China

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 Statue 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 licenses 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 license. However, there is no requirement for a project license 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 Three Rs.

 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:

  • Ordinary cosmetics (e.g. hair care, nail care, skin care and perfume) – these tend to be licensed at provincial level often without needing to be tested on animals
  • Special cosmetics (e.g. hair growth, hair colour, hair removal and sun block) – these require State registration which includes animal tests for eye and skin irritation.

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.

Animal Protection Law Draft

Be Cruelty Free FAQs about the Chinese cosmetics regulations

Japan

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 on 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 Three Rs 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

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.

Back to the Legislation page