HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

MON-877Ø5-6

Community register of GM food and feed.

Event MON 87705
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-877Ø5-6 soybean

2) Feed containing, consisting of, or produced from MON-877Ø5-6 soybean

3) Products other than food and feed containing or consisting of MON-877Ø5-6 soybean for the same uses as any other soybean with the exception of cultivation
Designation Genetically modified MON-877Ø5-6 soybean has a reduced expression of fatty acid Δ12-desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes, which results in increased oleic acid and reduced linoleic acid profile and expresses a 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. For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ’with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;

3. The words 'not for cultivation' shall appear on the label of and in the documents accompanying products containing or consisting of MON-877Ø5-6 soybean 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-877Ø5-6 soybean;

Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at:

URL: < href="http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx">http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
Reference material AOCS 0210-A and AOCS 0906-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
Unique identifier MON-877Ø5-6
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=108077
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 Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003 (Art.5 and Annex II(g) of Commission Decision 2015/696/UE of 24 April 2015
Date of authorisation 24/04/2015
Legal base Art. 7(3) and 19(3) of the Regulation (EC) No 1829/2003 Commission Decision 2015/696/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/2909.htm
http://www.efsa.europa.eu/en/efsajournal/pub/3507.htm