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Genetically Modified Organisms

SYN-IR162-4

EU register of genetically modified food and feed.

Event MIR162
Authorisation holder Name Syngenta Crop Protection NV/SA
On behalf of
Syngenta Crop Protection AG
Authorisation holder Address Syngenta Crop Protection NV/SA
Avenue Louise 489, 1050 Brussels, Belgium

On behalf of
Syngenta Crop Protection AG
Rosentalstrasse 67
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: ERMĀ®-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

Amended by Commission Implementing Decision (EU) 2019/60 of 11 January 2019
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