Japan Regulatory News

Update: On 1 April 2025, based on toxicity assessment data submitted by companies, the ministries decided to revoke the PAC designation of NPE (polyoxyethylene nonylphenyl ether) and reclassify it as ...

Update: On 1 April 2025, based on toxicity assessment data submitted by companies, the ministries decided to revoke the PAC designation of NPE (polyoxyethylene nonylphenyl ether) and reclassify it as a Class II Specified Chemical Substance. This update was released on the same day as its publication in the Japan CHEmicals Collaborative Knowledge database (J-CHECK) portal. Enforcement took effect on 1 April 2025. With this update, the Class II Specified Chemical Substance list now has 24 chemicals.  

Japan had earlier notified the WTO of the adoption of designating NPE as a Class II Specified Chemical Substance on 5 December 2024. 

Original Text: 

On 21 June 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) notified the World Trade Organization (WTO) of the designation of NPE (polyoxyethylene nonylphenyl ether) as a Class II Specified Chemical Substance under the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (hereinafter referred to as the Act). 

Class II Specified Chemical Substances are substances that are specified by Cabinet Order (Order for enforcement of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.), and that are believed to pose a risk of causing harm to humans or damage to flora and fauna in the human living environment, and a significant amount of the substance remains in the environment over a substantially extensive area, or it is reasonably likely that such a situation will arise in the near future. 

Regulatory Requirements 

This designation necessitates several regulatory requirements: 

1. Notification Requirement: 

• Manufacturers and importers of NPE must notify the planned quantity of NPE to be manufactured or imported, as stipulated in Article 35, paragraphs 1 and 6 of the Act. 

2. Technical Guidelines: 

• The handling of NPE and NPE-added water-based cleaning agents must comply with the measures outlined in the technical guidelines, as per Article 36, paragraph 1 of the Act. 

3. Labelling Requirements: 

• Containers and packaging of NPE and NPE-added water-based cleaning agents must display labels indicating compliance with the prescribed measures, in accordance with Article 37, paragraph 1 of the Act. 

Objective and Rationale: 

The primary objective of this designation is to protect animal and plant life, ensure public health, and protect the environment. This action reflects Japan's extensive efforts to protect the environment and ensure public health. 

Proposed Dates: 

• Date of Adoption: 1 October 2024 

• Date of Entry into Force: 1 April 2025 

• Deadline for Comments: 19 August 2024 

Companies are encouraged to review the proposed regulations. This proactive step is critical to ensuring that the regulations are comprehensive and effective in achieving their intended protective measures. 

Update: On 31 March and 1 April 2025, based on toxicity assessment data submitted by companies, the ministries decided to revoke the PAC designation of six chemicals and one chemical respectively list...

Update: On 31 March and 1 April 2025, based on toxicity assessment data submitted by companies, the ministries decided to revoke the PAC designation of six chemicals and one chemical respectively listed in the table below. The updates were released on the same days as its publication in the Japan CHEmicals Collaborative Knowledge database (J-CHECK) portal. The revocations took effect on 31 March and 1 April 2025, respectively.  

Also on 1 April 2025, the PAC designation of three newly assessed chemicals came into force. This update was also released on the same day as its publication in the Japan CHEmicals Collaborative Knowledge database (J-CHECK) portal. With this update the PACs list now has 221 chemicals. 

Original Text: 

On 12 February 2025, Japan’s Ministry of Environment (MoE), together with the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) released a joint draft notice on its portal to amend the Priority Assessment Chemical Substances (PACS) list. This update will add 3 newly designated PACS and remove 7 PACS from the list. Following assessment of the chemicals, the three ministries have opened a public consultation on the same. 

Background on PACS 

PACS are chemicals whose long-term effects on humans or the plants and animals that live in human habitats are not well understood. Therefore, in order to ensure compliance with METI laws and to encourage safety and responsibility in handling of chemicals, companies that manufacture or import these chemicals in quantities greater than 1 Tonne Per Annum (TPA) are required to file annual reports in order to protect living beings.     

Key Insights from the draft notice 

The draft notice lists the following chemicals that are proposed for addition to the PACS list because of their potential for causing long-term harm to humans or to plants and animals in the human environment is not fully understood: 

List of Newly Designated PACS 

The draft notice also lists the following chemicals whose PACS designation will be revoked due to: 

• Manufactured/imported volumes of less than 10 TPA reported for 3 consecutive years.  

• Indicated released volumes of less than 1 TPA to the environment. 

• Indication that they no longer pose a risk to living organisms. 

List of PACS to be delisted from the PACS list 

Comment Period  

Stakeholders are invited to comment on this joint draft notice till 13 March 2025. After receiving the comments, the three ministries will publicly announce further updates.  

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.