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. 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 incomplete, it shall return this to the applicant for supplementation or revision, indicating which information is lacking. 2 It shall give notice of receipt of the application in the Federal Gazette, when the application is complete, and shall ensure that the non-confidential documents are displayed for 30 days for examination: a. at the FOEN; b. in the local commune where the experimental release will take place. 3 Any person who claims party rights in accordance with the the Federal Act of 20 December 1968 on Administrative Procedure must object in writing during the display period, giving details of their party status. 4 During the display period all further persons may submit a written statement on the files. 5 The FOEN may take part in public information events to inform the public about the progress of the procedure.
Para. 3 — SR 172.021
Art. 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 shall forward the application to the following other authorities, who shall evaluate it in their field of responsibility and state their position within 50 days: a. the FOPH, FSVO and FOAG; b. the Swiss Expert Committee for Biosafety (SECB) and the Federal Ethics Committee on Non-human Biotechnology (ECNH); c. the designated authority of the canton in question for information about local features. 2 The FOEN shall supply the specialist agencies with the submissions in accordance with Article 36 paragraphs 3 and 4. 3 It shall supply the specialist agencies’ statements to the parties for their comments and the specialist agencies reciprocally for their information. 4 If the examination shows that the documents submitted are insufficient for assessing the application, the FOEN shall request additional documents from the applicant, stating the reasons
Art. 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 the receipt of the application in the Federal Gazette plus any extension of deadline, if: a. examination of the application, in particular the risk assessment in accordance with Annex 4, leads to the conclusion that, given the current state of scientific knowledge and experience, the experimental release cannot endanger human beings, animals and the environment or harm biological diversity and the sustainable use thereof (Art. 7 and 8, 12 and 13, or 15 and 16); b. the information sought cannot be gained through further experiments in contained systems; c. in the case of genetically modified organisms, additionally: 1. production that does not use genetically modified organisms and consumers’ freedom of choice are not harmed (Art. 9), 2. the assessment of the application, in particular based on the ev
Art. 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 documentation in accordance with Article 19 paragraph 2 letters b, c, f and g, or in accordance with Article 20 paragraph 2 letters b, c and f, or Article 21 paragraph 2 letters b, c and f; b. shorten the deadlines for statements to be submitted.
Art. 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 shall inform the FOEN. 2 In the case of information in accordance with paragraph 1 and Article 23, the FOEN shall, with the consent of the federal agencies involved in the procedure, prescribe appropriate measures. In particular, it may require that: a. the risk determination and assessment (Art. 19 para. 2 let. d, 20 para. 2 let. d, or 21 para. 2 let. d) be carried out again; b. the conditions of the experimental release be changed; c. the experimental release be interrupted or if necessary terminated and, as far as possible, the original conditions restored. 3 It shall consult the SECB and the ECNH.
Art. 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 representatives, in particular, of the canton in which the experimental release is taking place. The supervisory group: a. shall monitor the carrying out of the experimental release by spot checks at the site and examine, in particular, adherence to the conditions and stipulations associated with authorisation; in particular it shall have unannounced access to the site of the experimental release, it may take samples, and it may view all documents; b. shall inform the FOEN without delay about deviations from the conditions and stipulations associated with authorisation or about other observations and findings relevant to safety; c. may, with the agreement of the FOEN, provide public information about its mandate and planned procedure; d. shall keep records of its activities as well as its observations and findings; e. shall, af
Section 2 Putting Organisms into Circulation
Art. 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 return this to the applicant for supplementation or revision, indicating which information is lacking. 2 If the application concerns organisms that will be handled directly in the environment, the licensing authority shall announce receipt of the application in the Federal Gazette, once the application is complete, and shall ensure that the non-confidential documents are displayed for 30 days for examination. 3 During the display period, any person may submit a written statement on the application. Any person who makes use of this opportunity does not acquire party rights in the licensing procedure through this alone. 4 If the organisms concerned are genetically modified or pathogenic organisms that will be handled directly in the environment, the environmental protection organisations in accordance with Article 28 GT
Art. 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 specialist agencies, who shall evaluate it in their field of responsibility and state their position: a. the FOPH and FOEN; b. the FSVO and FOAG, if the application falls within their area of responsibility; c. the SECB and the ECNH. 2 The licensing authority shall supply the specialist agencies with the details in accordance with Article 42 paragraphs 3 and 4. 3 It shall supply the specialist agencies’ statements to the parties concerned for their comments and the specialist agencies reciprocally for their information. 4 If the examination shows that the documents submitted are insufficient for assessing the application, the FOEN shall request additional documents from the applicant and request comments on them from the parties and the specialist agencies.
