Animal testing has been strictly regulated in the UK since 1876. These regulations have been revised and extended over the course of more than 150 years, with the addition of an expert advisory committee to the Home Secretary, additional layers of ethical review, strict quality standards for labs and researchers, and species-specific requirements for care, housing and handling. 

The core piece of legislation governing animal experiments is the Animals (Scientific Procedures) Act 1986 (ASPA). In 2012, ASPA was revised and updated to conform to European Directive 2010/63/EU on the use of animals in science, however this directive was itself heavily based on existing UK law. 
 
These regulations are widely regarded as the strictest in the world and are subject to ongoing refinement and review.  
 
Central to the Animals (Scientific Procedures) Act 1986 is a harm-benefit analysis which must be applied before any research project involving animals can go ahead. Meaning that the harms, in terms of potential animal suffering, must be weighed against the potential benefits of the research. Animals must not be used if a non-animal alternative is available that can give equivalent data. 

Guidance on the operation of ASPA is constantly being updated, most recently in March 2020. This guidance explains what ASPA requires and provides detailed directions to holders of the various licenses required to undertake research using animals, as well as new licence applicants. It also provides guidance on how experiments should be classified in terms of their severity and advises on humane methods of killing. 

 

Licences required for animal testing

Three separate types of licence are required for animal research or testing, an establishment license, project licence, and personal license. Licenses are issued by the UK Home Office and are only granted if there is no effective way to carry out the research without animals 

The Animals (Scientific Procedures) Act 1986 says that animal procedures can only: 

• take place in research institutes or companies which have appropriate animal accommodation and veterinary facilities, and have been granted a certificate of designation via the establishment license 
• be part of an approved research or testing programme which has been given a project licence 
• be carried out by people with sufficient training, skills and experience as shown in their personal licence 
   

Licences are only granted if: 

• the potential results are important enough to justify the use of animals (the harm-benefit analysis) 
• the research cannot be done using non-animal methods 
• the minimum number of animals will be used 
• dogs, cats, horses or primates are only used when other species are not suitable 
• any discomfort or suffering is kept to a minimum by appropriate use of anaesthetics or pain killers 
• researchers and technicians conducting procedures have the necessary training, skills and experience 
• research premises have the necessary facilities to look after the animals properly (as laid down in a Home Office Code of Practice). 

 

Introducing the Animal Welfare Ethical Review Body and Animals in Science Committee

In addition to the above controls, a new level of regulation took effect in April 1999, with the introduction of local ethical review in the form of the Animal Welfare Ethical Review Body (AWERB). In most countries, the regulation of animal research operates either through local ethical committees or by statutory controls imposed by central government. The UK is the first country in the world to have both systems operating at the same time. 

The Home Secretary is also advised by the Animals in Science Committee (ASC), an expert group that can assist with more ethically challenging applications as well as casting an eye over how the system in general is operating. Prior to this committee, the Animal Procedures Committee fulfilled an identical role, but there has been such a body since 1912, following the recommendations of the Second Royal Commission on Vivisection. 

 

Animal testing that is allowed in the UK

The UK Home Office grants licenses for scientific, medical, veterinary, and environmental research using animals. Generally, half of all animal research is experimental, while the other half involves breeding animals whose genes have been mutated or modified to produce genetically altered offspring for use in experimental research. 

Experimental research can be primarily categorised into the following areas. 

Basic research: Approximately half of all experimental research that uses animals is carried out to expand our knowledge of living organisms and the environment. 

Applied or translational research: Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human or animal disease. Translation research accounts for approximately a quarter of experimental research. Around 1/3rd of translational research is for the benefit of animals.  

