Since the testing of cosmetic products (and their ingredients) on animals was banned in the UK in 1998, and the testing of completed household products was banned in 2015, many people assume that animal experiments have ended in the UK altogether. Sadly, this is not the case, and millions of animals are still used every year to study human diseases through basic and applied research, the development of new drugs, or to carry out safety testing for regulatory purposes.
The Law
A common misconception is that animal experiments carried out in the UK are required by law.
In fact, there is no legal requirement for animal experiments in the UK.
The Law around animal experiments
The UK has a long history of implementing laws to protect animals, and an important milestone was the 1876 The Cruelty to Animals Act. This Act introduced limits and a licencing system for animal experiments, ensuring that experiments which inflict pain on animals were to only be conducted when “absolutely necessary to save or prolong human life”.
This Act remained in place until it was replaced 110 years later by the Animals (Scientific Procedures) Act (ASPA) in 1986, which introduced stricter and more specific regulations, and is still in place today.
However, whilst ASPA is in place to protect animals used in research, there is often confusion around whether animals must be used in experiments at all, according to UK law. Many people don’t realise that the majority of UK research is carried out for basic or applied/translational purposes – for which there is no legal or regulatory requirement, while just a small percentage of research is carried out to meet regulatory guidelines.
This provides a significant yet underutilised opportunity to explore and use non-animal methods to study human diseases, yet many researchers default to outdated animal experiments through habit, lack of knowledge about new technologies or funding restrictions. A further issue is publication bias against research papers that don’t include animal data, with many high-impact journals reported to reject those that don’t contain data from animal experiments. However, as animal experiments are not required by law and animal-free alternative technologies continue to grow in popularity due to their superior, human-specific results, this outdated viewpoint is set to change.
The Animals (Scientific Procedures) Act 1986 (ASPA)
In the UK, the use of animals in experiments for medical research is regulated by the Animals (Scientific Procedures) Act 1986(ASPA), which is administered by the Animals in Science Regulation Unit (ASRU) of the Home Office. The latest version of this Act came into force on 1st January 2013, after the original 1986 Act was revised to include new regulations specified by the European Directive 2010/63/EU.
ASPA only covers experiments carried out on ‘protected’ animals for scientific or educational purposes that may cause pain, suffering, distress or lasting harm, including the methods used to kill them. It also covers the breeding and supply of animals for use in experiments, including the use of their organs or tissues.
ASPA only covers ‘protected animals’, which according to the Home Office are defined as: “Any living vertebrate, other than man, and any living cephalopod.. embryos after two-thirds of gestation, and fish and amphibian larvae after they become capable of free feeding as protected animals”. This means that any living animal, except for humans and cephalopods (any member of the Mollusca class, which includes squid, octopus, cuttlefish and nautilus – included in ASPA since 2013), which are after the first two thirds of their gestation period, or fish or amphibian larvae once they can feed themselves, are protected by ASPA.
The use of protected animals is regulated under ASPA – but this doesn’t mean they can’t be used in research – just that a project licence must be acquired from the Home Office.
Animals which don’t fall under this definition are not afforded any legal protection and can therefore be used without a licence. The number of unprotected animals used each year is not reported, so it is impossible to know how many animals are used under these circumstances. However, as using unprotected or embryonic animals removes the need for researchers to apply and pay fees for a licence, the numbers are likely to be high.
Some animals have additional protections to minimise their use. These specially protected animals are dogs, cats, horses and monkeys. These animals can still be used in research, but the law states they must only be used when other species are unsuitable or unavailable.
A note about terminology
At Animal Free Research UK, we recognise that language and the words we choose to use are powerful as they can reveal or conceal different perspectives, values and interests. We choose our words carefully in line with our values.
It is helpful to define some of the phrases that are used frequently throughout ASPA so that we can better understand the law. Some words have precise definitions which are different to everyday use, so we explain them here to help our supporters be better informed about the law – but that does not mean we endorse their use or the rationale behind them. Instead, we set out our position so that we are transparent about our views.
Alternative
ASPA has enshrined the concept of the development of ‘alternatives’ as a legal requirement. The wording in ASPA reads:
20B Alternative strategies
- (1) The Secretary of State must support the development and validation of alternative strategies.
