Regulation 3(1)

SCHEDULE 1 SRenewal of the authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize MIR604

Genetically modified organism and unique identifier S

1.  For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the unique identifier SYN-IR6Ø4-5 is specified for genetically modified maize MIR604.

Commencement Information

I1 Sch. 1 para. 1 in force at 31.5.2022, see reg. 1(1)

Authorisation S

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-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.

Commencement Information

I2 Sch. 1 para. 2 in force at 31.5.2022, see reg. 1(1)

Labelling S

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 the genetically modified maize SYN-IR6Ø4-5, with the exception of food and food ingredients.

Commencement Information

I3 Sch. 1 para. 3 in force at 31.5.2022, see reg. 1(1)

Method of detection S

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 referred to in paragraph 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 MIR604 using real time PCR”, reference “CRLVL04/05VP corrected version 1”.

(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”.

(4) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the reference material ERM®-BF423 is accessible from the Joint Research Centre (JRC) of the European Commission(1).

Commencement Information

I4 Sch. 1 para. 4 in force at 31.5.2022, see reg. 1(1)

Monitoring plan for the environmental effects S

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-IR6Ø4-5, reference number “RP476” submitted to the Food Safety Authority on 3 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

I5 Sch. 1 para. 5 in force at 31.5.2022, see reg. 1(1)

Authorisation holder S

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

I6 Sch. 1 para. 6 in force at 31.5.2022, see reg. 1(1)

Regulation 3(1)

SCHEDULE 2 SAuthorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize MZIR098

Genetically modified organism and unique identifier S

1.  For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the unique identifier SYN-ØØØ98-3 is specified for genetically modified maize MZIR098.

Commencement Information

I7 Sch. 2 para. 1 in force at 31.5.2022, see reg. 1(1)

Authorisation S

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-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.

Commencement Information

I8 Sch. 2 para. 2 in force at 31.5.2022, see reg. 1(1)

Labelling S

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 products containing or consisting of genetically modified maize SYN-ØØØ98-3, with the exception of food and food ingredients.

Commencement Information

I9 Sch. 2 para. 3 in force at 31.5.2022, see reg. 1(1)

Method for detection S

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 detection of the genetically modified maize referred to in paragraph 1.

(2) The method specified in this sub-paragraph is 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 by Real Time PCR”, reference “[F1 EURL-VL-04/17VP]”.

(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”.

(4) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the reference material AOCS 1114-B2 is accessible from the American Oil Chemists Society (AOCS)(2).

Textual Amendments

F1 Word in sch. 2 para. 4(2) substituted (26.4.2023) by The Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (Scotland) Regulations 2023 (S.S.I. 2023/59), regs. 1(1), 22(b)

Commencement Information

I10 Sch. 2 para. 4 in force at 31.5.2022, see reg. 1(1)

Monitoring plan for environmental effects S

5.—(1) The authorisation holder must implement 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.

(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

I11 Sch. 2 para. 5 in force at 31.5.2022, see reg. 1(1)

Authorisation holder S

6.—(1) The name and address of the authorisation holder is Sygenta Crop Protection AG, Rosentalsrasse 67, CH-4058 Basel, Switzerland.

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

Commencement Information

I12 Sch. 2 para. 6 in force at 31.5.2022, see reg. 1(1)

Regulation 3(1)

SCHEDULE 3 SAuthorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 ×MIR162 × NK603 and sub-combinations

Genetically modified organisms and unique identifiers S

1.  For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 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 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 × MON- ØØ6Ø3-6 for genetically modified maize MIR162 × NK603.

Commencement Information

I13 Sch. 3 para. 1 in force at 31.5.2022, see reg. 1(1)

Authorisation S

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 as referred to in paragraph 1,

(b) feed containing, consisting of or produced from genetically modified maize as referred to in paragraph 1,

(c) products containing or consisting from genetically modified maize as referred to in paragraph 1 for uses other than those in sub-paragraphs (a) and (b), with the exception of cultivation.

Commencement Information

I14 Sch. 3 para. 2 in force at 31.5.2022, see reg. 1(1)

Labelling S

3.—(1) For the purpose 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 products containing or consisting of genetically modified maize referred to in paragraph 1, with the exception of food and food ingredients.

