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Commission Decision of 17 June 2011 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 89034 × MON 88017 (MON-89Ø34-3xMON-88Ø17-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2011) 4164) (Only the Dutch and French texts are authentic) (Text with EEA relevance) (2011/366/EU)
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- Penderfyniadau yn deillio o’r UE
- 2011 No. 366
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ANNEX
(a) Applicant and authorisation holder
Name
:
Monsanto Europe SA
Address
:
Avenue de Tervuren 270-272, 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-89Ø34-3xMON-88Ø17-3 maize.
(2)Feed containing, consisting of, or produced from MON-89Ø34-3xMON-88Ø17-3 maize.
(3)Products other than food and feed containing or consisting of MON-89Ø34-3xMON-88Ø17-3 maize for the same uses as any other maize with the exception of cultivation.
The genetically modified MON-89Ø34-3xMON-88Ø17-3 maize, as described in the application, is produced by crosses between maize containing MON-89Ø34-3 and MON-88Ø17-3 events and expresses the Cry1A.105 and Cry2Ab2 proteins which confer protection against certain lepidopteran pests, Cry3Bb1 protein which confers protection against certain coleopteran pests and the CP4 EPSPS protein which confers tolerance to glyphosate 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 MON-89Ø34-3xMON-88Ø17-3 maize referred to in Article 2(b) and (c) of this Decision.
(d) Method for detection
Event specific real-time quantitative PCR based methods for genetically modified maize MON-89Ø34-3 and MON-88Ø17-3 maize validated on MON-89Ø34-3xMON-88Ø17-3 maize
Validated on seeds by the European Union Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
Reference material: AOCS 0406-A and AOCS 0906-E (for MON-89Ø34-3) and AOCS 0406-A and AOCS 0406-D (for MON-88Ø17-3) accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
(e) Unique identifier
MON-89Ø34-3xMON-88Ø17-3
(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.
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