Genetically Modified Organisms

BCS-GHØØ2-5 x BCS-GHØØ4-7 x BCS-GHØØ5-8

EU register of genetically modified food and feed.

Event GHB614 × T304-40 × GHB119
Authorisation holder Name BASF Agricultural Solutions Seed US LLC
Authorisation holder Address 100 Park Avenue, Florham Park,
New Jersey 07932, United States of America

Represented in the Union 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 BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8;
(2) Feed containing, consisting of, or produced from genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8;
(3) Products other than food and feed containing or consisting genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8 cotton for uses other than those provided for in points (1) and (2), with the exception of cultivation.
Designation The genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8 expresses the 2mepsps gene, which confers tolerance to glyphosate based herbicides, the bar gene, which confers tolerance to glufosinate-ammonium based herbicides, the cry1Ab, and the cry2Ae genes, which confer resistance to certain lepidopteran pests.
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 products containing or consisting of genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8referred to in Article 2(b) and (c).
Method for detection - The quantitative event-specific PCR detection methods for cotton GHB614 × T304-40 × GHB119 are those validated for genetically modified cotton events BCS-GHØØ2-5, BCS-GHØØ4-7 and BCS-GHØØ5-8. The detection methods have been validated on genomic DNA extracted from leaves of BCS-GHØØ2-5, BCS-GHØØ4-7, BCS-GHØØ5-8 and verified on genomic DNA extracted from leaves of BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8.

- Validated by the European Union reference laboratory established under Regulation (EC) No 1829/2003,
published at https://gmo-crl.jrc.ec.europa.eu/method-validations
Reference material - Reference Material: AOCS 1108-A5 (for BCS-GHØØ2-5) is accessible via the American Oil Chemists' Society (AOCS) at https://www.aocs.org/crm.
ERM-BF429 (for BCS-GHØØ4-7) and ERM-BF428 (BCS-GHØØ5-8) are accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/.
Unique identifier BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=116337
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) 2021/1389 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.2018.5349
Version: 1.1.3