
Article 1 
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 2 
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-BTØ11-1xSYN-IR6Ø4-5 maize;
((b)) feed containing, consisting of, or produced from SYN-BTØ11-1xSYN-IR6Ø4-5 maize;
((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 3 

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 4 

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 5 
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 6 
The authorisation holder shall be Syngenta Seeds SAS France, representing Syngenta Crop Protection AG, Switzerland.
Article 7 
This Decision shall apply for a period of 10 years from the date of its notification.
Article 8 
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
ANNEX
(a) 
NameSyngenta Seeds SASAddressChemin de l’Hobit 12, BP 27, 31790 Saint-Sauveur, France

On behalf of Syngenta Crop Protection AG, Schwarzwaldallee 215, CH-4058 Basel, Switzerland

(b) 

((1)) Foods and food ingredients containing, consisting of, or produced from SYN-BTØ11-1xSYN-IR6Ø4-5 maize;
((2)) feed containing, consisting of, or produced from SYN-BTØ11-1xSYN-IR6Ø4-5 maize;
((3)) 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.

The genetically modified SYN-BTØ11-1xSYN-IR6Ø4-5 maize, as described in the application, is produced by crosses between maize containing SYN-BTØ11-1 and SYN-IR6Ø4-5 events and expresses the Cry1Ab protein which confers protection against certain lepidopteran pests, the PAT protein which confers tolerance to glufosinate-ammonium herbicides and the Cry3A protein which provides protection against certain coleopteran pests. A pmi gene, which allows transformed maize cells to utilize mannose as a sole carbon source, was used as a selectable marker in the genetic modification process for SYN-IR6Ø4-5 event.

(c) 

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

(d) 

— Event specific real-time quantitative PCR based methods for genetically modified maize SYN-BTØ11-1 and SYN-IR6Ø4-5 maize validated on SYN-BTØ11-1xSYN-IR6Ø4-5 maize.
— Validated on seeds by the European Union Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
— Reference Material: ERM®-BF412 (for SYN-BTØ11-1) and ERM®-BF423 (for SYN-IR6Ø4-5) accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at https://irmm.jrc.ec.europa.eu/rmcatalogue

(e) 
SYN-BTØ11-1xSYN-IR6Ø4-5.

(f) 
Biosafety Clearing-House, Record ID: see [to be completed when notified].

(g) 
Not required.

(h) 
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

[Link: plan published on the Internet]

(i) 
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.