- (2) In particular, the Secretary of State must—
(a) assist the European Commission in identifying and nominating suitable laboratories to carry out validation studies on alternative strategies;
(b) nominate a person the Commission may contact for advice on the regulatory relevance and suitability of alternative strategies proposed by the Commission for validation;
(c) take such other steps as the Secretary of State considers appropriate to encourage research into alternative strategies;
(d) ensure the promotion of, and dissemination of information about, alternative strategies. - The Secretary of State may make grants to any person concerned with the development, promotion or validation of alternative strategies.
- “Alternative strategies” means scientific methods and testing strategies which do not use protected animals, or which (compared to existing scientific methods and testing strategies) use fewer protected animals or reduce the pain, suffering, distress or lasting harm caused to protected animals.
With the exception of clause (4), the aim of these regulations is to develop and promote alternatives at a Governmental level, not just at a scientific level. The Law requires the Government to ensure that scientific methods and testing strategies that do not use protected animals are used and developed, instead of similar methods that continue to use protected animals.
Animal Free Research UK supports the principle that the Government must ensure non-animal scientific methods are developed and used. However, millions of animals continue to be used in research every year. We want to see the Government do much more to proactively accelerate the growth of new approach methodologies that replace the use of animals. This is why we are calling for Herbie’s Law to prompt a ‘decade of change’, leading towards the replacement of animal experiments in UK medical research by 2035, encouraging and supporting researchers to use humane and effective animal-free methods.
Replacement
We prefer the term ‘replacement’ to ‘alternative’ because it makes our position clearer, as we do not believe that animals should be available to use as one option in the scientific toolbox. Instead, we believe the use of all animals should be replaced by ethical, scientifically superior new approach methodologies (NAMs), which use human cells, tissues and reagents to better predict human responses, and importantly, do not involve animal suffering.
Animal
At Animal Free Research UK, we define the term ‘animal’ as including all organisms of the Kingdom Animalia (excluding humans). This means that the research we fund must not use any animal from the Kingdom Animalia.
According to ASPA, a ‘protected animal’ is any living vertebrate other than humans or cephalopods. ‘Protected animals’ are not protected from being used in research, but rather their use is regulated under ASPA, while other animals outside of this definition are not afforded any legal protection. This definition is used within the UK and the European Union.
‘Specially protected’ animals (dogs, cats, horses and non-human primates) are offered an additional level of protection, where their use must be justified over the use of a different species, but these animals can still be, and are, used regularly in research laboratories in the UK.
Suffering
The process of obtaining a project licence requires researchers to define the level of suffering that animals are likely to experience in each experiment.
The categories of suffering set out in ASPA are:
- Sub-threshold (the procedure causes less pain, suffering, distress or lasting harm than would be caused by inserting a hypodermic needle according to good veterinary practice)
- Mild
- Moderate
- Severe
- Non-recovery (the entire procedure is carried out under general anaesthesia from which the animal will not regain consciousness)
According to the 2023 annual statistics of scientific ‘procedures’ using living animals in Great Britain report, 49,701 animal experiments carried out in UK laboratories were classified as ‘severe’ (3.4%) and 410,350 were classified as ‘moderate’ (27.9%), each causing considerable pain, discomfort and distress to the animals involved.
Almost half (49.3%) of all experiments in 2023 were classed as causing ‘mild’ suffering, with 723,674 experiments falling into this category, however this vague term is unlikely to accurately represent the true experience, stress and level of distress experienced by animals during experiments.
Severity assessments only acknowledge the suffering caused to an animal during an experiment, but don’t include other harms animals experience during their lives in a laboratory, such as stressful circumstances, relatively barren environment and lack of opportunities to express their natural instincts including companionship and play. In addition, cases of poor welfare conditions and additional suffering caused by negligence, lack of due care or even failure to provide food and water are reported each year by ASRU, highlighting the difficulties that some laboratory animals experience outside of the experiments they are used in.
In 2023, 63,845 experiments (4.3%) were classed as ‘non-recovery’, where the entire experiment is carried out while the animal is under general anaesthesia, from which the animal did not recover.
Procedure
A “regulated procedure” is defined under the Animal (Scientific Procedures) Act 1986 (ASPA) as “any procedure applied to a protected animal for a qualifying purpose which may have the effect of causing the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice”. This definition covers a wide range of potential practices, many potentially causing high levels of suffering to the animals involved.
Examples of regulated procedures include:
- Tests, experiments and other procedures done to animals for experimental, scientific, regulatory or educational purposes.
- The genetic modification of animals, including their breeding.
