Japan Regulatory News

On 4 July 2025, Japan’s Consumer Affairs Agency (CAA) released notice 437 regarding the addition of one chemical to the list of essential monomers which constitutes the base material in the Table 1,...

On 4 July 2025, Japan’s Consumer Affairs Agency (CAA) released notice 437 regarding the addition of one chemical to the list of essential monomers which constitutes the base material in the Table 1, Appendix 1 of the Standards for Food, Additives.  

3-methyl-1,5-pentanediol (CAS no 4457-71-0) has been added to the monomers list and, at the same time, removed from the optional substances list. The CAA started enforcing notice 437 from the date of publication. 

Standards and Criteria for Foods, Food Additives  

Requirements and guidelines for foods, milk and milk products, food additives, equipment, containers and packaging governed by the Food Sanitation Act and other laws are contained in the Standards and Criteria for Foods, Food Additives. The Ministry of Health, Labor and Welfare (MHLW) updates these standards on a regular basis to ensure they remain current and to safeguard the environment and public health. 

Key Insights from the Notice 

• The revision relates to Attachment 12, which governs polymers primarily composed of ester bonds. 

• The monomer “3-Methyl-1,5-pentanediol” has been reclassified: 

• Previously listed under “Optional Substances” 

• Now moved to the category of “Essential Monomers” 

• This change is in response to requests from industry stakeholders. 

Obligations for Stakeholders 

Only entries listed in the positive list (Base materials and Additives) of the Food Contact Materials (FCMs) are allowed to be used. New entities which are not listed must undergo a safety review procedure.  

On 14 July 2025, Japan's National Institute of Technology and Evaluation (NITE) published a list of 186 substances classified in accordance with the Globally Harmonized System for Classification a...

On 14 July 2025, Japan's National Institute of Technology and Evaluation (NITE) published a list of 186 substances classified in accordance with the Globally Harmonized System for Classification and Labelling (GHS) guidelines. NITE released the most recent list for FY 2024 on the portal on behalf of the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Environment (MoE), and the Ministry of Economy, Trade, and Industry (METI), which are in charge of GHS classification in Japan. 

Previous update in June 2024 

NITE previously released the FY 2023 GHS list covering 160 substances on its portal on 21 June 2024. More information can be found here.  

Important Takeaways from the List  

The FY 2024 list includes 43 newly classified substances and 143 substances with updated GHS classification.  It covers classifications from 1 April 2024 to 31 March 2025.  Furthermore, NITE has supplied comprehensive details including:  

• CAS and identification numbers;  

• Classification details;  

• Hazard class;  

• Hazard pictogram;  

• Precautionary and hazard statements;  

• Reference information and   

• Signal word 

Obligations for Companies  

It is recommended that businesses keep consult the latest GHS data when creating labels or Safety Data Sheets (SDSs).  Nevertheless, using the given classification is not mandatory.  Alternative data or test findings that are not covered by the MHLW, MoE and METI may be used by businesses. 

Update: On 30 June 2025, Japan’s Consumer Affairs Agency (CAA) released the promulgated order for new PFOS and PFOA standards for mineral water on the e-GOV Public Comment Portal.      Ori...

Update: On 30 June 2025, Japan’s Consumer Affairs Agency (CAA) released the promulgated order for new PFOS and PFOA standards for mineral water on the e-GOV Public Comment Portal.   

Original Text: 

On 26 February 2025, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) of a proposed revision to water quality standards under the Food Sanitation Act. This revision aims to establish specifications for sterilized or filter sterilized mineral water. At the same time, the CAA published this notice on Japan’s e-GOV Public Comment Portal.  

Background 

According to Article 12 of the Food Sanitation Act 1947, the Prime Minister may allow the sale of specific food additives. However, the Health and Welfare Public Notice No. 370 of 1959 prohibits the sale of food additives unless they comply with the regulations, as set out in Article 13 of the Act.  

