Registration of Chemicals in Japan
There is no harmonised registration regime for existing chemical substances in Japan. All commercially available substances are included in the METI list and have individually assigned numbers (METI numbers). Accordingly, listed substances can be directly imported or produced in Japan without prior registration.
If no METI number is provided, chemicals are considered new and have to be registered before they are made available on the Japanese market. Three authorities (METI, MHLW, MOE)1 share the responsibility for new chemicals registration.
Japanese regulations for new chemicals registration are quite unique due to their high emphasis on environmental safety. The CSCL (Chemical Substances Control Law) focuses on the prevention of environmental pollution and its impact on human health, fauna, and flora, while the ISHL (Industrial Safety and Health Law) secures the workplace health and safety. The key endpoint for new chemical registration is ready biodegradation. Substances having successfully passed the MITI test (OECD 301f) as readily biodegradable can be directly notified. For not readily biodegradable substances, the regulation requires applicants to identify and quantify transformation products as well as conduct a bioaccumulation and partition coefficient tests. Depending on the outcome of these tests, further toxicity and ecotoxicity tests may be required.
1 Involved Authorities: METI, MHLW, MOE
Together with our Japanese colleagues, SCC guides your chemicals to successful notification. In cooperation with experienced Japanese or EU laboratories, we set up the best suited testing strategy for your chemicals and prepare the submission in direct contact with authorities in Japan.
Our services include:
- Data gap analysis
- Developing testing and notification strategies
- Preparing & submitting notifications
- Communication with the authorities
Do you have any questions or want to learn how we can help you notify your chemicals in Japan? - Please contact us.