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In the sections below we have detailed the current legislation on animal experiments for Europe and the UK, USA, Canada & Brazil, and Asia.
Animal experiments in the Member States of the European Union are controlled by European Directive 2010/63/EU, which replaced the previous regulation in September 2010. The Directive lays down rules on:
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:
All non-human vertebrate animals, namely all species of mammals, birds, reptiles, amphibians and fish. The European Directive included all living cephalopods (octopus, squid, cuttlefish and nautilus) although previously, only Octopus vulgaris was included in the 1986 Act (see below). There is currently a push to include protection for decapods also.
Cosmetics and their ingredients which have been tested on animals are not allowed to be sold or advertised within the European Union, 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.
The first legislation anywhere in the world specifically to detail restrictions on the use of animals for experiments was The Cruelty to Animals Act 1876 in the UK. The Act made it an offence to perform on a living animal any experiment calculated to give pain, unless it was carried out with a view to advancing physiological knowledge, saving or prolonging life or alleviating suffering. This led to the creation of a regulatory system involving registration of premises where experiments were conducted and licensing of people who conducted the work, enforced by the newly establish Home Office Inspectorate.
More than a century after the 1876 Act came in to force, pressure again mounting on the Government in the UK and the promotion of alternatives to the use of animals in research resulted in the passing of the Animals (Scientific Procedures) Act 1986 (ASPA).
In January 2013 ASPA was amended to implement the requirements of the updated European regulations on animal experiments, European Directive 2010/63/EU (See above) whilst maintaining the high standards already required by ASPA.
In March 2014, after public consultation and discussions with interested parties the UK Government released a revised Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 . This gives detailed guidance on how ASPA is administered and enforced.
ASPA controls animal experimentation through a three tier licence system. In order for animal experiments to be allowed the PLACE they are done in must have a licence, the PERSON doing the experiment must have a licence and the PROJECT that the experiments are being done for must be licensed.
The 3Rs have always been an integral part of ASPA but the amendment makes it much more explicit than the previous version of the legislation.
ASPA is implemented by the Home Office in England, Scotland and Wales and by the Department for Health, Social Security and Public Safety in Northern Ireland. Within the Home Office it is the Animals in Science Regulation Unit (ASRU) and its inspectorate that make sure the guidance is being followed and the regulations are not being broken.
As of January 2021 the UK has officially left the European Union. As a result of this most legislation as has been transposed from the EU back into domestic UK law. As a result of this the UK is now operating under the following regulations and regulating bodies.
In the US it is the Animal Welfare Act which sets the minimum standards of care and treatment for animals used in research. This was first enacted into public law in 1966 and was then known as the Laboratory Animal Welfare Act. An amendment in 1970 changed the name to the current one and broadened the scope of the regulation to include animals used in exhibitions or the wholesale pet trade. It has been strengthened and broadened several times by further amendments since then. The US Department of Agriculture (USDA) enforces the Animal Welfare Act through the Animal Care Programme of the Animal and Plant Health Inspection Service (APHIS).
As with European law the Act lays down:
However, the US situation is much less restrictive and there are some important differences. The starkest of these is the exclusion of birds, rats (of the genus Rattus), mice (of the genus Mus), fish, and amphibians and reptiles from the definition of ‘animal’ and as such they are not protected by the Act. According to the Humane Society of the United States (HSUS) this means that approximately 95% of the animals used for research in the US aren’t afforded even the minimal protections of the Animal Welfare Act. A second difference is that the IACUC (Institutional Animal Care and Use Committee) is the body responsible for ensuring compliance with AWA and for providing documentation of all areas of that compliance to APHIS, so compliance is measured internally.
On the question of cosmetics, the law does not require or ban animal tests on cosmetics or their ingredients, but a bill, the Humane Cosmetics Act HR 2858, is currently (November 2015) going through the US legislature, led by Representative Martha McSally of Arizona. The bill would require all animal-based cosmetics tests to be phased out within a year of its adoption. It would prevent: “the internal or external application or exposure of any cosmetic to the skin, eyes, or other body part of a live non-human vertebrate for purposes of evaluating the safety or efficacy of a cosmetic.”
Current legislation in Canada requires that all cosmetic products are “safe when used as intended”, but does not specify animal testing. However, the Food and Drugs Act, which covers the subject, does not prohibit animal tests. Now Senator Carolyn Stewart Olsen of New Brunswick has proposed an amendment that would introduce a ban on tests being carried out in Canada, and on the sale of products that have been tested elsewhere. (November 2015)
Brazil has led developments in the 3Rs in Latin America although the first discussions on their implementation did not take place until 2003. Brazil was the host country for the 1st Latin American Congress on Alternative Methods for the Use of Animals in Education, Research and Industry (Congresso Latino Americano de Metodos Alternativos, COLAMA) in November 2012.
The Brazilian National Council for the Control of Animal Experimentation (CONCEA), set up in 2008, is the legal authority responsible for regulating the use of animals in teaching and scientific activities (Brazilian Law 11,794/2008). Among its activities is the establishment of a procedure to introduce validated alternative methods (Normative Resolution RN17/14).
In 2012 Brazil set up the Brazilian Centre for Validation of Alternative Methods (BraCVAM) and The National Network of Alternative Methods (RENAMA). BraCVAM is a partnership between the National Institute of Health Quality Control (INCQS/Fiocruz) and the National Health Surveillance Agency (ANVISA). Two years later BraCVAM recommended 17 validated alternative methods published by the OECD that were accepted by the CONCEA after hearing the Brazilian regulatory agencies. Those replacements must be in place by 2019.
