervisory organisation may also supervise financial intermediaries under article 2 paragraph 3 of the anti-money laundering act of 10 october 199784 (amla) with regard to compliance with their duties under amla, provided they are recognised as a self-regulatory organisation in accordance with article 24 amla.4 if the supervisory organisation is also active in accordance with paragraph 3 as a self-regulatory organisation, it shall ensure that this is evident to others at all times.art. 43b continuous supervision 1 the supervisory organisation shall continuously monitor whether portfolio managers and trustees in accordance with article 17 of the financial institutions act of 15 june 201885 are in compliance with the financial market legislation to which they are subject.862 where the supervisory organisation detects violations of supervisory provisions or other irregularities, it shall give the audited supervised person or entity an appropriate period to restore compliance with the law. if the period is not complied with, it informs finma.3 the federal council shall determine the main aspects and content of the continuous supervision. in doing so, it shall take account of the differing size and business risks of the supervised person or entity. it may authorise finma to issue implementing provisions on technical matters.85 sr 954.186 amended by annex 1 no 4 of the fa of 19 march 2021, in force since 1 jan. 2022 (as 2021 656; bbl 2019 5451).82 sr 954.183 amended by annex 1 no 4 of the fa of 19 march 2021, in force since 1 jan. 2022 (as 2021 656; bbl 2019 5451).84 sr 955.0chapter 2 authorisation art. 43c principle1 finma shall grant the supervisory organisation authorisation if the provisions of this chapter are complied with.2 it shall approve the supervisory organisation's articles of association and organisational regulations, as well as the appointment of the persons entrusted with its administration and management.3 prior authorisation or approval from finma must be obtained in the case of changes to circumstances requiring authorisation and documents requiring approval.4 if two or more supervisory organisations are established, the federal council may issue rules for the coordination of their activities and the subjection of the supervised persons and entities to a given supervisory organisation. art. 43d organisation 1 the supervisory organisation must effectively be managed from switzerland.2 it must have appropriate management rules and be organised in such a manner that it can fulfil its duties in accordance with this act. 3 it must have the financial and personnel resources necessary to perform its tasks.4 it must have a management board as the operational body. art. 43e guarantee of irreproachable business conduct and independence1 the supervisory organisation and the persons responsible for its management must provide a guarantee of irreproachable business conduct.2 moreover, the persons responsible for administration and management must enjoy a good reputation and have the specialist qualifications required for their functions.3 a majority of the persons charged with administration must be independent of the supervised persons and entities.4 the members of the management board must be independent of the persons and entities supervised by the supervisory organisation.5 the persons entrusted with supervision must be independent of the persons and entities they supervise. the tasks of a supervisory organisation under this act and those of a self-regulatory organisation under amla87 may be managed by the same persons and carried out by the same staff.art. 43f funding and reserves1 the supervisory organisation shall finance its supervisory in individual cases and when providing services from contributions paid by the supervised persons and entities. 2 the supervisory organisation shall form reserves within a reasonable time for the exercise of its supervisory activity in an amount equivalent to one annual budget.3 the confederation may grant the supervisory organisation a loan on market terms in order to guarantee its liquidity until the reserves in accordance with paragraph 2 have been formed in full.art. 43g liability article 19 applies by analogy to the supervisory organisation.87 sr 955.0chapter 3 supervision of the supervisory organisation art. 43h principles1 the supervisory organisation shall periodically inform finma about its supervisory activity. 2 finma shall verify whether the supervisory organisation meets the requirements under chapter 2 of this title and whether it is performing its supervisory tasks.3 the supervisory organisation must furnish finma with all the information and documents that finma requires to supervise the supervisory organisation.art. 43i measures1 finma shall take the necessary measures if the supervisory organisation does not meet the requirements under chapter 2 of this title or does not perform its supervisory tasks. 2 finma may dismiss persons who no longer fulfil the guarantee of irreproachable business conduct.3 if no other measure proves effective, finma may liquidate the supervisory organisation and transfer the supervisory activity to another supervisory organisation as a measure of last resort. 4 if there are indications of irregularities and the supervisory organisation does not take the measures required to restore compliance with the law, finma may:a. conduct an audit of the supervised person or entity;b. appoint an audit agent in accordance with article 24a; orc. make use of supervisory instruments in accordance with articles 29-37.chapter 4 data processing art. 43j article 23 applies by analogy.chapter 5 supervisory instruments of the supervisory organisation art. 43k auditing1 the supervisory organisation may carry out the audit of its supervised persons and entities itself or arrange for it to be carried out by an audit company that:a. is licensed as an auditor by the federal audit oversight authority in accordance with article 6 of the auditor oversight act of 16 december 200588;b. is adequately organised for this audit; andc. does not perform any other activity requiring authorisation under the financial market acts.2 for audits conducted by an audit company in accordance with paragraph 1, a lead auditor must be appointed who:a. is licensed by the federal audit oversight authority as an auditor in accordance with article 5 of the audit oversight act;b. possesses the required specialist knowledge and practical experience to conduct the audit in accordance with paragraph 1.3 articles 24 paragraphs 2-5 and 24a-28a apply by analogy.4 if so ordered by the supervisory organisation, the supervised persons and entities must make an advance payment to cover costs.art. 43l duty to provide information and to report 1 the supervised persons and entities, their audit companies and auditors as well as persons or companies that are qualified investors or that have a substantial participation in the supervised persons and entities must provide finma with all information and documents that it requires to carry out its tasks.2 the supervised persons and entities and the audit companies that conduct audits of them must also immediately report to finma any incident that is of substantial importance to the supervision.88 sr 221.302title 4 criminal provisions89 89 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). art. 44 activity without authorisation, recognition, a licence, registration or affiliation with a self-regulatory organisation90 1 any person who wilfully without authorisation, recognition, a licence, registration or affiliation with a self-regulatory organisation in accordance with article 24 paragraph 1 of the amla91 carries out an activity that requires authorisation, recognition, a licence, registration or affiliation with a self-regulatory organisation under the financial market acts is liable to a custodial sentence of up to three years or to a monetary penalty.922 where the offender acts through negligence, he or she is liable to a fine of up to 250 000 francs.3 .9390 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).91 sr 955.092 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).93 repealed by annex no 13 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 45 provision of false information 1 any person who wilfully provides finma, an audit company, a supervisory organisation a self-regulatory organisation, or an agent with false information is liable to a custodial sentence of up to three years or to a monetary penalty.942 where the offender acts through negligence, he or she is liable to a fine of up to 250 000 francs.3 .9594 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).95 repealed by annex no 13 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 46 violations of obligations by agents96 1 any person who as an agent wilfully and seriously violates the supervisory provisions by:97 a.98 falsely stating essential information in the report or withholding essential information;b. failing to make a mandatory report to finma; orc. failing to make an order under article 27 to the audited supervised person or entity,is liable to a custodial sentence of up to three years or to a monetary penalty.2 where the offender acts through negligence, he or she is liable to a fine of up to 250 000 francs.3 .9996 amended by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).97 amended by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).98 amended by annex no 8 of the fa of 20 june 2014 (consolidation of oversight through audit companies), in force since 1. jan. 2015 (as 2014 4073; bbl 2013 6857).99 repealed by annex no 13 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 47 audit of annual financial statements 1 any person who wilfully:a.100 fails to have the annual financial statements required by the financial market acts audited by a licensed audit company or to have an audit carried out that has been ordered by finma or a supervisory organisation;b. fails to fulfil his or her obligations vis--vis the audit company or the agent,is liable to a custodial sentence of up to three years or to a monetary penalty.2 where the offender acts through negligence, he or she is liable to a fine of up to 250 000 francs.3 .101100 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).101 repealed by annex no 13 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 48 non-compliance with rulings102 any person who wilfully fails to comply with a legally enforceable ruling issued by finma containing notice of the penalties under this article or with a decision of the appeal courts is liable to a fine of up to 100 000 francs.102 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 49 offences in business operations the ascertainment of the criminally liable persons may be dispensed with and instead the business operation may be ordered to pay the fine (art. 7 of the fa of 22 march 1974103 on administrative criminal law) where:a. the ascertainment of the persons who are criminally liable under article 6 of the federal act of 22 march 1974 on administrative criminal law requires investigative measures that are disproportionate in comparison with the penalty incurred; andb. a fine of a maximum of 50 000 francs is under consideration for the violations of the criminal provisions of this act or the financial market acts.103 sr 313.0art. 50 jurisdiction 1 for violations of the criminal provisions of this act or the financial market acts, the federal act of 22 march 1974104 on administrative criminal law applies, unless this act or the financial market acts provides otherwise. the authority responsible for prosecution and judgement is the fdf.2 where proceedings before the courts are requested or if the fdf is of the view that the requirements for a custodial sentence or a custodial measure are met, the offence is subject to federal jurisdiction. in such a case, the fdf shall refer the files to the office of the attorney general of switzerland for proceedings before the federal criminal court. the referral is deemed to be the bringing of charges articles 73-83 of the federal act of 22 march 1974 on administrative criminal law apply by analogy.3 the representatives of the office of the attorney general of switzerland and of the fdf are not required to appear in person at the trial.104 sr 313.0art. 51 unification of prosecution 1 in a criminal case, if both the jurisdiction of the fdf and federal or cantonal jurisdiction apply, the fdf may order that the prosecution be unified under the prosecution authority already dealing with the case, provided there is a close factual relation, the case is not yet pending before the competent court and unification will not unreasonably delay the ongoing proceedings.2 the appeals chamber of the federal criminal court decides on any disputes between the fdf and the office of the attorney general of switzerland or the cantonal authorities.art. 52 statute of limitations the prosecution of offences under this act and under the financial market acts become time barred after seven years.title 5 procedure and right of appeal105 105 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). art. 53 administrative procedure the procedure is governed by the provisions of the federal act of 20 december 1968106 on administrative procedure.106 sr 172.021art. 54 right of appeal 1 the contesting of finma rulings is governed by the provisions on the administration of federal justice.2 finma is entitled to appeal to the federal supreme court.title 6 final provisions107 107 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). chapter 1 implementation108 108 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). art. 55109 implementing provisions 1 the federal council shall issue the implementing provisions. in doing so, it shall observe the principles of regulation in article 7 paragraph 2 and base its regulation on the majority of the supervised persons or entities at the time. the foregoing is subject to more stringent requirements, in particular with regard to risks to the stability of the financial system.2 the federal council may authorise finma in matters of limited importance, and in particular in predominantly technical matters, to issue implementing provisions to this act and to the financial market acts.109 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 56 implementation finma is responsible for the implementation of this act and of the financial market acts.chapter 2 amendment of other legislative instruments110 110 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). art. 57 the amendment of current legislation is regulated in the annex.chapter 3 transitional provisions111 111 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). art. 58112 transitional provision to the amendment of 15 june 2018 applications for authorisation under article 43c paragraph 1 must be submitted no later than six months after the amendment of 15 june 2018 comes into force. finma shall issue a decision on the application within six months of receipt.112 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 59 transfer of employment relationships 1 the employment relationships of the staff of the federal banking commission, of the federal office of private insurance and of the anti-money laundering control authority shall be transferred in accordance with article 58 paragraph 1 to finma and shall be continued in accordance with this act.2 there is no right to the continuation of any function, field of work or position within the organisational system; however, staff have a right to their current salary for a period of one year.3 job application procedures will be carried out only if it proves necessary as a result of reorganisation or where there is more than one candidate.4 finma shall endeavour to carry out restructuring activities in a socially acceptable manner.art. 60 responsible employer 1 finma is the responsible employer for persons in receipt of a pension:a. who are allocated to the federal banking commission, the federal office of private insurance or the anti-money laundering control authority; andb. who have begun to draw an old age, invalidity or survivor's pension from the occupational pension scheme with the federal pension fund before the commencement of this act.2 where any incapacity to work, the cause of which subsequently leads to invalidity, begins before the commencement of this act and the related pension begins to be drawn after its commencement, finma is also the responsible employer.chapter 4 referendum and commencement113 113 amended by annex no ii 16 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). art. 61 1 this act is subject to an optional referendum.2 the federal council determines the date on which this act comes into force.commencement date:114articles 4, 7, 8, 9 paragraph 1 letters a-e and g-j as well as paragraphs 2-5, articles 10-14, 17-20, 21 paragraphs 3 and 4, 53-55, 58 paragraph 2 second sentence, 59 paragraphs 2-4; annex number 4 (federal administrative court act), heading before article 31 and 33 letter b: 1 february 2008other provisions: 1 january 2009114 as 2008 5205annex (art. 57)amendment of current law the federal acts below are amended as follows:.115115 the amendments may be consulted under as 2008 5207.

957.1 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal acton intermediated securities(federal intermediated securities act, fisa)of 3 october 2008 (status as of 1 february 2021)the federal assembly of the swiss confederation,based on articles 98 paragraph 1 and 122 paragraph 1 of the federal constitution1,and having considered the federal council dispatch dated 15 november 20062,decrees:1 sr 1012 bbl 2006 9315chapter 1 purpose, scope and definitions art. 1 subject-matter and purpose 1 this act regulates the custody of certificated and uncertificated securities by custodians and their transfer.2 it ensures the protection of property rights of investors. it contributes to legal certainty in international contexts, to the efficient settlement of securities transactions and to the stability of the financial system.art. 2 scope of application 1 this act applies to intermediated securities that are credited to a securities account by a custodian. 2 it does not affect any provision regarding the registration of registered shares in the share register. art. 3 intermediated securities 1 intermediated securities within the meaning of this act are personal or corporate rights of a fungible nature against an issuer which3:a. are credited to a securities account; andb. may be disposed of by the account holder in accordance with the provisions of this act.1bis an intermediated security within the meaning of this act shall also be deemed to be any financial instrument held in custody in accordance with foreign law and any right to such a financial instrument, if it has a comparable function in accordance with such foreign law.42 intermediated securities are effective against the custodian and any third party; they are beyond the reach of other creditors of the custodian.3 footnote not relevant to the english text.4 inserted by annex no 14 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 4 custodians 1 a custodian within the meaning of this act maintains securities accounts in the name of persons or groups of persons.2 the following are deemed to be custodians:a. banks within the meaning of the banking act of 8 november 19345;b.6 securities firms within the meaning of article 41 of the financial institutions act of 15 june 20187;c.8 fund management companies within the meaning of article 32 of the financial institutions act, insofar as they maintain unit accounts;d.9 central securities depositories within the meaning of article 61 of the financial market infrastructure act of 19 june 201510;e. the swiss national bank within the meaning of the national bank act of 3 october 200311;f.12 swiss post within the meaning of the postal services organisation act of 17 december 201013; andg.14 dlt trading facilities under articles 73a to 73f of the financial market infrastructure act of 19 june 201515 in relation to immobilised ledger-based securities under articles 973d to 973i of the code of obligations16.3 foreign banks, foreign securities firms and other foreign financial institutions, as well as central securities depositories and other financial intermediaries that maintain securities accounts in the course of their business activity are also deemed custodians.175 sr 952.06 amended by annex no ii 17 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).7 sr 954.18 amended by annex no ii 17 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).9 amended by annex no 14 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).10 sr 958.111 sr 951.1112 amended by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).13 sr 783.114 inserted by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 as 2021 33; bbl 2020 233).15 sr 958.116 sr 22017 amended by annex no ii 17 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 5 definitions in this act:a. sub-custodian means a custodian which maintains securities accounts for other custodians;b. account holder means a person or group of persons in whose name a custodian maintains a securities account;c. investor means an account holder other than a custodian, or a custodian holding intermediated securities for its own account;d. qualified investor means a custodian; an insurance company subject to prudential supervision; a public-law entity, a pension fund or a company with professional treasury management;e. certificated securities in collective custody means certificated securities within the meaning of article 973a of the code of obligations18;f. global certificate means a certificated security within the meaning of article 973b of the code of obligations;g.19 uncertificated securities means rights within the meaning of article 973c of the code of obligations;h.20 ledger-based securities means rights within the meaning of article 973d of the code of obligations.18 sr 22019 amended by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).20 inserted by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).chapter 2 creation, extinction and conversion of intermediated securities art. 6 creation 1 intermediated securities are created:a. when a custodian accepts certificated securities for collective custody and credits them to one or more securities accounts;b. when a custodian accepts a global certificate for custody and credits the respective rights to one or more securities accounts; c.21 when a custodian registers uncertificated securities in the main register and credits the respective rights to one or more securities accounts; ord.22 when ledger-based securities are transferred to a custodian and the respective rights are credited to one or more securities accounts.2 for each issue of uncertificated securities, a single custodian shall maintain the main register. the main register shall provide details of the issue, the quantity, and the nominal value of the uncertificated securities issued; it shall be public.233 on being transferred to a custodian, the ledger-based securities shall be immobilised in the securities ledger.2421 amended by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).22 inserted by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).23 amended by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).24 inserted by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).art. 7 conversion 1 unless otherwise provided by the terms of issue or the issuer's articles of association, an issuer may, at any time and without the account holder's consent, convert certificated securities in collective custody, global certificates or uncertificated securities held or registered as a basis for intermediated securities into another form.25 it shall bear the conversion cost.2 insofar as provided by the terms of issue or the issuer's articles of association, an account holder may at any time require the issuer to deliver certificated securities in the quantity and of the kind corresponding to intermediated securities credited to the account holder's securities account based on a global certificate or uncertificated securities.26 the account holder shall bear the cost of this conversion unless the terms of issue or the issuer's articles of association provide otherwise.3 the custodian shall ensure that the conversion of the securities does not alter the total number of the personal and corporate rights issued.25 amended by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).26 amended by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).art. 8 extinction and delivery in general27 1 an account holder may at any time require the custodian to deliver certificated securities in the quantity and of the kind corresponding to intermediated securities credited to the account holder's securities account provided that:a. certificated securities are held by the custodian or a sub-custodian; orb. the account holder is entitled to delivery of certificated securities under article 7 paragraph 2.2 the account holder shall be entitled to the delivery of certificated securities in accordance with the custom and usage of the market on which the securities are traded. 3 the custodian shall ensure that the delivery to the account holder occurs only after the corresponding securities have been debited to the latter's securities account.27 amended by no i 4 of the fa of 21 june 2019 on the implementation of the recommendations of the global forum on transparency and the exchange of information for tax purposes, in force since 1 nov. 2019 (as 2019 3161; bbl 2019 279).art. 8a28 delivery of bearer shares in companies limited by shares without listed equity securities in the case of companies limited by shares without listed equity securities whose bearer shares are organised as intermediated securities, the custodian designated by the company in accordance with article 697j paragraph 5 of the code of obligations29 shall ensure that the securities are only delivered:a. on the custodian ceasing its duties30: to the custodian in switzerland designed as the replacement by the company;b. on the conversion of the bearer shares into registered shares: to the company;c. on the destruction of the bearer shares: to the company.28 inserted by no i 4 of the fa of 21 june 2019 on the implementation of the recommendations of the global forum on transparency and the exchange of information for tax purposes, in force since 1 nov. 2019 (as 2019 3161; bbl 2019 279).29 sr 22030 corrected by the federal assembly drafting committee (art. 58 para. 1 parla; sr 171.10).chapter 3 sub-custody and availability of intermediated securities art. 9 authorisation for sub-custody 1 a custodian may hold intermediated securities, certificated securities, uncertificated securities and ledger-based securities with a sub-custodian in switzerland or abroad.31 the account holder's consent is not required.2 the account holder's express consent is nonetheless required where the foreign sub-custodian is not subject to adequate regulatory supervision.31 amended by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).art. 10 effects 1 a custodian credits to the securities account of its account holder the intermediated securities credited to its own securities account with a sub-custodian.2 if the custody of securities with a sub-custodian is not governed by this act, the credit confers upon the account holder rights that are at least equal to the rights acquired by the custodian with the sub-custodian.art. 11 available intermediated securities 1 each custodian shall hold with itself or with a sub-custodian intermediated securities (available securities) in a quantity and of a kind at least equal to the total of intermediated securities credited to the securities accounts of its account holders (credited securities).2 if the total number of available securities is less than the total number of credited securities, the custodian shall without delay acquire intermediated securities to the extent of the shortfall.3 the following are deemed to be available securities:a. intermediated securities credited to a securities account held by the custodian with a sub-custodian;b.32 certificated securities, ledger-based securities or global certificates that the custodian holds directly, or uncertificated securities entered in its main register; andc. readily available rights to delivery of intermediated securities from other custodians during the regulatory or customary settlement period for the corresponding market, provided that this period does not exceed eight days. 32 amended by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).art. 12 segregation of own securities and account holder securities 1 if a custodian holds its own intermediated securities and that of its account holders in separate securities accounts with a sub-custodian, the intermediated securities of the account holders and their claims for delivery of intermediated securities shall not be affected by: a. a set-off agreement between the custodian and the sub-custodian to which the account holder is not a party; b. any right of pledge, retention, or foreclosure of the sub-custodian or of another person to which the account holder has not consented. 2 the custodian may dispose of an account holder's intermediated securities only after having them transferred to its own account by exercising its right of use. 3 any agreement to the contrary shall be invalid. chapter 4 rights deriving from the custody of intermediated securities section 1 general rights of account holders art. 13 principle 1 the creation of intermediated securities does not affect the rights of investors against the issuer.2 unless otherwise provided by this act, account holders may exercise their rights only through their custodian.art. 14 seizure and attachment 1 where intermediated securities are seized, attached, or subjected to any other interim measure against the account holder, such measure shall be executed exclusively in the hands of the custodian maintaining the securities account to which the account holder's intermediated securities are credited.2 any seizure, attachment, or other interim measure executed against an account holder in the hands of a sub-custodian shall be void.art. 15 instructions 1 a custodian shall carry out the account holder's instructions to dispose of intermediated securities pursuant to the contract between both parties.2 the custodian shall not be obliged or entitled to verify the legal grounds for the instruction.3 the account holder may revoke an instruction until the point in time provided in the contract with the custodian or in the applicable rules of the securities clearing and settlement system. an instruction shall in any case become irrevocable once the custodian has debited the account holder's securities account.art. 16 statement an account holder may at any time require its custodian to draw up a statement of the intermediated securities credited to its securities account. this statement is not a certificated security.section 2 rights of account holders in the event of a custodian's liquidation art. 17 exclusion from custodian's estate 1 if a custodian is subject to proceedings for compulsory liquidation, the liquidator shall exclude from the custodian's estate up to the number of intermediated securities credited to securities account maintained by the custodian for its account holders:a. intermediated securities credited to a securities account that the custodian holds with a sub-custodian;b.33 certificated securities, ledger-based securities or global certificates that the custodian holds directly, or uncertificated securities entered in its main register; andc. readily available claims of the custodian to receive delivery of intermediated securities from third parties resulting from spot transactions, expired futures transactions, hedging transactions, or issues on behalf of account holders.2 if the custodian does not hold its own securities and that of its account holders in separate securities accounts with a sub-custodian, the securities credited to those accounts shall be presumed to belong to the custodian's account holders.3 the liquidator of a custodian shall satisfy claims of sub-custodians arising out of the custody of the intermediated securities or the financing of their acquisition. 4 intermediated securities and claims for delivery of intermediated securities excluded from the custodian's estate shall be:a. transferred to the custodian designated by the account holder; orb.34 delivered to the account holder in the form of certificated securities; orc.35 transferred to the account holder in the form of ledger-based securities.5 claims of the custodian under article 21 are reserved.33 amended by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).34 amended by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).35 amended by no i 9 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 feb. 2021 (as 2021 33; bbl 2020 233).art. 18 exclusion from sub-custodian's estate if a sub-custodian is subject to proceedings for compulsory liquidation, the custodian shall seek the exclusion of its account holders' intermediated securities from the sub-custodian's estate.art. 19 shortfall 1 if the intermediated securities excluded from the custodian's estate are not sufficient to satisfy the account holders in full, intermediated securities of the same kind held by the custodian for its own account shall also be excluded insofar as necessary, even where such intermediated securities have been held separately from the account holders' intermediated securities. 2 if the account holders are still not fully satisfied, they shall bear the shortfall in proportion to the number of intermediated securities of the missing kind credited to their respective securities accounts. they shall have a corresponding claim for compensation against the custodian.art. 20 finality of instructions an instruction issued by a custodian which is a participant in a securities clearing or settlement system shall be legally binding and effective against third parties even in the event of debt enforcement proceedings against that custodian, provided that:a. the instruction was entered into the system before the commencement of such proceedings; orb. it was entered into the system after the commencement of such proceedings and carried out on the day of commencement, if the system operator can prove that it was not aware, and should not have been aware, of the commencement of such proceedings.section 3 rights of a custodian in intermediated securities art. 21 right of retention and foreclosure 1 a custodian shall be entitled to retain and foreclose on intermediated securities credited to a securities account, provided a debt owed by the account holder is due and arises from the custody of the intermediated securities or the financing of their acquisition.2 the right of retention and foreclosure shall cease when the custodian credits the intermediated securities to the account of another account holder.art. 22 right of use 1 an account holder may authorise its custodian to dispose of its intermediated securities in its own name and on its own account, in particular to grant a security interest in the same. 2 unless the account holder is a qualified investor, authorisation must be granted in writing. it may not be included in general terms and conditions.art. 23 return of collateral 1 if an account holder has granted a security interest to a custodian, and the custodian has exercised a right of use by creating a security interest, the custodian shall return to the account holder intermediated securities in the same quantity and of the same kind no later than the due date for the performance of the secured obligation.2 these intermediated securities shall be subject to the same security interest as the original security interest, and shall be treated as if they had been provided at the same time as the original security interest.3 to the extent provided by the security agreement with the account holder, the custodian may realise the intermediated securities in accordance with article 31 instead of returning them.art. 23a36 passing on of information the custodian designated by a company limited by shares under article 697i paragraph 4 or article 697j paragraph 3 of the code of obligations37 must ensure that on request downstream custodians pass on the following information:a. the first name and surname or business name and address of the shareholder; andb. the first name and surname and address of the beneficial owner.36 inserted by no i 8 of the federal act of 12 dec. 2014 on the implementation of the revised recommendations 2012 of the financial action task force, in force since 1 july 2015 (as 2015 1389; bbl 2014 605).37 sr 220chapter 5 disposition of intermediated securities and effectiveness against third parties section 1 disposition of intermediated securities art. 24 credit38 1 a disposition of intermediated securities may be effected by:a. an instruction from the account holder to its custodian to transfer the intermediated securities; andb. a credit of the intermediated securities to the acquirer's securities account.2 the disposition shall be complete when the necessary credit has been made and has become effective against third parties. if the full legal rights are transferred as a result of the disposition, the transferor shall lose its rights in the intermediated securities.39 3 the foregoing is without prejudice to the provisions governing acquisition by virtue of universal succession or debt enforcement.4 this article does not affect restrictions on the transfer of registered shares. any other restriction is be ineffective against the transferee or third parties.38 amended by annex no 14 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).39 amended by annex no 14 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 2540 control agreement 1 an act of disposal for intermediated securities may also be created, and becomes effective against third parties when the account holder and the custodian agree irrevocably that the custodian must carry out instructions from the acquirer without any further consent or cooperation on the part of the account holder.2 the act of disposal may relate to:a. specific intermediated securities;b. all intermediated securities credited to a securities account; orc. a proportion of the intermediated securities credited to a securities account up to a specified value.40 amended by annex no 14 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 2641 agreement with the custodian 1 the account holder may dispose of intermediated securities in favour of the custodian by concluding an agreement with it. the act of disposal shall be effective against third parties upon conclusion of the agreement.2 article 25 paragraph 2 applies.41 amended by annex no 14 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).section 2 reversal art. 27 reversal of a debit 1 a debit to a securities account must be reversed if:a. it was made without instructions;b. it was made on the basis of an instruction that:1. is void, 2. was not issued by the account holder or the latter's agent,3. was revoked in due time by the account holder, or 4. was voided on the ground of mistake, erroneous transmission, fraud or duress; article 26 of the code of obligations42 is reserved;c. the credit of intermediated securities to the acquirer's securities account does not correspond to the instruction or is not executed within the customary settlement period.2 in the event of a reversal under paragraph 1 letter a or b, the account holder must prove that the instruction was defective. there is no right to reversal if the custodian proves that it did not know the defect in the instruction and could not be expected to know such defect despite the application of reasonable measures and procedures.3 the reversal shall place the account holder in the same position as if the debit had never been made. claims for damages under the provisions of the code of obligations are reserved.4 claims based on this article become time-barred three years after the defect is discovered, or at the latest ten years after the date on which debit was made.435 an account holder who is a qualified investor may derogate from this article by entering into an agreement with the custodian.42 sr 22043 amended by annex no 29 of the fa of 15 june 2018 (revision of the law of prescription), in force since 1 jan. 2020 (as 2018 5343; bbl 2014 235).art. 28 reversal of a credit 1 a custodian may reverse a credit of intermediated securities to a securities account if: a. the corresponding debit was reversed; orb. the credit does not correspond to the instruction.2 the account holder shall be notified of the reversal.3 a credit may not be reversed where intermediated securities of the same kind are no longer credited to that securities account or where third parties acting in good faith have acquired rights in those intermediated securities. in such cases the custodian shall have a claim for damages unless the account holder has disposed of the securities in good faith or had no reason to expect a demand for restitution when disposing of them. 4 claims based on this article become time-barred three years after the defect is discovered, or at the latest ten years after the date on which the credit was made.445 an account holder who is a qualified investor may derogate from this article by entering into an agreement with the custodian.44 amended by annex no 29 of the fa of 15 june 2018 (revision of the law of prescription), in force since 1 jan. 2020 (as 2018 5343; bbl 2014 235).section 3 effectiveness against third parties art. 29 protection of the bona fide purchaser 1 a person who acquires intermediated securities under articles 24, 25 or 26 for value and in good faith shall be protected in respect of the acquisition even where:a. the transferor had no power or authority to transfer the intermediated securities; orb. the credit of intermediated securities to the transferor's securities account was reversed.2 an acquirer who is not so protected is under a duty to make restitution of intermediated securities in the same quantity and of the same kind pursuant to the provisions of the code of obligations45 on unjust enrichment. the rights of third parties are not affected. the foregoing is without prejudice to other claims based on the code of obligations.3 where the acquirer who is bound to make restitution of the securities becomes subject to proceedings for compulsory liquidation, the beneficiary may require intermediated securities in the same quantity and of the same kind to be excluded from the acquirer's estate to the extent that it contains such intermediated securities.4 claims based on this paragraph 2 become time barred three years after the holder of the debited account becomes aware of its rights and of the identity of its debtor, or at the latest ten years after the debit date. article 60 paragraph 2 of the swiss code of obligations is reserved.465 where the conditions for reversal of a credit under article 28 are met, the acquirer may not object to the reversal on the basis of this article.45 sr 22046 amended by annex no 29 of the fa of 15 june 2018 (revision of the law of prescription), in force since 1 jan. 2020 (as 2018 5343; bbl 2014 235).art. 30 priorities 1 where intermediated securities or interests in intermediated securities are disposed of pursuant to provisions of this act, the disposition first in time shall prevail over further dispositions.2 if the custodian has entered into an agreement with the account holder under article 25 paragraph 1 without notifying the acquirer expressly of its rights created earlier, its right shall be deemed to be subordinated to the right of the acquirer.473 .484 the foregoing is without prejudice to agreements to modify the priorities of rights over intermediated securities, but such agreements are effective only as between the parties bound by them.47 amended by annex no 14 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).48 repealed by annex no 14 of the financial market infrastructure act of 19 june 2015, with effect from 1 jan. 2016 (as 2015 5339; bbl 2014 7483).chapter 6 realisation of collateral art. 31 power to realise collateral 1 the secured party may realise intermediated securities in which a security interest has been created according to the terms and conditions stipulated in the security agreement by:a. selling the intermediated securities and offsetting the proceeds against the secured debt; orb. appropriating the intermediated securities whose value can be determined objectively and offsetting their value against the secured debt.492 this power is not affected by the commencement of debt enforcement, reorganisation or protective proceedings in respect of the provider of the security interest.3 the custodian is not bound or entitled to verify whether the conditions for realisation of the intermediated securities are fulfilled.4 the foregoing is without prejudice to the liability of the beneficiary of a security interest who realises intermediated securities where the conditions for realisation are not fulfilled. 49 amended by annex no 14 of the financial market infrastructure act of 19 june 2015, in force since 1 jan. 2016 (as 2015 5339; bbl 2014 7483).art. 32 notice and accounts 1 the secured party shall give notice to the provider of the security interest before realisation. a provider of a security interest who is a custodian or a qualified investor may waive the notice requirement.2 the secured party shall account to the provider of the security interest and remit to the latter any excess proceeds of the realisation.chapter 7 liability art. 33 1 a custodian shall be liable for the loss caused to an account holder in relation to the custody or transfer of intermediated securities, pursuant to the provisions of the code of obligations50, unless otherwise provided in this article.2 a custodian which is authorised to hold intermediated securities with a sub-custodian shall be liable for any failure to exercise due care in the selection and instruction of the sub-custodian and in verifying its continued compliance with the selection criteria. 3 a custodian may waive its liability under paragraph 2 if the account holder has expressly designated the sub-custodian contrary to the custodian's advice.4 a custodian shall be liable, as if they were its own, for the acts of a sub-custodian which: a. independently and over a long period of time administers and settles all securities transactions on behalf of the custodian; or b. is part of the same economic entity as the custodian.5 agreements to the contrary shall be valid only as between custodians or when made in favour of investors. 50 sr 220chapter 8 final provisions art. 34 amendments to existing law amendments to existing law are contained in the annex hereto.art. 35 transitional provisions 1 issuers of uncertificated securities credited to securities accounts maintained by a custodian shall have the main registry set up by a custodian within six months from the effective date of this act and have the uncertificated securities registered therein.2 if, before this act comes into force, certificated securities in collective deposit, global certificates, or uncertificated securities held by a custodian are disposed of in a manner that fails to comply with the requirements of this act, the right thus created shall prevail over any right created after the commencement date of the act provided that the beneficiary effects the book entries required by the act or causes them to be effected within 12 months after the commencement date hereof.art. 36 referendum and commencement 1 this act is subject to an optional referendum.2 the federal council shall set the commencement date.commencement date:51 1 january 2010art. 470 para. 2bis of the code of obligations (no 3 of annex): 1 october 200951 fcd of 6 may 2009.annex (art. 34)amendment of current legislation the federal acts below are amended as follows:.5252 the amendments may be consulted under as 2009 3577.

958.1english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.federal act on financial market infrastructures and market conduct in securities and derivatives trading(financial market infrastructure act, finmia)of 19 june 2015 (status as of 1 august 2021)the federal assembly of the swiss confederation,based on articles 95 and 98 paragraphs 1 and 2 of the federal constitution1,and having considered the federal council dispatch dated 3 september 20142,decrees:1 as 2015 5339 sr 1012 bbl 2014 7483title 1 general provisions art. 1 subject matter and purpose 1 this act governs the organisation and operation of financial market infrastructures, and the conduct of financial market participants in securities and derivatives trading.2 it aims to ensure the proper functioning and transparency of securities and derivatives markets, the stability of the financial system, the protection of financial market participants and equal treatment of investors.art. 2 definitions for the purposes of this act, the following terms shall have the following meanings:a. financial market infrastructure:1. a stock exchange (art. 26 let. b);2 a multilateral trading facility (art. 26 let. c);3. a central counterparty (art. 48);4. a central securities depository (art. 61);5. a trade repository (art. 74);5a.3 a trading facility for dlt securities (dlt trading facility; art. 73a);6. a payment system (art. 81).b.4 securities: standardised certificated and uncertificated securities, in particular uncertificated securities in accordance with article 973c of the code of obligations5 (co) and ledger-based securities in accordance with article 973d of the co, as well as derivatives and intermediated securities, which are suitable for mass trading.bbis.6 distributed ledger technology securities (dlt securities): securities in the form of:1. ledger-based securities (art. 973d co); or2. other uncertificated securities that are held in distributed electronic registers and use technological processes to give the creditors, but not the obligor, power of disposal over the uncertificated security.c. derivatives or derivatives transactions: financial contracts whose value depends on one or several underlying assets and which are not cash transactions.d. participant: any person making direct use of financial market infrastructure services.e. indirect participant: any person making use of financial market infrastructure services indirectly via a participant.f. listing: the admission of a security to trading on a stock exchange in accordance with a standardised procedure whereby the stock exchange's requirements regarding issuers and securities are being verified.g. clearing: processing steps between the conclusion and the settlement of a transaction, in particular:the entry, reconciliation and confirmation of the transaction data;the assumption of obligations by a central counterparty or other risk mitigation measures;the netting of transactions;the reconciliation and confirmation of outstanding payments and securities transfers.h. settlement: fulfilment of the obligations entered into upon conclusion of the transaction, namely by transferring funds or securities.i. public takeover offers: offers to purchase or exchange shares, participation certificates, profit-sharing certificates or other participation rights (equity securities) which are made publicly to the holders of shares or other equity securities.j.7 insider information: confidential information whose disclosure would significantly affect the prices of securities admitted to trading on a trading venue or dlt trading facility which has its registered office in switzerland.3 inserted by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).4 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).5 sr 2206 inserted by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).7 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 3 group parent companies and significant group companies 1 the following are subject to articles 88 to 92 provided they are not subject to the bankruptcy jurisdiction of the swiss financial market supervisory authority (finma) within the scope of the supervision of the individual institution:a. group parent companies of a financial group which have their registered office in switzerland;b. those group companies which have their registered office in switzerland and perform significant functions for activities which require authorisation (significant group companies).2 the federal council shall set the criteria for assessing significance.3 finma shall identify significant group companies and keep a publicly accessible list of said companies.title 2 financial market infrastructures chapter 1 common provisions section 1 authorisation conditions and duties for all financial market infrastructures art. 4 duty to obtain authorisation 1 financial market infrastructures require authorisation from finma.2 a payment system requires authorisation from finma only if this is necessary for the proper functioning of the financial market or the protection of financial market participants and if the payment system is not operated by a bank.3 financial market infrastructures operated by the swiss national bank (snb) or on its behalf are not subject to finma authorisation and supervision within the scope of this activity.4 the financial market infrastructure may be entered in the commercial register only after finma has issued the authorisation.art. 5 authorisation conditions anyone who meets the conditions set out in this section and the supplementary conditions that apply to individual financial market infrastructures is entitled to authorisation.art. 6 additional requirements for systemically important financial market infrastructures systemically important financial market infrastructures (art. 22) have to meet the requirements set out in section 2 in addition to the conditions detailed in article 5.art. 7 changes in facts 1 the financial market infrastructure shall notify finma of any changes in the facts on which its authorisation or approval is based.2 if the changes are of material significance, the financial market infrastructure must obtain prior authorisation or approval from finma in order to pursue its activity.3 this provision applies by analogy to recognised foreign financial market infrastructures.art. 8 organisation 1 the financial market infrastructure must be a legal entity under swiss law and have its registered office and head office in switzerland.2 it must establish appropriate corporate management rules and be organised in such a way that it can fulfil its statutory duties. in particular, it must designate specific bodies responsible for its business management, on the one hand, and for its overall management, supervision and control on the other, and define the scope of these bodies' respective powers in such a way as to ensure proper and independent supervision of business management. it shall set out the relevant tasks and authorities in its articles of incorporation and organisational regulations.3 it shall identify, measure, control and monitor its risks and organise an effective internal control system. in particular, it shall establish an internal audit function that is independent of the business management body and a compliance department that is separate from operating business units.art. 9 guarantee of irreproachable business conduct 1 the financial market infrastructure and the persons responsible for its administration and management must provide the guarantee of irreproachable business conduct.82 moreover, the persons responsible for the administration and management of the financial market infrastructure must enjoy a good reputation and have the specialist qualifications required for their functions.3 qualified participants in a financial market infrastructure must also enjoy a good reputation and ensure that their influence is not detrimental to prudent and sound business activity. 4 persons who directly or indirectly hold at least 10% of the share capital or votes or who can significantly influence its business activity in another manner are deemed to be qualified participants in a financial market infrastructure.5 each person must notify finma before directly or indirectly acquiring or disposing of a qualified participation in accordance with paragraph 4 in a financial market infrastructure organised under swiss law. this notification duty also applies if a qualified participation is increased or reduced in such a way as to reach, exceed or fall below the thresholds of 20%, 33% or 50% of the share capital or votes.6 the financial market infrastructure shall notify finma of the persons who meet the conditions of paragraph 5 as soon as it becomes aware of the same. it must submit a list of its qualified participants to finma at least once a year.8 german text only amended by annex no ii 18 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 10 ancillary services 1 a legal entity may operate only one financial market infrastructure. the foregoing does not apply to the operation of a multilateral trading facility by a stock exchange.2 the provision of ancillary services subject to authorisation or approval by virtue of article 1 of the financial market supervision act of 22 june 20079 (financial market legislation) must be authorised or approved by finma and must be in compliance with the additional authorisation conditions.3 if the provision of ancillary services not subject to authorisation or approval by virtue of financial market legislation increases the risks of a financial market infrastructure, finma may require organisational measures or the establishment of additional own funds and sufficient liquidity.9 sr 956.1art. 11 outsourcing 1 if a financial market infrastructure wishes to outsource essential services such as risk management, prior approval must be obtained from finma. finma must consult the snb beforehand if the financial market infrastructure in question is considered systemically important by the snb.2 the financial market infrastructure shall set out the reciprocal rights and duties in a written agreement with the service provider.3 if a financial market infrastructure outsources services, it shall remain responsible for compliance with the duties arising from this act.art. 12 minimum capital 1 the minimum capital of the financial market infrastructure must be fully paid up.2 the federal council shall set the amount of the minimum capital.art. 13 business continuity 1 a financial market infrastructure must have an appropriate strategy to be able to maintain or restore operations in good time in the event of disruptions.2 if a financial market infrastructure holds participants' assets and positions, it must establish appropriate procedures to ensure that these assets and positions can be transferred or settled immediately in the event of the withdrawal or return of authorisation.art. 14 it systems 1 a financial market infrastructure shall operate it systems which:a. ensure fulfilment of the duties arising from this act and are appropriate for its activities;b. provide for effective emergency arrangements; andc. ensure the continuity of its business activity.2 it shall provide for measures to protect the integrity and confidentiality of information regarding its participants and their transactions.art. 15 financial groups 1 if a financial market infrastructure is part of a financial group, finma may make its authorisation contingent upon the existence of appropriate consolidated supervision by a financial market supervisory authority.2 two or more companies are deemed to be a financial group pursuant to this act if:a. at least one of them operates as a financial market infrastructure;b. they operate primarily in the financial sector; andc. they form an economic unit or other circumstances suggest that one or more of the companies under individual supervision is de jure or de facto obliged to provide assistance to group companies.3 the provisions of the banking act of 8 november 193410 apply by analogy.10 sr 952.0art. 16 protection against confusion and deception 1 the name of the financial market infrastructure must not lead to confusion or deception.2 the terms stock exchange, multilateral trading facility, mtf, central counterparty, ccp, securities settlement system, sss, central securities depository, csd, trade repository", tr, dlt trading system, dlt trading facility and dlt exchange may be used in connection with the provision of financial services only to designate a corresponding financial market infrastructure subject to this act.1111 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 17 international business a financial market infrastructure must notify finma before:a. establishing, acquiring or closing a foreign subsidiary, branch or representative office;b. acquiring or surrendering a qualified participation in a foreign company.art. 18 fair and open access 1 a financial market infrastructure shall ensure fair and open access to its services.2 it may restrict access to its services: a. if this increases safety or efficiency and this effect cannot be achieved with other measures; or b. if the features of the potential participant could jeopardise the business operations of the financial market infrastructure or its participants.art. 19 documentation and retention duties financial market infrastructures shall keep records of the services provided, the procedures and processes applied and the activities carried out, and shall retain all records for ten years.art. 20 prevention of conflicts of interest financial market infrastructures shall take effective organisational measures to identify, prevent, settle and monitor conflicts of interest.art. 21 publication of essential information 1 a financial market infrastructure shall regularly publish all essential information for participants, issuers and the general public, specifically:a. information about its organisation;b. the participation conditions;c. the rights and duties of participants and issuers.2 it shall take account of recognised international standards in doing so.section 2 special requirements for systemically important financial market infrastructures art. 22 systemically important financial market infrastructures and business processes 1 central counterparties, central securities depositories, payment systems and those dlt trading facilities that provide central custody, clearing or settlement services are deemed to be systemically important:12a. if their non-availability, arising in particular from technical or operational problems or financial difficulties, can lead to serious losses, liquidity shortfalls or operational problems for financial intermediaries or other financial market infrastructures, or can cause serious disruptions on financial markets; or b. if individual participants' payment or delivery difficulties can spill over to other participants or linked financial market infrastructures and can cause these serious losses, liquidity shortfalls or operational problems, or can cause serious disruptions on financial markets.2 a business process of a financial market infrastructure in accordance with paragraph 1 is systemically important:a. if its non-availability can cause serious losses, liquidity shortfalls or operational problems for financial intermediaries or other financial market infrastructures, or can cause serious disruptions on financial markets; andb. if participants cannot substitute the business process at short notice.12 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 23 special requirements 1 systemically important financial market infrastructures must fulfil special requirements in order to protect against the risks they pose to the stability of the financial system.2 the special requirements must take account of recognised international standards. they can relate to the contractual bases, the means of payment used, risk management, business continuity and it systems.3 the snb shall regulate the details in an ordinance.4 the snb may, after consulting finma, waive the obligation to meet the special requirements for a systemically important financial market infrastructure registered abroad which comes under snb oversight in accordance with article 19 paragraph 2 of the swiss national bank act of 3 october 200313 (nba):if it is subject to equivalent supervision and oversight abroad; andif the competent supervisory and oversight authorities cooperate with the snb in accordance with article 21 paragraph 2 of the nba14.13 sr 951.1114 now: in accordance with art. 21 let. b nba.art. 24 recovery and resolution plan 1 a systemically important financial market infrastructure shall draw up a recovery plan that sets out the measures it will use to ensure its stability on a sustainable basis in the event of a crisis and be able to maintain its systemically important business processes. 2 finma shall draw up a resolution plan that describes how the restructuring or winding-up of a systemically important financial market infrastructure that it has ordered can be carried out. it shall consult the snb about the resolution plan. 3 a financial market infrastructure shall provide finma with the recovery plan and the information necessary for drawing up a resolution plan.4 it shall implement the resolution plan measures in a preparatory manner if this is necessary for the uninterrupted maintenance of systemically important business processes.section 3 authorisation procedure art. 25 1 finma shall inform the snb of authorisation requests submitted by central counterparties, central securities depositories, payment systems and those dlt trading facilities that provide central custody, clearing or settlement services.152 after consulting finma, the snb shall designate by way of an order the systemically important financial market infrastructures and their systemically important business processes in accordance with article 22. it shall also define by way of an order which special requirements in accordance with article 23 the individual systemically important financial market infrastructures have to fulfil and shall assess their compliance.3 if a systemically important financial market infrastructure fulfils the special requirements, finma shall grant authorisation if the other authorisation conditions are also met.4 finma shall approve a systemically important financial market infrastructure's stabilisation plan in accordance with article 24 after consulting the snb.5 if the snb concludes that a financial market infrastructure is not systemically important, it shall inform finma. if the general authorisation conditions are met, finma shall grant authorisation.6 the procedure applies by analogy to requests for recognition submitted by foreign central counterparties.15 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).chapter 2 trading venues, organised trading facilities and power exchanges section 1 trading venues art. 26 definitions for the purposes of this act:a. trading venue means a stock exchange or a multilateral trading facility;b. stock exchange means an institution for multilateral securities trading where securities are listed, whose purpose is the simultaneous exchange of bids between several participants and the conclusion of contracts based on non-discretionary rules;c. multilateral trading facility means an institution for multilateral securities trading whose purpose is the simultaneous exchange of bids between several participants and the conclusion of contracts based on non-discretionary rules without listing securities.art. 27 self-regulation 1 the trading venue shall establish under finma supervision its own regulatory and supervisory organisation which is appropriate for its activity.2 the regulatory and supervisory tasks delegated to the trading venue must be carried out by independent bodies. the directors of these bodies must:a. provide the guarantee of irreproachable business conduct;b. enjoy a good reputation; and c. have the specialist qualifications required for their functions.3 the selection of the directors under paragraph 2 requires the approval of finma.4 the trading venue shall submit its regulations and their amendments to finma for approval.art. 28 organisation of trading 1 the trading venue shall issue regulations for the organisation of orderly and transparent trading.2 it shall register all of its orders and transactions in chronological order, as well as the transactions reported to it. in particular, it shall indicate the time, the identity of the participants, the securities traded and their number or nominal value, as well as their price.art. 29 pre- and post-trade transparency 1 the trading venue shall publish the bid and offer prices for shares and other securities in real time, as well as the sizes of the trading positions at these prices (pre-trading transparency).2 moreover, it shall immediately publish information on the transactions carried out on the trading venue and on the transactions conducted outside of the trading venue reported to it for all securities admitted to trading (post-trading transparency). in particular, the price, volume and time of the transactions must be published.3 taking account of recognised international standards and legal developments abroad, the federal council shall determine:a. the other securities subject to pre-trade transparency;b. exceptions with regard to pre- and post-trade transparency, particularly in relation to securities transactions involving large volumes or that are executed by the snb.art. 30 guarantee of orderly trading 1 a trading venue which operates a technical platform must have a trading facility which guarantees orderly trading even in the event of intense trading activity.2 it shall take effective measures to prevent disruptions to its trading facility.art. 31 supervision of trading 1 the trading venue shall supervise price formation and the transactions conducted on the trading venue so that insider trading, price and market manipulation and other violations of statutory and regulatory provisions can be detected. for this purpose, it shall also review the transactions conducted outside of the trading venue that are reported to it or are brought to its attention in any other way.2 in the event of suspected violations of the law or other irregularities, the body responsible for supervising trading (trading supervisory body) shall notify finma. if the violations of the law involve criminal offences, it shall also inform the competent prosecution authority without delay.3 finma, the competent prosecution authority, the takeover board and the trading supervisory body shall exchange information which they require within the context of their collaboration and in order to carry out their tasks. they shall use the information received solely to carry out their respective tasks.art. 32 collaboration between trading supervisory bodies 1 swiss supervisory bodies for various trading venues shall regulate the free, reciprocal exchange of trading data by agreement, provided that on the trading venues in question:a. identical securities are admitted to trading; orb. securities are admitted to trading which influence the pricing of securities that are admitted to trading on the other trading venue.2 they shall use the data received solely to carry out their respective tasks.3 swiss trading supervisory bodies may agree to the reciprocal exchange of information with foreign trading supervisory bodies, provided that:a. the conditions set out in paragraph 1 are fulfilled; andb. the foreign trading supervisory body in question is subject to a legal duty of confidentiality.art. 33 suspension of trading 1 when a stock exchange suspends trading in a security listed on it at the initiative of the issuer or due to extraordinary circumstances, it shall immediately publish its decision.2 if trading in a security is suspended, it shall also be suspended on all of the other trading venues where the security in question is admitted to trading.art. 34 admission of participants 1 the trading venue shall issue regulations on the admission, duties and exclusion of participants, thereby observing in particular the principle of equal treatment.2 the following may be admitted as participants in a stock exchange or a multilateral trading facility:a.16 securities firms in accordance with article 2 letter d of the financial institutions act of 15 june 201817 (finia);b. other parties supervised by finma in accordance with article 3 of the financial market supervision act of 22 june 200718 (finmasa), provided that the trading venue ensures that they fulfil equivalent technical and operational conditions to securities firms;19c. foreign participants authorised by finma in accordance with article 40;d. the snb.16 amended by annex no ii 18 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).17 sr 954.118 sr 956.119 term in accordance with annex no ii 18 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901). this modification has been made throughout the text.art. 35 admission of securities by a stock exchange 1 the stock exchange shall issue regulations on the admission of securities to trading, and particularly for the listing of securities.2 the regulations shall take account of recognised international standards and in particular shall contain provisions on:a.20 the requirements that apply to the securities and the issuers and the duties of the issuer, its representatives and third parties in connection with the listing or admission of securities to trading;b. the publication of information on which investors rely for assessing the characteristics of securities and the quality of the issuer;c. the duties of the issuer, its representatives and third parties for the entire duration of the listing or admission of securities to trading;d. the obligation, regarding the admission of equity securities and bonds, to comply with articles 7 and 821 of the federal act of 16 december 200522 on the licensing and oversight of auditors (aoa).2bis the prospectus requirement is governed exclusively by articles 35-57 of the financial services act of 15 june 201823.243 the stock exchange shall monitor compliance with the regulations and impose the sanctions provided for contractually in the event of violations.20 amended by annex no 5 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).21 art. 8 para. 1 let. b and d never came into force.22 sr 221.30223 sr 950.124 inserted by annex no 5 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).art. 36 admission of securities by a multilateral trading facility 1 the multilateral trading facility shall issue regulations on the admission of securities to trading. in particular, it shall set out therein the requirements for the securities and the issuers or third parties in connection with admission to trading.252 it shall monitor compliance with the regulations and impose the sanctions provided for contractually in the event of violations.3 the prospectus requirement is governed exclusively by articles 35-57 of the financial services act of 15 june 201826.2725 amended by annex no 5 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).26 sr 950.127 inserted by annex no 5 of the financial services act of 15 june 2018, in force since 1 jan. 2020 (as 2019 4417; bbl 2015 8901).art. 37 appeal body 1 the trading venue shall appoint an independent appeal body to which application may be made:a. when a participant is refused admission;b. when a security is refused admission;c. when a participant is excluded;d. when a security is delisted.2 it shall govern the organisation of the appeal body and its procedures.3 the organisation, the procedural rules and the appointment of the members of the appeal body require the approval of finma.4 an action may be brought before the civil court after the appeal procedure has been conducted.art. 38 record-keeping duty of participants the participants admitted to a trading venue shall keep a record of the orders and transactions they carry out, providing all the details necessary for overseeing and supervising their activity.art. 39 reporting duty of participants 1 the participants admitted to a trading venue must report all of the information necessary for transparent securities trading.2 finma shall determine which information is to be reported to whom and in what form.3 the snb is not subject to the reporting obligation within the framework of carrying out its public duties.art. 40 authorisation of foreign participants 1 finma shall grant authorisation to a foreign participant wishing to participate in a swiss trading venue but which has no registered office in switzerland:a. if it is subject to appropriate regulation and supervision;b. if it observes a code of conduct and record-keeping and reporting duties equivalent to the duties set out in swiss regulations; c. if it ensures that its activities are separate from the activities of any authorised swiss units; andd. if the competent supervisory authorities:1. do not have any objections to the participant's activity in switzerland,2. provide finma with administrative assistance.2 finma may reject authorisation if the state in which the foreign participant has its registered office does not grant swiss participants actual access to its markets or does not offer them the same competitive opportunities as those granted to domestic trading participants. any deviating international commitments are reserved.3 a foreign participant that already participates in a swiss trading venue shall inform finma if it wishes to participate in another swiss trading venue. in this case, the foreign supervisory authority has to confirm that it has no objection to the expansion of the foreign participant's activity in switzerland.4 finma authorisation is not required for participation in monetary policy transactions with the snb. art. 41 recognition of foreign trading venues 1 trading venues domiciled abroad must obtain recognition from finma before granting swiss participants supervised by finma direct access to their facilities.2 finma shall grant recognition:a. if the foreign trading venue is subject to appropriate regulation and supervision; andb. if the competent foreign supervisory authorities:1. do not have any objections to the cross-border activity of the foreign trading venue,2. guarantee that they will inform finma if they detect violations of the law or other irregularities on the part of swiss participants, and3. provide finma with administrative assistance.3 a foreign trading venue is deemed recognised if finma finds that:a. the state in which the trading venue has its registered office regulates and supervises its trading venues adequately; andb. the conditions in paragraph 2 letter b are met. 4 finma may refuse recognition if the state in which the foreign trading venue has its registered office does not grant swiss trading venues actual access to its markets or does not offer them the same competitive opportunities as those granted to domestic trading venues. any deviating international commitments are reserved.section 2 organised trading facilities art. 42 definition an organised trading facility is an establishment for:a. multilateral trading in securities or other financial instruments whose purpose is the exchange of bids and the conclusion of contracts based on discretionary rules;b. multilateral trading in financial instruments other than securities whose purpose is the exchange of bids and the conclusion of contracts based on non-discretionary rules;c. bilateral trading in securities or other financial instruments whose purpose is the exchange of bids. art. 43 duty to obtain authorisation or recognition 1 anyone who operates an organised trading facility requires authorisation as a bank, securities dealer or dlt trading facility, or authorisation or recognition as a trading venue.282 no authorisation is required for the operation of an organised trading facility within a financial group if this is conducted via a legal entity that:a. is controlled directly by a financial market infrastructure; andb. is subject to consolidated finma supervision.28 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 44 organisation and prevention of conflicts of interest anyone who operates an organised trading facility must:a. do this separately from the other business activities;b. take effective organisational measures to identify, prevent, settle and monitor conflicts of interest;c. ensure that client interests are comprehensively protected when conducting proprietary transactions on the organised trading facility operated by him.art. 45 guarantee of orderly trading 1 anyone who operates an organised trading facility must ensure that this guarantees orderly trading even in the event of intense trading activity.2 this person shall take effective measures to prevent disruptions to the trading facility.art. 46 trading transparency 1 anyone who operates an organised trading facility shall publish information on the transactions carried out on the trading facility, in particular the price, volume and time of the transactions.2 taking recognised international standards and foreign legal developments into account, the federal council shall regulate exemptions to this publication duty, particularly in relation to securities transactions involving large volumes or that are executed by the snb.3 it may make provision, in line with recognised international standards, for extending the publication duty to pre-trading transparency.section 3 power exchanges art. 47 1 the federal council may adopt provisions which deviate from this act for exchanges where electricity derivatives are traded and for trading on such exchanges in order to take account of the specific features of the electricity market, particularly so as to safeguard the public interest in a secure power supply.2 it may empower finma to issue provisions, in agreement with the federal electricity commission, in areas with a restricted scope, namely those that are primarily technical. chapter 3 central counterparties section 1 general provisions art. 48 definition a central counterparty is an entity based on uniform rules and procedures that interposes itself between the counterparties to a securities transaction or other contract involving financial instruments, thereby becoming the buyer to every seller and the seller to every buyer.art. 49 collateral 1 the central counterparty shall require its participants to provide appropriate collateral, particularly in the form of initial margins, variation margins and default fund contributions.2 this collateral shall be calculated at least in such a way that:a. a participant's variation margins cover the current credit exposures based on realised market price movements;b. a participant's initial margins will, with a high degree of confidence, cover the potential credit exposures arising for a central counterparty upon the participant's default based on expected market price movements;c. the initial margins, variation margins and default fund contributions will be sufficient to cover the loss resulting under extreme but plausible market conditions from the default of the participant to which the central counterparty has its greatest exposure.3 the central counterparty shall accept only liquid collateral with low credit and market risks. it shall value the collateral prudently.art. 50 fulfilment of payment obligations 1 the central counterparty and its participants shall fulfil their mutual payment obligations by transferring sight deposits held with a central bank.2 if this is impossible or impractical, they shall use a means of payment which carries low credit and liquidity risks. the central counterparty shall minimise these risks and monitor them on an ongoing basis.art. 51 capital adequacy and risk diversification 1 individually and on a consolidated basis, the central counterparty must have adequate capital and diversify its risk appropriately.2 the federal council shall set the amount of the capital based on the business activity and the risks, and shall determine the risk diversification requirements.art. 52 liquidity 1 the central counterparty must have sufficient liquidity:a. to fulfil its payment obligations in all currencies under extreme but plausible market conditions, even in the event of the default of the participant to which it has its greatest exposure; andb. to be able to duly execute its services and activities.2 it shall invest its financial resources solely in cash or in liquid financial instruments with a low market and credit risk.art. 53 procedure in the event of the default of a participant 1 the central counterparty shall take measures to limit the credit and liquidity risks in the event of a participant's default. 2 to cover any losses in the event of a participant's default, it shall use collateral and capital in the following order:a. margins of the defaulting participant;b. default fund contributions of the defaulting participant;c. dedicated capital of the central counterparty;d. default fund contributions of non-defaulting participants.3 it shall issue rules governing how more extensive losses are to be covered. it may not:a. use the initial margins of non-defaulting participants to cover losses caused by the default of another participant;b. use the collateral of indirect participants to cover losses caused by the default of a participant or other indirect participant; orc. use an indirect participant's funds in excess of the margin requirement deposited with it in accordance with article 59 paragraph 3 to cover losses caused by the default of a participant or other indirect participant.art. 54 segregation 1 the central counterparty must: a. separate its own assets, receivables and liabilities from the collateral, receivables and liabilities of its participants; andb. separate a participant's collateral, receivables and liabilities from those of other participants.2 it shall offer its participants the possibility of:a. separating their own collateral, receivables and liabilities from those of indirect participants;b. keeping and recording the collateral, receivables and liabilities of indirect participants together (omnibus customer accounts) or separately (individual customer accounts).art. 55 portability 1 the central counterparty shall ensure that, in the event of a participant's default, the collateral and positions held by the participant on behalf of an indirect participant can be transferred to another participant indicated by the indirect participant.2 a participant shall be considered to be in default if:a. it does not meet the admission requirements concerning the participant's financial capacity by the deadline set by the central counterparty; orb. compulsory winding-up proceedings were initiated against it for the purposes of general execution.section 2 interoperability agreements art. 56 non-discriminatory access 1 central counterparties may conclude an agreement on the interoperable clearing of financial transactions (interoperability agreement).2 a central counterparty is obliged to accept the request of another central counterparty concerning the conclusion of an interoperability agreement, unless the conclusion of such an agreement would jeopardise the security and efficiency of clearing. art. 57 approval 1 the conclusion of an interoperability agreement is subject to approval by finma.2 the interoperability agreement shall be approved if:a. the respective rights and duties of the central counterparties are governed;b. the central counterparties have appropriate procedures and instruments for managing the risks arising from the interoperability agreement; c. the central counterparty will cover the credit and liquidity risks arising from the interoperability agreement by immediately demanding appropriate collateral from the other central counterparty;d. the central counterparties are authorised or recognised by finma;e. the authorities responsible for supervising and overseeing the foreign central counterparty collaborate with the competent swiss authorities.3 if a central counterparty involved in the interoperability agreement is systemically important, finma shall obtain the snb's agreement before granting its approval.4 if a central counterparty involved in an interoperability agreement extends its activity to a new trading venue without this entailing new risks, the interoperability agreement does not require re-approval. section 3 participants art. 58 publication of prices a central counterparty's participants which render a central counterparty accessible to indirect participants shall publish the prices of the services they provide in connection with clearing.art. 59 segregation 1 a central counterparty's participant shall separate the collateral, receivables and liabilities of indirect participants from its own assets and positions with the central counterparty and in its own accounts.2 it shall offer indirect participants the possibility of keeping and recording the collateral, receivables and liabilities together with those of other indirect participants (omnibus customer accounts) or separately (individual customer accounts).3 if an indirect participant opts for individual client segregation, the participant must deposit all funds in excess of the indirect participant's margin requirement with the central counterparty and distinguish them from the margin of other indirect participants.4 a central counterparty's participant shall publish the costs and specifics concerning the level of protection granted by the type of account management under paragraph 2.section 4 recognition of foreign central counterparties art. 60 1 a central counterparty registered abroad must obtain finma recognition before it:a. grants supervised swiss participants direct access to its facilities;b. provides services for a swiss financial market infrastructure;c. enters into an interoperability agreement with a swiss central counterparty.2 finma shall grant recognition:a. if the foreign central counterparty is subject to appropriate regulation and supervision; andb. if the competent foreign supervisory authorities:1. do not have any objections to the cross-border activity of the foreign central counterparty,2. guarantee that they will inform finma if they detect violations of the law or other irregularities on the part of swiss participants, and3. provide finma with administrative assistance.3 finma may refuse recognition if the state in which the foreign central counterparty has its registered office does not grant swiss central counterparties actual access to its markets or does not offer them the same competitive opportunities as those granted to domestic central counterparties. any deviating international commitments are reserved.4 it may exempt a foreign central counterparty from the obligation to obtain recognition provided this does not adversely affect the protective purpose of this act.chapter 4 central securities depositories section 1 general provisions art. 61 definitions 1 a central securities depository is the operator of a central custodian or a securities settlement system.2 a central custodian is an entity for the central custody of securities and other financial instruments based on uniform rules and procedures.3 a securities settlement system is an entity for the clearing and settlement of transactions in securities and other financial instruments based on uniform rules and procedures.art. 62 principles for the custody, recording and transfer of securities 1 the central securities depository shall ensure the proper and lawful custody, recording and transfer of securities.2 it shall prohibit its participants from overdrawing their securities accounts for securities held in central custody with it.3 it shall check on a daily basis whether the number of an issuer's securities issued with it is equal to the number of securities recorded in the participants' securities accounts.4 it shall specify the time:a. after which a securities transfer order is irrevocable and may no longer be changed;b. when a securities transfer is settled.5 it shall transfer securities in real time if possible, but at the latest at the end of the value day.art. 63 settlement deadlines 1 the central securities depository shall set the deadlines for participants to settle their securities transactions in its system. in doing so, it shall take account in particular of international practices and its participants' needs.2 it shall enable its participants to settle transactions within the deadlines it sets. 3 it shall monitor whether transactions are settled within the allocated deadlines. it shall impose the contractually agreed sanctions in the event of late settlement.art. 64 collateral 1 the central securities depository shall use appropriate measures to cover risks arising from the granting of credit.2 it shall accept only liquid collateral with low credit and market risks. it shall value the collateral prudently.art. 65 fulfilment of payment obligations 1 the central securities depository shall enable the settlement of payments in connection with securities held in custody or recorded with it by transferring sight deposits held with a central bank.2 if this is impossible or impractical, it shall use a means of payment which carries no or only low credit and liquidity risks. it shall minimise these risks and monitor them on an ongoing basis.art. 66 capital adequacy and risk