Japanese government opened a public consultation on proposed regulatory measures targeting perfluorohexane sulfonic acid (PFHxS) and its structurally related compounds under the Chemical Substances Control Law (CSCL).
The move is part of Japan’s effort to align with obligations under the Stockholm Convention and responds to growing global momentum to restrict persistent per- and polyfluoroalkyl substances (PFAS).
📜 Background & Rationale
• In June 2022, PFHxS was listed for global elimination during the 10th Conference of the Parties (COP10) to the Stockholm Convention.
• Japan seeks to harmonize domestic law by updating the Enforcement Order of the CSCL.
• The Ministries of Health, Labour and Welfare (MHLW), Economy, Trade and Industry (METI), and the Environment (MoE) jointly released the draft Cabinet Order.
• Designation of PFHxS and related substances as Class I Specified Chemical Substances will trigger strict controls, including bans on manufacture, import, and use.
Japan has already implemented import restrictions since December 2023 (Cabinet Order No. 343), and this proposal further expands those controls.
📑 Key Provisions of the Draft Proposal
1. Expanded Definition: PFHxS-Related Substances
• The regulation extends beyond PFHxS to cover compounds with a (tridecafluorohexyl) sulfonyl or [(tridecafluorohexyl) sulfinyl]oxy group.
• These compounds can degrade into PFHxS or similar chemicals and would now be fully regulated.
2. Prohibition on Manufacture, Import, and Use
• All manufacture, import, and use will be banned, except for narrowly defined research or testing exemptions.
• Products containing PFHxS-related substances will also be banned from import.
3. Import Bans on Specific Product Categories
• Affected product categories include:
o Water/oil-repellent fabrics, clothing, carpets
o Semiconductor etching and anti-reflective agents
o Surface plating agents and photoresists
o Firefighting foams and foam concentrates
4. Removal of Exemptions
• The draft removes:
o The exemption for 1,6-dihydroxyhexafluorohexane in implantable medical devices.
o The “difficult-to-substitute” status of 8:2 fluorotelomer alcohol, eliminating previous loopholes.
5. Transitional Measures and Technical Standards
• Transitional provisions will help industries adapt before enforcement.
• Ministries will define labeling rules, technical standards, and penalty regimes for violations.
📆 Timeline & Consultation Process
• Final Order Promulgation: Expected by December 2025
• Partial Enforcement: Begins December 2025
• Full Enforcement: Expected by June 2026
🔍 Impacts and Industry Considerations
⚙️ Supply Chain & Compliance
• Manufacturers in textiles, electronics, semiconductors, firefighting must reassess formulations. • Companies face auditing, labeling, and substitution costs.
❌ Loss of Exemptions
• Narrowing of carveouts will accelerate demand for PFAS-free alternatives.
🌍 Global Trade Impact
• Exporters to Japan (from US, EU, China, Korea, India) must ensure compliance to avoid import bans.
🏛️ Regulatory Certainty
• Ministries may define permitting systems for specific uses, but final frameworks remain to be seen.
Japan's 2025 draft regulation marks a significant escalation in chemical control policy, aimed at eliminating PFHxS and related PFAS under domestic law. The proposal reflects a commitment to public health, environmental protection, and international treaty compliance.
Industries must now engage in the public comment process, inventory chemical usage, explore alternatives, and brace for a regulatory environment with minimal tolerance for delay or non-compliance.
Reference: e-GOV Public Comment Portal
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