Annexes to COM(2007)397 - Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation 1829/2003 (Only the French, Dutch and English texts are authentic)

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ANNEX

(a)   Applicants and Authorisation holders:

Name:Pioneer Overseas Corporation
Address:Avenue des Arts 44, B-1040 Brussels, Belgium

On behalf of Pioneer Hi-Bred International, Inc., 7250 NW 62nd Avenue, P. O. Box 552, Johnston, IA 50131-0552, United States;

and

Name:Dow AgroSciences Europe Ltd.
Address:European Development Centre, 3 Milton Park, Abingdon, Oxon OX14 4RN, United Kingdom

On behalf of Mycogen Seeds c/o Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States.

(b)   Designation and specification of the products:

(1)Foods and food ingredients containing, consisting of, or produced from DAS-59122-7 maize;

(2)Feed containing, consisting of, or produced from DAS-59122-7 maize;

(3)Products other than food and feed containing or consisting of DAS-59122-7 maize for the same uses as any other maize with the exception of cultivation.

The genetically modified maize DAS-59122-7, as described in the application, expresses Cry34Ab1 and Cry35Ab1 proteins which confer protection against certain coleopteran pests such as corn rootworm larvae (Diabrotica spp.) and the PAT protein, used as a selectable marker, which confers tolerance to the glufosinate-ammonium herbicide.

(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 DAS-59122-7 maize referred to in Article 2(b) and (c).

(d)   Method for detection:

Event specific real-time quantitative PCR based method for genetically modified maize DAS-59122-7.,

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®-BF424 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:

DAS-59122-7

(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.