diversification 1 individually and on a consolidated basis, the central securities depository must have adequate capital and diversify its risk appropriately.2 the federal council shall set the amount of the capital based on the business activity and the risks, and shall determine the risk diversification requirements.art. 67 liquidity 1 the central securities depository must have sufficient liquidity:a. to fulfil its payment obligations in all currencies under extreme but plausible market conditions, even in the event of the default of the participant to which it has its greatest exposure; andb. to be able to duly execute its services and activities.2 it shall invest its financial resources solely in cash or in liquid financial instruments with a low market and credit risk.art. 68 procedure in the event of the default of a participant the central securities depository shall provide for measures to limit the credit and liquidity risks that arise in the event of a participant's default.art. 69 segregation 1 the central securities depository must:a. separate its own assets from the securities of its participants; andb. separate a given participant's securities from those of other participants.2 it shall offer its participants the possibility of:a. separating their own securities from those of indirect participants;b. keeping and recording the securities of indirect participants together (omnibus customer accounts) or separately (individual customer accounts).section 2 links between central securities depositories art. 70 definition links between central securities depositories are understood as meaning agreements:a. between central securities depositories regarding the mutual execution of payment and transfer orders (interoperability links);b. regarding the direct or indirect participation of a central securities depository in another central securities depository (access links).art. 71 approval 1 the establishment of the following links between central securities depositories requires the approval of finma:a. interoperability agreements; b. access agreements in which a central securities depository provides services for the other party that it does not provide for other participants.2 approval is granted if the central securities depositories:a. apply rules, procedures and controls which allow them to identify, limit and monitor the risks arising from their agreement for their own protection and that of their participants;b. check their records are correct by comparing them; andc. set out in a written agreement their rights and duties, as well as the rights and duties of their participants if appropriate.3 if a central securities depository involved in a link between central securities depositories is systemically important, finma must obtain the snb's agreement before granting approval.art. 72 reporting the establishment of access links in which a central securities depository provides the same services for the other party as it provides for other participants must be reported to finma.section 3 segregation by participants art. 73 1 a central securities depository's participant shall separate the securities, receivables and liabilities of indirect participants from its own assets, receivables and liabilities with the central securities depository and in its own accounts.2 it shall offer indirect participants the possibility of keeping and recording securities, receivables and liabilities together with those of other indirect participants (omnibus customer accounts) or separately (individual customer accounts).3 if an indirect participant opts for individual client segregation, the participant must deposit all funds in excess of the individual participant's margin requirement with the central securities depository and distinguish them from the margin payments of other indirect participants.4 a central securities depository's participant shall publish the costs and specifics concerning the level of protection granted by the type of account management under paragraph 2.chapter 4a29 dlt trading facilities 29 inserted by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 73a definitions 1 a dlt trading facility is a commercially operated institution for multilateral trading of dlt securities whose purpose is the simultaneous exchange of bids between several participants and the conclusion of contracts based on non-discretionary rules and which meets at least one of the following criteria:a. it admits participants in accordance with article 73c paragraph 2 letter e.b. it holds dlt securities in central custody based on uniform rules and procedures.c. it clears and settles transactions in dlt securities based on uniform rules and procedures.2 the criterion of a commercial basis is deemed satisfied by an independent economic activity pursued on a permanent, for-profit basis.art. 73b applicability of certain requirements for trading venues dlt trading facilities are subject to the following requirements for trading venues:a. self-regulation (art. 27);b. organisation of trading (art. 28);c. pre- and post-trade transparency (art. 29);d. guarantee of orderly trading (art. 30);e. supervision of trading (art. 31);f. collaboration between trading supervisory bodies (art. 32);g. suspension of trading (art. 33 para. 2);h. appeal body (art. 37).art. 73c admission of participants and their duties 1 the following may be admitted as participants in a dlt trading facility:a. securities firms as defined in article 41 of the finia30;b. other parties supervised by finma in accordance with article 3 of the finmasa31 as well as parties supervised by a foreign authority, provided that the dlt trading facility ensures that they fulfil equivalent technical and operational conditions to securities firms;c. the snb;d. the bank for international settlements;e. other natural persons and legal entities, provided that they declare that they are participating in their own name and for their own account.2 participants domiciled in switzerland must provide finma with all information and documents that it requires to carry out its tasks. the dlt trading facility must ensure that foreign-domiciled participants provide the relevant information and documents if finma so requires.3 the provisions on the record-keeping duty (art. 38) and the reporting duty (art. 39) of participants also apply to participants in a dlt trading facility. the federal council may make exceptions for participants under paragraph 1 letter e.4 the federal council shall regulate the details regarding the admission, duties and exclusion of participants.5 the dlt trading facility shall issue regulations on the admission, duties and exclusion of participants, thereby observing in particular the principle of equal treatment.6 it shall monitor compliance with the regulations and impose the sanctions provided for contractually in the event of violations. 30 sr 954.131 sr 956.1art. 73d admission of dlt securities and other assets 1 the dlt trading facility shall issue regulations on the admission of dlt securities to trading and to the other services it provides. in particular, it shall set out therein the requirements to be met by the dlt securities and the issuers or third parties in connection with the admission. the duty to publish a prospectus is governed exclusively by articles 35-57 of the financial services act of 15 june 201832.2 a dlt trading facility that, in addition to dlt securities, admits other assets to trading or to its other services shall issue regulations on the admission of such assets.3 the federal council may:a. require that dlt securities be admitted to dlt trading facilities only if they meet certain minimum requirements, in particular as regards their integrity and the availability of public information;b. specify which dlt securities and other assets must not be admitted to dlt trading facilities in order to protect financial market participants or the stability or integrity of the financial system.4 the dlt trading facility shall monitor compliance with the regulations and impose the sanctions provided for contractually in the event of violations.32 sr 950.1art. 73e additional requirements 1 for dlt trading facilities that are open to participants under article 73c paragraph 1 letter e, the federal council may set requirements for the protection of these participants in addition to the requirements under articles 73b-73d.2 for dlt trading facilities that provide central custody, clearing and settlement services, the federal council shall set requirements in addition to those under articles 73a-73d, in particular with regard to:a. the central custody, clearing and settlement of dlt securities;b. collateral;c. capital adequacy;d. risk diversification;e. ancillary services;f. liquidity;g. procedure in the event of a participant's default;h. segregation.3 the federal council shall base the requirements under paragraph 2 on the requirements for central securities depositories (arts. 61-73).4 where necessary in order to take account of technology-specific risks, the federal council may authorise finma to draw up the requirements under paragraph 2.5 the competence of the snb to specify special requirements for systemically important dlt trading facilities by virtue of article 23 is reserved.art. 73f easing of requirements for small dlt trading facilities 1 for reasons of proportionality and while taking into account the protective purpose of this act, the federal council may ease the requirements for small dlt trading facilities under articles 6-21, 27-33 and 37, in particular the requirements on:a. separation of the bodies responsible for business management from those responsible for overall management, supervision and control (art. 8);b. the provision of ancillary services not subject to authorisation or approval by virtue of the financial market legislation (art. 10);c. the independence of the self-regulatory organisation (art. 27 para. 2) and of the appeal body (art. 37 para. 1).2 dlt trading facilities are deemed to be small if they pose a low risk in terms of the protection of financial market participants and the proper functioning and stability of the financial system, in particular because the number of participants, the trading volume, the volume of custody assets or the clearing and settlement volume is limited. the federal council shall set thresholds.3 dlt-handelssysteme, die erleichterungen nach diesem artikel erhalten, sind verpflichtet, dies gegenber ihren kundinnen und kunden offenzulegen. der bundesrat regelt die details.chapter 5 trade repositories section 1 general provisions art. 74 definition a trade repository is an entity which collects, manages and retains in a centralised manner the data on derivatives transactions reported to it in accordance with article 104.art. 75 data retention the trade repository shall record the reported data and retain it for at least ten years after the contract was due. art. 76 publication of data 1 the trade repository shall regularly publish the open positions, transaction volumes and values by derivatives category in aggregated and anonymised form on the basis of the reported data. 2 it may publish further data provided it is aggregated and anonymised.art. 77 data access for swiss authorities 1 the trade repository shall grant the following authorities free access to the data they require to perform their tasks:a. finma;b. the snb;c. other swiss financial market supervisory authorities;d. the federal electricity commission.2 the federal council shall regulate access to data concerning central bank transactions, taking account of recognised international standards.art. 78 data access for foreign authorities 1 the trade repository shall grant a foreign financial market supervisory authority free access to the data it requires to perform its tasks if an agreement regarding cooperation between the competent swiss and foreign supervisory authorities confirms fulfilment of the following conditions: a. the foreign financial market supervisory authority is subject to a statutory confidentiality duty.b. forwarding of the data by the foreign financial market supervisory authority to other foreign authorities is permitted only if, on transfer to a criminal authority, mutual assistance in accordance with the mutual assistance act of 20 march 198133 is possible.c. the swiss authorities mentioned in article 77 paragraph 1 have immediate access to trade repositories in the state of the foreign financial market supervisory authority.2 the federal council shall regulate access to data concerning central bank transactions, taking account of recognised international standards.33 sr 351.1art. 79 data transmission to private individuals 1 the trade repository may transmit data to private individuals in aggregated and anonymised form. 2 the transmission of data to private individuals regarding their own transactions is permitted without restriction. section 2 recognition of foreign trade repositories art. 80 1 a trade repository registered abroad must obtain recognition from finma before accepting reports in accordance with article 104.2 finma shall grant recognition:a. if the foreign trade repository is subject to appropriate regulation and supervision; andb. if the competent foreign supervisory authorities:1. do not have any objections to the cross-border activity of the foreign trade repository,2. guarantee that they will inform finma if they detect violations of the law or other irregularities on the part of swiss participants,3. confirm to the competent swiss financial market supervisory authority that the conditions set out in article 78 paragraph 1 letters b and c are fulfilled.3 a trade repository is deemed recognised if finma finds that:a. the state in which the foreign trade repository has its registered office regulates and supervises its trade repositories adequately; andb. the conditions in accordance with paragraph 2 letter b are met.4 finma may refuse recognition if the state in which the foreign trade repository has its registered office does not grant swiss trade repositories actual access to its markets or does not offer them the same competitive opportunities as those granted to the trade repositories of the state in question. any deviating international commitments are reserved.chapter 6 payment systems art. 81 definition a payment system is an entity that clears and settles payment obligations based on uniform rules and procedures.art. 82 duties the federal council may define specific duties for payment systems, namely in terms of capital adequacy, risk diversification and liquidity, if this is necessary for implementing recognised international standards. the competence of the snb to specify special requirements for systemically important payment systems by virtue of article 23 is reserved.chapter 7 supervision and oversight art. 83 responsibilities 1 finma is the supervisory authority. systemically important financial market infrastructures are also subject to oversight by the snb.2 finma shall supervise compliance with the authorisation conditions and duties insofar as this task is not covered by the snb by virtue of the oversight of the special requirements in accordance with article 23.3 finma and the snb shall jointly carry out their supervisory and oversight activities regarding systemically important financial market infrastructures, regularly exchange information and avoid overlaps in the execution of their tasks. when cooperating with foreign supervisory and oversight authorities, they shall coordinate the discharge of their duties and their communication.art. 84 auditing 1 financial market infrastructures and financial groups must instruct an audit firm licensed by the federal audit oversight authority in accordance with article 9a paragraph 1 aoa34 to conduct an audit in accordance with article 24 of the finmasa35. 2 they must have their annual accounts, and if applicable their consolidated accounts, audited by an audit firm subject to state oversight in accordance with the ordinary auditing principles set out in the code of obligations (co)36.3 finma may audit financial market infrastructures directly.34 sr 221.30235 sr 956.136 sr 220art. 85 suspension of voting rights finma may suspend the voting rights attached to shares or units held by qualified participants in order to enforce article 9 paragraphs 3 and 5.art. 86 voluntary authorisation return 1 a financial market infrastructure which wishes to return its authorisation must present a liquidation plan to finma for approval.2 the liquidation plan must contain details on:a. the settlement of financial obligations; b. the funds made available for this purpose;c. the person responsible.3 a financial market infrastructure is released from supervision by finma when it has fulfilled the duties set out in the liquidation plan.art. 87 authorisation withdrawal 1 as a complement to article 37 finmasa37, finma may withdraw authorisation or recognition from a financial market infrastructure if it:a. does not use the authorisation within twelve months; b. has not provided services permitted solely with the authorisation during the preceding six months;c. does not comply with the liquidation plan.2 the withdrawal of authorisation shall cause the dissolution of the legal entity. finma shall designate the liquidator and oversee its activity. the insolvency law provisions in accordance with chapter 8 remain reserved.37 sr 956.1chapter 8 insolvency law provisions art. 88 insolvency measures 1 articles 24 to 37 and 37d to 37g, with the exception of article 37g paragraph 4bis of the banking act of 8 november 193438 apply by analogy for financial market infrastructures unless this act contains provisions to the contrary.392 in the case of systemically important financial market infrastructures, finma shall consult the snb before taking insolvency measures.38 sr 952.039 amended by annex no 3 of the fa of 16 march 2018, in force since 1 jan. 2019 (as 2018 3263; bbl 2017 4125).art. 89 system protection 1 insofar as this is possible and to the extent that they are concerned, finma shall inform central counterparties, central securities depositories, payment systems and those dlt trading facilities that provide comparable central custody, clearing or settlement services, in switzerland and abroad, of the insolvency measures it intends to take against a participant and which limit the participant's power of disposal. it shall also inform them of the precise time of entry into effect of the measures.402 the orders given to a central counterparty, central securities depository, payment system or a dlt trading facility that provides comparable central custody, clearing or settlement services by a participant against which such an insolvency measure has been taken shall be legally enforceable and binding on third parties if:41a. they were introduced before the measure was ordered and were unalterable in accordance with the rules of the financial market infrastructure; orb. they were executed on the business day defined by the rules of the financial market infrastructure during which the measure was ordered and the financial market infrastructure proves that it was not and should not have been aware of the measure being ordered.3 paragraph 2 applies if:a. the financial market infrastructure is authorised in switzerland;b. the foreign financial market infrastructure is recognised or supervised in switzerland and grants swiss participants direct access to its facilities; orc. the participation agreement is subject to swiss law.4 paragraph 2 applies by analogy to:a. financial market infrastructures in accordance with article 4 paragraph 3;b. payment systems that are operated by banks.40 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).41 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 90 primacy of agreements in the event of participant insolvency 1 insolvency measures that are ordered against a central counterparty's participant have no effect on previously concluded agreements between the central counterparty and the participant regarding:a. the offsetting of receivables, including the agreed method and valuation;b. the direct realisation of collateral in the form of securities or other financial instruments whose value can be determined objectively;c. the transfer of receivables and liabilities, and collateral in the form of securities, or other financial instruments whose value can be determined objectively.2 following the netting or realisation carried out by the central counterparty in accordance with paragraph 1 letters a and b, the participant's remaining entitlements shall be segregated in favour of its clients and indirect participants.3 measures to the contrary ordered within the scope of the postponement of the termination of contracts by finma are reserved.art. 91 primacy of agreements in the event of insolvency of an indirect participant 1 insolvency measures that are ordered against a central counterparty's indirect participant have no effect on previously concluded agreements pursuant to article 90 paragraph 1 letters a to c between the participant and the indirect participant.2 following the netting or realisation carried out by the participant within the meaning of article 90 paragraph 1 letters a and b, the indirect participant's remaining entitlements shall be segregated in favour of its clients and indirect participants.3 paragraphs 1 and 2 shall also apply to insolvency measures against the indirect participant of another indirect participant.4 measures to the contrary ordered within the scope of the postponement of the termination of contracts by finma are reserved.art. 92 postponement of the termination of contracts if finma postpones the termination of contracts and the exercise of rights to terminate them, it shall take account of the implications for the financial markets and the secure and orderly operation of the affected financial market infrastructure, its participants and other financial market infrastructures associated with it.title 3 market conduct chapter 1 derivatives trading section 1 general provisions art. 93 scope 1 subject to the provisions set out below, this chapter applies to financial and non-financial counterparties which have their registered office in switzerland.2 the term financial counterparties means:a. banks in accordance with article 1 paragraph 1 of the banking act of 8 november 193442;b.43 securities firms in accordance with article 41 finia44;c. insurance and reinsurance companies in accordance with article 2 paragraph 1 letter a of the federal act of 17 december 200445 on the supervision of insurance companies;d. parent companies of a financial or insurance group or financial or insurance conglomerate;e.46 managers of collective assets and fund management companies in accordance with article 2 paragraph 1 letters c and d finia;f. collective investment schemes in accordance with the collective investment schemes act;g. occupational pension schemes and investment foundations in accordance with articles 48 to 53k of the federal act of 25 june 198247 on occupational old age, survivors' and invalidity pension provision.3 non-financial counterparties are companies that are not financial counterparties.4 the following establishments shall be subject only to the reporting duty in accordance with article 104:a. multilateral development banks; b. organisations, including social security institutions, belonging to the confederation, cantons or communes or for which the confederation, canton or commune in question is liable and provided that they are not financial counterparties.5 the federal council may subject swiss branches of foreign financial market participants to the provisions of this chapter if they are not subject to any equivalent regulations.42 sr 952.043 amended by annex no ii 18 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).44 sr 954.145 sr 961.0146 amended by annex no ii 18 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).47 sr 831.40art. 94 exemptions 1 this chapter does not apply to:a. the confederation, cantons and communes;b. the snb; c. the bank for international settlements. 2 the federal council may, for reasons of proportionality and taking account of recognised international standards, exclude other public sector bodies or financial market participants from the scope of this chapter in whole or in part.3 the following are not considered to be derivatives in accordance with this chapter:a. structured products such as capital-protected products, capped return products and certificates;b. securities lending and borrowing;c. derivatives transactions relating to goods that:1. must be physically delivered,2. cannot be settled in cash at a party's discretion, and3. are not traded on a trading venue or an organised trading facility.4 the federal council may exclude derivatives from the provisions of this chapter if this is in keeping with internationally recognised standards. art. 95 fulfilment of duties under foreign law the duties set out in this chapter shall be deemed fulfilled if:a. they are fulfilled under foreign law recognised as being equivalent by finma; b. a foreign financial market infrastructure recognised by finma was used to execute the transaction.art. 96 intra-group flow of information counterparties may exchange with their group companies and branches abroad all data necessary for immediate fulfilment of the duties arising from this chapter.section 2 clearing via a central counterparty art. 97 clearing duty 1 counterparties must clear transactions in derivatives in accordance with article 101 that were not conducted via a trading venue (otc derivatives transactions) through a central counterparty authorised or recognised by finma.2 this duty does not apply to transactions with small counterparties or for transactions between such counterparties.3 a counterparty may assume that its counterparty's declaration concerning its characteristics is correct insofar as there are no indications to the contrary.4 in order to complement the duty detailed in article 112, the federal council may order that all derivatives transactions conducted via a trading venue or organised trading facility must be cleared by a central counterparty authorised or recognised by finma.5 finma may allow clearing by an unrecognised central counterparty in individual cases, provided this does not adversely affect the protective purpose of this act.art. 98 small non-financial counterparties 1 a non-financial counterparty is deemed to be small if all of the rolling averages for its gross positions in relevant outstanding otc derivatives transactions calculated over 30 working days are below the thresholds. 2 if one of the average gross positions of an existing small non-financial counterparty calculated in accordance with paragraph 1 exceeds the relevant threshold, said counterparty will no longer be deemed small four months after the threshold is exceeded. 3 derivatives transactions intended to reduce risks are not factored into the calculation of the average gross position if they are directly associated with the business activity, liquidity management or asset management of the counterparty or group.art. 99 small financial counterparties 1 a financial counterparty is deemed to be small if the rolling average for its gross position in all outstanding otc derivatives transactions calculated over 30 working days is below the threshold.2 if an existing small financial counterparty's average gross position in accordance with paragraph 1 exceeds the threshold, said counterparty will no longer be deemed small four months after the threshold is exceeded.art. 100 thresholds 1 thresholds apply by derivatives category to non-financial counterparties' average gross positions in outstanding otc derivatives transactions.2 a single threshold shall apply to the average gross positions in all outstanding otc derivatives transactions of financial counterparties.3 if the counterparty is part of a fully consolidated group, all of the intra-group otc derivatives transactions concluded by the counterparty or by other counterparties shall also be factored into the calculation of the average gross positions.4 the federal council shall determine:a. for non-financial counterparties, the level of the thresholds for each derivatives category and how they are calculated;b. which derivatives transactions of non-financial counterparties are not to be taken into account when calculating the thresholds;c. the threshold for financial counterparties.art. 101 derivatives concerned 1 finma determines the derivatives which must be cleared via a central counterparty. in so doing, it considers:a. their degree of legal and operational standardisation;b. their liquidity;c. their trading volumes;d. the availability of pricing information in the given category;e. the counterparty risks associated with them.2 it shall take account of recognised international standards and foreign legal developments. it may phase in the introduction of the clearing duty by derivatives category.3 no clearing duty may be imposed for:a. derivatives that are not cleared by any authorised or recognised central counterparty;b. currency swaps and forward transactions, provided they are settled on a payment versus payment basis.art. 102 cross-border transactions the duty to clear through a central counterparty also applies if the foreign counterparty of the swiss counterparty subject to this duty would be subject to the clearing duty if it had its registered office in switzerland. art. 103 intra-group transactions derivatives transactions do not have to be cleared via a central counterparty:a. if the two counterparties are included in the same full consolidation basis; b. if the two counterparties are subject to appropriate centralised risk evaluation, measurement and control procedures; andc. if the transactions do not aim to circumvent the clearing duty.section 3 reporting to a trade repository art. 104 reporting duty 1 derivatives transactions must be reported to a trade repository authorised or recognised by finma.2 the following shall be obliged to report:a. in the case of transactions between a financial and a non-financial counterparty: the financial counterparty;b. in the case of transactions between two financial counterparties:1. the financial counterparty which is not small in accordance with article 99,2. the selling counterparty in the case of a transaction between two financial counterparties or between two small financial counterparties;c. the counterparty which has its registered office in switzerland if the foreign counterparty does not report.3 in the event of a transaction between non-financial counterparties, paragraph 2 letters b and c applies by analogy. a transaction between small non-financial counterparties does not have to be reported.4 if the transaction is cleared centrally, the report is submitted by the central counterparty. if a recognised foreign central counterparty does not submit reports, the reporting duty shall remain with the counterparties. 5 third parties may be involved in reporting.6 if there is no trade repository, the federal council shall indicate the body to which the report is to be submitted.art. 105 timing and content of reports 1 the report is to be submitted at the latest on the working day following the conclusion, amendment or termination of the derivatives transaction.2 for each transaction, the following must be reported as a minimum:a. the identity of the counterparties, particularly their business name and seat;b. the type of transaction;c. the maturity date;d. the nominal value;e. the price;f. the settlement date;g. the currency.3 the federal council may make provision for the reporting of other details and governs the reporting format.4 reports to a recognised foreign trade repository may include further details. if these consist of personal data, the approval of the person in question is to be obtained.art. 106 retention of supporting documents counterparties must retain the supporting documents for their derivatives transactions in accordance with the provisions of article 958f co48.48 sr 220section 4 risk mitigation art. 107 duties 1 otc derivatives transactions which do not have to be cleared by a central counterparty authorised or recognised by finma are subject to the duties set out in this section.2 these duties do not apply to:a. derivatives transactions with counterparties in accordance with article 93 paragraph 4 and article 94 paragraph 1;b.49 currency swaps and currency forward transactions, provided they are settled on a payment versus payment basis;c. derivatives transactions voluntarily cleared by a central counterparty authorised or recognised by finma.3 the federal council may make provision for further complete or partial exemptions for reasons of proportionality and taking account of recognised international standards. 49 amended by annex no ii 18 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 108 operational and counterparty risk mitigation counterparties shall record, observe and mitigate operating risks and counterparty risks associated with derivatives transactions in accordance with article 107 paragraph 1. in particular, they must:a. confirm the contractual terms of derivatives transactions in a timely manner;b. have procedures for reconciling portfolios and managing the associated risks, except for when the counterparty is a small non-financial counterparty;c. have procedures for identifying and resolving disputes between parties at an early stage;d. regularly, but at least twice per year, perform portfolio compression where this is appropriate to mitigate their counterparty risk and provided they have 500 or more non-centrally cleared otc derivatives transactions outstanding.art. 109 valuation of outstanding transactions 1 counterparties must value derivatives at current prices (mark to market) on a daily basis.2 this duty does not apply to transactions with small counterparties.3 where market conditions prevent marking to market, marking to model shall be used. the valuation models must be appropriate and recognised in practice.4 non-financial counterparties may involve third parties for the valuation.art. 110 exchange of collateral 1 counterparties, with the exception of small non-financial counterparties, shall exchange appropriate collateral. 2 they must be capable of segregating the collateral from their own assets in an appropriate manner. 3 agreements regarding the direct realisation of collateral exchanged in accordance with paragraph 1 whose value can be determined objectively shall remain in force even in foreclosure proceedings and in the case of insolvency measures against the protection seller. 4 the federal council shall regulate the requirements for the exchange of collateral.art. 111 intra-group transactions no collateral has to be exchanged:a. if the two counterparties are included in the same full consolidation basis; b. if the two counterparties are subject to appropriate centralised risk evaluation, measurement and control procedures;c. if there are no legal or factual impediments to the prompt transfer of own funds or the repayment of liabilities; andd. if the transactions do not aim to circumvent the duty to exchange collateral.section 5 trading via trading venues and organised trading facilities art. 112 duty 1 counterparties must trade all derivatives in accordance with article 113 via:a. a trading venue that is authorised or recognised by finma; orb. the operator of an organised trading facility that is authorised or recognised by finma.2 this duty does not apply to transactions with small counterparties or for transactions between such counterparties.art. 113 derivatives concerned 1 finma determines the derivatives which must be traded via a trading venue or a trading facility in accordance with article 112 paragraph 1. in so doing, it considers:a. their degree of legal and operational standardisation;b. their liquidity;c. their trading volumes;d. the availability of pricing information in the given category;e. the counterparty risks associated with them.2 it shall take account of recognised international standards and foreign legal developments. it may phase in the introduction of the duty to trade via a trading venue or a trading facility, according to derivative category.3 no duty to trade in accordance with article 112 may be imposed for:a. derivatives not admitted to trading by a relevant trading venue or trading facility;b. currency swaps and forward transactions, provided they are settled on a payment versus payment basis.art. 114 cross-border transactions the duty to trade derivatives in accordance with article 112 also applies if the foreign counterparty of the swiss counterparty subject to the duty would be subject to the same duty if it had its registered office in switzerland.art. 115 intra-group transactions the duty to trade in accordance with article 112 does not apply if:a. the two counterparties are included in the same full consolidation basis; b. the two counterparties are subject to appropriate centralised risk evaluation, measurement and control procedures; andc. the transactions do not aim to circumvent the duty.section 6 auditing art. 116 responsibilities 1 the auditors in accordance with articles 727 and 727a co50 shall verify the counterparties' compliance with the provisions of this chapter within the framework of their audits.2 the auditing of supervised parties is governed by the financial market acts.3 provisions on the supervision and overall supervision of occupational old age, survivors' and invalidity pension provision are reserved.50 sr 220art. 117 reports and notifications 1 the audit companies of supervised parties shall report to finma.2 the duty to notify in accordance with article 728c paragraphs 1 and 2 co51 applies to auditors of non-supervised parties in the event of infringements with regard to duties under this chapter.3 if the company fails to take appropriate measures despite the auditors' notification, the auditors shall report the infringements to the federal department of finance. 51 sr 220chapter 2 position limits for commodity derivatives art. 118 position limits 1 the federal council may introduce limits on the size of net positions which a person may hold in commodity derivatives insofar as this is necessary for orderly pricing and settlement as well as for convergence between prices on the derivatives market and on the underlying market. in doing so, it shall take account of recognised international standards and legal developments abroad.2 it governs the following for position limits:a. the calculation of net positions;b. the exemptions for positions which are held for a non-financial counterparty and which serve to reduce the risks directly associated with its business activity, liquidity management or asset management;c. the reporting duties required for the transparency of commodity derivatives trading.3 finma shall set position limits for the individual commodity derivatives.art. 119 supervision 1 the trading venue shall supervise open positions in order to enforce position limits. it may request each participant to:a. grant it access to all information required for enforcing the position limits;b. liquidate or reduce positions if the position limits have been exceeded.2 paragraph 1 applies by analogy to operators of organised trading facilities and their clients.chapter 3 disclosure of shareholdings art. 120 notification duty 1 anyone who directly or indirectly or acting in concert with third parties acquires or disposes of shares or acquisition or sale rights relating to shares of a company with its registered office in switzerland whose equity securities are listed in whole or in part in switzerland, or of a company with its registered office abroad whose equity securities are mainly listed in whole or in part in switzerland, and thereby reaches, falls below or exceeds the thresholds of 3%, 5%, 10%, 15%, 20%, 25%, 33%, 50% or 66% of the voting rights, whether exercisable or not, must notify this to the company and to the stock exchanges on which the equity securities are listed.2 financial intermediaries who acquire or dispose of shares or acquisition or sale rights on behalf of third parties are not subject to this notification duty.3 anyone who has the discretionary power to exercise the voting rights associated with equity securities in accordance with paragraph 1 is also subject to the notification duty.4 the following shall be deemed equivalent to an acquisition or disposal:a. the initial listing of equity securities;b. the conversion of participation certificates or profit-sharing certificates into shares;c. the exercise of conversion or acquisition rights; d. changes in the share capital; ande. the exercise of sale rights.5 all procedures that can ultimately confer the voting right to equity securities also constitute an indirect acquisition. this does not apply in the case of powers of attorney granted solely for the purposes of representation at a general meeting.art. 121 notification duty for organised groups a group organised pursuant to an agreement or otherwise must comply with the notification duty laid down in article 120 as a group and shall disclose:a. its total holdings;b. the identity of its members;c. the nature of the agreement;d. the representation.art. 122 communication to finma if a company or stock exchange has reason to believe that a shareholder is in violation of the notification duty, it shall inform finma of such fact.art. 123 powers of finma 1 finma shall issue provisions on:a. the scope of the notification duty;b. the treatment of acquisition and disposal rights;c. the calculation of voting rights;d. the time frame within which the notification duty has to be fulfilled;e. the time frame within which a company has to publish changes to its ownership structure in accordance with article 120.2 finma may, for good cause, make provision for exemptions to or easing of the notification or publication duty, particularly if the transactions:a. are of a short-term nature;b. are not associated with any intention to exercise the voting right; orc. are conditional.3 anyone who intends to acquire securities can obtain a ruling from finma as to whether or not they will be subject to the notification duty.art. 124 duty of the company to inform the company must publish the information which it receives in respect of changes in the voting rights.chapter 4 public takeover offers art. 125 scope 1 the provisions of this chapter and article 163 apply to public takeover offers relating to equity securities of companies (target companies): a. with their registered office in switzerland whose equity securities are at least partly listed on a stock exchange in switzerland; b. with their registered office abroad whose equity securities are at least in part mainly listed in switzerland.2 if both swiss and foreign law are simultaneously applicable to a public takeover offer, the provisions of swiss law may be relinquished if:a. the application of swiss law would lead to a conflict with the foreign law; andb. the protection provided by the foreign law to investors is equivalent to that provided by swiss law.3 companies may, prior to their equity securities being admitted to official listing on a stock exchange in accordance with paragraph 1, state in their articles of incorporation that an offeror shall not be bound by the obligation to make a public takeover offer in accordance with articles 135 and 163.4 a company may at any time adopt a provision in accordance with paragraph 3 in its articles of incorporation, provided that this does not prejudice the interests of shareholders within the meaning of article 706 co52.52 sr 220art. 126 takeover board 1 after consulting the stock exchanges, finma shall appoint a board for public takeover offers (takeover board). this board shall consist of expert representatives of securities firms, listed companies and investors. the organisational structure and procedures of the takeover board shall be submitted to finma for approval.2 the provisions which are issued by the takeover board in accordance with this act shall require the approval of finma.3 the takeover board shall check compliance with the provisions applicable to public takeover offers in individual cases.4 it shall report to finma once a year on its activities.5 the takeover board may levy fees on the parties involved in takeover proceedings. the federal council shall govern the fees. in doing so, it shall take account of the value of the transactions and the degree of difficulty of the proceedings.6 the stock exchanges shall bear the costs that are not covered by the fees.art. 127 duties of the offeror 1 the offeror must publish the offer in a prospectus containing true and complete information.2 the offeror must treat all holders of equity securities of the same class equally.3 the offeror's duties shall apply for all who act in concert with it.art. 128 review of the offer 1 the offeror shall, prior to publication, submit the offer to an audit firm licensed by the federal audit oversight authority in accordance with article 9a paragraph 1 aoa53 or to a securities firm for review.2 the reviewing entity shall check whether the offer is in compliance with the law and the implementing provisions.53 sr 221.302art. 129 right of withdrawal of the seller the seller may withdraw a contract or