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Genetically Modified Organisms

SYN-IR162-4

EU register of genetically modified food and feed.

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