HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9;
MON-87427-7 × MON-89Ø34-3 × MON-87411-9;
MON-87427-7 × SYN-IR162-4 × MON-87411-9;
MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9;
MON-87427-7 × MON-87411-9; MON-89Ø34-3 × MON-87411-9;
SYN-IR162-4 × MON-87411-9

Community register of GM food and feed.

Event MON 87427 × MON 89034 × MIR162 × MON 87411,

and three related GM maizes combining three different single GM events:
MON 87427 × MON 89034 × MON 87411;
MON 87427 × MIR162 × MON 87411;
MON 89034 × MIR162 × MON 87411 ;

and three related GM maizes combining two different single GM events:
MON 87427 × MON 87411;
MON 89034 × MON 87411;
MIR162 × MON 87411.
Authorisation holder name Bayer CropScience LP
Authorisation holder Address 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
Products (1) foods and food ingredients containing, consisting of, or produced from genetically modified maize (Zea mays L.) referred to in the "unique identifiers" row;
(2) feed containing, consisting of, or produced from genetically modified maize (Zea mays L.) referred to in the "unique identifiers" row;
(3) genetically modified maize (Zea mays L.) referred to in the "unique identifiers" row in products containing them or consisting of them for uses other than those provided for in points (1) and (2), with the exception of cultivation.
Designation The genetically modified maize MON-87427-7 expresses the CP4 epsps gene, which confers tolerance to glyphosate-based herbicides.

The genetically modified maize MON-89Ø34-3 expresses the cry1A.105 and cry2Ab2 genes, which confer protection against certain lepidopteran pests.

The genetically modified maize SYN-IR162-4 expresses a modified vip3Aa20 gene, which provides protection against certain lepidopteran pests. In addition, the pmi gene coding for the PMI protein was used as a selection marker in the genetic modification process.

The genetically modified maize MON-87411-9 expresses the CP4 epsps gene, which confers tolerance to glyphosate-based herbicides, the cry3Bb1 gene and the DvSnf7 dsRNA, which confer protection against corn rootworm (Diabrotica spp.)
Labelling 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';

The words 'not for cultivation' shall appear on the label of and in the accompanying documents of the products containing or consisting the maize specified with their unique identifiers, with the exception of foods and food ingredients.
Method for detection - The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-87427-7, MON-89Ø34-3, SYN-IR162-4 and MON-87411-9 and further verified on maize stack MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9.

- 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 0512 (for MON-87427-7), AOCS 0906 (for MON-89Ø34-3), AOCS 1208 (for SYN-IR162-4) and AOCS 0215 (for MON-87411-9) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm#maize.
Unique identifier MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9;
MON-87427-7 × MON-89Ø34-3 × MON-87411-9;
MON-87427-7 × SYN-IR162-4 × MON-87411-9;
MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9;
MON-87427-7 × MON-87411-9;
MON-89Ø34-3 × MON-87411-9;
SYN-IR162-4 × MON-87411-9.
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=116254
Conditions or restrictions on the placing on the market Not required
Monitoring plan
Post-market monitoring requirements Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Date of authorisation 22/01/2021
Legal base Commission Decision (EU) 2021/65 of 22 January 2021
Authorisation expiration date 21/01/2031
Further information on risk assessment Opinion of the European Food Safety Authority:
https://www.efsa.europa.eu/en/efsajournal/pub/5848