Rs 814.912.21 Order Of November 3, 2004 On The Transboundary Movement Of Genetically Modified Organisms (Order Of Cartagena, Gap)

Original Language Title: RS 814.912.21 Ordonnance du 3 novembre 2004 sur les mouvements transfrontières des organismes génétiquement modifiés (Ordonnance de Cartagena, OCart)

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814.912.21 order on the transboundary movement of GMOs (order of Cartagena, gap) of November 3, 2004 (status on June 1, 2012) the Swiss federal Council, view the art. 19, al. 2, let. a, of the Federal law of 21 March 2003 on genetic engineering, saw the Protocol of Cartagena of 29 January 2000 on the prevention of biotechnological risks relating to the Convention on biological diversity (the Cartagena Protocol), stop: Section 1 provisions general art. 1 scope of application this order regulates the transboundary movement of genetically modified organisms.
It does not apply to the transboundary movement of medicines for human use which contain genetically modified organisms.

Art. 2 definitions in this order, means: a. use in the environment: any use in the environment within the meaning of art. 3, let. i, of the order of 10 September 2008 on the dissemination in the environment (ODE); b. organism genetically modified: any organism genetically modified within the meaning of art. 3, let. d, ODE; c. confined, all confined to the senses of the art. 3, let. h, of the order of 9 may 2012 on contained use (OUC); d. transboundary movement, import, export and the transit of genetically modified organisms; e. Biosafety Clearing House, the international clearinghouse for prevention of biotechnological risks within the meaning of art. 20 of the Cartagena Protocol.

New content according to section 7 of Schedule 5 to the O from 10 sept. 2008 on the release into the environment, in effect since Oct. 1. 2008 (RO 2008 4377).
RS 814.911 new content according to section 7 of Schedule 5 to the O from 10 sept. 2008 on the release into the environment, in effect since Oct. 1. 2008 (RO 2008 4377).
New content according to section 11 of Schedule 5 to the O of 9 may 2012 on contained use, in force since June 1, 2012 (RO 2012 2777).
SR 814.912 Section 2 requirements for the transboundary movement of genetically modified organisms art. 3 duty of care anyone important, exports or makes transit of genetically modified organisms must: a. to act with the precautions that the situation demands so that the GMOs, their metabolites and trained waste can not endanger animals, the environment or, indirectly, human beings; b. manipulate them, pack them, label them and transport them taking into account of the national and international provisions relevant; c. provide , for each cross-border movement, documentation of support within the meaning of art. 4 art. 4 documentation of accompaniment in the case where the organisms genetically modified will be use in the environment, the documentation must contain the following information: a. a clear indication that he is genetically modified organisms; (b) the unique identifier as defined in the annex of the Regulation (EC) No 65/2004 of the Commission of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms or , in the absence of this identifier, the specification of the identity of the bodies with their features and relevant characteristics c. safety rules to be observed for the handling, storage, transport and use of these agencies; (d) the name and address of the person to contact for further information; (e) the name and address of the recipient; (f) a declaration that the movement is in conformity with the requirements of the Cartagena Protocol applicable to the exporter.

Where GMOs are intended to be processed or to be used directly for human or animal food, or when they are medicines for veterinary use, an indication, according to para. 1, let. a, must be supplemented by an indication specifying whether genetically modified organisms which must in no case be introduced directly into the environment.
In the case where the GMOs are intended for use in confined, only apply the requirements of para. 1, let. a to e.

OJ L 10 of 16.01.2004, p. 5. The text of the R is available from the federal Office for the environment (FOEN), 3003 Berne.

Art. 5 import anyone who intends to import genetically modified organisms that will be of use in the environment should be given permission to the senses of the art. 17 or 25 ODE.
Anyone who wants to import genetically modified organisms that will be of use in confined environment must comply with the requirements of the art. 4, 15 and 25 VHF.

