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Commission Implementing Decision (EU) 2026/2112 of 23 September 2026 authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean GMB151 × DAS-44406-6 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2026) 6604)

Published
23 September 2026
In force from
25 September 2026
Valid until
25 September 2036
Segments
9 articles · 14 recitals · 1 annexes
Official sourcesha25669b96546f7f2089c17bdf880251cb343f4d69bb66160ab43cea6aa0fba49f6ce

Text reproduced from Publications Office of the European Union, retrieved 29 September 2026. Acta is unofficial, and the hash above identifies the bytes Acta stored — not an official instrument. Always check the official source before relying on it. Not legal advice.

Recitals

Recital 1

On 29 May 2024, BASF SE, based in Germany, on behalf of BASF Agricultural Solutions Seed US LLC, based in the United States (‘the applicant’), submitted an application to the national competent authority of Belgium for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified soybean GMB151 × DAS-44406-6, 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 GMB151 × DAS-44406-6 for uses other than food and feed, with the exception of cultivation.

Recital 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 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.

Recital 3

On 27 January 2026, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion on genetically modified soybean GMB151 × DAS-44406-6 in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). The Authority concluded that genetically modified soybean GMB151 × DAS-44406-6, 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 GMB151 × DAS-44406-6 does not represent any nutritional concern for humans and animals.

Recital 4

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

Recital 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 containing or consisting of genetically modified soybean GMB151 × DAS-44406-6.

Recital 6

Taking into account those conclusions, the placing on the market of products containing, consisting of or produced from genetically modified soybean GMB151 × DAS-44406-6 should be authorised for the uses listed in the application.

Recital 7

By letter of 23 January 2026, BASF Agricultural Solutions US LLC, based in the United States, informed the Commission that BASF SE would convert its legal form and change its name to BASF Agricultural Solutions Belgium NV as of 1 July 2026.

Recital 8

A unique identifier should be assigned to genetically modified soybean GMB151 × DAS-44406-6 in accordance with Commission Regulation (EC) No 65/2004 (4).

Recital 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), points (a) and (b), 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 soybean GMB151 × DAS-44406-6, with the exception of foods and food ingredients, should contain a clear indication that they are not intended for cultivation.

Recital 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).

Recital 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 GMB151 × DAS-44406-6 or for the protection of particular ecosystems/environment or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e), of Regulation (EC) No 1829/2003.

Recital 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.

Recital 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 Council (7).

Recital 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,

Article 1

Genetically modified organism and unique identifier

Genetically modified soybean (Glycine max (L.) Merr.) GMB151 × DAS-44406-6, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier BCS-GM151-6 x DAS-444Ø6-6, in accordance with Regulation (EC) No 65/2004.

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Article 2

Authorisation

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 BCS-GM151-6 x DAS-444Ø6-6;

(b)

feed containing, consisting of or produced from genetically modified soybean BCS-GM151-6 x DAS-444Ø6-6;

(c)

products containing or consisting of genetically modified soybean BCS-GM151-6 x DAS-444Ø6-6 for uses other than those provided for in points (a) and (b) of this Article, with the exception of cultivation.

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Article 3

Labelling (1) For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2), points (a) and (b), 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 BCS-GM151-6 x DAS-444Ø6-6 as referred to in Article 1, with the exception of products referred to in Article 2, point (a).

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Article 4

Method for detection

The methods set out in point (d) of the Annex shall apply for the detection of genetically modified soybean BCS-GM151-6 x DAS-444Ø6-6.

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Article 5

Monitoring 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.

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Article 6

Community register

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.

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Article 7

Authorisation holder

The authorisation holder shall be BASF Agricultural Solutions US LLC, represented in the Union by BASF Agricultural Solutions Belgium NV.

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Article 8

Validity

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

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Article 9

Addressee

This Decision is addressed to BASF Agricultural Solutions US LLC, 2 T.W. Alexander Dr., Durham, NC 27713, United States of America, represented in the Union by BASF Agricultural Solutions Belgium NV, Technologiepark-Zwijnaarde 101, 9052, Ghent, Belgium.

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Annex 1

(a) Applicant and authorisation holder: Name: BASF Agricultural Solutions US LLC; Address: 2 T.W. Alexander Dr., Durham, NC 27713, United States; represented in the Union by BASF Agricultural Solutions Belgium NV, Technologiepark-Zwijnaarde 101, 9052, Ghent, Belgium. (b) Designation and specification of the products: (1) foods and food ingredients containing, consisting of or produced from genetically modified soybean BCS-GM151-6 x DAS-444Ø6-6; (2) feed containing, consisting of or produced from genetically modified soybean BCS-GM151-6 x DAS-444Ø6-6; (3) products containing or consisting of genetically modified soybean BCS-GM151-6 x DAS-444Ø6-6 for uses other than those provided for in points (1) and (2), with the exception of cultivation. The genetically modified soybean BCS-GM151-6 x DAS-444Ø6-6 expresses the 2mepsps gene, which confers tolerance to herbicides containing glyphosate, the aad-12 gene, which confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D), the pat gene, which confers tolerance to herbicides containing glufosinate-ammonium, the hppdPf-4Pa gene, which confers tolerance to 4-hydroxyphenylpyruvate dioxygenase (HPPD) inhibitor herbicides, such as isoxaflutole, and the cry14Ab-1.b gene, which confers resistance to plant parasitic nematodes. (c) Labelling: (1) For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2), points (a) and (b), 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 documents accompanying the products containing or consisting of genetically modified soybean BCS-GM151-6 x DAS-444Ø6-6, with the exception of products referred to in point (b)(1). (d) Method for detection: (1) the quantitative event-specific PCR detection methods are those individually validated for genetically modified soybean events BCS-GM151-6 and DAS-444Ø6-6, and further verified on soybean stack BCS-GM151-6 x DAS-444Ø6-6; (2) validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at https://gmo-crl.jrc.ec.europa.eu/method-validations (3) reference material: ERM®-BF443 a-e (for BCS-GM151-6) and ERM®-BF436 a-e (for DAS-444Ø6-6) are accessible via the Joint Research Center (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/. (e) Unique identifier: BCS-GM151-6 x DAS-444Ø6-6 (f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity: [Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified]. (g) Conditions or restrictions on the placing on the market, use or handling of the products: not required. (h) Monitoring plan for environmental effects: monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC [Link: plan published in the Community register of genetically modified food and feed] (i) Post-market monitoring plan: not required. Note: links to the relevant documents may need to be modified over time. Those modifications will be made available to the public through the updating of the Community register of genetically modified food and feed.

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