Brussels, 11 Nov 2005
Proposal for a
COUNCIL DECISION 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., hybrid MON 863 x MON 810) genetically modified for resistance to corn rootworm and certain lepidopteran pests of maize
1. In accordance with Article 13 of Directive 2001/18/EC , the German authorities received a notification (Reference C/DE/02/9) concerning the placing on the market 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.
2. The notification originally covered importation and use as for any other maize grains including feed, with the exception of food use and cultivation. In July 2005 Monsanto Europe S.A. agreed to limit the scope of the notification to import and processing, given that the placing on the market of feed products containing, consisting of, or produced from MON 863 x MON 810 maize was covered in its application under Regulation (EC) No 1829/2003 .
3. In accordance with Article 14 of the Directive, the German competent authority forwarded to the Commission its assessment report of the notification, which concluded that no reasons have emerged on the basis of which consent for the placing on the market of the Zea mays L. hybrid MON 863 x MON 810 should be withheld, provided that specific conditions are fulfilled.
4. The Commission forwarded the assessment report to all other Member States, some of which raised and maintained objections to the report in terms of molecular characterisation, allerginicity, toxicity, inadequate monitoring plan, accidental spillage, presence of an antibiotic resistance marker gene and detection of the product; whereby the Commission in accordance with Article 18 of Directive 2001/18/EC is required to take a decision in accordance with the procedure laid down in Article 30(2) of the Directive to which Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard the provisions of Article 8 thereof.
6. The Committee has not delivered an opinion, which requires that the Commission, in accordance with Article 5(4) of Decision 1999/468/EC , must, without delay, submit to the Council a proposal relating to the measures to be taken and inform the European Parliament (informed on 22 September 2005), which may consider appropriate to take a position in accordance with Article 8 of the above Decision.
7. Article 5(6) of Decision 1999/468/EC provides that the Council may, where appropriate in view of any such position, act by qualified majority within a period set at three months in accordance with Article 30(2) of Directive 2001/18/EC . If within that three-month period, the Council has indicated by qualified majority that it opposes the proposal, the Commission shall re-examine it; whereas if, on expiry of that period, the Council has neither adopted the proposed implementing act nor indicated its opposition, then the proposed implementing act shall be adopted by the Commission.