HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

GHØØ2-5 × ACS-GHØØ1-3 × MON-15985-7

Community register of GM food and feed.

Event GHB614 x LLcotton25 x MON 15985
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 BCS-GHØØ2-5 × ACS-GHØØ1-3 × MON-15985-7 cotton;
(2) feed containing, consisting of or produced from BCS-GHØØ2-5 × ACS-GHØØ1-3 × MON-15985-7 cotton;
(3) products containing or consisting of BCS-GHØØ2-5 × ACS-GHØØ1-3 × MON-15985-7 cotton for uses other than those provided in points (1) and (2), with the exception of cultivation.
Designation The genetically modified cotton GHB614 × LLCotton25 × MON 15985, as described in the application, expresses the 2mEPSPS protein which confers tolerance to glyphosate-containing herbicides, the PAT protein which confers tolerance to glufosinate-ammonium based herbicides, the Cry1Ac and the Cry1Ab2 proteins which confer protection against certain lepidopteran pests. In addition, uidA gene, coding for the GUS protein, nptII gene, conferring kanamycin and neomycin resistance, and aadA gene, conferring spectinomycin and streptomycin resistance, were used as selection markers in the genetic modification process.
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 documents accompanying the products containing or consisting of BCS-GHØØ2-5 × ACS-GHØØ1-3 × MON-15985-7 cotton, with the exception of products referred to in point (a) of Article 2 of Commission Implementing Decision 2019/1302 (EU).
Method for detection - The quantitative event-specific PCR detection methods for cotton GHB614 × LLCotton25 × MON 15985 are those validated for genetically modified cotton events BCS-GHØØ2-5, ACS-GHØØ1-3 and MON-15985-7. The detection methods have been validated on genomic DNA extracted from leaves BCS-GHØØ2-5, ACS-GHØØ1-3 and MON-15985-7 cotton.

- 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 1108-A5 (for BCS-GHØØ2-5), AOCS 0306-E2 (for ACS-GHØØ1-3) and AOCS 0804-D (for MON-15985-7) is accessible via the American Oil Chemists Society (AOCS) at https://www.aocs.org/crm
Unique identifier BCS-GHØØ2-5 × ACS-GHØØ1-3 × MON-15985-7
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=115402
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 26/07/2019
Legal base Commission Implementing Decision 2019/1302 (EU) of 26 July 2019
Authorisation expiration date 28/07/2029
Further information on risk assessment Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2018-00147