Japan Chemical Substance Control Law (Japan CSCL)

Japan

Japan Chemical Substance Control Law (Japan CSCL)

Little Pro on 2015-12-31

The Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (hereinafter the "Chemical Substances Control Law") was firstly enacted in 1973 to prevent environmental pollution by chemical substances that pose a risk to human health or the environment. That latest amendment was made in 2009. Full implementation of amended CSCL started from 1 April 2011.

Main Requirements of Japan CSCL

Japan CSCL controls both new and existing substances. For new substances, a strict pre-manufacture evaluation system is implemented. For existing substances, manufacturers or importers are required to report their quantity and uses annually if the volume of manufacture (M) or importation (I) exceeds certain amount. CSCL also designates substances subject to priority risk assessment and prohibits some substances from M/I.

Regulated Substances under Japan CSCL

The table below summarizes the definitions of different categories of chemicals under CSCL and how they are regulated in Japan.

Category	Definition and Requirement
New Substances	Definition: A substance that is not listed on Japan ENCS; Approval required prior to production/importation;
General Chemical Substances	Definition: All substances other than Priority Assessment Chemicals (PACs), Class I/II Specified Substances, Monitoring Substances and Exempt Substances; Annual report if the volume of M/I is >=1t/y;
Exempt Substances	Definition: Substances that are confirmed to be substances with no concern and announced by authorities; No need of annual report;
Priority Assessment Chemical Substances (PACs)	Definition: Substances prioritized for assessment due to their potential risks of long-term toxicity to human health or the environment; Annual report if the volume of M/I is >=1t/y; Manufacturers and importers may be requested to provide more hazard data.
Monitoring Chemical Substances	Definition: Existing chemical substances that are confirmed to be persistent and highly bio-accumulative(however, long-toxicity is unknown); Annual report if the volume of M/I is >1kg/y; Authority may order manufacturers and importers to investigate long-term toxicity for humans or for predator animals at higher trophic level.
Class II Specified Chemical Substances	Definition: Substances which have a risk of long-term toxicity for humans or environment; Notification of planned M/I quantity prior to M/I and actual amounts after M/I; Government may issue orders to change the planned manufacture and import amounts; Technical guidelines and recommendations will be given for the products containing those substances by cabinet order.
Class I Specified Chemical Substances	Definition: Persistent, highly bio-accumulative (BCF>5,000), and substances which have a risk of long-term toxicity to humans; Prior permission is required for manufacture and/or import (virtually prohibited except essential uses; The import of certain products containing those substances is prohibited;

Download lists from CHRIP.

New Substance Notification under Japan CSCL

A person who intends to manufacture or import a new chemical substance shall notify it to three ministries at least three months prior to the manufacture or importation. The three ministries are the Ministry of Economy, Trade and Industry (METI), the Ministry of Labor and Welfare (MHLW), and the Ministry of the Environment (MOE).

A new substance is defined as a chemical substance other than the following substances:

A substance that is on the list of existing and new chemical substances (ENCS);
Monitoring chemical substances;
Priority assessment chemical substances;
Class I or II specified chemical substance;

Japan ENCS consists of two parts:

Existing chemical substances placed on Japanese market before 16 Oct 1973 (approximately 20,600 substances);
New chemical substances that have been notified under the CSCL, determined to be "safe" and published on government Gazette((approximately 8,000 substances);

Note: Some substances are exempt from new substance notification. A new substance is also subject to notification under ISHL if it is not on ISHL list.

Annual Reporting of General Chemical Substances and PACs

This is a new requirement for manufacturers and importers under amended CSCL. The main purpose of annual reporting is to provide the Japanese government with the information on the volume and uses of existing chemical substances placed on Japanese market. Based on the info received and available knowledge on chemical hazards, the Japanese government may take further regulatory actions against those existing substances by adding them onto different regulatory lists such as the list of priority assessment chemicals or the list of specified chemical substances.

Annual report shall be submitted to the Ministry of Economy, Trade and Industry (METI) between April 1 and June 30. The table blow summarizes required info for annual reporting:

Category	Info Required
General Chemical Substances	Substance identity; Manufacture amount; Import amount; Specific shipment amount for each intended use.
Priority Assessment Chemical Substances	Substance identity; Manufacturing amount in each prefecture; Import amount sorted by the import county/region; Shipment amount sorted by prefecture and by use category (sub use category).

Not all substances are subject to annual reporting. The following substances are exempt from annual report:

Substances in articles or preparations that are sold to general consumers;
Substances that are manufactured and imported with a total amount less than 1t/y;
Substances for testing & research purpose;
Substances that have been confirmed as intermediate, PLCs or low production;
Substances that are announced as exempt due to their low concern(exemption list).

Be Careful with Class I Specified Chemical Substances

When chemical substances are designated as Class I Specified Chemical Substances under CSCL, people who intend to manufacture and import the substances are required to receive permission in advance, and they are prohibited against any use other than permitted uses. In addition, the Government of Japan imposes certain measures on products that use chemical substances designated as Class I Specified Chemical Substances, including an import ban on articles or preparations containing those substances.

Reference & Resources

Click here to access all references and resources for Japan including the English translation of regulations, regulatory lists and useful links to the websites of competent authorities.

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