Commission Implementing Decision (EU) 2021/1389 of 17 August 2021 authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × T304-40 × GHB119 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2021)5996) (Only the German text is authentic) (Text with EEA relevance)

• Published date: 24 August 2021
• Date of Signature: 17 August 2021
• Official Gazette Publication: Official Journal of the European Union, L 300, 24 August 2021

24.8.2021 EN Official Journal of the European Union L 300/29

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COMMISSION IMPLEMENTING DECISION (EU) 2021/1389

of 17 August 2021

authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × T304-40 × GHB119 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2021)5996)

(Only the German text is authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular to Articles 7(3) and 19(3) thereof,

Whereas:

(1) On 30 September 2014, Bayer CropScience AG submitted an application to the national competent authority of the Netherlands in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (‘the application’). The application covered the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified cotton GHB614 × T304-40 × GHB119. The application also covered the placing on the market of products containing or consisting of genetically modified cotton GHB614 × T304-40 × GHB119 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 25 July 2018, the European Food Safety Authority (‘the Authority’) issued a favourable opinion in accordance with Article 6 and Article 18 of Regulation (EC) No 1829/2003 (3). This opinion was invalidated for reasons of formal nature related to the application, which was further addressed by the applicant. On 31 July 2020, the Authority published a new favourable opinion. It concluded that genetically modified cotton GHB614 × T304-40 × GHB119, as described in the application, is as safe as, and nutritionally equivalent to, 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.

(4) In its 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 by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(5) The Authority also concluded that the monitoring plan for 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 GHB614 × T304-40 × GHB119 should be authorised for the uses listed in the application.

(7) By letter dated 1 August 2018, Bayer CropScience AG requested that the Commission transfer its rights and obligations pertaining to all authorisations and pending applications for genetically modified products, to BASF Agricultural Solutions Seed US LLC. By letter dated 19 October 2018, BASF Agricultural Solutions Seed US LLC confirmed its agreement with this transfer and authorised BASF SE, based in Germany, to act as its representative in the Union.

(8) A unique identifier should be assigned to genetically modified cotton GHB614 × T304-40 × GHB119 in accordance with Commission Regulation (EC) No 65/2004 (4).

(9) For the products covered by this Decision, 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. 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 GHB614 × T304-40 × GHB119, with the exception of foods and food ingredients, should contain a clear indication that they are not intended for cultivation.

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

(11) 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 or consisting of genetically modified cotton GHB614 × T304-40 × GHB119, or for the protection of particular ecosystems/environment or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.

(12) 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.

(13) 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 (7).

(14) 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,

HAS ADOPTED THIS DECISION:

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