Name

Syngenta Seeds SAS

Address

Chemin de l’Hobit 12, BP 27, 31790 Saint-Sauveur, France

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

1. (1)

   Foods and food ingredients containing, consisting of, or produced from SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9 maize;

2. (2)

   feed containing, consisting of, or produced from SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9 maize;

3. (3)

   products other than food and feed containing or consisting of SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9 maize for the same uses as any other maize with the exception of cultivation.

The genetically modified SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9 maize, as described in the application, is produced by crosses between maize containing SYN-BTØ11-1, SYN-IR6Ø4-5 and MON-ØØØ21-9 events and expresses the Cry1Ab protein which confers protection against certain lepidopteran pests, a PAT protein which confers tolerance to glufosinate-ammonium herbicides, the Cry3A protein which provides protection against certain coleopteran pests and the mEPSPS protein which confers tolerance to glyphosate herbicide. 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.

1. (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. (2)

   the words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9 maize referred to in Article 2(b) and (c) of this Decision.

• Event specific real-time quantitative PCR based methods for genetically modified maize SYN-BTØ11-1, SYN-IR6Ø4-5 and MON-ØØØ21-9 maize validated on SYN-BTØ11-1xSYN-IR6Ø4-5 xMON-ØØØ21-9 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 and AOCS 0407-A, AOCS 0407-B (for MON-ØØØ21-9) accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm

SYN-BTØ11-1xSYN-IR6Ø4-5xMON-ØØØ21-9.

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

Not required.

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

[Link: plan published on the Internet]

Not required.