HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

MON 8746Ø-4

EU register of genetically modified food and feed.

Event MON 87460
Authorisation holder Name Bayer Agriculture BVBA
Authorisation holder Address Scheldelaan 460, 2040 Antwerp, 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
Amended by Commission Implementing Decision (EU) 2019/1579 of 18 September 2019
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