rescind an executed sale if these were concluded or executed on the basis of a prohibited offer.art. 130 announcement of the result of the offer and extension of the offer period 1 the offeror must publish the result of the offer upon expiry of the offer period.2 if the conditions of the offer are met, the offeror must extend the offer period for those holders of shares and other equity securities who have not yet accepted the offer.art. 131 additional provisions the takeover board shall set out additional provisions relating to:a. the announcement of an offer prior to its publication;b. the contents and the publication of the prospectus as well as the conditions to which an offer can be subjected;c. the rules of fairness applicable to public takeover offers;d. the review of the offer by an audit firm licensed by the federal audit oversight authority in accordance with article 9a paragraph 1 aoa54 or a securities firm;e. the offer period and any extension thereof, the conditions under which the offer may be withdrawn or modified and the period within which a seller may withdraw;f. actions in concert with third parties;g. its procedures.54 sr 221.302art. 132 duties of target companies 1 the board of directors of the target company (art. 125 para. 1) shall submit a report to the holders of equity securities setting out its position in relation to the offer. the information in the report must be true and complete. the board of directors of the target company shall publish the report.2 from the moment the offer is published until the result is announced, the board of directors of the target company shall not enter into any legal transactions which would have the effect of significantly altering the assets or liabilities of the company. decisions taken by the general meeting of shareholders are not subject to this restriction and may be implemented irrespective of whether they were adopted before or after publication of the offer.3 the takeover board shall issue provisions on: a. the report to be issued by the board of directors of the target company; b. any measures which are aimed in an improper manner at frustrating an offer or preventing it from being successful.art. 133 competing offers 1 in the event of competing offers, the holders of equity securities in the target company must be free to choose which offer they accept.2 the takeover board shall issue provisions relating to competing offers and their effect on the first offer.art. 134 notification duty 1 the offeror or anyone who directly, indirectly or in concert with third parties holds a stake of at least 3% of the voting rights, whether exercisable or not, of the target company or, as the case may be, of another company whose equity securities are being offered in exchange must, from the time the offer is published until the expiry of the offer period, notify the takeover board and the stock exchanges on which the securities are listed of any acquisition or disposal of equity securities of such company.2 a group organised pursuant to an agreement or otherwise shall be subject to this notification duty solely as a group.3 the takeover board may subject to the same duty anyone who, from the time the offer is published until the expiry of the offer period, acquires or disposes of, directly, indirectly or acting in concert with third parties, a certain percentage of the equity securities of the target company or of another company whose equity securities are being offered in exchange.4 if a company or stock exchange has reason to believe that a shareholder is in violation of the notification duty, it shall inform the takeover board of such fact.5 the takeover board shall issue rules on the scope, form and time allowed for notification and on the percentage relevant for the application of paragraph 3.art. 135 duty to make an offer 1 anyone who directly, indirectly or acting in concert with third parties acquires equity securities which, added to the equity securities already owned, exceed the threshold of 33% of the voting rights of a target company, whether exercisable or not, must make an offer to acquire all listed equity securities of the company. target companies may raise this threshold to 49% of voting rights in its articles of incorporation.2 the price offered must be at least as high as the higher of the following two amounts:a. the stock exchange price;b. the highest price that the offeror has paid for equity securities of the target company in the preceding twelve months.3 if the target company has issued several classes of equity securities, there must be an appropriate relationship among the prices offered for the various classes of equity securities.4 finma shall issue provisions on the duty to make an offer. the takeover board shall have the right to put forward proposals.5 if there are sufficient indications that a person has not met the duty to make an offer, the takeover board may take the following measures until the duty to make an offer has been clarified or, as appropriate, the duty to make an offer has been fulfilled:a. suspend the voting rights and associated rights of this person; andb. prohibit this person from acquiring further shares or acquisition or disposal rights relating to shares of the target company, be it directly, indirectly or acting in concert with third parties.art. 136 exemptions from the duty to make an offer 1 in justified cases, the takeover board may grant exemptions from the duty to make an offer, particularly in the following cases:a. where the transfer of voting rights occurs within a group organised pursuant to an agreement or otherwise. in such a case, only the group as such shall be subject to the duty to make an offer;b. where the threshold is exceeded as a result of a decrease in the total number of voting rights of the company;c. where the threshold is exceeded only temporarily;d. where the securities have been acquired without consideration or on exercise of pre-emptive rights pursuant to a share capital increase;e. where the securities have been acquired for reorganisation purposes.2 the duty to make an offer does not apply if the voting rights have been acquired as a result of a donation, succession or partition of an estate, matrimonial property law or execution proceedings.art. 137 cancellation of outstanding equity securities 1 an offeror who holds more than 98% of the voting rights of the target company on expiry of the offer period may, within three months, petition the court to cancel the outstanding equity securities. for this purpose, the offeror must initiate an action against the company. the remaining shareholders may participate in these proceedings.2 the company shall reissue such equity securities and allot them to the offeror either against payment of the offer price or fulfilment of the exchange offer in favour of the holders of the equity securities which have been cancelled.art. 138 tasks of the takeover board 1 the takeover board shall issue the decisions necessary for the enforcement of the provisions of this chapter and its implementing provisions and shall monitor compliance with the statutory and regulatory provisions. it may publish the decisions.2 persons and companies subject to a notification duty in accordance with article 134, and persons and companies who are entitled to party status in accordance with article 139 paragraphs 2 and 3 must provide all the information and surrender any documents to the takeover board which the latter requires to perform its tasks.3 if the takeover board becomes aware of violations of the provisions of this chapter or of other irregularities, it shall ensure that an orderly situation is restored and that the irregularities are remedied.4 if the takeover board becomes aware of any general felonies or misdemeanours or infringements of this act, it shall promptly notify the competent prosecution authorities.art. 139 proceedings before the takeover board 1 subject to the following exemptions, the proceedings of the takeover board are governed by the provisions of the federal act of 20 december 196855 on administrative procedure.2 in proceedings with regard to public takeover offers, the following have party status:a. the offeror;b. the persons who act in concert with the offeror; andc. the target company.3 shareholders holding at least 3% of the voting rights of the target company, whether exercisable or not, also qualify as parties if they claim such status from the takeover board.4 the statutory provisions on legal holidays do not apply to proceedings of the takeover board regarding public takeover offers.5 the submission of legal documents by fax or by electronic means is permitted in correspondence with the takeover board and is recognised with regard to compliance with time limits.55 sr 172.021art. 140 appeal proceeding before finma 1 an appeal against decisions of the takeover board may be lodged with finma within a period of five trading days.2 the appeal must be made in writing to finma and be substantiated. in the event of an appeal, the takeover board will forward its files to finma.3 article 139 paragraphs 1, 4 and 5 apply to the proceeding for appeals lodged with finma.art. 141 appeal proceeding before the federal administrative court 1 an appeal against finma rulings regarding public takeover offers may be lodged with the federal administrative court in accordance with the federal act of 17 june 200556 on the federal administrative court.2 the appeal must be lodged within ten days of notification of the decision. it has no suspensive effect.3 the statutory provisions on legal holidays do not apply to proceedings regarding public takeover offers before the federal administrative court.56 sr 173.32chapter 5 insider trading and market manipulation art. 142 exploitation of insider information 1 any person who has insider information and who knows or should know that it is insider information or who has a recommendation that he or she knows or should know is based on insider information shall behave inadmissibly when he or she:a.57 exploits it to acquire or dispose of securities admitted to trading on a trading venue or dlt trading facility which has its registered office in switzerland or to use derivatives of such securities;b. discloses it to another;c.58 exploits it to recommend to another to acquire or dispose of securities admitted to trading on a trading venue or dlt trading facility which has its registered office in switzerland or to use derivatives of such securities.2 the federal council shall issue provisions regarding the admissible use of insider information, in particular in connection with:a. securities transactions in preparation of a public takeover offer;b. a special legal status on the part of the recipient of the information.57 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).58 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 143 market manipulation 1 a person behaves inadmissibly when he or she:a. publicly disseminates information which he or she knows or should know gives false or misleading signals regarding the supply, demand or price of securities admitted to trading on a trading venue or dlt trading facility which has its registered office in switzerland;b. carries out transactions or acquisition or disposal orders which he or she knows or should know give false or misleading signals regarding the supply, demand or price of securities admitted to trading on a trading venue or dlt trading facility which has its registered office in switzerland.592 the federal council shall issue provisions regarding admissible conduct, in particular in connection with:a. securities transactions for price stabilisation purposes;b. buyback programmes for a company's own securities.59 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).chapter 6 instruments for market supervision art. 144 suspension of voting rights and purchase ban if there are sufficient indications that a person has not met the notification duty in accordance with articles 120 and 121, finma may, until the notification duty has been clarified and, as appropriate, the notification duty has been fulfilled:a. suspend the voting rights and associated rights of this person; andb. prohibit this person from acquiring further shares or acquisition or sale rights relating to shares of the company in question, be it directly, indirectly or acting in concert with third parties.art. 145 supervisory instruments in accordance with the finmasa the supervisory instruments detailed in article 29 paragraphs 1, 30, 32, 34 and 35 finmasa60 apply to all persons who contravene articles 120, 121, 124, 142 or 143 of this act.60 sr 956.1art. 146 duty to provide information persons subject to a notification duty in accordance with article 134, as well as persons who in accordance with article 139 paragraphs 2 and 3 can have the status of party, must provide all information and surrender any documents to finma which the latter requires to perform its tasks.title 4 criminal provisions and final provisions chapter 1 criminal provisions art. 147 violation of professional secrecy 1 a custodial sentence not exceeding three years or a monetary penalty shall be imposed on any person who wilfully:a. discloses a secret entrusted to them in their capacity as a director or officer, employee, agent or liquidator of a financial market infrastructure or of which they have become aware in said capacity;b. attempts to induce a violation of professional secrecy;c. discloses to other persons a secret disclosed to them in violation of letter a or exploits such a secret for their own benefit or for the benefit of others.2 a custodial sentence not exceeding five years or a monetary penalty shall be imposed on any person who obtains a pecuniary advantage for themselves or another person through an action as detailed in paragraph 1 letter a or c .3 a fine not exceeding 250,000 francs shall be imposed on any person who commits the foregoing acts through negligence.614 any person who violates professional secrecy remains liable to prosecution after termination of the official or employment relationship or exercise of the profession.5 the federal and cantonal provisions relating to the duty to testify and the duty to provide information to the authorities are reserved.61 amended by annex no ii 18 of the financial institutions act of 15 june 2018, in force since 1 jan. 2020 (as 2018 5247, 2019 4631; bbl 2015 8901).art. 148 violation of the provisions on protection against confusion and deception and notification duties a fine not exceeding chf 500,000 shall be imposed on any person who wilfully:a. violates the provision on protection against confusion and deception (art. 16);b. fails to provide the supervisory authorities with the prescribed notifications in accordance with articles 9 and 17, or does so incorrectly or too late.art. 149 violation of the record-keeping and disclosure duties a fine not exceeding chf 500,000 shall be imposed on any person who wilfully:a. violates the record-keeping duty set out in article 38;b. violates the disclosure duty in accordance with article 39.art. 150 violation of duties regarding derivatives trading a fine not exceeding chf 100,000 shall be imposed on any person who wilfully:a. violates the clearing duty set out in article 97;b. violates the reporting duty cited in article 104;c. violates the risk mitigation duties cited in articles 107 to 110;d. violates the duty cited in article 112.art. 151 breach of notification duties 1 a fine not exceeding chf 10 million shall be imposed on any person who wilfully:a. violates the notification duty cited in article 120 or 121;b. as the owner of a qualified participation in a target company, fails to disclose the acquisition or sale of equity securities of that company (art. 134).2 a fine not exceeding chf 100,000 shall be imposed on persons who commit the foregoing acts through negligence.art. 152 breach of the duty to make an offer a fine not exceeding chf 10 million shall be imposed on any person who wilfully fails to comply with a legally binding duty to make an offer (art. 135).art. 153 breach of duties by the target company 1 a fine not exceeding chf 500,000 shall be imposed on any person who wilfully:a. fails to submit the mandatory report to the holders of equity security setting out his or her position in relation to the offer or fails to publish such a report (art. 132 para. 1);b. includes untrue or incomplete information in such report (art. 132 para. 1).2 a fine not exceeding chf 150,000 shall be imposed on persons who commit the foregoing acts through negligence.art. 154 exploitation of insider information 1 a custodial sentence not exceeding three years or a monetary penalty shall be imposed on any person who as a body or a member of a managing or supervisory body of an issuer or of a company controlling or controlled by them, or as a person who due to their holding or activity has legitimate access to insider information, if they gain a pecuniary advantage for themselves or for another with insider information by:a.62 exploiting it to acquire or dispose of securities admitted to trading on a trading venue or dlt trading facility which has its registered office in switzerland or to use derivatives of such securities;b. disclosing it to another;c.63 exploiting it to recommend that another acquire or dispose of securities admitted to trading on a trading venue or dlt trading facility which has its registered office in switzerland or to use derivatives of such securities.2 any person who through an act set out in paragraph 1 gains a pecuniary advantage exceeding one million francs shall be liable to a custodial sentence not exceeding five years or a monetary penalty.3 any person who gains a pecuniary advantage for themselves or for another by exploiting insider information or a recommendation based on insider information disclosed or given to them by a person referred to in paragraph 1 or acquired through a felony or misdemeanour in order to acquire or dispose of securities admitted to trading on a trading venue or dlt trading facility which has its registered office in switzerland or in order to use derivatives of such securities shall be liable to a custodial sentence not exceeding one year or to a monetary penalty.644 any person who is not a person referred to in paragraphs 1 to 3 and yet who gains a pecuniary advantage for themselves or for another by exploiting insider information or a recommendation based on insider information in order to acquire or dispose of securities admitted to trading on a trading venue or dlt trading facility which has its registered office in switzerland or to use derivatives of such securities shall be liable to a fine.6562 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).63 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).64 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).65 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 155 price manipulation 1 a custodial sentence not exceeding three years or a monetary penalty shall be imposed on any person who, with the intention of gaining a pecuniary advantage for themselves or for another, substantially influences the price of securities admitted to trading on a trading venue or dlt trading facility which has its registered office in switzerland in that they:66a. disseminate false or misleading information against their better knowledge;b. effect acquisitions and sales of such securities directly or indirectly for the benefit of the same person or persons connected for this purpose.2 any person who through activities set out in paragraph 1 gains a pecuniary advantage of more than one million francs shall be liable to a custodial sentence not exceeding five years or a monetary penalty.66 amended by no i 10 of the fa of 25 sept. 2020 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 33, 399; bbl 2020 233).art. 156 jurisdiction 1 prosecution and adjudication of acts under articles 154 and 155 are subject to federal jurisdiction. it is not permitted to transfer jurisdiction for prosecution and adjudication to the cantonal authorities.2 the cantons are responsible for the prosecution and adjudication of acts under article 147.chapter 2 final provisions section 1 implementation art. 157 1 the federal council is responsible for implementation of this act.2 it shall issue the implementing provisions.section 2 amendment of other legislative instruments art. 158 the amendment of other legislative instruments is set out in the annex.section 3 transitional provisions art. 159 financial market infrastructures 1 financial market infrastructures with authorisation or recognition at the time this act enters into force must submit a new request for authorisation or recognition within one year of this act coming into force. the authorisation or recognition procedure shall be limited to examination of the new requirements. the financial market infrastructures may continue their activity until the decision on their request is issued.2 financial market infrastructures which are now subject to this act shall report to finma within six months of this act entering into force. within one year of its entry into force, they must satisfy the requirements of this act and submit an authorisation or recognition request to finma. they may continue their activity until the authorisation or recognition decision is issued.3 in special cases, finma may extend the deadlines set out in paragraphs 1 and 2.art. 160 foreign participants on a trading venue foreign participants on a trading venue which at the time of this act's entry into force have finma authorisation as a foreign stock exchange member do not require new authorisation. they must meet the requirements of this act within one year of its entry into force.art. 161 interoperability agreements interoperability agreements existing at the time this act enters into force do not require re-approval by finma.art. 162 derivatives trading the federal council shall determine which derivatives transactions still outstanding at the time this act enters into force shall be subject to the notification and risk mitigation duties.art. 163 duty to make an offer 1 anyone who, on 1 february 1997, directly, indirectly or acting in concert with third parties held securities which granted him or her more than 33% but less than 50% of the voting rights of a target company must make an offer for all listed equity securities of the company if he or she acquires equity securities and thereby exceeds the threshold of 50% of the voting rights.2 paragraph 1 also applies to holdings which were covered by the provisions on public takeover offers for the first time on 1 may 2013.section 4 referendum and commencement art. 164 1 this act is subject to an optional referendum.2 the federal council shall determine the commencement date, subject to paragraph 3.3 it shall bring articles 112 to 115 (duty to trade via a trading venue or organised trading facility) into force only if and when international developments so require.commencement date: 1 january 201667art. 112-115: 1 august 20176867 fcd of 25 nov. 2015.68 o of 5 july 2017 (as 2017 3713).annex (art. 158)amendment of other legislative instruments the legislative instruments below are amended as follows:.6969 the amendments may be consulted under as 2015 5339.

958.11english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinance on financial market infrastructures and market conduct in securities and derivatives trading(financial market infrastructure ordinance, finmio)of 25 november 2015 (status as of 1 october 2021)the swiss federal councilbased on the financial market infrastructure act of 19 june 20151 (finmia),ordains:1 sr 958.1title 1 general provisions art. 1 subject matter (art. 1 and 157 finmia)this ordinance governs specifically:a. the authorisation conditions and duties for financial market infrastructures;b. the duties of financial market participants in derivatives trading;c. the disclosure of shareholdings;d. public takeover offers;e. the exceptions that apply with regard to the ban on insider trading and market manipulation.art. 2 definitions (art. 2 lit. b and c finmia)1 securities are deemed to be standardised and suitable for mass trading if they are publicly offered for sale in the same structure and denomination or are placed with more than 20 clients, insofar as they have not been created especially for individual counterparties.22 derivatives are deemed to comprise financial contracts whose price is derived specifically from:a. assets such as shares, bonds, commodities and precious metals;b. reference values such as currencies, interest rates and indices.3 the following are not deemed to be derivatives:a. spot transactions;b. derivatives transactions relating to electricity and gas which:1. are traded on an organised trading facility,2. must be physically delivered, and3. cannot be settled in cash at a party's discretion;c. derivatives transactions relating to climatic variables, freight rates, inflation rates or other official economic statistics that are settled in cash only in the event of a default or other termination event.4 spot transactions are deemed to be transactions that are settled either immediately or following expiry of the deferred settlement deadline within two business days. spot transactions are also deemed to be:transactions that are settled with a longer settlement deadline in accordance with the market norm for the currency pair in question;b. purchases or sales of securities, irrespective of their currency, which are paid for by the deadline prescribed by the regulator or by a deadline that is customary in the market;c. transactions that are continuously extended without there being a legal obligation or without such an extension between the parties being usual.2 amended by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).art. 3 significant group companies (art. 3 para. 2 finmia)the functions of a group company are significant with respect to the activities which require authorisation if they are necessary for the continuation of important business processes, in particular in the areas of liquidity management, treasury, risk management, master data administration and accounting, personnel, information technology, trading and settlement, and legal and compliance.title 2 financial market infrastructures chapter 1 common provisions section 1 authorisation conditions and duties for all financial market infrastructures art. 4 authorisation application (art. 4 and 5 finmia)1 the financial market infrastructure shall submit an authorisation application to the swiss financial market supervisory authority (finma). this shall contain all the information necessary for assessing it, specifically information on:a. the business area (art. 6);b. the place of management (art. 7);c. corporate governance (art. 8);d. risk management (art. 9);e. guarantee of irreproachable business conduct (art. 10);f. minimum capital (art. 13);g. capital adequacy and risk diversification (art. 48, 49, 56, 57 and 69);h. the audit firm (art. 71).2 the financial market infrastructure shall attach along with its authorisation application the necessary documentation, namely its articles of association or partnership agreements and regulations.art. 5 changes in facts (art. 7 finmia)1 the financial market infrastructure shall notify finma in particular of:a. any amendments to the articles of association or partnership agreements and regulations;b. any material change in the business activity of a subsidiary, branch or representation abroad;c. any change in audit firm or in the competent foreign supervisory authority with respect to any subsidiary, branch or representation abroad.2 it may only report any changes in its articles of association to the commercial register and put any changes in regulations into effect following finma's approval of the changes in question.art. 6 business area (art. 8 para. 2 finmia)1 the financial market infrastructure must describe its area of business in factually and geographically precise terms in the articles of association, partnership agreements or regulations.2 the business area and its geographical extent must be in harmony with the financial market infrastructure's financial capabilities and administrative organisation.art. 7 place of management (art. 8 paras. 1 and 2 finmia)1 the financial market infrastructure must effectively be managed from switzerland. an exception is made here for general directives and decisions within the context of group supervision if the financial market infrastructure forms part of a financial group that is subject to appropriate consolidated supervision by a foreign financial market supervisory authority.2 the persons entrusted with managing the financial market infrastructure must be resident in a place from which they can effectively exercise such management.art. 8 corporate governance (art. 8 para. 2 finmia)1 the financial market infrastructure must have an organisational structure and an organisational basis that set out the tasks, responsibilities, powers and accountability of the following bodies:a. body for business management;b. body for governance, supervision and control;c. internal audit function.2 the body for governance, supervision and control must comprise at least three members. these may not belong to the bodies described in paragraph 1 letters a and c.3 the body for governance, supervision and control shall set out the basic risk management principles and determine the risk tolerance of the financial market infrastructure. this body shall have its work evaluated regularly.4 the financial market infrastructure shall define, implement and maintain a compensation policy that promotes sound and effective risk management and does not create incentives to relax risk standards.5 it must have mechanisms in place that allow it to establish the needs of participants with regard to the services provided by the financial market infrastructure.art. 9 risk management (art. 8 para. 3 finmia)1 with regard to risk management, the financial market infrastructure must have a concept for the integrated identification, measurement, management and monitoring of risks, particularly with respect to:a. legal risks;b. credit and liquidity risks;c. market risks;d. operational risks;e. settlement risks;f. reputational risks;g. general business risks.2 it must have instruments in place and create incentives in order to ensure that participants can continuously manage and limit the risks arising for themselves or for the financial market infrastructure.3 insofar as the financial market infrastructure has indirect participants and these are identifiable, it must also identify, measure, control and monitor the risks posed to the financial market infrastructure by these parties.4 the internal documentation of the financial market infrastructure on passing a resolution and the monitoring of transactions associated with the risks should be designed in such a way that allows the audit firm to make a reliable assessment with respect to the business activity.5 the financial market infrastructure shall ensure an effective internal control system which, among other things, guarantees compliance with legal and internal company rules and regulations (compliance function).6 the internal audit function must submit a report to the body with responsibility for governance, supervision and control or to one of its committees. it must have sufficient resources as well as unrestricted audit rights.art. 10 guarantee of irreproachable business conduct (art. 9 paras. 2 and 3 finmia)1 the authorisation application for a new financial market infrastructure must contain the following information and documentation in particular on the members of the board and executive management in accordance with article 9 paragraph 2 finmia and on the owners of a qualified participation in accordance with article 9 paragraph 3 finmia:a. natural persons:1. details on nationality, domicile, qualified participations in other companies and any pending court or administrative proceedings,2. a curriculum vitae signed by the relevant person,3. references,4. an extract from the register of criminal convictions;b. companies:1. the articles of association,2. an extract from the commercial register or an attestation to this effect,3. a description of business activities, the financial situation and, if applicable, the group structure,4. details on completed and pending court or administrative proceedings.2 persons holding a qualified participation must make a declaration to finma stating whether they hold the participation in question for their own account or on a fiduciary basis for a third party, and whether they have granted options or similar rights with respect to this participation.3 the financial market infrastructure must submit to finma within 60 days of the end of the financial year a list of all qualified participants in the financial market infrastructure. this list shall contain details on the identity and participation rate of all qualified participants as at the relevant closing date, as well as any changes relative to the prior-year closing date. in addition, the information and documentation set out in paragraph 1 is to be submitted for any qualified participants being reported for the first time.art. 11 outsourcing (art. 11 finmia)1 an outsourcing situation in accordance with article 11 paragraph 1 finmia is deemed to exist if the financial market infrastructure has commissioned a service provider to independently and permanently provide an essential service for the financial market infrastructure in accordance with article 12.2 the following aspects in particular are to be addressed in the agreement with the service provider:a. the service to be outsourced and the services of the service provider;b. the responsibilities and the reciprocal rights and duties, particularly the financial market infrastructure's rights of inspection, instruction and control;c. the security requirements that must be fulfilled by the service provider;d. the service provider's adherence to the financial market infrastructure's business confidentiality and, insofar as legally protected data is provided to the service provider, the service provider's adherence to professional confidentiality;e. the rights of inspection and access of the internal audit function, the external audit firm, finma and - in the case of systemically important financial market infrastructures - the swiss national bank (snb).3 the financial market infrastructure must exercise care in the selection, instruction and controlling of the service provider. it shall integrate the outsourced service into its internal control system and monitor the services rendered by the service provider on an ongoing basis.4 outsourcing to foreign countries requires appropriate technical and organisational measures to ensure the observance of professional confidentiality and data protection in accordance with swiss law. contracting parties of a financial market infrastructure whose data is to be sent to a service provider abroad must be informed about this.5 the financial market infrastructure, its internal audit function, the external audit firm, finma and - in the case of systemically important financial market infrastructures - the snb must be able to inspect and review the outsourced service.6 paragraphs 1 to 5 do not apply if a central securities depository outsources some of its services or activities to a technical platform that connects securities settlement systems by way of providing a public service. this kind of outsourcing must be governed by means of a dedicated regulatory and operational framework, which requires the approval of finma.art. 12 essential services (art. 11 para. 1 finmia)1 essential services are deemed to be services that are necessary for the continuation of important business processes, in particular in the areas of liquidity management, treasury, risk management, master data administration and accounting, personnel, information technology, and legal and compliance.2 the following services are also deemed to be essential:a. in the case of trading venues:1. all activities conducted with the aim of ensuring fair, efficient and orderly trading,2. the operating of matching and market data distribution systems;b. in the case of central counterparties:1. contractually entering into securities transactions or other contracts involving financial instruments between two participants or between one participant and another central counterparty,2. the establishment of mechanisms relating to the planning for and protection against outages of participants or interoperably associated central counterparties, or relating to the segregation of the positions of indirect participants and clients of participants or to the transfer of positions to other participants;c. in the case of central securities depositories:1. the operation of a central custodian or securities settlement system,2. the initial recording of securities in a securities account,3. the reconciliation of holdings;d. in the case of trade repositories:1. the collection, management and retention of the reported data,2. the publication of reported data,3. the granting of access to reported data;e. in the case of payment systems:1. the acceptance and execution of participants' payment orders,2. the management of clearing accounts;f.3 in the case of trading facilities for distributed ledger technology securities (dlt trading facilities) that do not provide services in accordance with article 73a paragraph 1 letter b or c of the finmia:1. all activities conducted with the aim of ensuring fair, efficient and orderly trading,2. the operating of matching and market data distribution systems;g.4 in the case of dlt trading facilities that provide services in accordance with article 73a paragraph 1 letter b or c of the finmia:1. the services under letter f,2. the central custody of dlt securities or the clearing and settlement of transactions in dlt securities,3. the initial recording of dlt securities in a securities account,4. the reconciliation of holdings.3 inserted by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).4 inserted by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).art. 13 minimum capital (art. 12 finmia)1 the minimum capital shall amount to:a.5 for trading venues: chf 1 million;b. for central counterparties: chf 10 million;c. for central securities depositories: chf 5 million;d. for trade repositories: chf 500,000;e. for payment systems: chf 1.5 million;f.6 for dlt trading facilities that do not provide services in accordance with article 73a paragraph 1 letter b or c of the finmia: chf 1 million;g.7 for dlt trading facilities that provide services in accordance with article 73a paragraph 1 letter b or c of the finmia: chf 5 million.1bis for trading venues and dlt trading facilities, where justified, finma can stipulate a minimum amount that is up to 50% higher.82 in the event of non-cash capital contributions, the value of the assets brought in and the amount of the liabilities shall be reviewed by a licensed audit firm. this also applies when an existing company is transformed into a financial market infrastructure.5 amended by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).6 inserted by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).7 inserted by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).8 inserted by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).art. 14 business continuity (art. 13 finmia)1 the strategy detailed in article 13 paragraph 1 finmia must be enshrined in the company organisation and should regulate in particular:the tasks, responsibilities and powers;b. the frequency of the review of the business impact analysis in accordance with paragraph 2;c. reporting, communication and training.2 the financial market infrastructure shall prepare a business impact analysis which sets out the recovery point objective and the recovery time objective for the business processes that are necessary for operations.3 it shall set out the options for the recovery of the business processes that are necessary for operations.4 the strategy detailed in article 13 paragraph 1 finmia must be approved by the body responsible for governance, supervision and control.art. 15 it systems (art. 14 finmia)1 the it systems must be set up in such a way that:the requirements of information availability, integrity and confidentiality can be appropriately fulfilled with respect to the business activity in question;reliable access control is possible;c. arrangements are in place for identifying security deficiencies and being able to respond to them appropriately.2 the financial market infrastructure shall take appropriate measures to ensure that business-relevant data can be recovered in the event of loss.art. 16 international business (art. 17 finmia)1 the report that a financial market infrastructure must submit to finma prior to commencing activity abroad must contain all the necessary information and documentation for evaluating the activity in question, namely:a. a business plan that describes in particular the nature of the planned businesses and the organisational structure;b. the address of the office abroad;c. the names of the members of the board and executive management;d. the audit firm;e. the supervisory authority in the host country.2 the financial market infrastructure must also notify finma of:a. any discontinuation of business activity abroad;b. any material change in the business activity abroad;c. any change of audit firm;d. any change of supervisory authority in the host country.art. 17 fair and open access (art. 18 finmia)1 fair access is deemed not to be guaranteed in particular if excessively high or objectively unjustified requirements are made, or if excessive prices are demanded for use of the services offered. fee structures should not be conducive to disorderly market conditions.2 the financial market infrastructure may make access conditional upon fulfilment of operational, technical, financial and legal requirements.3 if it restricts access for reasons of efficiency, finma shall consult the competition commission as part of its assessment.art. 18 prevention of conflicts of interest (art. 20 finmia)if the disadvantaging of participants through conflicts of interest cannot be excluded with organisational measures, this should be disclosed to participants.art. 19 publication of essential information (art. 21 finmia)the financial market infrastructure shall regularly publish in addition to the information required under article 21 finmia:a. the rules and procedures that apply to the operation of the financial market infrastructure, including the rights and duties of the financial market infrastructure and participants;b. the fees and prices that apply to the services provided by the financial market infrastructure, including the conditions for the granting of discounts;c. the risks for participants associated with the services provided;d. the criteria for the suspension and exclusion of a participant;e. the rules and procedures that apply in the event of a default or outage of a participant;f. the rules and procedures required in order to keep the collateral, receivables and liabilities of participants and indirect participants segregated from one another, and the rules and procedures required for this collateral, receivables and liabilities to be both recorded and transferred;g. the aggregated transaction volumes and amounts;h. the number, nominal value and currency of issue of the securities held in central custody;i. other information in accordance with recognised international standards.section 2 special requirements for systemically important financial market infrastructures art. 20 recovery and resolution plan (art. 24 finmia)1 the recovery plan and the resolution plan must take into account the regulations of foreign supervisory authorities and central banks for stabilisation, restructuring and winding-up.2 the recovery plan shall in particular describe the measures to be taken and the resources required for their implementation. it must be approved by the body responsible for governance, supervision and control.3 the financial market infrastructure shall describe, upon submission of the plan, what measures it is preparing or has already implemented to improve its resolvability both in switzerland and abroad (art. 21).4 it shall submit to finma annually, and by the end of the second quarter of the year, the recovery plan and the information required for the resolution plan. the same documents should also be submitted if changes make a reworking necessary or if finma demands such a submission.5 finma shall grant the financial market infrastructure an appropriate period for the preparatory implementation of the measures envisaged in the resolution plan.art. 21 measures to improve resolvability (art. 24 para. 1 finmia)the measures to improve the financial market structure's resolvability can encompass in particular:a. structural improvements and unbundling by means of:1. amendments to the legal structure to create business-aligned legal entities,2. the creation of legally independent service units,3. the elimination or minimisation of de facto compulsory government support, particularly by creating an independent management structure,4. the reduction of geographical or balance sheet asymmetries;b. financial unbundling to contain risks of contagion by means of:1. the reduction of capital participations between legal entities at the same level,2. restrictions on the granting of unsecured loans and guarantees between legal entities at the same level within the financial group,3. the creation of an incentive structure that gives rise to the highest possible degree of market-consistent intra-group financing;c. operational unbundling to safeguard data and ensure continuation of important operational services by means of:1. ensuring access to and use of data resources, databases and it resources,2. the separation or permanent outsourcing of key functions,3. access to and continued use of systems essential to business operations.chapter 2 trading venues and organised trading facilities section 1 definitions art. 22 multilateral trading (art. 26 and 42 finmia)trading is deemed to be multilateral if it unites the interests of multiple participants in the acquisition and sale of securities or other financial instruments within the trading facility with a view to concluding a contract.art. 23 non-discretionary rules (art. 26 and 42 finmia)rules are deemed to be non-discretionary if they grant the trading venue or the operator of an organised trading facility no discretion in the amalgamation of offers.section 2 trading venues art. 24 regulatory and supervisory organisation (art. 27 finmia)1 an appropriate regulatory and supervisory organisation shall encompass the following bodies in particular:a body that fulfils regulatory tasks;b.9 a body that fulfils supervisory tasks;a body responsible for the admission of securities to trading;an appeal body.2 the body that fulfils the regulatory tasks of the trading venue must be independent of the business management of the trading venue and largely independent of the participants and issuers, both organisationally and with respect to personnel. it must have sufficient organisational, personnel and financial resources.102bis the body that fulfils the supervisory tasks of the trading venue must be independent of the business management of the trading venue and independent of the participants and issuers, both organisationally and with respect to personnel. it must have sufficient organisational, personnel and financial resources.113 both issuers and investors must be appropriately represented in the body responsible for the admission of securities to trading.4 the trading venue shall set out in its regulations the tasks and powers of the various bodies, as well as the representation of issuers and investors in the body that is responsible for the admission of securities to trading.9 amended by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).10 amended by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).11 inserted by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).art. 25 approval of regulations (art. 27 para. 4 finmia)1 when approving regulations, finma shall review in particular whether these:ensure transparency and the equal treatment of investors; andb. ensure the proper functioning of the securities markets.2 finma may consult the competition commission before making its decision. the latter shall give its opinion on whether the regulations are neutral in terms of competition and are conducive to anti-competitive arrangements or not.art. 26 organisation of trading (art. 28 finmia)the trading venue shall establish procedures in order that the relevant data on securities transactions can be confirmed on the same day that transactions are executed.art. 27 pre-trade transparency (art. 29 paras. 