In July 2015, the ANVISA Executive Board decided that all alternative methods recognised by CONCEA will be immediately accepted by ANVISA.
Brazil is the third largest cosmetics market and there have been considerable developments in introducing animal-free testing. ANVISA uses the European definition of a cosmetic (Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity, with a view to exclusively or mainly cleaning them, perfuming them, changing their appearance, protecting them, keeping them in a good condition, or correcting body odors.) but classifies them into two groups according to the likelihood of unwanted effects due to various factors.
Key dates
2003 Brazil adopts the 3R concept.
2008 Creation of the Nacional Council for the Control of Animal Testing CONCEA (Conselho Nacional de Experimentacao Animal)
2012 Brazil enters the OECD MAD Mutual Acceptance of Data for pesticide & chemicals. The Brazilian Centre for Validation of Alternative Methods (BraCVAM) and The National Network of Alternative Methods RENAMA are established.
2013 SBMAlt—the Brazilian society of alternative methods—aims to simplify the process between the BraCVAM, the RENAMA, and the CONCEA.
2014 Animal testing is prohibited in Sao Paulo state for cosmetic products, perfumes, and body hygiene products
In recent years China has undergone a rapid increase in biomedical research and testing. This has led to the building of new research facilities, additional government approved laboratory animal suppliers and the adoption of regulations that incorporate globally accepted principles of lab animal care and use. The scale of animal experimentation in China is massive e.g. in 2006 approximately 16 million animals were used (see Kong and Qin [2010] ) Control of animal experiments involves a complex set of Statutes and Guidelines that cover different aspects of animal use and are enforced at the State, provincial and local level.
The Ministry of Science and Technology (MOST) is the government agency responsible for establishing regulations related to the conduct of science in China. The first specific regulation the Statute on the Administration of Laboratory Animal Use was approved in 1988. Implementation of the Statute is done via provincial laws. In 2006 overarching national regulations were published in the Guidelines on the Humane Treatment of Laboratory Animals. A Provincial Department of Science and Technology (PDST) oversees lab animal use at the provincial Government level and local Administration Offices of Laboratory Animal Use enforce regulations, issue licences as well as conduct inspections. Institutional monitoring is done via Institutional Animal Care and Use Committees (IACUCs).
There are some parallels with the UK system in terms of licensing. The Chinese rules require breeding establishments, establishments where animals are used and individuals to have a licence. However, there is no requirement for a project licence although the IACUC must approve all work before it can commence.
In 2009 a draft Animal Protection Law of the People’s Republic of China was developed, with Chapter 6 focusing on the Legal Protection of Laboratory Animals. This draft has still not been made into law but if it gets passed it includes requirements for the establishment of ethics committees, rules on re-use and release of lab animals and specifically includes articles on the 3Rs.
Cosmetics
In China the State Food and Drug Administration requires animal toxicity (safety) test reports before it will license new cosmetics. They place cosmetics into two groups:
In recent years safety concerns have led to many ordinary cosmetics being re-categorised as special cosmetics. However, the cosmetics regulations have been under review which has led to some improvements. From June 2014, companies manufacturing “ordinary” cosmetics inside China will no longer be required to provide samples of new products to the government to be animal-tested. Instead, they will be given the option to conduct their own product risk assessment using ingredient safety data, including the possibility to rely on the results of non-animal test methods, provided the test methods are deemed scientifically valid by the European Union. However, cosmetics produced outside China and special cosmetics will still need to be tested on animals. See the Be Cruelty Free Website for further information.
Further Information:
Kong Q and Qin C (2010) Laboratory Animal Science in China: Current status and potential for the adoption of Three Rs alternatives. ATLA 38, 53-69
Bayne K and Wang J (2014) Oversight of animal research in China. In Guillen J (Ed.) Laboratory Animals Regulations and Recommendations for Global Collaborative Research. London: Elsevier.
Be Cruelty Free FAQs about the Chinese cosmetics regulations
In the past Japan has made pledges to raise its standards in animal welfare and environmental protection. In 2014 the European Business Council in Japan called on its government to honour that commitment, including the introduction of validated alternatives to animal testing wherever possible.
Animal use and testing is regulated by the Law for the Humane Treatment and Management of Animals (enacted in 1973). This was amended in 2005 to incorporate the 3Rs principles for laboratory animals but it does not give rules on what type of testing is required. Control of animal experiments is done on an institutional basis rather than nationally. To achieve this the Science Council of Japan issued Guidelines for Proper Conduct of Animal Experiments in 2006. For more information on this ‘self-control’ system please see Shoji (2007)
In terms of testing chemicals Japan has been influenced by other international legislation such as OECD guidelines and the EU REACH legislation. This has led to increasing participation in international efforts to find and validate alternatives to animal tests.
Cosmetics
Japanese law does not require animal based tests on cosmetics, but there is no prohibition either, so individual companies test in whatever way they see fit. The growth of European products in the Japanese market means that customers have been exposed to so-called ‘cruelty free’ products and there is now a growing demand for home produced cosmetics that meet the same standards.
Further information:
Useful Links
AAALAC International Regulations and Resources page: https://www.aaalac.org/resources/internationalregs.cfm
South Korea passed a law in late 2015 requiring the use of non-animal alternative tests for cosmetics with effect from 2018. However, alternative methods must be approved by the Ministry of Food and Drug Safety, so some tests will still take place. Accepted alternatives are tests for skin irritation and eye irritation. So far there are no approved alternatives in South Korea for skin sensitisation, phototoxicity and photosensitisation, repeated dose toxicity, reproductive and developmental toxicity.