30.4.2015   

EN

Official Journal of the European Union

L 112/56

(1)

On 30 November 2004, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of food and feed cottonseed oil and its constituents produced from genetically modified cotton MON 531 x MON 1445.

(2)

Food additives, feed materials and feed additives produced from genetically modified cotton MON 531 x MON 1445 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.

(3)

On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 531 x MON 1445 cotton.

(4)

The scope of the two applications, taken together, covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.

(5)

On 28 March 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion (2) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 531 x MON 1445 are as safe as products derived from the conventional counterpart, in the context of their intended uses.

(6)

EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 531 x MON 1445 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 531 x MON 1445.

(7)

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 Regulation (EC) No 1829/2003.

(8)

Consequently, authorisation should be granted for the products produced from genetically modified cotton MON 531 x MON 1445.

(9)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (3).

(10)

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, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 531 x MON 1445.

(11)

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

(12)

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 Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (4).

(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)

food produced from MON-ØØ531-6 x MON-Ø1445-2 cotton;

(b)

feed produced from MON-ØØ531-6 x MON-Ø1445-2 cotton.