2012/651/EU: Commission Implementing Decision of 18 October 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MIR162 (SYN-IR162-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2012) 7198) Text with EEA relevance
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Genetically modified organism and unique identifier
Genetically modified maize ( Zea mays L.) MIR162, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier SYN-IR162-4, as provided for in Regulation (EC) No 65/2004.
Authorisation
The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision: (a) foods and food ingredients containing, consisting of, or produced from SYN-IR162-4 maize; (b) feed containing, consisting of, or produced from SYN-IR162-4 maize; (c) SYN-IR162-4 maize in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.
Labelling
1. For the purposes of the labelling requirements laid down in Article 13(1) and Article 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 with the exception of products referred to in point (a) of Article 2.
Monitoring for environmental effects
1. The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented. 2. The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.
EU register
The information set out in the Annex to this Decision shall be entered in the EU register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.
Authorisation holder
The authorisation holder shall be Syngenta Seeds SAS, France, representing Syngenta Crop Protection AG, Switzerland.
Validity
This Decision shall apply for a period of 10 years from the date of its notification.
Addressee
This Decision is addressed to Syngenta Seeds SAS, 12, Chemin de l'Hobit, 31790 Saint-Sauveur, France.
ANNEX (a) Applicant and Authorisation holder Name : Syngenta Seed SAS Address : 12, Chemin de l'Hobit, 31790 Saint-Sauveur, France On behalf of Syngenta Crop Protection AG, Schwarzwaldallee 215, CH-4058 Basel, Switzerland. (b) Designation and specification of the 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-IR162-4 maize in products containing it or consisting of it for any other use than (1) and (2), with the exception of cultivation. The genetically modified SYN-IR162-4 maize, as described in the application, expresses the Vip3Aa20 protein which confers protection against certain lepidopteran pests and PMI protein which was used as a selectable marker. (c) Labelling (1) For the purposes of the specific labelling requirements laid down in Article 13(1) and Article 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 with the exception of products referred to in point (a) of Article 2. (d) Method for detection — Event specific real-time PCR-based method for the quantification of SYN-IR162-4 maize; — validated on seeds by the Community Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm — reference material: AOCS 1208-A and AOCS 0407-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm (e) Unique identifier SYN-IR162-4 (f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity Biosafety Clearing-House, Record ID: see [ to be completed when notified ]. (g) Conditions or restrictions on the placing on the market, use or handling of the products Not required. (h) Monitoring plan Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC. [Link: plan published on the internet ] (i) Post-market monitoring requirements for the use of the food for human consumption Not required. Note: links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.
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