RS 814.911 new content according to section 7 of Schedule 5 to the O from 10 sept. 2008 on the release into the environment, in effect since Oct. 1. 2008 (RO 2008 4377).
SR 814.912 new content according to section 11 of Schedule 5 to the O of 9 may 2012 on contained use, in force since June 1, 2012 (RO 2012 2777).

Art. 6 export anyone who intends to export for the first time to a given country of genetically-modified organisms that will be of use in the environment must get prior approval from the competent national authority of that country.
The request filed to that effect must contain at least the information specified in annex I.
A copy of the application and the decision of the importing country must be given to the federal Office for the environment (FOEN).

The name of the administrative unit has been adapted in application of art. 16 al. 3 o from 17 nov. 2004 on official publications (RS 170.512.1). This mod has been taken throughout the text.

Art. 7 obligation to keep a record of export to anyone who exports of genetically modified organisms that will be of use in the environment must keep a register of classified depending on the organizations and their quantity as well as annual exports of the country of destination.
This information must be made, on request, at the disposal of the FOEN.
They must be kept for at least 30 years from the last export.

Section 3 responsibilities of the authorities art. 8 tasks of the FOEN the FOEN is the correspondent for the issues related to the transboundary movement of genetically modified organisms. Its tasks include the following: a. liaise with the Secretariat as defined in art. 24 of the Convention of 5 June 1992 on biological diversity; b. He holds a public register of the non-confidential information contained in applications and decisions according to art. 6, al. 3; the confidentiality of the information is governed by art. 55 ODE.c. He advises exporters failure by an importing country of the time limits set by the Cartagena Protocol; d. it informs the federal Office of public health, the federal Office of agriculture, the federal food safety and Veterinary Affairs Office and the Swiss Institute for therapeutic products, according to their competences defined by the ODE and the OUC, cross-border movements as well as a possible cross-border dissemination unintentional of genetically modified organisms; e. it periodically publishes a report on the transboundary movement of genetically modified organisms; (f) it provides forms for documentation of support within the meaning of art. 4 RS 0.451.43 new content according to section 7 of Schedule 5 to the O from 10 sept. 2008 on the release into the environment, in effect since Oct. 1. 2008 (RO 2008 4377).
RS 814.911 the name of the administrative unit has been adapted to 1 Jan. 2014 in application of art. 16 al. 3 o from 17 nov. 2004 on official publications (RS 170.512.1). This mod has been taken throughout the text.
SR 814.912 art. 9 participation to the international mechanism for exchanging information the FOEN publishes, through the Biosafety Clearing House, information, and the following documents: a. the relevant federal legislation for the purposes of this Ordinance; b. any international agreement concluded by the Switzerland and related to the transboundary movement of genetically modified organisms; c. the name and address of the federal authorities referred to in art. 8, let. d, and 10; d. any decision on import, put into circulation or the experimental release of GMOs; e. any decision about the use in the environment of genetically modified organisms that are intended to be processed or to be used directly for human or animal food. This publication must contain at least the information requested in Schedule 2 and take action within a period of 15 days after the notification of the decision; f. the summaries of the available studies on biological security as well as summaries of other environmental studies relevant; g. unintended information related to cases of transboundary movement; h. reports established under art. 8, let e.

The federal authorities referred to in art. 8, let. d, put the information and documents within the meaning of para. 1 at the disposal of the FOEN.

Art. 10 measures in case of unintentional transboundary movements


In an extraordinary event that can lead to transboundary movement of genetically modified organisms, the cantons concerned shall notify this event to the FOEN and inform the population, the neighbouring cantons and the competent regional authorities of neighbouring countries.
The FOEN notifies the incident to the competent national authorities of neighbouring countries.
The notification to the authorities of neighbouring countries must contain at least the following information: a. estimated quantity and the traits and characteristics of the GMOs; b. the circumstances and date of the dissemination and the use of genetically modified organisms; c. hazards for humans, animals and the environment as well as potential damage to biological diversity and the sustainable use of its components; (d) the possible risk management measures.

