The Genetic Technology (Precision Breeding) Regulations 2025

• (4) With respect to the information provided under paragraphs 5 and 6 of Schedule 2 in the marketing notice, a description of how the genetic change introduced to the precision bred organism to which the application relates affects the edible part of the organism, including information on—

• (a) how the genetic change may affect the use of the organism in food and feed;

• (b) which parts of the organism are destined for use in food and feed;

• (c) a description of the intended use of the precision bred organism in food and feed.

• (5) Statements to demonstrate how the applicant has reached the conclusions in relation to the precision bred organism for each of the criteria set out in paragraphs (1)(b) and (c) of regulation 20 including accompanying descriptive text setting out the applicant’s key considerations and justification in respect of each criterion.

• (6) If the applicant is making a request under regulation 34 that information be considered commercially confidential—

• (a) a statement setting out the information which the applicant wishes to be treated as commercially confidential;

• (b) an explanation as to why disclosure of such information would, or would be likely to, prejudice the commercial interests of any person, or is a trade secret.

2

Additionally, in relation to an application under regulation 22, where the applicant reasonably concludes that one or more of the criteria in paragraph (1)(b) and (c) of regulation 20 does not, or may not, apply to the precision bred organism—

• (a) statements to explain why those criteria do not, or may not apply to the precision bred organism;

• (b) complete, unredacted copies of the supporting evidence used by the applicant to make the explanatory statements in sub-paragraph (a) in relation to the precision bred organism which evidence may include, but is not limited to, test results, scientific analyses, data studies, surveys or scientific records.

Schedule 5 — Consequential Amendments to legislation relating to precision bred organism

Part 1 — Amendment of assimilated direct legislation

Amendment to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed

1

• (1) Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed[^f00048] is amended as follows.

• (2) In Article 2, in point 5, after the second reference to “Directive 2001/18 EC”, insert “and, in relation to England, excluding precision bred plants”.

• (3) At the end of Article 2, insert—

(25) ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023.

Amendment to 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, etc.

2

• (1) 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, etc.[^f00049] is amended as follows.

• (2) After Article 2(2), insert—

(3) In relation to England, this Regulation does not apply to— (a) products consisting of, or containing, precision bred plants placed on the market in accordance with Part 2 of the Genetic Technology (Precision Breeding) Act 2023 and regulations made under it; (b) food and feed produced from precision bred plants placed on the market in accordance with Part 3 of the Genetic Technology (Precision Breeding) Act 2023 and regulations made under it.

• (3) In Article 3—

• (a) in point 1, after the second reference to “Directive 2001/18/EC”, insert “and, in relation to England, excluding precision bred plants”;

• (b) after point 15, insert—

(16) ‘Precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023.

Amendment to Regulation (EC) No 1946/2003 of the European Parliament and of the Council on transboundary movements of genetically modified organisms

3

• (1) Regulation (EC) No 1946/2003 of the European Parliament and of the Council on transboundary movements of genetically modified organisms[^f00050] is amended as follows.

• (2) After Article 2(2), insert—

(3) In relation to England, precision bred plants are excluded from the scope of this Regulation.

• (3) At the end of Article 3, insert—

(25) ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023.

Amendment to Regulation (EC) 1332/2008 of the European Parliament and of the Council on food enzymes, etc.

4

• (1) Regulation (EC) 1332/2008 of the European Parliament and of the Council on food enzymes, etc.[^f00051] is amended as follows.

• (2) In the heading to Article 8, at the end, insert “or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023”.

• (3) After Article 8(2), insert—

(3) In relation to England, a food enzyme falling within the scope of the Genetic Technology (Precision Breeding) Act 2023 may be authorised in accordance with this Regulation only when it is covered by a food and feed marketing authorisation under Part 3 of that Act. (4) In relation to England, when a food enzyme that is already authorised is produced from a different source falling within the scope of the Genetic Technology (Precision Breeding) Act 2023, it will not require a new authorisation under this Regulation, as long as the new source is covered by a food and feed marketing authorisation under Part 3 of that Act and the food enzyme complies with the specifications established under this Regulation.

Amendment to Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives

5

• (1) Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives[^f00052] is amended as follows.

• (2) In the heading of Article 13, at the end, insert “or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023”.

• (3) After Article 13(2), insert—

(3) In relation to England, a food additive falling within the scope of the Genetic Technology (Precision Breeding) Act 2023 may be authorised in accordance with this Regulation only when it is covered by a food and feed marketing authorisation under Part 3 of that Act. (4) In relation to England, when a food additive that is already authorised is produced from a different source falling within the scope of the Genetic Technology (Precision Breeding) Act 2023, it will not require a new authorisation under this Regulation, as long as the new source is covered by a food and feed marketing authorisation under Part 3 of that Act and the food additive complies with the specifications established under this Regulation.