The Food Safety Commission of Japan (FSCJ) has reviewed specifications and standards for mineral water and assessing the health effects of synthetic organofluorine chemical compounds, particularly per- and polyfluoroalkyl substances (PFAS), in food. As a result, Japan will establish water quality standards for perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) in sterilized or filter sterilized mineral waters under the Water Supply Act. 

New Standards for Mineral Water  

The following new standards for PFOS and PFAS in mineral water will be established: 

Comment Period and Enforcement Dates 

The 60-day comment period will end on 27 April 2025. The newly established standards are expected to be enforced from 1 April 2026.  

On 30 June 2025, Japan’s Ministry of Economy, Trade and Industry (METI) published its Implementation Report on the Chemical Substances Control Law (CSCL)  for Fiscal Year 2024 (FY2024) on its porta...

On 30 June 2025, Japan’s Ministry of Economy, Trade and Industry (METI) published its Implementation Report on the Chemical Substances Control Law (CSCL)  for Fiscal Year 2024 (FY2024) on its portal. METI releases this report annually to provide an update on the current status. The previous report, covering FY 2023, was released by METI on 21 June 2024. 

Key Insights from the Implementation Report 

1. Overview of the CSCL 

The CSCL aims to prevent environmental pollution caused by chemical substances that may harm human health or ecosystems. It mandates: 

• Pre-market evaluation of new chemical substances. 

• Post-market control through reporting on production/import volumes and toxicity information. 

• Regulatory designation of substances based on characteristics such as persistence, bioaccumulation, and toxicity. 

Substance categories include: 

• Class I Specified Chemical Substances: Most strictly regulated. 

• Class II Specified Chemical Substances: Pose long-term risks. 

• Monitored Chemical Substances: Persistent and bioaccumulative but with unknown toxicity. 

• Priority Assessment Chemical Substances and General Substances: Subject to reporting and potential future regulation. 

2. Notifications and Preliminary Evaluations (FY2024) 

• 319 new chemical notifications were assessed, with most classified as low-risk. 

• Breakdown: 34 substances showed concern for both human and environmental health. 115 were classified as low risk. 

• 1,825 low-volume (≤10 tons/year) new chemical confirmations were submitted.  

• Over 37,000 small-volume (≤1 ton/year) notifications were submitted. 

• Main uses include: Intermediates, electronic materials, paints/coatings, cleaning agents, adhesives and fragrances. 

3. Post-Market Risk Management 

• Annual reporting is required for general and priority chemicals produced or imported at ≥1 ton/year. 

• Risk evaluations are conducted using usage volume, hazard data, and monitoring results. 

• 48 substances have undergone Tier II (advanced) evaluations to date. 

• Based on these assessments, some substances may be designated as Class II Specified Chemicals. 

4. Regulatory Measures Based on Chemical Characteristics 

• Substances such as PFHxS, chlorpyrifos, MCCP, and LC-PFCA are under discussion for designation as Class I Specified Chemicals, in line with international obligations (e.g., Stockholm Convention). 

• The public consultation and regulatory updates are scheduled through FY2025 and early FY2026. 

5. Monitoring and Control Data 

• Production and import data for Monitored Chemicals and Class II Specified Chemicals are tracked annually. 

• Notable reductions have been observed for high-risk substances such as trichloroethylene and tetrachloroethylene. 

• Reported hazards from companies include biodegradability, bioaccumulation, and human/ecotoxicity findings (over 200 reports in FY2024). 

The full report can be found here. 

On 27 June 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) announced the addition of 119 new chemicals to the New Chemicals List under the Industrial Safety and Health Act (ISHA). This u...

On 27 June 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) announced the addition of 119 new chemicals to the New Chemicals List under the Industrial Safety and Health Act (ISHA). This update was announced through an official ISHA Notice published on the same day.   

The new entries, along with their ISHA official gazette serial numbers, chemical names, and structural formulas are available on MHLW's Workplace Safety Portal here.  