1 and 3 lit. b finmia)1 the trading venue shall publish the information communicated via its trading facilities on pre-trade transparency for shares throughout normal trading hours.2 for each share, the five best bid and offer prices as well as the volume of orders are to be published.3 paragraphs 1 and 2 also apply for actionable indications of interest.4 the trading venue may make provision for exceptions in its regulations for:a. reference price systems, as long as the reference prices are widely published and viewed by participants as reliable;b. systems that exist only to formalise transactions already negotiated;c. orders held in an order management facility of the trading venue pending disclosure;d. orders that are large in scale compared with normal market size.art. 28 post-trade transparency (art. 29 paras. 2 and 3 lit. b finmia)1 the trading venue shall publish the information on post-trade transparency with respect to transactions executed via the trading venue in accordance with its regulations.2 post-trade information with respect to transactions that were carried out on the trading venue outside of normal business hours are to be published by the trading venue prior to the start of trading on the trading day following execution of the transaction in question.3 paragraph 1 also applies to transactions that were conducted outside of the trading venue insofar as they were carried out during the course of the trading day on the most important market for the securities in question or during the normal trading hours of the trading venue. otherwise, the information is to be published immediately prior to the beginning of the ordinary trading hours of the trading venue, or at the latest prior to the start of the next trading day on the most important market for these securities.4 the trading venue may make provision for later publication in its regulations in the case of:a. large-volume transactions in accordance with article 27 paragraph 4 letter d;b. transactions:1. which are above a size specific to the securities in question,2. for which a liquidity provider would be exposed to inappropriate risks, and3. for which consideration has been given as to whether the contracting parties are retail or wholesale investors;c. transactions in securities for which no liquid market exists.art. 29 exceptions to pre-trade and post-trade transparency (art. 29 para. 3 lit. b finmia)1 securities transactions are not subject to the provisions on pre-trade and post-trade transparency if they are carried out as part of public tasks and not for investment purposes, namely on the part of:a. the confederation, cantons or communes;b. the snb;c. the bank for international settlements (bis);d. multilateral development banks in accordance with article 63 paragraph 2 letter c of the capital adequacy ordinance of 1 june 201212 (cao).2 securities transactions carried out by the following parties may be excluded from the provisions on pre-trade and post-trade transparency as long as the transactions are carried out as part of public tasks and not for investment purposes, and as long as reciprocal rights are granted and an exception does not stand in contradiction to the legislative purpose:a. foreign central banks;b. the european central bank (ecb);c. official bodies or state departments that are responsible for or involved in administering the national debt;d. the european financial stability facility (efsf);e. the european stability mechanism (esm).3 the federal department of finance (fdf) shall publish a list of the bodies covered by paragraph 2.4 the trading venue is to be informed in cases where transactions are carried out as part of public tasks and not for investment purposes.12 sr 952.03art. 30 guarantee of orderly trading (art. 30 finmia)1 the trading venue shall set transparent rules and procedures for fair, efficient and orderly trading, as well as objective criteria for the effective execution of orders. it must have measures in place to ensure the robust management of technical processes and the operation of its systems.2 it must possess effective systems, procedures and arrangements to ensure in particular that its trading facilities:a. are robust and equipped with sufficient capacity to deal with peak volumes of orders and announcements;b. are in a position to ensure orderly trading under conditions of severe market stress;c. are subject to effective emergency measures so that the restoration of business operations can be guaranteed in the event of disruptions to its trading facilities;d. reject orders that exceed pre-determined volume and price thresholds or are clearly erroneous;e. are in a position to suspend or restrict trading temporarily if there are significant short-term price movements with respect to a security on that market or a related market;f. are in a position to cancel, amend or correct any transaction in exceptional cases; andg. are regularly reviewed with a view to ensuring that the requirements under letters a to f are met.3 it must enter into an agreement, in writing or in another form that that allows for its proof by text, with all participants holding a special function, in particular participants that pursue a market-making strategy in the trading venue. it shall maintain systems and procedures that ensure that these participants comply with the regulations.134 it may also prescribe in its regulations that participants must flag up short-selling positions in its trading facility.13 amended by annex 1 no ii 14 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633).art. 31 algorithmic trading and high-frequency trading (art. 30 finmia)1 the trading venue must be able to identify the following:a. orders generated by algorithmic trading;b. the different algorithms used for the creation of orders;c. the participants' dealers who initiated these orders in the trading facility.2 it shall require participants that pursue algorithmic trading to flag the orders generated in this manner, record all entered orders, including order cancellations, and in particular to possess effective precautions and risk controls that ensure that their systems:a. are robust and equipped with sufficient capacity to deal with peak volumes of orders and announcements;b. are subject to appropriate trading thresholds and upper limits;c. do not cause or contribute to any disruptions in the trading venue;d. are effective for preventing violations of articles 142 and 143 finmia;e. are subject to appropriate tests of algorithms and control mechanisms, including precautions to:1. limit the proportion of unexecuted trading orders relative to the number of transactions that can be entered into the system by a participant,2. slow down the flow of orders if there is a risk of the capacity of the system being reached, and3. limit and enforce the minimum tick size that may be executed on the trading venue.3 in order to take account of the additional burden on system capacity, the trading venue may make provision for higher fees for:a. the placement of orders that are later cancelled;b. participants placing a high proportion of cancelled orders;c. participants with:1. an infrastructure intended to minimise delays in order transfer,2. a system that can decide on order initiation, generation, routing or execution, and3. a high intraday number of price offers, orders or cancellations.art. 32 supervision of trading (art. 31 para. 2 finmia)1 the trading supervisory body must have appropriate systems and resources to carry out its tasks.2 the functioning of the trading supervisory systems must also be guaranteed without restriction even in the event of high data volumes.3 the trading supervisory body shall monitor trading in such a way that forms of conduct in accordance with articles 142 and 143 finmia can be identified irrespective of whether they are attributable to manual, automated or algorithmic trading.art. 33 admission of securities by a stock exchange (art. 35 finmia)1 the stock exchange shall guarantee that all securities admitted to trading and all listed securities can be traded in a fair, efficient and orderly manner.2 in the case of derivatives, it shall ensure in particular that the way in which derivatives trading is structured facilitates orderly pricing.3 the stock exchange shall take the necessary measures to review the securities listed and admitted to trading for their fulfilment of the admission and listing requirements.art. 34 admission of securities by a multilateral trading facility (art. 36 finmia)1 the multilateral trading facility shall guarantee that all securities admitted to trading can be traded in a fair, efficient and orderly manner.2 in the case of derivatives, it shall ensure in particular that the way in which derivatives trading is structured facilitates orderly pricing.3 the multilateral trading facility shall take the necessary measures to review the securities admitted to trading for their fulfilment of the admission requirements.art. 35 appeal body (art. 37 paras. 1 to 3 finmia)1 the appeal body shall be independent in its adjudication and bound only by the law.2 the members may not belong to the body responsible for the admission of securities to trading, nor may they be in an employment relationship or any other contractual relationship with the trading venue that could lead to conflicts of interest.3 the provisions of the federal supreme court act of 17 june 200514 on recusal apply to the members of the independent appeal body.4 the regulations concerning the independent appeal body shall contain guidelines with respect to composition, election, organisation and proceedings before the appeal body.14 sr 173.110art. 36 record-keeping duty of participants (art. 38 finmia)1 the participants admitted to a trading venue shall keep a record of all orders they receive and all securities transactions they execute.2 the record-keeping duty also applies to orders and transactions in derivatives whose underlying instruments are securities admitted to trading on a trading venue. 3 the record-keeping duty applies not only to transactions on own account, but also to transactions executed on behalf of a client.4 finma shall regulate what information is necessary and in what form it must be recorded.art. 37 reporting duty of participants (art. 39 finmia)1 the participants admitted to a trading venue shall report all transactions they execute involving securities admitted to trading on a trading venue. in particular, the following must be reported:a. the name and number of purchased or sold securities;b. the volume, date and time of the transaction;c. the price; and d. the details necessary to identify the beneficial owner.2 the reporting duty also applies to transactions in derivatives whose underlying instruments are securities admitted to trading on a trading venue. 3 the reporting duty applies not only to transactions on own account, but also to transactions executed on behalf of a client.4 the following transactions executed abroad do not have to be reported: a. transactions in securities admitted to trading on a trading venue in switzerland and in derivatives with such securities as their underlying instruments, provided the information in question is regularly communicated to the trading venue on the basis of an agreement in accordance with article 32 paragraph 3 finmia or within the framework of an exchange of information between finma and the competent foreign supervisory authority if:1. they were executed by the branch of a swiss securities firm15 or by a foreign admitted participant, and2. the branch or the foreign participant is authorised to trade by the relevant foreign supervisory authority and is obliged to submit a report in the corresponding state or in its state of domicile;b. transactions in foreign securities admitted to trading on a trading venue in switzerland and in derivatives with such securities as their underlying instruments that are executed on a recognised foreign trading venue.5 third parties may be involved in reporting.15 term in accordance with annex 1 no ii 14 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633). this amendment has been made throughout the text.section 3 organised trading facilities art. 38 authorisation and recognition conditions (art. 43 para. 1 finmia)the authorisation and recognition conditions that apply to the operator of an organised trading facility are based on the financial market acts pursuant to article 1 paragraph 1 of the financial market supervision act of 22 june 200716.16 sr 956.1art. 39 organisation and prevention of conflicts of interest (art. 44 finmia)1 the operator of an organised trading facility shall issue regulations on the organisation of trading and monitor compliance with the statutory and regulatory provisions, as well as the trading process.2 it shall keep a chronological record of all orders and transactions carried out through the organised trading facility.3 in the event of agreements being made according to discretionary rules, identical client orders may be matched only if best execution can be guaranteed. exceptions are permissible only if the clients concerned have expressly waived any claim to best possible execution.art. 40 guarantee of orderly trading (art. 45 finmia)the operator of an organised trading facility shall set transparent rules and procedures for fair, efficient and orderly trading, as well as objective criteria for the effective execution of orders. it must have measures in place to ensure the robust management of technical processes and the operation of its systems in accordance with article 30 paragraphs 2 to 4.art. 41 algorithmic trading and high-frequency trading (art. 45 finmia)in order to prevent disruptions to its trading facility, the operator of an organised trading facility must take effective measures in accordance with article 31.art. 42 pre-trade transparency (art. 46 paras. 2 and 3 finmia)1 in the case of multilateral trading and bilateral trading where a liquid market exists, articles 27 and 29 apply by analogy.2 in the case of bilateral trading where no liquid market exists, price quotes on demand shall suffice.art. 43 post-trade transparency for securities (art. 46 paras. 1 and 2 finmia)1 in the case of multilateral trading, article 28 paragraphs 1 and 4 as well as article 29 apply by analogy.2 in the case of bilateral trading, aggregated publication at the end of the trading day shall suffice.chapter 3 central counterparties art. 44 function (art. 48 finmia)the central counterparty shall ensure, in particular, the standardised recording of all details of the transactions cleared by it, the positions of the participants and its reports to trade repositories.art. 45 organisation, business continuity and it systems (art. 8, 13 and 14 finmia)1 the central counterparty must appoint a risk committee that includes representatives of the participants, of the indirect participants and members of the body for governance, supervision and control. this committee shall advise the central counterparty on all matters that could have an impact on the risk management of the central counterparty.2 the central counterparty shall arrange procedures, capacity planning and sufficient capacity reserves so that, in the event of a disruption, its systems can still process all transactions still open by the close of trading.art. 46 collateral (art. 49 finmia)1 if predefined thresholds are exceeded, the central counterparty shall call in initial margins and variation margins at least once a day.2 it shall avoid concentration risks in the collateral and shall ensure that it can have prompt access to the collateral.3 it shall make provision for procedures by means of which it can review the models and parameters on which its risk management is based, and shall conduct these reviews on a regular basis.4 if the central counterparty holds its own assets or the collateral and assets of participants with third parties, it shall minimise the associated risks. in particular, it shall hold the collateral and assets with creditworthy financial intermediaries which, insofar as possible, are subject to supervision.art. 47 exchange-of-value settlement (art. 50 finmia)the central counterparty shall enable participants to eliminate their principal risk by ensuring that the settlement of one obligation occurs if and only if the settlement of the other obligation is guaranteed.art. 48 capital adequacy (art. 51 finmia)1 the central counterparty must hold total capital in the amount 8.0% (minimum capital requirement) to underpin credit risks, non-counterparty-related risks, market risks and operational risks in accordance with article 42 cao17. finma may demand additional capital in accordance with article 45 cao. titles 1 to 3 cao apply to the calculation.182 the dedicated capital in accordance with article 53 paragraph 2 letter c finmia shall amount to at least 25% of the required capital set out in title 3 cao.3 the central counterparty shall hold further capital in order to cover the costs of a voluntary cessation of business or restructuring. in the case of systemically important central counterparties, this capital must suffice to implement the plan set out in article 72, but must at least be sufficient to cover ongoing operating expenditure for six months.4 in special cases, finma can ease the requirements set out in the paragraphs 1 to 3 or impose more rigorous requirements.5 the central counterparty must have a plan that sets out how further capital is to be procured if its capital no longer fulfils the requirements set out in paragraphs 1 to 4. the plan must be approved by the body responsible for governance, supervision and control.6 if its capital falls short of 110% of the requirements set out in paragraphs 1 to 4, the central counterparty shall immediately inform finma and its audit firm, and shall provide finma with a plan that sets out how the threshold can once again be adhered to.17 sr 952.0318 amended by attachment no 2 to the o of 11 may 2016, in force since 1 july 2016 (as 2016 1725).art. 49 risk diversification (art. 51 finmia)the central counterparty shall monitor credit risks vis--vis an individual counterparty or a group of associated counterparties based on the calculation principles set out in section 4 of chapter 1 of title 4 cao19.19 sr 952.03art. 50 liquidity (art. 52 finmia)1 the following are deemed to constitute liquidity in a currency as set out in article 52 paragraph 1 finmia:a. cash balances in this currency with a central bank or a creditworthy financial institution;b. cash balances in other currencies that can be converted into this currency in a timely manner through foreign exchange transactions;c. contractually committed and approved unsecured lines of credit in this currency with a creditworthy financial institution that can be used without any further credit decision;d. collateral in accordance with article 49 finmia and assets that can be converted into cash in this currency in a timely manner through sales;e. collateral in accordance with article 49 finmia and assets that can be converted into cash in this currency in a timely manner by means of contractually committed and secured lines of credit or contractually committed repo lines with central banks or creditworthy financial institutions.2 the central counterparty shall regularly review compliance with the requirements set out in article 52 paragraph 1 finmia under various stress scenarios. in doing so, it shall apply collateral discounts (haircuts) to the liquidity that would be appropriate even under extreme but plausible market conditions. it shall diversify its sources of liquidity.3 the investment strategy of the central counterparty must be in harmony with its risk management strategy. it must avoid concentration risks.art. 51 portability (art. 55 finmia)1 portability is ensured if:a. the transfer is enforceable in the relevant jurisdictions; andb. the other participant has an obligation towards the indirect participant to assume the latter's collateral and positions.2 if a transfer cannot take place by the deadline set by the central counterparty, the central counterparty may take all precautions in accordance with its regulations to actively manage the risks with respect to the positions in question, including the liquidation of assets and collateral of the participant in default who holds this for the account of an indirect participant or its clients.chapter 4 central securities depositories art. 52 organisation (art. 8 finmia)1 the central securities depository shall set up a user committee for every securities settlement system operated by it, on which the issuers and participants in these securities settlement systems are represented. 2 the user committee shall advise the central securities depository in key matters affecting issuers and participants.art. 53 principles for the custody, recording and transfer of securities (art. 62 finmia)central securities depositories that use a common settlement infrastructure shall establish identical times for:a. the entry of payment and transfer orders into the system of the common settlement infrastructure; b. the irrevocability of payment and transfer orders.art. 54 collateral (art. 64 finmia)1 the central securities depository must have sufficient collateral in order to fully cover its current credit exposure.2 it shall avoid concentration risks in the collateral and shall ensure that it can have prompt access to the collateral.3 it shall make provision for procedures by means of which it can review the models and parameters on which its risk management is based, and shall conduct these reviews on a regular basis.4 if it holds its own assets or the collateral and assets of participants with third parties, it shall minimise the associated risks. in particular, it shall hold the collateral and assets with creditworthy financial intermediaries which, insofar as possible, are subject to supervision.art. 55 exchange-of-value settlement (art. 65 finmia)the central securities depository shall enable participants to eliminate their principal risk by ensuring that the settlement of one obligation occurs if and only if the settlement of the other obligation is guaranteed.art. 56 capital adequacy (art. 66 finmia)1 the central securities depository must hold total capital in the amount 8.0% (minimum capital requirement) to underpin credit risks, non-counterparty-related risks, market risks and operational risks in accordance with article 42 cao20. finma may demand additional capital in accordance with article 45 cao. titles 1 to 3 cao apply to the calculation.212 for all other matters, article 48 paragraphs 3 to 6 apply by analogy.20 sr 952.0321 amended by attachment no 2 to the ordinance of 11 may 2016, in force since 1 july 2016 (as 2016 1725).art. 57 risk diversification (art. 66 finmia)the central securities depository shall monitor credit risks vis--vis an individual counterparty or a group of associated counterparties based on the calculation principles set out in section 4 of chapter 1 of title 4 cao22.22 sr 952.03art. 58 liquidity (art. 67 finmia)1 the following are deemed to constitute liquidity in a currency as set out in article 67 paragraph 1 finmia:a. cash balances in this currency with a central bank or a creditworthy financial institution;b. cash balances in other currencies that can be converted into this currency in a timely manner through foreign exchange transactions;c. contractually committed and approved unsecured lines of credit in this currency with a creditworthy financial institution that can be used without any further credit decision;d. collateral in accordance with article 64 finmia and assets that can be converted into cash in this currency in a timely manner through sales;e. collateral in accordance with article 64 finmia and assets that can be converted into cash in this currency in a timely manner by means of contractually committed and secured lines of credit or contractually committed repo lines with central banks or creditworthy financial institutions.2 the central securities depository shall regularly review compliance with the requirements set out in article 67 paragraph 1 finmia under various stress scenarios. in doing so, it shall apply collateral discounts (haircuts) to the liquidity that would be appropriate even under extreme but plausible market conditions. it shall diversify its sources of liquidity.3 the investment strategy of the central securities depository must be in harmony with its risk management strategy. it must avoid concentration risks.chapter 4a23 dlt trading facilities 23 inserted by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400). section 1 definitions art. 58a multilateral trading and non-discretionary rules (art. 73a para. 1 finmia)the definitions for multilateral trading and non-discretionary rules under articles 22 and 23 apply by analogy to dlt trading facilities. art. 58b commercial activity (art. 73a para. 2 finmia)1 a dlt trading facility is operating commercially if it:a. thereby generates gross earnings of more than chf 50,000 per calendar year;b. per calendar year, has a business relationship with more than 20 participants in accordance with article 73c paragraph 1 letter e of the finmia (private participants) or with at least one participant in accordance with article 73c paragraph 1 letters a to d of the finmia; orc. has unlimited power of disposal over third-party dlt securities that exceed chf 5 million at any given time.2 if a threshold under paragraph 1 is exceeded, the dlt trading facility must report this to finma within 10 days. it must submit an application for authorisation as provided for in the finmia to finma within 60 days.3 provided the protective purpose of the finmia is not affected, finma may prohibit the applicant from exercising the activities reserved to a dlt trading facility until the decision is made on the application for authorisation.section 2 requirements art. 58c applicability of certain requirements for trading venues (art. 73b finmia)1 unless otherwise specified in this section, articles 24 to 32 and article 35 apply by analogy to dlt trading facilities.2 instead of the option under article 30 paragraph 2 letter f to cancel, amend or correct any transaction in exceptional cases, a dlt trading facility must have a mechanism in place that achieves an economically equivalent effect.art. 58d record-keeping and reporting duty (art. 73c para. 3 finmia)1 private participants are exempt from the record-keeping duty under article 38 of the finmia and the reporting duty under article 39 of the finmia.2 articles 36 and 37 of this ordinance apply by analogy to the other participants.art. 58e admission and exclusion of participants (art. 73c paras. 4 and 5 finmia)1 the dlt trading facility shall regulate in the regulations in accordance with article 73c paragraph 5 of the finmia whether and which private participants will be admitted. 2 the granting of non-discriminatory access in accordance with article 18 of the finmia is not binding for private participants. art. 58f admission of dlt securities and other assets (art. 73d finmia)1 the dlt trading facility shall regulate in the regulations in accordance with article 73d of the finmia which dlt securities and other assets will be admitted to its services. it may specify the admitted dlt securities and assets individually in the regulations or define them according to their type and function.2 if the dlt trading facility admits derivatives designed as dlt securities, only products without fair value or leverage components may be admitted to trading. 3 dlt securities and other assets which significantly hinder the implementation of the provisions of the anti-money laundering act of 10 october 199724, or which could adversely affect the stability and integrity of the financial system may not be admitted. finma can define these dlt securities and assets in more detail.4 the dlt trading facility shall make provision in the regulations for revoking the admission of dlt securities and other assets.5 the requirements under article 34 apply by analogy.24 sr 955.0art. 58g minimum requirements for the admission of dlt securities and regular auditing (art. 73d para. 3 finmia)1 dlt securities may be admitted by the dlt trading facility if the distributed ledger meets at least the requirements under article 973d paragraph 2 of the co25.2 if the distributed ledger is not operated by the relevant dlt trading facility itself, the facility shall audit the ledger before admitting the relevant dlt securities and regularly thereafter, but at least once a year, for compliance with the requirements under paragraph 1.3 it shall inform its participants of the audits performed and of the findings.25 sr 220art. 58h disclosures on transactions (art. 73d finmia)1 the dlt trading facility shall monitor all transactions conducted on its systems with admitted dlt securities. it shall disclose this data free of charge to all approved dlt trading facilities.2 if the dlt securities admitted for trading on the dlt trading facility are based on securities which are also admitted for trading on a swiss trading venue, the dlt trading facility shall disclose to that trading venue, free of charge, all transactions with these dlt securities.3 the trading venues and dlt trading facilities shall use this data exclusively to fulfil their tasks in the area of trade monitoring.4 finma may regulate the details of these disclosures.art. 58i duty of information (art. 73e para. 1 finmia)1 dlt trading facilities with private participants shall provide them with the associated prospectus or key information document for each dlt security admitted to the dlt trading facility.2 they shall inform these participants of the following aspects of the distributed ledger for the relevant dlt securities:a. its governance; andb. its technical risks, specifically the risk of loss.3 moreover, they shall immediately publish information on the transactions in other assets carried out on the dlt trading facility, in particular the price, the volume and the time of the transactions.art. 58j other requirements relating to services in the area of central custody, clearing or settlement (art. 73e para. 2 finmia)1 unless otherwise specified in this section, the requirements for central securities depositories under articles 62 to 73 of the finmia and 52 to 58 of this ordinance apply by analogy for dlt trading facilities that provide services in accordance with article 73a paragraph 1 letter b or c of the finmia.2 the segregation in accordance with article 69 of the finmia may take place in the distributed ledger underlying the dlt securities or in the systems of the dlt trading facility.3 a dlt trading facility may also enable the settlement of payments in another manner than that provided for in article 65 paragraph 1 of the finmia if it involves a finma-supervised institution for the purpose.4 for a dlt trading facility, liquidity in a currency in accordance with article 67 paragraph 1 of the finmia also includes cryptobased assets, insofar as the payment obligation is to be fulfilled in the same virtual currency.5 in derogation from article 52, the dlt trading facility does not have to set up a user committee.section 3 special requirements for small dlt trading facilities art. 58k small dlt trading facilities (art. 73f finmia)1 a dlt trading facility is deemed to be small if the following thresholds are undercut in relation to dlt securities:a. annual trading volume: chf 250 million;b. custody volume: chf 100 million; andc. annual settlement volume: chf 250 million.2 if a threshold is reached or exceeded, the dlt trading facility must report this to finma within 10 days. it must submit a modified application for authorisation as provided for in the finmia to finma within 90 days.3 the trading facility shall no longer be deemed to be small after 90 days from the time at which a threshold is reached or exceeded. the dlt trading facility may, however, continue to apply the eased requirements for small dlt trading facilities until finma makes its decision on the authorisation application.4 where this serves the protective purpose of the finmia, finma may prohibit the dlt trading facility from admitting further participants until the decision is made on the application for authorisation.art. 58l easing of requirements for small dlt trading facilities (art. 73f finmia)1 in derogation from the finmia and from this ordinance, the following eased requirements apply for small dlt trading facilities:a. in derogation from article 8 paragraph 2 second sentence of the finmia and article 8 paragraph 2 second sentence of this ordinance, it is sufficient if the majority of the members of the bodies responsible for overall management, supervision and control are not members of the body responsible for business management.b. if the provision of ancillary services not subject to authorisation or approval by virtue of financial market legislation increases the risks of a dlt trading facility, finma may require exclusively organisational measures (art. 10 para. 3 of the finmia). if the dlt trading facility also operates an organised trading facility (art. 43 of the finmia), finma may require additional capital and sufficient liquidity.c. the business continuity requirements may also be met by having another authorisation holder take over the operation of the dlt trading facility in the event of disruptions (art. 13 para. 1 of the finmia). the strategy and business impact analysis in accordance with article 14 of this ordinance may make provision for the operation of the dlt trading facility to be transferred to a third party.d. the regulatory tasks delegated to the dlt trading facility may also be carried out by a non-independent body (art. 27 para. 2 of the finmia).e. an independent appeal body is not necessary (art. 37 of the finmia).f. an internal audit is not necessary (art. 8 para. 1 lit. c of this ordinance).2 for small dlt trading facilities that provide services in accordance with article 73a paragraph 1 letter b or c of the finmia, the following eased requirements apply in addition, in derogation from the finmia:a. the capital requirements do not apply (art. 66 of the finmia).b. the liquidity requirements do not apply (art. 67 of the finmia).art. 58m duty of information for small dlt trading facilities (art. 73f finmia)before establishing a business relationship, small dlt trading facilities shall inform their clients, in writing or in another form demonstrable by text, of the specific eased requirements which the small dlt trading facility is applying.art. 58n minimum capital for small dlt trading facilities (art. 73f finmia)for small dlt trading facilities, the minimum capital requirement is:a. chf 500,000 if they do not provide services in accordance with article 73a paragraph 1 letter b or c;b. 5% of the dlt securities in custody, but at least chf 500,000 if they provide services in accordance with article 73a paragraph 1 letter b or c.art. 58o prohibition on lending (art. 73f finmia)small dlt trading facilities may not grant loans.chapter 5 trade repositories art. 59 ancillary services (art. 10 finmia)if the trade repository offers ancillary services, it must provide these in a way that is operationally segregated from its essential services.art. 60 data retention (art. 75 finmia)1 the trade repository must do the following with respect to the reported data:a. record it immediately and completely;b. save it both online and offline;c. copy it to an appropriate extent.2 it shall record all changes to the reported data, providing information on: a. at whose request the change was made;b. the reasons for the change;c. the time the change was made;d. and providing a clear description of the change.art. 61 publication of data (art. 76 finmia)1 the trade repository shall publish at least weekly the open positions, transaction volumes and values for the following derivative categories:a. commodity derivatives;b. credit derivatives;c. currency derivatives;d. equity derivatives;e. interest rate derivatives;f. other derivatives.2 the data must be easily accessible for the public.3 it should not be possible to draw conclusions with respect to a contracting party on the basis of the data published.art. 62 data access for swiss authorities (art. 77 finmia)1 the trade repository shall grant the following authorities access to the data, whereby paragraph 2 remains reserved:a. finma: all transaction data;b. the snb: all transaction data;c. the swiss takeover board: derivative transaction data with a connection to takeover proceedings;d. the federal audit oversight authority: derivative transaction data that it requires in specific supervisory proceedings involving audit firms;e. the competition commission: derivative transaction data with a connection to proceedings in the field of competition;f. the electricity commission: transaction data on derivatives whose underlying instrument relates to electricity.2 the trade repository shall reject enquiries concerning transactions and positions of central banks.art. 63 data access for foreign authorities (art. 78 finmia)1 the trade repository shall grant foreign financial market supervisory authorities access to transaction data solely for the purposes of enforcing financial market law under their responsibility.2 the trade repository shall reject enquiries concerning transactions and positions of central banks.art. 64 procedure (art. 77 and 78 finmia)1 the access of authorities shall be structured in line with the communication protocols, data exchange standards and reference data that are commonplace at the international level.2 the authorities must take suitable measures to ensure that only the employees who directly require the data for exercising their activities gain access to the data.3 the trade repository shall provide the authorities with a form for their enquiries in which the following information is required:a. details of the authority;b. reason for the data enquiry and relevance to its mandate;c. legal basis for the data enquiry;d. a description of the data it is requesting;e. an illustration of the measures it has taken to ensure the confidentiality of data received.4 from foreign authorities, it shall additionally request confirmation that an agreement is in place between the foreign and swiss authorities in accordance with article 78 paragraph 1 finmia.5 the trade repository shall keep a record of information on data access.art. 65 data transmission to private individuals (art. 79 finmia)1 the trade repository shall provide private individuals with a form for their enquiries in which the following information is required:a. personal details;b. reason for the data enquiry;c. a description of the data being requested.2 it should not be possible to draw conclusions with respect to another contracting party on the basis of the data transferred.chapter 6 payment systems art. 66 clearing and settlement principles (art. 82 finmia)1 the payment system shall ensure the proper and lawful clearing and settlement of payment obligations.2 it shall specify the time:a. after which a payment order is irrevocable and may no longer be changed;b. when a payment is settled.3 payment systems that use a common settlement infrastructure shall establish identical times for:a. the entry of payment orders into the system of the common settlement infrastructure; b. the irrevocability of payment orders.4 the payment system shall settle payments in real time if possible, but at the latest at the end of the value day.art. 67 collateral (art. 82 finmia)1 the payment system shall use appropriate measures to cover risks arising from the granting of credit.2 it shall accept only liquid collateral with low credit and market risks. it shall value the collateral prudently.3 it shall avoid concentration risks in the collateral and shall ensure that it can have prompt access to the collateral.4 it shall make provision for procedures by means of which it can review the models and parameters on which its risk management is based, and shall conduct these reviews on a regular basis.5 if it holds its own assets or the collateral and assets of participants with third parties, it shall minimise the associated risks. in particular, it shall hold the collateral and assets with creditworthy financial intermediaries which, insofar as possible, are subject to supervision.art. 68 fulfilment of payment obligations (art. 82 finmia)1 the payment system shall enable the settlement of payments by transferring sight deposits held with a central bank.2 if this is impossible or impractical, it shall use a means of payment which carries no or only low credit and liquidity risks. it shall minimise these risks and monitor them on an ongoing basis.3 where exchange-of-value settlement is concerned, the payment system shall enable participants to eliminate their principal risk by ensuring that the settlement of one obligation occurs if and only if the settlement of the other obligation is guaranteed.art. 69 capital adequacy (art. 82 finmia)in the case of systemically important payment systems, the capital must suffice to implement the plan set out in article 72, but must at least be sufficient to cover ongoing operating expenditure for six months.art. 70 liquidity (art. 82 finmia)1 the payment system must have sufficient liquidity in accordance with article 58 paragraph 1:a. to fulfil its payment obligations in all currencies under extreme but plausible market conditions, even in the event of the default of the participant to which it has its greatest exposure; andb. to be able to duly execute its services and activities.2 it shall invest its financial resources solely in cash or in liquid financial instruments with a low market and credit risk.3 it shall regularly review compliance with the requirements set out in paragraph 1 under various stress scenarios. in doing so, it shall apply collateral discounts (haircuts) to the liquidity that would be appropriate even under extreme but plausible market conditions. it shall diversify its sources of liquidity.4 the investment strategy of the payment system must be in harmony with its risk management strategy. it must avoid concentration risks.chapter 7 supervision and oversight art. 71 auditing (art. 84 para. 1 finmia)1 the audit firm of the financial market infrastructure shall review whether the latter fulfils the relevant duties as set forth in legislation, this ordinance and its own contractual basis.2 the audit firm of the trading venue shall coordinate its audit with the latter's trading supervisory body and shall pass on its audit reports to this body.art. 72 voluntary authorisation return (art. 86 finmia)1 systemically important financial market infrastructures shall draw up a plan as to how their systemically important business processes are to be terminated in an orderly way in the event of a voluntary cessation of business. the orderly wind-down plan shall take into account the period of time required for the participants to sign up to an alternative financial market infrastructure. it must be approved by the body responsible for governance, supervision and control.2 paragraph 1 also applies if the cessation of a systemically important business process does not lead to the return of the authorisation.chapter 8 insolvency law provisions art. 73 system protection (art. 89 finmia)1 the orders of participants include in particular instructions that:a. directly affect the settlement of payments or securities transactions; orb. serve the purpose of providing the financing or collateral required under the system's rules.2 a payment or transfer order may not be revoked either by a participant in the system or by a third party from the time set out in article 62 paragraph 4 letter a finmia and article 66 paragraph 2 letter a of this ordinance.art. 74 primacy of agreements in the event of insolvency (art. 90 and 91 finmia)1 the offsetting agreements shall include in particular netting provisions as well as the default agreements contained in bilateral or framework agreements.2 the transfer of receivables and liabilities is understood to mean in particular the assignment, cancellation, refounding via agreement and the closure of a position and subsequent reopening of an equivalent position.3 in the event of a transfer of a position, any collateral in the form of securities or other assets whose value can be determined objectively are automatically transferred, insofar as they were passed on within the transaction chain, to the taking-over participant.art. 75 postponement of the termination of contracts (art. 92 finmia)1 the following contracts in particular may be postponed:a. contracts on the purchase, sale, repurchase and lending of securities and book-entry securities and on trading in options on securities and book-entry securities;b. contracts on the purchase and sale with future delivery of commodities and on trading in options on commodities or on commodity deliveries;c. contracts on the purchase, sale or transfer of goods, services, rights or interest at a price and future date determined in advance (futures trades/forward trading);d. contracts on swap transactions relating to currencies, precious metals, loans and securities, book-entry securities, commodities and their indices.2 the financial market infrastructure shall ensure that new agreements or amendments to existing agreements which are subject to foreign law or envisage a foreign jurisdiction are agreed only if the counterparty recognises a postponement of the termination of agreements in accordance with article 30a banka.title 3 market conduct chapter 1 derivatives trading section 1 general art. 76 collective investment schemes (art. 93 para. 2 lit. e and f finmia)whether a collective investment scheme counts as a financial counterparty or as a small financial counterparty is determined on the basis of the otc derivatives transactions carried out for its own account in accordance with article 99 finmia, regardless of whether it can be ascribed legal personality or not.art. 77 companies (art. 93 para. 3 finmia)1 under the finmia, a company is deemed to be any legal entity entered in the commercial register.2 also classified as companies are foreign companies engaged in economic activities that are legal entities according to the law applicable to them, as well as trusts and similar constructs.art. 78 branches (art. 93 para. 5 finmia) if finma determines that a swiss branch of a foreign counterparty is subject to regulation that does not correspond to the statutory requirements to a significant extent, it can subject the derivatives transactions carried out by the branch in question to articles 93 to 117 finmia on derivatives trading.art. 79 exceptions for other public sector bodies (art. 94 para. 2 finmia)1 derivatives with the following counterparties are subject to the reporting duty set out in article 104 finmia, but not to the other derivatives trading duties:a. foreign central banks;b. the ecb;c. the efsf;d. the esm;e. official bodies or state departments that are responsible for or involved in administering the national debt; f. financial institutions set up by a central government or by the government of a subordinate regional body in order to grant promotional loans on the state's behalf on a non-competitive, non-profit-oriented basis.2 derivatives transactions with foreign central banks and with the bodies listed under paragraph 1 letter e may be exempted from the reporting duty provided reciprocity is granted. 