Amendment to Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods, etc.

6

• (1) Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods, etc. [^f00053] is amended as follows.

• (2) In the heading of Article 12, at the end, insert “or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023”.

• (3) After Article 12(2), insert—

(3) In relation to England, a flavouring or source material falling within the scope of the Genetic Technology (Precision Breeding) Act 2023 may be authorised in accordance with this Regulation only when it is covered by a food and feed marketing authorisation under Part 3 of that Act. (4) In relation to England, when a flavouring that is already authorised is produced from a different source falling within the scope of the Genetic Technology (Precision Breeding) Act 2023, it will not require a new authorisation under this Regulation, as long as the new source is covered by a food and feed marketing authorisation under that Act and the flavouring complies with the specifications established under this Regulation.

Amendment to Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, etc.

7

• (1) Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, etc.[^f00054] is amended as follows.

• (2) In Article 2(2)—

• (a) in point (g), omit “and”;

• (b) after point (h), insert—

(i) in relation to England, the Genetic Technology (Precision Breeding) Act 2023 and regulations made under it.

Amendment to Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, etc.

8

• (1) Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, etc. [^f00055] is amended as follows.

• (2) In Article 3—

• (a) at the end of paragraph 16, insert “but, in relation to England, does not include precision bred plants”;

• (b) after paragraph 34, insert—

(35) ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023.

Amendment to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (recast)

9

• (1) Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (recast)[^f00056] is amended as follows.

• (2) After Article 2(2)(g), insert—

(ga) in relation to England, precision bred plants.

• (3) After Article 3(26), insert—

(27) ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023.

Amendment to Commission Regulation (EU) No 68/2013 on the Catalogue of feed materials

10

• (1) Commission Regulation (EU) No 68/2013 on the Catalogue of feed materials[^f00057] is amended as follows.

• (2) In the Annex—

• (a) in Part A, in point (2), at the end of the first sentence, insert “and, in relation to England, to the Genetic Technology (Precision Breeding) Act 2023 for feed materials that are or are produced from precision bred plants or result from a fermentation process involving precision bred plants. In this Annex, “precision bred plants” has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023”;

• (b) in Part C, in chapter 12, after the first sentence, insert “In relation to England, feed materials listed in this chapter that are or are produced from precision bred plants, or result from a fermentation process involving precision bred plants, must be compliant with the Genetic Technology (Precision Breeding) Act 2023.”.

Amendment to Regulation (EU) No 1143/2014 of the European Parliament and of the Council on the prevention and management of the introduction and spread of invasive alien species

11

• (1) Regulation (EU) No 1143/2014 of the European Parliament and of the Council on the prevention and management of the introduction and spread of invasive alien species[^f00058] is amended as follows.

• (2) After Article 2(2)(b), insert—

(ba) in relation to England, precision bred plants within the meaning of section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023;

Amendment to Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, etc

12

• (1) Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, etc.[^f00059] is amended as follows.

• (2) After Article 2(2)(a), insert—

(aa) within England, food produced from precision bred plants within the meaning of section 1, as read with section 2(1), and section 30(2), of the Genetic Technology (Precision Breeding) Act 2023;

Part 2 — Amendment of subordinate legislation that applies in Great Britain

Amendment to the Genetically Modified Organisms (Contained Use) Regulations 2014

13

• (1) The Genetically Modified Organisms (Contained Use) Regulations 2014[^f00060] are amended as follows.

• (2) After regulation 3(2)(c), insert—

(d) in relation to England, a precision bred plant is released or marketed in cases or circumstances in which the notification or authorisation of the Secretary of State is required under the following provisions of the Genetic Technology (Precision Breeding) Act 2023— (i) section 4 (release of precision bred organism), (ii) section 5 (marketing of precision bred organism), (iii) section 26 (regulation of food or feed produced from precision bred organisms).

• (3) After regulation 3(6), insert—

(7) In paragraph (2)(d), “precision bred plants” means precision bred plants as defined in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023.

Part 3 — Amendment of subordinate legislation that applies in England

Amendment to the Environmental Damage (Prevention and Remediation) (England) Regulations 2015

14

• (1) The Environmental Damage (Prevention and Remediation) (England) Regulations 2015[^f00061] are amended as follows.

• (2) At the end of paragraph 9(2) of Schedule 2, insert “excluding precision bred plants within the meaning of section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023.”.

Signed

Daniel Zeichner — Minister of State — Department for Environment, Food and Rural Affairs — 13th May 2025

Explanatory note

(This note is not part of the Regulations)

Explanatory Note

These Regulations are made under powers in the Genetic Technology (Precision Breeding) Act 2023 (c. 6) (“the Act”) in connection with the coming into force of provisions of the Act in respect of precision bred plants. The Act provides for the regulation of precision bred organisms released or marketed in England.

