The Act on the Evaluation of Chemical Substance and Regulation of Their Manufacture, known as the Chemical Substance Control Law (CSCL), was enacted in 1973. CSCL was revised by the Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW), and the Ministry of the Environment (MOE). The current version of CSCL is published on March 19, 2018.
The "List of Existing and New Chemical Substances" (ENCS) consists of chemicals produced, imported, or used in Japan. New chemical substances refer to chemicals approved by competent authorities after August 20, 1974. Substances listed in the ENCS will be assigned a MITI number, while chemicals not listed in the ENCS are considered as new substances which are required to be notified before its manufacture or import.
| Notification Type | Tonnage | Data Requirement |
| Standard notification | None |
|
| Low tonnage confirmation | 10 t/y (Emission in Japan) |
|
| Small amount confirmation | 1 t/y (Emissions in Japan) | No specific data requirements |
| Intermediates | None | No specific data requirements. However, companies are required to take measures to prevent environment pollution, which can be inspected by the Japanese government. |
| Substances for export only | None | No specific data requirements. However, companies are required to take measures to prevent environment pollution, which can be inspected by the Japanese government. |
| Closed system | None | No specific data requirements. However, companies are required to take measures to prevent environment pollution, which can be inspected by the Japanese government. |
| Polymers of low concern (PLC) | None | Molecular weight, solubility, stability report |
a) Specific data requirements for new substance declaration
| Evaluation Points | Related Test | OECD TG |
| Biodegradation | Biodegradation test | TG301 |
| Bioaccumulation | Partition coefficient test | TG107, TG117 |
| BCF test (if Log Pow>3.5) | TG305 | |
| Toxicity | Ames test | TG471 |
| Chromosomal aberration test | TG473 | |
| 28 days repeated dose toxicity test | TG407 | |
| Eco-toxicity | Acute fish toxicity test | TG203 |
| Acute daphnia immobilization test | TG202 | |
| Algae growth inhibition test | TG201 |
Note: If the Bioconcentration Factor (BCF) of a substance equals to above 5000, or if the BCF falls within the range of 1000-5000, the following test data are required to be provided after being identified to be risky: chronic toxicity test, reproductive toxicity test, teratogenicity, mutagenicity, combined tests, tests on avian reproductivity, tests on algae growth, and tests on daphnia reproductivity.
If a company produces or imports existing chemical substances in quantities exceeding 1 t/y, the company is required to submit an annual report to the Japan Ministry of Economy, Trade and Industry (METI) between April 1 and June 30 each year. The annual report should include information about the company identifier, substance identifier (CHRIP database information), its intended use in polymers, quantities produced or imported, transportation quantities, and quantities for other intended uses.
Existing chemical substances are required to provide the following information:
Substances can be exempted from annual report submission in the following circumstances:
PACs refer to substances whose long-term toxicity to humans or to flora and fauna in the human living environment is unclear, that have been found, or are expected to be found, in considerable amounts over a substantially extensive area of the environment. They were therefore published under the Chemical Substances Control Law. Based on their characteristics, these substances are classified into three categories: substances that pose risks to human health, substances that pose risks to ecosystems, and substances that pose risks to both human health and ecosystems.
In accordance with CSCL, companies must submit an annual report by June 30 each year if the annual production/import volume is or above 1t. Importers or manufacturers may be required to provide additional hazard data under the request of authorities, and they are obliged to transmit information to downstream parties/users.
Monitoring Chemical Substances are those with high persistence and bioaccumulation, and long-term toxicity is unknown. For substances listed as monitoring chemicals, companies manufacturing or importing over 1 kg/y must report the production or import quantity in the previous fiscal year. Importers or manufacturers may be required to provide chemical hazard data upon regulatory authority request. When supplying monitoring chemical substances to other entities, companies must make efforts to provide the name and information indicating that the substance is a monitoring chemical.
Class I Specified Chemical Substances refer to substances that are persistent and highly bio-accumulative, and pose a risk of long-term toxicity to humans or predator animals at a higher trophic level. In accordance with CSCL, parties involving chemicals designated as Class I specified chemical substances shall obtain official approval prior to production/import (except when used for experimental research purpose). Any production or import is prohibited without authorization. Intended uses that do not comply with international regulations are prohibited. Import of articles or products containing Class I specified chemical substances specified in the decree is prohibited. Regulatory authorities may recycle these articles from their manufacturers, importers, and users when necessary.
Class II Specified Chemical Substances refer to substances that may pose a risk of long-term toxicity to humans or to flora and fauna in the human living environment, and that have been, or in the near future are reasonably likely to be, found in considerable amounts over a substantially extensive area of the environment. In accordance with CSCL, manufacturers/importers/importers of products made of chemicals designated as Class II Specified Chemical Substances shall submit a declaration at least one month in advance if their products containing more than 1kg of Class II specified chemical substances. The quantity to be produced or imported shall be indicated and actual quantity shall be reported afterwards.
Additionally, for each fiscal year, a report must be submitted to METI regarding the manufacturing or import quantities of each Class II Specified Chemical Substance or products using these substances during the preceding year, along with other items specified by METI.
Entities engaged in Class II Specified Chemical Substances have an obligation to comply with technical guidelines issued by regulatory authorities. Regulatory authorities shall define information to be displayed on containers, packaging, or shipping documents for each Class II Specified Chemical Substance to prevent environmental pollution caused by such substances. This information will be announced. Handlers of Class II Specified Chemical Substances, when transferring or providing these substances, must adhere to relevant regulations of the regulatory authorities and display information as stipulated.
Monitoring Chemical Substances
Class I Specified Chemical Substances
Class II Specified Chemical Substance
