Annexes to COM(2009)457 - Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 89034 (MON-89Ø34-3) pursuant to Regulation 1829/2003 (Only the French and Dutch texts are authentic)

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dossier COM(2009)457 - Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified ...
document COM(2009)457 EN
date September  8, 2009
ANNEX

(a) Applicant and Authorisation holder:

Name: Monsanto Europe S.A.

Address: Avenue de Tervuren 270-272, B-1150 Brussels - 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-89Ø34-3 maize;

(2) Feed containing, consisting of, or produced from MON-89Ø34-3 maize;

(3) Products other than food and feed containing or consisting of MON-89Ø34-3 maize for the same uses as any other maize with the exception of cultivation.

The genetically modified MON-89Ø34-3 maize, as described in the application, expresses the Cry1A.105 and Cry2Ab2 proteins which confer protection to certain lepidopteran pests.

(c) Labelling:

(1) For the purposes of the specific 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-89Ø34-3 maize referred to in Article 2(b) and (c) of this Decision.

(d) Method for detection:

- Event specific real-time PCR based method for the quantification of MON-89Ø34-3 maize;

- Validated on seeds 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: AOCS 0906-E accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm/corn.cfm

(e) Unique identifier:

MON-89Ø34-3

(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.

[1] OJ L 268, 18.10.2003, p. 1.

[2] OJ L 106, 17.4.2001, p. 1.

[3] http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2007-042

[4] OJ L 10, 16.1.2004, p. 5.

[5] OJ L 268, 18.10.2003, p. 24.

[6] OJ L 287, 5.11.2003, p. 1.