Commencement Information

I15 Sch. 3 para. 3 in force at 31.5.2022, see reg. 1(1)

Method for detection S

4.—(1) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the methods specified in sub-paragraphs (2) to (5) are to be used for detection of genetically modified maize referred to in paragraph 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 MON 87427 Using Real Time PCR”, reference “[F2 EURL-VL-03/12VP]”.

(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.

(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 MIR162 Using Real Time PCR”, reference “CRLVL08/08VP”.

(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-Protocol”, reference “CRLV27/04VP”.

(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”.

(7) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the reference materials AOCS 0512-A2, AOCS 0906-E2, AOCS 1208-A3 and ERM®-BF415 are accessible from the American Oil Chemists Society and the Joint Research Centre (JRC) of the European Commission(3).

Textual Amendments

F2 Word in sch. 3 para. 4(2) substituted (26.4.2023) by The Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (Scotland) Regulations 2023 (S.S.I. 2023/59), regs. 1(1), 22(c)

Commencement Information

I16 Sch. 3 para. 4 in force at 31.5.2022, see reg. 1(1)

Monitoring plan for environmental effects S

5.—(1) The authorisation holder must implement 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 “RP535” submitted to the Food Safety Authority on 5 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

I17 Sch. 3 para. 5 in force at 31.5.2022, see reg. 1(1)

Authorisation holder S

6.—(1) The name and address of the authorisation holder is Bayer CropScience LP, 800 N. Lindbergh Boulevard, St Louise, 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.

Commencement Information

I18 Sch. 3 para. 6 in force at 31.5.2022, see reg. 1(1)

Regulation 3(1)

SCHEDULE 4 SAuthorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411 and sub-combinations

Genetically modified organisms and unique identifiers S

1.  For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the following unique identifiers are specified for genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411 and its sub-combinations as follows—

(a) MON-84727-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9 for genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411,

(b) MON-84727-7 × MON-89Ø34-3 × MON-87411-9 for genetically modified maize MON 87427 × MON 89034 × MON 87411,

(c) MON-84727-7 × 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-84727-7 × 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.

Commencement Information

I19 Sch. 4 para. 1 in force at 31.5.2022, see reg. 1(1)

Authorisation S

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 as referred to in paragraph 1,

(b) feed containing, consisting of or produced from genetically modified maize as referred to in paragraph 1,

(c) products containing or consisting of genetically modified maize as referred to in paragraph 1 for uses other than those in sub-paragraphs (a) and (b), with the exception of cultivation.

Commencement Information

I20 Sch. 4 para. 2 in force at 31.5.2022, see reg. 1(1)

Labelling S

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 products containing or consisting of genetically modified maize referred to in paragraph 1, with the exception of food and food ingredients.

Commencement Information

I21 Sch. 4 para. 3 in force at 31.5.2022, see reg. 1(1)

Method for detection S

4.—(1) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 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) 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 MON 87427 Using Real-time PCR”, reference “[F3 EURL-VL-03/12VP]”.

(3) 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 MON 89034 Using Real-time PCR”, reference “CRLVL06/06VP”.

(4) 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 MIR162 Using Real-time PCR”, reference “CRLVL08/08VP”.

(5) 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 MON 87411 by Real-time PCR”, reference “EURL-VL-01/15VP”.

(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”.

(7) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the reference materials AOCS 0512-A2, AOCS 0906-E2, AOCS 1208-A3 and AOCS 0215-B are accessible from the American Oil Chemists Society(4).

Textual Amendments

F3 Word in sch. 4 para. 4(2) substituted (26.4.2023) by The Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (Scotland) Regulations 2023 (S.S.I. 2023/59), regs. 1(1), 22(d)

Commencement Information

I22 Sch. 4 para. 4 in force at 31.5.2022, see reg. 1(1)

Monitoring plan for environmental effects S

5.—(1) The authorisation holder must implement 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 “RP606” submitted to the Food Safety Authority on 11 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

I23 Sch. 4 para. 5 in force at 31.5.2022, see reg. 1(1)

Authorisation holder S

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.

