Welsh Statutory Instruments
Agriculture, Wales
Food, Wales
Made
25 April 2022
Laid before Senedd Cymru
27 April 2022
Coming into force
20 May 2022
The Welsh Ministers make these Regulations in exercise of the powers conferred by Articles 7(3), 9(2), 11, 19(3), 21(2), 23 and 35 of Regulation (EC) No. 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(1).
As required by Article 9 of Regulation (EC) 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(2), there has been open and transparent public consultation during the preparation and evaluation of these Regulations.
1.—(1) The title of these Regulations is the Genetically Modified Food and Feed (Authorisations) (Wales) Regulations 2022.
(2) These Regulations—
(a)extend to England and Wales;
(b)apply in relation to Wales;
(c)come into force on 20 May 2022.
2. In these Regulations—
“Decision 2009/770” (“Penderfyniad 2009/770”) means Commission Decision of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market(3);
“Food Safety Authority” (“Awdurdod Diogelwch Bwyd”) has the meaning given in Article 2(17) of Regulation 1829/2003;
“Regulation 1829/2003” (“Rheoliad 1829/2003”) means Regulation (EC) No. 1829/2003 of the European Parliament and of the Council on genetically modified food and feed;
“Regulation 1830/2003” (“Rheoliad 1830/2003”) means Regulation (EC) No. 1830/2003 of the European Parliament and of the Council concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC(4).
3.—(1) Schedules 1 to 9 have effect.
(2) Subject to Articles 11(4) and 23(4) of Regulation 1829/2003, the authorisations set out in Schedules 1 to 9 expire at the end of 19 May 2032.
4. The following instruments are revoked—
(a)Commission Decision (EC) 2009/813 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 89034 (MON-89Ø34-3)(5);
(b)Commission Decision (EC) 2009/814 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 88017 (MON-88Ø17-3)(6);
(c)Commission Decision (EC) 2009/866 authorising the placing on the market of products, containing, consisting of or produced from genetically modified maize MIR604 (SYN-IR6Ø4-5)(7);
(d)Commission Decision (EU) 2010/419 renewing the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified maize Bt11 (SYN-BTØ11-1), authorising foods and food ingredients containing or consisting of field maize Bt11 (SYN-BTØ11-1)(8);
(e)Commission Implementing Decision (EU) 2018/1111 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 (MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6) and genetically modified maize combining two of the events MON 87427, MON 89034 and NK603(9).
Lynne Neagle
Deputy Minister for Mental Health and Wellbeing, under the authority of the Minister for Health and Social Services, one of the Welsh Ministers
25 April 2022
Regulation 3
1. For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the unique identifier SYN-IR6Ø4-5 is specified for genetically modified maize MIR604.
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 SYN-IR6Ø4-5;
(b)feed containing, consisting of or produced from genetically modified maize SYN-IR6Ø4-5;
(c)products containing or consisting of genetically modified maize SYN-IR6Ø4-5 for uses other than those provided for in sub-paragraphs (a) and (b), with the exception of cultivation.
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 “maize”.
(2) The words “not for cultivation” must appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize SYN-IR6Ø4-5, with the exception of food and food ingredients.
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 SYN-IR6Ø4-5.
(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 MIR604 Using Real-time PCR”, reference “CRLVL04/05VP corrected version 1”, 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 “Maize Seeds Sampling and DNA Extraction Report on the Validation of a DNA Extraction Method from Maize Seeds”, reference “CRLVL04/05XP”, dated 3 April 2007.
(4) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the reference material “ERM®-BF423” is accessible via the Joint Research Centre (JRC) of the European Commission(10).
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 maize SYN-IR6Ø4-5, reference number “RP476” submitted to the Food Safety Authority on 3 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 to Decision 2009/770.
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.
Regulation 3
1. For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the unique identifier SYN-ØØØ98-3 is specified for genetically modified maize MZIR098.
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 SYN-ØØØ98-3;
(b)feed containing, consisting of or produced from genetically modified maize SYN-ØØØ98-3;
(c)products containing or consisting of genetically modified maize SYN-ØØØ98-3 for uses other than those provided for in sub-paragraphs (a) and (b), with the exception of cultivation.
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 SYN-ØØØ98-3, with the exception of food and food ingredients.
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 SYN-ØØØ98-3.
(2) Event-specific real-time quantitative PCR based method for detection of the genetically modified maize SYN-ØØØ98-3 as set out in the document entitled “Event-specific Method for the Quantification of Maize MZIR098 Using Real-time PCR”, reference “EURL-VL-04/17VP” and published 7 December 2018.
(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”, reference “CRLVL04/05XP”, and dated 3 April 2007.
