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: 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 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 |