The Animals (Scientific Procedures) Act 1986 (Amendment) Regulations 2026

Explanatory note

Reproduced verbatim from the instrument as published on legislation.gov.uk (Crown Copyright, Open Government Licence v3.0). The note is prepared by the responsible government department and is not part of the instrument itself.

These Regulations restate, revoke and replace assimilated law relating to animals used in scientific research, maintaining the current legislative framework by consolidating the provisions into the Animals (Scientific Procedures) Act 1986 (c. 14) (“the ASPA”).

The key EU legislation on the use of animals in scientific research was Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes (“ the Animals Directive ”), which was transposed into domestic legislation through the Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 ( S.I. 2012/3039 ) which amended the ASPA.

Article 6 of Regulation (EU) 2019/1010 amended Article 43(2) and (3) of the Animals Directive in 2019 and impacted the corresponding provisions in the ASPA, sections 5D(6) and 5F(3) and (4), due to having direct effect.

Regulations 3 to 11 amend the ASPA by restating, revoking and replacing relevant provisions of assimilated law that were previously reflected in, or operated by reference to, the Animals Directive.

Regulation 3 amends section 5(4) of the ASPA to set out the circumstances, previously reflected in Article 40.4 of the Animals Directive, in which a project licence may authorise a programme of work comprising of multiple generic projects.

Regulation 4 amends the ASPA by replacing assimilated law corresponding to Annex 6 of the Animals Directive with equivalent provision and updates a textual reference to Annex 6 in section 5A(1)(c). Annex 6 sets out the information that must be included in an application for a project authorisation.

Regulations 5 and 6 replace assimilated law corresponding to Annex 8 of the Animals Directive with equivalent provision, setting out the severity classification of procedures, with the text adapted for clarity and to ensure consistency with the ASPA. Regulation 5 also substitutes a reference to Annex 8 with new section 5BA and Schedule 2AA of the ASPA.

Regulation 7 amends section 5D(6) of the ASPA and specifies the requirement to publish a copy of the project summary that accompanied the application for the project licence within six months of granting a project licence, reflecting the amendments made to Article 43 of the Animals Directive by Article 6 of Regulation (EU) 2019/1010 .

Regulation 8 amends section 5F(3)(b) of the ASPA and specifies the requirement to publish a retrospective assessment of a project summary within six months of completing the assessment, reflecting the amendments previously made to Article 43 of the Animals Directive by Article 6 of Regulation (EU) 2019/1010 .

Regulation 9 omits references to the Animals Directive in section 30 of the ASPA.

Regulation 10 inserts Schedule 2AA into the ASPA for the purposes of new section 5BA(7). Schedule 2AA contains a list of procedures by reference to severity classification, replacing assimilated law corresponding to Annex 8 of the Animals Directive with equivalent provision.

Regulation 11 amends Schedule 2C to the ASPA. Regulation 11(a) and (d) substitute references that previously operated by reference to Annex 3 of the Animals Directive with references to any code of practice issued or approved under section 21 of the ASPA. Regulation 11(b) sets out the tasks of the Animal Welfare and Ethical Review Body that previously operated by reference to Article 27.1 of the Animals Directive. Regulation 11(c) sets out the information keeping requirements for licensed establishments that previously operated by reference to Article 30.1 of the Animals Directive. Regulation 11(e) substitutes references that previously operated by reference to Annex 8 of the Animals Directive with new section 5BA and Schedule 2AA of the ASPA.

Regulation 12 revokes Article 6(1) of Regulation (EU) 2019/1010 , the substance of which is now reflected in the ASPA, having been restated by these Regulations.

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.