Japan Chemical Substances Management System (CSCL/PRTR/OSHA)

Under the Act on the Promotion of Effective Utilization of Resources, this is Japan's chemical management system requiring designated electrical and electronic equipment to indicate the presence of six specified chemical substances (lead, mercury, cadmium, hexavalent chromium, PBB, and PBDE) in accordance with the JIS C 0950 standard, known as J-Moss. Often described as Japan's equivalent of the EU's RoHS Directive, the system is intended both to inform consumers and to promote proper recycling. Products containing any of the substances above the specified threshold must display an orange content mark and disclose details on the manufacturer's website, while products at or below the threshold may optionally display a green mark.

Under Japan's Chemical Substances Control Law (CSCL), this is a post-market management system designed to prevent environmental contamination and health damage caused by chemical substances manufactured or imported domestically. Manufacturers and importers are required to report annually to the national government on the volumes and intended uses of General Chemical Substances, Priority Assessment Chemical Substances, and Monitoring Chemical Substances above certain thresholds, based on the previous fiscal year's activity. The government uses this reported data to estimate environmental releases and to conduct staged safety assessments, including screening evaluations, in order to manage risk.

Following amendments to the Industrial Safety and Health Act, Japan is shifting away from a system of uniform, substance-specific ordinances, such as the Ordinance on Prevention of Hazards Due to Specified Chemical Substances, toward autonomous chemical substance management by businesses. As a core element of this shift, businesses that manufacture or handle chemical substances known to be capable of causing health damage through skin absorption are now fully required to have workers wear impervious protective equipment, including gloves, protective clothing, and safety goggles. The substances covered are broadly those classified under GHS Category 1 for skin or eye irritation or corrosion, or skin absorption, which includes a very large number of substances in everyday use in manufacturing, such as organic solvents, acids and alkalis, and certain metal compounds.

Following a decision at the Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants, Japan is designating the flame retardant Dechlorane Plus and the UV stabilizer UV-328 as Class I Specified Chemical Substances under the Chemical Substances Control Law (CSCL). Once designated, manufacturing and import of these substances will, in principle, be prohibited unless specifically permitted, and the import of products containing them, including automotive parts, electrical and electronic products, and molded resin products, will also be comprehensively banned.

Following amendments to the Order for Enforcement of the Industrial Safety and Health Act and related ministerial ordinances, Japan continues to transition toward an autonomous chemical substance management system. At business sites handling substances subject to risk assessment for which the Minister of Health, Labour and Welfare has established a concentration standard value by public notice, keeping worker exposure levels below that value is a statutory obligation. Following the first phase covering 225 substances that took effect in April 2024, the scope of covered substances is being substantially expanded in stages in April 2025 and April 2026.

The Chemical Substances Control Law (CSCL) is a Japanese law designed to prevent environmental contamination caused by chemical substances before it occurs. Businesses manufacturing or importing a new chemical substance are required to file a prior notification and undergo a pre-market review based on the substance's degradability, bioaccumulation potential, and toxicity. The law applies to substances not listed on the Existing Chemical Substances inventory, and classifies them according to their intended use and volume. The CSCL places significant weight on supply chain-wide risk assessment, and manufacturers and importers are expected to comply with its requirements rigorously.

Class I Specified Chemical Substances under the Chemical Substances Control Law (CSCL) are designated as chemical substances that are persistent, highly bioaccumulative, and have long-term toxicity. To minimize risk to people and the environment, this designation triggers a general prohibition on manufacturing and import, restrictions on use, and a ban on importing products containing the substance. In recent years, additions to this list have become more frequent in response to amendments to the international Stockholm Convention on Persistent Organic Pollutants (POPs), requiring manufacturers and their supply chains to promptly identify covered substances and transition to alternatives.

Under the Chemical Substances Control Law (CSCL), the Japanese government is progressively designating isomers or salts of PFOA (perfluorooctanoic acid) and related substances as Class I Specified Chemical Substances, in response to decisions under the Stockholm Convention on Persistent Organic Pollutants (POPs Convention), prohibiting their manufacture, import, and use in principle. While PFOA itself was already banned, regulation has now expanded to cover "PFOA-related substances" (such as perfluorooctyl iodide) that may degrade into PFOA, requiring significant substitution efforts in fluoropolymer processing, water/oil repellents, and anti-reflective coatings for semiconductors.

Following a decision under the Stockholm Convention (POPs Convention), Japan amended the Enforcement Order of the Chemical Substances Control Law (CSCL) to designate PFHxS (perfluorohexane sulfonic acid) and its salts as Class I Specified Chemical Substances. As a result, manufacturing and import of PFHxS are now prohibited in principle, and imports of designated products containing PFHxS — including fire extinguishers, water/oil-repellent-treated textiles, and anti-reflective coatings for semiconductor manufacturing (10 product categories) — are uniformly banned. Japanese manufacturers must strictly trace PFHxS content across their supply chains and complete substitution measures.

Under the Chemical Substances Control Law (CSCL), a "Class II Specified Chemical Substance" is a substance that, while not bioaccumulative, is poorly degradable and poses a risk of long-term harm to human health or to flora and fauna in the living environment. Designation triggers mandatory notification of planned annual manufacturing and import volumes, requirements to suppress environmental release, and compliance with technical management guidelines — strengthening risk management across the supply chain.