At Animal Free Research UK, we find the word ‘procedure’ to be sometimes unhelpful as it can conceal the true experience of the animal. Instead, we choose to use the word ‘experiment’. In addition, if we are talking about a particular test, then we do our best to describe what actually happens to the animals involved because we believe we have a responsibility to shine a light on the reality of the animals’ lived experience.
Research purposes
Only a small percentage of animal experiments carried out each year are carried out to meet ‘regulatory’ guidelines for drug or chemical testing, which are set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). However, these are guidelines, not the law.
Instead, most research carried out using animals in the UK is for ‘basic‘ (“curiosity-driven” research to gain basic knowledge) or ‘applied/translational‘ (the study of human diseases and the development of treatments) purposes. In 2023, over half of all experiments using animals were carried out for basic research, while a quarter were for applied/translational research .
Neither of these research types have a legal or regulatory requirement to use animals, but researchers can choose to do so.
Regulatory experiments (such as the testing of new drugs or the safety testing of chemicals) made up just 20.8% of all experiments carried out in UK laboratories in 2023.
In 2024,
2,637,578
procedures using animals were carried out in the UK.
52
of experiments were for basic research ("curiosity-driven" research to gain basic knowledge).
24
of experiments were for applied/translational research (study of human diseases and new drugs).
0
experiments were required by law.
Two species testing
The ICH brings together regulators and members of the pharmaceutical industry to write guidelines on the development of medicines which are then implemented by countries at a local level.
Within the regulatory guidelines that are followed by the UK, the ICH strongly suggest that new drugs should be tested on two species of animal (one rodent such as mice or rats, and one non-rodent such as dogs, pigs or monkeys) before proceeding to human clinical trials.
However, in response to a written question posed to the Department of Health and Social Care (DHSC) in 2023, the Government stated that “there is no United Kingdom legislation that mandates animal testing”, and that assessors will accept data from a “suitably validated model that has been demonstrated to be predictive […] in lieu of animal data”.
This means that in the UK, animal experiments are not required by law, and that non-animal data can be used to provide essential safety data for new drugs and chemicals, allowing them to move to human clinical trials or use in manufacture.
Despite this, in 2024, 148,694 procedures were carried out for the regulatory testing of medicinal products for human use alone.
Regulatory testing of cosmetics and household products
Whilst testing for cosmetics and finished household products is banned in the UK, under some circumstances the testing of ingredients on animals is required under other regulations, for example to ensure the safety of the workers that manufacture certain products. UK REACH (Registration, Evaluation, Authorisation and restriction of CHemicals) is a regulation that applies to chemical substances that are manufactured in or imported into England, Scotland or Wales.
Under UK REACH, or its EU equivalent, EU REACH, animal tests may still occur on ingredients for cosmetics or household products to “understand the potential harm to human health and the environment of chemical substances”.
In 2024, 59,814 experiments were carried out for industrial chemical legislation purposes, including 40,520 on rats and 1,414 on rabbits. A further 11,756 experiments were carried out for plant protection product legislation, while another 10,709 experiments were for testing of biocides, and food and feed legislation (including legislation for the safety of target animals, workers and environment).
The 3Rs: Replacement, Reduction and Refinement
ASPA has enshrined the principles of the 3Rs (Replacement, Reduction and Refinement) of the use of animals in research into UK Law. This is defined in Section 2A of ASPA 2012.
This means that when a scientist applies for a licence to conduct animal experiments, they must explain why there is no scientifically satisfactory non-animal method that can be used instead of an animal experiment. However, the burden of proof that the 3Rs have been thoroughly considered falls on the applicants, who do not have to provide evidence that they have thoroughly investigated the replacement options. Instead, they can provide basic reasons as to why animals must be used in their work.
We believe that progress to replace animals in laboratories is being made too slowly and that the principles of the 3Rs are not enough to push for the change that is needed. This is why we only fund research into Replacement.
We continue to work with MPs and policy-makers to call for Herbie’s Law: new legislation which will create lasting change and provide support for scientists to transition to animal-free methods.
At Animal Free Research UK, we believe that animal experiments are ethically unjustified, and that innovative human-specific research provides the best chance of developing new treatments for human diseases.
We only support and fund research that uses non-animal methods.
We do not fund Refinement or Reduction research, or any research that uses animals or animal-derived products in experiments.
A bold step towards a future where animals are no longer used in the name of science.
Herbie’s Law will prompt a ‘decade of change’, and would mandate the replacement of animals in medical research in the UK by 2035, replacing them with humane, effective alternatives.
Learn more about Herbie's Law