Art. 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 of the application leads to the conclusion that: a. the requirements of the applicable licensing procedure have been fulfilled; b. putting the organisms into circulation cannot endanger human beings, animals and the environment or harm biological diversity and the sustainable use thereof (Art. 7 and 8, 12 and 13, or 15 and 16); c. in the case of genetically modified organisms, additionally: 1. production that does not use genetically modified organisms (Art. 9) and consumers’ freedom of choice are not impaired, 2. the assessment of the application, in particular based on the evaluation of interests in accordance with Article 8 GTA , leads to the conclusion that the genetic modification has not failed to respect the dignity of living beings in the animals or plants used; d. putting the organism
Para. 1 let. e — Inserted by Annex No 4 of the Nagoya Ordinance of 11 Dec. 2015, in force since 1 Feb. 2016 (AS 2016 277). Para. 1 let. e — SR 451.61
Art. 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 authority. 2 The specialist agencies whose agreement is necessary for the issue of authorisation may demand that the licensing authority, in particular: a. change the conditions imposed for the putting the organisms into circulation; b. if necessary, prohibit putting the organisms into circulation temporarily or indefinitely; c. in serious cases, order the return of organisms put into circulation. 3 If the licensing authority comes into possession of such new findings or if such new findings are reported by the applicant or authorisation holder (Art. 31), it shall order the necessary measures after consulting the SECB and the ECNH, and with the agreement of the federal agencies involved in the procedure. No consultation is required for precautionary measures if the risk is imminent. The lic
Art. 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 with documentation, if there is reason to believe that organisms put into circulation could endanger human beings, animals or the environment, or could harm biological diversity or the sustainable use thereof. It shall give the distributor sufficient time to respond. The FOEN shall consult further federal agencies as required. 2 The FOEN may: a. demand that the person responsible for putting the organisms into circulation repeat the self-supervision within a certain period and, if necessary, supplement or amend it; b. prescribe the form and the content of the information supplied to recipients, in particular the details of the organisms’ properties and the recommendations and instructions for their handling in the environment; c. demand that the person responsible for putting the organisms into circulation remo
Art. 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 Therapeutic Products Act of 15 December 2000; b. for foodstuffs and utensils in accordance with the Foodstuffs Act of 9 October 1992; c. for plant propagation materials exclusively for use in forests in accordance with the Forests Ordinance of 30 November 1992; d. for plant propagation materials for all other uses in accordance with the Seeds Ordinance of 7 December 1998; e. for plant protection products in accordance with the PlantPPO; f. for fertilisers in accordance with the Fertilisers Ordinance of 10 January 2001; g. for animal feedstuffs in accordance with the Feedstuffs Ordinance of 26 May 1999; h. for immunological products for veterinary use in accordance with the Therapeutic Products Act of 15 December 2000; i. ... j. for biocidal products in accordance with the Biocidal Products Ordinance of 18 May 2005. 2 The responsible authority shall inform the FOEN a
Para. 1 let. a — SR 812.21 Para. 1 let. b — [AS 1995 1469; 1996 1725 Annex No 3; 1998 3033 Annex No 5; 2001 2790 Annex No 5; 2002 775; 2003 4803 Annex No 6; 2005 971; 2006 2197 Annex No 94 2363 No II; 2008 785; 2011 5227 No I 2.8; 2013 3095 Annex 1 No 3. AS 2017 249 Annex No I]. See now: the FA of 20 June 2014 (SR 817.0). Para. 1 let. c — SR 921.01 Para. 1 let. d — SR 916.151 Para. 1 let. e — Amended by Annex 10 No II 6 of the Plant Protection Products Ordinance of 20 Aug. 2025, in force since 1
Art. 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 subject to the controls stipulated by Article 47. 2 The cantonal authorities shall monitor by spot checks or at the request of the FOEN, in particular, whether: a. the regulations regarding the informing of recipients (Art. 5) are being observed; b. the putting of genetically modified or pathogenic organisms into circulation has been authorised; c. the handling of particular organisms is not prohibited; cbis. the putting of specific organisms into circulation is not prohibited; d. the conditions and stipulations linked to the authorisation for putting the organisms into circulation are being observed; e. genetically modified organisms are correctly labelled (Art. 10); f. the measures prescribed by the FOEN in accordance with paragraph 4 are being implemented. 3 If the monitoring shows that the provisions of paragraph 2 letters b-f are being contravened, the c
Para. 2 let. cbis — Inserted by No I of the O of 1 March 2024, in force since 1 Sept. 2024 (AS 2024 116).
Art. 48a Enforcement by the Federal Office for Customs and Border Security in relation to prohibited invasive alien organisms
1 The Federal Office for Customs and Border Security (FOCBS) shall monitor whether the import of organisms complies with the obligations in Article 15 paragraphs 2 and 2bis; to this end it shall in consultation with the FOEN conduct physical checks for limited periods of time. 2 If it detects or suspects an offence, the FOCBS may seize the goods temporarily; it shall inform the FOEN, which shall decide on how to proceed. If the FOEN orders the forfeiture of the goods, the FOCBS shall advise the person required to declare the goods that the goods may be disposed of at their current location rather than being forfeited. 3 The FOCBS shall provide the FOEN with the data required to enforce Article 15 paragraphs 2 and 2bis.
