The Genetic Technology (Precision Breeding) Regulations 2025

1. Introductory Text

2. Part 1 Introduction

   1. 1. Citation, commencement, extent and application

   2. 2. Interpretation

3. Part 2 Release of Precision Bred Organism

   1. 3. Notification requirement for release of precision bred organism in England

   2. 4. Transitional provisions for release

4. Part 3 Marketing of Precision Bred Organism

   1. 5. Application for precision bred confirmation - marketing notice

   2. 6. The advisory committee - reporting period etc.

   3. 7. Revocation of precision bred confirmation

   4. 8. Review of a precision bred confirmation or revocation decision

   5. 9. Appeal to the First-tier Tribunal

5. Part 4 The precision breeding register

   1. 10. Information to be included in the precision breeding register

   2. 11. Keeping of the precision breeding register

6. Part 5 Environmental risk assessment

   1. 12. Environmental risk assessment for precision bred organism in contained use

7. Part 6 Monitoring and inspection of release and marketing

   1. 13. Inspectors

   2. 14. Meaning of “Part 2 obligations”

   3. 15. Powers of entry

   4. 16. Powers of inspection

   5. 17. Powers of entry and inspection - supplementary provisions

8. Part 7 Food and feed produced from precision bred organisms

   1. 18. Interpretation of this Part

   2. 19. Marketing of food and feed produced from precision bred organisms - requirement for authorisation

   3. 20. Application for a food and feed marketing authorisation

   4. 21. Requirement to report verified applications for a food and feed marketing authorisation under regulation 20 to the Secretary of State

   5. 22. Application for a food and feed marketing authorisation - where a Food Standards Agency assessment is required

   6. 23. Verification of information in application made under regulation 22

   7. 24. Request for further information

   8. 25. Publication of verified applications

   9. 26. Assessment by the Food Standards Agency

   10. 27. Advice or information from the Food Standards Advisory Committee etc.

   11. 28. Requirement to report on safety assessment etc. to the Secretary of State

   12. 29. Withdrawal of application for a food and feed marketing authorisation

   13. 30. Determination on authorisation by the Secretary of State

   14. 31. Communication of the Secretary of State’s decision to the applicant

   15. 32. Duties on authorisation-holders and other persons placing authorised food and feed on the market

   16. 33. Revocation or variation of a food and feed marketing authorisation

   17. 34. Confidentiality

9. Part 8 The food and feed register

   1. 35. Food and feed marketing authorisations register

10. Part 9 Monitoring and inspection of Part 3 obligations

    1. 36. Part 3 obligation

    2. 37. Enforcement authorities

    3. 38. Inspectors

    4. 39. Powers of entry

    5. 40. Powers of inspection

    6. 41. Powers of entry and inspection - supplementary provisions

11. Part 10 Enforcement of relevant breaches

    1. 42. Relevant breaches

    2. 43. Defences to relevant breaches

    3. 44. Enforcement notices

    4. 45. Content of enforcement notices

    5. 46. Compliance notices

    6. 47. Stop notices

    7. 48. Monetary penalty notices

    8. 49. Review of enforcement notices

    9. 50. Appeal against enforcement notices

    10. 51. Costs

    11. 52. Review of, and appeal against, costs notices

12. Part 11 General

    1. 53. Notices

    2. 54. Consequential amendments

    3. 55. Revocation

13. Signature

14. Schedules

    1. Schedule 1

       Information that must be provided to the Secretary of State in a release notice

       1. 1. Name, address, telephone number and email address of the person...

       2. 2. Where the person whose details are provided in paragraph 1...

       3. 3. A description of any persons assisting in the release of...

       4. 4. A general description of the precision bred organism in accordance...

       5. 5. Confirmation that the person named in paragraph 1—

    2. Schedule 2

       Information that must be provided to the Secretary of State in a marketing notice

       1. 1. Name, organisation name, address, telephone number and email address of...

       2. 2. Where the person whose details are provided in paragraph 1...

       3. 3. A general description of the precision bred organism in accordance...

       4. 4. A description of the intended use of the precision bred...

       5. 5. Information about intended genetic changes made to the precision bred...

       6. 6. Information about any unintended genetic changes made to the precision...

       7. 7. Information about— (a) the analysis and procedures used to check...

       8. 8. A description of how intended genetic changes described in paragraph...

       9. 9. A description of the analysis and procedures used to confirm...

       10. 10. Where a marketing notice serves as a marketing notice in...

    3. Schedule 3

       General description information

       1. 1. Details of the precision bred organism

       2. 2. The intended alterations to characteristics of the organism.

       3. 3. The types of genetic changes introduced to cause the alterations...

       4. 4. The techniques of modern biotechnology used to make the genetic...

    4. Schedule 4

       Information that must be provided to the Food Standards Agency in a food and feed marketing authorisation application

       1. 1. (1) The name, organisation name, address, telephone number and email...

       2. 2. Additionally, in relation to an application under regulation 22, where...

    5. Schedule 5

       Consequential Amendments to legislation relating to precision bred organism

       1. Part 1 Amendment of assimilated direct legislation

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

          2. 2. 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.

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

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

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

          6. 6. 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.

          7. 7. 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.

          8. 8. 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.

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

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

          11. 11. 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

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

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

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

       3. Part 3 Amendment of subordinate legislation that applies in England

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

15. Explanatory Note