MON-87769-7 x MON-89788-1
EU register of genetically modified food and feed.
| Event | MON 87769 x MON 89788 |
| Authorisation holder Name | Bayer CropScience LP |
| Authorisation holder Address |
800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States,
represented in the Union by: Bayer Agriculture BV, Scheldelaan 460, BE-2040 Antwerp, Belgium |
| Products |
(1) foods and food ingredients containing, consisting of or produced from genetically modified soybean MON-87769-7 × MON-89788-1;
(2) feed containing, consisting of or produced from genetically modified soybean MON-87769-7 × MON-89788-1; (3) products containing or consisting of genetically modified soybean MON-87769-7 × MON-89788-1 for uses other than those provided for in points (1) and (2), with the exception of cultivation. |
| Designation |
The genetically modified soybean MON-87769-7 × MON-89788-1 expresses Δ15 desaturase, which results in conversion of linoleic acid to α-linolenic acid, and Δ6 desaturase, which results in conversion of α-linolenic to stearidonic acid (SDA). SDA is a normal intermediate in the formation of the long-chain omega-3 polyunsaturated fatty acids.
The genetically modified soybean MON-87769-7 × MON-89788-1 also expresses the cp4 epsps gene, which confers tolerance to glyphosate-containing herbicides. |
| Labelling |
For the purposes of the 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';
For the purposes of the labelling requirements laid down in Article 13(2) 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; The words 'not for cultivation' shall appear on the label of and in the accompanying documents of the products containing or consisting of the soybean specified with their unique identifiers, with the exception of foods and food ingredients. |
| Method for detection |
- Quantitative event-specific PCR detection methods individually validated for genetically modified soybean MON-87769-7 and MON-89788-1 and further verified on soybean stack MON-877969-7 × MON-89788-1;
- Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx |
| Reference material | Reference Material: AOCS 0809 (for MON-87769-7) and AOCS (for MON-89788-1) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm. |
| Unique identifier | MON-87769-7 x MON-89788-1 |
| Annex II to the Cartagena Protocol | To be provided later |
| 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.
(1) The authorisation holder shall collect the following information: (i) quantities of genetically modified soybean MON-87769-7 × MON-89788-1 for oil extraction, imported into the Union for their placing on the market; (ii) quantities of genetically modified soybean MON-87769-7 × MON-89788-1 oil, imported into the European Union for the placing on the market, in particular, quantities of refined bleached deodorised oil, and; (iii) quantities of products for food containing this refined bleached deodorised oil, imported into the European Union for the placing on the market; (iv) in case of import, consumption data for humans of products listed in points (i) to (iii). (2) The authorisation holder shall, based on the information collected and reported: (i) review the predicted consumption data of genetically modified soybean MON-87769-7 × MON-89788-1; (ii) verify that the conditions of use of genetically modified soybean MON-87769-7 × MON-89788-1 are those considered during the pre-market risk assessment. |
| Date of authorisation | 20/05/2022 |
| Legal base | Commission Decision (EU) 2022/798 of 19 May 2022 |
| Authorisation expiration date | 19/05/2032 |
| Further information on risk assessment |
Opinion of the European Food Safety Authority: https://doi.org/10.2903/j.efsa.2021.6589 |