News Details
Japan to revise Enforcement Order for Act on Chemical Substances Regulation
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
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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:
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PFOA isomers or their salts and PFOA related compounds.
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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.
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8:2 fluorotelomer alcohol, used in the manufacture of invasive and implantable medical devices, permitted until 3 December 2025.
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Perfluorooctyl iodide, for the manufacture of pharmaceutical products, permitted until 31 December 2036.
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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.
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Products containing PFOA isomers or their salts |
Products containing PFOA related compounds |
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1. Water-resistant paper and oil-resistant paper 2. Water-repellent textiles and oil-repellent textiles 3. Cleaning agents 4. Anti-reflection agents used in the manufacture of semiconductors 5. Paints and varnish 6. Water repellent and oil repellent 7. Adhesives and sealing fillers 8. Fire extinguishers, fire-extinguishing agents, and fire-extinguishing foam 9. Toners 10. Water-resistant clothes and oil- resistant clothes 11. Water-repellent floor coverings and oil-repellent floor coverings 12. Floor waxes 13. Photographic paper |
1. Water-repellent textiles and oil-repellent textiles 2. Antifoaming agents 3. Water repellent, oil repellent, antifouling agent and fiber protectant 4. Optical fiber or its surface coating agents 5. Fire extinguishers, fire-extinguishing agents, and fire-extinguishing foam 6. Water-resistant clothes and oil- resistant clothes 7. Water-repellent floor coverings and oil-repellent floor coverings 8. Floor waxes |
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.
We acknowledge that the above information has been compiled from WTO.
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