Explanatory Memorandum to COM(2011)40 - Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation 1829/2003

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The attached proposal for a Council Decision concerns food and feed containing, consisting of or produced from genetically modified cotton GHB614 (BCS-GHØØ2-5), for which a request for placing on the market was submitted by Bayer Cropscience AG to the competent authority of the Netherlands on 18 January 2008, under Regulation (EC) No 1829/2003 on genetically modified food and feed.

The attached proposal also concerns the placing on the market of products other than food and feed containing and consisting of GHB614 cotton for the same uses as any other cotton with the exception of cultivation.

On 10 March 2009, the European Food Safety Authority gave a favourable opinion in accordance with the Articles 6 and 18 of Regulation (EC) No 1829/2003. It considered that GHB614 cotton is as safe as its non-genetically modified counterpart and other conventional cotton varieties with respect to potential effects on human and animal health or environment. Therefore it concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from GHB614 cotton 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.

In its opinion the European Food Safety Authority recommended that, within general surveillance, specific measures are introduced to actively monitor the occurrence of feral cotton plants in areas where seed spillage and plant establishment are likely to occur.

Against this background, a draft Commission Decision authorising the placing on the Union market of products containing, consisting of or produced from genetically modified GHB614 cotton was submitted to the Standing Committee on the Food Chain and Animal Health, on 24 September 2010, for vote. The Committee delivered no opinion: 13 Member States (157 votes) voted in favour, 9 Member States (106 votes) voted against, 4 Member States (75 votes) abstained and one Member State (7 votes) was 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.