MON-877Ø5-6 x MON-89788-1
EU register of genetically modified food and feed.
| Event | MON 87705 × MON 89788 |
| 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-877Ø5-6 × MON-89788-1 soybean
2) Feed containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean 3) Products other than food and feed containing or consisting of MON-877Ø5-6 × MON-89788-1 soybean for the same uses as any other soybean with the exception of cultivation |
| Designation | Genetically modified MON-877Ø5-6 × MON-89788-1 soybean has a reduced expression of fatty acid Δ12-desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes, which results in increased oleic acid and reduced linoleic acid profile and expresses a CP4 EPSPS protein, which confers tolerance to glyphosate-based herbicides. |
| 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 increased monounsaturated fat and reduced polyunsaturated fat’ 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-877Ø5-6 soybean with the exception of products referred to in point (a) of Article 2. |
| Method for detection |
Event specific real-time PCR based PCR based methods for MON-877Ø5-6 and MON-89788-1 soybeans; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of MON-877Ø5-6 × MON-89788-1 soybean;
Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at: URL: http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx |
| Reference material | AOCS 0210-A and AOCS 0906-A (for MON-877Ø5-6) and AOCS 0906-B and AOCS 0906-A (for MON-89788-1) are accessible via the American Oil Chemists Society at http://www.aocs.org/ LabServices/content.cfm?ItemNumber=19248 |
| Unique identifier | MON-877Ø5-6 × MON-89788-1 |
| Annex II to the Cartagena Protocol | https://bch.cbd.int/database/record.shtml?documentid=110981 |
| 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 2016/1217/EU of 22 July 2016 |
| Date of authorisation | 25/07/2016 |
| Legal base |
Art. 7(3) and 19(3) of the Regulation (EC) No 1829/2003
Commission Decision 2016/1217/EU of 22 July 2016 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 | 25/07/2016 |
| Further information on risk assessment |
Opinion of the European Food Safety Authority:
http://www.efsa.europa.eu/en/efsajournal/pub/4178.htm |