3 the fdf shall publish a list of the foreign bodies covered by paragraph 2.art. 80 excluded derivatives (art. 94 para. 4 finmia)in addition to the derivatives listed under article 94 paragraph 3 finmia, the following derivatives are excluded from articles 93 to 117 finmia concerning derivatives trading:a. derivatives issued in the form of a security or uncertificated security; b. derivatives accepted in the form of a deposit.art. 81 fulfilment of duties under foreign law (art. 95 finmia)1 finma shall recognise foreign law as equivalent if the duties that apply for derivatives trading and the provisions on supervision are comparable with the swiss equivalent in their material impact.2 this condition is met with respect to the:a. clearing duty under article 97 finmia, if the clearing in question largely reduces the systemic and counterparty risks of standardised otc derivatives;b. reporting duty under article 104 finmia, if the report contains at least the information set out in the article 105 paragraph 2 finmia;c. the risk mitigation duty under articles 107 to 110 finmia, if the corresponding measures largely reduce the systemic and counterparty risks of non-standardised otc derivatives;d. the platform trading duty under article 112 finmia, if pre-trade and post-trade transparency in the derivatives market is appropriately improved through the trading of standardised derivatives via trading venues or organised trading facilities. 3 a swiss counterparty can fulfil its derivatives trading duties with another swiss counterparty under foreign supervisory legislation recognised by finma if the derivatives transaction in question or a counterparty to this transaction has an objective connection with this legislation. the simply choice of law does not create an objective connection.art. 82 intra-group flow of information (art. 96 finmia)if the counterparty commissions group companies and branches in switzerland and abroad with the fulfilment of its duties under articles 93 to 117 finmia, it may exchange all necessary information in this respect with these group companies and branches, including client data, without this requiring the approval of the client in question. art. 83 declaration concerning a counterparty's characteristics (art. 97 para. 3 finmia)1 the declaration of a counterparty with respect to its characteristics applies with respect to all the duties set out in this chapter.2 counterparties must inform the counterparties with which it regularly enters into derivatives transactions about any change in its status in a timely manner.art. 84 currency swaps and currency forward transactions (art. 101 para. 3, 107 para. 2, 113 para. 3 finmia)the currency swaps and currency forward transactions that are exempt from the clearing duty (art. 97 finmia), the risk mitigation duties (art. 107 to 111 finmia) and the platform trading duty (art. 112 finmia) comprise all transactions for the exchange of currencies in which real execution is guaranteed, irrespective of the clearing method.section 2 clearing via a central counterparty art. 85 commencement of duty (art. 97 and 101 para. 2 finmia)the duty to clear derivatives transactions via authorised or recognised central counterparties applies from the point at which finma publishes the clearing duty for the derivative category in question:a. after the expiry of six months: for derivatives transactions which participants in an authorised or recognised central counterparty conclude anew with one another;b. after the expiry of 12 months: for derivatives transactions which:1. participants in an authorised or recognised central counterparty conclude anew with other financial counterparties that are not small, or2. other financial counterparties that are not small conclude anew with one another;c. after the expiry of 18 months: for all other derivatives transactions concluded anew.art. 86 transactions not covered (art. 94 para. 4 and 97 para. 2 finmia)261 transactions with counterparties that are subject to the clearing duty for the first time in accordance with article 98 paragraph 2 or article 99 paragraph 2 finmia do not need to be cleared through a central counterparty if they were concluded prior to subjection to the clearing duty.2 derivatives transactions with counterparties which have their registered office or domicile in switzerland to which the derivatives trading provisions do not apply do not have to be cleared through a central counterparty.3 derivatives transactions in which a covered bond issuer or a legal entity of a cover pool for covered bonds is involved do not have to be cleared via a central counterparty if the following prerequisites are met:a. the derivatives transaction serves the sole purpose of hedging interest rate or currency risks arising from the covered bond for the cover pool.b. the derivatives transaction is not terminated in the event of restructuring or bankruptcy proceedings brought against the covered bond issuer or the legal entity of the cover pool.c. the counterparty of the covered bond issuer or of the legal entity of the cover pool is at least pari passu with the covered bond creditors, except in cases where:the counterparty is the defaulting or affected party; orthe counterparty renounces pari passu status.d. the other derivatives transactions entered into as part of the netting set are linked to the cover pool.e. the cover pool's collateral ratio is at least 102%.2726 amended by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).27 inserted by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).art. 87 derivatives transactions intended to reduce risks (art. 98 para. 3 finmia)derivatives transactions intended to reduce risks are directly associated with the business activity, liquidity management or asset management of the non-financial counterparty if they:a. serve to hedge the risks of a change in value of assets or liabilities which the non-financial counterparty or its group can reasonably be considered to hold, in keeping with its business activity;b. serve to hedge the risks to the value of assets and liabilities that result from indirect repercussions of fluctuations in interest rates, inflation rates, currency movements or credit risks;c. are recognised as hedging transactions according to an accounting standard that is recognised under article 1 of the ordinance of 21 november 201228 on recognised accounting standards; ord. are concluded as fixed hedging transactions in the context of the management of business risks (portfolio hedging or macro hedging) or are concluded according to the approximation method (proxy hedging) in keeping with recognised international standards.28 sr 221.432art. 88 thresholds (art. 100 finmia)1 the following thresholds apply to the average gross positions in outstanding otc derivatives transactions of non-financial counterparties:a. credit derivatives: chf 1.1 billion;b. equity derivatives: chf 1.1 billion;c. interest rate derivatives: chf 3.3 billion;d. currency derivatives: chf 3.3 billion;e. commodity derivatives and other derivatives: chf 3.3 billion.2 where the average gross position of all outstanding otc derivatives transactions of financial counterparties are concerned, a threshold of chf 8 billion applies at financial or insurance group level.art. 89 average gross position (art. 100 finmia)the following rules apply to the calculation of the average gross position of outstanding otc derivatives transactions:a. the latest exchange rates shall be used in the calculation.b. positions from otc derivatives transactions are factored into the calculation even if they are voluntarily cleared centrally.c. positions of fully-consolidated group companies, including those with their registered office outside switzerland, shall be factored in irrespective of the registered office of the parent company if these group companies would count as financial or non-financial counterparties in switzerland.d. adjustments to the nominal amount during the term shall be factored in if these were contractually envisaged at the start of the transaction.e. transactions in the subsequent transaction chain of hedging transactions of a non-financial counterparty likewise count as hedging transactions.f. the netting of opposing positions in derivatives is permitted insofar as these positions relate to the same underlying instrument, are denominated in the same currency and have the same maturity date. in such case, the reference interest rates for variable-interest positions, the fixed interest rates and the interest-setting reference dates must be identical.g. derivatives not covered by the clearing duty under article 101 paragraph 3 letter b finmia shall not be factored in.art. 90 cross-border transactions (art. 94 para. 2 and 102 finmia)cross-border transactions do not have to be cleared through a central counterparty if the foreign counterparty:a. has its registered office in a country whose legislation is recognised by finma as being equivalent; andb. the transactions in question are not subject to the clearing duty under the legislation of that country.art. 91 intra-group transactions (art. 103 lit. b finmia)non-financial counterparties are subject to appropriate centralised risk evaluation, measurement and control procedures if they maintain professional central treasury operations.section 3 reporting to a trade repository art. 92 duty (art. 104 finmia)1 derivatives transactions with parties that are exempted from the provisions on derivatives trading are to be reported by the counterparty subject to the legislation.2 subject to article 104 paragraph 4 finmia, centrally cleared transactions that are traded via a trading venue or an organised trading facility are to be reported by the counterparty closest to the central counterparty in the transaction chain.3 the definition of selling counterparty shall be based on conventional industry and recognised international standards, whereby agreement on another interpretation remains reserved.4 a counterparty may submit data to a trade repository in switzerland or abroad without the approval of, or without informing, its counterparty or an end client, as long as this is done in fulfilment of the duties set out in title 3 finmia, whereby article 105 paragraph 4 finmia remains reserved.art. 93 content of reports (art. 105 para. 2 finmia)reports are to contain the information set out in annex 2.section 4 risk mitigation art. 94 duties (art. 107 to 111 finmia)1 the risk mitigation duties apply only to derivatives transactions between companies.2 if finma determines that a derivatives transaction should no longer be subject to the clearing duty, it shall inform the counterparties promptly in this respect, granting them an appropriate period in which to make the necessary adjustments. art. 95 confirmation of contractual terms (art. 108 lit. a finmia)1 the contractual terms must be reciprocally confirmed at the latest within two business days of the conclusion of the otc derivatives transaction in question. 2 otc derivatives transactions concluded after 4 p.m. must be confirmed at the latest within three business days of the transaction being concluded.3 the deadlines that apply for complex transactions and small counterparties shall be extended by one business day. 4 the counterparties may agree that an otc derivatives transaction should also be considered confirmed if one of the counterparties does not raise any objection to a unilateral confirmation. art. 96 portfolio reconciliation (art. 108 lit. b finmia)1 the details for reconciling the portfolios must be agreed prior to completing an otc derivatives transaction.2 the portfolio reconciliation shall encompass the key terms of the concluded otc derivatives transactions and their valuation.3 it may also be carried out by a third party appointed by one of the counterparties.4 it must be carried out:a. every business day if there are 500 or more otc derivatives transactions outstanding between the counterparties;b. once a week if there are between 51 and 499 otc derivatives transactions outstanding between the counterparties at any point during the week;c. once a quarter if there are 50 or less otc derivatives transactions outstanding between the counterparties at any point during the quarter.5 derivatives not covered by the clearing duty under article 101 paragraph 3 letter b finmia are not factored in for purposes of determining outstanding transactions in accordance with paragraph 4.art. 97 dispute resolution (art. 108 lit. c finmia)1 the place of jurisdiction and the applicable law for any disputes must be agreed at the latest when an otc derivatives transaction is concluded.2 procedures are to be set out in the agreement:a. for the identification, recording and monitoring of disputes in connection with the recognition or valuation of the transaction and the exchange of collateral between the counterparties; the record of the dispute has to encompass at least how long the dispute has been going on for up to that point, the counterparty and the disputed amount;b. for the swift resolution of disputes and for a special process for disputes that cannot be resolved within five business days.art. 98 portfolio compression (art. 108 lit. d finmia)1 portfolio compression need not be undertaken if it would not lead to any meaningful reduction in counterparty risk and the counterparty subject to the obligation documents this at least every six months. 2 portfolio compression would not lead to any meaningful reduction in counterparty risk in particular if:a. the portfolio contains no or only a few offsettable otc derivatives transactions;b. such activity would jeopardise the effectiveness of internal risk processes and controls.3 portfolio compression also need not be undertaken if the corresponding work and expense would be disproportionate to the anticipated reduction in counterparty risk.art. 99 valuation of outstanding transactions (art. 109 finmia)1 market conditions that do not permit the valuation of otc derivatives transactions are deemed to hold sway if:a. the market in question is inactive; orb. the range of plausible fair value estimates is significant and the probabilities of the various estimates cannot be reasonably assessed.2 a market for an otc derivatives transaction is viewed as inactive if:a. the quoted prices are not automatically and regularly available; andb. the prices available do not represent market transactions that take place regularly and under standard market conditions.3 if a valuation is permissible on the basis of model prices, the model must:a. take into consideration all factors that the counterparties would take into account when determining a price, including the greatest possible use of market valuation information;b. be in line with recognised economic processes for determining the prices of financial instruments;c. be calibrated using the prices of observable latest market transactions with the same financial instrument, be reviewed with respect to its validity or be based on available and observable market data;d. be monitored and validated independently as part of internal risk management processes;e. be properly documented and approved by the management body, the executive management or a risk committee delegated by the latter, and be reviewed at least once a year.art. 10029 duty to exchange collateral (art. 110 finmia)1 if counterparties have to exchange collateral, this shall take the form of:a. an initial margin that is suitable for protecting the transaction partners from the potential risk that there could be market price changes during the closing and replacement of the position in the event of default on the part of a counterparty; andb. a variation margin that is suitable for protecting the transaction partners from the ongoing risk of market price changes following execution of the transaction.2 the duty to supply an initial margin applies only to counterparties whose aggregated month-end average gross position of otc derivatives not cleared through a central counterparty, including derivatives in accordance with article 107 paragraph 2 letter b of the finmia, is greater than chf 8 billion at group or financial or insurance group level for the months of march, april and may of the year; in this regard, intra-group transactions are not counted several times from the viewpoint of each group company.3 the duty under paragraph 2 always applies for the entirety of the subsequent calendar year.29 amended by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).art. 100a30 exceptions to the duty to exchange collateral (art. 110 finmia)1 the exchange of initial margins and variation margins may be waived if: a. the collateral to be exchanged would amount to less than chf 500,000;b. small non-financial counterparties are involved in the transaction.2 the exchange of initial margins may be waived if such margins would have to be provided for the currency components of currency derivatives where the nominal amount and interest in one currency are exchanged against the nominal amount and interest in another currency at a predefined time and according to a predefined method.3 if one of the counterparties to a derivatives transaction is a covered bond issuer or a legal entity of a cover pool for covered bonds, that counterparty may, subject to the conditions set out in article 86 paragraph 3, agree with its counterparty that:a. an exchange of initial margins will be dispensed with; orb. the covered bond issuer or the legal entity of a cover pool for covered bonds will pay no variation margins, and the counterparty will pay variation margins in cash.30 inserted by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).art. 100b31 initial margin reduction (art. 110 finmia)1 the counterparties may reduce initial margins by no more than chf 50 million.2 the amount of the initial margins of a counterparty that belongs to a financial or insurance group or a group is determined taking all of the group companies into account.3 in the case of intra-group transactions, the initial margin may be reduced by no more than chf 10 million.31 inserted by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).art. 10132 timing of initial margin calculation and payment (art. 110 finmia)1 the initial margin must be calculated for the first time within one business day of the execution of the derivatives transaction. it must be recalculated regularly, but at least every ten business days.2 if both of the counterparties are in the same time zone, the calculation is to be based on the previous day's netting set. if the two counterparties are not in the same time zone, the calculation is to be based on the netting set transactions that were executed on the previous day before 4pm in the earlier of the two time zones.3 the initial margin is to be paid on the respective calculation day according to paragraph 1. the customary timeframes apply for settlement.32 amended by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).art. 101a33 timing of variation margin calculation and payment (art. 110 finmia)1 variation margins are to be recalculated at least every business day. 2 the basis of the calculation is the valuation of the outstanding transaction in accordance with article 109 of the finmia. for all other matters, article 101 paragraph 2 is applicable by analogy.3 variation margins are to be paid on the respective calculation day according to paragraph 1. the customary timeframes apply for settlement.4 notwithstanding paragraph 3, variation margins may be paid up to two business days after the calculation day if:a. a counterparty not obliged to pay an initial margin provided additional collateral before the calculation day and the following conditions are met:1. the additional collateral was calculated taking account of a 99% one-tailed confidence interval for the valuation of the otc derivatives transactions to be secured for the relevant margin period of risk,2. the margin period of risk is at least as many days as the number of days between the calculation day and the variation margin payment day, whereby the calculation day and payment day also have to be counted; or b. the counterparties paid initial margins taking account of a margin period of risk spanning at least the following periods: 1. the period from the last variation margin payment day to the possible counterparty default, plus the days from the calculation day to the variation margin payment day, and2. the period deemed necessary to replace the otc derivatives transaction concerned or to hedge the resulting risks.33 inserted by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).art. 10234 treatment of initial margins (art. 110 finmia)1 no reciprocal offsetting may apply to initial margins. 2 initial margins paid in cash must be held with a central bank or a swiss bank independent of the paying counterparty or an independent foreign bank subject to appropriate regulation and supervision.3 initial margins not paid in cash may be held by the receiving counterparty or by a third party mandated by the counterparty. the third party may be the paying counterparty.4 the use of initial margins for other purposes is not permissible. this does not apply to the reutilisation of initial margins paid in cash by a custodial third party, provided it is contractually ensured that the reutilisation does not adversely affect the security and its usability. 5 the receiving counterparty and the custodial third party must keep the non-cash initial margins received separate from their own assets and conclude a segregation agreement. this shall prescribe in particular that: a. the initial margin payment should be immediately available to the receiving counterparty in the event of bankruptcy or default on the part of the other counterparty; andb. the counterparty making the initial margin payment should be sufficiently hedged against the possibility of bankruptcy or default on the part of the receiving party or the custodial third party.34 amended by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).art. 103 calculation of initial margins (art. 110 finmia)1 the initial margin is calculated as a percentage discount on the gross positions of the individual derivatives transactions. derivatives transactions that form the object of a netting agreement concluded between the counterparties (netting set) may be pooled.2 it shall amount to the following for each derivative category:a. 1% for interest rate derivatives with a residual term of up to two years;b. 2% for credit derivatives with a residual term of up to two years and interest rate derivatives with a residual term of two to five years;c. 4% for interest rate derivatives with a residual term of more than five years;d. 5% for credit derivatives with a residual term of two to five years;e. 6% for foreign currency derivatives;f. 10% for credit derivatives with a residual term of more than five years;g. 15% for equity, commodity and all other derivatives.3 if a transaction can be classified in more than one derivative category in accordance with paragraph 2, it shall be assigned:a. to the derivative category with the greatest risk factor insofar as this can be clearly identified in the transaction in question;b. to the derivative category with the highest percentage discount if the greatest risk factor cannot be clearly identified in the transaction in question.4 the initial margin for a netting set is calculated in accordance with annex 3.5 financial counterparties that use a market risk model approach approved by finma in accordance with article 88 cao35 for calculating positions according to risk weighting, or that use a market model approved by finma in accordance with articles 50a to 50d of the insurance oversight ordinance of 9 november 200536 for calculating solvency as part of the swiss solvency test (sst), may calculate the initial margin payment on that basis so long as no internationally harmonised standard model that is recognised throughout the industry has been established. finma shall regulate the technical criteria that the model approach or the market model must meet.6 .3735 sr 952.0336 sr 961.01137 repealed by no i of the o of 5 july 2017, with effect from 1 aug. 2017 (as 2017 3715).art. 104 admissible collateral for initial and variation margins (art. 110 finmia)1 the following count as admissible collateral:a. cash deposits, including medium-term notes or comparable instruments issued by a bank;b. high-quality debt securities issued by a central government, a central bank, a public-law entity with the right to levy taxes, the bis, the international monetary fund, the esm and multilateral development banks;c. high-quality debt securities of companies;d. high-quality mortgage bonds (pfandbriefe) and other covered debt securities;e. shares of a major index in accordance with article 4 letter b cao38, including convertible bonds;f. gold;g. money market funds;h.39 units in securities funds in accordance with article 53 of the federal act of 23 june 200640 on collective investment schemes, if:1. the units are valued daily, and2. the securities funds invest solely in assets in accordance with letters a to g or in derivatives that hedge such assets.2 collateral is deemed to be high value if it is highly liquid, has a strong track record of preserving its value even in a period of stress and can be monetised within an appropriate period.3 resecuritisation positions are not admissible as collateral.4 the collateral must be valued anew each day.38 sr 952.0339 inserted by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).40 sr 951.31art. 105 discounts on collateral (art. 110 finmia)1 the value of the collateral should be marked down by means of discounts on the market value in accordance with annex 4.2 an additional discount of 8% must be applied in cases where: a. the currency of the initial margin paid is different from the currency agreed for the termination payment;b. the currency of non-cash variation margins provided is different from the currencies agreed in the derivatives contract, the netting framework agreement or the credit support annex for variation margins.413 counterparties may ascertain the discounts that apply using their own estimates of market price and exchange rate volatility if they meet the qualitative and quantitative minimum standards in accordance with annex 5.4 they shall take measures to:a. exclude risk concentrations with respect to certain types of collateral;b. rule out the possibility that the collateral accepted was issued by the collateral provider or a company associated with the collateral provider;c. avoid key correlation risks with respect to the collateral received.41 amended by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).art. 106 cross-border transactions (art. 94 para. 2 and 107 finmia)1 the duty to exchange collateral in the case of cross-border transactions shall also apply, subject to the exemption envisaged in paragraphs 2, 2bis and 2ter, if the foreign counterparty of the swiss counterparty which has the duty to exchange collateral would also be subject to this duty if it had its registered office in switzerland.422 no collateral has to be exchanged if the foreign counterparty:a. has its registered office in a country whose legislation is recognised by finma as being equivalent; andb. does not have to exchange collateral under the legislation of that country.2bis the swiss counterparty may dispense with the payment of initial margins and variation margins to the foreign counterparty if an independent legal review showed that: a. the netting or guarantee agreements vis--vis the foreign counterparty are not definitely legally enforceable at all times; orb. agreements on the separation of collateral are not in line with internationally recognised standards.432ter it can dispense with requiring the foreign counterparty to pay initial margins and variation margins if the conditions under paragraph 2bis letter a or b are met and: a. an independent legal review showed that the acceptance of initial or variation margin payments from the foreign counterparty in accordance with the provisions of the finmia or this ordinance would not be possible; andb. the unsecured transactions concluded and outstanding after the entry into force of the duty to call for the payment of initial margins and variation margins account for less than 2.5% of all otc derivatives transactions, whereby intra-group transactions are not to be included in the calculation.443 the other risk mitigation duties that would require the involvement of the counterparty may be fulfilled unilaterally insofar as this corresponds to recognised international standards.42 amended by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).43 inserted by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).44 inserted by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).art. 107 intra-group transactions (art. 111 finmia)1 insolvency law provisions do not count as legal impediments in the sense of article 111 letter c finmia.2 furthermore, article 91 applies.section 5 trading via trading venues and organised trading facilities art. 108 commencement of duty (art. 112 finmia)the duty to trade a derivatives transaction via a trading venue or organised trading facility in accordance with article 112 finmia (platform trading duty) shall apply from the point at which finma publishes such a duty for the derivatives transaction in question:a. after the expiry of six months: for derivatives transactions which participants in an authorised or recognised central counterparty conclude anew with one another; b. after the expiry of nine months: for derivatives transactions: 1. which participants in an authorised or recognised central counterparty conclude anew with other financial counterparties, or2. which other financial counterparties that are not small conclude anew with one another;c. after the expiry of 12 months: for all other derivatives transactions concluded anew.art. 109 transactions not subject to the trading duty (art. 112 finmia)1 counterparties newly subject to the platform trading duty in accordance with article 98 paragraph 2 or article 99 paragraph 2 finmia do not have to trade transactions they concluded prior to the start of this duty via authorised or recognised trading venues or via operators of an organised trading facility. 2 derivatives transactions with counterparties in accordance with article 94 paragraph 1 finmia are not covered by the platform trading duty.art. 110 trading via foreign organised trading facilities (art. 95 and 112 finmia)the platform trading duty may be fulfilled through trading via a foreign organised trading facility if this facility is subject to foreign regulation that has been recognised by finma as being equivalent in analogous application of article 41 finmia.art. 111 cross-border transactions (art. 94 para. 2 and 114 finmia)cross-border transactions do not have to be traded through a trading venue or an organised trading facility if the foreign counterparty:a. has its registered office in a country whose legislation is recognised by finma as being equivalent;b. is not subject to the platform trading duty under the legislation of that country.art. 112 intra-group transactions (art. 94 para. 2 and 115 finmia)for intra-group transactions, article 91 applies.section 6 documentation and auditing art. 113 documentation (art. 116 finmia)1 financial and non-financial counterparties shall regulate, in writing or in another form that that allows for proof by text, the processes with which they ensure fulfilment of the duties with respect to:45a. clearing via a central counterparty (art. 97 finmia);b. determining thresholds (art. 100 finmia);c. reporting to a trade repository (art. 104 finmia); d. risk mitigation (art. 107 finmia);e. trading via trading venues and organised trading facilities (art. 112 finmia).1bis the transitional period under paragraph 1 is extended until 30 september 2022.462 non-financial counterparties which do not want to trade in derivatives may set out this resolution in writing or in another form that that allows for proof by text, in which case they are exempt from the duty set out in paragraph 1.473 financial counterparties appointed by other financial or non-financial counterparties to implement their duties shall regulate the corresponding processes in accordance with paragraph 1 by analogy.45 amended by annex 1 no ii 14 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633).46 inserted by no i of the o of 25 aug. 2021, in force since 1 oct. 2021 (as 2021 539).47 amended by annex 1 no ii 14 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633).art. 114 auditing and notifications (art. 116 and 117 finmia)1 in the case of non-financial counterparties, the auditor shall review whether these counterparties have taken measures, in particular to comply with the derivatives trading duties set out in article 113 paragraph 1 letters a to e. 2 when carrying out its audit, it shall take account of the principles of risk-oriented review and materiality.3 the auditor in accordance with article 727 of the swiss code of obligations48 (co) shall set out the results of its audit in a comprehensive report for the board of directors in accordance with article 728b paragraph 1 co.4 the auditor in accordance with article 727a co shall inform the responsible body of the audited company of the results of the audit.5 if the auditor identifies violations of the provisions on derivatives trading, it shall incorporate these into its report in accordance with paragraphs 3 and 4. it shall set a deadline for rectification of the reported violations.6 if the audited company has not executed any derivatives transactions during the audit period and no derivatives transactions are outstanding at the end of this period, the reports required under paragraphs 3 and 4 may be waived.7 the auditor shall report the violations to the fdf if the company does not remedy the violations in accordance with paragraph 5 by the deadline set, or if it repeats these violations.48 sr 220chapter 2 disclosure of shareholdings art. 115 (art. 120 finmia)1 the equity securities of a company having its registered office abroad are deemed to be mainly listed in switzerland if the company has to fulfil at least the same duties for its listing and maintenance of its listing on a stock exchange in switzerland as companies having their registered office in switzerland.2 the stock exchange shall publish which equity securities of companies having their registered office abroad are mainly listed in switzerland.3 companies having their registered office abroad whose equity securities are mainly listed in switzerland must publish the current total number of equity securities issued and the associated voting rights.chapter 3 public takeover offers art. 116 main listing (art. 125 para. 1 finmia)for public takeover offers, article 115 regarding main listing applies. art. 117 fees for the review of a takeover offer (art. 126 para. 5 finmia)1 the swiss takeover board shall levy a fee for reviewing the takeover offer whenever such an offer is made by any party.2 the fee is calculated as a proportion of the value of the transaction:a. 0.05% for amounts up to chf 250 million;b. 0.02% for the part between chf 250 million and chf 625 million;c. 0.01% for the part in excess of chf 625 million.3 the fee shall amount to at least chf 50,000 and a maximum of chf 250,000. in special cases, the fee may be reduced or increased by up to 50% depending on the scope and complexity of the transaction in question.4 if securities listed on the stock exchange are offered for exchange, the total amount of the offer shall be ascertained on the basis of the volume-weighted average closing price over the last 60 trading days prior to submission of the offer, or prior to the offer being reported to the swiss takeover board. for illiquid or unlisted securities, the fee shall be ascertained on the basis of the auditor's valuation.5 in special cases, in particular if the target company or a qualified shareholder causes the swiss takeover board an unusual amount of work, the swiss takeover board may also require the target company or the qualified shareholder to pay a fee. this shall amount to at least chf 20,000, but no more than the fee payable by the offeror.art. 118 fees for other decisions (art. 126 para. 5 finmia)1 the swiss takeover board shall also levy a fee if it has to make a decision in other circumstances relating to takeovers, particularly on whether or not a duty to make an offer exists. it may also levy a fee for reviewing requests for information.2 the fee shall amount to up to chf 50,000 depending on the scope and complexity of the case in question. 