Considerations on COM(2005)564 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L., hybrid MON 863 x MON 810) genetically modified for resistance to corn rootworm and certain lepidopteran pests of maize

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dossier COM(2005)564 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L., hybrid MON 863 x MON 810) ...
document COM(2005)564 EN
date January 13, 2006
 
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 two genetically modified maize products (Zea mays L., line MON 863 and hybrid MON 863 × MON 810) was submitted by Monsanto Europe S.A. to the competent authority of Germany (Reference C/DE/02/9). A unique identifier (MON-ØØ863-5×MON-ØØ81Ø-6) has been assigned to the MON 863 × MON 810 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).

(3)The notification originally covered importation and use as for any other maize grains including feed, with the exception of food use and cultivation in the Community of varieties derived from the MON 863 transformation event and of the MON 863 × MON 810 hybrid.

(4)In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, the competent authority of Germany prepared an assessment report, which was forwarded in April 2003 to the Commission. The Commission forwarded the full notification and assessment report to the other Member States in May 2003. That assessment report concludes that no reasons have emerged on the basis of which consent for the placing on the market of MON 863 as well as MON 863 × MON 810 should be withheld, if specific conditions are fulfilled.

(5)The competent authorities of other Member States raised objections to the placing on the market of MON 863 as well as MON 863 × MON 810.

(6)The placing on the market of MON 810 maize is authorised in accordance with Commission Decision 98/294/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line MON 810), pursuant to Council Directive 90/220/EEC (4). The placing on the market of MON 863 is authorised in accordance with Commission Decision 2005/608/EC of 8 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line MON 863) genetically modified for resistance to corn rootworm (5).

(7)On 2 April 2004, the European Food Safety Authority considered that it is scientifically valid to use the data from the single lines MON 863 and MON 810 to support the safety assessment of MON 863 × MON 810, but decided, with regard to the need for confirmatory data for the safety assessment of the hybrid itself, to request a 90-day sub-chronic rat study with the maize hybrid in order to complete its safety assessment.

(8)The opinion adopted on 8 June 2005 by the European Food Safety Authority, concluded, from all evidence provided, that MON 863 × MON 810 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 scope of the monitoring plan provided by the applicant was in line with the intended uses of MON 863 × MON 810.

(9)On 8 July 2005, Monsanto Europe S.A. agreed to limit the scope of the present Decision to import and processing. An application for the placing on the market of food and feed containing, consisting of, or produced from MON 863 × MON 810 has been made by Monsanto Europe S.A. under Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (6).

(10)An examination of the information submitted in the notification, the objections maintained by Member States in the framework of Directive 2001/18/EC, and the opinion of the European Food Safety Authority, discloses no reason to believe that the placing on the market of Zea mays L. hybrid MON 863 × MON 810 will adversely affect human or animal health or the environment.

(11)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.

(12)In the light 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.

(13)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.

(14)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 (7), the measures should be adopted by the Commission,