Japan Regulatory News

Update: On 14 May 2025, Japan’s Consumer Affairs Agency (CAA) published a revised Q&A document on its portal to further clarify the provisions of a Positive List for Food Contact Materials (FCMs). T...

Update: On 14 May 2025, Japan’s Consumer Affairs Agency (CAA) published a revised Q&A document on its portal to further clarify the provisions of a Positive List for Food Contact Materials (FCMs). The CAA has also added a comparison of the previous and newly updated Q&A provisions. 

Original Text: 

On 6 February 2025, Japan’s Consumer Affairs Agency (CAA) published a Q&A document on its portal to clarify the provisions of a Positive List for Food Contact Materials (FCMs). The Positive List is currently in a 5-year transition period ending on 1 June 2025. At the end of the transition period, only entries on the list will be permitted in food contact applications. New materials must undergo assessment before they can be added to the list. 

Key Insights from the Q&A Document  

The main focus of the Q&A document is the Positive List of FCMs, which is governed by the Food Sanitation Act and overseen by the CAA. In general, this Act provides the basis for establishing standards for FCMs.   

The Q&A document covers topics which include following:  

• Scope and definition of the Positive List.  

• Exclusions from the list. 

• Specific product categories. 

• Provisions for polymeric substances. 

• Limits for additives. 

• Implementation guideline. 

Guidance for Stakeholders  

The Food Sanitation Act regulates FCMs in Japan, and the CAA frequently updates its portal to reflect the most recent changes to the requirements and criteria for foods and food additives. The purpose of this Q&A document is to help suppliers, importers, and manufacturers in making efficient use of the Positive List. Adhering to the list helps to prevent non-compliance in the manufacture, import and supply of FCMs. 

On 14 May 2025, Japan’s Consumer Affairs Agency (CAA) published safety review procedures for new substances used in food contact materials (FCMs) on the portal. These procedures primarily focus on n...

On 14 May 2025, Japan’s Consumer Affairs Agency (CAA) published safety review procedures for new substances used in food contact materials (FCMs) on the portal. These procedures primarily focus on newly approved and applied substances, which are usually listed publicly. A specific application procedure has also been developed to protect the intellectual property (IP) for businesses that are concerned that revealing the names and usage of substances could harm their ability to compete. 

Key insights from the Safety Procedures 

• Added provisions for the safety assessment of new substances and the re-assessment of already approved substances. 

• A specific procedure has been added to protect intellectual property (IP). 

Positive List for Food Contact Materials (FCM) 

The Positive List is currently in a five-year transitional phase that ends on 1 June 2025.  Only substances on the list will be allowed in food contact applications after the transition period.  New materials must be evaluated before being added to the list,.  

Guidance for Stakeholders   

In Japan, FCMs are governed by the Food Sanitation Act, and the CAA regularly updates its portal to reflect the latest modifications to standards and specifications for foods and food additives. This document aims to assist manufacturers, importers, and suppliers comply with the safety review process for new substances. Following the procedure helps to prevent non-compliance with FCM supply, import, and manufacturing regulations. 

Update: On 1 April 2025, Japan’s MHLW, METI and MOE jointly published the revised manual for the methods, procedures, and documents to be submitted for notification and application procedures for ne...

Update: On 1 April 2025, Japan’s MHLW, METI and MOE jointly published the revised manual for the methods, procedures, and documents to be submitted for notification and application procedures for new chemical substances. The ministries shared the manual for preparing and submitting notification documents on the METI portal. 

Original Text: 

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 10 April 2025, Japan’s Ministry of Health, Labour, and Welfare (MHLW) updated its list of chemicals identified as strong mutagens on the Workplace Safety Site. With this update, MHLW added 17 new...

On 10 April 2025, Japan’s Ministry of Health, Labour, and Welfare (MHLW) updated its list of chemicals identified as strong mutagens on the Workplace Safety Site. With this update, MHLW added 17 newly notified chemicals. Mutagenic chemicals are regulated under the country’s Industrial Safety and Health Law (ISHL). With this addition, the list now contains a total of 1363 chemicals including 244 existing and 1119 newly notified mutagens. 

Understanding Strong Mutagens 

Mutagens are substances or agents that can cause genetic mutations, leading to changes in an organism’s DNA. Mutagenic effects can result in serious health problems such as cancer, birth defects, and genetic disorders. Strong mutagens are chemicals or physical agents with a high potential to cause significant genetic mutations. 

Previous Update in November 2023 

On 30 November 2023, the MHLW added 18 newly notified chemicals to the list of strong mutagens, bringing the total to 1346 at that time. 

Obligations for Stakeholders 

Under Notification No. 312 (published on 17 May 1993), entities involved in the manufacturing and handling of strong mutagens are required to: 

• Measure the work environment  

• Implement exposure prevention strategies 

• Provide occupational health education 

• Prepare labelling and Safety Data Sheets (SDS) 

• Maintain records for up to 30 years 

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.  

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 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.