On September 16, 2025, Japan's Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE) jointly released the Draft Amendment to the Enforcement Order of the Chemical Substances Control Law (CSCL) and initiated a public consultation period running from the same day until October 15, 2025.
Background
Following a decision at the 10th Conference of the Parties to the Stockholm Convention, perfluorohexane sulfonic acid (PFHxS) and its related substances have been listed for elimination. To fulfill its international obligations, the Pharmaceutical Affairs and Food Sanitation Council of MHLW, the Chemical Substances Council of METI, and the Central Environment Council of MOE have decided to designate these substances as Class I Specified Chemical Substances under the CSCL. Consequently, a corresponding amendment to the Enforcement Order is required.
Class I Specified Chemical Substances are those designated by government order as being persistent, highly bioaccumulative, and posing a long-term toxicity risk to humans or top predators. Once designated as a Class I Specified Chemical Substance, its manufacture, import, and use are generally prohibited. The import of products containing these substances is also banned.
Key Amendments
- Addition of Class I Specified Chemical Substances
PFHxS-related substances are added as Class I Specified Chemical Substances. PFHxS-related substances refer to compounds containing a (tridecafluorohexyl)sulfonyl group (limited to those with 6 carbon atoms) or a [(tridecafluorohexyl)sulfinyl]oxy group (limited to those with 6 carbon atoms) that can chemically transform via natural processes to yield PFHxS or perfluoroalkane sulfonic acids, as specified by ordinances of the MHLW, METI, and MOE.
- Clarification of Prohibited Import Products
The draft explicitly prohibits the import of the following products containing PFHxS-related substances:
- Fabrics, clothing, and carpets treated for water or oil repellency.
- Etching agents for metal processing.
- Etching agents and anti-reflective agents for semiconductor manufacturing.
- Surface treatment agents for plating and their preparation additives.
- Photoresists for semiconductors.
- Water repellents, oil repellents, and fiber protectants.
- Fire extinguishers and firefighting agents (including foam concentrates) for fire extinguishers.
- Tightening of Existing Exemptions
The exemption allowing the use of 1,6-dihydroxyhexafluorohexane for manufacturing synthetic resin materials used in certain implantable medical devices is deleted.
- Transitional Measures
The draft allows relevant ministries to establish necessary ministerial ordinances before the Amendment Order comes into effect. Penalties for actions occurring before the effective date of the order will be handled according to previous regulations.
Implementation Schedule
Official Announcement: Expected around December 2025
Effective Date: Expected around December 2025
Full Implementation: Expected by June 2026
