Brussels, 30 Jun 2004
Proposal for a
authorising the placing on the market of foods and food ingredients derived from genetically modified maize line NK 603 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
On 24 April 2001, Monsanto submitted, under Article 4 of the Novel Food Regulation (EC) N° 258/97 , a request to the competent authorities of the Netherlands for the placing on the market of foods and food ingredients derived from genetically modified maize line NK 603 as novel foods or as novel food ingredients.
The initial assessment report from the Netherlands concluded that foods and food ingredients derived from genetically modified maize line NK 603 were as safe as foods and food ingredients derived from conventional maize and may be used in the same manner but other Member States raised reasoned objections to their placing on the market. Therefore an authorisation Decision via comitology procedure was required in accordance with Article 7 (1) of Regulation (EC) No 258/97 . In view of the Member States' objections, the Commission requested an opinion from the European Food Safety Authority, which was delivered on 25 November 2003 and concluded that NK 603 maize is as safe as conventional maize and therefore its placing on the market for food or feed or processing is unlikely to have an adverse effect on human and animal health and, in that context, the environment1.
Against this background, a draft Commission Decision to place food and food ingredients derived from genetically modified maize line NK 603 on the Community market was submitted to the Standing Committee on Food Chain and Animal Health, on 30 April 2004, for vote. The result of the vote was as follows:
50 votes in favour: (BE, FR, IE, IT, NL, FI, SE, UK)
19 votes against: (DK, EL, LU, AT, PT)
18 votes through abstention: (DE, ES)
The Committee failed to deliver, by qualified majority, an opinion on the draft submitted by the Commission. 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 must without delay 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 European Parliament, which may consider appropriate to take a position in accordance with Article 8 of the above Decision.
In accordance with Article 46 of Regulation (EC) No 1829/2003 on genetically modified food and feed, the authorisation in case must be granted under the provisions of Regulation (EC) No 258/97 . However, in order take into account the new legislative framework for the authorisation of genetically modified food and feed, the Commission proposal includes also the particulars required by Article 6, paragraph 5 and Article 7, paragraph 2 of Regulation (EC) No 1829/2003 .