Legislation & Regulation
Keep up to date with legislation & regulation across the globe.
In China, animal use in research is regulated nationally by the Ministry of Science and Technology (MOST). In 1988 they produced the Regulations for the Administration of Affairs Concerning Experimental Animals. These regulations included details on:
Under these regulations, a laboratory animal is defined as any animals bred and reared according to relevant standards and intended to be used in experiments or for other scientific purposes. This does not, however, provide much detail on the species that are covered. Also, unlike other countries, these regulations do not define what is classed as a regulated procedure when conducting research. Any research using animals must be licensed, with licensing regulated by MOST, and provincial under Provincial Bureaus of Science and Technology (BOST). Ethical review bodies can be established at different administrative levels, and may belong to a local/regional laboratory animal ethical review board, or an individual institution.
China also set out housing standards for animals used in research under the Laboratory Animals – Requirements of Environment and Housing Facilities 2010. These regulations require that housing is species specific and meets each species needs, in terms of husbandry requirements and behavioural needs.
In 2018, the Guidelines for the Ethical Review of Laboratory Animal Welfare – Peoples Republic of China National Standard, was issued. This is the most recent piece of legislation regarding laboratory animal use in China. It is a comprehensive document outlining the requirements of ethical review and animal welfare management when producing, transporting and using laboratory animals, providing considerable detail on humane endpoints, the 3R’s, the Five Freedoms, review bodies, and training, amongst many other aspects.
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, leading 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 still require animal testing.
The Law for the Humane Treatment and Management of Animals 1973 (also known as the Act on Welfare and Management of Animals), a piece of general animal welfare legislation, also sets out some provisions for the use of animals in scientific research. Article 41 states that consideration should be given to appropriate alternatives in order to reduce the number of animals used, if the same outcome can be attained. Whilst this doesn’t fully imply application of the 3R’s, the 2005 amendment of the act now incorporates the 3R’s principle as a whole. This section also states that methods used throughout the research should minimise pain and distress to the animal, and that humane methods (although no examples provided) should be used to euthanise animals when necessary. The Minister of the Environment has the power to set standards for these methods.
Overall, control of animal experimentation in Japan is done on an institutional basis, rather than being regulated nationally. To achieve this, the Science Council of Japan issued Guidelines for Proper Conduct of Animal Experiments in 2006. These guidelines provide details on the responsibilities of institutions. This includes the formation of Institutional Animal Care and Use Committees, care and management of laboratory animals, animal health, facilities management, inspections, and training, amongst others. The guidelines also state that each institution should formulate voluntary in-house regulations for proper scientific conduct of animal experiments based on the guidelines. These guidelines define ‘laboratory animal’ as any animal of mammalian, avian or reptilian species used within animal experiments. Notably, this excludes any species of fish from protection, as well as species of cephalopod.
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.
Keep up to date with legislation & regulation in the Americas.