The Chemical Substances Control Law consists of two components.
- Pre-manufacturing evaluation of new chemical substances
- Monitoring and regulations based on the properties of chemical substances
- Regulations for Class I Specified Chemical Substances and Class II Specified Chemical Substances
- Measures for Type I Monitoring Chemical Substances, Type II Monitoring Chemical Substances, and Type III Monitoring Chemical Substances
Pre-manufacturing Evaluation
Hazard-based assessment is conducted prior to manufacture or import of new chemical
substances. Four subject areas are evaluated: biodegradation, bioaccumulation, long-term
toxicity for human health and the environment.
If a chemical substance is evaluated as not-biodegradable (persistent) and bioaccumulative, chronic
toxicity study, reproductive and developmental toxicity study, teratogenicity
study, bacterial reverse mutation test, in vitro mammalian chromosomal
aberration test, micronucleus test, carcinogenicity study, toxicokinetics
study, pharmacological study and avian reproduction test are required to
identify long-term toxicity for human beings and animals at the top of
the food chain (higher predators).
If a chemical substance is evaluated as not-biodegradable
(persistent) and not-bioaccumulative, repeated does toxicity study,
mutagenicity studies and acute ecotoxicity studies are required to identify potential
of long- term toxicity for human health and the environment.
Monitoring and Regulation
The government designates chemical substances that are identified
as not-biodegradable (persistent), not-bioaccumulative and suspected of
long-term toxicity for human health or the environment as Type II Monitoring
Chemical Substances or Type III Monitoring Chemicals Substances. Manufacturers
and importers of Type II and III Monitoring Chemicals are required to report
the quantities they manufactured and imported.
The government designates existing chemical substances
that are identified as not-biodegradable (persistent) and bioaccumulative as
Type I Monitoring Chemical Substances. Manufacturers and importers of Type I
Monitoring Chemicals are required to report the quantities they manufactured
and imported.
Type I, II and III Monitoring Chemical Substances undergo risk-based management.
If a Type I Monitoring Chemical is identified as having long- term toxicity for human beings and animals at the top of
the food chain (higher predators), the government designates that chemical
substance as Class I Specified Chemical Substances. Permission is required for
manufacture and import Class I Specified Chemical Substances. Import of
articles containing Class I Chemical Substances is restricted. Use of Class I
Chemical Substances is also restricted.
If a Type II and/or III Monitoring Chemical Substances are identified as having risk of hurting human
health and plants and animals in the living environment, the government
designates that chemical substance as Class II Specified Chemical Substances. The
manufacturers and importers of Class II Specified Chemical Substances are
required to report the expected and actual quantity manufactured and imported
and the substancefs intended use. The government may order a reduction of
quantity manufactured or imported if it is necessary to reduce the risk for
human health and plants and animals in the living environment.
Figure 3-1. Overview of the Evaluation and Regulation System under the Law Concerning the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc.
