|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
4058 Bâle, SWITZERLAND
||(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.
||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.
||(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: 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
|Annex II to the Cartagena Protocol
|Conditions or restrictions on the placing on the market
|Post-market monitoring requirements
||Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
|Date of authorisation
||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
|Further information on risk assessment
||Opinion of the European Food Safety Authority: