| 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 |
