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Genetically Modified Organisms

SYN-BTØ11-1xMON-ØØØ21-9

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 http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx
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 http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm and AOCS 0407 (for MON-ØØØ21-9 ) accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
Unique identifier SYN-BTØ11-1xMON-ØØØ21-9
Annex II to the Cartagena Protocol http://bch.cbd.int/database/record-v4.shtml?documentid=101307
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: http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2009-00747