Annexes to COM(2007)814 - Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize MON863xNK603 (MON-ØØ863-5xMON-ØØ6Ø3-6) pursuant to Regulation 1829/2003 (Only the French and Dutch texts are authentic)

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dossier COM(2007)814 - Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified ...
document COM(2007)814 EN
date March  2, 2010
ANNEX

(a)Applicant and authorisation holder:
Name:Monsanto Europe SA
Address:Scheldelaan 460, Haven 627, 2040 Antwerp, Belgium

On behalf of Monsanto Company, 800 N. Lindbergh Boulevard, St Louis, Missouri 63167, United States of America.

(b)Designation and specification of the products:
1.Foods and food ingredients containing, consisting of, or produced from MON-ØØ863-5xMON-ØØ6Ø3-6 maize;

2.Feed containing, consisting of, or produced from MON-ØØ863-5xMON-ØØ6Ø3-6 maize;

3.Products other than food and feed containing or consisting of MON-ØØ863-5xMON-ØØ6Ø3-6 maize for the same uses as any other maize with the exception of cultivation.

The genetically modified maize MON-ØØ863-5xMON-ØØ6Ø3-6, as described in the application, is produced by crosses between maize containing MON-ØØ863-5 and MON-ØØ6Ø3-6 events and expresses the CryBb1 protein which confers protection against certain coleopteran insect pests (Diabrotica spp.) and the CP4 EPSPS protein which confers tolerance to herbicide glyphosate. An nptII gene, conferring kanamycin resistance, was used as a selectable marker in the genetic modification process.

(c)Labelling:
1.For the purposes of the labelling requirements laid down in Articles 13(1) and 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 MON-ØØ863-5xMON-ØØ6Ø3-6 maize referred to in Article 2(b) and (c).

(d)Method for detection:
—Event specific real-time quantitative PCR based methods for genetically modified maize MON-ØØ863-5 and MON-ØØ6Ø3-6 validated on MON-ØØ863-5xMON-ØØ6Ø3-6 maize,

—Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.it/statusofdoss.htm

—Reference material: ERM®-BF416 (for MON-ØØ863-5) and ERM®-BF415 (for MON-ØØ6Ø3-6) accessible via the Joint Research Centre (JRC) of the European Commission, the Institute of Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm

(e)Unique identifier:

MON-ØØ863-5xMON-ØØ6Ø3-6

(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 time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.