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SYN-BTØ11-1 x SYN-IR6Ø4-5

EU register of genetically modified food and feed.

Event BtxMIR604
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-IR6Ø4-5 maize;
(2) Feed containing, consisting of, or produced from SYN-BTØ11-1xSYN-IR6Ø4-5 maize;
(3) Products other than food and feed containing or consisting of SYN-BTØ11-1xSYN-IR6Ø4-5 maize for the same uses as any other maize with the exception of cultivation.
Designation The genetically modified SYN-BTØ11-1xSYN-IR6Ø4-5 maize, as described in the application, expresses the Cry1Ab and Cry3A proteins which confer protection against certain lepidopteran and coleopteran pests and the 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-BTØ11-1xSYN-IR6Ø4-5 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-IR6Ø4-5.

- 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)
Unique identifier SYN-BTØ11-1xSYN-IR6Ø4-5
Annex II to the Cartagena Protocol http://bch.cbd.int/database/record.shtml?documentid=103015
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 2011/893/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-2010-00833