Release Ordinance (RO)

By Steph2
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In The Matter OfRelease Ordinance (RO)
Exhibit A
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English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

Section 1 General Requirements for Handling Organi

Art. 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 organisms, their metabolic products and wastes to human beings, animals or the environment as well as to biological diversity or the sustainable use thereof; and b. arrive at a justifiable conclusion that no such hazards and harm are to be expected. 2 The assessment referred to in paragraph 1 letter a must in particular consider: a. the organisms’ potential for survival, dissemination and replication in the environment; b. possible interactions with other organisms and communities as well as impacts on habitats.

Art. 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 their properties in relation to public health and the environment; b. instruct the recipient in such a way that handling the organisms in the environment in accordance with the regulations and the instructions will not endanger human beings, animals or the environment, or harm biological diversity or the sustainable use thereof; c. instruct the recipient as to the safety measures to be taken in the event of unintentional release.

Art. 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 endanger human beings, animals or the environment; b. do not harm biological diversity or its sustainable use. 2 In particular, the relevant regulations and the distributor's instructions and recommendations must be observed.

Section 2 Requirements for Handling Genetically Mo

Art. 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 manner that it neither endangers human beings, animals and the environment nor harms biological diversity or the sustainable use thereof, and in particular so that: a. the health of human beings and animals cannot be endangered, in particular by toxic or allergenic substances or through the spread of antibiotic resistances; b. the genetically modified organisms cannot spread or multiply in an uncontrolled way in the environment; c. no undesired properties can be permanently passed on to other organisms; d. populations of protected organisms, in particular those included in the Red Lists, or organisms that are important for the ecosystem in question, in particular those that are important for the growth and reproduction of plants, are not affected; e. no species of non-target organisms can be endangered; f. the material balance of the environment is not severely or permanently harmed; g. im

Para. 2 let. tab — Amended by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS 2012 2777). Para. 2 let. tab — SR 814.912

Art. 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 protection, the direct handling of genetically modified organisms is permissible only if it serves to prevent or eliminate hazards to human beings, animals, the environment, biological diversity or the sustainable use thereof, or impairments to the same. For areas in accordance with paragraph 2 letters a, e and f, deviating provisions in the applicable protection regulations are reserved. 2 Habitats and landscapes that are particularly sensitive or worthy of protection are: a. areas that are designated nature reserves, on the basis of federal or cantonal law; b. surface waters and a strip 3 m wide along or around them; c. subterranean waters and catchment areas S1 and, for microorganisms, catchment areas S2 and Sh of groundwater protection zones; d. forests; e. protected areas in accordance with Article 11 of the Hunting Act of 20 June 1986; f. areas under landscape protection in accordance with federal or canton

Para. 2 let. c — Amended by Annex No 3 of the Ordinance of 4 Nov. 2015, in force since 1 Jan. 2016 (AS 2015 4791). Para. 2 let. e — SR 922.0

Art. 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 staffing measures to prevent undesired mixing with non-genetically modified organisms; in particular, he or she must: a. observe the required distances for production that does not use genetically modified organisms; b. clean all equipment and machines thoroughly after use in accordance with recognised methods, if they are also used for non-genetically modified organisms; c. take precautions to prevent losses of genetically modified organisms; d. keep the relevant information about the handling and forward it to the recipients in an appropriate form. 2 Any person who handles genetically modified organisms directly in the environment must, in exceptional events, document losses of genetically modified organisms and take appropriate measures to restore the original conditions. 3 Any person who puts genetically modified organisms into circulation must ha

Para. 4 let. a — OJ. L 10 of 16.1.2004, p. 5; the text of the Regulation can be obtained from FOEN, 3003 Bern.

Art. 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, with the note «genetically modified». 2 Labelling may be waived for mixtures, articles and products that contain genetically modified organisms if it is demonstrated that the mixtures, articles and products contain only unintentional traces of authorised genetically modified organisms. The content of such traces may not: a. exceed 0.1 percent by mass for mixtures, articles and products that are handled directly in the environment; b. exceed 0.9 percent by mass for all other mixtures, articles and products. 3 The corresponding requirements for the labelling of mixtures, articles and products that contain genetically modified organisms stipulated by the regulations on therapeutic products and agriculture are reserved. 4 The requirements for foodstuffs guaranteeing freedom of choice for consumers are regulated in the legislati

