Acta
Library
32026D2121Decisionin forceOJ authentic text

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)

Published
23 September 2026
In force from
25 September 2026
Valid until
25 September 2036
Segments
9 articles · 14 recitals · 1 annexes
Official sourcesha2565bdfa7c20d3941f729d8365bf016a4348203b22ca1775fb62501aefe47b0de22

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

Commission Implementing Decision (EU) 2015/683 (2) 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.

Recital 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.

Recital 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 (3). 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).

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 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.

Recital 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.

Recital 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.

Recital 8

A unique identifier was assigned to genetically modified maize MON 87460, pursuant to Commission Regulation (EC) No 65/2004 (5), in the context of its initial authorisation by Decision (EU) 2015/683. That unique identifier should continue to be used.

Recital 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 (6), 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.

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 (7).

Recital 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.

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 (8).

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 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.

anchor art_1 · hash e415745c7ed7d6912a7da2f728a345230bdb432e404c26f7539989558c579c1e

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.

anchor art_2 · hash 8a32a0f4a8bb9f9e9bc7072d753d34fa78bd461cd5b100939aef750d102012e9

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).

anchor art_3 · hash 64e3d5c536cc24232cdefc820bd160d4ebacea89ebf6259fe71374f7585eece9

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.

anchor art_4 · hash b529ba0df865efa625d3594bec2697540d6ef787bf2641608db93df9e34b901e

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.

anchor art_5 · hash b3dae4fccbf8ca3b176626dcb23360f25289d998387b32a4c8e57caf85f1a143

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.

anchor art_6 · hash b016e632bd28f25548f6bd355e3b7ca130990ae7e3d054e48199064f5e192c88

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.

anchor art_7 · hash d0cc60a696601e03971aacd9b14517ad47d3c89cf6df390539e360484abde774

Article 8

Validity

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

anchor art_8 · hash f82ec076ba790965d20fc09852494cc6aabfed744ac9eab1a7d02af9f89e9e41

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.

anchor art_9 · hash ceac9f9246c89dab0f4cea485a9c092b5c1001fba2be4736a596cc80838f9b5c

Annex 1

(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: (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. 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. (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). (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. (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. 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.

anchor annex_1 · hash 3713fe0c3c1721719cc2c97e874ada1cb69e7fd2633ba02987194650d2fe7f9c