MON-8746Ø-4
EU register of genetically modified food and feed.
| Event | MON 87460 |
| Authorisation holder Name |
Bayer Agriculture BV, Belgium representing Bayer CropScience LP, United States |
| Authorisation holder Address |
Bayer Agriculture BV Scheldelaan 460, 2040 Antwerp, Belgium On behalf of Bayer CropScience LP, 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 Amended by Commission Implementing Decision (EU) 2021/184 of 12 February 2021 |
| 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 |