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

Published: Thu 18th Jun 26

These Regulations amend the Animals (Scientific Procedures) Act 1986 to incorporate and restate clinical and administrative standards formerly contained in EU legislation, specifically the Animals Directive (2010/63/EU).

They establish a domestic framework for classifying the severity of scientific procedures on animals, mandate specific reporting timelines for project summaries, and define the advisory tasks of Animal Welfare and Ethical Review Bodies.

The instrument applies to researchers, scientific establishments, and the Secretary of State across England, Wales, Scotland, and Northern Ireland.

Arguments For

The Regulations aim to maintain the existing legislative framework for animal research by consolidating provisions previously held in EU law directly into the Animals (Scientific Procedures) Act 1986.
The document states that these changes ensure the UK's regulatory environment for scientific procedures remains functional after the revocation of retained EU law.
Proponents argue that replacing references to EU Directives with specific domestic schedules (such as Schedule 2AA) provides greater clarity and accessibility within the primary UK statute.
The legislation asserts that incorporating reporting obligations from Regulation (EU) 2019/1010 into the Act maintains transparency regarding project summaries and retrospective assessments.

Arguments Against

Legal scholars might note that while the Regulations aim to restate existing law, the transition from EU-derived Annexes to domestic Schedules could lead to interpretive differences in how "severity" is classified by different authorities.
Animal welfare organizations may monitor whether the shift from EU oversight to domestic codes of practice (as mentioned in Regulation 11 regarding installations and equipment) affects the rigorousness of inspections.
Affected research institutions may face minor administrative updates to ensure their internal Animal Welfare and Ethical Review Bodies are citing the newly inserted sections of the 1986 Act rather than the now-revoked EU Directive articles.

PART 1 General

Citation, commencement and extent

-(1) These Regulations may be cited as the Animals (Scientific Procedures) Act 1986 (Amendment) Regulations 2026 and come into force on the day after the day on which they are made.

(2) These Regulations extend to England and Wales, Scotland and Northern Ireland.

This section establishes the official title of the regulations and sets the date they become legally active as the day following their making.

It also defines the geographical reach of the law, ensuring it applies throughout the entire United Kingdom.

PART 2 Amendment of the Animals (Scientific Procedures) Act 1986

The Animals (Scientific Procedures) Act 1986( a ) is amended in accordance with this Part.

Amendment to section 5 (project licences: general)

In section 5 (project licences: general)( b ), for subsection (4) substitute-

'(4) A project licence may specify a programme of work which consists of multiple generic projects if the projects-

(a) are to be carried out to satisfy regulatory requirements, or
(b) use animals for production or diagnostic purposes, in accordance with established methods.'.

This part initiates the formal modification of the 1986 Act.

It specifically revises the criteria for project licences, allowing a single licence to cover multiple generic projects if they are required by regulation or involve routine production and diagnostic methods.

Amendment to section 5A (application for a project licence)

In section 5A (application for a project licence)( c )-

(a) in subsection (1)(c), for 'Annex 6 of the Animals Directive' substitute 'subsection (1A)';
(b) after subsection (1), insert-

'(1A) The matters referred to in subsection (1)(c) are-

(a) the relevance of, and justification for, the regulated procedures specified in the application;
(b) the proposed application of methods to replace, reduce or refine the use of animals in those procedures;
(c) the proposed severity classification of the procedures specified in the application (see section 5B(3)(c));
(d) the relevance of, and justification for, the use of animals in those procedures;
(e) the following matters in relation to the animals to be used in those procedures-
(i) their estimated number;
(ii) their type and species;
(iii) their life stages;
(iv) their origin;
(f) the proposed housing conditions, husbandry conditions and care conditions of those animals;
(g) the steps proposed for the avoidance, reduction or alleviation of pain, suffering or distress in those animals, from birth to death where appropriate, including, in particular-

(i) the planned use of anaesthesia, analgesia or other methods of relieving pain;

(ii) the use of humane end-points;
(h) any proposed experimental or observational strategy or statistical design for minimising the following where appropriate-
(i) the number of animals to be used;
(ii) their pain, suffering or distress;
(iii) the environmental impact of the procedures;
(i) the cumulative effects of any proposed reuse on those animals;
(j) any proposed methods of killing those animals;
(k) the steps proposed for the avoidance of any unjustified duplication of procedures where appropriate;
(l) the competence of persons involved in the proposed programme of work.'.

