MON-883Ø2-9 x ACS-BNØØ5-8 x ACS-BNØØ3-6; MON-883Ø2-9 x ACS-BNØØ5-8; MON-883Ø2-9 x ACS-BNØØ3-6
EU register of genetically modified food and feed.
| Event | MON88302 x Ms8 x Rf3 |
| Authorisation holder Name |
BASF Agricultural Solutions Seed US LLC
Represented by BASF SE, Germany and Bayer Agriculture BV, Belgium representing Bayer CropScience LP, United States |
| Authorisation holder Address |
BASF Agricultural Solutions Seed US LLC, 100 Park Avenue, Florham Park, New Jersey 07932, United States of America
Represented by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen, Germany and Bayer Agriculture BV, Belgium, 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 oilseed rapes MON88302 x Ms8 x Rf3, MON88302 x Ms8 and MON88302 x Rf3;
(2) Feed containing, consisting of, or produced from oilseed rapes MON88302 x Ms8 x Rf3, MON88302 x Ms8 and MON88302 x Rf3; (3) Products, other than food and feed, containing or consisting of oilseed rapes MON88302 x Ms8 x Rf3, MON88302 x Ms8 and MON88302 x Rf3, with the exception of cultivation. |
| Designation |
MON88302 oilseed rape expresses the CP4 EPSPS protein, which confers tolerance to glyphosate-based herbicides;
Ms8 oilseed rape expresses the barnase protein and the PAT protein, which confers tolerance to glufosinate ammonium-based herbicides; Rf3 oilseed rape expresses the barstar protein and PAT protein, which confers tolerance to glufosinate ammonium-based herbicides. The expression of barnase and barstar proteins from Bacillus amyloliquefaciens constitutes the basis of a male fertility control system, through the use of the barnase gene, which removes male fertility in order to promote hybridisation, and the barstar gene which restores male fertility with oilseed rape lines Ms8 and Rf3 for obtaining heterosis (hybrid vigour). |
| Labelling |
(1) 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 ’oilseed rape’;
(2) The words 'not for cultivation' shall appear on the label of and in the accompanying documents of the products containing or consisting the oilseed rapes MON88302 x Ms8 x Rf3, MON88302 x Ms8, MON88302 x Rf3, with the exception of foods and food ingredients. |
| Method for detection |
(1) Event specific real-time quantitative PCR based methods for MON88302, Ms8 and Rf3 oilseed rapes; the detection methods are validated on the single events and verified on genomic DNA extracted from seeds of MON88302 x Ms8 x Rf3 oilseed rape;
(2) 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 | AOCS 1011-A (for MON88302), AOCS 0306-F6 (for Ms8) and AOCS 0306-G5 (for Rf3) accessible via the American Oil Chemists Society at http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248 |
| Unique identifier |
MON-883Ø2-9 × ACSBNØØ5-8 × ACS-BNØØ3-6;
MON-883Ø2-9 × ACSBNØØ5-8; MON-883Ø2-9 × ACS-BNØØ3-6. |
| Annex II to the Cartagena Protocol | http://bch.cbd.int/database/record.shtml?documentid=113289 |
| Conditions or restrictions on the placing on the market | Not required |
| Monitoring plan | |
| Post-market monitoring requirements | Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC. |
| Date of authorisation | 21/12/2017 |
| Legal base |
Commission Decision 2017/2453 of 21 December 2017
Amended by Commission Implementing Decision (EU) 2019/1167 of 28 June 2019 Amended by Commission Implementing Decision (EU) 2021/183 of 12 February 2021 |
| Authorisation expiration date | 22/12/2027 |
| Further information on risk assessment |
Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionDocumentsLoader?question=EFSA-Q-2017-00230 |