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Contents of this enactment

Document textGeneral document text1ArticlesRegular articles in this version64AnnexesAnnexes and attachments in this version12
Document text1
Articles64
1Chapter 1 General Provisions
Art. 1 – PurposeArt. 1 Purpose 1 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 metabol… Direct link
Art. 2 – Scope and area of validityArt. 2 Scope and area of validity 1 This Ordinance regulates the handling of organisms, their metabolic products and wastes in the environment, in particular the handling of genetically modified, pathogenic or alien org… Direct link
Art. 3 – DefinitionsArt. 3 Definitions 1 In this Ordinance: a. organisms means cellular or non-cellular biological entities capable of replication or of transferring genetic material. Mixtures and articles and products containing such enti… Direct link
1Chapter 2 Requirements for Handling Organisms in the Environment
2Section 1 General Requirements for Handling Organisms
Art. 4 – Self-supervision for putting organisms into circulationArt. 4 Self-supervision for putting organisms into circulation 1 Any person who intends to put organisms into circulation for use in the environment must first: a. assess the possible hazards and harm caused by the orga… Direct link
Art. 5 – Informing the recipientsArt. 5 Informing the recipients Any person putting organisms into circulation for use in the environment must: a. inform the recipient of the identity of the organisms, their metabolic products and wastes, as well as of… Direct link
Art. 6 – Taking due careArt. 6 Taking due care 1 Any person handling organisms in the environment in ways other than putting them into circulation must take all due care to ensure that organisms, their metabolic and waste products: a. cannot e… Direct link
2Section 2 Requirements for Handling Genetically Modified Organisms
Art. 7 – Protection of human beings, animals, the environment and biological diversity from genetically modified organismsArt. 7 Protection of human beings, animals, the environment and biological diversity from genetically modified organisms 1 The handling of genetically modified organisms in the environment must be carried out in such a… Direct link
Art. 8 – Protecting habitats and landscapes that are particularly sensitive or worthy of protection against genetically modified organismsArt. 8 Protecting habitats and landscapes that are particularly sensitive or worthy of protection against genetically modified organisms 1 In habitats and landscapes that are particularly sensitive or worthy of protecti… Direct link
Art. 9 – Protection of production that does not use genetically modified organismsArt. 9 Protection of production that does not use genetically modified organisms 1 Any person who handles genetically modified organisms directly in the environment must take the required technical, organisational and s… Direct link
Art. 10 – Labelling of genetically modified organismsArt. 10 Labelling of genetically modified organisms 1 Any person who puts genetically modified organisms into circulation must inform the recipient of the nature of the organisms through an easily recognisable label, wi… Direct link
Art. 11 – Liability guarantee for genetically modified organismsArt. 11 Liability guarantee for genetically modified organisms 1 Any person who intends to release genetically modified organisms that require authorisation for experimental purposes (Art. 17) must guarantee sufficient… Direct link
2Section 3 Requirements for Handling Pathogenic Organisms
Art. 12 – Protection of human beings, animals, the environment and biological diversity from pathogenic organismsArt. 12 Protection of human beings, animals, the environment and biological diversity from pathogenic organisms 1 The handling of pathogenic organisms in the environment must be carried out in such a manner that it neit… Direct link
Art. 13 – Protecting habitats that are particularly sensitive or worthy of protection against pathogenic organismsArt. 13 Protecting habitats that are particularly sensitive or worthy of protection against pathogenic organisms 1 In habitats that are particularly sensitive or worthy of protection in accordance with Article 8 paragra… Direct link
Art. 14 – Liability guarantee for pathogenic organismsArt. 14 Liability guarantee for pathogenic organisms 1 Any person who intends to release pathogenic organisms that require authorisation for experimental purposes (Art. 17) must guarantee sufficient financial reserves f… Direct link
2Section 4 Requirements for Handling Alien Organisms
Art. 15 – Protection of human beings, animals, the environment and biological diversity from alien organismsArt. 15 Protection of human beings, animals, the environment and biological diversity from alien organisms 1 The handling of alien organisms in the environment must be carried out in such a manner that it neither endang… Direct link
Art. 16 – Protecting habitats and landscapes that are particularly sensitive or worthy of protection against alien organismsArt. 16 Protecting habitats and landscapes that are particularly sensitive or worthy of protection against alien organisms 1 In habitats that are particularly sensitive or worthy of protection in accordance with Article… Direct link
1Chapter 3 Licensing and Notifications
2Section 1 Experimental Releases