Regulatory research: Chemicals in everyday use, such as medicines, household products, and those used in manufacturing or plant protection products, must be tested to make sure they are as safe and effective for people, animals and the environment. Regulatory research accounts for approximately a quarter of experimental research, or 12% of research overall. Regulatory research, or safety testing, is usually carried out so that medicines and treatments meet particular UK, foreign or international regulations. Relevant UK laws and regulations include: 

• Medicines Act 1968 
• Health and Safety at Work Act 1974 
• Food and Environment Protection Act 1985 
• Control of Pesticides Regulations 1986 
• Consumer Protection Act 1987 
• Control of Substances Hazardous to Health 1988 
• Food Safety Act 1990 
• UK REACH 2019 

 

Animal testing that is banned in the UK

In the UK, there are multiple products that are banned from being tested on animals including cosmetics, alcohol, tobacco, and household products. These products are covered by non-legislative policy bans, such as the 1997 ban on animal testing for cosmetic products, which prevents the use of animals in cosmetics testing without the need to change any laws. Similarly, a ban on the testing of alcohol and tobacco products on animals was brought into effect in 1997 and a policy was implemented to ban the testing of household products on animals in 2015. 

Policy bans that are currently in place in the UK include: 

• a ban on the testing of finished cosmetic products on animals (6 November 1997) 
• a ban on the use of great apes (6 November 1997) - though none had been used since the passing of the 1986 Act 
• a ban on the testing of alcohol and tobacco products on animals (6 November 1997) 
• a de facto ban on the testing of cosmetic ingredients (16 November 1998) 
• a ban on the use of animals to produce monoclonal antibodies by the ascites method, save in exceptional cases (from 1 January 1999) 
• a ban on the acute oral Lethal Dose 50% (LD50) test save in exceptional circumstances (21 October 1999), and 
• a ban on the use of animals to test the safety of household products (October 2015) 

 

Regulating animal research in the UK

The Animals in Science Regulation Unit (ASRU) are responsible for regulating animal research in the UK. Their purpose is to protect animals in science by managing compliance with the Animals (Scientific Procedures) Act 1986 (ASPA) and is part of the UK Home Office. 

ASRU provide advice to scientists on animal research regulations, manage the licenses required by ASPA, and work to make sure license holders comply with ASPA and the terms of their license. 

ASRU carry out regular inspections of licensed establishments, often unannounced. ASRU publishes an annual report detailing its work, including the number of inspections carried out, and information regarding non-compliance cases. Whilst the majority of non-compliance cases are self-reported by the facilities in question, ASRU acts as an independent body for reporting concerns. The regulator can also decide to conduct special reviews into particular experiments or experimental methods, with a view to ensuring they are only permitted when appropriate. 

 

Animal Testing Statistics

The Animals (Scientific Procedures) Act 1986 (ASPA) requires all licensed facilities to report the annual number of procedures carried out on different animal species, the severity of procedures, and areas of research.  

These figures are published annually by the Home Office under Statistics of scientific procedures on living animals. 

At UAR, we provide a yearly breakdown of these statistics so that as many people as possible have the opportunity to view and understand the numbers in full. Read our annual statistics articles for more. 

 

Regulations outside of the UK

The European Union - European Directive 2010/63 

Heavily based on the UK’s Animals (Scientific Procedures) Act 1986 (ASPA), The European Directive was finalised and signed on 22 September 2010. It was formally published in the Official Journal of the European Union on the 20 October 2010 and was given its final name: 2010/63/EU. The Directive came into force across the EU on 1 January 2013.  

European Directive 2010/63 does not apply to the UK following our exit from the EU however, ASPA was revised in 2012 to conform to the directive.  

For more information see European Directive 2010/63.  

For more information on animal research across Europe see EARA.eu  

 

North America – Animal Welfare Act (AWA) 

Regulations around animal testing vary by continent, country, and state. For example, great apes such as chimpanzees and gorillas cannot be used in UK research as they are banned, but they can be used in the USA in special cases. In the USA, experiments on animals are regulated under the Animal Welfare Act.   

For more information on the regulations around animal testing in North America see ampprogress.org and fbresearch.org.  

 

Oceania - The Australian Code for the Care and Use of Animals for Scientific Purposes and the New Zealand Animal Welfare Act 1999 

Oceania refers to Australia and New Zealand, both of which have their own strict regulations in place regarding animal research, The Australian Code for the Care and Use of Animals for Scientific Purposes, and the Animal Welfare Act 1999.  

For more information on the regulations around animal testing in Oceania see uaroceania.org.