Brussels, 01 Aug 2005
Proposal for a
authorising the placing on the market of foods and food ingredients produced from genetically modified Roundup Ready maize line GA21 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 produced from genetically modified maize line GA21, for which a request for placing on the market was submitted by Monsanto to the competent authorities of the Netherlands on 24 July 1998, under Regulation (EC) No 258/97 .
Following the initial assessment report from the Netherlands, who considered GA21 maize as safe as conventional maize, reasoned objections were raised by some Member States. These objections were referred to the Scientific Committee on Foods which delivered the opinion, on February 2002, that GA21 maize is as safe as conventional maize. The detection method was validated and published by the Joint Research Centre (JRC) on 17 January 2005.
The original application of Monsanto concerned food and food ingredients derived from genetically modified organisms. On 24 April 2002, Monsanto asked to limit the request to food and food ingredients produced from genetically modified organisms.
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 GA21 on the Community market was submitted to the Standing Committee on Food Chain and Animal Health, on April 2005, for vote. Nine Member States voted in favour, five Member States voted against and eight Member States abstained. Three Member States were 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 The European Parliament was informed on 28 April 2005.