Considerations on COM(2005)284 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinate-ammonium

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dossier COM(2005)284 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L., line 1507) genetically ...
document COM(2005)284 EN
date November  3, 2005
 
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 a Member State, 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 1507) was submitted by Pioneer Hi-Bred International, INC and Mycogen Seeds to the competent authority of the Netherlands (ref C/NL/00/10).

(3)The notification covers importation and use as for any other maize grains including feed, with the exception of cultivation and uses as or in food, in the Community, of varieties derived from the 1507 transformation event.

(4)In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, the competent authority of the Netherlands prepared an assessment report, which was submitted to the Commission and the competent authorities of the other Member States; whereby the assessment report concluded that no reasons have emerged on the basis of which consent for the placing on the market of Zea mays L. line 1507 should be withheld, provided that specific conditions are fulfilled.

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

(6)The opinion adopted on 24 September 2004 by the European Food Safety Authority, concluded that Zea mays L. line 1507 is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed use. The European Food Safety Authority also deemed that the monitoring plan provided by the applicant was in line with the intended uses of 1507 maize.

(7)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 1507 will adversely affect human or animal health or the environment.

(8)A unique identifier should be assigned to the 1507 maize for the purposes of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (2) and Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (3).

(9)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 (4).

(10)In view of the opinion of the European Food Safety Authority, it is not necessary to establish specific conditions for the intended uses with regard to the handling or packaging of the product and the protection of particular ecosystems, environments or geographical areas.

(11)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 validated detection methodology, should be applicable.

(12)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 (5) the measures should be adopted by the Commission;