On 12 April 2024, Japan's Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) formally notified the World Trade Organization (WTO) of the revision of the Order for Enforcement of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (the Act).

Key Revisions to the Act

5. Designation of Class I Specified Chemical Substances: Pursuant to Articles 17 and 22 of the Act, the following substances will now require authorization for manufacture or import:

   • PFOA isomers or their salts and PFOA related compounds.

5. Designation of Permitted Chemical Substances and Uses: Article 25 of the Act allows the use of the following substances for a specified period of time.

   • 8:2 fluorotelomer alcohol, used in the manufacture of invasive and implantable medical devices, permitted until 3 December 2025.

   • Perfluorooctyl iodide, for the manufacture of pharmaceutical products, permitted until 31 December 2036.

5. Prohibition on Import of Products: Under Article 24 of the Act, the import of following products containing PFOA isomers or their salts, and PFOA-related compounds will be prohibited.

Addressing Environmental Concerns: Objective of the Revision

The objective of the revision is to address environmental concerns arising from the non-biodegradability, bioaccumulation potential and chronic toxicity of PFOA isomers or their salts and PFOA-related compounds. The decision is in line with the decisions taken at the Ninth Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants in 2019.

Timeline and Procedure:

Proposed Adoption Date: June 2024.

Proposed Entry into Force: The revised regulations will take effect in two phases. Firstly, the designation of PFOA isomers or their salts is proposed to take effect in August 2024. Subsequently, the designation of PFOA-related compounds and the addition of banned products are scheduled to take effect in December 2024.

Deadline for Comments: Stakeholders have 60 days from the date of notification to provide feedback.

The revision underscores Japan's commitment to environmental protection and public health by regulating hazardous chemical substances and their uses.

In a significant step to protect the environment and public health, Japan's Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environment (MOE) have jointly initiated a consultation on the designation of certain perfluorooctanoic acid (PFOA) isomers, their salts, and PFOA-related compounds as Class I Specified Chemical Substances under the Chemical Substance Control Law (CSCL).

The proposed ban, if enacted, would affect the manufacture, import, and use of these substances throughout Japan. The consultation period commenced on 1 February 2024 and is set to conclude on 1 March 2024.

Details of the proposed ban and classification framework

Under the CSCL framework, chemicals are classified on the basis of their persistence, bioaccumulation, and toxicity upon continued exposure to the environment. The substances targeted in this proposal have been identified as exhibiting characteristics of being persistent, highly bioaccumulative, or toxic to humans over the long term.

Prohibited and exempted substances

Specifically, the proposal seeks to designate the following substances as Class I Specified Chemical Substances:

• Perfluoroalkane acid with a branched structure and eight carbon atoms and its salts.
• PFOA-related compounds including perfluorooctyl iodide, 8:2 fluorotelomer alcohol, and compounds with the pentadecafluoroalkyl group bonded directly to the carbon atom, resulting from natural chemical reactions with PFOA or perfluoroalkane acid with a branched structure and eight carbon atoms.

Highlights of the ban on specific products containing PFOA and PFOA-related compounds are summarized in table below:

Notably, the proposal includes exemptions for two essential uses of PFOA:

• Perfluorooctyl iodide (PFOI) intended for the production of perfluorooctyl bromide (PFOB) for pharmaceutical products.
• 8:2 fluorotelomer alcohol (8:2 FTOH) for the manufacture of invasive and implantable medical devices.

International alignment

Japan’s approach to regulation PFOA will be in line with international limits on PFOA under the UN's Stockholm Convention on Persistent Organic Pollutants (POPs).