Prospective

Statutory Instruments

2023 No. 235

Agriculture, England

Food, England

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

Made

28th February 2023

Laid before Parliament

2nd March 2023

Coming into force

26th April 2023

The Secretary of State makes these Regulations in exercise of the powers conferred by Articles 7(3), 19(3) and 35(3) 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) No. 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.

Prospective

PART 1Introduction

Citation, commencement, extent and application_I1

1. These Regulations—

(a)may be cited as the Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (England) Regulations 2023;

(b)come into force on 26th April 2023;

(c)extend to England and Wales; and

(d)apply in relation to England only.

Interpretation_I2

2. In these Regulations—

“Regulation 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” 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/EC3);

“Decision 2009/770” means Commission 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 the placing on the market, pursuant to Decision 2009/770/EC of the European Parliament and of the Council(Directive 2001/18/EC4).

PART 2Authorisations

Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified organisms_I3

3.—(1) Schedules 1 to 7, which contain authorisations for products containing, consisting of, or produced from genetically modified organisms, have effect.

(2) Schedule 8, which contains an authorisation for products containing or consisting of genetically modified organisms, has effect.

PART 3Modifications of existing authorisations

Amendment of Commission Decision 2011/891/EU_I4

4.—(1) Commission Decision 2011/891/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236×3006-210-23 (DAS-24236-5×DAS-21Ø23-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(5) is amended as follows.

(2) In Article 6 (authorisation holder), for the text substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 8 (addressee), for the text substitute—

“This Decision is addressed to Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, Indiana, 46268-1054, United States of America, represented in Great Britain by Corteva Agriscience UK Limited, Cpc2 Capital Park, Fulbourn, Cambridge, England, CB21 5XE.”.

(4) In the Annex for point (a) (applicant and authorisation holder) substitute—

“(a)Authorisation holder

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision 2012/84/EU_I5

5.—(1) Commission Implementing Decision 2012/84/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 356043 (DP-356Ø43-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(6) is amended as follows.

(2) In Article 6 (authorisation holder), for the text substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 8 (addressee), for the text substitute—

(4) In the Annex, for point (a) (applicant and authorisation holder) substitute—

“(a)Authorisation holder

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision 2013/648/EU_I6

6.—(1) Commission Implementing Decision 2013/648/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON89034 × 1507 × NK603 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(7) is amended as follows.

(2) In Article 6 (authorisation holders), for paragraph 1, substitute—

“(1)The authorisations holders are:

(a)Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited, and

(b)Bayer CropScience LP, United States of America, represented in Great Britain by Bayer CropScience Limited.”.

(3) In Article 8 (addressees), for the text substitute—

“This Decision is addressed to:

(a)Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, Indiana, 46268-1054, United States of America, represented in Great Britain by Corteva Agriscience UK Limited, Cpc2 Capital Park, Fulbourn, Cambridge, England, CB21 5XE, and

(b)Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America, represented in Great Britain by Bayer CropScience Limited, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.”.

(4) In the Annex, for point (a) (applicants and authorisation holders) substitute—

“(a)Authorisation holders

(1)Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, Indiana, 46268-1054, United States of America, represented in Great Britain by Corteva Agriscience UK Limited, Cpc2 Capital Park, Fulbourn, Cambridge, England, CB21 5XE, and

(2)Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America, represented in Great Britain by Bayer CropScience Limited, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.”.

Amendment of Commission Implementing Decision 2013/650/EU_I7

(2) In Article 6 (authorisation holders), for paragraph 1, substitute—

“(1)The authorisation holders are:

(a)Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited, and

(b)Bayer CropScience LP, United States of America, represented in Great Britain by Bayer CropScience Limited.”.

(3) In Article 8 (addressees), for the text substitute—

“This Decision is addressed to:

(4) In the Annex, for point (a) (applicant and authorisation holders) substitute—

“(a)Authorisation holders

(2)Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America. represented in Great Britain by Bayer CropScience Limited, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.”.

Amendment of Commission Implementing Decision (EU) 2015/698_I8

8.—(1) Commission Implementing Decision (EU) 2015/698 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 (DP-3Ø5423-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(9) is amended as follows.

(2) In Article 7 (authorisation holder), for the text substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 9 (addressee), for the text substitute—

(4) In the Annex, for point (a) (applicant and authorisation holder) substitute—

“(a)Authorisation holder

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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2016/1215_I9

9.—(1) Commission Implementing Decision (EU) 2016/1215 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST- FGØ72-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(10) is amended as follows.

(2) In Article 6 (authorisation holder), for the text substitute—

“The authorisation holder is Syngenta Crop Protection AG, Switzerland represented in Great Britain by Syngenta Limited.”.

(3) In Article 8 (addressee), for the text substitute—

“This Decision is addressed to Syngenta Crop Protection AG, Rosentalstrasse 67, CH-4058 Basel, Switzerland, represented in Great Britain by Syngenta Limited, Jealott’s Hill International Research Centre, Bracknell, Berkshire, England, RG42 6EY.”.

(4) In the Annex, for point (a) (applicant and authorisation holder) substitute—

“(a)Authorisation holder:

(1)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.”.

Amendment of Commission Implementing Decision (EU) 2017/1211_I10

10.—(1) Commission Implementing Decision (EU) 2017/1211 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 (DAS-24236-5 × DAS-21Ø23-5 × MON-88913-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(11) is amended as follows.

(2) In Article 6 (authorisation holder), for the text substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 8 (addressee), for the text substitute—

(4) In the Annex, for point (a) (applicant and authorisation holder) substitute—

“(a)Authorisation holder:

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2017/1212_I11

11.—(1) Commission Implementing Decision (EU) 2017/1212 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize DAS-40278-9, pursuant to Regulation (EC) No 1829/2003 of the European parliament and of the Council on genetically modified food and feed(12) is amended as follows.

