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The Genetically Modified Food and Feed (Authorisations) (Scotland) Regulations 2022
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Regulation 3(1)
SCHEDULE 6SRenewal of the authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11
This schedule has no associated Policy Notes
Genetically modified organism and unique identifierS
1. For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the unique identifier SYN-BTØ11-1 is specified for genetically modified maize Bt11.
Commencement Information
I1Sch. 6 para. 1 in force at 31.5.2022, see reg. 1(1)
AuthorisationS
2. The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) 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 SYN-BTØ11-1,
(b)feed containing, consisting of or produced from genetically modified maize SYN-BTØ11-1,
(c)products containing or consisting of genetically modified maize SYN-BTØ11-1 for uses other than those provided for in sub-paragraphs (a) and (b), with the exception of cultivation.
Commencement Information
I2Sch. 6 para. 2 in force at 31.5.2022, see reg. 1(1)
LabellingS
3.—(1) For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) 1829/2003, and in Article 4(6) of Regulation (EC) 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 SYN-BTØ11-1, with the exception of food and food ingredients.
Commencement Information
I3Sch. 6 para. 3 in force at 31.5.2022, see reg. 1(1)
Method of detectionS
4.—(1) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the method specified in sub-paragraph (2) is to be used for the detection of genetically modified maize SYN-BTØ11-1.
(2) The method specified in this sub-paragraph is 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 Bt11 using real time PCR-Protocol”, reference “CR-VL-10/07VP 20/06/2008”.
(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 “Maize Seeds Sampling and DNA Extraction Report on the Validation of a DNA Extraction Method from Maize Seeds and Grains”, reference “CRL-VL-12/05XP 18/04/2007”.
(4) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the reference material ERM®-BF412 is accessible from the Joint Research Centre (JRC) of the European Commission(1).
Commencement Information
I4Sch. 6 para. 4 in force at 31.5.2022, see reg. 1(1)
Monitoring plan for environmental effectsS
5.—(1) The authorisation holder must implement the monitoring plan for environmental effects, which accompanied the application for renewal of the authorisation of genetically modified maize SYN-BTØ11-1, reference number “RP620” submitted to the Food Safety Authority on 12 March 2021.
(2) The authorisation holder must submit to the Food Safety Authority annual reports on the implementation of, and the results of the activities as set out in the monitoring plan, in accordance with the format set out in Annex 2 of Decision 2009/770/EC.
Commencement Information
I5Sch. 6 para. 5 in force at 31.5.2022, see reg. 1(1)
Authorisation holderS
6.—(1) The name and address of the authorisation holder is Syngenta Crop Protection AG, Rosentalstrasse 67, CH-4058 Basel, Switzerland.
(2) The authorisation holder is represented in Great Britain by Syngenta Limited, Jealott’s Hill International Research Centre, Bracknell, Berkshire, England, RG42 6EY.
Commencement Information
I6Sch. 6 para. 6 in force at 31.5.2022, see reg. 1(1)
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