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Genetic Technology (Precision Breeding) Act 2023 in Scotland

2023 c. 6 · Enacted 23 March 2023 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 13 November 2025.

An Act to make provision about the release and marketing of, and risk assessments relating to, precision bred plants and animals, and the marketing of food and feed produced from such plants and animals; and for connected purposes.

[23rd March 2023]

Be it enacted by the King’s most Excellent Majesty, by and with the advice and consent of the Lords Spiritual and Temporal, and Commons, in this present Parliament assembled, and by the authority of the same, as follows:—

Contents

  1. Part 1: Precision breeding: definitions
  2. 1Precision bred organism
  3. 2Meaning of “plant” and “animal”
  4. Part 5: General
  5. 41Consequential amendments of the Environmental Protection Act 1990
  6. 42Power to make consequential provision
  7. 43Regulations
  8. 44Interpretation
  9. 45Financial provisions
  10. 46Crown application
  11. 47Extent and application to sea areas
  12. 48Short title and commencement

1Precision bred organismI1 E+W+S

(1)

In this Act “precision bred organism” means a precision bred plant or a precision bred animal.

(2)

For the purposes of this Act an organism is “precision bred” if—

(a)

any feature of its genome results from the application of modern biotechnology,

(b)

every feature of its genome that results from the application of modern biotechnology is stable,

(c)

every feature of its genome that results from the application of modern biotechnology could have resulted from traditional processes, whether or not in conjunction with selection techniques, alone, and

(d)

its genome does not contain any feature that results from the application of any artificial modification technique other than modern biotechnology.

(3)

In this Act “modern biotechnology” means any technique mentioned in regulation 5(1)(a) or (b) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. 2002/2443).

(4)

A feature of an organism’s genome is “stable” if it is capable of being propagated whenever the organism is reproduced, whether by sexual or asexual reproduction.

(5)

In determining whether a feature of an organism’s genome could have resulted from traditional processes, no account is to be taken of—

(a)

the copy number of the feature,

(b)

its epigenetic status, or

(c)

its location in the genome.

(6)

In this section “traditional processes” means—

(a)

in relation to plants—

(i)

sexual fertilisation,

(ii)

spontaneous mutation,

(iii)

in vitro fertilisation,

(iv)

polyploidy induction,

(v)

embryo rescue,

(vi)

grafting,

(vii)

induced mutagenesis, or

(viii)

somatic hybridisation or cell fusion of plant cells of organisms which are capable of exchanging genetic material by a process within sub-paragraphs (i) to (vii);

(b)

in relation to animals—

(i)

sexual fertilisation,

(ii)

spontaneous mutation,

(iii)

artificial insemination,

(iv)

in vitro fertilisation,

(v)

embryo transfer,

(vi)

polyploidy induction, or

(vii)

recovery and transfer of primordial germ cells.

(7)

An “artificial modification technique” means any technique by which genes or other genetic material can be artificially modified within the meaning of Part 6 of the Environmental Protection Act 1990 (as it has effect from time to time).

(8)

If the category of techniques by which, or circumstances in which, genes or other genetic material are taken to be, or not to be, artificially modified for the purposes of Part 6 of the Environmental Protection Act 1990 changes by virtue of—

(a)

regulation 5 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. 2002/2443) being modified, or

(b)

regulations being made under subsection (4B) or (4C) of section 106 of the Environmental Protection Act 1990,

regulations may modify this section so as to make corresponding changes (with or without variation) to the definition of “modern biotechnology”.

(9)

Regulations under subsection (8) are subject to the affirmative procedure.

(10)

An organism to which subsection (11) applies does not fail to be precision bred merely because it does not meet the condition in subsection (2)(d).

(11)

This subsection applies to an organism which, for the purposes of Part 6 of the Environmental Protection Act 1990, is to be taken not to be a genetically modified organism by virtue of—

(a)

paragraph (3) of the regulation referred to in subsection (8)(a), or

(b)

regulations under subsection (4C) of section 106 of that Act.

2Meaning of “plant” and “animal”I1 E+W+S

(1)

In this Act “plant” means an organism in the taxonomic group—

(a)

Archaeplastida, or

(b)

Phaeophyceae.