(4) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the reference material “AOCS 1114-B2” is accessible via the American Oil Chemists Society (AOCS)(11).
5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for authorisation of genetically modified maize SYN-ØØØ98-3, reference number “RP526” submitted to the Food Safety Authority on 5 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 to Decision 2009/770.
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.
Regulation 3
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 MON 87427 × MON 89034 × MIR162 × NK603 and its sub-combinations as follows—
(a)MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-ØØ6Ø3-6 for genetically modified maize MON-87427-7 × MON 89034 × MIR162 × NK603;
(b)MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 for genetically modified maize MON 87427 × MON 89034 × MIR162;
(c)MON-87427-7 × MON 89Ø34-3 × MON ØØ6Ø3-6 for genetically modified maize MON 87427 × MON 89034 × NK603;
(d)MON-87427-7 × SYN-IR162-4 × MON ØØ6Ø3-6 for genetically modified maize MON 87427 × MIR162 × NK603;
(e)MON-89Ø34-3 × SYN-IR162-4 × MON ØØ6Ø3-6 for genetically modified maize MON 89034 × MIR162 × NK603;
(f)MON-87427-7 × MON 89Ø34-3 for genetically modified maize MON 87427 × MON 89034;
(g)MON-87427-7 × MON ØØ6Ø3-6 for genetically modified maize MON 87427 × NK603;
(h)MON-87427-7 × SYN-IR162-4 for genetically modified maize MON 87427 × MIR162;
(i)MON-89Ø34-3 × MON-ØØ6Ø3-6 for genetically modified maize MON 89034 × NK603;
(j)MON-89Ø34-3 × SYN-IR162-4 for genetically modified maize MON 89034 × MIR162;
(k)SYN-IR162-4 × MON-ØØ6Ø3-6 for genetically modified maize MIR162 × NK603.
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 referred to in paragraph 1;
(b)feed containing, consisting of or produced from genetically modified maize referred to in paragraph 1;
(c)products containing or consisting from genetically modified maize referred to in paragraph 1 for uses other than those in sub-paragraphs (a) and (b), with the exception of cultivation.
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 referred to in paragraph 1, with the exception of food and food ingredients.
4.—(1) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the methods specified in sub-paragraphs (2) to (5) are to be used for the detection of genetically modified maize referred to in paragraph 1.
(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 MON 87427 Using Real-time PCR”, reference “EURL-VL-03/12VP”, and dated 9 June 2015.
(3) 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 89034 Using Real-time PCR”, reference “CRLVL06/06VP”, and dated 21 October 2008.
(4) 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 MIR162 Using Real-time PCR”, reference “CRLVL08/08VP”, and dated 31 January 2011.
(5) 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 quantitation of maize line NK603 using real-time PCR”, reference “CRLVL27/04VP”, and published 10 January 2005.
(6) The method of DNA extraction for use in the detection method specified in sub-paragraphs (2) to (5) 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.
(7) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the reference materials “AOCS 0512-A2” (for MON-87427-7), “AOCS 0906-E2” (for MON-89Ø34-3) and “AOCS 1208-A3” (for SYN-IR162-4) are accessible via the American Oil Chemists Society (AOCS)(12). “ERM®-BF415” (for MON-ØØ6Ø3-6) is accessible via the Joint Research Centre (JRC) of the European Commission(13).
5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for authorisation of the genetically modified maize referred to in paragraph 1, reference number “RP535” submitted to the Food Safety Authority on 5 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 to Decision 2009/770.
6.—(1) The name and address of 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 Ltd, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.
Regulation 3
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 MON 87427 × MON 89034 × MIR162 × MON 87411 and sub-combinations as follows—
(a)MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9 for genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411;
(b)MON-87427-7 × MON-89Ø34-3 × MON-87411-9 for genetically modified maize MON 87427 × MON 89034 × MON 87411;
(c)MON-87427-7 × SYN-IR162-4 × MON-87411-9 for genetically modified maize MON 87427 × MIR162 × MON 87411;
(d)MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9 for genetically modified maize MON 89034 × MIR162 × MON 87411;
(e)MON-87427-7 × MON-87411-9 for genetically modified maize MON 87427 × MON 87411;
(f)MON-89Ø34-3 × MON-87411-9 for genetically modified maize MON 89034 × MON 87411;
(g)SYN-IR162-4 × MON-87411-9 for genetically modified maize MIR162 × MON 87411.
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 referred to in paragraph 1;
(b)feed containing, consisting of or produced from genetically modified maize referred to in paragraph 1;
(c)products containing or consisting of genetically modified maize referred to in paragraph 1 for uses other than those in sub-paragraphs (a) and (b), with the exception of cultivation.
