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

Regulation 3

SCHEDULE 5 Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 × MIR 162 × MON 810 × NK 603 maize and its sub-combinations

Genetically modified organism and unique identifier

1.—(1) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the following unique identifiers are specified for genetically modified maize 1507 × MIR 162 × MON 810 × NK 603 maize and its sub-combinations as follows—

(a) DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6 for genetically modified maize 1507 × MIR162 × MON810 × NK603,

(b) DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ81Ø-6 for genetically modified maize 1507 × MIR162 × MON810,

(c) DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ6Ø3-6 for genetically modified maize 1507 × MIR162 × NK603,

(d) SYN-IR162-4 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6 for genetically modified maize MIR162 × MON810 × NK603,

(e) SYN-IR162-4 × MON-ØØ81Ø-6 for genetically modified maize MIR162 × MON810.

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 maize as referred to in paragraph 1,

(b) feed containing, consisting of, or produced from genetically modified maize as referred to in paragraph 1,

(c) products containing or consisting of genetically modified maize as referred to in paragraph 1 for uses other than those 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 ‘maize’.

(2) The words ‘not for cultivation’ must appear on the label of and in documents accompanying products containing or consisting of genetically modified maize as referred to in paragraph 1, 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 maize referred to in paragraph 1.

(2) The methods are set out in—

(a) for DAS-Ø15Ø7-1, the document entitled “Event-specific method for the quantitation of maize line TC1507 using real-time PCR”, “Version B”, reference “JRC 113269” and dated 24 September 2018,

(b) for SYN-IR162-4, the document entitled “Event-specific Method for the Quantification of Maize MIR162 Using Real-time PCR”, reference “CRLVL08/08VP” and dated 31 January 2011,

(c) for MON-ØØ81Ø-6, the document entitled “CRL assessment on the validation of an event specific method for the relative quantitation of maize line MON 810 DNA using real-time PCR as carried out by Federal Institute for Risk Assessment (BfR)”, reference “CRL-VL-25/04VR” and dated 10 March 2006,

(d) for MON-ØØ6Ø3-6, the document entitled “Event-specific method for the quantitation of maize line NK603 using real-time PCR”, reference “CRLVL27/04VP” and dated 10 January 2005.

(3) The method of DNA extraction for use in the detection methods specified in sub-paragraph (2) is as set out in the document entitled “Report on the In-house Validation of a DNA Extraction Method from Ground Maize Seeds and Validated DNA Extraction Method”, reference “EURL-VL-02/14XP” and dated 10 April 2018.

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

(a) the following reference materials are accessible from the Joint Research Centre of the European Commission(1)—

(i) ERM®-BF418 (for DAS-Ø15Ø7),

(ii) ERM®-BF413 (for MON-ØØ81Ø-6),

(iii) ERM®-BF415 (for MON-ØØ6Ø3-6),

(b) the reference material AOCS 1208-A3 (for SYN-IR162-4) is accessible from the American Oil Chemists’ Society(2).

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 genetically modified maize referred to in paragraph 1, reference number “RP1184” submitted to the Food Safety Authority on 5 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 Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, Indiana, 46268, 1054, United States of America.

(2) The authorisation holder is represented in Great Britain by Corteva Agriscience UK Limited, Cpc2 Capital Park, Fulbourn, Cambridge, England, CB21 5XE.

(1)

https://crm.jrc.ec.europa.eu/

(2)

https://www.aocs.org/crm