30.6.2012 Official Journal of the European Union L 171/13 DECISIONS COMMISSION IMPLEMENTING DECISION of 28 June 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87701 x MON 89788 (MON-87701-2 x MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2012) 4312) (Only the Dutch and French texts are authentic) (Text with EEA relevance) (2012/347/EV) 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 () ) On 14 August 2009, Monsanto Europe SA submitted to the competent authority of the Netherlands an appli- cation, 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 MON 87701 x MON 89788 soybean (‘the applicatior). The application also covers the placing on the market of MON 87701 x MON 89788 soybean as present in products other than food and feed containing or consisting of MON 87701 x MON 89788 soybean for the same uses as any other soybean with the exception of cultivation. In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes Il 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. L 268, 18.10.2003, p. 1. L 106, 17.4.2001, p. 1. ) On 15 February 2012, 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 MON 87701 x MON 89788, as described in the application, is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment (3). 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 that Regulation. 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 MON 87701 x MON 89788 soybean and all products containing it or consisting of it and for food and feed produced from it as described in the application (‘the products’). Products other than food and feed produced from MON 87701 x MON 89788 soybean do not fall under the scope of Regulation (EC) No 1829/2003 and are not covered by this authori- sation. A unique identifier should be assigned to each genetically modified organism (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 (%). () http:/[registerofquestions.efsa.europa.eu/rogFrontend/questionLoader? question=EFSA-Q-2009-00761 ( OJ L 10, 16.1.2004, p. 5.