HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

MON-877Ø8-9 x MON-89788-1

Community register of GM food and feed.

Event MON 87708× MON 89788
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-877Ø8-9 × MON-89788-1 soybean

2) Feed containing, consisting or produced from MON-877Ø8-9 × MON-89788-1 soybean

3) Products other than food and feed containing or consisting of MON-877Ø8-9 × MON-89788-1 soybean for the same uses as any other soybean with the exception of cultivation
Designation The genetically modified soybean MON-877Ø8-9 expresses the DMO (dicamba mono-oxygenase) protein which confers tolerance to dicamba-based herbicides and the CP4 EPSPS protein which confers tolerance to glyphosate-based herbicides.
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 ’soybean’;

2. The words 'not for cultivation' shall appear on the label of and in the documents accompanying products containing or consisting of MON-877Ø8-9 × MON-89788-1 soybean with the exception of products referred to in point (a) of Article 2;
Method for detection Event specific real-time quantitative PCR based methods for MON-877Ø8-9 and MON-89788-1 soybeans; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of MON-877Ø8-9 × MON-89788-1 soybean.

Validated on 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 0311-A and AOCS 0906-A (for MON-877Ø8-9), and AOCS 0906-B and AOCS 0906-A (for MON-89788-1) accessible via the American Oil Chemists Society at http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248.
Unique identifier MON-877Ø8-9 × MON-89788-1
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=110987
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 25/07/2016
Legal base Art. 7(3) and 19(3) of the Regulation (EC) No 1829/2003
Commission Decision 2016/1216/UE of 22 July 2016
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 25/07/2026
Further information on risk assessment http://www.efsa.europa.eu/en/efsajournal/pub/4136.htm