Japan Regulatory News

On 28 May 2025, Japan’s Consumer Affairs Agency (CAA) released updated guidelines relating to Food-Contact Materials (FCMs) under the Food Sanitation Act. The CAA published the guidelines on its off...

On 28 May 2025, Japan’s Consumer Affairs Agency (CAA) released updated guidelines relating to Food-Contact Materials (FCMs) under the Food Sanitation Act. The CAA published the guidelines on its official portal. This time, the CAA has revised the procedures for:  

1. Appendix 1 of the Standards for Food, Additives, etc for substances to be added or revised. 

2. The Monomer Notification, which lists allowable monomers and processing agents in food-contact materials.  

These updates replace the 2020 guidelines and aligns with the end of the Positive List (PL) transitional period on 31 May 2025. The new guidelines are mandatory from 1 June 2025. 

Previous Update in May 2020 

The CAA previously revised the guidelines for FCMs in May 2020. 

Key Insights from the Standards: 

1. Two Types of Revisions: 

• Appendix 1: For substances expected to be widely used. 

• Monomer Notification: For additions or changes to monomers and treatment agents. 

2. Procedure: 

• Advance consultation with the Consumer Affairs Agency is required. 

• Submit official forms (Form 1 or 2) with supporting documents. 

• Safety and migration data must follow Japan's Food Safety Commission 2019 Guidelines. 

• A withdrawal form (Form 3) is provided if needed. 

3. Required Documents:  

Substance name, structure, safety data, usage scope, migration test results, and global regulatory status. 

Update 2: On 26 May 2025, Japan’s Consumer Affairs Agency (CAA) released an updated Q&A document on its portal for the Positive List for Food Contact Materials (FCMs). This time, the CAA addressed c...

Update 2: On 26 May 2025, Japan’s Consumer Affairs Agency (CAA) released an updated Q&A document on its portal for the Positive List for Food Contact Materials (FCMs). This time, the CAA addressed concerns regarding products that are similar to those sold, manufactured, imported, or used before 1 June 2020, and the process by which these products are verified as complying with the Positive List (PL). 

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 16 May 2025, Japan’s Ministry of Health, Labour, and Welfare (MHLW) published the revised list of compounds and mixtures that required labelling and safety data sheets (SDS). The list is availabl...

On 16 May 2025, Japan’s Ministry of Health, Labour, and Welfare (MHLW) published the revised list of compounds and mixtures that required labelling and safety data sheets (SDS). The list is available on the country’s Workplace Safety Portal, managed by the Ministry. According to the Industrial Safety and Health Act (ISHA), the Globally Harmonized System (GHS) for labelling must be followed.  

List of Labelling & SDS Delivery 

According to Article 57 and 57-2 of the ISHA, it is mandatory to provide a label and SDS for the listed chemicals to safeguard workers’ health and the environment. A total of 2316 chemicals are now listed, with requirements coming into effect in phases from April 2025 and April 2026. 

Previous Update in March 2025 

In March 2025, the MHLW released a list of 7 chemicals subject to labelling and SDS delivery. 

Insights from the Amended List 

From the revised list, the following must have label and SDSs: 

• 1530 chemicals applicable from 1 April 2025 

• 779 chemicals applicable from 1 April 2026 

Obligations for Stakeholders 

Manufacturers, importers, suppliers, and employers are subject to labelling and Safety Data Sheet (SDS) delivery obligations under Japan's Industrial Safety and Health Act (ISHA).  

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