(2) In Article 6 (authorisation holder), for the text substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 8 (addressee), for the text substitute—

(4) In the Annex, for point (a) (authorisation holder) substitute—

“(a)Authorisation holder:

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2017/2448_I12

12.—(1) Commission Implementing Decision (EU) 2017/2448 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 × 40-3-2 (DP-3Ø5423-1 × MON-Ø4Ø32-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(13) is amended as follows.

(2) In Article 7 (authorisation holder), for the text substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 9 (addressee), for the text substitute—

(4) In the Annex, for point (a) (applicant and authorisation holder) substitute—

“(a)Authorisation holder:

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2017/2449_I13

13.—(1) Commission Implementing Decision (EU) 2017/2449 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-68416-4, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(14) is amended as follows.

(2) In Article 7 (authorisation holder), for the text substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 9 (addressee), for the text substitute—

(4) In the Annex, for point (a) (authorisation holder) substitute—

“(a)Authorisation holder:

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2017/2450_I14

14.—(1) Commission Implementing Decision (EU) 2017/2450 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-44406-6, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(15) is amended as follows.

(2) In Article 7 (authorisation holder)—

(a)in the heading, for “holder” substitute “holders”;

(b)for the text substitute—

“The authorisation holders are Corteva Agriscience LLC, United States of America and M.S. Technologies LLC, United States of America, both represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 9 (addressee)—

(a)in the heading, for “Addressee” substitute “Addressees”;

(b)for the text substitute—

“This Decision is addressed to Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, Indiana, 46268-1054, United States of America and to M.S. Technologies LLC, 103 Avenue D, West Point, IA 52656, United States of America, represented in Great Britain by Corteva Agriscience UK Limited, Cpc2 Capital Park, Fulbourn, Cambridge, England, CB21 5XE.”.

(4) In the Annex, for point (a) (authorisation holder) substitute—

“(a)Authorisation holders:

(1)The authorisation holders are—

Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, Indiana, 46268-1054, United States of America; and

M.S. Technologies LLC, 103 Avenue D, West Point, IA 52656, United States of America.

(2)Both authorisation holders are represented in Great Britain by Corteva Agriscience UK Limited, Cpc2 Capital Park, Fulbourn, Cambridge, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2017/2452_I15

15.—(1) Commission Implementing Decision (EU) 2017/2452 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(16) is amended as follows.

(2) In Article 7 (authorisation holders)—

(a)in the heading, for “holders” substitute “holder”; and

(b)for paragraphs 1 and 2 substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 9 (addressee), for the text substitute—

(4) In the Annex, for point (a) (applicants and authorisation holders) substitute—

“(a)Authorisation holder:

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2018/1109_I16

16.—(1) Commission Implementing Decision (EU) 2018/1109 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(17) is amended as follows.

(2) In Article 7 (authorisation holders)—

(a)in the heading, for “holders” substitute “holder”; and

(b)for paragraphs 1 and 2 substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 9 (addressee), for paragraphs 1 and 2 substitute—

(4) In the Annex, for point (a) (applicants and authorisation holders) substitute—

“(a)Authorisation holder:

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2018/1110_I17

17.—(1) Commission Implementing Decision (EU) 2018/1110 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 × 59122 × MON 810 × NK603, and genetically modified maize combining two or three of the single events 1507, 59122, MON 810 and NK603, and repealing Decisions 2009/815/EC, 2010/428/EU and 2010/432/EU(18) is amended as follows.

(2) In Article 7 (authorisation holder), for the text substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 10 (addressee), for the text substitute—

(4) In the Annex, for point (a) (applicant and authorisation holder) for the text substitute—

“(a)Authorisation holder:

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2019/1304_I18

18.—(1) Commission Implementing Decision (EU) 2019/1304 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 4114 (DP-ØØ4114-3), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(19) is amended as follows.

(2) In Article 7 (authorisation holder), for the text substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 9 (addressee), for the text substitute—

(4) In the Annex, for point (a) (applicant and authorisation holder) substitute—

“(a)Authorisation holder:

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2019/1306_I19

19.—(1) Commission Implementing Decision (EU) 2019/1306 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize 1507 × NK603 (DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(20) is amended as follows.

(2) In Article 7 (authorisation holders)—

(a)in the heading, for “holders” substitute “holder”;

(b)for paragraphs 1 and 2 substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 9 (addressees)—

(a)in the heading, for “Addressees” substitute “Addressee”;

(b)for the text substitute—

(4) In the Annex, for point (a) (applicants and authorisation holders) substitute—

“(a)Authorisation holder:

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2019/2085_I20

20.—(1) Commission Implementing Decision (EU) 2019/2085 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 and sub-combinations MON 89034 × NK603 × DAS-40278-9, 1507 × NK603 × DAS-40278-9 and NK603 × DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(21) is amended as follows.

(2) In Article 7 (authorisation holder), for the text substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 9 (addressee), for the text substitute—

(4) In the Annex, for point (a) (applicant and authorisation holder) substitute—

“(a)Authorisation holder:

(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, England, CB21 5XE.”.

Amendment of Commission Implementing Decision (EU) 2019/2086_I21

21.—(1) Commission Implementing Decision (EU) 2019/2086 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS-40278-9 and genetically modified maize combining two, three or four of the single events MON 89034, 1507, MON 88017, 59122 and DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(22) is amended as follows.

(2) In Article 7 (authorisation holder), for the text substitute—

“The authorisation holder is Corteva Agriscience LLC, United States of America, represented in Great Britain by Corteva Agriscience UK Limited.”.

(3) In Article 9 (addressee), for the text substitute—

(4) In the Annex, for point (a) (applicant and authorisation holder) substitute—

“(a)Authorisation holder:

(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, England, CB21 5XE.”.

PART 4Revocations

Revocation of Commission Decision 2010/429/EU_I22

22. Commission Decision 2010/429/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 88017 × MON 810 (MON-88Ø17-3 × MON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(23) is revoked.

Neil O’Brien

Parliamentary Under-Secretary of State,

Department of Health and Social Care

28th February 2023

Prospective

SCHEDULES

Regulation 3

SCHEDULE 1Authorisation 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_I23

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_I24

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; and

(c)products containing or consisting of genetically modified soybean DAS-81419-2 × DAS-444Ø6-6 for uses other than those in sub-paragraphs (a) and (b), with the exception of cultivation.

Labelling_I25

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 DAS-81419-2 × DAS-444Ø6-6, with the exception of food and food ingredients.

Method for detection_I26

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(24)—

(a)“ERM®-BF437” (for DAS-81419-2);

(b)“ERM®-BF436” (for DAS-444Ø6-6).

Monitoring plan for environmental effects_I27

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 DAS-81419-2 × DAS-444Ø6-6, reference number “RP1133” submitted to the Food Safety Authority(25) 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 of Decision 2009/770.

Authorisation holder_I28

6.—(1) The name and address of 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, England, CB21 5XE.

Regulation 3

SCHEDULE 2Authorisation 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_I29

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_I30

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; and

(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_I31

(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_I32

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.

Monitoring plan for environmental effects_I33

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for authorisation of genetically modified soybean DAS-81419-2, reference number “RP1134” submitted to the Food Safety Authority on 8 June 2021, is implemented.

Authorisation holder_I34

6.—(1) The name and address of 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, England, CB21 5XE.

Regulation 3

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

Genetically modified organism and unique identifier_I35

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_I36

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; and

(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_I37

(2) The words ‘not for cultivation’ must appear on the label of, and in documents accompanying, products containing or consisting of genetically modified soybean SYN-ØØØH2-5, with the exception of food and food ingredients.

Method for detection_I38

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 (AOCS)(26).

Monitoring plan for environmental effects_I39

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for authorisation of genetically modified soybean SYN-ØØØH2-5, reference number “RP1138” submitted to the Food Safety Authority on 10 June 2021, is implemented.

Authorisation holder_I40

6.—(1) The name and address of 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, England, RG42 6EY.

Regulation 3

SCHEDULE 4Authorisation 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 its sub-combinations

Genetically modified organism and unique identifier_I41

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 its sub-combinations as follows—

(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_I42

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 as referred to in paragraph 1;

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

(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.

Labelling_I43

(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.

Method for detection_I44

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 June 2007.

(3) The method of DNA extraction for use in the detection methods 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—

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

(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—

(i)“ERM®-BF418” (for DAS-Ø15Ø7-1);

(ii)“ERM®-BF424” (for DAS-59122-7).

Monitoring plan for environmental effects_I45

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 “RP1180” submitted to the Food Safety Authority on 2 July 2021, is implemented.

Authorisation holder_I46

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 Limited, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.

Regulation 3

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

Genetically modified organism and unique identifier_I47

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 its sub-combinations as follows—

(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_I48

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 as referred to in paragraph 1;

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

(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.

Labelling_I49

Method for detection_I50

(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 as 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—

(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.

Monitoring plan for environmental effects_I51

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for authorisation of genetically modified maize referred to in paragraph 1, reference number “RP1184” submitted to the Food Safety Authority on 5 July 2021, is implemented.

Authorisation holder_I52

6.—(1) The name and address of the authorisation holder is Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, Indiana, 46268, 1054, USA.

(2) The authorisation holder is represented in Great Britain by Corteva Agriscience UK Limited, CPC2 Capital Park, Fulbourn, Cambridge, England, CB21 5XE.

Regulation 3

SCHEDULE 6Authorisation 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_I53

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

Authorisation_I54

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; and

(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_I55

(2) The words ‘not for cultivation’ must appear on the label of, and in documents accompanying, 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_I56

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” 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;

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

(i)ERM®-BF429 (for BCS-GHØØ4-7);

(ii)ERM®-BF428 (for BCS-GHØØ5-8).

Monitoring plan for environmental effects_I57

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for authorisation of the genetically modified cotton referred to in paragraph 1, reference number “RP1205” submitted to the Food Safety Authority on 28 July 2021, is implemented.

Authorisation holder_I58

6.—(1) The name and address of 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, England, SK1 3GG.

Regulation 3

SCHEDULE 7Renewal 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_I59

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_I60

2. The following products are authorised(27) 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; and

(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_I61

(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 MON-88Ø17-3 × MON-ØØ81Ø-6, with the exception of food and food ingredients.

Method for detection_I62

(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.

(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;

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

Monitoring plan for environmental effects_I63

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for the renewal of the authorisation of genetically modified maize MON-88Ø17-3 × MON-ØØ81Ø-6, reference number “RP1179” submitted to the Food Safety Authority on 2 July 2021, is implemented.

Authorisation holder_I64

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 Limited, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.

Regulation 3

SCHEDULE 8Renewal of the authorisation of the placing on the market of products containing or consisting of genetically modified oilseed rape GT73 (other than food)

Genetically modified organism and unique identifier_I65

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_I66

2. The following products are authorised(28) 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; and

(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_I67

(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 oilseed rape MON- ØØØ73-7, referred to in paragraph 2.

Method for detection_I68

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.

