Decision 2011/354 - 2011/354/EU: Commission Decision of 17 June 2011 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation 1829/2003 (notified under document C(2011) 4177) - Main contents

EN

Official Journal of the European Union

L 160/90

On 18 January 2008, Bayer CropScience AG submitted to the competent authority of the Netherlands an application, in accordance with Article 5 and Article 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 GHB614 cotton (‘the application’).

The application also covers the placing on the market of products other than food and feed containing or consisting of GHB614 cotton for the same uses as any other cotton with the exception of cultivation. Therefore, in accordance with Article 5(5) and Article 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 (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. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

On 10 March 2009, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Article 6 and Article 18 of Regulation (EC) No 1829/2003. It considered that cotton GHB614 is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment. Therefore it concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from GHB614 cotton as described in the application (‘the products’) will have any adverse effects on human or animal health or the environment in the context of their intended uses (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 particular, EFSA concluded that GHB614 cotton is compositionally and agronomically equivalent to its non-genetically modified counterpart and other conventional cotton varieties except for the introduced trait and that the molecular characterisation provided no indication of unintended effects of the genetic modification 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 environmental 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 and plant establishment are likely to...