Article 1Genetically modified organism and unique identifier

Genetically modified maize (Zea mays L.) Bt11xMIR604, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier SYN-BTØ11-1xSYN-IR6Ø4-5, as provided for in Regulation (EC) No 65/2004.

Article 2Authorisation

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:

  1. (a)

    foods and food ingredients containing, consisting of, or produced from SYN-BTØ11-1xSYN-IR6Ø4-5 maize;

  2. (b)

    feed containing, consisting of, or produced from SYN-BTØ11-1xSYN-IR6Ø4-5 maize;

  3. (c)

    products other than food and feed containing or consisting of SYN-BTØ11-1xSYN-IR6Ø4-5 maize for the same uses as any other maize with the exception of cultivation.

Article 3Labelling

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-BTØ11-1xSYN-IR6Ø4-5 maize referred to in Article 2(b) and (c).

Article 4Monitoring 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.

Article 5Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Article 6Authorisation holder

The authorisation holder shall be Syngenta Seeds SAS France, representing Syngenta Crop Protection AG, Switzerland.

Article 7Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Article 8Addressee

This Decision is addressed to Syngenta Seeds SAS, Chemin de l’Hobit 12, BP 27, 31790 Saint-Sauveur, France.

Done at Brussels, 22 December 2011.

For the Commission

John Dalli

Member of the Commission