Monitoring plan for environmental effects_I69

5.—(1) The authorisation holder must ensure that the monitoring plan for environmental effects, which accompanied the application for the renewal of the authorisation of genetically modified oilseed rape MON- ØØØ73-7, reference number “RP1263” submitted to the Food Safety Authority on 22 September 2021, is implemented.

Authorisation holder_I70

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 Limited, 230 Cambridge Science Park, Milton Road, Cambridge, England, CB4 0WB.

Prospective

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations authorise the placing on the market of specified genetically modified food and feed products in England. They also modify the terms of existing authorisations.

Part 2 and Schedules 1 to 8 contain the authorisations, in relation to England, of products containing, and consisting of, or produced from the specified genetically modified organisms, in accordance with Articles 7(3) and 19(3) of Regulation (EC) No. 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (“Regulation 1829/2003”) as follows—

(a)Schedule 1 is a new authorisation for genetically modified soybean DAS-81419-2 × DAS-44406-6;

(b)Schedule 2 is a new authorisation for genetically modified soybean DAS-81419-2;

(c)Schedule 3 is a new authorisation for genetically modified soybean SYHT0H2;

(d)Schedule 4 is a new authorisation for genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and its sub-combinations;

(e)Schedule 5 is a new authorisation for genetically modified maize 1507 × MIR162 × MON 810 × NK603 and its sub-combinations;

(f)Schedule 6 is a new authorisation for genetically modified cotton GHB614 × T304-40 × GHB119;

(g)Schedule 7 renews the authorisation for genetically modified maize MON 88017 × MON 810;

(h)Schedule 8 renews the authorisation for genetically modified oilseed rape GT73. This renewal is limited to products containing or consisting of genetically modified oilseed rape GT73 (other than food). It does not cover products “produced from” that genetically modified organism.

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 and will expire at the end of 25th April 2033. 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.

Part 3 amends, in relation to England, 18 retained EU Decisions containing existing authorisations for genetically modified food and feed. The amendments all relate to changes to the names and addresses of the respective authorisation holders, and their representatives in Great Britain.

Part 4 revokes, in relation to England, the retained EU Decision containing the previous authorisation for the products now authorised by Schedule 7.

In each Schedule, paragraph 4 specifies the methods for detection, including sampling, which have 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. Hard copies of these documents are available for inspection at the Food Standards Agency, Floors 6 and 7, Clive House, 70 Petty France, London SW1H 9EX, at reasonable times, following a written request to that address or to GM.Inquiries@food.gov.uk.

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 Article 9(1) and Article 15(1)(e) of Regulation (EC) No. 1946/2003 of the European Parliament and of the Council 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, Floors 6 and 7, Clive House, 70 Petty France, London SW1H 9EX or by writing to GM.Inquiries@food.gov.uk.

An impact assessment has not been produced for this instrument as no, or no significant, impact on the public, private or voluntary sector is foreseen.

(1)

EUR 2003/1829, amended by S.I. 2019/705 and 2022/377. There are other amendments, but these are not relevant for this instrument. The terms “appropriate authority” and “prescribe” are defined in Article 2 of EUR 2003/1829. With respect to food, Article 7(3) applies in relation to modifications, and renewals of authorisations as read with Articles 9(2) and 11 respectively. With respect to feed, Article 19(3) applies in relation to modifications, and renewals of authorisations as read with Articles 21(2) and 23 respectively.

(2)

EUR 2002/178; relevant amending instrument S.I. 2019/641. There are other amendments, but these are not relevant for this instrument.

(3)

EUR 2003/1830; relevant amending instruments are S.I. 2019/90, 2019/778 and 2020/1421.

(4)

EUDN 2009/770, amended by S.I. 2019/90.

(5)

EUDN 2011/891, amended by S.I. 2019/705.

(6)

EUDN 2012/84, amended by S.I. 2019/705.

(7)

EUDN 2013/648, amended by S.I. 2019/705.

(8)

EUDN 2013/650, amended by S.I. 2019/705.

(9)

EUDN 2015/698, amended by S.I. 2019/705.

(10)

EUDN 2016/1215, amended by S.I. 2019/705.

(11)

EUDN 2017/1211, amended by S.I. 2019/705.

(12)

EUDN 2017/1212, amended by S.I. 2019/705.

(13)

EUDN 2017/2448, amended by S.I. 2019/705.

(14)

EUDN 2017/2449, amended by S.I. 2019/705.

(15)

EUDN 2017/2450, amended by S.I. 2019/705.

(16)

EUDN 2017/2452, amended by S.I. 2019/705.

(17)

EUDN 2018/1109, amended by S.I. 2019/705.

(18)

EUDN 2018/1110, amended by S.I. 2019/705.

(19)

EUDN 2019/1304, amended by S.I. 2019/705.

(20)

EUDN 2019/1306, amended by S.I. 2019/705.

(21)

EUDN 2019/2085, amended by S.I. 2019/705.

(22)

EUDN 2019/2086, amended by S.I. 2019/705.

(23)

EUDN 2010/429, amended by S.I. 2019/705. See Schedule 7 of these Regulations for the renewal of the authorisation contained in EUDN 2010/429.

(24)

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

(25)

“Food Safety Authority” is defined in Article 2(17) of 1829/2003, as regards England, as the Food Standards Agency.

(26)

https://www.aocs.org/crm

(27)

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.

(28)

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 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 p11). Directive 2001/18/EC

(1)

(2)

EUR 2002/178; relevant amending instrument S.I. 2019/641. There are other amendments, but these are not relevant for this instrument.

(3)

EUR 2003/1830; relevant amending instruments are S.I. 2019/90, 2019/778 and 2020/1421.

(4)

EUDN 2009/770, amended by S.I. 2019/90.

(5)

EUDN 2011/891, amended by S.I. 2019/705.

