HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

ACS-GHØØ1-3

Community register of GM food and feed.

Event LLCotton25
Authorisation holder Name BASF Agricultural Solutions Seed US LLC Represented by BASF SE
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 (1) foods and food ingredients containing, consisting of or produced from genetically modified cotton LLCotton25;
(2) feed containing, consisting of or produced from genetically modified cotton LLCotton25;
(3) products containing or consisting of genetically modified cotton LLCotton25 for uses other than those provided in points (1) and (2), with the exception of cultivation.
Designation The genetically modified cotton LLCotton25 expresses the bar gene which confers tolerance to glufosinate-ammonium 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 ‘cotton’.

(2) The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying the products containing or consisting of genetically modified cotton LLCotton25, with the exception of products referred to in point (a) of Article 2 of Commission Implementing Decision 2019/2082 (EU).
Method for detection - Event specific real-time PCR based method for the detection of genetically modified cotton LLCotton25. - 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 0306-A3 and AOCS 0306-E2 accessible via the American Oil Chemists Society at https://www.aocs.org/crm
Unique identifier ACS-GHØØ1-3
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=115426
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 28/11/2019
Legal base Art. 7(3), and 19(3) of the Regulation (EC) No 1829/2003

Commission Decision 2019/2082 of 28 November 2019
Authorisation expiration date 27/11/2029
Further information on risk assessment Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2005-047
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2018-00814