Regulation 3
SCHEDULE 8E+WRenewal of the authorisation of the placing on the market of products (other than food) containing or consisting of genetically modified oilseed rape GT73
Genetically modified organism and unique identifierE+W
1. For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the unique identifier MON-ØØØ73-7 is specified for genetically modified oilseed rape GT73.
Commencement Information
I1Sch. 8 para. 1 in force at 26.4.2023, see reg. 1(2)(c)
AuthorisationE+W
2. The following products are authorised(1) 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)feed containing or consisting of genetically modified oilseed rape MON-ØØØ73-7;
(b)products containing or consisting of genetically modified oilseed rape MON-ØØØ73-7 for uses other than those provided for in sub-paragraph (a) and other than food, with the exception of cultivation.
Commencement Information
I2Sch. 8 para. 2 in force at 26.4.2023, see reg. 1(2)(c)
LabellingE+W
3.—(1) For the purposes of the labelling requirements 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 “oilseed rape”.
(2) The words “not for cultivation” must appear on the label of, and in documents accompanying, the products containing or consisting of genetically modified oilseed rape MON-ØØØ73-7 referred to in paragraph 2.
Commencement Information
I3Sch. 8 para. 3 in force at 26.4.2023, see reg. 1(2)(c)
Method for detectionE+W
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 oilseed rape MON-ØØØ73-7.
(2) The method is set out in the document entitled “Event-specific Method for the Quantification of Oilseed Rape Line RT73 Using Real-time PCR”, reference “CRLVL26/04VP”, and dated 7 February 2007.
(3) The method of DNA extraction for use in the detection method specified in sub-paragraph (2) is set out in the document entitled “Report on the Validation of an Oilseed Rape DNA Extraction Method from Seeds”, “Corrected version 1”, reference “CRLVL26/04XP Version 1”, and dated 25 July 2017.
(4) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the reference material AOCS 0304-B3 is accessible via the American Oil Chemists’ Society(2).
Commencement Information
I4Sch. 8 para. 4 in force at 26.4.2023, see reg. 1(2)(c)
Monitoring plan for the environmental effectsE+W
5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for renewal of the authorisation of genetically modified oilseed rape MON-ØØØ73-7, reference number “RP1263” submitted to the Food Safety Authority(3) on 22 September 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 to Decision 2009/770.
Commencement Information
I5Sch. 8 para. 5 in force at 26.4.2023, see reg. 1(2)(c)
Authorisation holderE+W
6.—(1) The authorisation holder is Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America.
(2) The authorisation holder is represented in Great Britain by Bayer CropScience Limited, 230 Cambridge Science Park, Milton Road, Cambridge, CB4 0WB, United Kingdom.
Commencement Information
I6Sch. 8 para. 6 in force at 26.4.2023, see reg. 1(2)(c)
This authorisation is a renewal of the authorisation previously granted pursuant to Commission Decision 2005/635/EC concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of an oilseed rape product (Brassica napus L., GT73 line) genetically modified for tolerance to the herbicide glyphosate (OJ No L 228, 3.9.2005 p.11).
“Food Safety Authority” is defined in Article 2(17) of Regulation 1829/2003.