Legislation & Regulation

ASPA currently regulates:

• Procedures that are carried out on ‘protected animals’ for scientific or educational purposes that may cause pain, suffering, distress or lasting harm.
• The breeding and supply of certain species of animals for use in regulated procedures or for the scientific use of their organs or tissues.
• The methods used to kill protected animals.

In March 2014, a document called the Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 was produced after a public consultation. This document gives detailed guidance on how ASPA should be administered and enforced.

This includes further details on:

• What constitutes a regulated procedure
• Which animals are protected under ASPA, and animals that acquire a higher level of protection (dogs, cats, primates, etc)
• Licensing requirements
• The principle of the 3R’s – which is a major component of ASPA
• Species specific methods of humane euthanasia
• Rehoming and re-release procedures for animals
• Housing and husbandry facilities
• Animal Welfare and Ethical Review Bodies
• Inspections
• Penalties for non-compliance amongst other aspects.

Under ASPA, a regulated procedure is defined as any procedure applied to a protected animal that will cause a level of pain, suffering, harm or distress, equivalent to or higher than that of a needle being inserted under good veterinary practice.

A protected animals, as defined by ASPA, is any living vertebrate other than man, and any living cephalopod. ASPA also extends protection to any vertebrate in foetal, larval or embryonic form, if, in the case of mammals, birds and reptiles, they are two thirds of the way through gestation or incubation period, or in other cases, when they become capable of independent feeding. Early life stage protection is not extended to cephalopods.

ASPA regulates animal experimentation through a three tier licensing system. This means that an establishment license for the premises, a personal license for the person conducting the experiment, and a project license for the specific programme of research that the project being carried out under, must all be in place. Licenses are issued by the Home Office in England, Scotland and Wales, and by the Department of Health, Social Service and Public Safety in Northern Ireland.

As of January 2021 the UK has officially left the European Union. As a result of this, most legislation has been transposed from the EU back into domestic UK law. The UK is now operating under the following regulations and regulatory bodies:

• ASPA (Animals (Scientific Procedures) Act 1986 Regulated by ASRU (Animals in Science Regulation Unit) a department of the Home Office.
• UK REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) regulation regulated by the Health & Safety Executive (HSE).
• The Human Medicines Regulation 2020 and the Medical Devices Regulation 2020 are regulated by MRHA (Medicines and Healthcare products Regulatory Agency).

In member states of the European Union, animal experimentation is controlled by the European Directive 2010/63/EU.

The directive sets out rules on:

• The 3R’s
• The origin, breeding, marking, care and accommodation and killing of animals
• The operations of breeders, suppliers and users
• The evaluation and authorisation of projects
• Reporting obligations

Each Member State of the European Union had to revise or introduce new legislation in order to comply with this Directive. 

The 3Rs are now an integral part of the Directive so Member States have to ensure: 

• wherever possible, a scientifically satisfactory method or testing strategy, not using live animals, should be used instead of an animal procedure. 
• the number of animals used in projects is reduced to a minimum without compromising the objectives of the project. 
• refinement of breeding, accommodation and care, and of methods used in procedures, eliminating or reducing to the minimum any possible pain, suffering, distress or lasting harm to the animals. 

The directive applies to all live vertebrates, namely all species of mammals, birds, amphibians and fish, and live cephalopods. Like ASPA, protection is also extended to specific early life-stages of some species.

Cosmetics and their ingredients which have been tested on animals are banned from being sold or advertised within the EU, under the Cosmetics Directive Regulation (EC) No 1223/2009.

The testing of chemicals in Europe is controlled by the REACH legislation. REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. Whilst the Cosmetic Regulation bans the testing of cosmetic ingredients on animals, in some instances REACH overrules this and requires animal tests, for example when chemicals for cosmetics have other, non-cosmetic uses, and for evaluating the risk of exposure of new (cosmetic) chemicals to protect those working with them. REACH states animal testing as a last resort to obtain relevant safety data, but non-animal tests in some areas do not yet exist.