Proposed Council Decision concerning the placing on the market of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests and for tolerance to the he

Brussels, 29 Jun 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 1507) genetically modified for resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinate-ammonium
Full Text

EXPLANATORY MEMORANDUM

1. In accordance with Article 13 of Directive 2001/18/EC , the Dutch authorities received a notification (Reference C/NL/00/10) concerning the placing on the market of maize product (Zea mays L. line 1507), genetically modified for resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinate-ammonium.

2. 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.

3. In accordance with Article 14 of the Directive, the Dutch 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. line 1507 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 said report in terms of molecular characterisation, sampling methods, 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 24 September 2004, that from all evidence provided, the 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 EFSA also found that the scope of the monitoring plan provided by the applicant is in line with the intended uses of 1507 maize.

6. 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.

7. Since both the Dutch authorities and the EFSA gave a positive assessment concerning the placing on the market of 1507 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.

8. 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 .

9. The Committee did not deliver an opinion on 17 May 2005, 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 ­ which was informed on 24 May 2005.

10. 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.

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Brussels, 29.6.2005 COM(2005) 284 final Previous Item Back to Titles Print Item