Commencement Information

I24 Sch. 4 para. 6 in force at 31.5.2022, see reg. 1(1)

Regulation 3(1)

SCHEDULE 5 SAuthorisation of the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788

Genetically modified organism and unique identifier S

1.  For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 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.

Commencement Information

I25 Sch. 5 para. 1 in force at 31.5.2022, see reg. 1(1)

Authorisation S

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 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.

Commencement Information

I26 Sch. 5 para. 2 in force at 31.5.2022, see reg. 1(1)

Labelling S

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 “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.

Commencement Information

I27 Sch. 5 para. 3 in force at 31.5.2022, see reg. 1(1)

Method for detection S

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) The method specified in this sub-paragraph is 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”.

(3) The method specified in this sub-paragraph is 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”.

(4) The method specified in this sub-paragraph is 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 87708 Using Real-time PCR”, reference “EURL-VL-02/11VP”.

(5) The method specified in this sub-paragraph is 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-Protocol”, reference “CRLVL05/06VP”.

(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”.

(7) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the reference materials AOCS 0215-A, AOCS 0809-A2, AOCS 0311-A2 and AOCS 0906-B2 are accessible from the American Oil Chemists Society(5).

Commencement Information

I28 Sch. 5 para. 4 in force at 31.5.2022, see reg. 1(1)

Monitoring plan for environmental effects S

5.—(1) The authorisation holder must implement 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.

(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

I29 Sch. 5 para. 5 in force at 31.5.2022, see reg. 1(1)

Authorisation holder S

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.

Commencement Information

I30 Sch. 5 para. 6 in force at 31.5.2022, see reg. 1(1)

Regulation 3(1)

SCHEDULE 6 SRenewal of the authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11

Genetically modified organism and unique identifier S

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

I31 Sch. 6 para. 1 in force at 31.5.2022, see reg. 1(1)

Authorisation S

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

I32 Sch. 6 para. 2 in force at 31.5.2022, see reg. 1(1)

Labelling S

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

I33 Sch. 6 para. 3 in force at 31.5.2022, see reg. 1(1)

Method of detection S

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(6).

Commencement Information

I34 Sch. 6 para. 4 in force at 31.5.2022, see reg. 1(1)

Monitoring plan for environmental effects S

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

I35 Sch. 6 para. 5 in force at 31.5.2022, see reg. 1(1)

Authorisation holder S

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

I36 Sch. 6 para. 6 in force at 31.5.2022, see reg. 1(1)

Regulation 3(1)

SCHEDULE 7 SAuthorisation of the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and sub-combinations

Genetically modified organisms and unique identifiers S

1.  For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the following unique identifiers are specified for genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and its 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.

Commencement Information

I37 Sch. 7 para. 1 in force at 31.5.2022, see reg. 1(1)

Authorisation S

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 as referred to in paragraph 1,

(b) feed containing, consisting of or produced from genetically modified maize as referred to in paragraph 1,

(c) products containing or consisting of genetically modified maize as referred to in paragraph 1 for uses other than those in sub-paragraphs (a) and (b), with the exception of cultivation.

Commencement Information

I38 Sch. 7 para. 2 in force at 31.5.2022, see reg. 1(1)

Labelling S

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 products containing or consisting of genetically modified maize as referred to in paragraph 1, with the exception of food and food ingredients.

Commencement Information

I39 Sch. 7 para. 3 in force at 31.5.2022, see reg. 1(1)

Method of detection S

4.—(1) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 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) 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 MON 87427 Using Real-time PCR”, reference “[F4 EURL-VL-03/12VP]”.

(3) 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 MON 87460 Using Real-time PCR – Protocol”, reference “CRLVL04/09VP”.

(4) 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 MON 89034 Using Real-time PCR”, reference “CRLVL06/06VP”.

(5) The method specified in this sub-paragraph is event-specificreal-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 MIR162 Using Real-time PCR”, reference “CRLVL08/08VP”.

(6) 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 quantitation of maize line NK603 using real time PCR-Protocol”, reference “CRLV27/04VP”.

(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”.

