Annexes to COM(2008)218 - Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified soybean A2704-12 (ACS-GHØØ5-3) pursuant to Regulation 1829/2003

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ANNEX

(a)   Applicant and authorisation holder:

Name:Bayer CropScience AG.
Address:Alfred-Nobel-Strasse 50, D-40789 Monheim am Rhein, Germany.

(b)   Designation and specification of the products:

1. Foods and food ingredients containing, consisting of, or produced from ACS-GMØØ5-3 soybean.

2. Feed containing, consisting of, or produced from ACS-GMØØ5-3 soybean.

3. Products other than food and feed containing or consisting of ACS-GMØØ5-3 soybean for the same uses as any other soybean with the exception of cultivation.

The genetically modified ACS-GMØØ5-3 soybean, as described in the application, expresses 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 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 ‘soybean’.

2. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of ACS-GMØØ5-3 soybean 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 ACS-GMØØ5-3 soybean,

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

reference material: AOCS 0707-A, AOCS 0707-B and AOCS 0707-C accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm/bayer_soy.cfm

(e)   Unique identifier:

ACS-GMØØ5-3.

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