Brussels, 26 Jul 2005
Proposal for a
COUNCIL DECISION authorising the placing on the market of foods and food ingredients derived from genetically modified maize line MON 863 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
The attached draft Council Decision concerns foods and food ingredients derived from genetically modified maize line MON 863, for which a request for placing on the market was submitted by Monsanto to the competent authorities of Germany on 15 July 2002, under Regulation (EC) No 258/97 .
Following the initial assessment report from Germany, who came to the conclusion that an additional assessment was required because of the presence of an antibiotic resistance marker gene (nptII) used in the product concerned, reasoned objections were raised by some Member States. These objections were referred to the European Food Safety Authority which delivered the opinion, on 2 April 2004, that MON 863 maize is as safe as conventional maize. The detection method was validated by the Joint Research Centre (JRC).
Regulation (EC) No 1829/2003 on GM food and feed is applicable from 18 April 2004. In the light of Article 46(1) of this Regulation, requests submitted under Regulation (EC) No 258/97 before 18 April 2004 and for which an additional assessment report has been transmitted to the Commission before that date, shall be processed under Regulation (EC) No 258/97 .
Against this background, a draft Commission Decision to place food and food ingredients produced from modified maize line MON 863 on the Community market was submitted to the Standing Committee on Food Chain and Animal Health, on 19 May 2005, for vote. Ten Member States voted in favour, eight Member States voted against and six Member States abstained. One Member State was not present.
The Committee delivered no opinion. Consequently, pursuant to Article 13, paragraph 4 b) of Regulation (EC) No 258/97 and in accordance with Article 5 of Council Decision 1999/468/EC , the Commission is required to submit to the Council a proposal relating to the measures to be taken, the Council having three months in which to act by a qualified majority, and inform the Parliament.