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 referred to in paragraph 1, with the exception of food and food ingredients.
4.—(1) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the methods specified in sub-paragraphs (2) to (5) are to be used for the detection of genetically modified maize referred to in paragraph 1.
(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 MON 87427 Using Real-time PCR”, reference “EURL-VL-03/12VP”, and dated 9 June 2015.
(3) 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 89034 Using Real-time PCR”, reference “CRLVL06/06VP”, and dated 21 October 2008.
(4) 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 MIR162 Using Real-time PCR”, reference “CRLVL08/08VP”, and dated 31 January 2011.
(5) 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 MON 87411 by Real-time PCR”, reference “EURL-VL-01/15VP” and published 4 July 2016.
(6) The method of DNA extraction for use in the detection methods specified in sub-paragraphs (2) to (5) 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.
(7) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the reference materials “AOCS 0512-A2” (for MON-87427-7), “AOCS 0906-E2” (for MON-89Ø34-3), “AOCS 1208-A3” (for SYN-IR162-4) and “AOCS 0215-B” (for MON-87411-9) are accessible via the American Oil Chemists Society (AOCS)(14).
5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for authorisation of the genetically modified maize referred to in paragraph 1, reference number “RP606” submitted to the Food Safety Authority on 11 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 to Decision 2009/770.
6.—(1) The name and address of 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 Ltd, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.
Regulation 3
1. For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the unique identifier MON-87751-7 × MON-877Ø1-2 × MON-877Ø8-9 × MON-89788-1 is specified for genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788.
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 soybean MON-87751-7 × MON-877Ø1-2 × MON-877Ø8-9 × MON-89788-1;
(b)feed containing, consisting of or produced from genetically modified soybean MON-87751-7 × MON-877Ø1-2 × MON-877Ø8-9 × MON-89788-1;
(c)products containing or consisting of genetically modified soybean MON-87751-7 × MON-877Ø1-2 × MON-877Ø8-9 × MON-89788-1 for uses other than those in sub-paragraphs (a) and (b), with the exception of cultivation.
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 “soybean”.
(2) The words “not for cultivation” must appear on the label of and in documents accompanying products containing or consisting of genetically modified soybean MON-87751-7 × MON-877Ø1-2 × MON-877Ø8-9 × MON-89788-1, with the exception of food and food ingredients.
4.—(1) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the methods specified in sub-paragraphs (2) to (5) are to be used for the detection of genetically modified soybean MON-87751-7 × MON-877Ø1-2 × MON-877Ø8-9 × MON-89788-1.
(2) Event-specific real-time quantitative PCR based method of detection of the genetically modified soybean as set out in the document entitled “Event-specific Method for the Quantification of Soybean MON 87751 Using Real-time PCR”, reference “EURL-VL-03/14VP Corrected version 1”, and dated 1 August 2016.
(3) Event-specific real-time quantitative PCR based method of detection of the genetically modified soybean as set out in the document entitled “Event-specific Method for the Quantification of Soybean MON 87701 Using Real-time PCR”, reference “CRLVL05/09VP”, and dated 13 July 2011.
(4) Event-specific real-time quantitative PCR based method of detection of the genetically modified soybean as set out in the document entitled “Event-specific Method for the Quantification of Soybean MON87708 Using Real-time PCR”, reference “EURL-VL-02/11VP”, and dated 6 May 2013.
(5) Event-specific real-time quantitative PCR based method of detection of the genetically modified soybean as set out in the document entitled “Event-specific Method for the Quantification of Soybean Line MON 89788 Using Real-time PCR”, reference “CRLVL05/06VP”, and dated 18 February 2008.
(6) The method of DNA extraction for use in the detection methods specified in sub-paragraphs (2) to (5) is as set out in the document entitled “Report on the Validation of a DNA Extraction Method for Soybean Seeds”, reference “CRL-VL-05/06XP Corrected version 2”, and dated 16 March 2018.
(7) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the reference materials “AOCS 0215-A” (for MON-87751-7), “AOCS 0809-A2” (for MON 877Ø1-2), “AOCS 0311-A2” (for MON-877Ø8-9) and “AOCS 0906-B2” (for MON-89788-1) are accessible via the American Oil Chemists Society (AOCS)(15).
5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for authorisation of the genetically modified soybean MON-87751-7 × MON-877Ø1-2 × MON-877Ø8-9 × MON-89788-1, reference number “RP607” submitted to the Food Safety Authority on 11 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 to Decision 2009/770.
6.—(1) The name and address of 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 Ltd, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.
