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The Genetic Technology (Precision Breeding) Regulations 2025

Draft. This instrument was laid in draft and may differ from the one made. Look for the made version under its title.

Draft 2025, ISBN 9780348269123

Original text. legislation.gov.uk does not revise statutory instruments, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Draft Regulations laid before Parliament under section 43(4) of the Genetic Technology (Precision Breeding) Act 2023, for approval by resolution of each House of Parliament.

AGRICULTURE, ENGLAND

ENVIRONMENTAL PROTECTION, ENGLAND

FOOD, ENGLAND

Made ***

Coming into force in accordance with regulation 1(1)

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 4(1)(b), (3) and (4), 6(2), 9(1), (2) and (4), 16(1), (2) and (4), 17(1) and (3), 18(1) and (6), 20(1), (2) and (3), 21(3), 23(1), 26(1), (2), (3), (4), (6), (7) and (8), 27(1) and (2), 28(1) and (3), 29(4), 31(3), 32(1) and (2), 33(2), 34(2), 35(3) and (4), 36(1) and (3), 37(1) and (2), 38(1), (4), (5) and (7), 40(1), 42(1) and (2), 43(3) and (6) of the Genetic Technology (Precision Breeding) Act 2023 (“the Act”)f1.

In relation to Parts 7, 8, 9 and 10 of, and Schedule 4 to, this instrument, there has been consultation 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 safetyf2.

In accordance with section 43(4) of the Act, a draft of this instrument has been laid before, and approved by a resolution of, each House of Parliament.

Annotations to the whole text

Footnotes

f1

2023 c. 6 (“the Act”).

f2

EUR 2002/178 to which there are amendments not relevant to these Regulations.

Contents

  1. Part 1: Introduction
  2. 1Citation, commencement, extent and application
  3. 2Interpretation
  4. Part 2: Release of Precision Bred Organism
  5. 3Notification requirement for release of precision bred organism in England
  6. 4Transitional provisions for release
  7. Part 3: Marketing of Precision Bred Organism
  8. 5Application for precision bred confirmation - marketing notice
  9. 6The advisory committee - reporting period etc.
  10. 7Revocation of precision bred confirmation
  11. 8Review of a precision bred confirmation or revocation decision
  12. 9Appeal to the First-tier Tribunal
  13. Part 4: The precision breeding register
  14. 10Information to be included in the precision breeding register
  15. 11Keeping of the precision breeding register
  16. Part 5: Environmental risk assessment
  17. 12Environmental risk assessment for precision bred organism in contained use
  18. Part 6: Monitoring and inspection of release and marketing
  19. 13Inspectors
  20. 14Meaning of “Part 2 obligations”
  21. 15Powers of entry
  22. 16Powers of inspection
  23. 17Powers of entry and inspection - supplementary provisions
  24. Part 7: Food and feed produced from precision bred organisms
  25. 18Interpretation of this Part
  26. 19Marketing of food and feed produced from precision bred organisms - requirement for authorisation
  27. 20Application for a food and feed marketing authorisation
  28. 21Requirement to report verified applications for a food and feed marketing authorisation under regulation 20 to the Secretary of State
  29. 22Application for a food and feed marketing authorisation - where a Food Standards Agency assessment is required
  30. 23Verification of information in application made under regulation 22
  31. 24Request for further information
  32. 25Publication of verified applications
  33. 26Assessment by the Food Standards Agency
  34. 27Advice or information from the Food Standards Advisory Committee etc.
  35. 28Requirement to report on safety assessment etc. to the Secretary of State
  36. 29Withdrawal of application for a food and feed marketing authorisation
  37. 30Determination on authorisation by the Secretary of State
  38. 31Communication of the Secretary of State’s decision to the applicant
  39. 32Duties on authorisation-holders and other persons placing authorised food and feed on the market
  40. 33Revocation or variation of a food and feed marketing authorisation
  41. 34Confidentiality
  42. Part 8: The food and feed register
  43. 35Food and feed marketing authorisations register
  44. Part 9: Monitoring and inspection of Part 3 obligations
  45. 36Part 3 obligation
  46. 37Enforcement authorities
  47. 38Inspectors
  48. 39Powers of entry
  49. 40Powers of inspection
  50. 41Powers of entry and inspection - supplementary provisions
  51. Part 10: Enforcement of relevant breaches
  52. 42Relevant breaches
  53. 43Defences to relevant breaches
  54. 44Enforcement notices
  55. 45Content of enforcement notices
  56. 46Compliance notices
  57. 47Stop notices
  58. 48Monetary penalty notices
  59. 49Review of enforcement notices
  60. 50Appeal against enforcement notices
  61. 51Costs
  62. 52Review of, and appeal against, costs notices
  63. Part 11: General
  64. 53Notices
  65. 54Consequential amendments
  66. 55Revocation
  67. Signature
  68. Schedule 1: Information that must be provided to the Secretary of State in a release notice
  69. 1Paragraph 1
  70. 2Paragraph 2
  71. 3Paragraph 3
  72. 4Paragraph 4
  73. 5Paragraph 5
  74. Schedule 2: Information that must be provided to the Secretary of State in a marketing notice
  75. 1Paragraph 1
  76. 2Paragraph 2
  77. 3Paragraph 3
  78. 4Paragraph 4
  79. 5Paragraph 5
  80. 6Paragraph 6
  81. 7Paragraph 7
  82. 8Paragraph 8
  83. 9Paragraph 9
  84. 10Paragraph 10
  85. Schedule 3: General description information
  86. 1Details of the precision bred organism
  87. 2Details of the precision bred organism
  88. 3Details of the precision bred organism
  89. 4Details of the precision bred organism
  90. Schedule 4: Information that must be provided to the Food Standards Agency in a food and feed marketing authorisation application
  91. 1Paragraph 1
  92. 2Paragraph 2
  93. Schedule 5: Consequential Amendments to legislation relating to precision bred organism
  94. Part 1: Amendment of assimilated direct legislation
  95. 1Amendment to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed
  96. 2Amendment 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.
  97. 3Amendment to Regulation (EC) No 1946/2003 of the European Parliament and of the Council on transboundary movements of genetically modified organisms
  98. 4Amendment to Regulation (EC) 1332/2008 of the European Parliament and of the Council on food enzymes, etc.
  99. 5Amendment to Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives
  100. 6Amendment 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.
  101. 7Amendment 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.
  102. 8Amendment 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.
  103. 9Amendment to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (recast)
  104. 10Amendment to Commission Regulation (EU) No 68/2013 on the Catalogue of feed materials
  105. 11Amendment 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
  106. 12Amendment to Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, etc
  107. Part 2: Amendment of subordinate legislation that applies in Great Britain
  108. 13Amendment to the Genetically Modified Organisms (Contained Use) Regulations 2014
  109. Part 3: Amendment of subordinate legislation that applies in England
  110. 14Amendment to the Environmental Damage (Prevention and Remediation) (England) Regulations 2015
  111. Explanatory note