Art. 17 – Licensing requirementArt. 17 Amended by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS 2012 2777). Amended by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS… Direct link
Art. 18 – Exceptions from the licensing requirementArt. 18 Exceptions from the licensing requirement 1 Authorisation is not required for experimental releases involving genetically modified organisms, if they are authorised for a particular direct application in the env… Direct link
Art. 19 – Applications for authorisation for experimental releases of genetically modified organismsArt. 19 Applications for authorisation for experimental releases of genetically modified organisms 1 The application for authorisation for an experimental release of genetically modified organisms must contain all the r… Direct link
Art. 20 – Applications for authorisation for experimental releases of pathogenic organismsArt. 20 Applications for authorisation for experimental releases of pathogenic organisms 1 The application for authorisation for an experimental release of pathogenic organisms must contain all the required information… Direct link
Art. 21 – Applications for authorisation for experimental releases of alien small invertebratesArt. 21 Applications for authorisation for experimental releases of alien small invertebrates 1 The application for authorisation for an experimental release of alien small invertebrates must contain all the required in… Direct link
Art. 22 – Simplified licensing procedureArt. 22 Simplified licensing procedure 1 The applicant may request a simplified licensing procedure for experimental releases of genetically modified organisms, pathogenic organisms or alien small invertebrates if: a. a… Direct link
Art. 23 – Changes and new findingsArt. 23 Changes and new findings 1 The applicant or authorisation holder must inform the FOEN without delay about: a. new findings and observations that might require a reassessment of the risk; b. changes to the experi… Direct link
Art. 24 – ReportingArt. 24 Reporting 1 The authorisation holder must submit a report to the FOEN within 4 months of completion of the experimental release. The FOEN may extend the deadline upon reasonable request. The report shall be publ… Direct link
2Section 2 Putting Organisms into Circulation
Art. 25 – Licensing requirementArt. 25 Amended by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS 2012 2777). Amended by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS… Direct link
Art. 26 – Applicable licensing procedureArt. 26 Applicable licensing procedure Authorisation in accordance with Article 25 shall be issued by one of the following authorities, in accordance with the product, as part of the applicable licensing procedure: Appl… Direct link
Art. 27 – Exceptions from the licensing requirementArt. 27 Exceptions from the licensing requirement Authorisation is not required for putting the following into circulation: a. plant reproductive material in accordance with Article 14a of the Seeds Ordinance of 7 Decem… Current article Direct link
Art. 28 – Applications for authorisation to put genetically modified organisms into circulationArt. 28 Applications for authorisation to put genetically modified organisms into circulation 1 The application for authorisation to put genetically modified organisms into circulation, which must be submitted as part o… Direct link
Art. 29 – Applications for authorisation to put pathogenic organisms into circulationArt. 29 Applications for authorisation to put pathogenic organisms into circulation 1 The application for authorisation to put pathogenic organisms into circulation, which must be submitted as part of the applicable lic… Direct link
Art. 30 – Applications for authorisation to put alien small invertebrates into circulationArt. 30 Applications for authorisation to put alien small invertebrates into circulation 1 The application for authorisation to put alien small invertebrates into circulation, which must be submitted as part of the appl… Direct link
Art. 31 – New findingsArt. 31 New findings 1 The applicant or the authorisation holder must inform the licensing authority without delay of new findings or observations that might require a reassessment of the risk. 2 At the same time, the a… Direct link
Art. 32 – Notification of the release of genetically modified organisms in the environmentArt. 32 Notification of the release of genetically modified organisms in the environment 1 Any person who releases directly in the environment genetically modified organisms that are authorised for being put into circul… Direct link
2Section 3 Common Provisions
Art. 33 – Residence, business premisesArt. 33 Residence, business premises 1 Any person who applies to release organisms for experimental purposes or to put them into circulation must have a residence or business premises in Switzerland. 2 In relation to pu… Direct link
Art. 34 – Number of copies of applicationArt. 34 Number of copies of application 1 The application for authorisation should be submitted in the required number of copies. For experimental releases, the application should also be submitted in the official langu… Direct link
Art. 35 – Legal successionArt. 35 Legal succession 1 The legal successor of the holder of authorisation for experimental release or putting into circulation in accordance with Article 26 letters c and k must request transfer of authorisation fro… Direct link