(2)

In this Act “animal” means an organism in the taxonomic group Metazoa, other than a human (or a human admixed embryo).

(3)

In subsections (1) and (2), references to an organism—

(a)

include an embryo and all subsequent developmental stages of the organism;

(b)

in the case of a plant, also include a seed or a vegetative propagule;

(c)

do not include a gamete.

(4)

In this Act “gamete”—

(a)

does not include an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo, but

(b)

otherwise includes a mature germ cell capable of initiating fusion with a germ cell of the opposite sex.

(5)

In this section—

  • “embryo” includes an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo;

  • “human” includes a human embryo and all subsequent developmental stages of a human;

  • “human admixed embryo” has the same meaning as it has in the Human Fertilisation and Embryology Act 1990 by virtue of section 4A(6) and (11) of that Act.

41Consequential amendments of the Environmental Protection Act 1990I1I2 E+W+S

(1)

The Environmental Protection Act 1990 is amended as follows.

(2)

After section 106 insert—

“Exclusion of precision bred organisms from English application of Part

106A
(1)

In this Part as it applies in relation to England, references to genetically modified organisms (except in this section and section 127)—

(a)

do not include references to precision bred organisms;

(b)

so far as they relate to marketing, also do not include references to gametes of precision bred organisms.

(2)

For the purposes of subsection (1), this Part applies in relation to England so far as it applies in relation to—

(a)

importing genetically modified organisms where their destination is in England;

(b)

acquiring genetically modified organisms which are in England;

(c)

keeping or releasing genetically modified organisms in England;

(d)

marketing a genetically modified organism so far as the organism (or, where the organism is marketed by virtue of a product consisting of or including the organism being made available to other persons, that product) is made available for delivery in England.

(3)

In this section “precision bred organism” and “gamete” have the same meanings as in the Genetic Technology (Precision Breeding) Act 2023.”

(3)

In section 124 (advisory committee for purposes of Part 6), in subsection (1), at the end insert—

“For other functions of the committee, see Part 2 of the Genetic Technology (Precision Breeding) Act 2023.”

42Power to make consequential provisionI1

(1)

Regulations may make supplementary, incidental or consequential provision in connection with any provision of or made under this Act.

(2)

Regulations under this section may modify legislation.

(3)

Regulations under this section which contain provision modifying primary legislation (with or without other provision) are subject to the affirmative procedure.

(4)

Other regulations under this section are subject to the negative procedure.

43RegulationsI1

(1)

This section applies to regulations under this Act other than regulations under section 48 (commencement regulations).

(2)

Regulations are to be made by statutory instrument.

(3)

A power to make regulations includes power—

(a)

to make—

(i)

different provision for different purposes;

(ii)

transitional, transitory or saving provision;

(b)

to confer a function involving the exercise of a discretion.

(See section 42(1) for power to make consequential, incidental and supplemental provision.)

(4)

Where regulations under this Act are subject to the affirmative procedure, the regulations may not be made unless a draft of the statutory instrument containing them has been laid before, and approved by a resolution of, each House of Parliament.

(5)

Where regulations under this Act are subject to the negative procedure, the statutory instrument containing them is subject to annulment in pursuance of a resolution of either House of Parliament.

(6)

Any provision that may be made by regulations under this Act subject to the negative procedure may be made in regulations subject to the affirmative procedure.

44InterpretationI1

In this Act the following terms have the following meanings—

  • “advisory body” means the advisory committee or welfare advisory body;

  • “the advisory committee” has the meaning given by section 22(1);

  • “the affirmative procedure” has the meaning given by section 43(4);

  • “animal” has the meaning given by section section 2(2);

  • “compliance notice” has the meaning given by section 33(1);

  • “control” is to be read in accordance with section 3(2);

  • “enforcement authority” means a body designated as such under section 28(1);

  • “enforcement notice” has the meaning given by section 32(3);

  • “the environment” includes land, air, water and living organisms supported by any of those media;

  • “gamete” has the meaning given by section 2(4);

  • “legislation” means—

    1. (a)

      primary legislation,

    2. (b)

      retained direct EU legislation, or

    3. (c)

      subordinate legislation;

  • “marketable precision bred organism” has the meaning given by section 5(2);

