(1)

On 25 March 2011, Bayer submitted to the competent authority of The Netherlands 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 GHB119 cotton (‘the application’). The application also covered the placing on the market of genetically modified cotton GHB119 in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.

(2)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also included a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(3)

On 21 October 2016, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). It concluded that genetically modified cotton GHB119, as described in the application, is as safe and as nutritious as its conventional counterpart as regards the potential effects on human and animal health and the environment in the context of the scope of the application.

(4)

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 Article 18(4) of Regulation (EC) No 1829/2003.

(5)

EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant, is in line with the intended uses of the products.

(6)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified cotton GHB119.

(7)

A unique identifier should be assigned to cotton GHB119, in accordance with Commission Regulation (EC) No 65/2004 (4).

(8)

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 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5), appear to be necessary for the products covered by this Decision. However, in order to ensure the use of those products within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of cotton GHB119, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(9)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with the standard reporting format set out in Commission Decision 2009/770/EC (6). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.

(10)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed referred to in Regulation (EC) No 1829/2003.

(11)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(12)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from cotton GHB119;

(b)

feed containing, consisting of, or produced from cotton GHB119;

(c)

Cotton GHB119 in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.