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

SCHEDULES

Regulation 3

SCHEDULE 1 Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-81419-2 × DAS-44406-6

Genetically modified organism and unique identifier

1.  For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the unique identifier DAS-81419-2 × DAS-444Ø6-6 is specified for genetically modified soybean DAS-81419-2 × DAS-44406-6.

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 soybean DAS-81419-2 × DAS-444Ø6-6;

(b) feed containing, consisting of, or produced from genetically modified soybean DAS-81419-2 × DAS-444Ø6-6;

(c) products containing or consisting of genetically modified soybean DAS-81419-2 × DAS-444Ø6-6 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 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, the products containing or consisting of genetically modified soybean DAS-81419-2 × DAS-444Ø6-6, 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 soybean DAS-81419-2 × DAS-444Ø6-6.

(2) The methods are set out in—

(a) for DAS-81419-2, the document entitled “Event-specific Method for the Quantification of Soybean DAS-81419-2 by Real-time PCR”, reference “EURL-VL-03/13 VP”, and dated 13 March 2015;

(b) for DAS-444Ø6-6, the document entitled “Event-specific Method for the Quantification of Soybean DAS-44406-6 by Real-time PCR”, reference “EURL-VL-01/12 VP”, and dated 17 March 2015.

(3) The method of DNA extraction for use in the detection methods specified in sub-paragraph (2) is set out in the document entitled “Report on the In-house Validation of a DNA Extraction Method from Soybean Grains and Validated Method”, reference “EURL-VL-11/10XP”, and dated 13 May 2014.

(4) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the following reference materials are accessible via the Joint Research Centre of the European Commission(1)—

(a) ERM®-BF437 (for DAS-81419-2);

(b) ERM®-BF436 (for DAS-444Ø6-6).

Monitoring plan for the environmental effects

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for the authorisation of genetically modified soybean DAS-81419-2 × DAS-444Ø6-6, reference number “RP1133” submitted to the Food Safety Authority(2) on 8 June 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.

Authorisation holder

6.—(1) 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, CB21 5XE, United Kingdom.

Regulation 3

SCHEDULE 2 Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-81419-2

Genetically modified organism and unique identifier

1.  For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the unique identifier DAS-81419-2 is specified for genetically modified soybean DAS-81419-2.

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 soybean DAS-81419-2;

(b) feed containing, consisting of, or produced from genetically modified soybean DAS-81419-2;

(c) products containing or consisting of genetically modified soybean DAS-81419-2 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 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, the products containing or consisting of genetically modified soybean DAS-81419-2, 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 soybean DAS-81419-2.

(2) The method is set out in the document entitled “Event-specific Method for the Quantification of Soybean DAS-81419-2 by Real-time PCR”, reference “EURL-VL-03/13 VP”, and dated 13 March 2015.

(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 In-house Validation of a DNA Extraction Method from Soybean Grains and Validated Method”, reference “EURL-VL-11/10XP”, and dated 13 May 2014.

(4) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the reference material ERM®-BF437 is accessible via the Joint Research Centre of the European Commission(3).

Monitoring plan for the environmental effects

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for the authorisation of genetically modified soybean DAS-81419-2, reference number “RP1134” submitted to the Food Safety Authority(4) on 8 June 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.

Authorisation holder

6.—(1) 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, CB21 5XE, United Kingdom.

Regulation 3

SCHEDULE 3 Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified soybean SYHT0H2

Genetically modified organism and unique identifier

1.  For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the unique identifier SYN-ØØØH2-5 is specified for genetically modified soybean SYHT0H2.

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 soybean SYN-ØØØH2-5;

(b) feed containing, consisting of, or produced from genetically modified soybean SYN-ØØØH2-5;

(c) products containing or consisting of genetically modified soybean SYN-ØØØH2-5 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 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, the products containing or consisting of genetically modified soybean SYN-ØØØH2-5, 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 soybean SYN-ØØØH2-5.

(2) The method is set out in the document entitled “Event-specific Method for the Quantification of Soybean SYHT0H2 by Real-time PCR”, reference “EURL-VL-04/12VP”, and dated 3 August 2016.

(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 a DNA Extraction Method for Soybean Seeds”, reference “CRLVL04/07XP”, and dated 22 January 2009.

(4) For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the reference material AOCS 0112-A is accessible via the American Oil Chemists’ Society(5).

Monitoring plan for the environmental effects

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for the authorisation of genetically modified soybean SYN-ØØØH2-5, reference number “RP1138” submitted to the Food Safety Authority(6) on 10 June 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.

