Containment Ordinance (ContainO)

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In The Matter OfContainment Ordinance (ContainO)
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

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, the Plant Protection Products Ordinance of 20 August 2025 or the Biocidal Products Ordinance of 18 May 2005: a. genetically modified organisms; b. pathogenic organisms; c. organisms subject to a containment obligation: 1. alien small invertebrates, 2. invasive alien organisms as defined in Annex 2.1 of the Release Ordinance, and 3. 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 2018, and organisms that are considered potential quarantine organisms in accordance with the Ordinance issued by the Feder

Para. 1 — SR 814.911 Para. 1 — SR 916.161 Para. 1 — SR 813.12 Para. 1 — Amended by Annex 10 No II 7 of the Plant Protection Products Act of 20 Aug. 2025, in force since 1 Dec. 2025 (AS 2025 565). Para. 1 let. c — Amended by Annex 8 No 4 of the Plant Health Ordinance of 31 Oct. 2018, in force since 1 Jan. 2020 (AS 2018 4209). Para. 1 let. c let. 2 — Amended by Annex No 1 of the O of 1 March 2024, in force since 1 Sept. 2024 (AS 2024 116). Para. 1 let. c let. 3 — SR 916.20

Art. 5a 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; and d. 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 April 2015 on Microbiological Laboratories; b. the competent veterinary authorities responsible for measures to combat disease in accordance with Ar

Art. 5a — Inserted by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131). Para. 2 let. a — SR 818.101.32 Para. 2 let. b — SR 916.401 Para. 2 let. c — SR 916.20

Art. 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 fin

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 asse

Para. 4 — SR 832.321

Section 2 Requirements for Handling Genetically Mo

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 TSV, this must be obtained before starting the activity.

Para. 3 — SR 916.401

Art. 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).

Para. 3 — 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. 3 The competent federal office may order in specific cases that: a. individual spe

Para. 2 — 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); and b. 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; or c. there is a strong suspicion of improper use. 2 The cantons shall inform the competent federal office of any reported incidents.

Para. 1 let. c — Inserted by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).