LegalizeRegulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (Text with EEA relevance)
Placing on the market of traces of a GMO or combination of GMOs in products intended for direct use as food or feed or for processing shall be exempted from Articles 13 to 21 provided that they meet the conditions referred to in Article 47 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed ([^E0010]).
This Article shall be applicable for a period of three years after the date of application of Regulation (EC) No 1829/2003.
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- The following Article shall be inserted: ‘Article 26a Measures to avoid the unintended presence of GMOs
Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.
The Commission shall gather and coordinate information based on studies at Community and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of genetically modified, conventional and organic crops.’
Article 44
Information to be provided in accordance with the Cartagena Protocol
Any authorisation, renewal, modification, suspension or revocation of authorisation of a GMO, food or feed referred to in Articles 3(1)(a) or (b) or 15(1)(a) or (b) shall be notified by the Commission to the Parties to the Cartagena Protocol through the biosafety clearing house in accordance with Article 11(1) or Article 12(1) of the Cartagena Protocol, as the case may be.
The Commission shall provide a copy of the information, in writing, to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the biosafety clearing house.
The Commission shall also process requests for additional information made by any Party in accordance with Article 11(3) of the Cartagena Protocol and shall provide copies of the laws, regulations and guidelines in accordance with Article 11(5) of that Protocol.
Article 45
Penalties
The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission six months after the date of entry into force of this Regulation at the latest and shall notify it without delay of any subsequent amendment affecting them.
Article 46
Transitional measures for requests, labelling and notifications
Requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be transformed into applications under Chapter II, Section 1 of this Regulation where the initial assessment report provided for under Article 6(3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with Article 6(3) or (4) of Regulation (EC) No 258/97. Other requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be processed under the provisions of Regulation (EC) No 258/97, notwithstanding Article 38 of this Regulation.
The labelling requirements referred to in this Regulation shall not apply to products, the manufacturing process of which has commenced before the date of application of this Regulation, provided that these products are labelled in accordance with the legislation applicable to them before the date of application of this Regulation.
Notifications concerning products including their use as feed submitted under Article 13 of Directive 2001/18/EC before the date of application of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation where the assessment report provided for in Article 14 of Directive 2001/18/EC has not yet been sent to the Commission.
Requests submitted for products referred to in Article 15(1)(c) of this Regulation under Article 7 of Directive 82/471/EEC before the date of application of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation.
Requests submitted for products referred to in Article 15(1) of this Regulation under Article 4 of Directive 70/524/EEC before the date of application of this Regulation shall be supplemented by applications under Chapter III, Section 1 of this Regulation.
Article 47
Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation
The presence in food or feed of material which contains, consists of or is produced from GMOs in a proportion no higher than 0,5 % shall not be considered to be in breach of Article 4(2) or Article 16(2), provided that:
- (a) this presence is adventitious or technically unavoidable;
- (b) the genetically modified material has benefited from a favourable opinion from the Community Scientific Committee(s) or the Authority before the date of application of this Regulation;
- (c) the application for its authorisation has not been rejected in accordance with the relevant Community legislation; and
- (d) detection methods are publicly available.
In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of such materials.
Measures designed to amend non-essential elements of this Regulation by supplementing it and lowering the thresholds referred to in paragraph 1, in particular for GMOs sold directly to the final consumer, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(3).
Detailed rules for implementing this Article shall be adopted in accordance with the procedure referred to in Article 35(2).
This Article shall remain applicable for a period of three years after the date of application of this Regulation.
Article 48
Review
No later than 7 November 2005 and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation and in particular of Article 47, accompanied, where appropriate, by any suitable proposal. The report and any proposal shall be made accessible to the public.
Without prejudice to the powers of national authorities, the Commission shall monitor the application of this Regulation and its impact on human and animal health, consumer protection, consumer information and the functioning of the internal market and, if necessary, will bring forward proposals at the earliest possible date.
Article 49
Entry into force
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
It shall apply from six months after the date of publication of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
DUTIES AND TASKS OF THE COMMUNITY REFERENCE LABORATORY
- 1.The Community reference laboratory referred to in Article 32 is the Commission's Joint Research Centre.
- 2.For the duties and tasks outlined in this Annex, the Community reference laboratory shall be assisted by the national reference laboratories referred to in Article 32, which shall consequently be considered as members of the consortium referred to as the ‘European Network of GMO laboratories’.
- 3.The Community reference laboratory shall be responsible, in particular, for:
- (a) the reception, preparation, storage, maintenance and distribution to the members of the European Network of GMO laboratories of the appropriate positive and negative control samples, subject to assurance given by such members of the respect of the confidential nature of the data received where applicable;
- (b) without prejudice to the responsibilities of the Community reference laboratories laid down in Article 32 of Regulation (EC) No 882/2004 of the European Parliament and of the Council ([^E0011]), the distribution to national reference laboratories within the meaning of Article 33 of that Regulation of the appropriate positive and negative control samples, subject to assurance given by such laboratories of the respect of the confidential nature of the data received where applicable;
- (c) evaluating the data provided by the applicant for authorisation for placing the food or feed on the market, for the purpose of testing and validation of the method for sampling and detection;
- (d) testing and validating the method for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed;
- (e) submitting full evaluation reports to the Authority.
- 4.The Community reference laboratory shall play a role in dispute settlements concerning the results of the tasks outlined in this Annex, without prejudice to the responsibilities of the Community reference laboratories laid down in Article 32 of Regulation (EC) No 882/2004.
[^E0001]: OJ L 126, 13.5.1983, p. 23.
[^E0002]: Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
[^E0003]: OJ L 268, 18.10.2003, p. 1.’
[^E0004]: OJ L 268, 18.10.2003, p. 1.’
[^E0005]: OJ L 31, 1.2.2002, p. 1.’
[^E0006]: OJ L 268, 18.10.2003, p. 1.’
[^E0007]: OJ L 31, 1.2.2002, p. 1.’
[^E0008]: OJ L 268, 18.10.2003, p. 1.
[^E0009]: OJ L 31, 1.2.2002, p. 1.’
[^E0010]: OJ L 268, 18.10.2003, p. 1.’
[^E0011]: OJ L 165, 30.4.2004, p. 1, as corrected by OJ L 191, 28.5.2004, p. 1.
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