Trade Information - Policy Information

(2) Overview of the Law

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 substancefs 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 Examination and Regulation of Manufacture of Chemical Substances 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.

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