Commission Implementing Decision (EU) 2026/1125of 26 May 2026terminating the procedures for renewing the authorisations for the placing on the market of genetically modified cotton MON 88913 (MON-88913-8), MON 15985 (MON-15985-7), MON 1445 (MON-Ø1445-2), MON 531 × MON 1445 (MON-ØØ531-6 x MON-Ø1445-2) and MON 531 (MON-ØØ531-6), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(notified under document C(2026) 3262)(Only the Dutch text is authentic)(Text with EEA relevance)
European Union
Commission Implementing Decision (EU) 2026/1125 of 26 May 2026 terminating the procedures for renewing the authorisations for the placing on the market of genetically modified cotton MON 88913 (MON-88913-8), MON 15985 (MON-15985-7), MON 1445 (MON-Ø1445-2), MON 531 × MON 1445 (MON-ØØ531-6 x MON-Ø1445-2) and MON 531 (MON-ØØ531-6), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2026) 3262) (Only the Dutch 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 OJ L 268, 18.10.2003, p. 1, ELI: http://data.europa.eu/eli/reg/2003/1829/oj. , and in particular to Article 11(4) and Article 23(4) thereof, Whereas: (1) Commission Implementing Decision (EU) 2015/688 Commission Implementing Decision (EU) 2015/688 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton MON 88913 (MON-88913-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 112, 30.4.2015, p. 26, ELI: http://data.europa.eu/eli/dec_impl/2015/688/oj). authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified cotton MON 88913 (MON-88913-8). The scope of that authorisation also covers the placing on the market of products, other than food and feed, containing or consisting of genetically modified cotton MON 88913 for the same uses as any other cotton, with the exception of cultivation. (2) Commission Implementing Decision (EU) 2015/685 Commission Implementing Decision (EU) 2015/685 of 24 April 2015 authorising the placing on the market of genetically modified cotton MON 15985 (MON-15985-7) and renewing the authorisation for existing genetically modified cotton MON 15985 (MON-15985-7) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 112, 30.4.2015, p. 11, ELI: http://data.europa.eu/eli/dec_impl/2015/685/oj). authorised the placing on the market of genetically modified cotton MON 15985 (MON-15985-7) and renewed the authorisation for existing genetically modified cotton MON 15985 products. (3) Commission Implementing Decision (EU) 2015/693 Commission Implementing Decision (EU) 2015/693 of 24 April 2015 renewing the authorisation for existing genetically modified cotton MON 1445 (MON-Ø1445-2) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 112, 30.4.2015, p. 48, ELI: http://data.europa.eu/eli/dec_impl/2015/693/oj). renewed the authorisation for existing genetically modified cotton MON 1445 (MON-Ø1445-2) products. (4) Commission Implementing Decision (EU) 2015/695 Commission Implementing Decision (EU) 2015/695 of 24 April 2015 renewing the authorisation for existing genetically modified cotton MON 531 x MON 1445 (MON-ØØ531-6 x MON-Ø1445-2) products and authorising the placing on the market of cottonseed oil produced from genetically modified cotton MON 531 x MON 1445 (MON-ØØ531-6 x MON-Ø1445-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 112, 30.4.2015, p. 56, ELI: http://data.europa.eu/eli/dec_impl/2015/695/oj).
renewed the authorisation for existing genetically modified cotton MON 531 × MON 1445 (MON-ØØ531-6 × MON-Ø1445-2) products and authorised the placing on the market of cottonseed oil produced from genetically modified cotton MON 531 × MON 1445. (5) Commission Implementing Decision (EU) 2015/689 Commission Implementing Decision (EU) 2015/689 of 24 April 2015 renewing the authorisation for existing genetically modified cotton MON 531 (MON-ØØ531-6) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 112, 30.4.2015, p. 31, ELI: http://data.europa.eu/eli/dec_impl/2015/689/oj). renewed the authorisation for existing genetically modified cotton MON 531 products. (6) On 28 February 2024, 29 February 2024, 5 March 2024, 7 March 2024, 8 March 2024, respectively, Bayer Agriculture B.V., based in Belgium, on behalf of Bayer CropScience LP, based in the United States, (the applicant) submitted five applications to the Commission, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of the authorisations pursuant to those five authorisation decisions (the five renewal applications). (7) The Commission mandated the European Food Safety Authority (the Authority) to carry out the risk assessment in accordance with Regulation (EC) No 1829/2003 in relation to the five renewal applications. (8) On 13 May 2025, the Authority issued a favourable opinion on the application for the renewal of the authorisation for the placing on the market of genetically modified cotton MON 88913 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2025. Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21234). EFSA Journal 2025; 23(5):9377. https://doi.org/10.2903/j.efsa.2025.9377. in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that the renewal application did not contain evidence of any new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on genetically modified cotton MON 88913, issued by the Authority in 2013 EFSA GMO Panel, 2013. Scientific Opinion on application EFSA-GMO-UK-2007-41 for the placing on the market of herbicide-tolerant genetically modified cotton MON 88913 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto. EFSA Journal 2013; 11(7):3311. https://doi.org/10.2903/j.efsa.2013.3311. . (9) Taking into account those conclusions, the Commission submitted the draft decision renewing the authorisation of the placing on the market of genetically modified cotton MON 88913 to be the taken to the Standing Committee on Plants, Animals, Food and Feed. (10) By letter dated 28 October 2025, the applicant requested the withdrawal of the five renewal applications. The applicant indicated that the withdrawal of the five renewal applications is the result of a business decision to discontinue placing on the market of genetically modified cotton MON 88913, MON 15985, MON 1445, MON 531 × MON 1445 and MON 531 in the Union although the Authority already issued a favourable opinion regarding the safety of one of them, namely MON 88913.
(11) Taking into account the request of the applicant expressed in its letter of 28 October 2025, this Decision should terminate the procedure for the five renewal applications by virtue of which the authorisation period of the products was extended until a decision is taken in accordance with Article 11(4) and Article 23(4). (12) By the letter of 19 January 2026, Bayer Agriculture B.V., based in Belgium, informed the Commission that Bayer CropScience LP converted its legal form and changed its name to Bayer CropScience LLC as of 1 January 2026. (13) All relevant information on the termination of the procedures for the authorisation of the products covered by this Decision is to be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003. (14) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS DECISION:
Article 1
Termination of renewal procedures The procedure for renewing the authorisation for the placing on the market of any of the following is terminated: (a) genetically modified cotton (Gossypium hirsutum L. and Gossypium barbadense L.) MON 88913; (b) genetically modified cotton (Gossypium hirsutum L. and Gossypium barbadense L.) MON 15985; (c) genetically modified cotton (Gossypium hirsutum L. and Gossypium barbadense L.) MON 1445; (d) genetically modified cotton (Gossypium hirsutum L. and Gossypium barbadense L.) MON 531 × MON 1445; (e) genetically modified cotton (Gossypium hirsutum L. and Gossypium barbadense L.) MON 531.
Article 2
Addressee This Decision is addressed to Bayer CropScience LLC, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States, represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040 Antwerp, Belgium. Done at Brussels, 26 May 2026. For the Commission Olivér Várhelyi Member of the Commission
Metadata
- Type
- Afgørelse
- År
- 2026
- Ikrafttrædelsesdato
- 1. januar 1970