Revision of  the Order for Enforcement of the Act on the Regulation of 
Manufacture and Evaluation of Chemical Substances   
                                                                         
April  2024 
 
Office of Chemical Safety,  
Pharmaceutical  Safety  Bureau, 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  9th Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants 
(from April to May 2019), a decision  was made  to add Perfluorooctanoic acid (PFOA) , its salts and 
PFOA related compounds  to its scope for elimination . 
In response to this, in December 2023 and January 2024 , the Pharmaceutical Affairs and Food 
Sanitation Council of the Ministry of Health, Labor and Welfare, the Chemical Substances Council 
of the Ministry of Economy, Trade and Industry, and the Central Environment Council of the Ministry 
of the Environment , decided  to designate  PFOA isomers or the ir salts and PFOA related compounds 
shown in Table 1  as Class I Specified Chemical Substances1 as stipulated in  the Act on the Regulation 
of Manufacture and Evaluation of Chemical Substances . For this reason, the Act will additionally 
designate PFOA isomers or the ir salts and PFOA related compounds  to prohibit the manufacture , 
import and use  (excludes some uses in Table 2 that are difficult to replace)  of these chemical 
substances, and the impo rt of products  in which  PFOA isomers or the ir salts and PFOA related 
compounds  are used in Table 3 .  
 
Table 1. Chemical Substance s to be designated as Class I  Specified Chemical Substance s under 
the Act on the Regulation of Manufacture and Evaluation of Chemical Substances   
Perfluoro  alkanoic acid (limited to those with a branched structure and 8 carbon atoms) or their 
salts 
PFOA related compounds  
(1) 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8 -heptadecafluoro -8-iodooctane (also known as 
perfluorooctyl iodide . Hereafter referred to as perfluorooctyl iodide ) 
(2) 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10 -heptadecafluorodecan -1-ol (also known as 8:2 
fluorotelomer alcohol . Hereafter referred to as  8:2 fluorotelomer alcohol )  
(3) Compound s designate  by Ordinance of the Ministry of Health, Labor and Welfare, 
Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance of the 
Ministry of the Environment as pentadecafluoroalkyl group s (limited to those with 7 
carbon atoms) directly bonded to a carbon atom, and generate perfluorooctanoic acid or 
perfluoro  alkanoic acid due to a chemical change due to natural action  
 
 
 
 
 
1 The list of Class I Specified Chemical Substances covers chemical substances designated under the order of enforcement that a re 
persistent, highly bioaccumulative, and have the potential for long -term toxicity to humans or long -term toxicity to predatory a nimals 
at a higher trophic level. Once designated as a Class I Specified Chemical Substance, their manufacture, import, and use are 
prohibited in principle, and the import of products that use Class I Specified Chemical Substances designated under the orde r of 
enforcement is also prohibited.  Table 2. PFOA related compounds  that are allowed to be used for a certain period of time and their 
uses 
period of time  Class I  Specified Chemical 
Substance s uses 
December 3,2025  8:2 fluorotelomer alcohol  manufacture of invasive and  
implantable medical devices  
December 31,2036  perfluorooctyl iodide  the production of perfluorooctyl 
bromide for the purpose of 
producing pharmaceutical 
products  
 
Table 3. Products to be banned as import s, in which  PFOA isomers or the ir salts and PFOA 
related compounds  are used 
PFOA isomers or the ir salts  Water -resistant paper and oil -resistant paper   
Water -repellent textiles and oil -repellent textiles   
Cleaning agents   
Anti-reflection agents used in the manufacture of 
semiconductors   
Paints and varnish   
Water repellent and oil repellent   
Adhesives and sealing fillers   
Fire extinguishers, fire -extinguishing agents, and fire -
extinguishing foam   
Toners   
Water -resistant clothes and oil - resistant clothes   
Water -repellent floor coverings and oil -repellent floor coverings   
Floor waxes   
Photographic paper  
PFOA related compounds  Water -repellent textiles and oil -repellent textiles   
Antifoaming agent s  
Water repellent , oil repellent , antifouling agent  and fiber 
protectant  
Optical fiber or its surface coating agents   
Fire extinguishers, fire-extinguishing agents, and fire -
extinguishing foam   
Water -resistant clothes and oil - resistant clothes   
Water -repellent floor coverings and oil -repellent floor coverings   
Floor waxes  
 
2. Purpose  
 In order to  prevent environmental pollution by chemical substances that could pose a risk of 
impairing human health or of interfering with the population and/or growth of flora and fauna.  
 
3. The expected date of enforcement  
The r evision of the Order of Enforcement  of Act on the Regulation of Manufacture and Evaluation 
of Chemical Substances  will enter into force around  August 2024 for designation of PFOA isomers 
or the ir salts as Class I  Specified Chemical Substances , and  around  December  2024  for designation 
of PFOA related compounds  as Class I  Specified Chemical Substances  and the addition of products 
to be prohibited from being import ed, in which PFOA isomers or the ir salts and PFOA related 
compounds  are used .