Regulation 3 and Schedules 1 and 3 set out the notification requirements for the release of precision bred plants and the content of release notices.

Regulation 4 makes transitional provision relating to regulation 3 concerning the release of qualifying higher plants already notified under the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. 2002/2443) (as to which, see also regulation 55).

Regulations 5 and 6 and Schedules 2 and 3 provide for the content of marketing notices and the process and procedure for making an application to the Secretary of State for precision bred confirmation in respect of a precision bred plant.

Regulation 7 sets out the process for revoking a precision bred confirmation.

Regulations 8 and 9 provide for the review and appeal of a decision not to issue a precision bred confirmation or a decision to revoke a precision bred confirmation.

Regulations 10 and 11 provide for the precision breeding register.

Regulation 12 sets out the risk assessment requirements for precision bred plants imported into, and acquired in, England, for contained use.

Part 6 provides for the monitoring and inspection of precision bred organisms.

Regulations 18 to 25 and Schedule 4 set out the processes for applying for marketing authorisations for food and feed produced from precision bred plants and the required information for inclusion in an application made under regulation 20 or 22. An application under regulation 22 requires additional information to enable a safety assessment to be carried out by the Food Standards Agency.

Regulations 26 to 29 provide for the assessment of applications for food and feed marketing authorisations by the Food Standards Agency, including obtaining expert advice and the provision of reports to the Secretary of State.

Regulations 30 and 31 set out the requirements for the consideration of marketing authorisation applications, and the issuing of marketing authorisations, by the Secretary of State.

Regulations 32 and 33 record the duties on the authorisation-holders of marketing authorisations and other persons proposing to place authorised food and feed on the market and sets out the circumstances and process for varying and revoking food and fees marketing authorisations.

Regulation 34 provides a process for the management of commercially confidential information under Part 7. Regulation 35 provides for a food and feed register.

Part 9 provides for the monitoring and inspection of food and feed marketing authorisations.

Part 10 provides for enforcement by way of civil enforcement notices including monetary penalty notices and for reviews and appeals against such notices.

Regulations 53 and 54 and Schedule 5 make general provision in relation to notices and consequential amendments. Regulation 55 revokes the Genetically Modified Organisms ) (Deliberate Release) (Amendment) (England) Regulations 2022 (S.I. 2022/347) and removes the amendments made by those Regulations to the Genetically Modified Organisms (Deliberate Release) Regulations 2002.

A full impact assessment has not been produced for this instrument as no, or no significant impact on the private, voluntary or public sector is foreseen. A de minimis assessment of the effect that this instrument will have on the cost of business has been prepared and is available from the Department for Environment, Food and Rural Affairs, 2 Marsham Street, London, SW1P 4DF.

Footnotes

[^f00001]: 2023 c. 6 (“the Act”).

[^f00002]: EUR 2002/178 to which there are amendments not relevant to these Regulations.

[^f00003]: “Plant” is defined in section 2(1) of the Act and “precision bred” is defined in section 1 of the Act.

[^f00004]: “Release” is defined in section 3(3) of the Act.

[^f00005]: “Release notice” is defined in section 4(1)(a) of the Act.

[^f00006]: See regulation 53.

[^f00007]: See also regulation 55.

[^f00008]: S.I. 2002/2443 amended by S.I. 2019/88, 2022/347; there are other amending instruments but none is relevant. “Qualifying higher plant” is defined in regulation 2 of those Regulations.

[^f00009]: “Notifier” is defined in section 6(1) of the Act.

[^f00010]: “Modern biotechnology” is defined in section 1(3) of the Act.

[^f00011]: “Precision bred confirmation” is defined in section 8(1)(a)(i) of the Act.

[^f00012]: The Food Standards Agency is established by section 1 of the Food Standards Act 1999 (c. 28) (see also section 28(2)(a) of the Act).

[^f00013]: “Food and feed register” is defined in section 27(1) of the Act.

[^f00014]: See also regulation 53.

[^f00015]: “Traditional processes” is defined in section 1(6) of the Act.

[^f00016]: “Acquire” is defined in section 17(5)(a) of the Act.

[^f00017]: “Environmental risk assessment” is defined in section 17(2) of the Act.

[^f00018]: “Inspector”, in respect of Part 2 of the Act, means an inspector appointed by the Secretary of State under section 19(1) of the Act.

[^f00019]: “Part 2 obligation” is defined in section 21(1) of the Act. See also regulation 14.

[^f00020]: 1990 c. 43; part 6 was amended by S.I. 2002/2443; there are other amending instruments but none is relevant.