This section replaces a reference to EU law with a detailed domestic list of requirements for project licence applications.

Applicants must now explicitly provide information on animal numbers, species, housing conditions, and strategies for the 'three Rs' (replacement, reduction, and refinement).

Amendment to section 5B (determining an application: evaluation of the programme of work)

In section 5B (determining an application: evaluation of the programme of work)( a )-

(a) in subsection (3)(c), after 'work' insert '(see section 5BA)';
(b) omit subsection (6).

Insertion of section 5BA (determining an application: classification of the severity of the procedure)

After section 5B, insert-

'5BA Determining an application: classification of the severity of the procedure

(1) This section applies for the purposes of classifying the likely severity of a regulated procedure under section 5B(3)(c).
(2) The likely severity of the procedure is to be determined by the degree of pain, suffering, distress or lasting harm expected to be experienced by an animal during the course of the procedure.
(3) A procedure that falls within a description set out in column 1 of the following Table is to be assigned to the category that is specified in column 2 of the Table in relation to that description- [Table defining Mild, Moderate, Severe, and Non-recovery] ... (4) The assignment... must be based on the most severe effects... (5) The Secretary of State... must first assign the procedure to a category on the basis of factors relating to the type of procedure only ('step 1'), and... determine whether to assign... to a different category on the basis of additional factors ('step 2'). [detailed factors follow in subsections 6-10].

This section introduces a formal mechanism for the Secretary of State to classify the severity of animal procedures into four categories: Mild, Moderate, Severe, or Non-recovery.

It mandates a two-step process that first considers the procedure type and then adjusts based on specific factors like animal age, genotype, and potential for reuse.

Amendment to section 5D (granting a project licence)

In section 5D(6) (granting a project licence)( a ), after 'licence' insert 'before the end of the period of six months beginning with the day on which the project licence was granted'.

Amendment to section 5F (retrospective assessment of programme of work)

In section 5F(3)(b) (retrospective assessment of programme of work)( b ), after 'altered' insert 'before the end of the period of six months beginning with the day on which the assessment was completed'.

These amendments impose strict six-month deadlines for administrative actions.

The government must publish project summaries within six months of granting a licence and publish retrospective assessments within six months of their completion.

Amendment to section 30 (short title, interpretation and commencement)

In section 30 (short title, interpretation and commencement)( c )-

(a) in subsection (2), omit the definition of 'the Animals Directive';
(b) omit subsection (2A).

Insertion of Schedule 2AA (severity of procedures)

Before Schedule 2B, insert Schedule 2AA set out in the Schedule to these Regulations.

This section removes definitions that linked the 1986 Act to the EU Animals Directive, effectively decoupling the UK law from the European treaty.

It also inserts a new schedule that provides specific examples of different severity levels for various scientific procedures.

Amendment of Schedule 2C (conditions in licences)

In Schedule 2C (conditions in licences)( d )- ... [detailed amendments to paragraphs 4, 6, 8, 11, and 23 follow].

This section updates licence conditions for establishments that house or breed animals for research.

It requires compliance with domestic codes of practice for installations and equipment, defines the advisory duties of animal welfare bodies, and specifies exactly what records must be kept regarding animal origin, species, and outcomes.

PART 3 Revocation of Article 6(1) of Regulation (EU) 2019/1010

Article 6(1) of Regulation (EU) 2019/1010 of the European Parliament and of the Council of 5 June 2019 on the alignment of reporting obligations in the field of legislation related to the environment is revoked.

This final part revokes a specific piece of retained EU law.

Since the reporting obligations from that EU regulation have now been written directly into the amended 1986 Act, the original EU provision is redundant.

SCHEDULE

Severity of procedures

'SCHEDULE 2AA

Severity of procedures

PART 1 - General; PART 2 - Mild procedures; PART 3 - Moderate procedures; PART 4 - Severe procedures. [List includes specific procedures like ear biopsies (mild), organ transplantation (moderate), and toxicity testing where death is the end-point (severe)].

This schedule provides a technical catalogue of scientific procedures categorized by their expected impact on animal welfare.

It serves as the primary reference for researchers and regulators to determine the severity level of proposed work, ranging from non-invasive imaging to procedures causing organ failure.

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