Authorisation holder

6.—(1) The authorisation holder is Syngenta Crop Protection AG, Rosentalstrasse 67, CH-0458 Basel, Switzerland.

(2) The authorisation holder is represented in Great Britain by Syngenta Limited, Jealott’s Hill International Research Centre, Bracknell, Berkshire, RG42 6EY, United Kingdom.

Regulation 3

SCHEDULE 4 Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and sub-combinations

Genetically modified organism and unique identifier

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 × 1507 × MON 87411 × 59122 and the listed sub-combinations—

(a) MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122;

(b) MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 for genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411;

(c) MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7 for genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × 59122;

(d) MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87427 × MON 87460 × MON 89034 × MON 87411 × 59122;

(e) MON-87427-7 × MON-8746Ø-4 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87427 × MON 87460 × 1507 × MON 87411 × 59122;

(f) MON-87427-7 × MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87427 × MON 89034 × 1507 × MON 87411 × 59122;

(g) MON-8746Ø-4 × MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87460 × MON 89034 × 1507 × MON 87411 × 59122;

(h) MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 × DAS-Ø15Ø7-1 for genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507;

(i) MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 × MON-87411-9 for genetically modified maize MON 87427 × MON 87460 × MON 89034 × MON 87411;

(j) MON-87427-7 × MON-8746Ø-4 × MON-89Ø34-3 × DAS-59122-7 for genetically modified maize MON 87427 × MON 87460 × MON 89034 × 59122;

(k) MON-87427-7 × MON-8746Ø-4 × DAS-Ø15Ø7-1 × MON-87411-9 for genetically modified maize MON 87427 × MON 87460 × 1507 × MON 87411;

(l) MON-87427-7 × MON-8746Ø-4 × DAS-Ø15Ø7-1 × DAS-59122-7 for genetically modified maize MON 87427 × MON 87460 × 1507 × 59122;

(m) MON-87427-7 × MON-8746Ø-4 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87427 × MON 87460 × MON 87411 × 59122;

(n) MON-87427-7 × MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 for genetically modified maize MON 87427 × MON 89034 × 1507 × MON 87411;

(o) MON-87427-7 × MON-89Ø34-3 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87427 × MON 89034 × MON 87411 × 59122;

(p) MON-87427-7 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87427 × 1507 × MON 87411 × 59122;

(q) MON-8746Ø-4 × MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 for genetically modified maize MON 87460 × MON 89034 × 1507 × MON 87411;

(r) MON-8746Ø-4 × MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7 for genetically modified maize MON 87460 × MON 89034 × 1507 × 59122;

(s) MON-8746Ø-4 × MON-89Ø34-3 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87460 × MON 89034 × MON 87411 × 59122;

(t) MON-8746Ø-4 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87460 × 1507 × MON 87411 × 59122;

(u) MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 89034 × 1507 × MON 87411 × 59122;

(v) MON-87427-7 × MON-8746Ø-4 × DAS-Ø15Ø7-1 for genetically modified maize MON 87427 × MON 87460 × 1507;

(w) MON-87427-7 × MON-8746Ø-4 × MON-87411-9 for genetically modified maize MON 87427 × MON 87460 × MON 87411;

(x) MON-87427-7 × MON-8746Ø-4 × DAS-59122-7 for genetically modified maize MON 87427 × MON 87460 × 59122;

(y) MON-87427-7 × DAS-Ø15Ø7-1 × MON-87411-9 for genetically modified maize MON 87427 × 1507 × MON 87411;

(z) MON-87427-7 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87427 × MON 87411 × 59122;

(aa) MON-8746Ø-4 × MON-89Ø34-3 × DAS-Ø15Ø7-1 for genetically modified maize MON 87460 × MON 89034 × 1507;

(bb) MON-8746Ø-4 × MON-89Ø34-3 × MON-87411-9 for genetically modified maize MON 87460 × MON 89034 × MON 87411;

(cc) MON-8746Ø-4 × MON-89Ø34-3 × DAS-59122-7 for genetically modified maize MON 87460 × MON 89034 × 59122;

(dd) MON-8746Ø-4 × DAS-Ø15Ø7-1 × MON-87411-9 for genetically modified maize MON 87460 × 1507 × MON 87411;

(ee) MON-8746Ø-4 × DAS-Ø15Ø7-1 × DAS-59122-7 for genetically modified maize MON 87460 × 1507 × 59122;

(ff) MON-8746Ø-4 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87460 × MON 87411 × 59122;

(gg) MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 for genetically modified maize MON 89034 × 1507 × MON 87411;

(hh) MON-89Ø34-3 × MON-87411-9 × DAS-59122-7 for genetically modified maize MON 89034 × MON 87411 × 59122;