(8) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the reference materials AOCS 0512-A2, AOCS 0709-A2, AOCS 0906-E2, AOCS 1208-A3 and ERM®-BF415 are accessible from the American Oil Chemists Society and the Joint Research Centre (JRC) of the European Commission(7).

Textual Amendments

F4 Word in sch. 7 para. 4(2) substituted (26.4.2023) by The Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (Scotland) Regulations 2023 (S.S.I. 2023/59), regs. 1(1), 22(e)

Commencement Information

I40 Sch. 7 para. 4 in force at 31.5.2022, see reg. 1(1)

Monitoring plan for environmental effects S

5.—(1) The authorisation holder must implement 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.

(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

I41 Sch. 7 para. 5 in force at 31.5.2022, see reg. 1(1)

Authorisation holder S

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.

Commencement Information

I42 Sch. 7 para. 6 in force at 31.5.2022, see reg. 1(1)

Regulation 3(1)

SCHEDULE 8 SRenewal of 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 S

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

Commencement Information

I43 Sch. 8 para. 1 in force at 31.5.2022, see reg. 1(1)

Authorisation S

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 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.

Commencement Information

I44 Sch. 8 para. 2 in force at 31.5.2022, see reg. 1(1)

Labelling S

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 MON-88Ø17-3, with the exception of food and food ingredients.

Commencement Information

I45 Sch. 8 para. 3 in force at 31.5.2022, see reg. 1(1)

Method of detection S

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 MON 88Ø17-3.

(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 88017 Using ReaL-time PCR-Protocol”, reference “CRLVL16/05VP Corrected Version 1”.

(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 from Maize Seeds and Grains”, reference “CRLVL16/05XP corrected version 2”.

(4) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the reference material AOCS 0406-D2 is accessible from the American Oil Chemists Society(8).

Commencement Information

I46 Sch. 8 para. 4 in force at 31.5.2022, see reg. 1(1)

Monitoring plan for the environmental effects S

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 MON 88Ø17-3, reference number “RP715” submitted to the Food Safety Authority on 26 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

I47 Sch. 8 para. 5 in force at 31.5.2022, see reg. 1(1)

Authorisation holder S

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.

Commencement Information

I48 Sch. 8 para. 6 in force at 31.5.2022, see reg. 1(1)

Regulation 3(1)

SCHEDULE 9 SRenewal of the authorisation of the placing on the market products containing, consisting of, or produced from genetically modified maize 89034

Genetically modified organism and unique identifier S

1.  For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the unique identifier MON-89Ø34-3 is specified for genetically modified maize 89034.

Commencement Information

I49 Sch. 9 para. 1 in force at 31.5.2022, see reg. 1(1)

Authorisation S

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 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.

Commencement Information

I50 Sch. 9 para. 2 in force at 31.5.2022, see reg. 1(1)

Labelling S

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 referred to in paragraph 1, with the exception of food and food ingredients.

Commencement Information

I51 Sch. 9 para. 3 in force at 31.5.2022, see reg. 1(1)

Method of detection S

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 event genetically modified maize MON- 89Ø34-3.

(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 MON 89034 Using Real Time PCR”, reference “CRLVL06/06VP”.

(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 from Maize Seeds and Grains”, reference “CRLVL16/05XP corrected version 2”.

(4) For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the reference material AOCS 0906-E2 is accessible from the American Oil Chemists Society(9).

Commencement Information

I52 Sch. 9 para. 4 in force at 31.5.2022, see reg. 1(1)

Monitoring plan for the environmental effects S

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 MON- 89Ø34-3, reference number “RP716” submitted to the Food Safety Authority on 26 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

I53 Sch. 9 para. 5 in force at 31.5.2022, see reg. 1(1)

Authorisation holder S

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.

Commencement Information

I54 Sch. 9 para. 6 in force at 31.5.2022, see reg. 1(1)

(1)

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

(2)

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

(3)

https://www.aocs.org/crm, https://crm.jrc.ec.europa.eu/.

(4)

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

(5)

https://www.aocs.org/crm

(6)

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

(7)

https://www.aocs.org/crm, https://crm.jrc.ec.europa.eu/

(8)

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

(9)

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