Genetically Modified Organisms

SYN-IR162-4

EU register of genetically modified food and feed.

Event MIR162
Authorisation holder Name Syngenta Crop Protection AG represented in the Union by Syngenta Crop Protection NV/SA
Authorisation holder Address Rosentalstrasse 67, CH-4058 Basel, Switzerland Represented in the Union by Syngenta Crop Protection NV/SA, Avenue Louise, 489, 1050 Brussels, Belgium
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) products containing or consisting of genetically modified maize SYN-IR162-4 for uses other than those provided for in points (1) and (2), with the exception of cultivation
Designation The genetically modified maize SYN-IR162-4 expresses the vip3Aa20 gene, which confers resistance to certain lepidopteran pests, and the pmi gene, which 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'.

The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize SYN-IR162-4, with the exception of the products referred to in point 1 of the "products" row.
Method for detection (1) Event specific real-time quantitative PCR based method for genetically modified maize SYN-IR162-4.

(2) 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®-BF446 is accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.jrc.ec.europa.eu/.
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 required.
Post-market monitoring requirements Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Date of authorisation 16/10/2023
Legal base Commission Decision 2012/651 of 18 October 2012

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

Commission Implementing Decision (EU) 2023/2143 of 13 October 2023:
https://eur-lex.europa.eu/eli/dec_impl/2023/2143/oj
 
Authorisation expiration date 15/10/2033
Further information on risk assessment Opinion of the European Food Safety Authority:
https://doi.org/10.2903/j.efsa.2012.2756  
https://doi.org/10.2903/j.efsa.2022.7562
https://doi.org/10.2903/j.efsa.2023.7935
Version: 1.1.3