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SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9

EU register of genetically modified food and feed.

Event BtxMIR604xGA21
Authorisation holder Name Syngenta Seeds SAS
Authorisation holder Address Syngenta Seeds SAS
Chemin de l'Hobit 12, BP 27
31790 Saint-Sauveur FRANCE
On behalf of
Syngenta Crop Protection AG
Schwarzwaldallee 215
4058 Bâle, SWITZERLAND
Products (1) Foods and food ingredients containing, consisting of, or produced from SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9 maize;
(2) Feed containing, consisting of, or produced from SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9 maize;
(3) Products other than food and feed containing or consisting of SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9 maize for the same uses as any other maize with the exception of cultivation.
Designation The genetically modified SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9 maize, as described in the application, expresses the Cry1Ab and Cry3A proteins which confer protection against certain lepidopteran and coleopteran pests, the PAT protein which confers tolerance to glufosinate-ammonium herbicides and the mEPSPS protein which confers tolerance to glyphosate 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 documents accompanying products containing or consisting of SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9 maize referred to in Article 2(b) and (c).
Method for detection - Event specific real-time quantitative PCR based method for genetically modified maize SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9.

- Validated by the European Union Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
Reference material - Reference Material: ERM®-BF412 (for SYN-BTØ11-1) and ERM®-BF423 (for SYN-IR6Ø4-5) accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) and AOCS 0407-A, AOCS 0407-B (for MON-ØØØ21-9) accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
Unique identifier SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9
Annex II to the Cartagena Protocol http://bch.cbd.int/database/record.shtml?documentid=103017
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 22/12/2011
Legal base Art. 7(3), and 19(3) of the Regulation (EC) No 1829/2003
Commission Decision 2011/894/EU of 22 December 2011
Authorisation expiration date 21/12/2021
Further information on risk assessment Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2010-00834