In 1973, the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (hereinafter “the Act” or “CSCA”) was established in Japan to prevent damages to human health caused by chemical substances. This was triggered by the environmental pollution problems caused by Polychlorinated Biphenyls (PCBs) in the 1960s. The CSCA was the first in the world to mandate premarketing evaluation on new chemicals and regulate manufacture, import and use of chemical substances that have properties similar to PCBs (i.e., being persistent and bioaccumulative and imposing a risk of harming human health).

Then, 1986, CSCA underwent a major revision with the aim to prevent environmental pollution such as underground water contamination with trichloroethylene . In 2003, the Act was amended to introduce a system for evaluation and regulation of chemicals with a focus on the impacts of chemical substances on flora and fauna, as well as to refine the chemicals evaluation and control scheme considering the possibilities of release of chemicals into the environment. In 2009, CSCA was further amended to introduce fully comprehensive control system that covers all chemical substances include existing ones, and to ensure the harmonization with international regulations on chemicals.

Recently, in 2017, CSCA was revised to improve the chemicals evaluation system to more rational one and to control chemicals in a way closely optimized for the real practice. With this revision, environmental pollution caused by chemical substances is expected to be prevented more appropriately.

The purpose of CSCA is to prevent environmental pollution caused by chemical substances that pose a risk of harming human health or interfering with the inhabitation and/or growth of flora and fauna, with the following three pillars:

  • Evaluation and control of new chemicals
  • Continuous control of chemicals that are already put on the market
  • Control of chemicals based on their properties

 

I. Evaluation and control of new chemicals

Chemical substances to be newly manufactured or imported (“new chemical substances”) cannot be manufactured or imported until 1) the substances are notified to designated three ministers (the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment) prior to the start of manufacturing or importing, 2) whether the substance falls under substances regulated under CSCA or not is determined by the three ministers, and 3) the results are notified to the manufacturer/importer.

 

1. New chemical substances that are subject to the mandatory pre-marketing evaluation requirement

New chemical substances are required to be notified, except for those listed below:

(a) Chemical substances that have been determined not to fall under the class I specified chemical substances or equivalent and publicly noticed as such
(b) Class I specified chemical substances, class II specified chemical substances and priority assessment chemical substances
(c) Existing chemical substances
(d) chemical substances subject to type II monitoring and chemical substances subject to type III monitoring under CSCA before the 2009 revision

2. Cases in which notification is not needed

(a) When a person intends to import a new chemical substance from anyone abroad who has already notified the substance to competent authorities in their country and have received a notice that the substance is not subject to regulatory control there.
(b) When a person intends to manufacture or import a new chemical substance for testing and research purposes
(c) When a person intends to manufacture or import a new chemical substance as a reagent
(d) When a person manufactures or imports a new chemical substance that has been confirmed by the three ministers to be intermediates, used in closed systems, or exported only and the manufacture or importation is conducted pursuant to the confirmation.
(e) When a person manufactures or imports a chemical substance that has been confirmed by the three ministers not to pose a risk of causing damage to human health, and the manufacture or importation is conducted pursuant to the confirmation.
(f) When the chemical substance notified is a polymer and has been confirmed by the three ministers to satisfy the criteria for low concern polymers, and the manufacture or importation is conducted pursuant to the confirmation.

3. Evaluation of new chemical substances

The chemical substances notified will be examined by the three ministers according to the following procedure.

(1) Within three months from the date of receipt of the notification (within four months for notifications from foreign countries), the three Ministers evaluate the persistency, bioaccumulation, long-term toxicity to humans and ecotoxicity of the substance notified based on existing knowledge, and determine if the substance falls under any of the followings:

  • Chemical substances that are equivalent to the class I specified chemical substances;
  • Chemical substances that are persistent and suspected of having long-term toxicity to humans (not ecotoxic);
  • Chemical substances that are persistent and ecotoxic (not suspected of having long-term toxicity to humans);
  • Chemical substances that are persistent, suspected of having long-term toxicity to humans, and ecotoxic;
  • Chemicals that do not fall under the any of the above items (i) to (iv); or
  • Chemicals for which it is unclear whether they fall under any of the above items (i) to (v)

The three ministers shall also notify the result of the determination to the person who has given the notification.

(2) When the three ministers have determined that the chemical substance notified falls under the item (vi), they shall make a promptly make a decision on which one of items (i) to (v) the substance falls under, based on the results of tests conducted on the new chemical substance, and notify the result of the determination to the person who has given the notification. The three ministers may request the person who has given the notification to submit results of tests conducted on the new chemical substance, as needed.

(3) When the three ministers have determined that the new chemical substance falls under any of the items (ii) to (iv) and poses a risk of seriously harming human health if taken in continuously or seriously damaging ecosystems if exposed to the environment continuously (hereinafter “specified new chemical substance”), the three ministers should notify the result thereof to the person who has given the notification.

(4) The determination made by the three ministers under the item (1) or (2) above can be summarized as below:

  • Chemical substances that have been determined to fall under item (i) above shall be designated as the class I specified chemical substances by ordinances and accordingly regulated.
  • Chemical substances that have been determined NOT to fall under (i) shall be publicly noticed with their names and will not be treated as new chemical substances in the future. If a substance has been determined to be a specified new chemical substance as set forth in item (3) above, the fact that it has been determined to be a specified new chemical substance will also be publicly announced. After a public notice is issued, they will be treated as specified general chemical substances.