Regulation 3
1. For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the unique identifier SYN-BTØ11-1 is specified for genetically modified maize Bt11.
2. The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No. 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.
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 SYN-BTØ11-1, with the exception of food and food ingredients.
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 SYN-BTØ11-1.
(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 Bt11 using Real-time PCR”, reference “CRLVL10/07VP”, and dated 20 June 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 “CRLVL12/05XP”, and dated 18 April 2007.
(4) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the reference material “ERM®-BF412” is accessible via the Joint Research Centre (JRC) of the European Commission(16).
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 maize SYN-BTØ11-1, reference number “RP620” submitted to the Food Safety Authority on 12 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 to Decision 2009/770.
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.
Regulation 3
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 MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and sub-combinations as follows—
(a)MON-87427-7 × MON-8746Ø-4 × MON- 89Ø34-3 × SYN-IR162-4 × MON-ØØ6Ø3-6 for genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603;
(b)MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 × SYN-IR162-4 for genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162;
(c)MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 × MON-ØØ6Ø3-6 for genetically modified maize MON 87427 × MON 87460 × MON 89034 × NK603;
(d)MON-87427-7 × MON-8746Ø-4 × SYN-IR162-4 × MON-ØØ6Ø3-6 for genetically modified maize MON 87427 × MON 87460 × MIR162 × NK603;
(e)MON-8746Ø-4 × MON-89Ø34-3 × SYN-IR162-4 × MON-ØØ6Ø3-6 for genetically modified maize MON 87460 × MON 89034 × MIR162 × NK603;
(f)MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 for genetically modified maize MON 87427 × MON 87460 × MON 89034;
(g)MON-87427-7 × MON-8746Ø-4 × SYN-IR162-4 for genetically modified maize MON 87427 × MON 87460 × MIR162;
(h)MON-87427-7 × MON-8746Ø-4 × MON-ØØ6Ø3-6 for genetically modified maize MON 87427 × MON 87460 × NK603;
(i)MON-8746Ø-4 × SYN-IR162-4 × MON-ØØ6Ø3-6 for genetically modified maize MON 87460 × MIR162 × NK603;
(j)MON-8746Ø-4 × MON-89Ø34-3 × SYN-IR162-4 for genetically modified maize MON 87460 × MON 89034 × MIR162;
(k)MON-8746Ø-4 × MON-89Ø34-3 × MON-ØØ6Ø3-6 for genetically modified maize MON 87460 × MON 89034 × NK603;
(l)MON-87427-7 × MON-8746Ø-4 for genetically modified maize MON 87427 × MON 87460;
(m)MON-8746Ø-4 × SYN-IR162-4 for genetically modified maize MON 87460 × MIR162;
(n)MON-8746Ø-4 × MON-ØØ6Ø3-6 for genetically modified maize MON 87460 × NK603;
(o)MON-8746Ø-4 × MON-89Ø34-3 for genetically modified maize MON 87460 × MON 89034.
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 referred to in paragraph 1;
(b)feed containing, consisting of or produced from genetically modified maize referred to in paragraph 1;
(c)products containing or consisting of genetically modified maize referred to in paragraph 1 for uses other than those in sub-paragraphs (a) and (b), with the exception of cultivation.
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.
4.—(1) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the methods specified in sub-paragraphs (2) to (6) are to be used for the detection of genetically modified maize referred to in paragraph 1.
(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 MON 87427 Using Real-time PCR”, reference “EURL-VL-03/12VP”, and dated 9 June 2015.
(3) 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 MON 87460 Using Real-time PCR”, reference “CRLVL04/09VP”, and dated 18 January 2012.
(4) 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 89034 Using Real-time PCR”, reference “CRLVL06/06VP”, and dated 21 October 2008.
(5) 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 MIR162 Using Real-time PCR”, reference “CRLVL08/08VP”, and dated 31 January 2011.
(6) 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 quantitation of maize line NK603 using real-time PCR”, reference “CRLVL27/04VP”, and dated 10 January 2005.
(7) The method of DNA extraction for use in the detection method specified in sub-paragraphs (2) to (6) 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.
(8) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the reference materials “AOCS 0512-A2” (for MON-87427-7), “AOCS 0709-A2” (for MON-8746Ø-4), “AOCS 0906-E2” (for MON-89Ø34-3) and “AOCS 1208-A3” (for SYN-IR162-4) are accessible via the American Oil Chemists Society (AOCS)(17). “ERM®-BF415” (for MON-ØØ6Ø3-6) is accessible via the Joint Research Centre (JRC) of the European Commission(18).
5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for authorisation of the genetically modified maize referred to in paragraph 1, reference number “RP714” 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 to Decision 2009/770.
