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Official Journal EN
of the European Union L series
2026/1185 4.6.2026
COMMISSION IMPLEMENTING DECISION(EU) 2026/1185
of 2 June 2026
authorising the placing on the market of products containing, consisting of or produced from
genetically modified soybean MON 94637 pursuant to Regulation (EC) No 1829/2003 of the
European Parliament and of the Council
(notified under document C(2026) 3549)
(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(1), and in particular Article 7(3) and Article 19(3) thereof,
Whereas:
(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 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 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 1829/2003(3). 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.
(1) 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).
(2) 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).
(3) 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 Journal2025; 23(10):9581; https://doi.org/10.2903/j.efsa.2025.9581.
ELI: http://data.europa.eu/eli/dec_impl/2026/1185/oj 1/5EN
OJ L, 4.6.2026
(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 65/2004(4).
(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 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 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/EC(6).
(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 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,
(4) 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).
(5) 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).
(6) 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).
(7) 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).
2/5 ELI: http://data.europa.eu/eli/dec_impl/2026/1185/ojEN
OJ L, 4.6.2026
HAS ADOPTED THIS DECISION:
Article 1
Genetically modified organism and unique identifier
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.
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 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.
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
Method for detection
The method set out in point (d) of the Annex shall apply for the detection of genetically modified soybean MON-94637-8.
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.
ELI: http://data.europa.eu/eli/dec_impl/2026/1185/oj 3/5EN
OJ L, 4.6.2026
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.
Article 7
Authorisation holder
The authorisation holder shall be Bayer CropScience LLC, represented in the Union by Bayer Agriculture B.V.
Article 8
Validity
This Decision shall apply for a period of 10 years from the date of its notification.
Article 9
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, 2 June 2026.
For the Commission
Olivér VÁRHELYI
Member of the Commission
4/5 ELI: http://data.europa.eu/eli/dec_impl/2026/1185/ojEN
OJ L, 4.6.2026
ANNEX
(a) Applicant and authorisation holder:
Name: Bayer CropScience LLC
Address: 800 N. Lindbergh Boulevard, St. Louis, Missouri, 63167, United States;
represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040 Antwerp, Belgium.
(b) Designation and specification of the products:
(1) foods and food ingredients containing, consisting of or produced from genetically modified soybean (Glycine
maxL.) MON-94637-8;
(2) feed containing, consisting of or produced from genetically modified soybean (Glycine maxL.) MON-94637-8;
(3) products containing or consisting of genetically modified soybean (Glycine max L.) MON-94637-8 for uses
other than those provided for in points (1) and (2), with the exception of cultivation.
The genetically modified soybean MON-94637-8 expresses the cry1A.2and cry1B.2genes, which confer protection
against certain lepidopteran pests.
(c) 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 documents accompanying the products
containing or consisting of genetically modified soybean MON-94637-8, with the exception of products
referred to in point (b)(1).
(d) Method for detection:
(1) event-specific real-time PCR-based method for the quantification of genetically modified soybean MON-94637-8;
(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: AOCS 1023-A (for MON-94637-8) and AOCS 0906-A (for its non-GM counterpart), are
accessible via the American Oil Chemists Society (AOCS), at https://www.aocs.org/crm?SSO=True.
(e) Unique identifier:
MON-94637-8
(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 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 requirements for the use of the food for human consumption:
not required.
Note: links to 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.
ELI: http://data.europa.eu/eli/dec_impl/2026/1185/oj 5/5