Proposed Decision establishing the information format for notifications of GMO products that are to be placed on the market

July 8, 2002

Brussels, 05 July 2002

Proposal for a
establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products Full Text


1. Under Part C of Directive 2001/18/EC , prior notification must be given to the competent national authority of the planned placing on the market of a genetically modified organism (GMO), or a combination of such organisms.

2. That notification comprises, inter alia, a summary of the relevant dossier, which the competent authority must send to the competent authorities of the other Member States and to the Commission, and which the Commission must immediately make available to the public. That summary must be drawn up in accordance with a particular format.

3. That format should reflect the need to enable the fullest possible exchange of relevant information, presented in a standardised and easily comprehensible manner, without prejudice to the fact that the information thus provided cannot serve as the basis for an environmental risk assessment.

4. Article 13(2)(h) of the Directive stipulates that the summary notification information format must be drawn up in accordance with the procedure laid down in Article 30. A draft of the measures to be taken has accordingly been submitted for opinion to the committee set up under Article 30 of the Directive.

5. The committee has not delivered an opinion on the proposal. In such a case, Article 30 stipulates that the Commission must forthwith propose to the Council the measures to be adopted and inform the European Parliament thereof. The Council must then act by qualified majority.

6. If, by the expiry of the time limit, the Council has not adopted the proposed implementing measures or has not indicated its opposition to the proposed implementing measures, they shall be adopted by the Commission.

Brussels, 04.07.2002 COM(2002) 362 final

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