Commission Implementing Decision (EU) 2026/2121 of 23 September 2026 renewing the authorisation for placing on the market of products containing, consisting of or produced from genetically modified maize MON 87460 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2026) 6605) (Only the Dutch text is authentic) (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/decision/2026/2121@2026-09-23/en
Contents
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, and in particular Article 11(3) and Article 23(3) thereof,
Whereas:
(1) Commission Implementing Decision (EU) 2015/683 authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 87460. The scope of that authorisation also covered the placing on the market of products other than food and feed containing or consisting of genetically modified maize MON 87460, for the same uses as any other maize, with the exception of cultivation.
(2) On 11 March 2024, Bayer Agriculture BV, based in Belgium, submitted on behalf of Bayer CropScience LP, based in United States (the applicant), an application to the Commission for renewal of that authorisation.
(3) On 8 December 2025, the European Food Safety Authority (the Authority) published a favourable scientific opinion on the assessment of genetically modified maize MON 87460 for the renewal authorisation. 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 maize MON 87460, published by the Authority in 2012.
(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.
(5) The Authority also concluded that the monitoring plan for the environmental effects, consisting of a general surveillance plan, submitted by the applicant, is in line with the intended uses of the products containing or consisting of genetically modified maize MON 87460.
(6) Taking into account the Authority’s conclusions, the authorisation for the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 87460 and of products containing it or consisting of it for uses other than food and feed, with the exception of cultivation, should be renewed.
(7) By letter of 19 January 2026, Bayer Agriculture BV, 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 was assigned to genetically modified maize MON 87460, pursuant to Commission Regulation (EC) No 65/2004, in the context of its initial authorisation by Decision (EU) 2015/683. That unique identifier should continue to be used.
(9) As regards 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, appear to be necessary. However, in order to ensure that the use of products containing or consisting of genetically modified maize MON 87460 remains within the limits of the authorisation granted by this Decision, the labelling of such products, with the exception of food 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.
(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 food and feed containing, consisting of or produced from genetically modified maize MON 87460, or for the protection of particular ecosystems, the 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.
(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.
(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:
Article 1 Genetically modified organism and unique identifier
Genetically modified maize (Zea mays L.) MON 87460, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON 8746Ø-4, in accordance with Regulation (EC) No 65/2004.
Article 2 Renewal of the authorisation
The authorisation for placing on the market of the following products is renewed as regards: (a) foods and food ingredients containing, consisting of or produced from genetically modified maize MON 8746Ø-4; (b) feed containing, consisting of or produced from genetically modified maize MON 8746Ø-4; (c) products containing or consisting of genetically modified maize MON 8746Ø-4, for uses other than those provided for in points (a) and (b), with the exception of cultivation.
(a) foods and food ingredients containing, consisting of or produced from genetically modified maize MON 8746Ø-4;
(b) feed containing, consisting of or produced from genetically modified maize MON 8746Ø-4;
(c) products containing or consisting of genetically modified maize MON 8746Ø-4, 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), 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 maize.
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 maize 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 maize MON 8746Ø-4.
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 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, United States, represented in the Union by Bayer Agriculture BV, based in Belgium.
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 of America, represented in the Union by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.
Done at Brussels, 23 September 2026. For the Commission Olivér Várhelyi Member of the Commission
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 BV, Scheldelaan 460, 2040 Antwerp, Belgium. (1) foods and food ingredients containing, consisting of or produced from genetically modified maize MON-8746Ø-4; (2) feed containing, consisting of or produced from genetically modified maize MON-8746Ø-4; (3) products containing or consisting of genetically modified maize MON-8746Ø-4, for uses other than those provided for in points (1) and (2), with the exception of cultivation. (b) Designation and specification of the products: The genetically modified maize MON-8746Ø-4 expresses the CspB gene, which confers tolerance to drought. In addition, the nptII gene, conferring kanamycin and neomycin resistance, was used as a selection marker in the genetic modification process. (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 maize; (2) The words not for cultivation shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize MON-8746Ø-4, with the exception of the products referred to in point (b)(1). (c) Labelling: (1) event-specific method for the quantification of genetically modified maize MON-8746Ø-4 using real-time PCR; (2) validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx; (3) reference material: AOCS 0709-A (for MON-8746Ø-4) and AOCS 0406-A (for the non-genetically modified counterpart) are accessible through the American Oil Chemists Society (AOCS) at https://www.aocs.org/crm. (d) Method for detection: (e) Unique identifier: MON-8746Ø-4 (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 of the European Parliament and of the Council. [Link: plan published in the Community register of genetically modified food and feed] (i) Post-market monitoring requirements: Not required. Anx. annex. 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.
