Japan Designates PFOA isomers and PFOA-related compounds as Class I Specified Substances

SafeGuardSAutomotive, Electrical & Electronics, Hardgoods, Personal and Protective Equipment, Softlines, Toys and Juvenile Products16 Jul 2024

SG 113/24

Japan has added PFOA isomers, their salts and PFOA-related compounds as part of the nation’s management program on Class I Specified Substances. With a few exceptions, many of the provisions in the new cabinet order will apply from January 10, 2025.

On July 10, 2024, Japan issued Cabinet Order No. 244 in the nation’s Official Journal (time limited for free viewing) to amend the nation’s Enforcement Order of the Act on the Examination of Chemical Substances and Regulation of Their Manufacturing, etc. (Cabinet Order No. 202 of 1974) by designating perfluorooctanoic acid (PFOA) isomers or its salts and PFOA-related compounds as Class I Specified Chemical Substances.

Unless authorized/permitted, the manufacture, import and use of a Class I Specified Chemical Substance is, in principle, prohibited, and the import of products containing such a substance is also banned (see SafeGuardS 54/24 for a guidance document in English covering products that cannot be imported if they contain Class I Specified Chemical substances)

Cabinet Order No. 244 contains several important provisions. It:

Expands entry 34 for ‘PFOA or its salts’ to include ‘PFOA isomers’ as Class I Specified Chemical Substances (the phrase ‘PFOA or its salts’ is consistently replaced with ‘PFOA or its isomers, or their salts’ in the regulatory text)

Replaces existing entry 35 (PFHxS, now under entry 36) with PFOA-related compounds as Class I Specified Substances, defined as perfluorooctyl iodide (PFOI), 8:2 fluorotelomer alcohol (8:2 FTOH) and substances that degrade to PFOA as specified by the Ministry of Health, Labor and Welfare (MHLW) and other competent authorities

Prohibits the importation of several categories of products if these contain PFOA-related compounds (see Table 1 below)

Provides the following transitional measures:

8:2 FTOH may be used for the manufacture of invasive and implantable medical devices until December 3, 2025
PFOI may be used in the manufacture of perfluorooctyl bromide (PFOB) for pharmaceutical products until December 31, 2036

PFOA-related compounds may, subject to permission, be used in fire extinguishers, fire extinguishing agents for fire extinguishers and fire extinguishing foams

Substance	Products prohibited from import	Effective date
PFOA-related compounds	Antifoaming agents Clothing treated with oil- or water repellent properties Fabrics treated with oil- or water-repellent properties Fire extinguishers, fire extinguishing agents for fire extinguishers, and fire extinguishing foams Floor coverings treated with oil- or water-repellent properties Floor wax Oil-repellent, water-repellent and antifouling agents and fiber protecting agents Optical fibers or coating agents applied to optical fiber	January 10, 2025

Table 1

With the exception of a few provisions, Cabinet Order No. 244 will become effective on January 10, 2025 – six months after the date of promulgation.

Further information on the amendment can be found on the Ministry of Economy, Trade and Industry website.

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