Commission Implementing Decision (EU) 2023/2134 of 13 October 2023 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87419 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2023) 6729)

Genetically modified organism and unique identifier

Article 1

Genetically modified maize ( Zea mays L.) MON 87419, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-87419-8, in accordance with Regulation (EC) No 65/2004.

Authorisation

Article 2

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 maize MON-87419-8; (b) feed containing, consisting of or produced from genetically modified maize MON-87419-8; (c) products containing or consisting of genetically modified maize MON-87419-8 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) 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 MON-87419-8 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-87419-8.

Monitoring 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 LP, represented in the Union by Bayer Agriculture BV.

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 LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States, represented in the Union by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.

ANNEXSupplementary provisions

ANNEX (a) Applicant and Authorisation holder: Name : Bayer CropScience LP 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 ( Zea mays L.) MON-87419-8; (2) feed containing, consisting of or produced from genetically modified maize ( Zea mays L.) MON-87419-8; (3) products containing or consisting of genetically modified maize ( Zea mays L.) MON-87419-8 for uses other than those provided for in points (1) and (2), with the exception of cultivation. The genetically modified maize MON-87419-8 expresses the dmo and the pat genes, which confer tolerance to dicamba- and glufosinate-ammonium-based herbicides. (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 ‘maize’. (2) The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of genetically modified maize MON-87419-8, with the exception of products referred to in point (b)(1) of this Annex. (d) Method for detection: (1) Event specific real-time PCR based method for the quantification of genetically modified maize MON-87419-8. (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 0818-A2 and AOCS 0406-A2 (for the non-GM counterpart) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm (e) Unique identifier:   MON-87419-8 (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 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 for the use of the food for human consumption:   Not required. Note: links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.