Previous addition: 157 New Chemical Substances in March 2025   

This revision follows the addition of 157 new chemicals to the list, as reported in an ISHA notification published on 27 March 2025, via the MHLW Workplace Safety Portal. The update can be found here.  

  
Obligations for Stakeholders   

Currently, the list of chemicals known as the Existing and New Chemical Substances (ENCS) list includes 72,720 entries. According to the Industrial Safety and Health Act, Japanese enterprises that produce or import such compounds must notify the MHLW. In order to safeguard industrial workers' health, the notification must contain the name of the new chemical compound and details of its risk assessment.   

Japan’s Positive List (PL) for food contact materials (FCMs) entered into force on 1 June 2025. On the same day, the Consumer Affairs Agency (CAA) published a manual introducing the positive list on...

Japan’s Positive List (PL) for food contact materials (FCMs) entered into force on 1 June 2025. On the same day, the Consumer Affairs Agency (CAA) published a manual introducing the positive list on its official portal. The PL system regulates synthetic resins used in food-contact utensils and packaging under the Food Sanitation Act. Only materials listed in the official PL may be used, unless they meet certain exemption criteria, such as migration into food below 0.01 ppm or use in non-contact layers that do not affect food safety.

Key Insights from the Manual

1. Legal Basis:

• Article 16: Bans harmful substances in utensils, containers, and packaging (UCP).

• Article 18: Enables the establishment of safety standards and manufacturing criteria.

2. Structure of Standards:

• General Standards: Ban certain harmful substances such as lead and certain dyes.

• Material-specific and Use-specific Standards: Apply to categories such as glass, rubber, and heat-processed materials (e.g. retort pouches).

3. Annex I (Positive List):

• Table 1: Lists 21 categories of approved base polymers.

• Table 2: Includes approximately 840 approved additives, each with usage limits by material class.

4. Scope of Application:

• Covers all synthetic resin layers in UCPs.

• Excludes non-resin materials, surface coatings, and unintended by-products.

5. Procedures for Adding New Substances:

• Inclusion via PL amendment, safety review, or monomer notification update - depending on intended use and risk.

6. Transition Period:

• A 5-year grace period until 1 June 2030.

• Products sold or made before enforcement are considered compliant during this period.

Stakeholder Obligations

• Manufacturers and importers of raw materials and UCPs must provide evidence of PLcompliance.

• Users and distributors must verify and communicate compliance.

• Disclosure of individual substances is not mandatory; documentation such as specification sheets or certificates is sufficient.

The PL system is designed to enhance food safety by systematically controlling materials used in food-contact applications.

On 6 June 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a list of 50 carcinogenic chemicals on the ASEAN-Japan Chemical Safety Database portal. The update was also released o...

On 6 June 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a list of 50 carcinogenic chemicals on the ASEAN-Japan Chemical Safety Database portal. The update was also released on the country’s National Institute of Technology and Evaluation - Chemical Risk Information Platform (NITE-CHRIP) portal.  

Background 

In Japan, carcinogenic substances are subject to strict obligations under the Industrial Safety and Health Act (ISHA), which requires records to be kept for up to 30-years. 

Previous update in December 2022 

Earlier, in December 2022, the MHLW classified 200 chemicals as carcinogenic and started enforcement in a phased manner starting from April 2023. More details can be found here.  

Obligations for Stakeholders 

From 1 April 2027, the following will be mandatory for stakeholders: 

• Mandatory GHS-compliant labelling and provision of Safety Data Sheets (SDS). 

• Risk assessment before use, implementation of exposure control measures, and health monitoring for workers.  

• Employers must conduct regular medical examinations, particularly for substances classified as Group 1 or 2A carcinogens, maintain detailed exposure and health records, and notify authorities when required.  

• Additional regulations, such as the Chemical Substances Control Law (CSCL) and PRTR Law, also apply to environmental reporting and emissions control.