HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

ACS-BNØØ5-8, ACS-BNØØ3-6, ACS-BNØØ5-8 x ACS-BNØØ3-6

Community register of GM food and feed.

Event Ms8, Rf3, Ms8xRf3
Authorisation holder Name BASF Agricultural Solutions Seed US LLC, United States, represented by BASF SE, Germany
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, D-67063 Ludwigshafen, Germany
Products (a) Foods and food ingredients containing, consisting of or produced from Ms8, Rf3, Ms8xRf3 oilseed rapes;
(b) Feed containing, consisting of or produced from Ms8, Rf3, Ms8xRf3 oilseed rapes
(c) Ms8, Rf3, Ms8xRf3 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 Ms8, Rf3 and Ms8 x Rf3 oilseed rapes express the phosphinothricin acetyl transferase (PAT) protein which confers tolerance to the herbicidal active ingredient glufosinate-ammonium and barnase (Ms8) and barstar (Rf3) proteins for male sterility and restorer of fertility
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 Event specific real-time PCR detection method for Ms8, Rf3, Ms8xRf3 oilseed rapes

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-B, AOCS 0306-F and AOCS 0306-G are accessible via the American Oil Chemists Society at URL: http://www.aocs.org/crm
Unique identifier ACS-BNØØ5-8

ACS-BNØØ3-6

ACS-BNØØ5-8 x ACS-BNØØ3-6
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=115401
https://bch.cbd.int/database/record.shtml?documentid=110593
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring requirements Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Date of authorisation Commission Decision of 25 June 2013: foods and food ingredients containing, consisting of or produced from produced from MS8, RF3, MS8xRF3 oilseed rape; feed produced from MS8, RF3, MS8xRF3 oilseed rape.

Amended on 26/07/2019 as regards the renewal of the authorisation to place on the market feed containing or consisting of genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3
Legal base Commission Implementing Decision of 25 June 2013

Commission Implementing Decision of 26 July 2019
Authorisation expiration date 24/06/2023
Further information on risk assessment Opinion of the European Food Safety Authority:

http://www.efsa.europa.eu/en/efsajournal/pub/2875.htm
https://www.efsa.europa.eu/en/efsajournal/pub/5067
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2010-00947
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2017-00713