(6)

EUDN 2012/84, amended by S.I. 2019/705.

(7)

EUDN 2013/648, amended by S.I. 2019/705.

(8)

EUDN 2013/650, amended by S.I. 2019/705.

(9)

EUDN 2015/698, amended by S.I. 2019/705.

(10)

EUDN 2016/1215, amended by S.I. 2019/705.

(11)

EUDN 2017/1211, amended by S.I. 2019/705.

(12)

EUDN 2017/1212, amended by S.I. 2019/705.

(13)

EUDN 2017/2448, amended by S.I. 2019/705.

(14)

EUDN 2017/2449, amended by S.I. 2019/705.

(15)

EUDN 2017/2450, amended by S.I. 2019/705.

(16)

EUDN 2017/2452, amended by S.I. 2019/705.

(17)

EUDN 2018/1109, amended by S.I. 2019/705.

(18)

EUDN 2018/1110, amended by S.I. 2019/705.

(19)

EUDN 2019/1304, amended by S.I. 2019/705.

(20)

EUDN 2019/1306, amended by S.I. 2019/705.

(21)

EUDN 2019/2085, amended by S.I. 2019/705.

(22)

EUDN 2019/2086, amended by S.I. 2019/705.

(23)

EUDN 2010/429, amended by S.I. 2019/705. See Schedule 7 of these Regulations for the renewal of the authorisation contained in EUDN 2010/429.

(24)

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

(25)

“Food Safety Authority” is defined in Article 2(17) of 1829/2003, as regards England, as the Food Standards Agency.

(26)

https://www.aocs.org/crm

(27)

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.

(28)

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 p11).

footnote	commentary	transitional and savings	in force status	related provisions	geo extent	insert/omit	source count	in force adj
I1	Reg. 1 in force at 26.4.2023, see reg. 1(b)
I2	Reg. 2 in force at 26.4.2023, see reg. 1(b)
I3	Reg. 3 in force at 26.4.2023, see reg. 1(b)
I4	Reg. 4 in force at 26.4.2023, see reg. 1(b)
I5	Reg. 5 in force at 26.4.2023, see reg. 1(b)
I6	Reg. 6 in force at 26.4.2023, see reg. 1(b)
I7	Reg. 7 in force at 26.4.2023, see reg. 1(b)
I8	Reg. 8 in force at 26.4.2023, see reg. 1(b)
I9	Reg. 9 in force at 26.4.2023, see reg. 1(b)
I10	Reg. 10 in force at 26.4.2023, see reg. 1(b)
I11	Reg. 11 in force at 26.4.2023, see reg. 1(b)
I12	Reg. 12 in force at 26.4.2023, see reg. 1(b)
I13	Reg. 13 in force at 26.4.2023, see reg. 1(b)
I14	Reg. 14 in force at 26.4.2023, see reg. 1(b)
I15	Reg. 15 in force at 26.4.2023, see reg. 1(b)
I16	Reg. 16 in force at 26.4.2023, see reg. 1(b)
I17	Reg. 17 in force at 26.4.2023, see reg. 1(b)
I18	Reg. 18 in force at 26.4.2023, see reg. 1(b)
I19	Reg. 19 in force at 26.4.2023, see reg. 1(b)
I20	Reg. 20 in force at 26.4.2023, see reg. 1(b)
I21	Reg. 21 in force at 26.4.2023, see reg. 1(b)
I22	Reg. 22 in force at 26.4.2023, see reg. 1(b)
I23	Sch. 1 para. 1 in force at 26.4.2023, see reg. 1(b)
I24	Sch. 1 para. 2 in force at 26.4.2023, see reg. 1(b)
I25	Sch. 1 para. 3 in force at 26.4.2023, see reg. 1(b)
I26	Sch. 1 para. 4 in force at 26.4.2023, see reg. 1(b)
I27	Sch. 1 para. 5 in force at 26.4.2023, see reg. 1(b)
I28	Sch. 1 para. 6 in force at 26.4.2023, see reg. 1(b)
I29	Sch. 2 para. 1 in force at 26.4.2023, see reg. 1(b)
I30	Sch. 2 para. 2 in force at 26.4.2023, see reg. 1(b)
I31	Sch. 2 para. 3 in force at 26.4.2023, see reg. 1(b)
I32	Sch. 2 para. 4 in force at 26.4.2023, see reg. 1(b)
I33	Sch. 2 para. 5 in force at 26.4.2023, see reg. 1(b)
I34	Sch. 2 para. 6 in force at 26.4.2023, see reg. 1(b)
I35	Sch. 3 para. 1 in force at 26.4.2023, see reg. 1(b)
I36	Sch. 3 para. 2 in force at 26.4.2023, see reg. 1(b)
I37	Sch. 3 para. 3 in force at 26.4.2023, see reg. 1(b)
I38	Sch. 3 para. 4 in force at 26.4.2023, see reg. 1(b)
I39	Sch. 3 para. 5 in force at 26.4.2023, see reg. 1(b)
I40	Sch. 3 para. 6 in force at 26.4.2023, see reg. 1(b)
I41	Sch. 4 para. 1 in force at 26.4.2023, see reg. 1(b)
I42	Sch. 4 para. 2 in force at 26.4.2023, see reg. 1(b)
I43	Sch. 4 para. 3 in force at 26.4.2023, see reg. 1(b)
I44	Sch. 4 para. 4 in force at 26.4.2023, see reg. 1(b)
I45	Sch. 4 para. 5 in force at 26.4.2023, see reg. 1(b)
I46	Sch. 4 para. 6 in force at 26.4.2023, see reg. 1(b)
I47	Sch. 5 para. 1 in force at 26.4.2023, see reg. 1(b)
I48	Sch. 5 para. 2 in force at 26.4.2023, see reg. 1(b)
I49	Sch. 5 para. 3 in force at 26.4.2023, see reg. 1(b)
I50	Sch. 5 para. 4 in force at 26.4.2023, see reg. 1(b)
I51	Sch. 5 para. 5 in force at 26.4.2023, see reg. 1(b)
I52	Sch. 5 para. 6 in force at 26.4.2023, see reg. 1(b)
I53	Sch. 6 para. 1 in force at 26.4.2023, see reg. 1(b)
I54	Sch. 6 para. 2 in force at 26.4.2023, see reg. 1(b)
I55	Sch. 6 para. 3 in force at 26.4.2023, see reg. 1(b)
I56	Sch. 6 para. 4 in force at 26.4.2023, see reg. 1(b)
I57	Sch. 6 para. 5 in force at 26.4.2023, see reg. 1(b)
I58	Sch. 6 para. 6 in force at 26.4.2023, see reg. 1(b)
I59	Sch. 7 para. 1 in force at 26.4.2023, see reg. 1(b)
I60	Sch. 7 para. 2 in force at 26.4.2023, see reg. 1(b)
I61	Sch. 7 para. 3 in force at 26.4.2023, see reg. 1(b)
I62	Sch. 7 para. 4 in force at 26.4.2023, see reg. 1(b)
I63	Sch. 7 para. 5 in force at 26.4.2023, see reg. 1(b)
I64	Sch. 7 para. 6 in force at 26.4.2023, see reg. 1(b)
I65	Sch. 8 para. 1 in force at 26.4.2023, see reg. 1(b)
I66	Sch. 8 para. 2 in force at 26.4.2023, see reg. 1(b)
I67	Sch. 8 para. 3 in force at 26.4.2023, see reg. 1(b)
I68	Sch. 8 para. 4 in force at 26.4.2023, see reg. 1(b)
I69	Sch. 8 para. 5 in force at 26.4.2023, see reg. 1(b)
I70	Sch. 8 para. 6 in force at 26.4.2023, see reg. 1(b)

