EU register of genetically modified food and feed.
|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:
|Reference material||AOCS 0809-B and AOCS 0906-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm.|
|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: