The Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (England) Regulations 2023

Regulation 3

SCHEDULE 6 Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614 × T304-40 × GHB119

Genetically modified organism and unique identifier

1.  For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the following unique identifier BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8 is specified for genetically modified cotton GHB614 × T304-40 × GHB119.

Authorisation

2.  The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation 1829/2003, in accordance with the conditions set out in this Schedule—

(a) food and food ingredients containing, consisting of, or produced from genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8;

(b) feed containing, consisting of, or produced from genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8; and

(c) products containing or consisting of genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8 for uses other than those provided for in sub-paragraphs (a) and (b), with the exception of cultivation.

Labelling

3.—(1) For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation 1829/2003, and in Article 4(6) of Regulation 1830/2003, the ‘name of the organism’ is ‘cotton’.

(2) The words ‘not for cultivation’ must appear on the label of, and in documents accompanying, products containing or consisting of genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8, with the exception of food and food ingredients.

Method for detection

4.—(1) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the methods specified in sub-paragraph (2) are to be used for the detection of genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8.

(2) The methods are set out in—

(a) for BCS-GHØØ2-5, the document entitled “Event-specific Method for the Quantification of Cotton Line GHB614 Using Real-time PCR”, reference “CRLVL14/07VP” and dated 5 September 2008;

(b) for BCS-GHØØ4-7, the document entitled “Event-specific Method for the Quantification of Cotton T304-40 using Real-time PCR”, reference “EURL-VL-05/11VP” and dated 19 December 2012.

(c) for BCS-GHØØ5-8, the document entitled “Event-specific Method for the Quantification of Cotton GHB119 Using Real-time PCR”, reference EURL VL04/11 VP and dated 11 October 2012.

(3) The method of DNA extraction for use in the detection methods specified in sub-paragraph (2) is set out in the document entitled “Cotton Seeds Sampling and DNA Extraction Report on the Validation of DNA Extraction Method from Cotton Seeds”, reference “CRLVL13/04XP” dated 14 March 2007.

(4) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003—

(a) the reference material “AOCS 1108-A6” (for BCS-GHØØ2-5) is accessible via the American Oil Chemists’ Society;

(b) the following reference materials are accessible via the Joint Research Centre of the European Commission—

(i) ERM®-BF429 (for BCS-GHØØ4-7);

(ii) ERM®-BF428 (for BCS-GHØØ5-8).

Monitoring plan for environmental effects

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for authorisation of the genetically modified cotton referred to in paragraph 1, reference number “RP1205” submitted to the Food Safety Authority on 28 July 2021, is implemented.

(2) The authorisation holder must submit to the Food Safety Authority annual reports on the implementation of, and the results of the activities set out in, the monitoring plan in accordance with the format set out in Annex 2 of Decision 2009/770.

Authorisation holder

6.—(1) The name and address of the authorisation holder is BASF Agricultural Solutions Seed US LLC, 100 Park Avenue, Florham Park, New Jersey 07932, United States of America.

(2) The authorisation holder is represented in Great Britain by BASF Plc, 2 Stockport Exchange, Railway Road, Stockport, Cheshire, England, SK1 3GG.