[^f00021]: “Food and feed marketing authorisation” is defined in section 30(1) of the Act.

[^f00022]: 1999 c. 28 to which there are amendments not relevant to these Regulations.

[^f00023]: Section 30(3) of the Act makes provision about the meaning of food or feed being placed on the market.

[^f00024]: “Marketable precision bred organism” is defined in section 5(2) of the Act.

[^f00025]: “Qualifying progeny” is defined in section 24 of the Act.

[^f00026]: “In force” in respect of a precision bred confirmation is defined in section 5(5) of the Act.

[^f00027]: See also regulation 35.

[^f00028]: See also regulation 35.

[^f00029]: “Part 3 obligation” is defined in section 29(1) of the Act (see also section 29(3)(b) of the Act).

[^f00030]: EUR 2015/2283 amended by S.I. 2019/702; there are other amendments but none is relevant. Schedule 5 to this instrument inserts article 2(2)(aa).

[^f00031]: “Enforcement authorities” are defined in section 28(1) of the Act.

[^f00032]: Section 5 was amended by paragraph 16(1) of Schedule 9 to the Local Government (Wales) Act 1994 (c. 19), paragraph 163(2) of Schedule 13 to the Local Government etc (Scotland) Act 1994 (c. 39), paragraphs 7, 8, and 9 of Schedule 5 to the Food Standards Act 1999 (c. 28) and Part 1 of Schedule 3 to the Public Health etc. (Scotland) Act 2008 (asp 5).

[^f00033]: 1970 c. 40. Section 67(1) was amended by Schedule 30 to the Local Government Act 1972 (c. 70), paragraph 15(3) of Schedule 8 to the Local Government Act 1985 (c. 51), paragraph 38(5) of Schedule 16 and Schedule 18 to the Local Government (Wales) Act 1994 (c. 19) and S.S.I. 2020/467.

[^f00034]: “Relevant breach” is defined in section 31(1) of the Act.

[^f00035]: “Inspector” is defined in section 19(1) as regards Part 2 of the Act, and in section 30(1) as regards Part 3 of the Act.

[^f00036]: “Enforcement notice” is defined in section 32(3) of the Act.

[^f00037]: “Compliance notice” is defined in section 33(1) of the Act.

[^f00038]: “Stop notice” is defined in section 34(1) of the Act.

[^f00039]: “Monetary penalty notice” is defined in section 35(1) of the Act.

[^f00040]: “Relevant obligation” is defined in section 31(2)(b) of the Act.

[^f00041]: The Monetary Policy Committee is established under section 13 of the Bank of England Act 1998 (c. 11).

[^f00042]: “Appropriate authority” is defined in section 38(2) of the Act.

[^f00043]: See regulation 48(6).

[^f00044]: “Relevant decision” is defined in section 38(6) of the Act.

[^f00045]: S.I. 2002/2443 amended by S.I. 2019/88, 2022/347; there are other amending instruments but none is relevant.

[^f00046]: S.I. 2022/347.

[^f00047]: See also regulation 4.

[^f00048]: EUR 2003/1829 amended by S.I. 2019/705, 2020/1504 and 2023/959; there are other amendments but none is relevant. [the numbering of this amendment takes into account regulation 14 of the draft Food and Feed (Regulated Products) (Amendment etc) Regulations due to come into force before these Regulations].

[^f00049]: EUR 2003/1830 amended by S.I. 2019/90 and 2020/1421; there are other amendments but none is relevant.

[^f00050]: EUR 2003/1946 amended by S.I. 2019/90; there are other amending instruments but none is relevant.

[^f00051]: EUR 2008/1332 amended by S.I. 2019/860; there are other amending instruments but none is relevant.

[^f00052]: EUR 2008/1333 amended by S.I. 2019/860; there are other amending instruments but none is relevant.

[^f00053]: EUR 2008/1334 amended by S.I. 2019/860; there are other amending instruments but none is relevant.

[^f00054]: EUR 2009/767 amended by S.I. 2019/654; there are other amending instruments but none is relevant.

[^f00055]: EUR 2009/1107 amended by S.I. 2019/556; there are other amending instruments but none is relevant.

[^f00056]: EUR 2012/649 amended by S.I. 2019/720; there are other amending instruments but none is relevant.

[^f00057]: EUR 2013/68 amended by S.I. 2019/654; there are other amending instruments but none is relevant.

[^f00058]: EUR 2014/1143 to which there are amendments not relevant to these Regulations.

[^f00059]: EUR 2015/2283 to which there are amendments not relevant to these Regulations.

[^f00060]: S.I. 2014/1663 to which there are amendments not relevant to these Regulations.

[^f00061]: S.I. 2015/810, to which there are amendments not relevant to these Regulations.