Japan: Legislation & Animal Welfare Oversight

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Japan: Programs & Policies

Japan: Legislation & Animal Welfare Oversight

Last updated: April 27, 2011

The latest survey conducted by the Japanese Association for Laboratory Animal Science reported “a total of 11,337,334 live laboratory animals were being maintained on June 1, 2009 in Japan.” In a February 2011 presentation, Dr. Ikeda discussed a growing interest in international trends and regulations related to animal testing, but also an insufficient knowledge of international efforts about the 3Rs and alternative methods. He explained this as possibly due to language and informational barriers.

The Law for the Humane Treatment and Management of Animals (enacted in 1973) regulates animal use and testing in Japan. This law was amended in June 2005 (changes came into force June 2006) with key points related to the 3Rs principles of refinement, replacement, and reduction for laboratory animals. The MHLW, MEXT, and MAFF – three governmental ministries which are the regulatory agencies involved in science and technology in Japan, “established new basic guidelines for experimentation performed in their jurisdictional research and testing facilities.” The registration of laboratory animal facilities, training of personnel, and regulatory inspections, however, are still not required. The Guidelines for interpretation of this law are provided by the Science Council of Japan. The Ministry of the Environment also provides guidance for the humane handling of laboratory animals as the Standards Relating to the Care and Management of Laboratory Animals and Relief of Pain and the Ministry of Education Culture, Sport, Science and Technology provides the Fundamental Guidelines for Proper Conduct of Animal Experiments and Related Activities in Academic Research Institutions. These regulations and guidelines are used to establish in-house regulations at each institution conducting animal studies. The Law for the Humane Treatment and Management of Animals is currently being revised again.

JaCVAM was one of the four parties that participated in the 2009 signing of a Memorandum of Cooperation for the International Cooperation on Alternative Test Methods (ICATM). The goal of this international agreement between Japan, the US, the EU, and Canada is to reduce animal use worldwide for toxicity testing by expanding cooperation on the validation and evaluation of new toxicity test methods used in regulatory assessments.

International and regional legislation on chemical safety and testing has also affected Japan. Japan is a member of the OECD, and therefore “accepts” the use of OECD Test Guidelines for regulatory testing purposes. The EU REACH (Registration, Evaluation, Authorisation and Restriction of Chemical substances) legislation has influenced the chemical regulatory systems of Asian countries. Japan and others have had to react to the regulatory gap between EU REACH and their chemical regulation systems.

A Japanese newspaper, the Asahi Shimbun, published an article on the EU ban on the testing of cosmetics and their ingredients on animals.

This May 2009 article outlines the relevant differences between Japan and the EU and US. Some of the highlights include the following:

  • In Japan, “quasi-drugs” such as skin-lightening products, suntan lotion, and hair growth tonics must be tested on animals whenever the manufacturer adds new ingredients.
  • These kinds of products cannot be sold in Japan without animal testing. Yet, if they are manufactured and animal-tested in Japan, these products won’t be marketable in the EU.
  • Japan eased its animal testing requirements somewhat in 2006 when regulations were revised to allow for alternative methods in two of the 12 testing items required when applying for the inclusion of new ingredients in quasi-drugs.
  • In Japan, it normally takes five to ten years to verify the efficacy of new, animal-free tests.
  • In 2005, the Japanese Center for the Validation of Alternative Methods (JaCVAM) was created, but it was given a five-year time limit, and only one full-time staff member.
  • In contrast to the west, where reports must be submitted to the government when constructing animal testing facilities or when conducting such tests, Japan has no legal basis for scrutinizing the type of animal testing being conducted.

Since the publication of the above 2009 article, JaCVAM has endorsed 4 additional alternative methods and is participating in several additional validation studies.

Dr. Sagami provided the following update at a 2011 meeting on the implementation of 3Rs at Japanese pharmaceutical companies. “In Japan, the Japan Pharmaceutical Manufacturers Association (JPMA)…established “the guidance for animal experiments” in January 2005, which can be used as a guide for member companies to establish a company standard for the management of animal experiments. Based on this guidance, each member formulated or revised their company regulations, and promoted appropriate self-management of animal experiments based on the 3Rs, addressing the reduction of animals use, development of alternative methods as well as the refinement of animal experiments such as modification of anesthesia. In June 2006, the revised “Law for the Humane Treatment and Management of Animals” came into effect and “Basic Policies for the Conduct of Animal Experimentation” was notified by the Japanese MHLW. Based on these law and policies, pharmaceutical companies have revised their own internal rules and self-management systems for animal experiments. Today, to increase the transparency of self-management systems, Japanese pharmaceutical companies have started to study external evaluation…for the self-management of animal experiments.”

At the same 2011 meeting, Dr. Kotachi and Dr. Itagaki provided similar updates on the 3Rs activities of the chemical and cosmetic industries, respectively, in Japan. Japanese companies have been actively participating in international efforts and supporting validation studies for alternative test methods.