1Chapter 4 Responsibilities of the Authorities
2Section 1 Experimental Releases
Art. 36 – Application documents, publication and public informationArt. 36 Application documents, publication and public information 1 The FOEN shall examine whether the documentation submitted (Art. 19, 20 or 21) for evaluating the application is complete. If the documentation is inco… Direct link
Art. 37 – Examination of the application, involvement of the specialist agenciesArt. 37 Examination of the application, involvement of the specialist agencies 1 The FOEN shall examine the application. Concomitantly with announcement of the receipt of the application in the Federal Gazette, the FOEN… Direct link
Art. 38 – Issue of authorisationArt. 38 Issue of authorisation 1 The FOEN shall authorise the experimental release, taking into consideration the statements received from the parties and the specialist agencies, as a rule within 3 months of announcing… Direct link
Art. 39 – Simplified licensing procedureArt. 39 Simplified licensing procedure 1 If the conditions of Article 22 have been fulfilled, the FOEN shall carry out a simplified licensing procedure. 2 It may in particular: a. waive the need to submit the documentat… Direct link
Art. 40 – New findingsArt. 40 New findings 1 If any of the specialist agencies involved in the procedure (Art. 37 para. 1) comes into possession of new findings on the risks posed by the experimental release after issue of authorisation, it… Direct link
Art. 41 – Monitoring of authorised experimental releasesArt. 41 Monitoring of authorised experimental releases 1 The FOEN shall monitor the carrying out of experimental releases and order the necessary measures. 2 For this purpose, it may appoint a supervisory group with rep… Direct link
2Section 2 Putting Organisms into Circulation
Art. 42 – Application documents and publicationArt. 42 Application documents and publication 1 The licensing authority under Article 26 shall examine whether the documentation submitted (Art. 28, 29 or 30) is complete. If the documentation is incomplete, it shall re… Direct link
Art. 43 – Examination of the application, involvement of federal offices and committeesArt. 43 Examination of the application, involvement of federal offices and committees 1 The licensing authority in accordance with Article 26 shall examine the application. It shall forward it to the following other spe… Direct link
Art. 44 – AuthorisationArt. 44 Authorisation 1 The licensing authority shall authorise putting the organisms into circulation, taking into consideration the statements received from the parties and the specialist agencies, if the assessment o… Direct link
Art. 45 – New findingsArt. 45 New findings 1 If one of the specialist agencies involved in the procedure comes into possession of new findings about the risks posed by the putting the organisms into circulation, it shall inform the licensing… Direct link
Art. 46 – Monitoring of self-supervisionArt. 46 Monitoring of self-supervision 1 For organisms that may be put into circulation without authorisation, the FOEN may demand evidence from the distributor that he or she is exercising self-supervision, together wi… Direct link
Art. 47 – Subsequent monitoring (supervising the market) in accordance with other regulationsArt. 47 Subsequent monitoring (supervising the market) in accordance with other regulations 1 Subsequent monitoring (supervising the market) shall be carried out: a. for therapeutic products in accordance with the Thera… Direct link
Art. 48 – Subsequent monitoring (supervising the market) in accordance with this OrdinanceArt. 48 Subsequent monitoring (supervising the market) in accordance with this Ordinance 1 The cantons are responsible for subsequent monitoring (supervising the market) of organisms put into circulation which are not s… Direct link
Art. 48a – Enforcement by the Federal Office for Customs and Border Security in relation to prohibited invasive alien organismsArt. 48a Inserted by No I of the O of 1 March 2024, in force since 1 Sept. 2024 (AS 2024 116). Inserted by No I of the O of 1 March 2024, in force since 1 Sept. 2024 (AS 2024 116). Enforcement by the Federal Office for… Direct link
2Section 3 Monitoring the Duty of Care
Art. 49Art. 49 1 The cantonal authorities shall monitor observance of the duty of care when handling organisms in the environment, in accordance with Articles 6–9, 12, 13, 15 and 16. 2 If the monitoring shows cause for complai… Direct link
2Section 4 Monitoring Environmental Pollution and Control of Organisms
Art. 50 – SurveysArt. 50 Surveys 1 The FOEN shall carry out surveys that are necessary to assess the environmental pollution caused by particular organisms, by particular properties of organisms, or by particular genetic material. 2 For… Direct link
Art. 51 – Environmental monitoringArt. 51 Environmental monitoring 1 The FOEN shall ensure the establishment of a monitoring system for the early recognition of possible hazards to the environment and impairments of biological diversity by genetically m… Direct link
Art. 52 – ControlArt. 52 Control 1 If organisms appear that could endanger human beings, animals or the environment or could harm biological diversity and the sustainable use thereof, the cantonal authorities shall prescribe appropriate… Direct link