Art. 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 financial reserves for determining, preventing or correcting possible hazards or impairments caused by genetically modified organisms. 2 Any person who intends to release genetically modified organisms that require authorisation for experimental purposes must guarantee legal liability: a. of 10 million Swiss francs to cover damage to persons or property (Art. 30 GTA ); and b. of 1 million Swiss francs to cover damage to the environment (Art. 31 GTA ). 3 Any person who intends to put organisms into circulation for direct handling in the environment for the first time must guarantee legal liability: a. of 20 million Swiss francs to cover damage to persons or property (Art. 30 GTA ); and b. of 2 million Swiss francs to cover damage to the environment (Art. 31 GTA ). 4 The obligation to guarantee liability can be fulfilled: a. by taking

Para. 6 — Inserted by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS 2012 2777). Para. 7 — Inserted by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS 2012 2777).

Section 3 Requirements for Handling Pathogenic Org

Art. 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 neither endangers human beings, animals or the environment nor harms biological diversity or the sustainable use thereof, and in particular so that: a. the health of human beings and animals cannot be endangered, in particular not by toxic or allergenic substances or through the spread of antibiotic resistances; b. the organisms cannot spread or multiply in an uncontrolled way in the environment; c. populations of protected organisms are not harmed, in particular those included in the Red Lists, or organisms that are important for the ecosystem in question, in particular those that are important for the growth and reproduction of plants; d. no species of non-target organisms species can be endangered; e. the material balance of the environment is not severely or permanently harmed; f. important functions of the ecosystem in question, in particular the fertility of the soil, are not se

Para. 2 — SR 814.912 Para. 2 — Amended by Annex No 2 of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).

Art. 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 paragraph 2 letters a–d, the direct handling of pathogenic organisms is permissible only if it serves to prevent or eliminate hazards to human beings, animals, the environment, biological diversity or the sustainable use thereof, or impairments to the same. 2 For areas in accordance with Article 8 paragraph 2 letter a, deviating provisions in the applicable protection regulations are reserved.

Art. 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 for determining, preventing or correcting possible hazards or impairments caused by such organisms. 2 Any person who intends to release pathogenic organisms that require authorisation for experimental purposes must guarantee legal liability: a. of 1 million Swiss francs to cover damage to persons or property (Art. 59abis para. 1 EPA); and b. of 100,000 Swiss francs to cover damage to the environment (Art. 59abis para. 9 EPA). 3 Any person who intends to put such organisms into circulation for direct handling in the environment for the first time must guarantee legal liability: a. of 2 million Swiss francs to cover damage to persons or property (Art. 59abis para. 1 EPA); and b. of 200,000 Swiss francs to cover damage to the environment (Art. 59abis para. 9 EPA). 4 The obligation to guarantee liability can be fulfilled: a. by

Para. 6 — Inserted by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS 2012 2777). Para. 7 — Inserted by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS 2012 2777).

Section 4 Requirements for Handling Alien Organism

Art. 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 endangers human beings, animals or the environment nor harms biological diversity or the sustainable use thereof, and in particular so that: a. the health of human beings and animals cannot be endangered, in particular not by toxic or allergenic substances; b. the organisms cannot spread or multiply in an uncontrolled way in the environment; c. populations of protected organisms are not harmed, in particular those included in the Red Lists, or organisms that are important for the ecosystem in question, in particular those that are important for the growth and reproduction of plants; d. no species of non-target organisms species can be endangered; e. the material balance of the environment is not severely or permanently harmed; f. important functions of the ecosystem in question, in particular the fertility of the soil, are not severely or permanently harmed. 2 Invasive alien organi

Para. 2 — Amended by No I of the O of 1 March 2024, in force since 1 Sept. 2024 (AS 2024 116). Para. 2bis — Inserted by No I of the O of 1 March 2024, in force since 1 Sept. 2024 (AS 2024 116). Para. 3 — Amended by No I of the O of 1 March 2024, in force since 1 Sept. 2024 (AS 2024 116). Para. 4 — Amended by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS 2012 2777).

Art. 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 8 paragraph 2 letters a–d, the direct handling of alien organisms is permissible only if it serves to prevent to eliminate hazards to human beings, animals, the environment, biological diversity or the sustainable use thereof, or impairments to the same. 2 For areas in accordance with Article 8 paragraph 2 letter a, deviating provisions in the applicable protection regulations are reserved.