ANNEX 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. (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 BV, Scheldelaan 460, 2040 Antwerp, Belgium. (1) foods and food ingredients containing, consisting of or produced from genetically modified maize MON-8746Ø-4; (2) feed containing, consisting of or produced from genetically modified maize MON-8746Ø-4; (3) products containing or consisting of genetically modified maize MON-8746Ø-4, for uses other than those provided for in points (1) and (2), with the exception of cultivation. (b) Designation and specification of the products: The genetically modified maize MON-8746Ø-4 expresses the CspB gene, which confers tolerance to drought. In addition, the nptII gene, conferring kanamycin and neomycin resistance, was used as a selection marker in the genetic modification process. (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 maize; (2) The words not for cultivation shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize MON-8746Ø-4, with the exception of the products referred to in point (b)(1). (c) Labelling: (1) event-specific method for the quantification of genetically modified maize MON-8746Ø-4 using real-time PCR; (2) validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx; (3) reference material: AOCS 0709-A (for MON-8746Ø-4) and AOCS 0406-A (for the non-genetically modified counterpart) are accessible through the American Oil Chemists Society (AOCS) at https://www.aocs.org/crm. (d) Method for detection: (e) Unique identifier: MON-8746Ø-4 (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 of the European Parliament and of the Council. [Link: plan published in the Community register of genetically modified food and feed] (i) Post-market monitoring requirements: Not required.
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 BV, Scheldelaan 460, 2040 Antwerp, Belgium.
(b) Designation and specification of the products: The genetically modified maize MON-8746Ø-4 expresses the CspB gene, which confers tolerance to drought. In addition, the nptII gene, conferring kanamycin and neomycin resistance, was used as a selection marker in the genetic modification process. (1) foods and food ingredients containing, consisting of or produced from genetically modified maize MON-8746Ø-4; (2) feed containing, consisting of or produced from genetically modified maize MON-8746Ø-4; (3) products containing or consisting of genetically modified maize MON-8746Ø-4, for uses other than those provided for in points (1) and (2), with the exception of cultivation.
(b)
(1) foods and food ingredients containing, consisting of or produced from genetically modified maize MON-8746Ø-4;
(2) feed containing, consisting of or produced from genetically modified maize MON-8746Ø-4;
(3) products containing or consisting of genetically modified maize MON-8746Ø-4, for uses other than those provided for in points (1) and (2), with the exception of cultivation.
(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 maize; (2) The words not for cultivation shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize MON-8746Ø-4, with the exception of the products referred to in point (b)(1).
(c)
(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 maize;
(2) The words not for cultivation shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize MON-8746Ø-4, with the exception of the products referred to in point (b)(1).
(d) Method for detection: (1) event-specific method for the quantification of genetically modified maize MON-8746Ø-4 using real-time PCR; (2) validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx; (3) reference material: AOCS 0709-A (for MON-8746Ø-4) and AOCS 0406-A (for the non-genetically modified counterpart) are accessible through the American Oil Chemists Society (AOCS) at https://www.aocs.org/crm.
(d)
(1) event-specific method for the quantification of genetically modified maize MON-8746Ø-4 using real-time PCR;
(2) validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;
(3) reference material: AOCS 0709-A (for MON-8746Ø-4) and AOCS 0406-A (for the non-genetically modified counterpart) are accessible through the American Oil Chemists Society (AOCS) at https://www.aocs.org/crm.
(e) Unique identifier: MON-8746Ø-4
(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 of the European Parliament and of the Council. [Link: plan published in the Community register of genetically modified food and feed]
(i) Post-market monitoring requirements: Not required.