The Genetically Modified Food and Feed (Authorisations) (England) Regulations 2022

Regulation 3

SCHEDULE 8 Renewal of the authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 88017

Genetically modified organism and unique identifier

1.  For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the unique identifier MON-88Ø17-3 is specified for genetically modified maize MON 88017.

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 MON-88Ø17-3;

(b) feed containing, consisting of or produced from genetically modified maize MON-88Ø17-3; and

(c) products containing or consisting of genetically modified maize MON-88Ø17-3 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 ‘maize’.

(2) The words ‘not for cultivation’ must appear on the label of and in documents accompanying the products containing or consisting of genetically modified maize MON-88Ø17-3, 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 method specified in sub-paragraph (2) is to be used for the detection of genetically modified maize MON-88Ø17-3.

(2) Event-specific real-time quantitative PCR based method of detection of the genetically modified maize as set out in the document entitled “Event-specific Method for the Quantification of Maize Line MON 88017 Using Real-time PCR”, reference “CRLVL16/05VP corrected version 1” and dated 30 March 2010.

(3) The method of DNA extraction for use in the detection method specified in sub-paragraph (2) is as set out in the document entitled “Report on the Validation of a DNA Extraction Method for Maize Seeds and Grains”, reference “CRLVL16/05XP corrected version 2” and dated 26 July 2017.

(4) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the reference material “AOCS 0406-D2” is accessible via the American Oil Chemists’ Society (AOCS).

Monitoring plan for environmental effects

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects(1), which accompanied the application for renewal of the authorisation of genetically modified maize MON-88Ø17-3, reference number “RP715” submitted to the Food Safety Authority on 26 March 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 Bayer CropScience LP of 800 N. Lindbergh Boulevard, St Louis, Missouri, 63167, United States of America.

(2) The authorisation holder is represented in Great Britain by Bayer CropScience Ltd of 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.

(1)

A copy of this document can be obtained from the Food Standards Agency (see Explanatory Note for further details).