Registration of chemicals with CSCL and IHSL

Unlike under REACH in the EU, there is no registration regime for existing chemical substances in Japan. Registrants, however, need to verify that their substance matches an entry on the METI list. If the substance has already a METI number, it is an existing substance and no registration is needed before import into or production in Japan.

New chemicals, i.e. those not included in the METI list, need to be registered before they can be made available on the Japanese market. Three authorities (METI, MHLW, MOE)1 share the responsibility registering new chemicals. While CSCL (Chemical Substances Control Law) focuses on the prevention of environmental pollution and its impact on human health, fauna, and flora, ISHL (Industrial Safety and Health Law) secures the workplace health and safety.

The regulations for the registration of new chemicals in Japan are quite unique in so far as they put high emphasis on environmental safety. The key endpoint is ready biodegradation. Substances that have successfully passed the MITI test (OECD 301f) as readily biodegradable can directly proceed to notification. For substances, which are found not to be readily biodegradable, the regulation mandates that transformation products be identified and quantified and studies performed on bioaccumulation (bioaccumulation test / partition coefficient test). This can turn out to be a scientific challenge and a financial hurdle. Depending on the outcome of these tests, further toxicity and ecotoxicity tests may be required.

In collaboration with our Japanese colleagues SCC guides your way 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.

1 Involved Authorities: METI, MHLW, MOE

METI: Ministry of Economy, Trade and Industry

MHLW: Ministry of Health, Labour and Welfare

MOE: Ministry of Environment