Japan Regulatory News

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 chemi...

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. 

On 27 March 2025, the Japanese Ministry of Health, Labour and Welfare (MHLW) added 157 new chemicals to the New Chemicals List under the Industrial Safety and Health Act (ISHA). This update was announ...

On 27 March 2025, the Japanese Ministry of Health, Labour and Welfare (MHLW) added 157 new chemicals to the New Chemicals List under the Industrial Safety and Health Act (ISHA). This update was announced through an ISHA Notice that was released on that same day.  

Details such as the name, ISHA official gazette serial number, chemical and structural formula of the new chemical substances are published alongside the updated list on the MHLW's Workplace Safety Portal. The list is available here. 

Previous addition: 131 New Chemical Substances in December 2024  

This update follows the addition of 131 chemical substances to the list announced in a notice issued under ISHA on December 27, 2024, and published through the MHLW' Workplace Safety Portal. The update can be found here. 

 
Obligations for Stakeholders  

At present, the list of chemicals known as the Existing and New Chemical Substances (ENCS) list includes 72,601 items. The Industrial Safety and Health Act mandates that manufacturers, importers, or companies in Japan notify the MHLW before producing or importing such chemicals. The notification must include the name of the new chemical compound and the specifics of its danger evaluation to protect industrial workers' health.  

On 17 March 2025, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly published the amended process for t...

On 17 March 2025, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly published the amended process for the notification procedure for new chemical substances under the Chemical Substances Control Law (CSCL). The ministries also shared the manual for preparation and submission of documents for notification on the National Institute of Technology and Evaluation (NITE) portal. 

New Chemical Substances Covered by the 2025 Notification 

The following categories of new chemical substances are covered by this notification process:    

• New chemical substances: Chemicals not listed in the Existing Chemical Substances Inventory and imported or manufactured in Japan in quantities > 1 t/y. 

• Low-volume new chemical substances: This category applies to chemicals manufactured or imported in quantities ≤ 10 t/y.  

For background on the timeline leading up to the revision, see our previous GPC news here.  

On 6 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) released the final enforcement notice for the Revised Criteria for Poisonous and Deleterious Substances and related provisions....

On 6 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) released the final enforcement notice for the Revised Criteria for Poisonous and Deleterious Substances and related provisions. The MHLW published the notice via Pharmaceuticals and Medical Devices Agency Notification No. 0306-6 on the notification portal of Japan’s National Institute of Health Sciences (NIHS). This enforcement took effect on the same day that the MHLW published the notice. 

For background on the draft criteria and consultation process, see the original news here. 

On 3 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) notified the World Trade Organization (WTO) of draft revisions to the Industrial Safety and Health Act (ISHA) aimed at enhancin...

On 3 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) notified the World Trade Organization (WTO) of draft revisions to the Industrial Safety and Health Act (ISHA) aimed at enhancing the delivery of safety data sheets (SDSs). The MHLW has made significant changes to the Safety Data Sheets content aiming to improve the safety of employees when handling hazardous chemicals.  

Background on ISHA: Delivery of Documents 

Under Article 57-2 of ISHA, the delivery of documents such as labels or safety data sheets is crucial for hazardous chemicals. Exposure to these chemicals might cause harm or side effects to employees working on-site. Transferors and suppliers are obliged to provide updated SDSs to the personnel working there. 

Key Provisions in the Draft Revision  

The MHLW has made the following three provisions in the draft notice for SDS delivery: 

1. Establishment of a punitive clause for non-compliance with hazard statement notifications for transferors/providers of chemical substances. 

2. Changes to the notification provisions for transferors and providers will become the new obligatory regulations.  

3. Allows notification using alternative names for confidential business information. Obligations to record and maintain information on ingredients, provide information to doctors, and report to labour standards inspection agencies. 

Comment Period and Enforcement Dates 

Stakeholders are invited to submit comments on this draft notice till 2 May 2025. The Ministry has not yet confirmed the adoption date of these provisions, but has released the scheduled enforcement dates. 

