L 299/36 Official Journal of the European Union 8.11.2008 COMMISSION COMMISSION DECISION of 29 October 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified LLCotton25 (ACS-GHO@1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2008) 6204) (Only the German text is authentic) (Text with EEA relevance) (2008/837[EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, 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 Articles 7(3) and 19(3) thereof, Whereas: *) e 0) 0 On 3 March 2005, 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 LLCotton25 (the application). The application also covers the placing on the market of other products containing or consisting of LLCotton25 for the same uses as any other cotton with the exception of cultivation. Therefore, in accordance with the provisions of Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes I 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 () 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. L 268, 18.10.2003, p. 1. L 106, 17.4.2001, p. 1. 3) ) On 16 April 2007, 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 LLCotton25 as described in the appli- cation (the products) will have any adverse effects on human or animal health or the environment in the context of their intended 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 Articles 6(4) and 18(4) of that Regulation. In particular, EFSA concluded that the comparative compositional analysis and agronomic analyses show that LLCottton25 is substantially equivalent to its non- genetically modified counterpart and, as a consequence, that no additional safety studies with laboratory animals (e.g. a 90-day toxicity study in rats) are needed. In its opinion, EFSA also concluded that the environmen- tal monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended use of the products. However, due to the physical characteristics of cotton seeds and methods of transportation, EFSA recommended that, within general surveillance, specific measures are introduced to actively monitor the occurrence of feral cotton plants in areas where seed spillage is likely to occur. The monitoring plan submitted by the applicant has been modified to comply with this EFSA recommendation. Taking into account those considerations, authorisation should be granted for the products. () http:/fwww.efsa.europa.cu/EFSA/efsa_locale-1178620753816_ 1178620785856.htm