HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

Bt11 × MIR162 × 1507 × GA21

Community register of GM food and feed.

Event Bt11 × MIR162 × 1507 × GA21,
And the sub-combinations
Bt11 × MIR162 × 1507;
MIR162 × 1507 × GA21;
MIR162 × 1507.
Authorisation holder Name Syngenta Crop Protection AG
Represented by
Syngenta Crop Protection NV/SA
Authorisation holder Address Syngenta Crop Protection AG
Rosentalstrasse 67
CH 4058 Basel - Switzerland

Represented by Syngenta Crop Protection NV/SA, Avenue Louise 489, 1050 Brussels, Belgium.
Products (1) foods and food ingredients containing, consisting of or produced from genetically modified maize (Zea mays L.) as referred to in the "unique identifiers" row;
(2) feed containing, consisting of or produced from genetically modified maize (Zea mays L.) as referred to in the "unique identifiers" row;
(3) products containing or consisting of genetically modified maize as referred to in the "unique identifiers" row for uses other than those provided for in points (1) and (2), with the exception of cultivation.
Designation The genetically modified SYN-BTØ11-1 maize expresses the Cry1Ab protein, which confers protection against certain lepidopteran pests, and the PAT protein, which confers tolerance to glufosinate-ammonium-based herbicides.
The genetically modified SYN-IR162-4 maize expresses the Vip3Aa20 protein, which confers protection against certain lepidopteran pests, and the PMI protein, which was used as a selectable marker.
The genetically modified DAS-Ø15Ø7-1 maize expresses the Cry1F protein, which confers protection against certain lepidopteran pests, and the PAT protein, which confers tolerance to glufosinate-ammonium-based herbicides.
The genetically modified MON-ØØØ21-9 maize expresses the mEPSPS protein, which confers tolerance to glyphosate-based herbicides.
Labelling (1) For the purposes of the labelling requirements laid down in Articles 13(1) and 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 accompanying documents of the products containing or consisting of the maize specified with their unique identifiers, with the exception of products referred to in point (1) of the raw “Products”.
Method for detection - The quantitative event-specific PCR detection methods for maize Bt11 × MIR162 × 1507 × GA21 are those validated for genetically modified maize events SYN-BTØ11-1, SYN-IR162-4, DAS-Ø15Ø7-1 and MON-ØØØ21-9.

- 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 ERM®-BF412 (for SYN-BTØ11-1) and ERM®-BF418 (for DAS-Ø15Ø7-1) are accessible via the Joint Research Centre (JRC) of the European Commission at https://ec.europa.eu/jrc/en/reference-materials/catalogue/, and AOCS 1208-A and AOCS 0407-A (for SYN-IR162-4), AOCS 0407-A and AOCS 0407-B (for MON-ØØØ21-9) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm#maize.
Unique identifier SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;
SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1;
SYN-IR162-4 × DAS-Ø15Ø7-1 × MON-ØØØ21-9;
SYN-IR162-4 × DAS-Ø15Ø7-1.
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=115406
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring requirements Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Date of authorisation 26/07/2019
Legal base Commission Implementing Decision 2019/1305 (EU) of 26 July 2019
Authorisation expiration date 28/07/2029
Further information on risk assessment Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2018-00467