Decision 2010/141 - 2010/141/: Commission Decision of 2 March 2010 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON863xNK603 (MON-ØØ863-5xMON-ØØ6Ø3-6) pursuant to Regulation 1829/2003 (notified under document C(2010) 1203) - Main contents

EN

Official Journal of the European Union

L 55/78

On 22 October 2004, Monsanto Europe SA, submitted to the competent authorities of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON863xNK603 maize (the application).

The application also covers the placing on the market of other products containing or consisting of MON863xNK603 maize for the same uses as any other maize with the exception of cultivation. Therefore, in accordance with the provision of Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC.

On 31 March 2006, the European Food Safety Authority (EFSA) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from MON863xNK603 maize as described in the application (the products) will have adverse effects on human or animal health or the environment (3). In its opinion, EFSA concluded that it was acceptable to use the data for the single events in support of the safety of the products and considered all specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities provided for by Articles 6(4) and 18(4) of that Regulation.

In October 2006, upon request of the Commission, EFSA published detailed clarifications on how the comments of the competent authorities of the Member States had been taken into account in its opinion and also published further information on the different elements considered by the Scientific Panel on Genetically Modified Organisms of EFSA.

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended use of the products.

On 26 February 2007, in the light of a report published by the World Health Organisation listing kanamycin and neomycin as ‘critically important antibacterial agents for human medicine and for risk management strategies of non-human use’, the European Medicines Agency issued a statement highlighting the therapeutic relevance of both antibiotics in human and veterinary medicine. On 13 April 2007, taking into account this statement, EFSA indicated that the therapeutic effect of the antibiotics at stake will not be compromised by the presence of the nptII gene in GM plants. This is due to the extremely low probability of gene transfer from plants to bacteria and...