Prováděcí rozhodnutí Komise (EU) 2026/1185 ze dne 2. června 2026 o povolení uvedení produktů, které obsahují geneticky modifikovanou sóju MON 94637, sestávají z ní nebo jsou z ní vyrobeny, na trh podle nařízení Evropského parlamentu a Rady (ES) č. 1829/2003 (oznámeno pod číslem C(2026) 3549)

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 feedRegulation (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 Article 7(3) and Article 19(3) thereof,

Genetically modified soybean (Glycine max L.) MON 94637, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-94637-8, in accordance with Regulation (EC) No 65/2004.

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).

(1) On 24 January 2024 , Bayer Agriculture B.V., based in Belgium, on behalf of Bayer CropScience LP, based in the United States (the applicant), submitted an application to the national competent authority of the Netherlands for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified soybean MON 94637, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (the application). The application also covered the placing on the market of products containing or consisting of genetically modified soybean MON 94637 for uses other than food and feed, with the exception of cultivation.

(2) Pursuant to 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 CouncilDirective 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1 , ELI: http://data.europa.eu/eli/dir/2001/18/oj). . 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 23 October 2025 , the European Food Safety Authority (the Authority) issued a favourable scientific opinion on genetically modified soybean MON 94637 in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2025. Scientific Opinion on the assessment of genetically modified soybean MON 94637 (application GMFF-2023-21116). EFSA Journal 2025; 23(10):9581; https://doi.org/10.2903/j.efsa.2025.9581. . The Authority concluded that genetically modified soybean MON 94637, as described in the application, is as safe as its conventional counterpart and the tested non-genetically modified soybean 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 soybean MON 94637 does not represent any nutritional concern.

(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 soybean MON 94637 should be authorised for the uses listed in the application.

(7) 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 .

(8) A unique identifier should be assigned to genetically modified soybean MON 94637 in accordance with Commission Regulation (EC) No 65/2004Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, p. 5 , ELI: http://data.europa.eu/eli/reg/2004/65/oj). .

(9) 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 CouncilRegulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p. 24 , ELI: http://data.europa.eu/eli/reg/2003/1830/oj). , 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 soybean MON 94637, 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/ECCommission Decision 2009/770/EC of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (OJ L 275, 21.10.2009, p. 9 , ELI: http://data.europa.eu/eli/dec/2009/770/oj). .

(11) The opinion of the Authority does not justify the imposition of other specific conditions or restrictions for the placing on the market, for the use and handling of food and feed containing, consisting of or produced from genetically modified soybean MON 94637 or for the protection of particular ecosystems or the environment and/or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (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 Article 9(1) and Article 15(2), point (c), of Regulation (EC) No 1946/2003 of the European Parliament and of the CouncilRegulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, p. 1 , ELI: http://data.europa.eu/eli/reg/2003/1946/oj). .

(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,

The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003, in accordance with the conditions set out in this Decision:

(a) foods and food ingredients containing, consisting of or produced from genetically modified soybean MON-94637-8;

(b) feed containing, consisting of or produced from genetically modified soybean MON-94637-8;

(c) products containing or consisting of genetically modified soybean MON-94637-8 for uses other than those provided for in points (a) and (b), with the exception of cultivation.

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1 , ELI: http://data.europa.eu/eli/dir/2001/18/oj).

Article 1 Article 1 Genetically modified organism and unique identifier

Article 2 Article 2 Authorisation

Article 3 Article 3 Labelling 1.For the purposes of the labelling requirements laid down 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, the name of the organism shall be soybean. 2.The words not for cultivation shall appear on the label of and in the documents accompanying the products containing or consisting of genetically modified soybean MON-94637-8 as referred to in Article 1, with the exception of products referred to in Article 2, point (a).

Article 4 Article 4 Method for detection

Article 5 Article 5 Monitoring plan for environmental effects 1.The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented. 2.The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the format set out in Decision 2009/770/EC.

Article 6 Article 6 Community register

Article 7 Article 7 Authorisation holder

Article 8 Article 8 Validity

Article 9 Article 9 Addressee

For the purposes of the labelling requirements laid down 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, the name of the organism shall be soybean.

The words not for cultivation shall appear on the label of and in the documents accompanying the products containing or consisting of genetically modified soybean MON-94637-8 as referred to in Article 1, with the exception of products referred to in Article 2, point (a).

EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2025. Scientific Opinion on the assessment of genetically modified soybean MON 94637 (application GMFF-2023-21116). EFSA Journal 2025; 23(10):9581; https://doi.org/10.2903/j.efsa.2025.9581.

The method set out in point (d) of the Annex shall apply for the detection of genetically modified soybean MON-94637-8.

Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, p. 5 , ELI: http://data.europa.eu/eli/reg/2004/65/oj).

The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.

The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the format set out in Decision 2009/770/EC.

Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p. 24 , ELI: http://data.europa.eu/eli/reg/2003/1830/oj).

The information set out in the Annex shall be entered in the Community register of genetically modified food and feed, as referred to in Article 28(1) of Regulation (EC) No 1829/2003.

Commission Decision 2009/770/EC of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (OJ L 275, 21.10.2009, p. 9 , ELI: http://data.europa.eu/eli/dec/2009/770/oj).

The authorisation holder shall be Bayer CropScience LLC, represented in the Union by Bayer Agriculture B.V.

Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, p. 1 , ELI: http://data.europa.eu/eli/reg/2003/1946/oj).

This Decision shall apply for a period of 10 years from the date of its notification.

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.

HAS ADOPTED THIS DECISION: