HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6;
DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ81Ø-6;
DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ6Ø3-6;
SYN-IR162-4 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6 ;
SYN-IR162-4 × MON-ØØ81Ø-6

Community register of GM food and feed.

Event 1507 × MIR162 × MON810 × NK603,

and three related GM maizes combining three different single GM events:
1507 × MIR162 × MON810;
1507 × MIR162 × NK603;
MIR162 × MON810 × NK603

and one related GM maizes combining two different single GM events:
MIR162 × MON810.
Authorisation holder Name Pioneer Hi-Bred International, Inc.
Authorisation holder Address 7100 NW 62nd Avenue, P.O. Box 1014,
Johnston, IA 50131-1014,
United States of America

Represented in the Union by: Pioneer Overseas Corporation, Rue Montoyer 25, 1000 Brussels, 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 DAS-Ø15Ø7-1 expresses the pat gene, which confers tolerance to glufosinate-ammonium based herbicides, and the cry1F gene, which confers 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-ØØ81Ø-6 expresses the cry1Ab gene, which confer protection against certain lepidopteran pests.

The genetically modified maize MON-ØØ6Ø3-6 expresses the CP4 epsps and the CP4 epsps L214P genes, which confers tolerance to glyphosate-based herbicides.
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 AS-Ø15Ø7-1, SYN-IR162-4, MON-ØØ81Ø-6 and MON-ØØ6Ø3-6 and further verified on maize AS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6.

- 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: ERM®-BF418 (for AS-Ø15Ø7), ERM®-BF413 (for MON-ØØ81Ø-6) and ERM®-BF415 (for MON-ØØ6Ø3-6) is accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/ and AOCS 1208 (for SYN-IR162-4) is accessible via the American Oil Chemists Society at https://www.aocs.org/crm#maize.
Unique identifier DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6;
DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ81Ø-6;
DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ6Ø3-6;
SYN-IR162-4 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6;
SYN-IR162-4 × MON-ØØ81Ø-6.
Annex II to the Cartagena Protocol To be provided later
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 18/08/2021
Legal base Commission Implementing Decision (EU) 2021/1388 of 17 August 2021
Authorisation expiration date 17/08/2031
Further information on risk assessment Opinion of the European Food Safety Authority: https://doi.org/10.2903/j.efsa.2021.6348