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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 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.