Revision of the Order for Enforcement  of the Act on the Regulation of 
Manufacture and Evaluation of C hemical Substances, Etc.  
          
September 2023 
 
Office of Chemical Safety, Pharmaceutical Safety Health Burea u, Ministry of Health, Labour and 
Welfare 
Chemical Safety Office, 
Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry 
Chemicals Evaluation Office, Environmental Health Department , Ministry of the Environment 
 
 
1. Background  
At the 10th Conference of the Pa rties to the Stockholm Convention on Persistent Organic Pollutants 
(June 2022), a decision was made to add perfluorohexane sulfonic acid  (PFHxS), its salts and PFHxS-
related compounds to its scope for elimination. 
In response to this, in November 2022, the Phar maceutical Affairs and Food Sanitation Council of 
the Ministry of Health, Labor and Welfare, the Chemical Substances Counc il of the Ministry of 
Economy, Trade and Industry, and the Central Environment Council of the Ministry of the 
Environment, decided to designa te perfluoro (hexane-1-sulfonic acid) (also known as PFHxS), 
perfluoro (alkane sulfonic acid) (l imited to those with a branched structure and 6 carbon atoms) or 
their salts (hereinafter PFHxS, its isomers or th eir salts) as Class I Specified Chemical Substances1) 
as stipulated in the Act on the Regulation of Manufacture and Eval uation of Chemical Substances.  
For this reason, the Act will additionally designate PFH xS, its isomers, or thei r salts to prohibit the 
manufacture, import and use of these chemical s ubstances, and the import of products in which 
PFHxS, its isomers, or their salts are used.  
Please note that PFHxS-related substances are not in cluded in the content of this revision, as the 
scope of designation under the Act on the Regula tion of Manufacture and Evaluation of Chemical 
Substances is still under review. 
 1) The list of Class I Specified Chemical Substa nces covers chemical su bstances designated under 
the order of enforcement that are persistent, hi ghly bioaccumulative, and have the potential for long-
term toxicity to humans or long-te rm toxicity to predatory animals  at a higher trophic level. Once 
designated as a Class I Specified Chemical Subs tance, their manufacture, import, and use are 
prohibited in principle, and the im port of products that use Class I Specified Chemical Substances 
designated under the order of en forcement is also prohibited. 
 <Chemical Substances to be desi gnated as Class I Specified Che mical Substances under the Act 
on the Regulation of Manufacture and Eval uation of Chemical Substances > 
PFHxS, its isomers o
r their salts 
 
<Products to be banned as im ports, in which PFHxS, its isom ers or their salts are used> 
Wate r-repellent textiles and oil-repellent textiles 
Etching agents used for metal pr ocessing 
Etchants used in the ma nufacture of semiconductors 
Surface treatment agents for plati ng and such preparation additives 
Antireflection agents used in semiconductor manufacturing 
Resists for semiconductor Water repellent, oil repellent and fabric protection agents 
Fire extinguishers, fire-e xtinguishing agents, and fire-extinguishing foam 
Water-repellent clothes and oil-repellent clothes 
Water-repellent floor coverings a nd oil-repellent floor coverings 
 
2. Purpose 
 In order to prevent e nvironmental pollution by chemical subs tances that coul d pose a risk of 
impairing human health or of interfering with the population and/or grow th of flora and fauna. 
 3. The expected date of enforcement 
The revision of the Order of Enforcement of Ac t on the Regulation of Ma nufacture and Evaluation 
of Chemical Substances will enter into for ce around January 2024 for de signation of PFHxS, its 
isomers or their salts as Class I Specified Chemi cal Substances, and around May 2024 for the addition 
of products to be prohibited from being imported, in which PFHxS, its isomers or their salts are used.