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Genetically Modified Organisms


EU register of genetically modified food and feed.

Event Bt11xGA21
Authorisation holder Name Syngenta Seeds SAS
Authorisation holder Address Syngenta Seeds SAS

Chemin de l'Hobit 12, BP 27

31790 Saint-Sauveur FRANCE
Products (1) Foods and food ingredients containing, consisting of, or produced from SYN-BTØ11-1xMON-ØØØ21-9 maize;

(2) Feed containing, consisting of, or produced from SYN-BTØ11-1xMON-ØØØ21-9 maize;

(3) Products other than food and feed containing or consisting of SYN-BTØ11-1xMON-ØØØ21-9 maize for the same uses as any other maize with the exception of cultivation.
Designation The genetically modified SYN-BTØ11-1xMON-ØØØ21-9 maize, as described in the application, expresses the Cry1Ab protein which confers protection against certain lepidopteran pests, the mEPSPS protein which confers tolerance to glyphosate herbicides and a PAT protein which confers tolerance to glufosinate-ammonium 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-BTØ11-1xMON-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-BTØ11-1xMON-ØØØ21-9.

- Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at
Reference material - Reference Material: ERM®-BF412 (for SYN-BTØ11-1) accessible via the Joint Research Centre (JRC) of the European Commission, the Institute of Reference Materials and Measurements (IRMM) at and AOCS 0407 (for MON-ØØØ21-9 ) accessible via the American Oil Chemists Society at
Unique identifier SYN-BTØ11-1xMON-ØØØ21-9
Annex II to the Cartagena Protocol
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 28/07/2010
Legal base Art. 7(3), and 19(3) of the Regulation (EC) No 1829/2003

Commission Decision 2010/426 of 28 July 2010
Authorisation expiration date 27/07/2020
Further information on risk assessment Opinion of the European Food Safety Authority: