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Chemical Substance
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New Chemical Substance Application in Japan

We provide a variety of services for the application of new chemical substances under the Law Concerning the Examination and Regulation of the Manufacture of Chemical Substances (CSCL) and the Industrial Safety and Health Law (ISHL).

The CSCL requires prior application by the manufacturer and importer (corporate) of new chemical substances to prevent hazards to human health and contamination of the environment by chemical substances.
The ISHL requires prior application by the manufacturer and importer (corporate) of new chemical substances to prevent health hazards to workers.

Business contents

Conduct of studies for application

We can conduct the required studies for the application.

Application work

Total support will be provided, including the preparation of application documents for new chemical substances, and correspondence for inquiries received from the authority.

Consulting

We also cover technical consulting and consultations with the authority for the application, as well as surveys on the state of chemical substance regulations, including application requirements, exemptions for research, and the handling of substances that are difficult to research.

Main category of application

Law Concerning the Examination and Regulation of the Manufacture of Chemical Substances (CSCL)

Type of procedure Volume limit of manufacture or import
Normal No limit
Small Volume 1 ton/year (in Japan)
Low Volume 10 ton/year (in Japan)
Others Intermediate, Closed system, Export only: No limit*
Small Volume Intermediate: less than or equal to 1 ton/year (per company)
Polymer low concern No limit

* Estimated environmental emissions etc. are restricted.

Industrial Safety and Health Law (ISHL)

Type of notification Annual volume of manufacture/import per business place
Application of new chemicals More than 100 kg
Confirmation application to the Minister of health, labor and welfare Non-exposure substance etc. (Application only)
Small Volume Less than or equal to 100 kg (Application only)

Support operation including risk assessment in response to a revision of the CSCL

  • Preparing summaries of the literature on chemical substances with prioritized assessments, USE information, etc.
    Consulting on risk assessments
  • Daphnia magna reproduction tests, fish early-stage life toxicity (ELST) tests, and other tests

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