MON-87769-7
EU register of genetically modified 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 |