SG 81/24
Japan has initiated a one-month consultation over its draft cabinet order to ban several categories of product if they contain PFOA isomers and PFOA-related compounds. The provisions are expected to be enforced from January 2025.
In February 2024, we informed you that Japan was planning to include PFOA isomers and PFOA-related compounds as Class I Specified Chemical Substances (SafeGuardS 28/24).
In April 2024, Japan’s Ministry of Health, Labor and Welfare (MHLW) and other competent authorities announced a draft cabinet order to revise the nation’s Enforcement Order of the Act on the Examination and Regulation of Manufacturing of Chemical Substances (Cabinet Order No. 202, 1974) by designating PFOA isomers 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.
The draft cabinet order contains several important provisions. It:
- Expands the entry for ‘PFOA or its salts’ to include ‘PFOA isomers’ as Class I Specified Chemical Substances. It is important to note that Japan has prohibited the importation of 13 categories of product if these contain PFOA or its salts (entry 18 to Products that cannot be imported if they contain Class I Specified Chemical Substances (in Japanese) or SafeGuardS 54/24 for guidance document in English)
- Adds PFOA-related substances as a Class I Specified Substance, defined as PFOI, 8:2 fluorotelomer alcohol (8:2 FTOH) and substances that degrade to PFOA (limited to those containing a perfluoroheptyl group with the moiety C7F15C)
- Bans the importation of several categories of product if these contain PFOA-related substances (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 PFOB for manufacturing pharmaceutical products until the end of 2036
- PFOA-related compounds may, for the time being, be used in fire extinguishers, fire extinguishing agents for fire extinguishers and fire extinguishing foam
| Substance | Products prohibited from import |
| PFOA-related compounds |
|
Table 1
The cabinet order is planned for publication in July 2024, with the provisions expected to be enforced from January 2025.
Abbreviations
| Abbreviation | Name/Synonym |
| PFOA |
|
| PFOB |
|
| PFOI |
|
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