THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular its Articles 8(6) and 20(6), as well as its Articles 9(2) and 21(2) thereof,

Whereas:

(1) By Commission Decision 2005/608/EC(2), the placing on the market of feed containing or consisting of MON 863 maize and MON 863 maize in products consisting of it or containing it for any other uses than food and feed, with the exception of cultivation, is authorised in accordance with Directive 2001/18/EC of the European Parliament and of the Council(3), until 12 January 2016.

(2) By Commission Decision 2006/68/EC(4), the placing on the market of food containing, consisting of, or produced from MON 863 maize is authorised in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council(5), until 12 January 2016.

(3) Food additives, feed materials and feed additives produced from genetically modified maize MON 863 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation when it came into force.

(4) On 13 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 8(4), 11, 20(4) and 23 of Regulation (EC) No 1829/2003, for renewal of the authorisation for continued marketing of existing food additives, feed materials and feed additives produced from MON 863 maize which were previously notified in accordance with Article 8(1)(b) and Article 20(1)(b) of that Regulation (‘the application’). On 30 March 2010, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Article 6 and Article 18 of Regulation (EC) No 1829/2003 and concluded that the new information provided in the renewal application and the review of the scientific literature that has been published since the previous scientific opinions on MON 863 maize by EFSA do not require changes of the opinions. Therefore it reiterated its previous conclusions that MON 863 maize is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed uses. In its opinion EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.