30.4.2015   

EN

Official Journal of the European Union

L 112/48

(1)

Food additives, feed materials and feed additives produced from genetically modified cotton 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.

(2)

On 17 April 2007, Monsanto Europe SA 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 1445 (‘the application’).

(3)

On 16 June 2011, Monsanto Europe SA requested an extension of the scope of the application to include food cottonseed oil produced from genetically modified cotton MON 1445, which was previously notified as an existing product in accordance with Article 8(1)(a) of Regulation (EC) No 1829/2003.

(4)

The scope of the application as extended 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 16 December 2011, 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 1445, as described in the application, are as safe as products derived from its conventional counterpart, in the context of their intended uses.

(6)

EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton 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 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 renewed for the products produced from genetically modified cotton MON 1445.

(9)

A unique identifier should be assigned to each genetically modified organism 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 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 Articles 9(1) and 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-Ø1445-2 cotton;

(b)

feed produced from MON-Ø1445-2 cotton.