Release Ordinance (RO)
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 Experimental Releases
Art. 17 Licensing requirement
Any person who intends to release the following organisms for experimental purposes shall require authorisation from the FOEN: a. genetically modified organisms; b. pathogenic organisms; c. alien small invertebrates that are intended for use in the environment and not as pets.
Art. 17 — Amended by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS 2012 2777).
Art. 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 environment in accordance with Article 25 and if the experimental release aims to gather further information for the same application. 2 Authorisation is not required for experimental releases involving pathogenic organisms if they: a. are authorised for a particular direct application in the environment in accordance with Article 25; or b. are not alien and are not pathogenic to human beings or vertebrates. 3 Authorisation is not required for experimental releases involving alien small invertebrates if they are authorised for a particular direct application in the environment in accordance with Article 25.
Art. 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 required information to prove that the experimental release cannot contravene the requirements of Articles 7–9 and 11. 2 The application must contain the following documents, in particular: a. a description of the experiment with at least the following details: 1. details of the objective and context of the experiment, 2. reasons why the information sought cannot be obtained through experiments in contained systems, 3. a presentation of the anticipated new scientific results in terms of the impacts on human beings, animals or the environment, biological diversity and the sustainable use thereof and the efficacy of safety measures which can be gained thanks to the experiment; b. a technical dossier with the information in accordance with Annexes IIIA or IIIB of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release
Para. 2 let. b — OJ. L 106 of 17.4.2001, p. 1; the text of the Directive can be obtained from the FOEN, 3003 Bern.
Art. 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 to prove that the experimental release cannot contravene the requirements of Articles 12–14. 2 The application must contain the following documents, in particular: a. details of the objective and context of the experiment; b. a technical dossier with the information in accordance with Annex 3.1; c. the results of previous experiments, in particular: 1. results of preliminary experiments in contained systems to determine biological safety, 2. data, results and evaluations of experimental releases carried out with the same organisms under comparable climatic conditions and with comparable fauna and flora; d. the risk determination and assessment in accordance with Annex 4; e. a monitoring plan to show how the applicant will examine whether the assumptions of the risk determination and assessment in accordance with Annex 4 are correct and whether the measures t
Art. 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 information to prove that the experimental release cannot contravene the requirements of Articles 15 and 16. 2 The application must contain the following documents, in particular: a. details of the objective and context of the experiment; b. a technical dossier with the information in accordance with Annex 3.3; c. the results of previous experiments, in particular: 1. results of preliminary experiments in contained systems to determine biological safety, 2. data, results and evaluations of experimental releases carried out with the same organisms under comparable climatic conditions and with comparable fauna and flora; d. the risk determination and assessment in accordance with Annex 4; e. a monitoring plan to show how the applicant will examine whether the assumptions of the risk determination and assessment in accordance with Annex 4 are correct and whether the m
Art. 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. an experimental release with comparable possible hazards and harm has been authorised in Switzerland, in particular, if it involves the same organisms; b. these organisms originate from the crossing of two organisms that have already been authorised for being put into circulation for direct use in the environment, and it can be shown that the sum of the properties of the crossing do not differ from the sum of the properties of the authorised organisms. [tab] 2 For a simplified licensing procedure, at least the documents in accordance with Article 19 paragraph 2 letters a, d, e and h or in accordance with Article 20 paragraph 2 letters a, d, e and g or Article 21 paragraph 2 letters a, d and e must be submitted.
Art. 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 experimental conditions and the monitoring plan. 2 The applicant or authorisation holder must examine the measures listed in the authorisation and, if the observance of the requirements in accordance with Articles 7–9, 12 and 13 or 15 and 16 is directly and seriously endangered, take the additional measures required. 3 The FOEN shall inform the specialist agencies concerned (Art. 37 para. 1).
Art. 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 publicly accessible and shall encompass, in particular, the following details: a. the actual course of the experimental release; b. description of the deviations from the planned course of the experiment and their evaluation in terms of a hazard to human beings, animals or the environment or an impairment of biological diversity and the sustainable use thereof; c. results and conclusions of the monitoring. 2 The applicant or authorisation holder must submit to the FOEN as soon as possible the rest of the results and findings of the experiment. If these are published in a scientific organ, a copy of the article must be submitted to the FOEN on its publication. 3 The FOEN shall inform the specialist agencies (Art. 37 para. 1).
Section 2 Putting Organisms into Circulation
Art. 25 Licensing requirement
Any person who intends to put the following organisms into circulation for use in the environment either for the first time or for a new use shall require authorisation from the FOEN: a. genetically modified organisms; b. pathogenic organisms; c. alien small invertebrates that are intended for use in the environment and not as pets
Art. 25 — Amended by Annex 5 No 10 of the Containment Ordinance of 9 May 2012, in force since 1 June 2012 (AS 2012 2777).