Defined Term	Section/Article	ID	Scope of Application
AOCS 0112-A	para 4. of SCHEDULE 3	AOCS_0112-_rtiXhFG
AOCS 0215-B	para 4. of SCHEDULE 4	legTermFItIKbuW
AOCS 0304-B3	para 4. of SCHEDULE 8	AOCS_0304-_rtzPczt
AOCS 0406-D2	para 4. of SCHEDULE 7	AOCS_0406-_lg1A0ck
AOCS 0512-A2	para 4. of SCHEDULE 4	legTermDp1ldzXa
AOCS 0709-A2	para 4. of SCHEDULE 4	legTermdvE8xJ3o
AOCS 0906-E2	para 4. of SCHEDULE 4	legTermNo0I6acF
AOCS 1108-A6	para 4. of SCHEDULE 6	AOCS_1108-_lg04RJm
appropriate authority	Unknown	appropriat_lgatLKJ
Corrected version 1	para 4. of SCHEDULE 8	Corrected__rtQKR0B
CRL-VL-25/04VR	para 4. of SCHEDULE 5	CRL-VL-25/_rtm6rwh
CRLVL02/04VP	para 4. of SCHEDULE 4	CRLVL02/04_rtgT8ew
CRLVL03/05VP – corrected version 1	para 4. of SCHEDULE 4	CRLVL03/05_rtAcXCM
CRLVL04/07XP	para 4. of SCHEDULE 3	CRLVL04/07_rtVSLBO
CRLVL04/09VP	para 4. of SCHEDULE 4	CRLVL04/09_rtCfmkM
CRLVL06/06VP	para 4. of SCHEDULE 4	CRLVL06/06_rtTXIHT
CRLVL08/08VP	para 4. of SCHEDULE 5	CRLVL08/08_rt6jlYI
CRLVL13/04XP	para 4. of SCHEDULE 6	CRLVL13/04_rtRmamH
CRLVL14/07VP	para 4. of SCHEDULE 6	CRLVL14/07_rtbMf1o
CRLVL16/05VP corrected version 1	para 4. of SCHEDULE 7	CRLVL16/05_rt1Eoyr
CRLVL16/05XP	para 4. of SCHEDULE 7	CRLVL16/05_rtSYMKs
CRLVL16/05XP corrected version 2	para 4. of SCHEDULE 4	CRLVL16/05_rtwn4Fp
CRLVL26/04VP	para 4. of SCHEDULE 8	CRLVL26/04_rtM0Q8q
CRLVL26/04XP Version 1	para 4. of SCHEDULE 8	CRLVL26/04_rtGcJ56
CRLVL27/04VP	para 4. of SCHEDULE 5	CRLVL27/04_rtUX3Mb
Decision 2009/770	reg. 2. of PART 1	Decision_2_lg2ruXe
ERM®-BF413	para 4. of SCHEDULE 7	ERM®-BF413_lgwXv77
ERM®-BF418	para 4. of SCHEDULE 4	legTerm2MDU1WZg
ERM®-BF424	para 4. of SCHEDULE 4	legTermCAYFkIHw
ERM®-BF436	para 4. of SCHEDULE 1	legTermKN6gOt7a
ERM®-BF437	para 4. of SCHEDULE 1	legTermIY4tvDO8
ERM®-BF437	para 4. of SCHEDULE 2	ERM®-BF437_rt7YpIf
EURL-VL-01/12 VP	para 4. of SCHEDULE 1	EURL-VL-01_rtmUVb8
EURL-VL-01/15VP	para 4. of SCHEDULE 4	EURL-VL-01_rtJq4YY
EURL-VL-02/14XP	para 4. of SCHEDULE 5	EURL-VL-02_rt6dF7G
EURL-VL-03/12VP	para 4. of SCHEDULE 4	EURL-VL-03_rtsQuT0
EURL-VL-03/13 VP	para 4. of SCHEDULE 1	EURL-VL-03_rtxgP73
EURL-VL-03/13 VP	para 4. of SCHEDULE 2	EURL-VL-03_rtOQVVI
EURL-VL-04/12VP	para 4. of SCHEDULE 3	EURL-VL-04_rt074xZ
EURL-VL-05/11VP	para 4. of SCHEDULE 6	EURL-VL-05_rtVlP2J
EURL-VL-11/10XP	para 4. of SCHEDULE 1	EURL-VL-11_rtq98gp
EURL-VL-11/10XP	para 4. of SCHEDULE 2	EURL-VL-11_rt6DFXo
Event-specific Method for the Quantification of Cotton GHB119 Using Real-time PCR	para 4. of SCHEDULE 6	Event-spec_rtC2Szs
Event-specific Method for the Quantification of Cotton Line GHB614 Using Real-time PCR	para 4. of SCHEDULE 6	Event-spec_rtyXmWy
Event-specific Method for the Quantification of Cotton T304-40 using Real-time PCR	para 4. of SCHEDULE 6	Event-spec_rtDXN6F
Event-specific Method for the Quantification of Maize Line MON 88017 Using Real-time PCR	para 4. of SCHEDULE 7	Event-spec_rtAnwzS
