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Genetically Modified Organisms

MON-87769-7

EU register of genetically modified food and feed.

Event MON 87769
Authorisation holder Name Monsanto Europe S.A.
Authorisation holder Address Avenue de Tervuren 270-272, B-1150 Brussels, Belgium
On behalf of Monsanto Company, 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
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