On 26 February 2025, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) of a proposed revision to water quality standards under the Food Sanitation Act. This revis...

On 26 February 2025, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) of a proposed revision to water quality standards under the Food Sanitation Act. This revision aims to establish specifications for sterilized or filter sterilized mineral water. At the same time, the CAA published this notice on Japan’s e-GOV Public Comment Portal.  

Background 

According to Article 12 of the Food Sanitation Act 1947, the Prime Minister may allow the sale of specific food additives. However, the Health and Welfare Public Notice No. 370 of 1959 prohibits the sale of food additives unless they comply with the regulations, as set out in Article 13 of the Act.  

The Food Safety Commission of Japan (FSCJ) has reviewed specifications and standards for mineral water and assessing the health effects of synthetic organofluorine chemical compounds, particularly per- and polyfluoroalkyl substances (PFAS), in food. As a result, Japan will establish water quality standards for perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) in sterilized or filter sterilized mineral waters under the Water Supply Act. 

New Standards for Mineral Water  

The following new standards for PFOS and PFAS in mineral water will be established: 

Comment Period and Enforcement Dates 

The 60-day comment period will end on 27 April 2025. The newly established standards are expected to be enforced from 1 April 2026.   

On 17 February 2025, Japan released a document entitled "J4CE 2024 Noteworthy Cases", which highlights key circular economy initiatives, led by businesses and local governments under the Japan Circula...

On 17 February 2025, Japan released a document entitled "J4CE 2024 Noteworthy Cases", which highlights key circular economy initiatives, led by businesses and local governments under the Japan Circular Economy Partnership (J4CE).  

Background: Japan Partnership for Circular Economy (J4CE) 

In March 2021, the Ministry of the Environment, the Ministry of Economy, Trade, and Industry, and the Japan Business Federation (Keidanren) launched the Japan Circular Economy Partnership (J4CE), a public-private project in Japan. It aims to advance the principles of circular economy by encouraging cooperation between companies, governmental bodies, and trade associations. In order to promote sustainable resource management, waste reduction, and recycling innovations in Japan, J4CE facilitates policy discussions, business networking, and knowledge exchange. This collaboration is critical to coordinating Japan's activities with international circular economy projects, such as those outlined by the G7.  

Key Highlights from the “J4CE 2024 Noteworthy Cases” Report 

The report highlights a wide range of initiatives across multiple sectors: 

• Plastic Recycling and Repurposing: In order to produce new goods, creative projects focus on collecting and recycling used domestic plastics, industrial plastic waste, and plastic packaging (e.g. Aeon Co., Ltd). 

• Construction Waste Management: Initiatives include recycling glass and plastic waste from construction sites, reusing construction materials, and implementing digital tracking systems (e.g. Taisei Corporation). 

• Household Waste and Consumer Engagement: Programs encourage the recycling of consumer goods and used packaging, including small gadgets and diapers often use digital platforms to provide incentives for participation (e.g. Mercari Co Ltd.).  

• Automotive and Industrial Recycling: To reduce landfill waste and carbon emissions, programs concentrate on recovering and recycling plastic materials from end-of-life automobiles and industrial by-products (e.g. Mitsui and Co., Ltd.).  

• Technological Innovation: To maximize resource recovery and boost recycling effectiveness, businesses are using digital technologies and AI-driven analytics.  

Other Initiatives Supporting Japan’s Circular Economy 

With an emphasis on resource efficiency, waste reduction, and sustainable business models, Japan has created a number of frameworks to move towards a circular economy. Among the crucial frameworks are: 

1. Basic Act for Establishing a Sound Material-Cycle Society (2000) 

2. Plastic Resource Circulation Act (2022) 

3. Circular Economy Roadmap (2021) 

4. Japan Circular Economy Partnership (J4CE, 2021) 

5. Extended Producer Responsibility (EPR) Policies 

These frameworks, along with the efforts of J4CE, highlight Japan's commitment to sustainable resource management and its proactive approach to addressing environmental challenges through collaborative and innovative solutions.