Japan: METI consults on revision of PAC list for ethyl hydrogen sulphate

Update: On 31 March 2025, based on toxicity assessment data submitted by companies, the ministries decided to revoke the PAC designation of ethyl hydrogen sulphate and reclassify it as a general chemical substance. This update was released on the same day as its publication in the Japan CHEmicals Collaborative Knowledge database (J-CHECK) portal. The reclassification took effect directly on 31 March 2025. With this update, the PAC list now has 221 chemicals. 

Original Text: 

On 18 October 2024, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and Ministry of Environment (MOE) jointly released a notice seeking toxicity information for ethyl hydrogen sulphate and 26 related chemicals. 

Based on the data submitted by the companies, these 27 chemicals will be designated as either Priority Assessment Chemicals (PACs) or General Chemical Substances under the Chemical Substances Control Law (CSCL). The designation will be enforced from the beginning of FY 2025.  

Council Negotiation in January 2024 

In January 2024, METI, MHLW and MoE jointly held a council negotiation for the delisting of ethyl hydrogen sulphate (Serial Number: 244) from the PAC list and the revision of the assessment unit. The Council concluded that delisting will occur at the end of FY 2024 and will depend on the results of the assessment units which involve toxicity data along with other information. Once delisted from the PACs list, the CAS number will be revised in the notification.  

Priority Assessment Chemicals  

The possible negative effects of Priority Assessment Chemicals (PACs) have led to heightened monitoring of these substances. According to the Chemical Risk Information Platform of the National Institute of Technology and Evaluation (NITE), 225 chemicals are now classified as PACs.  

Companies that manufacture or import these compounds in quantities of more than one tonne per year are required to submit annual reports to ensure compliance with METI laws and to promote overall safety and accountability in the handling of chemicals. 

Company Obligations 

Companies are required to submit the following information for ethyl hydrogen sulfate: 

• CAS Registry Number 

• Toxicity information (algae growth inhibition test, daphnia acute immobilization test and fish acute toxicity test) 

• Hazard assessment information 

• Physical and chemical properties 

Submission Procedure and Deadline 

Companies can submit the relevant information to METI by 22 November 2024, either mail or in-person. According to the results of the screening evaluation conducted by new assessment units, ethyl hydrogen sulphate will either be designated as a PAC at the start of FY 2025 or treated as a general chemical substance.