(1)

On 19 September 2018, BASF Agricultural Solutions Belgium NV, based in Belgium, which is a branch of BASF SE, based in Germany, submitted, on behalf of BASF Agricultural Solutions Seed US LLC, based in the United States, an application to the national competent authority of Spain (‘the application’) for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified cotton GHB811, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003. The application also covered the placing on the market of products containing or consisting of genetically modified cotton GHB811 for uses other than food and feed, 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 information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council (2). It also included the information required pursuant to Annexes III and IV to that Directive and a monitoring plan for environmental effects in accordance with Annex VII to that Directive.

(3)

On 16 August 2021, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). The Authority concluded that genetically modified cotton GHB811, as described in the application, is as safe as its conventional counterpart and the tested non-genetically modified cotton reference varieties with respect to the potential effects on human and animal health and the environment. The Authority also concluded that the consumption of food and feed from genetically modified cotton GHB811 does not represent a nutritional concern for humans and animals.

(4)

In its scientific opinion, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(5)

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

(6)

Taking into account those conclusions, the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB811 should be authorised for the uses listed in the application.

(7)

A unique identifier should be assigned to genetically modified cotton GHB811 in accordance with Commission Regulation (EC) No 65/2004 (4).

(8)

For the products covered by this Decision, no specific labelling requirements, other than those provided for in Article 13(1) and Article 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. However, in order to ensure that the use of those products remains within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of genetically modified cotton GHB811, with the exception of foods and food ingredients, should contain a clear indication that they are not intended for cultivation.

(9)

The authorisation holder should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environment effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (6).

(10)

The opinion of the Authority does not justify the imposition of specific conditions or restrictions for the placing on the market, for the use and handling, including post-market monitoring requirements regarding the consumption of the food and feed containing, consisting of or produced from genetically modified cotton GHB811, or for the protection of particular ecosystems/environment or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.

(11)

All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of 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 (7).

(13)

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 genetically modified cotton BCS-GH811-4;

(b)

feed containing, consisting of or produced from genetically modified cotton BCS-GH811-4;

(c)

products containing or consisting of genetically modified cotton BCS-GH811-4 for uses other than those provided for in points (a) and (b), with the exception of cultivation.