Brussels, 26 Apr 2005
Proposal for a
COUNCIL DECISION concerning the provisional restriction of the use and sale in Germany of genetically modified maize (Zea mays L. line Bt 176) pursuant to Directive 2001/18/EC
1. Concerning the placing on the market of genetically modified maize (Zea mays L. line Bt 176), it has been decided by Commission Decision 97/98/EC of 23 January 1997, pursuant to Council Directive 90/220/EEC , that consent shall be given for the placing on the market of the product.
2. On 5 February 1997 the French authorities granted consent for the placing on the market of that product.
3. Pursuant to Article 35(1) of Directive 2001/18/EC which replaced Directive 90/220/EEC procedures in respect of notifications concerning the placing on the market of genetically modified organisms which have not been completed by 17 October 2002 are subject to the provisions of Directive 2001/18/EC .
4. In accordance with Article 16 of Directive 90/220/EEC , the German authorities informed the Commission on 28 February as well as on 2 March and 4 April 2000 of their decision to provisionally restrict the use and sale of the genetically modified maize in question and gave reasons therefore.
5. The Scientific Committee on Plants considered that the information submitted by Germany did not constitute new relevant scientific evidence which had not been taken into account during the original evaluation of the dossier and which would occasion a review of the earlier opinions of the Scientific Committee on Food, the Scientific Committee for Animal Nutrition and the Scientific Committee for Pesticides on this product.
6. On 9 January as well as on 9 and 17 February 2004 Austria submitted to the Commission additional information in support of its national measures concerning maize line Bt 176.
7. The European Food Safety Authority considered that the information submitted by Austria did not constitute new scientific evidence which would invalidate the environmental risk assessment of maize line Bt 176.
8. Under such circumstances Article 23 of Directive 2001/18/EC requires the Commission to take a decision in accordance with the procedures 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.
9. Since the Scientific Committee on Food, the Scientific Committee for Animal Nutrition, the Scientific Committee for Pesticides and the Scientific Committee on Plants as well as the EFSA considered that the product did not constitute a risk to human health or the environment the Commission prepared a draft Decision asking Germany to repeal its measures concerning maize line Bt 176.
10. 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 . 11. No opinion was delivered by the Committee, following its consultation, 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.
12. 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.