  • “marketing notice” has the meaning given by section 6(1);

  • “modern biotechnology” has the meaning given by section 1(3);

  • “modify”, in relation to legislation, includes amend, repeal or revoke (and related terms are to be read accordingly);

  • “monetary penalty notice” has the meaning given by section 35(1);

  • “the negative procedure” has the meaning given by section 43(5);

  • “notifier”, in relation to a marketing notice, has the meaning given by section 6(1) (but see section 11(9));

  • “organism” (except in section 2) means plant or animal;

  • “Part 2 obligation” has the meaning given by section 21;

  • “Part 3 obligation” has the meaning given by section 29;

  • “plant” has the meaning given by section 2(1);

  • “precision bred” has the meaning given by section 1;

  • “precision bred animal marketing authorisation” means a marketing authorisation issued under section 13(1);

  • “precision bred confirmation” has the meaning given by section 8(1)(a)(i);

  • “precision bred organism” has the meaning given by section 1(1);

  • “precision bred trait”, in relation to a relevant animal, means a trait of the animal which results from a feature of the animal’s genome that results from the application of modern biotechnology;

  • “prescribed” means prescribed by regulations;

  • “primary legislation” means—

    1. (a)

      an Act,

    2. (b)

      an Act of the Scottish Parliament,

    3. (c)

      an Act or Measure of Senedd Cymru, or

    4. (d)

      Northern Ireland legislation;

  • “progeny”, in relation to a precision bred organism, includes any progeny of the organism, whether resulting from sexual or asexual reproduction;

  • “qualifying progeny” has the meaning given by section 24;

  • “the register” has the meaning given by section 18;

  • “regulations” means regulations made by the Secretary of State;

  • “relevant animal” has the meaning given by section 10;

  • “relevant breach” has the meaning given by section 31(1);

  • “stop notice” has the meaning given by section 34(1);

  • “subordinate legislation” means an instrument made under primary legislation or under retained direct EU legislation;

  • “the welfare advisory body” has the meaning given by section 22(3).

45Financial provisionsI1

The following are to be paid out of money provided by Parliament—

(a)

any expenditure incurred under or by virtue of this Act by the Secretary of State or the Food Standards Agency, and

(b)

sums payable out of money so provided under any other Act.

46Crown applicationI1

(1)

This Act binds the Crown.

(2)

If the Secretary of State certifies that it appears to the Secretary of State appropriate in the interests of national security that powers of entry conferred under this Act should not be exercisable in relation to Crown premises specified in the certificate, those powers are not exercisable in relation to those premises.

(3)

In subsection (2), “Crown premises” means premises held, or used, by or on behalf of the Crown.

(4)

No power of entry conferred under this Act may be exercised in relation to land belonging to His Majesty in right of His private estates.

(5)

In subsection (4), the reference to His Majesty’s private estates is to be construed in accordance with section 1 of the Crown Private Estates Act 1862.

47Extent and application to sea areasI1

(1)

Subject as follows, this Act extends to England and Wales only.

(2)

Part 1 and section 41 extend to England and Wales and Scotland only.

(3)

Sections 42 to 46, this section and section 48 extend to England and Wales, Scotland and Northern Ireland.

(4)

This Act—

(a)

applies to the territorial sea adjacent to England as it applies in England;

(b)

applies to any area for the time being designated under section 1(7) of the Continental Shelf Act 1964 as it applies in England.

48Short title and commencementI1

(1)

This Act may be cited as the Genetic Technology (Precision Breeding) Act 2023.

(2)

Part 1 comes into force on the day on which this Act is passed.

(3)

Parts 2 to 4 and sections 39 and 40 come into force—

(a)

so far as necessary to enable the exercise of any power to make regulations, on the day on which this Act is passed;

(b)

for remaining purposes, on such day as regulations may appoint.

(4)

Section 41 comes into force on such day as regulations may appoint.

(5)

The rest of this Part comes into force on the day on which this Act is passed.

(6)

Regulations under this section may appoint different days for different purposes.

(7)

Regulations may make transitional, transitory or saving provision in connection with the coming into force of any provision of this Act.

(8)

Regulations under this section are to be made by statutory instrument.