What changed
In May 2026, Japan announced an amendment to the Enforcement Order of the Chemical Substances Control Law (CSCL), adding long-chain perfluorocarboxylic acids (LC-PFCA), their salts and related substances, as well as medium-chain chlorinated paraffins (MCCP), to the list of Class I Specified Chemical Substances.
Timing: The new substance designations and related import restrictions take full effect on 22 November 2026.
1. MCCP and LC-PFCA move into Class I Specified Chemical Substance control
Class I Specified Chemical Substances are subject to very strict control in Japan. Manufacture and import are, in principle, prohibited unless specifically allowed, and use is also restricted.
2. Not every product containing these substances becomes import-banned
Japan also added specific product categories to the import-ban list. For LC-PFCA, examples include lubricating oils, water/oil repellent treated fabrics, coatings and adhesives. For MCCP, examples include lubricating oils, cutting oils, hydraulic oils, flame-retardant additives, plasticisers, coatings and adhesives. Medical devices are not included in the newly added product list.
3. Medical devices sit under a separate legal interface
Article 55 of the CSCL provides a carve-out interface for products governed by other laws, including PMD Act-defined medical devices. As a result, the relevant CSCL provisions do not apply directly in the same way to those medical devices. That means companies should not jump straight from “MCCP or LC-PFCA is now Class I” to “medical devices containing them become import-banned from November.”
What to check now
For Japan medical device projects, the first step is to confirm the boundaries clearly:
Product identity
Are the relevant products, accessories or consumables all PMD Act-defined medical devices? Do not assume that everything sold together with a device automatically falls into the same legal bucket.
Separately imported materials
Could MCCP or LC-PFCA appear in separately imported lubricants, cutting oils, coatings, adhesives or sealing materials rather than only in the finished medical device?
Supplier changes
If suppliers change materials because of PFAS or POPs requirements in other markets, can the current change-control process detect any knock-on effects for Japan products?
Sometimes the most useful outcome from a regulatory update is confirming whether action is needed at all. For Japan medical device projects, first separate product identity from substance-use scenarios, then decide whether further assessment is necessary. A new Class I listing does not automatically turn a medical device into an import-banned product.
Sources
- Primary official sourceCabinet Decision on the Order Partially Amending the Enforcement Order of the Chemical Substances Control Law (opens in a new tab)Japan Ministry of Health, Labour and Welfare
- Supporting sourceChemical Substances Control Law — Article 55 (opens in a new tab)Japan Ministry of Health, Labour and Welfare
- Supporting sourceComparison Table for the Order Partially Amending the Enforcement Order of the Chemical Substances Control Law (opens in a new tab)Japan Ministry of Health, Labour and Welfare