Brussels, Apr 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. line MON 863) genetically modified for resistance to corn rootworm
1. In accordance with Article 13 of Directive 2001/18/EC , the German authorities received a notification (Reference C/DE/02/09) concerning the placing on the market of maize product (Zea mays L. line MON 863 and hybrid MON 863 x MON 810), genetically modified for resistance to different insects.
2. The notification covers importation and use as for any other maize grains including feed but not food use, with the exception of the cultivation in the Community of varieties derived from the MON 863 transformation event as well as with the exception of the cultivation in the Community of MON 863 x MON 810 hybrids.
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 MON 863 maize as well as MON 863 x MON 810 maize should be withheld, if 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 said report in terms of molecular characterisation, agronomic equivalence, sampling methods, antibiotic resistance marker gene, allergenicity, toxicity and monitoring of the product.
5. Since objections were maintained, the Commission decided to consult the European Food Safety Authority (EFSA). The EFSA concluded, in an opinion adopted on 2 April 2004, that from all evidence provided, the Zea mays L. line MON 863 is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed use. The EFSA also found that the scope of the monitoring plan provided by the applicant is in line with the intended uses of MON 863.
6. Concerning hybrid MON 863 x MON 810, the EFSA 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 hybrid MON 863 x MON 810, but decided regarding 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. Thus, only the safety assessment of the maize line MON 863 has been finalised.
7. Under such circumstances, Article 18 of Directive 2001/18/EC requires the Commission 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 to the provisions of Article 8 thereof.
8. Since both the German authorities and the EFSA gave a positive assessment concerning the placing on the market of MON 863 maize, the Commission prepared a draft Decision authorising the use of this product, with the exception of cultivation and uses as or in food, and its placing on the market subject to specific conditions. Regarding hybrid MON 863 x MON 810, the Commission decided not to propose any decision pending the availability and assessment of the scientific information requested by EFSA. 9. The draft Decision was submitted, in accordance with Article 5(2) of Decision 1999/468/EC , for opinion, to the Committee set up under Article 30 of Directive 2001/18/EC .
10. The Committee has not delivered an opinion on 29 November 2004, which requires that, the Commission, in accordance with Article 5(4) of Decision 1999/468/EC , shall, without delay, submit to the Council a proposal relating to the measures to be taken and shall inform the European Parliament.
11. 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.