A Monitoring Chemical Substance under the Chemical Substances Control Law (CSCL) is a substance that is persistent and has low bioaccumulation potential, but raises concerns about hazard or environmental persistence. The system is designed to track and manage environmental exposure by requiring businesses to report their manufacturing and import volumes, thereby preventing environmental contamination before it occurs. Businesses subject to the system must report their manufacturing and import volumes annually, and the government uses this data to reassess the safety of the substance, moving it to the Priority Assessment Chemical Substances category or imposing manufacturing restrictions where necessary.

The 2024 amendment to the Chemical Substances Control Law (CSCL) is aimed at strengthening controls on hazardous substances such as PFAS (per- and polyfluoroalkyl substances) and responding more quickly to international trends in chemical substance management. The amendment enhances the notification and review process for new chemical substances manufactured or imported into Japan, and revises the criteria used to select substances for ongoing screening and risk assessment among existing chemical substances. The framework requires stricter emission controls and data management across the chemical industry and its supply chains.

Under the Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (the PRTR Act), the PRTR system requires businesses to calculate and self-report, once a year, the volume of designated chemical substances they release into the environment (air, water, and soil) and transfer as waste. The aggregated data is published, promoting voluntary management improvements by businesses aimed at reducing the environmental risk of chemical substances, and increasing public understanding.

Under three laws, the Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (Chemical Substance Control Promotion Act), the Industrial Safety and Health Act, and the Poisonous and Deleterious Substances Control Act, businesses are required to communicate the hazard information of chemical substances through safety data sheets (SDS) and product labels. The transitional measures for fully migrating to the Japanese Industrial Standard JIS Z 7253:2019 (aligned with GHS Revision 6) end on May 24, 2025. After the transition period ends, SDS and labels based on the previous JIS standard (such as JIS Z 7253:2012) may no longer be used, requiring every company across the supply chain that manufactures, sells, or distributes products containing covered chemical substances within Japan to update their labeling and information provision to meet the latest JIS requirements.

This is a safety management requirement covering trace impurities, byproduct aromatic amines such as ortho-anisidine, found in azo pigments including the organic pigment Pigment Yellow 74 (PY74). Under the Ministry of Health, Labour and Welfare's Act on Control of Household Products Containing Harmful Substances, limits are set on the leaching of specified aromatic amines known to be carcinogenic, and industry bodies such as the Japan Chemical Industry Association have established voluntary standards for safe use in printing inks, paints, stationery, and textiles.

Following amendments to the Order for Enforcement of the Industrial Safety and Health Act and related ministerial ordinances, Japan is moving away from uniform regulation under individual laws, such as the Ordinance on Prevention of Hazards Due to Specified Chemical Substances, toward a system of autonomous chemical substance management. Under this system, businesses are required to conduct their own risk assessments based on hazard information and to determine and implement exposure prevention measures. Key obligations include the mandatory appointment of a chemical substance manager and a protective equipment management officer at every business site handling substances subject to risk assessment; a substantial expansion in the number of substances subject to mandatory SDS provision, from around 900 to approximately 2,900 by 2026; the introduction of concentration standard values, such as an eight-hour time-weighted average, that must not be exceeded; and management obligations around the selection and use of protective equipment, including appointment of a protective equipment management officer.

Regulation of Class II Specified Chemical Substances under the CSCL targets substances that are poorly degradable and toxic to humans or to flora and fauna in the living environment, despite low bioaccumulation potential — aiming to prevent environmental contamination and health damage before it occurs. Businesses handling designated substances are legally required to pre-notify manufacturing and import volumes, comply with technical guidelines, and maintain facilities to control environmental emissions.

The Poisonous and Deleterious Substances Control Act is a law aimed at preventing harm to public health caused by highly acute-toxic chemical substances, classified as poisonous or deleterious substances, from a public health perspective. It establishes registration and notification requirements for the manufacture, import, sale, and use or storage of these substances at designated business sites, along with accident-prevention standards covering theft and loss prevention, labeling, and spill prevention.

Priority Assessment Chemical Substances under the Chemical Substances Control Law (CSCL) are substances manufactured or imported in large volumes that are judged to pose a relatively high risk to human health or the environment. This framework provides for ongoing safety evaluation and monitoring of existing chemical substances. In recent years, the scope of designated substances has expanded and evaluation methods have become more sophisticated; businesses are required to identify applicable substances, report manufacturing/import volumes, and submit hazard information as needed. Compliance checked against the latest official notifications is essential to ensure transparency and risk management across the supply chain.

Following amendments to the Order for Enforcement of the Industrial Safety and Health Act and related ministerial ordinances, aimed at preventing occupational illness caused by chemical substances, the number of substances subject to mandatory provision of a safety data sheet (SDS), container and packaging labeling, and risk assessment is being expanded in stages, from approximately 900 substances to approximately 2,900 substances. Following the first phase in April 2024, which added 234 substances, a second phase takes effect on April 1, 2025, and a third phase on April 1, 2026, bringing a broad range of industrial chemicals, intermediates, and mixtures distributed and used in Japan within the scope of regulation.