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Genetically Modified Organisms

MON 8746Ø-4

EU register of genetically modified food and feed.

Event MON 87460
Authorisation holder Name Monsanto Europe S.A.
Authorisation holder 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.
Products 1) Foods and food ingredients containing, consisting of, or produced from MON 8746Ø-4 maize

2) Feed containing, consisting of, or produced from MON 8746Ø-4 maize

3) Products other than food and feed containing or consisting of MON 8746Ø-4 maize for the same uses as any other maize with the exception of cultivation
Designation The genetically modified MON 8746Ø-4 maize, expresses the cold shock protein B (CspB) which aims to reduce yield loss caused by drought stress and an nptII gene, conferring kanamycine and neomycine resistance, used as a selective marker.
Labelling 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’;
The words 'not for cultivation' shall appear on the label of and in documents accompanying products containing or consisting of MON 8746Ø-4 maize with the exception of products referred to in point (a) of Article 2.
Method for detection Event specific real-time PCR based method for the quantification of MON 8746Ø-4 maize;
Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at:
URL: http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
Reference material AOCS 0709-A and AOCS 0406-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
Unique identifier MON 8746Ø-4
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=108075
Conditions or restrictions on the placing on the market Not required
Monitoring plan Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Post-market monitoring requirements Not required
Date of authorisation 24/04/2015
Legal base Art. 7(3) and 19(3) of the Regulation (EC) No 1829/2003
Commission Decision 2015/683/UE of 24 April 2015
Authorisation expiration date 26/04/2025
Further information on risk assessment Opinion of the European Food Safety Authority:
http://www.efsa.europa.eu/en/efsajournal/pub/2936.htm