Art. 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: Application Competent authority Applicable licensing procedure a.therapeutic products Swiss Agency for Therapeutic Products Therapeutic Products Ordinance of 21 September 2018 b.foodstuffs, additives and processing aids Federal Food Safety and Veterinary Office (FSVO) Foodstuffs and Utility Articles Ordinance of 23 November 2005 c.plant propagation material exclusively for use in forests FOEN Release Ordinance of 10 September 2008 d.plant propagation material for all other uses Federal Office for Agriculture (FOAG) Seeds Ordinance of 7 December 1998 e. plant protection products and beneficial organisms FSVO PlantPPO f.fertilisers FOAG Fertilisers Ordinance of 10 January 2001 g.animal feedstuffs FOAG Feedstuffs Ordinance of 26 May 1999 h.... i.... j. biocidal products FOPH Biocidal Products Ordinance of 18 May 200
SR 812.212.21.The reference has been modified as of 1 Jan. 2019 pursuant to Art. 12 para. 2 of the Publications Act of 18 June 2004 (SR 170.512). The change has been made throughout the text. The name of this administrative unit was changed in application of Art. 16 para. 3 of the Publications Ordinance of 17 Nov. 2004 (AS 2004 4937) on 1 Jan. 2014. The change has been made throughout the text. [AS 2005 5451; 2006 4909; 2007 1469 Annex 4 No 47; 2008 789 4377 Annex 5 No 8 5167 6025; 2009 1611; 20
Art. 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 December 1998; b. animal feedstuffs in accordance with Article 21b Feedstuffs Ordinance of 26 May 1999; c. foodstuffs, if the requirements of Article 23 of the Foodstuffs and Utility Articles Ordinance of 23 November 2005 have been fulfilled.
let. a — SR 916.151 let. b — [AS 1999 1780; 2748 Annex 5 No 6; 2001 3294 No II 14; 2002 4065; 2003 4927; 2005 973; 2695 No II 19; 5555; 2007 4477 No IV 70; 2008 3655; 4377 Annex 5 No 14; 2009 2599; 2011 2405. AS 2011 5409 Art. 77]. See now: O of 26 Oct. 2011 (SR 916.307). let. c — [AS 2005 5451; 2006 4909; 2007 1469 Annex 4 No 47; 2008 789 4377 Annex 5 No 8 5167 6025; 2009 1611; 2010 4611; 2011 5273 Art. 37 5803 Annex 2 No II 3; 2012 4713 6809; 2013 3041 No I 7 3669; 2014 1691 Annex 3 No II 4 20
Art. 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 of the applicable licensing procedure in accordance with Article 26, must contain all the required information to prove that the handling of the organisms cannot contravene the requirements of Articles 7–11. 2 The application must contain the following documents, in particular: a. a technical dossier with the information in accordance with Annexes IIIA or IIIB and IV of the Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/ EEC ; b. the results of previous experiments using the same organisms concerning hazards to human beings or the environment, or impairments caused to the same, in particular, experiments in contained systems or, possibly, field trials; c. if available, any authorisations and evaluations from S
Para. 2 let. a — OJ. L 106 of 17.4.2001, p. 1; the text of the Directive can be obtained from the FOEN, 3003 Bern. Para. 2 let. i — Inserted by Annex No 4 of the Nagoya Ordinance of 11 Dec. 2015, in force since 1 Feb. 2016 (AS 2016 277). Para. 2 let. i — SR 451.61
Art. 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 licensing procedure in accordance with Article 26, must contain all the required information to prove that the handling of the organisms cannot contravene the requirements of Articles 12–14. 2 The application must contain the following documents, in particular: a. a technical dossier with the information in accordance with Annex 3.2; b. the results of previous experiments using the same organisms concerning hazards to human beings or the environment, or impairments caused to the same, in particular, experiments in contained systems or field trials; c. if available, any authorisations and evaluations from Swiss and foreign authorities for the experimental release and putting into circulation of the same organisms; d. a risk determination and assessment in accordance with Annex 4; e. a monitoring plan to show how the applicant will examine whether the assump
Para. 2 let. h — Inserted by Annex No 4 of the Nagoya Ordinance of 11 Dec. 2015, in force since 1 Feb. 2016 (AS 2016 277). Para. 2 let. h — SR 451.61
Art. 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 applicable licensing procedure in accordance with Article 26, must contain all the required information to prove that the handling of the organisms cannot contravene the requirements of Articles 15 and 16. 2 The application must contain the following documents, in particular: a. a technical dossier with the information in accordance with Annex 3.4; b. the results of previous experiments using the same organisms concerning hazards to human beings or the environment, or impairments caused to the same, in particular, experiments in contained systems or, possibly, field trials; c. if available, any authorisations and evaluations from Swiss and foreign authorities for the experimental release and putting into circulation of the same organisms; d. a risk determination and assessment in accordance with Annex 4; e. a monitoring plan to show how the applicant will examin
Para. 2 let. g — Inserted by Annex No 4 of the Nagoya Ordinance of 11 Dec. 2015, in force since 1 Feb. 2016 (AS 2016 277). Para. 2 let. g — SR 451.61
Art. 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 authorisation holder must examine the measures given in the authorisation and, if adherence to any of the requirements of Articles 7–9, 12 and 13 or 15 and 16 is directly and seriously endangered, take the additional measures required. 3 The FOEN shall inform the specialist agencies (Art. 43 para. 1).
Art. 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 circulation must notify the FOEN by two weeks after the release at the latest of: a. his or her name and address; b. the unique identifier of the genetically modified organisms, in accordance with the Annex to the Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms, or, if this is lacking, the identity of the organisms, giving the essential characteristics; c. the sites on which the organisms are being released; d. the timeframe, in particular the beginning and end of the release of the organisms; e. the type of use and release of the organisms. 2 Any person who releases genetically modified organisms directly in the environment must keep records of this; he or she must give the required information to the FOEN and carry out or tolerate investigat
Para. 1 let. b — OJ. L 10 of 16.1.2004, p. 5; the text of the Regulation can be obtained from the FOEN, 3003 Bern.
Section 3 Common Provisions
Art. 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 putting foodstuffs into circulation, the provisions of the legislation on foodstuffs are reserved.
Art. 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 language of the local community where the experimental release will take place. 2 Further copies in the required number should be submitted for public information purposes; these must contain at least the details in accordance with Article 54 paragraph 4.
Art. 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 from the FOEN. 2 Authorisation shall be transferred once the conditions for authorisation have been fulfilled.