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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)

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)

Implementing Decision (EU) 2026/2121 · Decision · 10 articles

In force

Version historyWe hold this version only; in force from 2026-09-23.

Data as of 2026-10-01 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Genetically modified organism and unique identifier

Article 1

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.

Renewal of the authorisation

Article 2

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.

Labelling

Article 3

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).

Method for detection

Article 4

The method set out in point (d) of the Annex shall apply for the detection of genetically modified maize MON 8746Ø-4.

Monitoring plan for environmental effects

Article 5

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.

Community register

Article 6

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.

Authorisation holder

Article 7

The authorisation holder shall be Bayer CropScience LLC, United States, represented in the Union by Bayer Agriculture BV, based in Belgium.

Validity

Article 8

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

Addressee

Article 9

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.

Supplementary provisions

ANNEXSupplementary provisions

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: (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.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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