(ii) DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7 for genetically modified maize 1507 × MON 87411 × 59122;

(jj) MON-8746Ø-4 × DAS-Ø15Ø7-1 for genetically modified maize MON 87460 × 1507;

(kk) MON-8746Ø-4 × MON-87411-9 for genetically modified maize MON 87460 × 87411;

(ll) MON-8746Ø-4 × DAS-59122-7 for genetically modified maize MON 87460 × 59122;

(mm) DAS-Ø15Ø7-1 × MON-87411-9 for genetically modified maize 1507 × MON 87411;

(nn) MON-87411-9 × DAS-59122-7 for genetically modified maize MON 87411 × 59122.

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 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 provided for in sub-paragraphs (a) and (b), with the exception of cultivation.

Labelling

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 genetically modified maize 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 MON-87427-7, 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;

(b) for MON-8746Ø-4, 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;

(c) for MON-89Ø34-3, 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;

(d) for DAS-Ø15Ø7-1, the document entitled “Event-specific method for the quantitation of maize line TC1507 using real-time PCR”, reference “CRLVL02/04VP” and, dated 9 March 2005;

(e) for MON-87411-9, the document entitled “Event-specific Method for the Quantification of maize MON 87411 by Real-time PCR”, reference “EURL-VL-01/15VP”, and dated 4 July 2016;

(f) for DAS-59122-7, the document entitled “Event-specific method for the quantitation of maize 59122 using real-time PCR”, reference “CRLVL03/05VP - corrected version 1”, and dated 8 July 2007.

(3) The method of DNA extraction for use in the detection methods specified in sub-paragraph (2) is 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—

(a) the following reference materials are accessible via the American Oil Chemists’ Society(7)—

(i) AOCS 0512-A2 (for MON-87427-7);

(ii) AOCS 0709-A2 (for MON-8746Ø-4);

(iii) AOCS 0906-E2 (for MON-89Ø34-3);

(iv) AOCS 0215-B (for MON-87411-9);

(b) the following reference materials are accessible via the Joint Research Centre of the European Commission(8)—

(i) ERM®-BF418 (for DAS-Ø15Ø7-1);

(ii) ERM®-BF424 (for DAS-59122-7).

Monitoring plan for the environmental effects

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for the authorisation of the genetically modified maize referred to in paragraph 1, reference number “RP1180” submitted to the Food Safety Authority(9) on 2 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 to Decision 2009/770.

Authorisation holder

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.

Regulation 3

SCHEDULE 5 Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 × MIR162 × MON 810 × NK603 and sub-combinations

Genetically modified organism and unique identifier

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 and the listed sub-combinations—

(a) DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6 for genetically modified maize 1507 × MIR162 × MON 810 × NK603;

(b) DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ81Ø-6 for genetically modified maize 1507 × MIR162 × MON 810;

(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 × MON 810 × NK603;

(e) SYN-IR162-4 × MON-ØØ81Ø-6 for genetically modified maize MIR162 × MON 810.

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 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 provided for in sub-paragraphs (a) and (b), with the exception of cultivation.

Labelling

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 genetically modified maize 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 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 via the Joint Research Centre of the European Commission(10)—

(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 via the American Oil Chemists’ Society(11).

Monitoring plan for the environmental effects

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for the authorisation of the genetically modified maize referred to in paragraph 1, reference number “RP1184” submitted to the Food Safety Authority(12) 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 to Decision 2009/770.

Authorisation holder

6.—(1) 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, CB21 5XE, United Kingdom.

Regulation 3

SCHEDULE 6 Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614 × T304-40 × GHB119

Genetically modified organism and unique identifier

1.  For the purposes of Articles 7(3) and 19(3) of Regulation 1829/2003, the unique identifier BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8 is specified for genetically modified cotton GHB614 × T304-40 × GHB119.

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 cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8;

(b) feed containing, consisting of, or produced from genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8;

(c) products containing or consisting of genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8 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 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 “cotton”.

(2) The words “not for cultivation” must appear on the label of, and in documents accompanying, the products containing or consisting of genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8, 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 cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8.

(2) The methods are set out in —

(a) for BCS-GHØØ2-5, the document entitled “Event-specific Method for the Quantification of Cotton Line GHB614 Using Real-time PCR”, reference “CRLVL14/07VP”, and dated 5 September 2008;

(b) for BCS-GHØØ4-7, the document entitled “Event-specific Method for the Quantification of Cotton T304-40 using Real-time PCR”, reference “EURL-VL-05/11VP”, and dated 19 December 2012;

(c) for BCS-GHØØ5-8, the document entitled “Event-specific Method for the Quantification of Cotton GHB119 Using Real-time PCR”, reference “EURL VL04/11 VP”, and dated 11 October 2012.

