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 issued the Draft Amendment to the Enforcement Order of the Chemical Substances Control Law (CSCL) and opened a public consultation period from September 16 to October 15, 2025.

Background:

Following the 10th Conference of the Parties to the Stockholm Convention, perfluorohexane sulfonic acid (PFHxS) and related substances were listed for elimination. To meet international obligations, the Pharmaceutical Affairs and Food Sanitation Council (MHLW), Chemical Substances Council (METI), and Central Environment Council (MOE) have proposed designating these substances as Class I Specified Chemical Substances under the CSCL. Accordingly, an amendment to the Enforcement Order is required.

Class I Specified Chemical Substances are identified by government order as persistent, highly bioaccumulative, and posing long-term toxicity risks to humans or top predators. Once designated, the manufacture, import, and use of these substances are generally prohibited, and imports of products containing them are banned.

Key Amendments:

1. Addition of Class I Substances:

a. PFHxS-related substances are added, including compounds containing a (tridecafluorohexyl)sulfonyl group or a [(tridecafluorohexyl)sulfinyl]oxy group (both limited to 6 carbon atoms) that can naturally transform into PFHxS or perfluoroalkane sulfonic acids, as defined by ministry ordinances.

2. Prohibited Import Products:

a. Fabrics, clothing, and carpets treated for water or oil repellency

b. Etching agents for metal processing

c. Etching and anti-reflective agents for semiconductors

d. Surface treatment agents for plating and additives

e. Photoresists for semiconductors

f. Water repellents, oil repellents, and fiber protectants

g. Fire extinguishers and firefighting agents, including foam concentrates

3. Tightening of Exemptions:

a. Removal of the exemption allowing 1,6-dihydroxyhexafluorohexane in certain implantable medical device resins.

4. Transitional Measures:

a. Ministries may issue ordinances before the amendment comes into effect.

b. Penalties for actions before the effective date will follow previous regulations.

Implementation Schedule:

· Official Announcement: Expected around December 2025

· Effective Date: Expected around December 2025

· Full Implementation: Expected by June 2026

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