Genetically Modified Organisms

MON-87419-8

EU register of genetically modified food and feed.

Event MON 87419
Authorisation holder Name Bayer CropScience LP represented in the Union by Bayer Agriculture BV.
Authorisation holder Address 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.
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.
Designation The genetically modified maize MON-87419-8 expresses the dmo and the pat genes, which confer tolerance to dicamba- and glufosinate-ammonium-based herbicides.
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 1 of the "Products" row.
Method for detection Event specific real-time PCR based method for the quantification of genetically modified maize MON-87419-8.

Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx  
Reference material 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
Unique identifier MON-87419-8
Annex II to the Cartagena Protocol BCH-DEC-EU-265971-1
Conditions or restrictions on the placing on the market Not required.
Post-market monitoring requirements Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Date of authorisation 16/10/2023
Legal base Commission Implementing Decision (EU) 2023/2134 of 13 October 2023
https://eur-lex.europa.eu/eli/dec_impl/2023/2134/oj
Authorisation expiration date 15/10/2033
Further information on risk assessment Opinion of the European Food Safety Authority:
https://doi.org/10.2903/j.efsa.2023.7730
Version: 1.1.3