Art. 53 – CostsArt. 53 Costs 1 If scientific investigations lead to the conclusion that it may be assumed with sufficient probability that there is a causal connection between damage to human beings, animals or the environment or impa… Direct link
2Section 5 Accessibility of Information
Art. 54 – Public nature of the informationArt. 54 Public nature of the information 1 Information obtained in the enforcement of this Ordinance or other federal legislation on the handling of genetically modified organisms or products obtained from them, or of p… Direct link
Art. 55 – Confidentiality of informationArt. 55 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 sh… Direct link
Art. 56 – RegistersArt. 56 Registers 1 The FOEN shall maintain a register of all authorised experimental releases. The register shall record whether, when, where, by whom and with what an experimental release was carried out. 2 It shall a… Direct link
2Section 6 Fees
Art. 57Art. 57 1 Fees shall be charged for orders and services provided by the FOEN in accordance with the Ordinance of 3 June 2005SR 814.014 on the Fees charged by the FOEN. SR 814.014 2 A fee shall be charged for statements… Direct link
2Section 7 Further Duties of the FOEN and of DETEC
Art. 58 – Guidelines, training and further educationArt. 58 Guidelines, training and further education 1 The FOEN may issue guidelines on the enforcement of this Ordinance if required. It shall first consult the specialist agencies concerned. 2 The FOEN together with the… Direct link
Art. 59 – Modification of the lists in Annexes2.1 and 2.2Art. 59 Amended by No I of the O of 1 March 2024, in force since 1 Sept. 2024 (AS 2024 116). Amended by No I of the O of 1 March 2024, in force since 1 Sept. 2024 (AS 2024 116). Modification of the lists in Annexes2.1 a… Direct link
1Chapter 5 Final Provisions
Art. 60 – Repeal of current legislationArt. 60 Repeal of current legislation The Release Ordinance of 25 August 1999 [AS 1999 2748; 2001 522 Annex No 4 1191 Art. 51 No 2 3294 No II 9; 2003 4793 No I 2; 2004 4801 Art. 14; 2005 973 No II 2603 Art. 8 No 1 2695… Direct link
Art. 61 – Amendment of current legislationArt. 61 Amendment of current legislation The amendment of current legislation is regulated in Annex 5. Direct link
Art. 62 – Transitional provisionsArt. 62 Transitional provisions Genes inserted by gene technology methods and inducing resistance to antibiotics that are authorised for use in human and veterinary medicine may be used in field trials up to 31 December… Direct link
Art. 63 – CommencementArt. 63 Commencement This Ordinance comes into force on 1 October 2008. Direct link
Annexes12
Definition of gene technology methodsAnnex 1 (Art. 3 letter 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 the organism ar…Direct link
AnhangAnhangDirect link
Invasive alien organisms whose direct handling in the environment is prohibitedAnnex 2.1 (Art. 15 para. 2) Invasive alien organisms whose direct handling in the environment is prohibited 1 Plant Scientific name English name German name French name Italian name Ailanthus altissima Ailanthus, tree o…Direct link
Invasive alien organisms that may not be put into circulation for direct handling in the environmentAnnex 2.2 (Art. 15 para. 2 bis ) Invasive alien organisms that may not be put into circulation for direct handling in the environment Scientific name English name German name French name Italian name Acacia dealbata Sil…Direct link
AnhangAnhangDirect link
Information for applications for authorisation concerning pathogenic and alien organismsAnnex 3 Information for applications for authorisation concerning pathogenic and alien organismsDirect link
Applications for authorisation for releases of pathogenic organisms for experimental purposesAnnex 3.1 (Art. 20) Applications for authorisation for releases of pathogenic organisms for experimental purposes 1 General information 11 Name and address of the applicant (company or institution); 12 Name, qualificati…Direct link
Application for authorisation to put pathogenic organisms into circulationAnnex 3.2 (Art. 29) Application for authorisation to put pathogenic organisms into circulation 1 General information 11 Name and address of the applicant (company or institution); 12 Description of the type and extent o…Direct link
Application for authorisation for experimental releases of alien invertebrates (arthropods, annelids, nematodes, platyhelminths)Annex 3.3 (Art. 21) Application for authorisation for experimental releases of alien invertebrates (arthropods, annelids, nematodes, platyhelminths) 1 General information 11 Name and address of the applicant (company or…Direct link
Application for authorisation to put alien invertebrates (arthropods, annelids, nematodes, platyhelminths) into circulationAnnex 3.4 (Art. 30) Application for authorisation to put alien invertebrates (arthropods, annelids, nematodes, platyhelminths) into circulation 1 General information 11 Name and address of the applicant (company or inst…Direct link
Determination and assessment of riskAnnex 4 (Art. 19, 20, 21, 28, 29 and 30) Determination and assessment of risk 1 Purpose and procedure 1 The purpose of determining the risk is to determine and assess the consequences of the real case of handling organi…Direct link
Amendments to existing ordinancesAnnex 5 (Art. 61) Amendments to existing ordinances …Direct link

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