Art. 48a — Inserted by No I of the O of 1 March 2024, in force since 1 Sept. 2024 (AS 2024 116).
Section 3 Monitoring the Duty of Care
Art. 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 complaint, the canton in question shall order the necessary measures to be taken.
Section 4 Monitoring Environmental Pollution and C
Art. 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 this purpose it shall ensure, as required: a. the development of appropriate methods to detect these organisms, these properties or this genetic material in the environment; b. the targeted investigation of environmental samples for the presence of these organisms, these properties or this genetic material.
Art. 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 modified organisms and their transgenic genetic material, or by invasive alien organisms. 2 For this purpose, it shall designate the specific monitoring objectives and shall stipulate the required methods, indicators and assessment criteria. Before establishing the methods, indicators and assessment criteria, it shall consult the federal agencies and cantons concerned and the stakeholders. 3 For the monitoring, it shall use, as far as possible, data from existing monitoring systems in the environmental and agricultural sector, and shall also examine particular observations of third parties. 4 The federal and cantonal authorities responsible for enforcing this Ordinance shall provide the FOEN with the necessary information on request; in particular the FOAG shall supply the data on the basis of the Ordina
Para. 4 — SR 919.117.71 Para. 4 — SR 910.13 Para. 4 — SR 910.18 Para. 4 — SR 919.118 Para. 4 — Amended by Annex 8 No 3 of the Plant Health Ordinance of 31 Oct. 2018, in force since 1 Jan. 2020 (AS 2018 4209).
Art. 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 control measures and, if necessary and useful, measures to prevent their future occurrence. 2 The cantonal authorities shall inform the FOEN and other affected federal agencies about the occurrence and control of such organisms. They may draw up a publicly accessible cadastral register of the sites of the organisms. 3 The FOEN shall coordinate, as far as is necessary, the control measures and shall develop, together with the other affected federal agencies and the cantons, a national strategy to control the organisms. 4 Regulations in other federal legislation on the control of harmful organisms are reserved.
Art. 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 impairments of biological diversity and the sustainable use thereof and the presence of pathogenic, alien or genetically modified organisms or their transgenic material, the authorisation holder shall bear the costs: a. of determining the damage, the impairment and the causal connection; b. of the prevention and remediation of the damage and the impairment. 2 The costs in accordance with paragraph 1 shall also be borne by persons who carry out experimental releases that are not subject to authorisation or who put organisms not subject to authorisation into circulation, if it can be shown with sufficient probability that they have caused the damage.
Section 5 Accessibility of Information
Art. 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 pathogenic or alien organisms, shall be made public, in the absence of any legitimate and overriding private or public interests. 2 The FOEN shall provide public information about the results of the surveys (Art. 50), of the monitoring (Art. 51) and the control (Art. 52), in the absence of any legitimate and overriding private or public interests. 3 In particular, the protection of business and production secrets shall be worthy of protection. 4 The following information shall in every case be made public: a. the names and addresses of those responsible for the experimental release or for putting the organisms into circulation; b. a general description of the organisms and their properties; c. the aim of the experimental release or the use of the organisms being put into circulation; d. the site of the experimen
Art. 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 shall classify this information as such when forwarding it to other authorities. 2 Any person submitting documents to the authorities must: a. indicate information which is to be treated as confidential; and b. justify the need for confidentiality. 3 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.
Art. 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 also maintain a register of genetically modified organisms authorised for being put into circulation. The federal and cantonal authorities responsible for enforcing this Ordinance shall provide the necessary information. 3 It shall maintain a register of genetically modified organisms authorised for being put into circulation that are released directly (Art. 32); the register shall record what, when, where and for what purpose the release was carried out. 4 The registers shall contain no confidential information and shall be publicly accessible via automated information and communication services. They may be published in full or in part.
Section 6 Fees
Art. 57
1 Fees shall be charged for orders and services provided by the FOEN in accordance with the Ordinance of 3 June 2005 on the Fees charged by the FOEN. 2 A fee shall be charged for statements from federal agencies that submit a statement as part of the issuing of orders and the provision of services by the FOEN in accordance with Article 8 of the General Ordinance on Charges of 8 September 2004.
Para. 1 — SR 814.014 Para. 2 — SR 172.041.1
Section 7 Further Duties of the FOEN and of DETEC
Art. 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 FOPH shall ensure basic and continuing professional education events are held regularly for persons who carry out duties under this Ordinance.
Art. 59 Modification of the lists in Annexes2.1 and 2.2
The DETEC shall modify the lists in Annex 2.1 and 2.2 after consulting the federal agencies concerned, the cantons and other stakeholders concerned if it comes into possession of new findings about the invasiveness of alien organisms.
Art. 59 — Amended by No I of the O of 1 March 2024, in force since 1 Sept. 2024 (AS 2024 116).