(3) The method of DNA extraction for use in the detection methods specified in sub-paragraph (2) is set out in the document entitled “Cotton Seeds Sampling and DNA Extraction Report on the Validation of DNA Extraction Method from Cotton Seeds”, reference “CRLVL13/04XP”, and dated 14 March 2007.

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

(a) the reference material AOCS 1108-A6 (for BCS-GHØØ2-5) is accessible via the American Oil Chemists’ Society(13);

(b) the following reference materials are accessible via the Joint Research Centre of the European Commission(14)—

(i) ERM®-BF429 (for BCS-GHØØ4-7);

(ii) ERM®-BF428 (for BCS-GHØØ5-8).

Monitoring plan for the environmental effects

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for the authorisation of genetically modified cotton BCS-GHØØ2-5 × BCS-GHØØ4-7 × BCS-GHØØ5-8, reference number “RP1205” submitted to the Food Safety Authority(15) on 28 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 to Decision 2009/770.

Authorisation holder

6.—(1) The authorisation holder is BASF Agricultural Solutions Seed US LLC, 100 Park Avenue, Florham Park, New Jersey 07932, United States of America.

(2) The authorisation holder is represented in Great Britain by BASF Plc, 2 Stockport Exchange, Railway Road, Stockport, Cheshire, SK1 3GG, United Kingdom.

Regulation 3

SCHEDULE 7 Renewal of the authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 88017 × MON 810

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 × MON-ØØ81Ø-6 is specified for genetically modified maize MON 88017 × MON 810.

Authorisation

2.  The following products are authorised(16) 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 × MON-ØØ81Ø-6;

(b) feed containing, consisting of, or produced from genetically modified maize MON-88Ø17-3 × MON-ØØ81Ø-6;

(c) products containing or consisting of genetically modified maize MON-88Ø17-3 × MON-ØØ81Ø-6 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 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 × MON-ØØ81Ø-6, 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 MON-88Ø17-3 × MON-ØØ81Ø-6.

(2) The methods are set out in—

(a) for MON-88Ø17-3, 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;

(b) 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.

(3) The method of DNA extraction for use in the detection methods specified in sub-paragraph (2) is set out in the document entitled “Report on the Validation of a DNA Extraction Method for Maize Seeds and Grains”, reference “CRLVL16/05XP”, and dated 13 October 2008.

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

(a) the reference material AOCS 0406-D2 (for MON-88Ø17-3) is accessible via the American Oil Chemists’ Society(17);

(b) the reference material ERM®-BF413 (for MON-ØØ81Ø-6) is accessible via the Joint Research Centre of the European Commission(18).

Monitoring plan for the environmental effects

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 × MON-ØØ81Ø-6, reference number “RP1179” submitted to the Food Safety Authority(19) on 2 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 to Decision 2009/770.

Authorisation holder

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.

Regulation 3

SCHEDULE 8 Renewal 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 identifier

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.

Authorisation

2.  The following products are authorised(20) 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.

Labelling

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.

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 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(21).

Monitoring plan for the environmental effects

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(22) 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.

Authorisation holder

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.

(1)

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

(2)

“Food Safety Authority” is defined in Article 2(17) of Regulation 1829/2003.

(3)

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

(4)

“Food Safety Authority” is defined in Article 2(17) of Regulation 1829/2003.

(5)

https://www.aocs.org/crm/

(6)

“Food Safety Authority” is defined in Article 2(17) of Regulation 1829/2003.

(7)

https://www.aocs.org/crm/

(8)

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

(9)

“Food Safety Authority” is defined in Article 2(17) of Regulation 1829/2003.

(10)

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

(11)

https://www.aocs.org/crm/

(12)

“Food Safety Authority” is defined in Article 2(17) of Regulation 1829/2003.

(13)

https://www.aocs.org/crm/

(14)

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

(15)

“Food Safety Authority” is defined in Article 2(17) of Regulation 1829/2003.

(16)

This authorisation is a renewal of the authorisation previously granted under Commission Decision 2010/429/EU. That instrument is revoked by regulation 22 of these Regulations.

(17)

https://www.aocs.org/crm/

(18)

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

(19)

“Food Safety Authority” is defined in Article 2(17) of Regulation 1829/2003.

(20)

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).

(21)

https://www.aocs.org/crm/

(22)

“Food Safety Authority” is defined in Article 2(17) of Regulation 1829/2003.