Considerations on COM(2004)193 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L. line NK603) genetically modified for glyphosate tolerance

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dossier COM(2004)193 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L. line NK603) genetically ...
document COM(2004)193 EN
date September 18, 2004
 
table>(1)Pursuant to Directive 2001/18/EC, the placing on the market of a product containing or consisting of a genetically modified organism or a combination of genetically modified organisms is subject to written consent being granted by the competent authority of the Member State that received the notification for the placing on the market of that product in accordance with the procedure laid down in that Directive.
(2)A notification concerning the placing on the market of a genetically modified maize product (Zea mays L. line NK603), to be used as any other maize but not for cultivation, was submitted by Monsanto SA to the competent authority of Spain which transmitted it to the Commission and to the competent authorities of other Member States with a positive opinion.

(3)The competent authorities of other Member States raised objections to the placing on the market of the product.

(4)The opinion adopted on 25 November 2003 by the European Food Safety Authority, as established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (2), concluded that Zea mays L. line NK603 is as safe as conventional maize and that its placing on the market for food, feed or processing is therefore unlikely to have an adverse effect on human or animal health or, in that context, on the environment.

(5)An examination of each of the objections in the light of Directive 2001/18/EC, of the information submitted in the notification and of the opinion of the European Food Safety Authority, discloses no reason to believe that the placing on the market of Zea mays L. line NK603 will adversely affect human or animal health or the environment.

(6)A unique identifier should be assigned to the product for the purposes of Regulation (EC) No 1830/2003.

(7)Adventitious or technically unavoidable traces of genetically modified organisms in products are exempted from labelling and traceability requirements in accordance with thresholds established under Directive 2001/18/EC and Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (3).

(8)Taking account of the opinion of the European Food Safety Authority, there is no reason to establish specific conditions with regard to the handling or packaging of the product and the protection of particular ecosystems/environments and/or geographical areas.

(9)Prior to the placing on the market of the product, the necessary measures to ensure its labelling and traceability at all stages of its placing on the market, including verification by appropriate detection methodology, should be applicable.

(10)The measures provided for in this Decision are not in accordance with the opinion of the Committee established under Article 30 of Directive 2001/18/EC and the Commission therefore submitted to the Council a proposal relating to these measures. Since on the expiry of the period laid down in Article 30(2) of Directive 2001/18/EC the Council had neither adopted the proposed measures nor indicated its opposition to them in accordance with Article 5(6) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (4) the measures should be adopted by the Commission,