Explanatory Memorandum to COM(2010)298 - Proposal for a Council Decision renewing the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified maize Bt11 (SYN-BTØ11-1), authorising foods and food ingredients containing or consisting of field maize Bt11 (SYN-BTØ11-1) pursuant to Regulation (EC) No 1829/2003 and repealing Commission Decision 2004/657/EC (Only the French text is authentic)

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The attached proposal for a Council Decision concerns the renewal of the authorisation for continued marketing of existing foods and food ingredients produced from genetically modified maize Bt11, the renewal of the authorisation for continued marketing of existing feed containing, consisting of or produced from Bt11 maize and products other that food and feed containing or consisting of Bt11 maize with the exception of cultivation, for which a request was submitted by Syngenta Seeds S.A.S. to the Commission on 17 April 2007, under Regulation (EC) No 1829/2003 on genetically modified food and feed.

The attached proposal also concerns the renewal of the authorisation for placing on the market of foods and food ingredients containing or consisting of sweet maize Bt11 which are authorised under Commission Decision 2004/657/EC and the authorisation of foods and food ingredients containing or consisting of field maize which were never authorised in the EU.

On 17 February 2009, the European Food Safety Authority gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It considered that Bt11 maize is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment. Therefore it concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from Bt11 maize as described in the application will have any adverse effects on human or animal health or the environment in the context of their intended uses.

Against this background, a draft Commission Decision renewing the authorisation for continued marketing of products containing, consisting of or produced from genetically modified Bt11 maize, authorising foods and food ingredients containing or consisting of field maize Bt11 and repealing Commission Decision 2004/657/EC was submitted to the Standing Committee on the Food Chain and Animal Health, on 19 April 2010, for vote. The Committee delivered no opinion: 12 Member States (167 votes) voted in favour, 9 Member States (84 votes) voted against, 3 Member States (46 votes) abstained and 3 Member States (48 votes) were not represented.

Consequently, pursuant to Article 35, paragraph 2 of Regulation (EC) No 1829/2003 and in accordance with Article 5 of Council Decision 1999/468/EC modified by Council Decision 2006/512/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.