L 40/10 Official Journal of the European Union 14.2.2012 COMMISSION IMPLEMENTING DECISION of 10 February 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A5547-127 (ACS-GM©@©@6-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2012) 691) (Only the German text is authentic) (Text with EEA relevance) (2012/81/EU) 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 ('), and in particular Article 7(3) and Article 19(3) thereof, Whereas: (1) ¢ O] 0] On 31 March 2008, Bayer CropScience AG submitted to the competent authority of the Netherlands an appli- cation, in accordance with Articles 5 and 17 of Regu- lation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from A5547-127 soybean (the application’). The application also covers the placing on the market of products other than food and feed containing or consisting of A5547-127 soybean for the same uses as any other soybean with the exception of cultivation. Therefore, in accordance with 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  and  repealing  Council  Directive 90/220/EEC (3 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. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC. On 10 May 2011, the European Food Safety Authority (EFSA) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that soybean A5547-127, as described in the L 268, 18.10.2003, p. 1. L 106, 17.4.2001, p. 1. application, is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment (?). 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 Articles 6(4) and 18(4) of that Regu- lation. In particular, EFSA concluded that soybean A5547-127 is compositionally and agronomically not different from its non-genetically modified counterpart and equivalent to commercial varieties, except for the introduced trait and as a consequence, that animal safety studies with the whole food|feed (e.g. a 90-day toxicity study in rats) are not needed. In its opinion, EFSA also concluded that the environ- mental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended use of the products. Taking into account those considerations, authorisation should be granted for the products containing, consisting of, or produced from A5547-127 soybean as described in the application (the products’). A unique identifier should be assigned to each GMO as provided for in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (*). On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from A5547- 127 soybean. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of feed containing or (®) http:/[registerofquestions.efsa.europa.eu/rogFrontend/questionLoader? question=EFSA-Q-2011-00292 (4 O] L 10, 16.1.2004, p. 5.