Event-specific Method for the Quantification of Maize Line MON 89034 Using Real-time PCR	para 4. of SCHEDULE 4	Event-spec_rtZypLa
Event-specific Method for the Quantification of Maize MIR162 Using Real-time PCR	para 4. of SCHEDULE 5	Event-spec_rtRLD9L
Event-specific Method for the Quantification of maize MON 87411 by Real-time PCR	para 4. of SCHEDULE 4	Event-spec_rt7jXhu
Event-specific Method for the Quantification of Maize MON 87427 Using Real-time PCR	para 4. of SCHEDULE 4	Event-spec_rtdUnCO
Event-specific Method for the Quantification of Maize MON 87460 Using Real-time PCR	para 4. of SCHEDULE 4	Event-spec_rtr4bBn
Event-specific Method for the Quantification of Oilseed Rape Line RT73 Using Real-time PCR	para 4. of SCHEDULE 8	Event-spec_rtD46H3
Event-specific Method for the Quantification of Soybean DAS-44406-6 by Real-time PCR	para 4. of SCHEDULE 1	Event-spec_rtcEkVp
Event-specific Method for the Quantification of Soybean DAS-81419-2 by Real-time PCR	para 4. of SCHEDULE 1	Event-spec_rt9DvNw
Event-specific Method for the Quantification of Soybean DAS-81419-2 by Real-time PCR	para 4. of SCHEDULE 2	Event-spec_rtPJWPT
Event-specific Method for the Quantification of Soybean SYHT0H2 by Real-time PCR	para 4. of SCHEDULE 3	Event-spec_rt5YqX0
Event-specific method for the quantitation of maize 59122 using real-time PCR	para 4. of SCHEDULE 4	Event-spec_rtmgRom
Event-specific method for the quantitation of maize line NK603 using real-time PCR	para 4. of SCHEDULE 5	Event-spec_rtYUA21
Event-specific method for the quantitation of maize line TC1507 using real-time PCR	para 4. of SCHEDULE 4	Event-spec_rtqjqRe
Event-specific method for the quantitation of maize line TC1507 using real-time PCR	para 4. of SCHEDULE 5	Event-spec_rtyQj9a
Food Safety Authority	Unknown	Food_Safet_rto4yVy
JRC 113269	para 4. of SCHEDULE 5	JRC_113269_rtLi5i5
prescribe	Unknown	prescribe_lg26Lby
Regulation 1829/2003	reg. 2. of PART 1	Regulation_lgeb4WP
Regulation 1829/2003	Unknown	legTermd0HGpeM1
Regulation 1830/2003	reg. 2. of PART 1	Regulation_lgg2BvW
Report on the Validation of a DNA Extraction Method for Maize Seeds and Grains	para 4. of SCHEDULE 4	Report_on__rtYYiSa
Report on the Validation of a DNA Extraction Method for Maize Seeds and Grains	para 4. of SCHEDULE 7	Report_on__rtbtRHX
Report on the Validation of a DNA Extraction Method for Soybean Seeds	para 4. of SCHEDULE 3	Report_on__rtcl7lv
Report on the Validation of an Oilseed Rape DNA Extraction Method from Seeds	para 4. of SCHEDULE 8	Report_on__rtjiwjl
RP1133	para 5. of SCHEDULE 1	RP1133_rtc9iZb
RP1134	para 5. of SCHEDULE 2	RP1134_rtwuwp0
RP1138	para 5. of SCHEDULE 3	RP1138_rtTOoa2
RP1179	para 5. of SCHEDULE 7	RP1179_rtKKgPO
RP1180	para 5. of SCHEDULE 4	RP1180_rt6fHPv	alert
RP1184	para 5. of SCHEDULE 5	RP1184_rtoMgqT	alert
RP1205	para 5. of SCHEDULE 6	RP1205_rtOmxtK	alert
RP1263	para 5. of SCHEDULE 8	RP1263_rt3VCOr
Version B	para 4. of SCHEDULE 5	Version_B_rtv1Zg6