3 if the applicant subsequently submits a takeover offer after a committee has made a decision, the swiss takeover board may subtract this amount from the fee set out in article 117.art. 119 advance payment of fees (art. 126 para. 5 finmia)the swiss takeover board may request an advance fee payment amounting to the probable fee from each party.art. 120 calculation of voting rights in the case of the cancellation of outstanding equity securities (art. 137 para. 1 finmia)in order to determine whether the threshold of 98% in accordance with article 137 paragraph 1 finmia has been exceeded or not, the following shares shall be taken into account in addition to the shares held directly:a. those with dormant voting rights;b. those held by the offeror indirectly or in concert with third parties at the time of the application for cancellation.art. 121 proceedings for cancelling outstanding equity securities (art. 137 finmia)1 if the offeror brings an action against the company in an attempt to have the latter's outstanding equity securities cancelled, the court shall make this known to the public and inform the remaining shareholders that they may participate in the proceedings. in this respect, it shall set a timeframe of at least three months, beginning on the day of the first announcement.2 the announcement shall be published three times in the swiss official gazette of commerce. in special cases, the court may arrange for appropriate publication in another manner.3 if shareholders participate in the proceedings, they shall be independent of the defendant company in their litigious acts.4 notice of the cancellation must be published immediately in the swiss official gazette of commerce, as well as elsewhere at the court's discretion.chapter 4 exceptions to the ban on insider trading and market manipulation art. 122 subject matter (art. 142 para. 2 and 143 para. 2 finmia)the provisions of this chapter shall determine the cases in which forms of conduct that fall under article 142 paragraph 1 and article 143 paragraph 1 finmia are permissible.art. 123 buyback of own equity securities (art. 142 para. 2 and 143 para. 2 finmia)1 the buyback of own equity securities at market price as part of a public buyback offer (buyback programme) in accordance with article 142 paragraph 1 letter a and article 143 paragraph 1 finmia is permissible, subject to article 124, if:the buyback programme lasts a maximum of three years;the scope of the buyback programme does not exceed a total of 10% of the capital and voting rights and 20% of the free float of the equity securities;c. the scope of the buyback does not exceed 25% of the average daily volume traded on the regular trading line during the 30 days prior to the publication of the buyback programme;d. the purchase price is not greater than:1. the last independently achieved closing price on the regular trading line, or2. the best current independent bid price on the regular trading line, provided this is below the price referred to in item 1;e. no prices are provided during breaks in trading and during the opening or closing auction;f. sales of own equity securities during the buyback programme are made solely to fulfil employee participation programmes or meet the following conditions:1. they are reported to the stock exchange on the trading day following their execution,2. they are published by the issuer no later than the fifth trading day after their execution, and3. their scope does not exceed 5% of the average daily volume traded on the regular trading line during the 30 days prior to the publication of the buyback programme;g. the key content of the buyback programme is published by means of a buyback notice before the start of the buyback programme and remains publicly accessible for the duration of the buyback programme; andh. the individual buybacks are reported to the stock exchange as part of the buyback program no later than the fifth trading day following the buyback and are published by the issuer.2 the buyback of own equity securities at a fixed price or through the issuance of put options in accordance with article 142 paragraph 1 letter a and article 143 paragraph 1 finmia is permissible, subject to article 124, if:the buyback programme lasts for at least ten trading days;b. the scope of the buyback programme does not exceed a total of 10% of the capital and voting rights and 20% of the free float of the equity securities;c. the key content of the buyback programme is published by means of a buyback notice before the start of the buyback programme and remains publicly accessible for the duration of the buyback programme; andd. the individual buybacks are published by the issuer no later than one stock market day after the end of the buyback programme.3 in individual cases, the swiss takeover board may authorise buybacks of a larger scope than those referred to in paragraph 1 letters b and c and paragraph 2 letter b if this is compatible with the interests of investors.4 it is assumed that article 142 paragraph 1 letter a and article 143 paragraph 1 finmia are not violated if the purchase price paid on a separate trading line is a maximum of 2% higher than:a. the last closing price achieved on the regular trading line; orb. the best current bid price on the regular trading line, provided this is below the price referred to under letter a;art. 124 blackout periods (art. 142 para. 2 and 143 para. 2 finmia)1 article 123 paragraphs 1 and 2 shall not apply to the buyback of own equity securities if the buyback programme is announced or the buyback of own equity securities occurs:while the issuer postpones the announcement of a price-relevant fact in keeping with stock exchange provisions;during the ten trading days prior to the public announcement of financial results; ormore than nine months after the reference date of the last published consolidated closing accounts.2 the buyback at market price remains reserved if this is undertaken by:a securities firm that was commissioned prior to the start of the buyback programme, and the security firm's decisions are made within the parameters originally prescribed by the issuer without the latter having any further influence;a trading unit that is segregated with information barriers, insofar the issuer itself is a securities firm.3 the parameters under paragraph 2 letter a must have been set prior to publication of the buyback offer and may be adjusted once a month for the duration of the buyback programme. if the parameters are set or adjusted within one of the periods set out in paragraph 1, the buyback may be performed only after a waiting period of 90 days.art. 125 content of buyback notices (art. 142 para. 2 and 143 para. 2 finmia)the buyback notice in accordance with article 123 paragraph 1 letter g and paragraph 2 letter c must contain at least the following information:information on the issuer, in particular:1. its identity,2. the issued capital,3. its holding of its own capital,4. the shareholder participations in accordance with article 120 finmia;the nature, purpose and object of the buyback programme;the schedule.art. 126 price stabilisation after a public placement of securities (art. 142 para. 2 and 143 para. 2 finmia)securities transactions which are intended to stabilise the price of a security that has been admitted to trading on a trading venue or dlt trading facility in switzerland and which fall under article 142 paragraph 1 letter a and article 143 paragraph 1 of the finmia are permissible if:49they are carried out within 30 days of the public placement of the securities to be stabilised;b. they are executed at a price that is no higher than the issue price, or, in the case of trading with subscription or conversion rights, at a price that is no higher than the market price;c. the maximum period during which the securities transactions can be carried out and the identity of the securities firm responsible for carrying them out are published before the start of trading with the securities to be stabilised;d.50 they are reported to the trading venue or dlt trading facility at the latest on the fifth trading day following their execution and published by the issuer at the latest on the fifth trading day after the expiry of the deadline under letter a; ande.51 the issuer informs the public at the latest on the fifth trading day following the exercising of an overallotment option (greenshoe) about the timing of the exercising, as well as the number and type of the securities concerned.49 amended by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).50 amended by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).51 amended by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).art. 127 other permissible securities transactions (art. 142 para. 2 and 143 para. 2 finmia)1 the following securities transactions are permissible even if they fall under article 142 paragraph 1 letter a and article 143 paragraph 1 finmia:securities transactions to implement an own decision to carry out a securities transaction, in particular the purchase of securities of the target company by the potential offeror with regard to the publication of a public takeover offer, provided the decision was not taken on the basis of insider information;b. securities transactions carried out in the course of the fulfilment of public tasks rather than for investment purposes by:1. the confederation, cantons or communes,2. the snb,3. the bis, and4. multilateral development banks in accordance with article 63 paragraph 2 letter c cao52.2 paragraph 1 may also be declared applicable to securities transactions carried out by the following parties as long as the transactions are carried out in connection with public tasks and not for investment purposes, and as long as reciprocal rights are granted and an exception does not stand in contradiction to the legislative purpose: a. foreign central banks;b. the ecb;c. official bodies or state departments that are responsible for or involved in administering the national debt;d. the efsf;e. the esm.3 the fdf shall publish a list of the bodies covered by paragraph 2.52 sr 952.03art. 128 admissible communication of insider information (art. 142 para. 2 finmia)the communication of insider information to a person does not fall under article 142 paragraph 1 letter b finmia if:a. this person requires the insider information in order to fulfil his or her statutory or contractual obligations; orb. the communication is required with regard to the conclusion of a contract and the information holder:1. makes it clear to the information recipient that the insider information may not be exploited, and2. documents the disclosure of the insider information and the clarification under item 1 above.title 4 transitional and final provisions art. 12953 financial market infrastructures 1 the duties set out in article 27, article 28 paragraphs 2 to 4, article 30 paragraphs 2 and 3, article 31, article 40 second sentence, and articles 41 to 43 must be fulfilled no later than 1 january 2018.541bis the record-keeping and disclosure duties set out in article 36 paragraph 2 and article 37 paragraph 1 letter d and paragraph 2 must be fulfilled no later than 1 october 2018. facts occurring between 1 january 2018 and 30 september 2018 that come under these duties are to be recorded and retroactively reported no later than 31 december 2018.551ter foreign branches of swiss securities firms and foreign participants on a trading venue must fulfil their duties under article 36 paragraph 2 and article 37 paragraph 1 letter d and paragraph 2 no later than 1 january 2019.562 the exemption from the reporting duty set out in article 37 paragraph 4 may be claimed up to 31 december 2017 without an agreement in accordance with article 32 paragraph 3 finmia or an exchange of information between finma and the competent foreign supervisory authority.53 amended by no i of the o of 29 june 2016, in force since 1 aug. 2016 (as 2016 2703)54 amended by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).55 inserted by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).56 inserted by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).art. 130 reporting to a trade repository 1 the duty to report to a trade repository under article 104 finmia must be fulfilled at the latest:a. within six months of the first authorisation or recognition of the trade repository by finma: for derivatives transactions outstanding at this point if the person obliged to report is not a small financial counterparty or a central counterparty;b. within nine months of the first authorisation or recognition of the trade repository by finma: for derivatives transactions outstanding at this point if the person obliged to report is a small financial counterparty or a non-financial counterparty which is not small;c. by 1 january 2024: for derivatives transactions outstanding at this point in all other cases.572 the deadlines set out in paragraph 1 shall be extended by six months in each case for the reporting of derivatives transactions that are traded via trading venues or via the operator of an organised trading facility. 3 in special cases, finma may extend the timeframes set out in this article.57 amended by no i of the o of 14 sept. 2018, in force since 1 jan. 2019 (as 2018 3377).art. 131 risk mitigation duties 1 the duties that apply with respect to timely confirmation, portfolio reconciliation, dispute resolution and portfolio compression in accordance with article 108 letters a to d finmia shall apply by the following deadlines following the entry into force of this ordinance:a. after 12 months: for derivatives transactions outstanding at this point between counterparties that are not small, and for derivatives transactions outstanding at this point with a small financial counterparty;b. after 18 months: for all other derivatives transactions outstanding at this point.2 the duty to value outstanding derivatives transactions in accordance with article 109 finmia shall apply to outstanding derivatives transactions 12 months after the entry into force of this ordinance. 3 the duty to exchange collateral in accordance with article 110 of the finmia applies only to derivatives transactions concluded after the duties under paragraphs 4 and 5bis have entered into force.58 4 the duty to exchange variation margins shall apply:a. from 1 september 2016: for counterparties whose aggregated month-end average gross position of non-centrally-cleared otc derivatives at group or financial or insurance group level for the months of march, april and may 2016 is greater than chf 3,000 billion;b. from 1 september 2017: for all other counterparties.5 the duty to exchange initial margins shall apply for counterparties whose aggregated month-end average gross position of non-centrally-cleared otc derivatives at group or financial or insurance group level:a. is greater than chf 3,000 billion for each of the months of march, april and may 2016: from 1 september 2016;b. is greater than chf 2,250 billion for each of the months of march, april and may 2017: from 1 september 2017;c. is greater than chf 1,500 billion for each of the months of march, april and may 2018: from 1 september 2018;d. is greater than chf 750 billion for each of the months of march, april and may 2019: from 1 september 2019;dbis.59 is greater than chf 50 billion for each of the months of march, april and may 2020: from 1 september 2020;e.60 is greater than chf 8 billion for each of the months of march, april and may 2020: from 1 september 2021.615bis the duty to exchange collateral applies from 1 january 2024 for non-centrally cleared otc derivatives transactions that are options on individual equities, index options or similar equity derivatives such as derivatives on baskets of equities.626 finma may extend the timeframes set out in this article in order to take account of recognised international standards and foreign legal developments.58 amended by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).59 inserted by annex 1 no ii 14 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633).60 amended by annex 1 no ii 14 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633).61 amended by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).62 inserted by no i of the o of 5 july 2017 (as 2017 3715). amended by no i 10 of the o of 18 june 2021 on the adaptation of federal law to developments in distributed ledger technology, in force since 1 aug. 2021 (as 2021 400).art. 132 auditing the duty to have an audit performed by the auditors in accordance with article 114 shall apply 12 months following the entry into force of this ordinance.art. 13363 occupational pension schemes and investment foundations 1 for occupational pension schemes and investment foundations in accordance with articles 48 to 60a of the federal act of 25 june 198264 on occupational old age, survivors' and invalidity pension provision, the clearing duty set out in article 97 of the finmia shall not apply up to 30 september 2021 for derivatives transactions that these institutions enter into with a view to reducing risk in accordance with article 87.652 the federal department of home affairs may extend the timeframe set out in this paragraph 1 in order to take account of recognised international standards and foreign legal developments.63 amended by no i of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).64 sr 831.4065 amended by no i of the fdfa o of 4 sept. 2020, in force since 1 oct. 2020 (as 2020 3801).art. 134 amendment of other legislative instruments the amendment of other legislative instruments is set out in annex 1.art. 135 commencement this ordinance comes into force on 1 january 2016.annex 1 (art. 134)amendment of other legislative instruments the legislative instruments below are amended as follows:.6666 the amendments may be consulted under as 2015 5413.annex 267 67 revised by annex 1 no ii 14 of the financial institutions ordinance of 6 nov. 2019, in force since 1 jan. 2020 (as 2019 4633).(art. 93)data to be reported to trade repositories legend for column validation for t / p / v:t: reporting of an individual transaction68 m: mandatoryp: reporting of a position69 u: under reservationv: reporting of a valuation o: optional n: not applicablefielddata to be reportedvalidation forpermitted valuesadditional explanationstpvcontracting partiestpvcontracting parties1 id of reporting counterpartycode for identifying the reporting counterpartymmmid of reporting counterpartycode for identifying the reporting counterparty2 id of non-reporting counterpartycode for identifying non-reporting counterpartymmolegal entity identifier (lei) consisting of 20 characters, validity may already have lapsedif lei is not available: business identifier code (bic) in accordance with iso 9362:2014 consisting of 11 charactersif neither lei nor bic is available: internal code consisting of a maximum of 50 characters3 name of reporting counterpartycompany or name of reporting counterpartymmntext consisting of a maximum of 100 characters4 registered office of reporting counterpartyinformation on the registered office, consisting of a full address, city and country of the reporting counterpartymmntext consisting of a maximum of 500 characters5 corporate sector of reporting counterpartytype of business activities of reporting counterpartymmnfor financial counterparties:- a = banks in accordance with article 1 paragraph 1 of the banking act of 8 november 193470- b = securities firms in accordance with article 41 of the financial institutions act of 15 june 201871 (finia)- c = insurance and reinsurance companies in accordance with article 2 paragraph 1 letter a of the insurance oversight act of 17 december 200472- d = group parent companies of a financial or insurance group or of a financial or insurance conglomerate- e = managers of collective assets und fund management companies in accordance with articles 24 and 32 finia- f = collective investment schemes in accordance with the collective investment schemes act- g = occupational pension schemes and investment foundations in accordance with article 48 et seq. of the federal act of 25 june 198273 on occupational old age, survivors' and invalidity pension provision non-financial counterparties:- h = oil and natural gas- i = basic materials (chemicals, raw materials)- j = industrial companies (construction, electronics, production technology, transportation, etc.)- k = consumer goods (food, household appliances, etc.)- l = healthcare- m = consumer service (travel, media, etc.)- n = telecommunications- o = utilities (electricity, water, etc.)- p = technology (software and hardware)for central counterparties:- q = central counterparty6 status of reporting counterpartyindication whether the reporting counterparty is a financial or non-financial counterparty and whether the counterparty is small in accordance with articles 98 and 99 finmiammnfp = financial counterparty which is not considered a small financial counterparty under article 99 finmiafm = small financial counterparty under article 99 finmianp = non-financial counterparty under article 93 paragraph 3 finmia which is not considered a small non-financial counterparty under article 98 finmianm = non-financial counterparty under article 93 paragraph 3 finmiaq = central counterparty7 reporting entity idcode for identifying reporting entitymmmvalid legal entity identifier (lei) consisting of 20 characters8 id of clearing member of reporting counterpartycode for identifying the clearing member of the reporting counterpartyuunlegal entity identifier (lei) consisting of 20 characters, validity may already have lapsedif lei is not available: business identifier code (bic) in accordance with iso 9362:2014 consisting of 11 charactersmust be indicated if the reporting counterparty is not a clearing member and the transaction in question is a centrally cleared transaction9 clearing thresholdindication as to whether the reporting counterparty exceeds the clearing threshold at the time of reporting in accordance with articles 98 or 99 finmiammny = the reporting counterparty has exceeded the threshold in accordance with article 100 finmia at the time of reporting.n = the reporting counterparty has not exceeded the threshold in accordance with article 100 finmia at the time of reporting.section 2a - contract type10 product taxonomytaxonomy of the product code of the contractmmnu = unique product identifier (upi) in accordance with recognised international standards if upi is not available: i = international securities identification number (isin) in accordance with iso 6166:2013if neither upi nor isin is available: a = alternative instrument identifier (aii) in accordance with esma guidelinesif neither upi, isin nor aii is available: e = exchange product code (epc) issued by the relevant trading venueif none of these codes is available: n = not available c = classification of financial instruments (cfi) in accordance with iso 10962:2015the order of the permitted values corresponds to the expected value depending on its availability.11 id of productdetails of the product code of the contractmmnvalid code as per taxonomy used 12 asset categoryindication of type of underlyingmmnco = commodity / energycr = creditcu = currencyeq = equity securityir = interest rateot = other derivative13 type of contractdetails of type of contractmmncd = contract for difference (cfd)fr = forward rate agreementfu = futurefw = forwardop = optionsw = swapsb = spreadbetex = exotic product14 underlying taxonomytaxonomy of the underlying instrument of the contractmmnisin in accordance with iso 6166:2013if isin is not available: country code in accordance with iso 3166:2013 if the issuer of the underlying is a state; in all other cases:if neither isin nor country code is available: upi in accordance with recognised international standardsif neither isin, country code nor upi is available: id of the basket of underlyings or if this is not available the value na; or in the case of indices for which no isin is available: full name of indexin all other cases: the value nathe order of the permitted values corresponds to the expected value depending on its availability.15 id of underlyingdetails of the underlying code of the contractmmnvalid code as per taxonomy usedsection 2b - transaction details16 trade ida unique trade id provided by the reporting counterparty at the request of the other counterpartymmmtext with a maximum of 52 characters17 side of reporting counterpartyindication whether the reporting counterparty is acting as buyer or sellermmnb = buyers = sellerto be determined in accordance with recognised international standards18 compression (numerical reduction of outstanding contracts)indication whether the contract results from such a compression exercisemony = the amount reported is the remaining transaction or position amount following compression.n = the reported transaction or position does not result from compression.in the case of positions that remain as a result of netting transactions, this field remains empty. 19 price/rateprice per derivative excluding, where applicable, commission and accrued interestmondecimal value20 price quotationthe manner in which the price is expressedmonu = the price is expressed as an absolute value.p = the price is expressed as a percentage value.21 currency of pricethe currency in which the price is expressed, if applicableuonin the cases of prices given as absolute values, the currency of the price in accordance with iso 4217:2008, or other recognised international standards, should be indicated22 nominal value 1current reference value of the contractmundecimal valuemust be indicated if the field amount exhibits the value 123 nominal value 2in the case of swap transactions and currency forward transactions, the current second reference value of the contractoondecimal value24 currency of denomination 1currency of nominal value mmncurrency in accordance with iso 4217:2008 or other recognised international standardthe currency in this field corresponds to the currency of nominal value 1.in the case of interest rate derivative contracts, this is the nominal currency of leg 1.25 currency of denomination 2currency of nominal value. in the case of interest rate derivative contracts, this is the nominal currency of leg 2. uuncurrency in accordance with iso 4217:2008 or other recognised international standardmust be indicated if nominal value 2 was reportedin the case of interest rate derivatives, this is the nominal currency of leg 2.in the case of foreign currency contracts, this is the second currency.26 currency to be deliveredcurrency to be delivered, if applicableuuncurrency in accordance with iso 4217:2008 or other recognised international standardmust be indicated if the contract is settled in cash27 price multiplierthe number of units of the financial instrument which are contained in a trading lot, e.g. the number of derivatives represented by one exchange-traded contractmmndecimal value28 amountnumber of reported contractsmmndecimal valuethe value 0 is permissible only if the field type of report exhibits the value c.29 type of deliveryindication whether the contract is settled in physical form or in cashmmnc = cash settlementp = physical settlemento = optional for the counterparty30 conclusion datedate on which the contract was concludedmmndate and time format in accordance with iso 8601:2004may be provided in either coordinated universal time (utc) or local swiss timeif the information is not expressed in utc, this should be indicated to the trade repository31 effective datedate when obligations under the contract come into effectmondata format in accordance with iso 8601:200432 maturity dateoriginal date of expiry of the reported contract. an early termination is not reported in this fieldmmndata format in accordance with iso 8601:200433 termination datedate on which the reported contract terminatesuundata format in accordance with iso 8601:2004this field should be used in the event of early expiry (report via type of report = c) or in the event of compression (report via type of report = m). in all other cases it should be left empty.34 date of settlementlast date for settlement of underlyingsoondata format in accordance with iso 8601:200435 market value of contractvaluation of contract at mark to market or mark to model pricesoomdecimal valuemust be provided in the case of a valuation report36 currency in which the current mark to market value of the contract is expressedcurrency in which the mark to market or mark to model price valuation was effectedoomcurrency in accordance with iso 4217:2008 or other recognised international standardmust be provided in the case of a valuation report37 date of valuationdate of last valuation at mark to market or mark to model pricesoomdata format in accordance with iso 8601:2004must be provided in the case of a valuation report38 time of valuationtime of last valuation at mark to market or mark to model pricesoomtime format in accordance with iso 8601:2004must be provided in the case of a valuation reportmay be provided in either coordinated universal time (utc) or local swiss timeif the information is not expressed in utc, this should be indicated to the trade repository39 type of valuationindication as to whether the valuation was effected at mark to market or mark to model pricesoomm = mark to market priceo = mark to model pricemust be provided in the case of a valuation report40 collateralisationindication as to whether collateralisation has taken placemmoun = uncollateralisedpc = partially collateralisedpl = one-way collateralisedfc = fully collateralisedthe value un should be used if no credit support agreement (csa) or pledge agreement was used or if the contract of the counterparties envisages neither the provision of an initial margin nor the provision of variation margins.the value pc should be used if it is contractually prescribed that both counterparties must regularly provide variation margins.the value pl should be used if only one of the counterparties is contractually obliged to an initial margin and/or variation margin.the value fc should be used if it is contractually prescribed that both counterparties must provide an initial margin and regular variation margins.for centrally cleared derivatives, the value pl should be used.41 types of collateralisationif collateralisation was effected, it must be indicated whether this took place on the basis of a collateralisation annex to a framework agreement or pledge agreementuuocsa = collateralisation annex to a framework agreement (credit support annex)pledge = pledge agreementthe value csa corresponds to an irregular right of lien under swiss law.the value pledge corresponds to a regular right of lien under swiss law.42 type of framework agreementreference to the framework agreement if used for the reported contractoontext with a maximum of 50 characterssample values isda master agreement, master power purchase and sale agreement, international forex master agreement, european master agreement or any local or internal framework agreements43 version of framework agreementyear of the framework agreement version used for the reported trade, if applicableoontext with a maximum of 20 characterssample values: 1992, 2002section 2c - clearing44 clearing dutyindication as to whether the reported contract and both counterparties are subject to a clearing duty under article 97 et seq. finmiamnny = the reported contract and both counterparties are subject to a swiss clearing dutyn = the value y is not applicable45 date of clearingdate of clearing if the contract was settled via a central counterpartyuondata format in accordance with iso 8601:2004must be provided in the case of a centrally cleared transaction46 id of central counterpartyindication of the standard code of the central counterparty which cleared the contractuonvalid lei consisting of 20 charactersif lei is not available: bic in accordance with iso 9362:2014 consisting of 11 charactersmust be provided in the case of a centrally cleared transaction47 intra-group transactionsindication as to whether the contract was entered into as an intra-group transaction in accordance with article 103 finmiammny = the transaction is an intra-group transaction in accordance with article 103 finmian = the value y is not applicablesection 2d - interest rates48 interest type leg 1indication of the type of interest rate of leg 1uunf = fixed interest ratel = variable interest rate49 interest type leg 2indication of the type of interest rate of leg 2uunf = fixed interest ratel = variable interest ratemust be provided for interest rate swaps50 interest rate leg 1details of the fixed interest rate that applies to leg 1 or details of the regular fixing of the reference interest rate used to determine the variable interest rate, if applicableuundecimal value in the case of fixed interest ratestext in the case of variable interest ratesin the case of variable interest rates, the name of the reference interest rate and the reference period is to be indicated in the format reference period/reference interest rate (e.g. 3m/euribor)51 interest rate leg 2details of the fixed interest rate that applies to leg 2 or details of the regular fixing of the reference interest rate used to determine the variable interest rate, if applicableuundecimal value in the case of fixed interest ratestext in the case of variable interest ratesmust be provided for interest rate swapsin the case of variable interest rates, the name of the reference interest rate and the reference period is to be indicated in the format reference period/reference interest rate (e.g. 3m/euribor)52 interest practice leg 1interest payment practice in the calculation period in question, if applicableuunmarket-standard indication of interest practicemust be provided for interest rate derivatives format: days per month/days per year (e.g. actual/365, 30/360, actual/actual, etc.)53 interest practice leg 2interest payment practice in the calculation period in question, if applicableuunmarket-standard indication of interest practicemust be provided for interest rate swapsformat: days per month/days per year (e.g. actual/365, 30/360, actual/actual, etc.)54 payment frequency leg 1payment frequency of leg 1, if applicableuuninteger value plus:- y = year- m = month- w = week- d = daymust be provided for interest rate derivativessample values 5y, 3m or 10dthe smallest possible integer value should always be given (e.g. 1m and not 30d)55 payment frequency leg 2payment frequency of the variable leg, if applicableuuninteger value plus:- y = year- m = month- w = week- d = daymust be provided for interest rate swapssample values 5y, 3m or 10dthe smallest possible integer value should always be given (e.g. 1m and not 30d)56 interest rate redefinition frequency for leg 1 frequency of the redefinition of the variable interest rate of leg 1, if applicableuuninteger value plus:- y = year- m = month- w = week- d = daymust be provided for interest rate derivativessample values 5y, 3m or 10dthe smallest possible integer value should always be given (e.g. 1m and not 30d)57 variable interest rate redefinition frequency for leg 2 frequency of the redefinition of the variable interest rate of leg 2, if applicableuuninteger value plus:- y = year- m = month- w = week- d = daymust be provided for interest rate swapssample values 5y, 3m or 10dthe smallest possible integer value should always be given (e.g. 1m and not 30d)section 2e - foreign exchange58 forward exchange rateforward exchange rate on value dateuundecimal valuemust be provided for forward exchange transactions59 exchange rate basiscurrency pair for exchange rateuuncurrency pair with currencies in accordance with iso 4217:2008 or other recognised international standard, separated by a forward slashmust be provided for all currency derivatives, e.g. usd/chf, chf/eursection 2f - commoditiesgeneralmandatory general information for all commodity derivatives60 commodity underlyingtype of commodities underlying the contractuunag = agriculturalen = energyfr = freightme = metalin = indexev = environmentalex = exotic or not otherwise applicable61 commodity detailsdetails of the particular commodity beyond the data provided in field 60uungo = grains / oilseedsda = dairy productsli = livestockfo = forestryso = softsdr = dry freightwt = wet freightoi = oilng = natural gasco = coalel = electricityie = inter-energypr = precious metalnp = non-precious metalwe = weatherem = emissionsot = otherenergymust be provided if the field delivery point or zone is to be completed62 delivery point or zonedelivery point(s) of market area(s)uunenergy identification code (eic) consisting of 16 charactersmust be provided if the delivery point or zone is in europe and the commodity details line exhibits the value ng or el63 interconnection pointindication of the border(s) or border crossing(s) of a transport contractuuntext with a maximum of 50 characters64 load typeidentification of last delivery profile according to the delivery periods per dayuunbl = base loadpl = peak loadop = off-peakbh = hour/block hourssh = shapedgd = gas dayot = other65 delivery start date and timedelivery start date and timeuundate and time format in accordance with iso 8601:2004may be provided in either coordinated universal time (utc) or local swiss timeif the information is not expressed in utc, this should be indicated to the trade repository66 delivery end date and timedelivery end date and timeuundate and time format in accordance with iso 8601:2004may be provided in either coordinated universal time (utc) or local swiss timeif the information is not expressed in utc, this should be indicated to the trade repository67 contracted capacityquantity per delivery intervaluuntext with a maximum of 50 characters68 quantity unitdaily or hourly quantity delivered in mwh or kwh/d depending on the underlyinguunkwkwh/hkwh/dmwmwh/hmwh/dgwgwh/hgwh/dtherm/dktherm/dmtherm/dcm/dmcm/d69 price per time interval quantitiesif applicable, price per time interval quantitiesuundecimal valuesection 2g - optionsmandatory information for all non-exotic options70 option typeindication of option typeuunp = putc = callo = other71 exercise typeindication of type of exercise for the option in questionuuna = americanb = bermudane = europeans = asiano = other72 strike price (cap/floor rate)strike price of the option expressed in the corresponding reference currency or reference amountuundecimal valuesection 2h - credit derivatives73 seniorityorder of underlying claims in the schedule of claimsuunsr = senior/not subordinatesb = subordinateot = othermandatory information for credit derivatives74 premium / couponthe annual premium / annual coupon of the contract as a percentage of the nominal valueuundecimal valuemandatory information for credit derivatives75 date of last credit eventdate of last credit event of the underlying claimsuundata format in accordance with iso 8601:2004mandatory information for credit derivatives76 id of indexserial number of reference index, if applicableuuntext with a maximum of 10 charactersmandatory information for credit derivatives that refer to an index as the underlying77 index factoradjustment factor of the reference index with respect to past credit eventsuuninteger with a maximum of 3 charactersmandatory information for credit derivatives that refer to an index as the underlyingsection 2i - report modifications78 report typeindication of report type mmmn = transaction is being reported for the first timeto be used for the first-time reporting of a transaction or position insofar as the report type x does not apply.an otc derivatives transaction that is cleared centrally on the same day it is concluded is at least to be reported as a centrally cleared transaction. the reporting of transactions taking place before clearing on the same day is permitted but is not mandatory.an otc derivatives transaction that is not cleared centrally on the same day or not cleared centrally at all is at least to be reported on the basis of its status at the end of the trading day. the reporting of transactions taking place beforehand on the same day is permitted but is not mandatory.block trades (in which a large pooled position is received and then individually assigned) which are not assigned on the same day are to be reported. if the assignment does take place on the same day, there is no need to report the block trade. in both cases, the assigned transactions are to be reported.indication as to whether the report refers to an individual transaction or a positionx = transaction is being reported for the first time and the transfer of the transaction to a position is envisaged on the same day.the resulting sum of transactions is to be reported at the end of the day as a position via the field level = p. a renewed reporting of individual transactions as compressed is therefore inapplicable.this report type is primarily envisaged for exchange-traded derivatives (etds) and contracts for difference (cfds).in the case of exchange-traded derivatives involving clearing through a central counterparty, the reporting duty exists only at central clearing level (cleared allocation). the steps prior to central clearing do not yet need to be reported. m = modification of erroneous data, supplementation of missing data or updating of positionse = report was made erroneously and should be deletede.g. the double reporting of the same transactions with a different trade idc = premature termination/cancellation of a contractpredefined termination does not need to be reported.for modification reports, report type = m should be used.z = compression of an otc derivatives transactionintended for compressions in accordance with article 108 letter d finmia.the transaction is thereby closed.v = reporting of a valuationongoing report of valuations in accordance with article 109 finmia. the first valuation report can be entered either as report type = n or in a subsequent report as report type = v.in the case of centrally cleared transactions, the valuation of the central counterparty is to be used.no valuation is to be reported for transactions that do not have to be valued by law.d = modification of the trade id, provided this had not yet been determined at the time of reporting.l = modifications that arise as a result of certain events during the term of the contract and for which no other value applies (lifecycle events)all events during the term of exchange-traded derivatives must always be reported at position level.an example of this kind of event is the partial exercise of an option which reduces the overall position of this option.79 report levelmmnt = transactionp = positiona renewed report has to be submitted for a position only if it has changed.it is permissible to report derivatives transactions only at transaction level.68 field level of reporting exhibits the value t69 field level of reporting exhibits the value p70 sr 952.071 sr 954.172 sr 961.0173 sr 831.10annex 3 (art. 103 para. 4)calculation of the initial margin for a netting set 1 the initial margin for a netting set is calculated using the formula: net initial margin = 0.4 * gross initial margin + 0.6 * ngr * gross initial margin2 the following apply in this respect:2.1 the net initial margin is deemed to be the reduced amount of the initial margin requirements for all derivatives contracts with a counterparty included in a netting set;2.2 the ngr is the net gross ratio, calculated as the ratio between the net replacement value of a netting set with a counterparty (numerator of ratio) and the gross replacement value of this netting set (denominator of ratio);2.3 the net replacement value of a netting set is the sum of the market values of all transactions, whereby no negative values are permitted;2.4 the gross replacement value of a netting set is the sum of the market values of all transactions in accordance with article 109 finmia and article 99 finmio with positive values in the netting set.annex 474 74 amended by no ii of the o of 5 july 2017, in force since 1 aug. 2017 (as 2017 3715).(art. 105 para. 1)discounts (haircuts) on collateral rating class as per annexes 2 to 4 ca75oterm to maturityhaircut on collateral in cash deposits in % haircuts on collateral as per art. 104 para. 1 lit. b in %haircuts on collateral as per art. 104 para. 1 lit. c and d in %haircuts on collateral as per art. 104 para. 1 lit. e and f in %haircuts for securities fundsn.a.n.a.0n.a.n.a.15haircut applicable to invested assets (weighted average)1 or 2, or 1 for short-dated debt securities 1 yearn.a.0.51n.a.> 1 year and 5 years24> 5 years483 or 4, or 2 or 3 for short-dated debt securities 1 jahr12> 1 year and 5 years36> 5 year6125all15not recognisedsecurities that would be classified in rating classes 6 or 7 in accordance with annex 2 cao are generally not recognised as collateral.75 sr 952.03annex 5 (art. 105 para. 3)quantitative and qualitative minimum standards for collateral 1 quantitative minimum standards 1.1 if debt securities have a credit rating from an approved rating agency, volatility estimates for each category of securities may be provided.1.2 when delimiting securities categories, the type of issuer, its rating, the residual term and the modified duration must be taken into account. volatility estimates must be representative of the securities actually contained in this category.1.3 for the other debt securities or shares recognised as collateral, the haircuts must be individually calculated for each security.1.4 the volatilities of the collateral and the currency mismatch must be individually estimated. the estimated volatilities may not take into account the correlations between claims without collateral, collateral and exchange rates.1.5 if the haircuts are determined using own estimates, the following quantitative requirements must be met:1.5.1 when determining the haircut, a one-sided 99% confidence interval is to be used.1.5.2 the minimum holding period is ten business days.1.5.3 if the frequency of the revaluation amounts to more than one day, the minimum haircut is to be scaled according to the number of business days between the revaluation, with the help of the following formula: h = hm [(nr + (tm - 1)) / tm] the following abbreviations apply here: h = the haircut to be applied hm = the haircut with daily revaluation nr = the actual number of business days between the revaluations tm = the minimum holding period for the transaction in question.1.5.4 account must be taken of the illiquidity of assets of lower quality. in cases where a predefined holding period is too short in view of the liquidity of the collateral, the holding period must be increased. banks must recognise if historical data underestimates the potential volatility, e.g. in the case of pegged exchange rates. in such cases, the data is to be subjected to a stress test.1.5.5 the survey period for determining the haircut must amount to at least one year. where individual daily observations with different weightings are taken into account, the weighted average observation period must be at least a year (i.e. the weighted average time lag for the individual figures may not be less than a year).1.5.6 the data must be updated at least once every three months. if market conditions require it, it must be updated immediately.2 qualitative requirements 2.1 the estimated volatilities and holding periods must be used in the bank's daily risk management process.2.2 the banks must ensure that the requirements of this annex are accurately reflected in the internal guidelines, controls and procedures with respect to the risk measurement system.2.3 the risk measurement system must be used in connection with internal credit limits.2.4 an independent review of the risk management system must be regularly carried out as part of the internal audit process. this must encompass at least the following points:2.4.1 the embedding of risk measurement in daily risk management;2.4.2 the validation of any material change in risk measurement procedures;2.4.3 the accuracy and completeness of position data;2.4.4 the review of the consistency, promptness and reliability of the data sources used for the internal models, including the independence of such data sources; and2.4.5 the accuracy and appropriateness of the volatility assumptions.

