HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

ACS-BNØØ5-8 × ACS-BNØØ3-6 × MON-ØØØ73-7;
ACS-BNØØ5-8 × MON-ØØØ73-7;
ACS-BNØØ3-6 × MON-ØØØ73-7

Community register of GM food and feed.

Event Ms8 × Rf3 × GT73;
Ms8 × GT73;
Rf3 × GT73.
Authorisation holder Name Bayer CropScience LP and BASF Agricultural Solutions Seed US LLC
Authorisation holder Address Bayer CropScience LP
Address: 800 N. Lindbergh Boulevard,
St. Louis, Missouri 63167, United States of America
Represented in the Union by: Bayer Agriculture BV, Scheldelaan 460, BE-2040 Antwerp, Belgium

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, D-67063 Ludwigshafen, Germany
Products (a) Foods and food ingredients containing, consisting of or produced from genetically modified ACS-BNØØ5-8 × ACS-BNØØ3-6 × MON-ØØØ73-7,ACS-BNØØ5-8 × MON-ØØØ73-7 and ACS-BNØØ3-6 × MON-ØØØ73-7 oilseed rapes, with the exception of isolated seed protein;
(b) Feed containing, consisting of or produced from genetically modified ACS-BNØØ5-8 × ACS-BNØØ3-6 × MON-ØØØ73-7,ACS-BNØØ5-8 × MON-ØØØ73-7 and ACS-BNØØ3-6 × MON-ØØØ73-7oilseed rapes
(c) Genetically modified ACS-BNØØ5-8 × ACS-BNØØ3-6 × MON-ØØØ73-7,ACS-BNØØ5-8 × MON-ØØØ73-7 and ACS-BNØØ3-6 × MON-ØØØ73-7 oilseed rapes in products containing them or consisting of them for uses other than those provided in points (a) and (b), with the exception of cultivation.
Designation The genetically modified ACS-BNØØ5-8 oilseed rape expresses the pat gene, which confers tolerance to glufosinate-ammonium-based herbicides, and the barnase gene, which confers male sterility during anther development.

The genetically modified ACS-BNØØ3-6 oilseed rape expresses the pat gene, which confers tolerance to glufosinate-ammonium-based herbicides, and the barstar gene, which restores fertility after crossing with ACSBNØØ5-8.

The genetically modified oilseed rape MON-ØØØ73-7 expresses the cp4 epsps and goxv247 genes, which confer tolerance to glyphosate-based herbicides.
Labelling (1) For the purposes of the labelling requirements laid down in Articles 13(1) and 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 documents accompanying products containing or consisting of genetically modified oilseed rapes referred to in Article 2 of Commission Implementing Decision of 26 July 2019, with the exception of foods and food ingredients."
Method for detection The quantitative event-specific PCR detection methods are those individually validated for genetically modified oilseed rape events ACS-BNØØ5-8, ACS-BNØØ3-6 and MON-ØØØ73-7 and further verified on oilseed rape stack ACSBNØØ5-8 × ACS-BNØØ3-6 × MON-ØØØ73-7

Validated on seeds 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 Reference Material: AOCS 0306-F (for ACSBNØØ5-8), AOCS 0306-G (for ACS-BNØØ3-6) and AOCS 0304-B (for MON-ØØØ73-7) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm.
Unique identifier ACS-BNØØ5-8 × ACS-BNØØ3-6 × MON-ØØØ73-7;
ACS-BNØØ5-8 × MON-ØØØ73-7;
ACS-BNØØ3-6 × MON-ØØØ73-7.
Annex II to the Cartagena Protocol To be provided later
Conditions or restrictions on the placing on the market Not required
Post-market monitoring requirements Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Date of authorisation 18/08/2021
Legal base Commission Implementing Decision (EU) 2021/1391 of 17 August 2021
Authorisation expiration date 17/08/2031
Further information on risk assessment Opinion of the European Food Safety Authority:
https://doi.org/10.2903/j.efsa.2016.4466
https://doi.org/10.2903/j.efsa.2020.6200