(1)

On 12 March 2009, Dow AgroSciences Europe 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 281-24-236 × 3006-210-23 × MON 88913 cotton.

(2)

The application also covers the placing on the market of 281-24-236 × 3006-210-23 × MON 88913 cotton in products consisting of it or containing it for any other uses than food and feed as any other cotton, with the exception of cultivation.

(3)

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 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 Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 8 April 2016, the European Food Safety Authority (‘EFSA’) issued a favourable opinion (3) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 is as safe and as nutritious as its conventional counterpart in the context of its intended uses.

(5)

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 Regulation (EC) No 1829/2003.

(6)

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 uses of the products.

(7)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913.

(8)

A unique identifier should be assigned to genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 in accordance with Commission Regulation (EC) No 65/2004 (4).

(9)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from cotton 281-24-236 × 3006-210-23 × MON 88913. However, in order to ensure the use of the products containing or consisting of cotton 281-24-236 × 3006-210-23 × MON 88913 within the limits of the authorisation provided for by this Decision, the labelling of those products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.

(10)

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 Commission Decision 2009/770/EC (5).

(11)

The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or of specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or 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.

(12)

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.

(13)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act 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 DAS-24236-5×DAS-21Ø23-5×MON-88913-8 cotton;

(b)

feed containing, consisting of, or produced from DAS-24236-5×DAS-21Ø23-5×MON-88913-8 cotton;

(c)

DAS-24236-5×DAS-21Ø23-5×MON-88913-8 cotton in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.