MON-15985-7
EU register of genetically modified food and feed.
| Event | MON15985 |
| 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-15985-7 cotton 2.) Feed containing, consisting or produced from MON-15985-7 cotton 3.) Products other than food and feed containing or consisting of MON-15985-7 cotton for the same uses as any other cotton with the exception of cultivation |
| Designation | Genetically modified cotton line MON-15985-7 expresses the Cry2Ab2 and Cry1Ac proteins which confer protection against certain lepidopteran pests and GUS protein which acts as selection marker. In addition, an nptII gene, conferring kanamycin and neomycin resistance, and aadA gene, conferring spectinomycin and streptomycin resistance, were used as selective markers in the genetic modification process. |
| 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 ’cotton’; (2) The words 'not for cultivation' shall appear on the label of and in documents accompanying products containing or consisting of MON-15985-7 cotton with the exception of products referred to in point (a) of Article 2. |
| Method for detection |
Event specific real-time quantitative PCR based method for genetically modified MON-15985-7 cotton Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at: URL: http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm |
| Reference material | AOCS 0804-D and AOCS 0804-A accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm |
| Unique identifier | MON-15985-7 |
| Annex II to the Cartagena Protocol | https://bch.cbd.int/database/record.shtml?documentid=108056 |
| 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), 11(3), 19(3) and 23(3) of the Regulation (EC) No 1829/2003 Commission Decision 2015/685/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/3770.htm |