
COMMISSION IMPLEMENTING DECISION (EU) 2015/2279 of 4 December 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603 × T25 (MON-ØØ6Ø3-6 × ACS-ZMØØ3-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 8581) (Only the Dutch and French texts are authentic) (Text with EEA relevance) (revoked) 

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Genetically modified organism and unique identifier
Article 1 
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Authorisation
Article 2 
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Labelling
Article 3 
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Monitoring for environmental effects
Article 4 
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Register
Article 5 
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               Authorisation holder
            
Article 6 
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Validity
Article 7 
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               Addressee
            
Article 8 
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ANNEX


((a)) 
                                 Applicant and authorisation holder:
                              

                                    Name
                                 Bayer Agriculture BVBA
                                    Address
                                 Scheldelaan 460, 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-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize;
((2)) feed containing, consisting of, or produced from MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize;
((3)) MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize in products containing it or consisting of it for any other use than those provided in points (1) and (2), with the exception of cultivation.
The genetically modified MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize, as described in the application, expresses the CP4 EPSPS protein which confers tolerance to glyphosate herbicides and PAT protein which confers tolerance to glufosinate ammonium herbicides.
((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 the accompanying documents of the products containing or consisting of MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize with the exception of products referred to in point (a) of Article 2.
((d)) Method for detection:

((1)) Event-specific real-time quantitative PCR-based methods for MON-ØØ6Ø3-6 and ACS-ZMØØ3-2 maize; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize;
((2)) Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx)
((3)) Reference material: ERM®-BF415 (for MON-ØØ6Ø3-6) accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at https://irmm.jrc.ec.europa.eu/rmcatalogue) and AOCS 0306-H6 and AOCS 0306-C2 (for ACS-ZMØØ3-2) accessible via the American Oil Chemists Society at http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248)
((e)) Unique identifier:
MON-ØØ6Ø3-6 × ACS-ZMØØ3-2
((f)) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
(Biosafety Clearing-House, Record ID number: published in the ... register of genetically modified food and feed when notified).
((g)) Conditions or restrictions on the placing on the market, use or handling of the products:
Not required.
((h)) Monitoring plan for environmental effects:
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(Link: plan published in the ... register of genetically modified food and feed)
((i)) Post-market monitoring requirements for the use of the food for human consumption:
Not required.