6.—(1) The name and address of 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 Ltd, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.
Regulation 3
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.
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;
(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.
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.
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)(19).
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 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 to Decision 2009/770.
6.—(1) The name and address of 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 Ltd, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.
Regulation 3
1. For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the unique identifier MON-89Ø34-3 is specified for genetically modified maize MON 89034.
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-89Ø34-3;
(b)feed containing, consisting of or produced from genetically modified maize MON-89Ø34-3;
(c)products containing or consisting of genetically modified maize MON-89Ø34-3 for uses other than those provided for in sub-paragraphs (a) and (b), with the exception of cultivation.
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-89Ø34-3, with the exception of food and food ingredients.
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 event genetically modified maize MON- 89Ø34-3.
(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 89034 Using Real-time PCR”, reference “CRLVL06/06VP”, and dated 21 October 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 “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 0906-E2” is accessible via the American Oil Chemists Society (AOCS)(20).
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 maize MON- 89Ø34-3, reference number “RP716” 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 to Decision 2009/770.
6.—(1) The name and address of 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 Bayer CropScience Ltd, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.
(This note is not part of the Regulations)
The Welsh Ministers make these Regulations pursuant to retained Regulation (EC) No. 1829/2003 on genetically modified food and feed (“Regulation 1829/2003”). These Regulations authorise the placing on the market of nine food and feed products containing, consisting of, or produced from genetically modified organisms.
Regulation 3 and Schedules 1 to 9 provide for the authorisation of the nine products—
Schedule 1 renews the authorisation for genetically modified maize MIR604;
Schedule 2 is a new authorisation for genetically modified maize MZIR098;
Schedule 3 is a new authorisation for genetically modified maize MON 87427 × MON 89034 × MIR162 × NK603 and its sub-combinations;
Schedule 4 is a new authorisation for genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411 and the sub-combinations that are not covered by Schedule 3;
Schedule 5 is a new authorisation for genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 and its sub-combinations;
Schedule 6 renews the authorisation for genetically modified maize Bt11;
Schedule 7 is a new authorisation for genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and the sub-combinations that are not covered by Schedule 3;
Schedule 8 renews the authorisation for genetically modified maize MON 88017;
Schedule 9 renews the authorisation for genetically modified maize MON 89034.
Authorisations granted by these Regulations are valid for a period of ten years in accordance with Articles 7(4) and 19(4) of Regulation 1829/2003. This is subject to Articles 11(4) and 23(4) of that Regulation, which provide for an extension of the authorisation period in certain circumstances where an application for renewal has been submitted.
Paragraphs (a) to (d) of regulation 4 revoke, in relation to Wales, retained EU Decisions that contain the previous authorisations (which have expired) for the products now authorised by Schedules 1, 6, 8 and 9.
Paragraph (e) of regulation 4 revokes, in relation to Wales, retained Commission Implementing Decision (EU) 2018/1111, which contains the existing authorisation for four of the sub-combinations of the product now authorised by Schedule 3. The existing authorisation has been consolidated within Schedule 3.
In each Schedule, paragraph 4 specifies the method, for detection, including sampling, which has been validated for use in relation to the authorised products. The documents referred to have been published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx.
All relevant information on the authorisation of the products will be entered in the register of genetically modified food and feed referred to in Article 28(1) of Regulation 1829/2003.
The authorisations made by this instrument will be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(1)(e) of retained Regulation (EC) No. 1946/2003 on transboundary movements of genetically modified organisms.
Further information, including in relation to the register or the information notified pursuant to the Cartagena Protocol, can be obtained from the Food Standards Agency, 11th Floor, Southgate House, Cardiff, CF10 1EW or by writing to regulated.products.wales@food.gov.uk.
The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, it was not considered necessary to carry out a regulatory impact assessment as to the likely costs and benefits of complying with these Regulations.
EUR 1829/2003; relevant amending instruments are S.I 2019/705, 2020/1504 and 2022/377. The terms “appropriate authority” and “prescribe” are defined in Article 2 of Regulation 1829/2003.
EUR 178/2002; relevant amending instruments are S.I. 2019/641 and 2020/1504.
EUD 2009/770, amended by S.I. 2019/90 and 2020/1421.
EUR 1830/2003; relevant amending instruments are S.I. 2019/90, 2019/778 and 2020/1421.
EUD 2009/813, amended by S.I. 2019/705.
EUD 2009/814, amended by S.I. 2019/705.
EUD 2009/866, amended by S.I. 2019/705.
EUD 2010/419, amended by S.I. 2019/705.
EUD 2018/1111, amended by S.I. 2019/705.