4. Special rules for evaluation of low volume new chemical substances

For new chemical substances with a planned quantity to be manufactured or imported of less than 10 tons, notification is still required but they are allowed to be manufactured and imported without undergoing toxicity testing if: 1) the substances are determined and noticed not to be bioaccumulative in the premarketing evaluation (i.e., not having possibilities to fall under class I specified chemical substances); 2) the substance undergoes premarketing confirmation and postmarketing monitoring by the three ministers; and 3) the substance will not be discharged into the environment over 10 tons in total.

5. Restriction on manufacture and import of new chemical substances

Any person shall not manufacture or import any new chemical substance that has been notified to the three ministers until the person receives a notice from the ministers.

 

II．Continuous control of chemicals that are already put on the market

Any person who has manufactured or imported general chemical substances (including existing chemical substances) exceeding a certain quantity shall make notification on the quantity manufactured or imported.

Based on the quantities notified, chemical substances for which risk assessment shall be conducted with priority are designated as the priority assessment chemical substances. To effectively collect information needed for conducting the risk assessment of priority assessment chemical substances, rules have been established on notification of quantities manufactured or imported, sharing of chemicals-related information among business operators, study and report of hazardous properties, and report on handling of priority assessment chemical substances. Based on the risk assessment results, they are designated as class II specified chemical substances as needed, and then accordingly regulated.

1. Control measures for general chemical substances

(1) Scope of general chemical substances
General chemical substances are defined as chemical substances that are not priority assessment chemical substances, monitoring chemical substances, class I specified chemical substances or class II specified chemical substances. For general chemical substances, notification of quantities manufactured or imported is mandated.
Additionally, among general chemical substances, those that pose a risk of seriously harming human health if taken continuously or seriously damaging ecosystems if exposed to the environment continuously are defined as “specified general chemical substances.” Persons who handle specified general chemical substances are subject to best endeavors obligation for information provision.

(2) Notification of quantity manufactured
A person who has manufactured or imported 1 or more tons of general chemical substances shall notify the Minister of Economy, Trade and Industry of the quantity manufactured or imported and other related matters every fiscal year. In addition, if a person manufactures or imports a new chemical substance that has undergone premarketing evaluation and of which evaluation result has been noticed, the person must notify the quantity manufactured or imported of the new chemical substance even before the public notice is made.

(3) Best endeavours obligation on provision of information
When a person transfers or provides a specified general chemical substance to another business operator, the person must endeavor to provide information to the other party with regard to the fact that the substance is a specified new chemical substance.

2. Control measures for priority assessment chemical substances

(1) Designation and public notice of priority assessment chemical substances
Chemical substances that are identified as those with higher priority in terms of risk assessment for human health, based on the contents of notifications on general chemical substances and other available knowledge, are designated as “priority assessment chemical substances” and their names are publicly noticed.

(2) Notification of quantity to be manufactured or imported
A person who has manufactured or imported 1 or more tons of priority assessment chemical substances shall notify the Minister of Economy, Trade and Industry of the quantity manufactured or imported and other related matters every fiscal year.

(3) Instruction on study of hazardous properties
The three ministers may request persons who manufacture or import priority assessment chemical substances to submit results of toxicity testing (bacterial reverse mutation tests, repeated dose 28-day toxicity studies, etc.) or other relevant information. When the three ministers have determined, based on the results of the toxicity tests and other knowledge, that the priority assessment chemical substance has a toxicity equivalent to class II specified chemical substances, the ministers may instruct the business operator to conduct a long-term toxicity study on the substance and to report the results thereof. As a result of the toxicity study instructed, the substance may be designated as a class II specified chemical substance as needed.

(4) Best endeavours obligation on provision of information
When a person transfers or provides a priority assessment chemical substance to another business operator, the person must endeavor to provide information to the other party on the fact that the substance to be transferred or provided is a priority assessment chemical substance.

 

III. Control of chemical substances based on their properties

The CSCA controls chemical substances by classifying them into two groups according to their properties (i.e., persistency, bioaccumulation and long-term toxicity to human health) and the current accumulation in the environment. The control measures for these two groups cover not only new chemical substances, but also existing chemical substances if any concerned properties are found in safety testing.

1. Control of class I specified chemical substances

Chemical substances with three properties similar to PCBs, namely persistency, high bioaccumulation, and long-term toxicity, are designated as the class I specified chemical substances and strictly regulated. Manufacture and importation of the class I specified chemical substances are not allowed without permission and allowed only for specified purposes. Among existing chemical substances, there are ones of which persistent and highly bioaccumulative propertied are known but of which long-term toxicity is unknown. The Act designated such chemical substances as “monitoring chemical substances,” for which the quantities manufactured and imported are monitored, and in some cases, instructions are given to investigate whether or not they have long-term toxicity. If it has been confirmed that they have long-term toxicity, they will be promptly designated as class I specified chemical substances.

2. Control of class II specified chemical substances

Among chemical substances that are not highly bioaccumulative but have long-term toxicity, ones that have remained or are expected to remain in the environment over considerable extensive areas are designated as class II specified chemical substances, for which the planned quantity to be manufactured or imported must be notified. Depending on the status of environmental pollution, the authority may order the manufacturer/importer to change the planned quantities already notified.