HEALTH AND FOOD SAFETY Genetically Modified Organisms

Genetically Modified Organisms

BCS-GHØØ5-8

Community register of GM food and feed.

Event BCS-GHØØ5-8
Authorisation holder Name 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-GHØØ5-8 cotton;
(2) Feed containing, consisting of, or produced from BCS-GHØØ5-8 cotton;
(3) Products, other than food and feed, containing or consisting of BCS-GHØØ5-8 cotton for the same uses as any other cotton with the exception of cultivation.
Designation BCS-GHØØ5-8 as described in the application, expresses the PAT protein which confers tolerance to glufosinate ammonium-based herbicides and Cry2Ae protein which confers 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 BCS-GHØØ5-8 cotton and referred to in Article 2(b) and (c).
Method for detection (1) Event specific real-time PCR based method for the quantification of BCS-GHØØ5-8 cotton.

(2) Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from seeds of BCS-GHØØ5-8 cotton, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx.
Reference material ERM-BF428 accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.jrc.ec.europa.eu/.
Unique identifier BCS-GHØØ5-8
Annex II to the Cartagena Protocol http://bch.cbd.int/database/record.shtml?documentid=112237
Conditions or restrictions on the placing on the market Not required
Monitoring plan
Post-market monitoring requirements Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
Date of authorisation 04/07/2017
Legal base Art. 7(3), Art. 9(2), Art. 19(3) and Art. 21(2) of the Regulation (EC) No 1829/2003
Commission Decision 2017/1208/UE of 4 July 2017
Amended by Commission Implementing Decision (EU) 2019/1195 of 10 July 2019
Authorisation expiration date 03/07/2027
Further information on risk assessment Opinion of the European Food Safety Authority:
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2016-00582