2023 No. 235

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

PART 1Introduction

Citation, commencement, extent and applicationI1

InterpretationI2

PART 2Authorisations

Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified organismsI3

PART 3Modifications of existing authorisations

Amendment of Commission Decision 2011/891/EUI4

Amendment of Commission Implementing Decision 2012/84/EUI5

Amendment of Commission Implementing Decision 2013/648/EUI6

Amendment of Commission Implementing Decision 2013/650/EUI7

Amendment of Commission Implementing Decision (EU) 2015/698I8

Amendment of Commission Implementing Decision (EU) 2016/1215I9

Amendment of Commission Implementing Decision (EU) 2017/1211I10

Amendment of Commission Implementing Decision (EU) 2017/1212I11

Amendment of Commission Implementing Decision (EU) 2017/2448I12

Amendment of Commission Implementing Decision (EU) 2017/2449I13

Amendment of Commission Implementing Decision (EU) 2017/2450I14

Amendment of Commission Implementing Decision (EU) 2017/2452I15

Amendment of Commission Implementing Decision (EU) 2018/1109I16

Amendment of Commission Implementing Decision (EU) 2018/1110I17

Amendment of Commission Implementing Decision (EU) 2019/1304I18

Amendment of Commission Implementing Decision (EU) 2019/1306I19

Amendment of Commission Implementing Decision (EU) 2019/2085I20

Amendment of Commission Implementing Decision (EU) 2019/2086I21

PART 4Revocations

Revocation of Commission Decision 2010/429/EUI22

SCHEDULES

SCHEDULE 1Authorisation 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 identifierI23

AuthorisationI24

LabellingI25

Method for detectionI26

Monitoring plan for environmental effectsI27

Authorisation holderI28

SCHEDULE 2Authorisation 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 identifierI29

AuthorisationI30

LabellingI31

Method for detectionI32

Monitoring plan for environmental effectsI33

Authorisation holderI34

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

Genetically modified organism and unique identifierI35

AuthorisationI36

LabellingI37

Method for detectionI38

Monitoring plan for environmental effectsI39

Authorisation holderI40

SCHEDULE 4Authorisation 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 its sub-combinations

Genetically modified organism and unique identifierI41

AuthorisationI42

LabellingI43

Method for detectionI44

Monitoring plan for environmental effectsI45

Authorisation holderI46

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

Genetically modified organism and unique identifierI47

AuthorisationI48

LabellingI49

Method for detectionI50

Monitoring plan for environmental effectsI51

Authorisation holderI52

SCHEDULE 6Authorisation 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 identifierI53

AuthorisationI54

LabellingI55

Method for detectionI56

Monitoring plan for environmental effectsI57

Authorisation holderI58

SCHEDULE 7Renewal 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 identifierI59

AuthorisationI60

LabellingI61

Method for detectionI62

Monitoring plan for environmental effectsI63

Authorisation holderI64

SCHEDULE 8Renewal of the authorisation of the placing on the market of products containing or consisting of genetically modified oilseed rape GT73 (other than food)

Genetically modified organism and unique identifierI65

Citation, commencement, extent and application_I1

Interpretation_I2

Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified organisms_I3

Amendment of Commission Decision 2011/891/EU_I4

Amendment of Commission Implementing Decision 2012/84/EU_I5

Amendment of Commission Implementing Decision 2013/648/EU_I6

Amendment of Commission Implementing Decision 2013/650/EU_I7

Amendment of Commission Implementing Decision (EU) 2015/698_I8

Amendment of Commission Implementing Decision (EU) 2016/1215_I9

Amendment of Commission Implementing Decision (EU) 2017/1211_I10

Amendment of Commission Implementing Decision (EU) 2017/1212_I11

Amendment of Commission Implementing Decision (EU) 2017/2448_I12

Amendment of Commission Implementing Decision (EU) 2017/2449_I13

Amendment of Commission Implementing Decision (EU) 2017/2450_I14

Amendment of Commission Implementing Decision (EU) 2017/2452_I15

Amendment of Commission Implementing Decision (EU) 2018/1109_I16

Amendment of Commission Implementing Decision (EU) 2018/1110_I17

Amendment of Commission Implementing Decision (EU) 2019/1304_I18

Amendment of Commission Implementing Decision (EU) 2019/1306_I19

Amendment of Commission Implementing Decision (EU) 2019/2085_I20

Amendment of Commission Implementing Decision (EU) 2019/2086_I21

Revocation of Commission Decision 2010/429/EU_I22

Genetically modified organism and unique identifier_I23

Authorisation_I24

Labelling_I25

Method for detection_I26

Monitoring plan for environmental effects_I27

Authorisation holder_I28

Genetically modified organism and unique identifier_I29

Authorisation_I30

Labelling_I31

Method for detection_I32

Monitoring plan for environmental effects_I33

Authorisation holder_I34

Genetically modified organism and unique identifier_I35

Authorisation_I36

Labelling_I37

Method for detection_I38

Monitoring plan for environmental effects_I39

Authorisation holder_I40

Genetically modified organism and unique identifier_I41

Authorisation_I42

Labelling_I43

Method for detection_I44

Monitoring plan for environmental effects_I45

Authorisation holder_I46

Genetically modified organism and unique identifier_I47

Authorisation_I48

Labelling_I49

Method for detection_I50

Monitoring plan for environmental effects_I51

Authorisation holder_I52

Genetically modified organism and unique identifier_I53

Authorisation_I54

Labelling_I55

Method for detection_I56

Monitoring plan for environmental effects_I57

Authorisation holder_I58

Genetically modified organism and unique identifier_I59

Authorisation_I60

Labelling_I61

Method for detection_I62

Monitoring plan for environmental effects_I63

Authorisation holder_I64

Genetically modified organism and unique identifier_I65

Authorisation_I66

Labelling_I67

Method for detection_I68

Monitoring plan for environmental effects_I69

Authorisation holder_I70