HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

MON-87769-7

Community register of GM food and feed.

Event MON 87769
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-87769-7 soybean

2) Feed containing, consisting or produced from MON-87769-7 soybean

3) Products other than food and feed containing or consisting of MON-87769-7 soybean for the same uses as any other soybean with the exception of cultivation
Designation Genetically modified soybean line MON-87769-7 expresses Δ15 desaturase which results in conversion of linoleic acid to α-linolenic acid and Δ6 desaturase which results in conversion of α-linolenic acid to stearidonic acid (SDA). SDA is a normal intermediate in the formation of the long chain omega-3 polyunsaturated fatty acids.
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 stearidonic acid’ 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-87769-7 soybean 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-87769-7 soybean

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 0809-B and AOCS 0906-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm.
Unique identifier MON-87769-7
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=108081
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 2015/686/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 2015/686/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/3644.htm