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dossier	COM(2010)298 - Proposal for a Council Decision renewing the authorisation for continued marketing of products containing, consisting of, or ...
document	COM(2010)298
date	July 28, 2010

ANNEX

(a) Applicant and authorisation holder:

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, 4058 Basel, Switzerland

(b) Designation and specification of the products:

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

2.	feed containing, consisting of, or produced from SYN-BTØ11-1 maize;

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

The genetically modified SYN-BTØ11-1 maize, as described in the application, expresses the Cry1Ab protein which confers protection against certain lepidopteran pests and the PAT protein which confers tolerance to the glufosinate-ammonium herbicide.

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

(d) Method for detection:

—	event specific real-time PCR-based method for the quantification of SYN-BTØ11-1 maize

—	validated 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: ERM®-BF412 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)   Unique identifier:

SYN-BTØ11-1

(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.