In case of extraordinary events in facilities within the meaning of art. 1, al. 2, let. b, and al. 3, let. b, of the Ordinance of 27 February 1991 on major accidents, the provisions of this Ordinance relating to information and the alarm are also applicable.
The FOEN records notifications from abroad and advises the cantons concerned. They inform the public in an appropriate manner.

SR 814.012 art. 11 monitoring the FOEN ensures that the provisions on the export of genetically modified organisms which will be of use in the environment are respected.
He ordered the measures required if the provisions governing export give rise to challenges.
With regard to monitoring of the provisions relating to the importation and transit of genetically modified and the prescription of the measures required, skills are defined by the VHF and the ODE.

SR 814.912 SR 814.911 art. 12 training and development the FOEN ensures that meetings be held necessary to ensure the training and development of individuals who perform tasks under this order.

Art. 13 performance of duties by a third the FOEN may entrust tasks to third parties, including with regard to the compilation of statistics.

Section 4 provisions final art. 14 changes to the law in force.

The mod. can be found at the RO 2012 2777.

Art. 15 entry into force this order comes into force on January 1, 2005.

Annex 1 (art. 6) information to be included in the application according to art. 6. name and address of the exporter; (b) name and address of the importer; (c) name of the genetically modified organism, unique identifier within the meaning of the annex of the Regulation (EC) No 65/2004 of the Commission of 14 January 2004 establishing a system for the development and assignment of identifiers for genetically modified organisms, if the identifier exists, and indication of the group to which belongs the body , to the senses of the art. 6 FM; (d) date of the cross-border movement; e. common names and taxonomy, point of collection or acquisition, and characteristics of biological safety relevant receiving Agency; (f) centres of origin and centres of diversity of the receiving organization and donor agencies, where these centres are known, and description of the habitats where the organisms may persist or proliferate; g. common names and taxonomy point of collection or acquisition, and characteristics of the organization or relevant biological safety donor agencies; h. description of the nucleic acid or of the introduced genetic modification, the technique used and the characteristics of the genetically modified organism resulting; i. intended use of GMOs or products derived, namely transformed material originating with GM agencies , which contains new combinations of replicable genetic material obtained through the use of modern biotechnology detectable; j. quantity or volume of organisms genetically modified to transfer; k. assessment of the risk carried out in accordance with annex 4 ODE; l. methods proposed for the handling, storage, transport, and the safe use of genetically modified organisms, including packaging, labelling , documentation, methods of disposal and emergency procedures to follow as appropriate; Mr. legal status in Switzerland of the organism genetically modified; n. decisions taken by other States in response to a request to export the body genetically modified; o. statement that the above information is accurate.

OJ n L 10 of January 16, 2004, p. 5. The text of the regulation is available from the FOEN, 3003 Bern.
SR 814.912 RS 814.911 State on January 1, 2014, annex 2 (art. 9, para. 1, let. e) information to be provided pursuant to art. 9, al. 1, let. e a. name and address of the applicant; (b) name and address of the authority issuing the decision; (c) name and identity of the organism genetically modified; d. description of the genetic modification, the technique used and the characteristics of the genetically modified organism resulting; e. unique identifier as defined in the annex of the Regulation (EC) No 65/2004 of the Commission of 14 January 2004 establishing a system for development and assignment of unique for organizations identifiers genetically changed; f. common names and taxonomy, point of collection or acquisition, and characteristics of the relevant biological safety receiver body; (g) centres of origin and centres of diversity of the receiving organization and donor agencies, where these centres are known, and description of the habitats where the organisms may persist or proliferate; h. common names and taxonomy, point of collection or acquisition , and characteristics of the organization or relevant biological safety donor agencies; i. permitted uses of genetically modified organisms; j. risk assessment carried out in accordance with annex 4 ODE; k. methods proposed for the handling, storage, transport and safe use of genetically modified organisms, including packaging, labelling, documentation, disposal methods and to follow appropriate emergency procedures.

OJ n L 10 of January 16, 2004, p. 5. The text of the regulation is available from the FOEN, 3003 Bern.
RS 814.911 State on January 1, 2014

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