HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

MON-877Ø8-9 × MON-89788-1 × ACS-GMØØ6-4

Community register of GM food and feed.

Event MON 87708 × MON 89788 × A5547-127
Authorisation holder Name Bayer CropScience LP, United States
Represented by
Bayer Agriculture BV, Belgium
Authorisation holder Address Bayer CropScience LP
800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States
Represented by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.
Products (1) foods and food ingredients containing, consisting of or produced from genetically modified soybean MON-877Ø8-9 × MON-89788-1 × ACS-GMØØ6-4;
(2) feed containing, consisting of or produced from genetically modified soybean MON-877Ø8-9 × MON-89788-1 × ACS-GMØØ6-4;
(3) products containing or consisting of genetically modified soybean MON-877Ø8-9 × MON- 89788-1 × ACS-GMØØ6-4 for uses other than those provided for in points (1) and (2), with the exception of cultivation.
Designation The genetically modified soybean MON-877Ø8-9 × MON-89788-1 × ACS-GMØØ6-4 expresses the dmo gene, which confers tolerance to dicamba based herbicides, the CP4 epsps gene which confers tolerance to glyphosate based herbicides and the pat gene, which confers tolerance to glufosinate-ammonium based herbicides
Labelling (1) For the purposes of the labelling requirements laid down in Articles 13(1) and 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 documents accompanying the products containing or consisting of genetically modified soybean MON-877Ø8-9 × MON-89788-1 × ACS-GMØØ6-4, with the exception of products referred to in point 1 of the “Products” row.
Method for detection - Event-specific PCR detection methods are those individually validated for genetically modified soybean events MON-877Ø8-9, MON-89788-1 and ACS-GMØØ6-4 and further verified on soybean stack MON-877Ø8-9 × MON-89788-1 × ACS-GMØØ6-4.

- Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx
Reference material AOCS 0311 (for MON-877Ø8-9), AOCS 0906 (for MON-89788-1) and AOCS 0707 (for ACS-GMØØ6-4) are accessible via the American Oil Chemists Society (AOCS) at https://www.aocs.org/crm
Unique identifier MON-877Ø8-9 × MON-89788-1 × ACS-GMØØ6-4
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=115734
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring requirements Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Date of authorisation 28/09/2020
Legal base Commission Implementing Decision (EU) 2020/1360 of 28 September 2020
Amended by Commission Implementing Decision (EU) 2021/184 of 12 February 2021
Authorisation expiration date 27/09/2030
Further information on risk assessment Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2016-00688