| Event |
MIR162 |
| Authorisation holder Name |
Syngenta Seeds S.A.S.
On behalf of
Syngenta Crop Protection AG
|
| Authorisation holder Address |
Syngenta Seeds S.A.S..
Chemin de l'Hobit 12, BP 27
F-31790 Saint-Sauveur - France
On behalf of
Syngenta Crop Protection AG
Schwarzwaldallee 215
CH 4058 Basle - Switzerland
|
| Products |
(1) Foods and food ingredients containing, consisting of, or produced from SYN-IR162-4 maize;
(2) Feed containing, consisting of, or produced from SYN-IR162-4 maize;
(3) SYN-IR162-maize in products containing it or consisting of it for any other use than (1) and (2), with the exception of cultivation.
|
| Designation |
The genetically modified maize SYN-IR162-4, as described in the application, expresses a modified Vip3Aa20 protein which provides protection to certain lepidopteran pests. A pmi gene, allowing transformed maize cells to utilize mannose as a sole carbon source, was used as a selectable marker. |
| 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-IR162-4 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-IR162-4.
- 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®-BF423 accessible via the joint Research Centre (JRC) of the European Commission, the institute of Reference Materials and Measurements (IRMM) at American Oil Chemists Society (AOCS) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm |
| Unique identifier |
SYN-IR162-4 |
| Annex II to the Cartagena Protocol |
http://bch.cbd.int/database/record.shtml?documentid=104797 |
| Conditions or restrictions on the placing on the market |
Not applicable |
| Post-market monitoring requirements |
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC |
| Date of authorisation |
18/10/2012 |
| Legal base |
Art. 7(3), and 19(3) of the Regulation (EC) No 1829/2003
Commission Decision 2012/651 of 18 October 2012
|
| Authorisation expiration date |
17/10/2022 |
| Further information on risk assessment |
Opinion of the European Food Safety Authority: http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2010-00972 |