958.11 english is not an official language of the swiss confederation. this translation is provided for information purposes only and has no legal force.ordinanceof the swiss financial market supervisory authority on financial market infrastructures and market conduct in securities and derivatives trading(finma financial market infrastructure ordinance, finmio-finma)of 3 december 2015 (status as of 26 november 2021)the swiss financial market supervisory authority (finma),based on article 51 paragraph 2 of the financial institutions act of 15 june 20181 (finia), article 74 paragraph 4 of the financial institutions ordinance of 6 november 20192 (finio),articles 39 paragraph 2, 101 paragraphs 1 and 2, 123 paragraphs 1 and 2 and 135 paragraph 4 of the financial market infrastructure act of 19 june 20153 (finmia),and article 36 paragraph 4 of the financial market infrastructure ordinance of 25 november 20154 (finmio),5hereby decrees:1 sr 954.12 sr 954.113 sr 958.14 sr 958.115 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).chapter 1 record-keeping and documenting requirements (art. 74 para. 4 finio; art. 36 para. 4 finmio)6art. 1 1 securities firms under finia and participants7 admitted to a trading venue record the orders and transactions which must be recorded under article 74 finio and article 36 finmio in a ledger, regardless of whether or not the securities or derivatives are traded on a trading venue. the ledger may also be divided into journals.82 the following shall be recorded in the ledger for all received orders:a. the name of the securities and derivatives;b. the time the order was received;c. the name of the person placing the order;d. the name of the transaction and order type;e. the volume of the order.3 the following shall be recorded in the ledger for completed transactions:a. the time of execution;b. the volume of the execution;c. the attained or allocated price;d. the place of execution;e. the name of the counterparty;f. the value date.4 the received orders and completed transactions, regardless of whether they are subject to the reporting duty outlined in chapter 2, shall be recorded in a standardised format, so that the information can be delivered to finma promptly and in its entirety on request.7 as most participants are legal entities, gender-neutral terminology is not used in this text.8 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).6 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).chapter 2 reporting duty (art. 51 finia; art. 39 finmia)9art. 210 transactions to be reported securities firms under finia and participants admitted to a trading venue must report all transactions under article 75 finia and article 37 finmio to the addressee under article 5.10 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).art. 3 contents of the report 1 the report shall contain the following details:a.11 the name of the securities firm subject to the reporting duty in accordance with finia or the participant admitted to a trading venue;b. the transaction type (buy/sell);c. the exact name of the securities or derivatives in question;d. the volume of the transaction as follows: nominal amount for bonds, units or contracts for other securities and derivatives;e. the price;f. the date and time of execution;g. the value date;h. whether it is a proprietary or client transaction;i. the designation of the counterparty as a stock exchange member, other securities firm12, customer; in the case of transmissions of orders: designation of the party to which the order was transmitted;j. the name of the trading venue where the security or derivative was traded, or the notification that the transaction was made outside a trading venue;k. for client transactions: a standardised reference enabling the identification of the beneficial owner of the transaction (art. 37 para. 1 let. d finmio and art. 31 para. 1 let. d finio).2 for client transactions, it shall further contain a standardised reference enabling the identification of the beneficial owner of the transaction (art. 37 para. 1 let. d finmio and art. 75 para. 1 let. d finio).1311 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).12 term in accordance with annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327). this amendment has been made throughout the text.13 inserted by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).art. 4 reporting deadline transactions shall be reported within the deadlines outlined in the regulations of the trading venue to which the report is addressed.art. 5 report addressee 1 securities transactions must be reported to the trading venue where the securities are admitted for trading.2 if a security is admitted for trading at more than one trading venue in switzerland licensed by finma, the reporting parties may choose at which trading venue to fulfil their reporting obligations. 3 the derivatives transactions under article 75 paragraph 2 finio and article 37 paragraph 2 finmio must be reported to the trading venue where the underlying is admitted for trading. if the derivative has more than one security as underlyings, the report may be made to the trading venue where one of the underlyings is admitted for trading.144 trading venues shall have a dedicated office (reporting office) in their organisation for receiving and processing reports.5 the reporting office shall issue a set of regulations. it may request adequate compensation for any duties commissioned by finma. the rates are submitted to finma for approval.14 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).9 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).chapter 3 otc derivatives transactions for clearing (art. 101 finmia)art. 6 principle 1 the derivatives categories to be cleared via a central counterparty are listed in annex 1.2 the decision whether to list derivatives categories in annex 1 is based on whether:a. the contract conditions contain the usual legal documents for the sector with the usual contract specifications listed by counterparties;b. the operational processes are subject to automated post-trade processing and there are standardised lifecycle events managed in accordance with a generally agreed schedule;c. the margin or financial requirements of the central counterparty are adequately proportionate to the risk being mitigated by the obligatory clearing;d. the size and depth of the product's market are stable over the long term;e. if a participant in a central counterparty defaults, the market segmentation remains sufficiently high;f. the number and value of the previously concluded transactions are sufficiently high;g. the information required for the formation of prices is readily available on normal commercial conditions;h. there is a heightened systemic risk that counterparties may be unable to meet their payment and delivery obligations to each other if there are strong interdependencies between them.art. 7 determination of the otc derivatives for clearing 1 when licensing a swiss central counterparty or recognising a foreign central counterparty, finma determines which of the derivatives cleared by the central counterparty are subject to the clearing obligation. finma shall take into consideration the criteria under article 6 paragraph 2 as well as international standards when determining the clearing obligation.2 if the central counterparty clears additional derivatives categories subsequently to obtaining a licence or recognition, it shall inform finma thereof.3 upon request it must deliver all information to finma necessary to determine the derivatives categories subject to the clearingobligation.chapter 4 correspondence and determination of deadlines in relation to the disclosure of shareholdings and takeovers art. 8 correspondence (art. 123 para. 1, 139 para. 5 finmia)1 notifications and submissions sent by fax or e-mail pertaining to the disclosure of shareholdings and takeovers are admitted in correspondence outside of administrative proceedings and recognised for the purpose of adhering to deadlines.2 as a rule, recommendations by the disclosure offices are served upon the parties, applicants and finma by fax or e-mail.3 the ordinance of 18 june 201015 on electronic communication in administrative proceedings applies to electronic submissions in administrative proceedings. submissions to the takeover board may also be made by fax.15 sr 172.021.2art. 9 determination of deadlines (art. 123 para. 1 finmia)1 any deadline calculated by trading days starts on the first trading day following the trigger event.2 any deadline calculated by weeks ends in the last week on the same day as the day on which the trigger event took place. if this day is not a trading day, the deadline is on the next trading day.3 any deadline calculated by months ends in the last month on the same date as the date on which the trigger event took place. in the absence of such date, the deadline ends on the last day of the last month; if the day is not a trading day, the deadline ends on the next trading day.4 trading days are days on which the relevant stock exchange in switzerland is open for trading in accordance with its trading calendar.chapter 5 disclosure of shareholdings section 1 notification duty art. 10 principles (art. 120 paras. 1 and 3, 123 para. 1 finmia)1 the beneficial owners of equity securities under article 120 paragraph 1 finmia are subject to the notification duty. a beneficial owner is the party controlling the voting rights stemming from a shareholding and bearing the associated economic risk. 2 if the voting rights are not exercised directly or indirectly by the beneficial owner, any person who has full discretionary powers to exercise the voting rights is also subject to the notification duty in accordance with article 120 para. 3 finmia. if the person who has full discretionary powers to exercise voting rights is directly or indirectly controlled, their notification duty is met where the controlling person reports on a consolidated basis. in such case, the controlling person is considered to be subject to the notification duty.163 there is no notification duty, if:a. notification of reaching a threshold was provided and that threshold is exceeded, without the subsequent threshold being reached or exceeded;b. notification of reaching or exceeding a threshold was provided and that threshold is met again, without having reached or exceeded the subsequent threshold;c. a threshold is temporarily reached, exceeded or fallen below during a trading day.16 amended by no i of the finma ordinance of 26 jan. 2017, in force since 1 march 2017 (as 2017 547).art. 11 indirect acquisition and indirect disposal (art. 120 para. 5, 123 para. 1 finmia)the following cases in particular qualify as an indirect acquisition or indirect disposal of a shareholding:a. the acquisition and disposal via a third party in their own name and on behalf of the beneficial owner;b. the acquisition and disposal through directly or indirectly controlled legal entities;c. the acquisition and disposal of a shareholding which directly or indirectly transfers control of a legal entity which directly or indirectly holds equity securities.art. 12 acting in concert or as an organised group (art. 120 para. 1, 121, 123 para. 1 finmia)1 any party who coordinates their conduct regarding the acquisition or disposal of shareholdings or the exercising of voting rights with third parties by contract, other organised arrangement or by law, is acting in concert or as an organised group.2 acquisitions and disposals between persons who are acting in concert or as an organised group and have disclosed their total shareholding are exempt from the notification duty.3 changes in the composition of the group and the nature of the arrangement or of the group must be reported.art. 13 triggering of the notification duty (art. 120 paras. 1, 3 and 4, 123 para. 1 finmia)1 the notification duty under article 120 paragraph 1 finmia is triggered by the emergence of the claim to acquire or dispose of equity securities (binding transaction), irrespective of whether this claim is conditional. the indication of an intended acquisition or disposal does not trigger a notification duty, provided there are no legal obligations associated therewith.2 the triggering of the notification duty at the time of the binding transaction under paragraph 1 and an associated disconnection of beneficial owner status and voting entitlement, do not trigger a separate notification duty under article 120 paragraph 3 finmia either for the acquirer or the person disposing of the shareholding.3 if a threshold is reached, exceeded or fallen below of as a result of a company with registered office in switzerland increasing, decreasing of restructuring its share capital, the notification duty is triggered by the correspondent publication in the swiss official gazette of commerce. in the case of companies with registered office abroad whose equity securities are mainly listed in whole or in part in switzerland the notification duty is triggered by the publication in accordance with article 115 paragraph 3 finmio.art. 14 calculation of the positions requiring notification (art. 120 paras. 1 and 3, 123 para. 1 finmia)1 any person who reaches, exceeds or falls short of a threshold in one or both of the positions below, must calculate the positions individually and separately and report them simultaneously:a. acquisition positions:1. shares and equity-related units and voting rights under article 120 paragraph 3 finmia,2. conversion and acquisition rights (art. 15 para. 2 let. a),3. granted (written) sales rights (art. 15 para. 2 let. b),4. other equity derivatives (art. 15 para. 2);b. disposal positions:1. sales rights (art. 15 para. 2 let. a),2. granted (written) conversion and acquisition rights (art. 15 para. 2 let. b),3. other equity derivatives (art. 15 para. 2).2 the positions requiring notification shall be calculated for companies with registered office in switzerland based on the total number of voting rights in accordance with the entry in the commercial register. the calculation of the positions requiring notification for companies with registered office abroad shall be based on the publication in accordance with article 115 paragraph 3 finmio.art. 15 equity derivatives (art. 120 paras. 1, 4 and 5, 123 para. 1 finmia)1 equity derivatives for the purpose of this ordinance are instruments whose values are derived, at least partially, from the value or performance of equity securities of companies under article 120 para. 1 finmia.2 the following shall be reported:a. the acquisition or disposal of convertible and acquisition rights, particularly call options, and of sales rights, particularly put options which are designed for or permit physical settlement;b. the granting (writing) of convertible and acquisition rights, particularly call options, and of sales rights, particularly put options which are designed for or permit physical settlement; andc. equity derivatives designed for or permitting cash settlement as well as other contracts for difference, including financial futures.3 the exercise or non-exercise of equity derivatives reported under paragraph 2 must be reported again if it leads to one of the thresholds under article 120 paragraph 1 finmia being reached, exceeded or fallen below.art. 16 other facts requiring notification (art. 120 paras. 1 and 4, 123 para. 1 finmia)1 a notification duty applies in particular when one of the thresholds under article 120 paragraph 1 finmia is achieved, exceeded or fallen below of:a. due to an increase, decrease or restructuring of share capital;b. due to the acquisition or disposal of proprietary equity securities by a company;c.17 due to the acquisition and disposal of equity securities for in-house funds in accordance with article 71 of the financial services act of 15 june 201818 (finsa);d. through the proportion of voting rights in the acquisition positions in accordance with article 14 paragraph 1 letter a 1, alone, whether exercisable or not and regardless of whether the total proportion of voting rights including equity derivatives under article 15 reaches, exceeds or falls below a threshold;e. when transferring equity securities by virtue of the law or following a court or authority ruling.2 changes in information under article 22 paragraphs 1 letters d and e, 2 letters c, d and f and 3 again trigger a notification duty.17 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).18 sr 950.1art. 17 securities lending and similar transactions (art. 120 para. 1, 123 para. 1 finmia)1 lending transactions and similar transactions, such as repurchase agreements or collateral transactions with transfer of ownership must be reported.2 the notification duty is only incumbent on the contracting party acquiring temporary ownership of the securities through such transactions:a. for lending transactions: the borrower;b. for repurchase agreements: the buyer; andc. for collateral transactions: the collateral taker.3 on expiry of the transaction, the returning contracting party under paragraph 2 is again subject to a notification duty if a threshold in accordance with article 120 paragraph 1 finmia is reached or fallen below.4 lending transactions and repurchase agreements do not need to be reported if they are processed in a standardised manner via trading platforms for liquidity management purposes.art. 18 collective investment schemes (art. 120 para. 1, 121, 123 para. 1 finmia)1 the notification duties under article 120 paragraph 1 finmia for shareholdings held by approved collective investment schemes under the collective investment schemes act of 23 june 200619 (cisa) must be met by the licence holder20 (art. 5 para. 1 in conjunction with article 2 paragraph 1 letter d finia, article 13 paragraph. 2 letters a-d cisa and article 15 paragraph 1 letter e in conjunction with article 120 paragraph 1 cisa).212 fulfilling the notification duty involves:a. notification duties for more than one collective investment scheme of the same licence holder shall be fulfilled comprehensively (i.e. including all collective investment schemes) and for each collective investment scheme if they individually reach, exceed or fall below relevant thresholds.b. fund management companies within a group of companies are not required to aggregate their holdings with the holdings of said group of companies.c. the notification duty of externally managed investment companies with variable capital (sicav) is met by the fund management company.d. each sub-fund of an open-ended collective investment scheme with sub-funds qualifies as an individual collective investment scheme under paragraph 1.3 for foreign collective investment schemes not approved for offer which do not depend on a group of companies, the notification duties in article 120 paragraph 1 finmia shall be met by the fund management company or the legal entity itself. the requirements of paragraph 2 apply.224 for foreign collective investment schemes not approved for offer which depend on a group of companies, the reporting requirements in article 120 paragraph 1 finmia are met by the group.235 the independence of the fund management company or the legal entity is contingent on the following:a. personal independence: persons controlling the exercise of the voting right for the fund management company or legal entity act independently of the group parent company and those companies under its control;b. organisational independence: the group ensures through its organisational structures:1. that the group parent company and other companies under its control do not influence the fund management company or legal entity in exercising voting rights either through instructions or by any other method, and2. that no information is exchanged or disseminated between the fund management company or legal entity and the group parent company or other companies under its control which could influence the exercise of voting rights.6 the group of companies must provide the competent disclosure office with the following documents for those cases under paragraph 3:a. a list with the names of the fund management companies or legal entities;b. a declaration that the independence requirements in paragraphs 3 and 5 are fulfilled and maintained.7 the group of companies must provide the competent disclosure office with details of every change to the list under paragraph 6 letter a.8 for those cases under paragraph 3, the competent disclosure office may request further documentation supporting compliance with the independence conditions at any time.9 details of the investor's identity are not required.19 sr 951.3120 as most licence holders are companies, gender-neutral terminology is not used in this text.21 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).22 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).23 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).art. 19 banks and securities firms (art. 123 para. 2 finmia)1 when calculating their acquisition positions (art. 14 para. 1 let. a) and disposal positions (art. 14 para. 1 let. b), banks and securities firms under the finia may disregard equity securities and equity derivatives which they hold:24a. in their trading book, provided their share does not reach 5% of voting rights;b. as part of securities loans, collateral transactions or repurchase agreements provided their share does not reach 5% of voting rights;c. only for up to two trading days and exclusively for clearing and settling purposes.2 the calculation under paragraph 1 is only permitted if there is no intention to exercise the voting rights or to intervene in the management of the issuer'25 in any other way, and the voting share does not exceed 10% of the voting rights.3 equity securities for in-house funds under article 71 finsa shall be attributed to the bank's or securities firm's proprietary holdings.2624 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).25 as most issuers are legal entities, gender-neutral terminology is not used in this text.26 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).art. 20 takeover proceedings (art. 123 para. 1 finmia)1 from the publication of the pre-announcement or of the prospectus (offer prospectus) of the takeover offer until the end of the extension period, the following persons are subject exclusively to the notification duties of the takeover board based on article 134 paragraph 5 finmia: a. the offeror27;b. persons acting in concert or as an organised group with the offeror;c. persons under article 134 paragraph 1 finmia holding at least 3% of the voting rights directly, indirectly or in concert with third parties, whether exercisable or not, in the target company or, if applicable, in another company whose equity securities are being offered in exchange;d. persons designated by the takeover board in accordance with article 134 paragraph 3 finmia.2 cases requiring notification which occur during the takeover proceedings must be reported in accordance with the provisions of this ordinance after expiry of the extension period.3 paragraphs 1 and 2 do not apply to the buy-back of proprietary equity securities.27 as most offerors are legal entities, gender-neutral terminology is not used in this text.art. 21 preliminary ruling (art. 123 paras. 1 and 3 finmia)1 requests for a preliminary ruling regarding the applicability of a notification duty must be submitted to the competent disclosure office in good time prior to the transaction.2 the competent disclosure office may exceptionally admit requests for already concluded transactions.section 2 notification and publication art. 22 contents of the notification (art. 123 para. 1 finmia)1 the notification contains the following details:a. the proportion of voting rights, type and number of all equity securities or equity derivatives under article 15 and the associated voting rights held by the persons involved. when falling below the threshold of 3%, the notification to that effect may be given without specifying the actual voting proportion;b. the trigger event, such as:1. acquisition, 2. disposal, 3. transfer of voting rights with full discretionary power (art. 120 para. 3 finmia), 4. exercising or non-exercising of equity derivatives under article 15, 5. securities lending and similar transactions under article 17,6. change in share capital, 7. court or authority ruling, 8. acting in concert, 9. change in the composition of a group, or 10. change in notified details;c. date of the triggering of the notification duty;d. transfer date of the equity securities, if different to the triggering date of the notification duty;e. last name, first name and place of residence or corporate name and registered office of the acquiring, disposing or associated persons.2 in the following instances, the information in paragraph 1 shall be supplemented with:a.28 in the cases outlined in article 120 paragraph 3 finmia:1. concerning the notification of the person with full discretionary powers over the exercise of the voting rights: the proportion of voting rights covered by the authorisation to exercise,2. where the notification is not submitted by the person with full discretionary powers to exercise voting rights, but by the person who directly or indirectly controls the person with full discretionary powers to exercise voting rights (consolidated reporting): a respective reference;b. when acting in concert or as an organised group under article 12: the details in accordance with article 121 finmia and article 12 paragraph 3 of this ordinance;c. for equity derivatives under article 15 with an international securities identification number (isin): the isin;d. for equity derivatives under article 15, without an isin: the relevant details, including:1. the identity of the issuer,2. the underlying,3. the subscription ratio,4. the strike price,5. the exercise period,6. the exercise type;e.29 for collective investment schemes in accordance with article 18 paragraph 3: confirmation that the requirements under article 18 paragraph 5 are met;f. for transactions under article 17:1. the proportion of voting rights, type and number of transferred equity securities or equity derivatives under article 15 and the associated voting rights, 2. the nature of the transaction,3. the agreed time of return or, whether the party subject to the notification duty under article 17 paragraph 2 or the counterparty has discretion as to the time of return.3 in the event of an indirect acquisition or indirect disposal (art. 11), the notification must contain the full details of the person making the direct acquisition or disposal as well as of the beneficial owner.28 amended by no i of the finma ordinance of 26 jan. 2017, in force since 1 march 2017 (as 2017 547).29 correction of 26 nov. 2021 (as 2021 775).art. 23 supplementary details (art. 123 para. 1 finmia)every notification to the disclosure office and company must contain the details of a contact person including their last name, first name, address, telephone number and e-mail address.art. 24 notification deadlines (art. 123 para. 1 finmia)1 the notification must be received by the company and competent disclosure office within four trading days following the triggering of the notification duty. the disclosure office shall supply the requisite forms.2 in the event of an acquisition through inheritance, the period under paragraph 1 is twenty trading days.3 the company must publish the notification within two trading days of receiving it.4 for transactions in proprietary securities, the company must provide notification to the competent disclosure office and publish the notification within four trading days following the triggering of the notification duty.art. 25 publication (art. 123 para. 1, 124 finmia)1 the company publishes the notification pursuant to article 22 via the electronic publishing platform of the competent disclosure office. it must also refer to the previous publication relating to the same notifying person.2 if a company fails to publish a notification or if it publishes an incomplete or erroneous notification, the disclosure offices may publish the necessary information without delay and invoice the company for the costs incurred through the substitute measure. the disclosure offices may publish the reasons for the substitute measure. the company must be informed in advance.art. 26 exemptions and easing provisions (art. 123 paras. 1 and 2, 124 finmia)1 exemptions or easing provisions to the duty of notification and publication may be granted, provided there is good cause for doing so, and particularly if the transactions:a. are of short-term nature;b. do not entail any intention to exercise the voting right; orc. are subject to conditions.2 requests to this effect must be made to the competent disclosure office prior to the transaction in question.3 requests for completed transactions shall only be admitted by the competent disclosure office as an exception and in extraordinary circumstances.section 3 monitoring art. 27 disclosure office (art. 123, 124 finmia)1 stock exchanges have a dedicated office (disclosure office) for monitoring the duty of notification and publication. the disclosure office also processes requests for a preliminary ruling (art. 21) and for exceptions and easing provisions (art. 26).2 if the establishment of such an office proves excessive, this role may be transferred to another stock exchange; the regulations governing the cooperation must be submitted to finma for approval.3 the disclosure offices keep the public informed of their activities. they may issue communications and regulations and publish information required to fulfil the purpose of the law in an appropriate format. as a rule, recommendations are published in anonymous form.4 the disclosure offices may request adequate compensation for any duties commissioned by finma and for processing requests. the rates must be submitted to finma for approval.art. 28 procedure (art. 123, 124 finmia)1 requests for a preliminary ruling (art. 21) and for exemptions or easing provisions (art. 26) must contain the relevant facts, motion and statement of reasons. the facts must be documented appropriately and have to include all the details outlined in article 22.2 the disclosure office issues recommendations to the applicants; these must be substantiated and submitted to finma.3 the disclosure office may address its recommendations to the company. fundamental interests of the applicant, such as business secrets, remain reserved.4 finma issues a decision, if:a. it wishes to rule on the matter itself;b. the applicant rejects or fails to observe the recommendation; orc. the disclosure office approaches it for a decision.5 if finma wishes to decide on the matter itself, it shall make its intentions known within five trading days.6 a rejected recommendation must be substantiated by the applicant in a submission to finma within five trading days. finma may extend this deadline on request.7 in cases under paragraph 4, finma shall immediately initiate proceedings and inform the disclosure office and parties to that effect. it shall also instruct the disclosure office to submit its files.art. 29 investigations (art. 8, 31, 123 para. 1 finmia)finma may instruct the disclosure offices to conduct investigations.chapter 6 duty to make an offer section 1 duty to make an offer art. 30 applicable provisions (art. 135 para. 4 finmia)in addition to art. 135 finmia and the following provisions, articles 125-134, 136-141, 152 and 163 finmia and the implementing provisions of the federal council and takeover board pertaining to public takeover offers apply to the duty to make an offer.art. 31 principle (art. 135 paras. 1 and 4 finmia)the duty to make an offer is incumbent on any person who acquires equity securities directly or indirectly and, by doing so, exceeds the legal or statutory threshold under article 135 paragraph 1 finmia (threshold).art. 32 indirect acquisition (art. 135 paras. 1 and 4 finmia)article 120 paragraph 5 finmia and article 11 of this ordinance apply by analogy to those holdings of the target company requiring an offer when making an indirect acquisition.art. 33 acting in concert or as an organised group (art. 135 paras. 1 and 4, 136 para. 2 finmia)article 12 paragraph 1 applies to persons acting in concert or as an organised group to acquire holdings requiring an offer with respect to the target company with the aim of controlling the target company.art. 34 calculation of the threshold (art. 135 paras. 1 and 4 finmia)1 the threshold is calculated based on the total number of voting rights in accordance with the entry in the commercial register.2 when determining whether the threshold has been exceeded, all equity securities are taken into account which are owned by the acquiring person or whose voting rights have been transferred to the acquiring person in another way, regardless of whether the voting rights may be exercised.3 voting rights restricted to a power of attorney granted solely for the purposes of representation at one general meeting are excluded from the calculation.art. 35 definition of the duty to make an offer (art. 135 paras. 1 and 4 finmia)1 the duty to make an offer must be extended to all types of listed equity securities of the target company.2 it must also include new equity securities created through equity derivatives, if the associated rights are exercised prior to expiry of the extension under article 130 paragraph 2 finmia.art. 36 transfer of the duty to make an offer to the acquiring person (art. 135 para. 4, 136 para. 2, 163 finmia)if the person previously entitled to the equity securities was subject to the duty to make an offer for all equity securities on exceeding the threshold of 50% of voting rights pursuant to the transitional regulation of article 163 finmia, this duty passes over to the person acquiring a holding between 33 and 50% of the voting rights, if that person is exempted from the duty to make an offer under article 136 paragraph 2 finmia.art. 37 resurgence of the duty to make an offer (art. 135 para. 4 finmia)a person who reduces a holding of 50% or more of the voting rights in a company acquired prior to 1 january 1998 to under 50% must make an offer under article 135 finmia, if the said person's holding subsequently exceeds the threshold of 50%. art. 38 duty to make an offer and conditions (art. 135 paras. 1 and 4, 136 para. 2 finmia)1 the duty to make an offer may not be made subject to conditions unless there is good cause for doing so.2 good cause is particularly present if:a. an official authorisation is required for the acquisition;b. the equity securities to be acquired do not procure voting rights; orc. the offeror wants the specifically mentioned economic substance of the target company to remain unchanged.art. 39 time period (art. 135 paras. 1 and 4 finmia)1 the mandatory offer must be made within two months of exceeding the threshold.2 the takeover board may grant an extension if there is good cause for doing so.section 2 exceptions to the duty to make an offer art. 40 general exceptions (art. 135 para. 4, 136 finmia)1 the duty to make an offer lapses, if:a. the threshold is exceeded during a restructuring resulting from a capital reduction immediately followed by a capital increase for the purpose of offsetting a loss;b.30 banks or securities firms under finia acting independently or as a syndicate acquire equity securities as part of an issue and undertake to sell the number of equity securities exceeding the threshold within three months after exceeding the threshold and the sale actually takes place within this period.2 the claim to an exception under paragraph 1 or article 136 paragraph 2 finmia has to be notified to the takeover board. the takeover board shall initiate an administrative procedure within five trading days if it has reason to suspect that the conditions in paragraph 1 are not met.3 the takeover board may extend the period under paragraph 1 letter b upon application if there is adequate justification for doing so.30 amended by annex no 5 of the finma o of 4 nov. 2020 on financial institutions, in force since 1 jan. 2021 (as 2020 5327).art. 41 particular exceptions (art. 135, 136 para. 1 finmia)1 in the cases outlined under article 136 paragraph 1 finmia and in other justified cases, a person obliged to make an offer may be exempted from the duty to make an offer if there is good cause for doing so.2 further justified cases under article 136 paragraph 1 finmia are particularly those cases where:a. the acquiring person cannot control the target company because another person or group has a higher voting share;b. a member of an organised group in accordance with article 136 paragraph 1 letter a finmia exceeds the threshold individually; orc. the previous acquisition was made indirectly (art. 32), provided this acquisition is not one of the main purposes of the transaction and the interests of the target company's shareholders remain preserved.3when granting exceptions conditions may be attached; in particular the acquiring person may be made subject to certain obligations.4 the conditions under paragraph 3 transfer to a legal successor who acquires a shareholding exceeding 33% even if the legal successor is exempt from the duty to make an offer under article 136 paragraph 2 finmia.section 3 determining the offer price art. 42 stock exchange price (art. 135 paras. 2-4 finmia)1 the offer price must be at least equal to the stock exchange price for every type of equity security in the target company.2 the stock exchange price in accordance with article 135 paragraph 2 letter a finmia corresponds to the volume-weighted average price of the on-order-book trades of the last 60 trading days prior to the publication of the offer or to the pre-announcement.3 it must be adjusted to negate the effects of significant price influences triggered by special events, such as a dividend distribution or capital transactions, to which it is subject during this period. an audit firm in accordance with article 128 paragraph 1 finmia must confirm the adequacy of the adjustment and show the calculation basis in its report.4 if the listed equity securities are not liquid prior to the publication of the offer or the pre-announcement, the audit firm has to carry out a valuation of the company. the report shall outline the valuation methods and the basis for the valuation as well as provide an explanation of whether and, if so, to what extent, the setting of the minimum price is to deviate from the stock exchange price or company value.art. 43 price of the previous acquisition (art. 135 paras. 2-4 finmia)1 the price of the previous acquisition under article 135 paragraph 2 letter b finmia corresponds to the highest price paid by the buyer for equity securities in the target company over the past 12 months prior the to publication of the offer or to the pre-announcement.2 it must be defined separately for each type of equity security. the price of the most expensive equity security relative to the nominal value shall form the basis for setting the appropriate ratio between the prices of different types of equity securities under article 135 paragraph 3 finmia.3 the equity securities in the target company acquired through the exchange of securities as part of the previous acquisition shall be calculated at their value at the time of the exchange.4 if the person buying or selling has added other benefits in addition to the main payment for the previous acquisition, and in particular if the person has provided guarantees or benefits in kind, the price for the previous purchase shall be reduced or increased correspondingly.5 an audit firm (art. 128 finmia) must review the valuation of the equity securities under paragraph 3 and the adequacy of the increase or decrease under paragraph 4 and present its calculation details in its report.art. 44 indirect prior acquisition (art. 135 paras. 2-4 finmia)1 if the prior acquisition was indirect within the meaning of article 32 in conjunction with article 11 letter c, the offeror must disclose in the offer prospectus the share of the total price paid attributable to the target company's equity securities.2 the valuation of this share must be audited by an audit firm.art. 45 payment of the offer price (art. 135 paras. 2-4 finmia)1 the offer price may be paid in cash or exchanged against securities.2 payment against exchange of securities is permitted provided full payment in cash is offered as an alternative.art. 46 valuation of securities (art. 135 paras. 2-4 finmia)article 42 paragraphs 2-4 apply to determining the value of the securities offered in exchange.art. 47 exceptions (art. 135 paras. 2-4 finmia)the takeover board may grant exemptions from the regulations of this section (art. 40-44) to the offeror in individual cases if there is good cause for doing so.chapter 7 cooperation between finma, the takeover board and stock exchanges art. 48 (arts. 122, 123 para. 1 finmia; art. 39 para. 1 finmasa)1 finma, the takeover board, the stock exchange's registration and disclosure offices and trading supervisory bodies shall provide each other, either proactively or on request, with all information and relevant documentation required by these authorities and offices or bodies for performing their respective duties. in particular, they shall inform each other if they have grounds for suspecting a violation of the law requiring investigation by the relevant authority, office or bodies.2 in doing so, the authorities, offices and bodies involved shall observe official, professional and business secrecy and only use the information and relevant documentation received for the performance of their legal duties.chapter 8 final provisions art. 49 repeal and amendment of other legislation the repeal and amendment of other legislative instruments are regulated in annex 2.art. 50 transitional provision on the disclosure of shareholdings 1 disclosure notifications made under existing law retain their validity. cases which arose prior to the finmia coming into force and which need to be disclosed due to that act and this ordinance must be reported by 31 march 2016.2 cases requiring notification which arise after this ordinance comes into force may initially be reported and published under the current law, including a notice to that effect, up to 31 march 2016. the notification under the new legal regime must be submitted to the competent disclosure office and the company by 31 march 2016.3 a disclosure office that does not have an electronic publishing platform when this ordinance comes into force must have such a platform available and fully operational by 1 january 2017.4 until an electronic publishing platform becomes operational in accordance with paragraph 3, the company publishes its disclosure notifications in the swiss official gazette of commerce and in at least one of the prominent electronic media used for disseminating stock exchange information. the relevant point in time in determining compliance with the deadline under article 24 paragraph 2 is the communication of the disclosure notification to the electronic media. such disclosure notification must be sent to the disclosure office at the same time.art. 50a31 transitional provision to the amendment of 26 january 2017 the duty to report under article 10 para. 2 finmio-finma in its version amended on 26 january 2017 must be met by 31 august 2017.31 inserted by no i of the finma ordinance of 26 jan. 2017, in force since 1 march 2017 (as 2017 547).art. 51 commencement this ordinance comes into force on 1 january 2016.annex 132 32 amended by no 1 of the finma ordinance of 3 may 2018, in force since 1 sept. 2018 (as 2018 2387).(art. 6 para. 1)clearing of derivatives categories via a central counterparty i. otc interest rate derivatives typereference interest ratesettlement currencytermtype of settlement currencyoptiontype of nominal value1. basis-swapeuriboreur28d-50ysame currencynoconstant or variable2. basis-swapliborgbp28d-50ysame currencynoconstant or variable3. basis-swapliborjpy28d-30ysame currencynoconstant or variable4. basis-swapliborusd28d-50ysame currencynoconstant or variable5. fixed-to-floateuriboreur28d-50ysame currencynoconstant or variable6. fixed-to-floatliborgbp28d-50ysame currencynoconstant or variable7. fixed-to-floatliborjpy28d-30ysame currencynoconstant or variable8. fixed-to-floatliborusd28d-50ysame currencynoconstant or variable9. forward rate agreementeuriboreur3d-3ysame currencynoconstant or variable10. forward rate agreementliborgbp3d-3ysame currencynoconstant or variable11. forward rate agreementliborusd3d-3ysame currencynoconstant or variable12. overnight index swapeoniaeur7d-3ysame currencynoconstant or variable13. overnight index swapfedfundsusd7d-3ysame currencynoconstant or variable14. overnight index swapsoniagbp7d-3ysame currencynoconstant or variableii. otc credit derivatives typesubtyperegionreference indexsettlement currencyseriesterm1. index cdsindex, not tranched europeitraxx europe maineurfrom 175y2. index cdsindex, not tranched europeitraxx europe crossovereurfrom 175yannex 2 (art. 49)repeal and amendment of other legislation ithe finma stock exchange ordinance of 25 october 200833 is repealed.iithe following legislative instruments are amended as follows:.3433 [as 2008 6521; 2011 6285; 2013 1117]34 the amendments may be consulted under as 2015 5509.