Japan Regulatory News

On 27 June 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) announced the addition of 119 new chemicals to the New Chemicals List under the Industrial Safety and Health Act (ISHA). This u...

On 27 June 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) announced the addition of 119 new chemicals to the New Chemicals List under the Industrial Safety and Health Act (ISHA). This update was announced through an official ISHA Notice published on the same day.   

The new entries, along with their ISHA official gazette serial numbers, chemical names, and structural formulas are available on MHLW's Workplace Safety Portal here.  

Previous addition: 157 New Chemical Substances in March 2025   

This revision follows the addition of 157 new chemicals to the list, as reported in an ISHA notification published on 27 March 2025, via the MHLW Workplace Safety Portal. The update can be found here.  

  
Obligations for Stakeholders   

Currently, the list of chemicals known as the Existing and New Chemical Substances (ENCS) list includes 72,720 entries. According to the Industrial Safety and Health Act, Japanese enterprises that produce or import such compounds must notify the MHLW. In order to safeguard industrial workers' health, the notification must contain the name of the new chemical compound and details of its risk assessment.   

Japan’s Positive List (PL) for food contact materials (FCMs) entered into force on 1 June 2025. On the same day, the Consumer Affairs Agency (CAA) published a manual introducing the positive list on...

Japan’s Positive List (PL) for food contact materials (FCMs) entered into force on 1 June 2025. On the same day, the Consumer Affairs Agency (CAA) published a manual introducing the positive list on its official portal. The PL system regulates synthetic resins used in food-contact utensils and packaging under the Food Sanitation Act. Only materials listed in the official PL may be used, unless they meet certain exemption criteria, such as migration into food below 0.01 ppm or use in non-contact layers that do not affect food safety.

Key Insights from the Manual

1. Legal Basis:

• Article 16: Bans harmful substances in utensils, containers, and packaging (UCP).

• Article 18: Enables the establishment of safety standards and manufacturing criteria.

2. Structure of Standards:

• General Standards: Ban certain harmful substances such as lead and certain dyes.

• Material-specific and Use-specific Standards: Apply to categories such as glass, rubber, and heat-processed materials (e.g. retort pouches).

3. Annex I (Positive List):

• Table 1: Lists 21 categories of approved base polymers.

• Table 2: Includes approximately 840 approved additives, each with usage limits by material class.

4. Scope of Application:

• Covers all synthetic resin layers in UCPs.

• Excludes non-resin materials, surface coatings, and unintended by-products.

5. Procedures for Adding New Substances:

• Inclusion via PL amendment, safety review, or monomer notification update - depending on intended use and risk.

6. Transition Period:

• A 5-year grace period until 1 June 2030.

• Products sold or made before enforcement are considered compliant during this period.

Stakeholder Obligations

• Manufacturers and importers of raw materials and UCPs must provide evidence of PLcompliance.

• Users and distributors must verify and communicate compliance.

• Disclosure of individual substances is not mandatory; documentation such as specification sheets or certificates is sufficient.

The PL system is designed to enhance food safety by systematically controlling materials used in food-contact applications.

Update: On 6 June 2025, Japan’s Ministry of Health, Labour, and Welfare (MHLW) published the revised list of 155 chemicals which require labelling and safety data sheets (SDS) on the ASEAN-Japan Che...

Update: On 6 June 2025, Japan’s Ministry of Health, Labour, and Welfare (MHLW) published the revised list of 155 chemicals which require labelling and safety data sheets (SDS) on the ASEAN-Japan Chemical Safety Database portal. The updated list was also  made available on the nation's National Institute of Technology and Evaluation-Chemical Risk Information Platform (NITE-CHRIP) website.  Enforcement will begin on 1 April 2027. 

Original Text: 

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).  

On 6 June 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a list of 50 carcinogenic chemicals on the ASEAN-Japan Chemical Safety Database portal. The update was also released o...

On 6 June 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a list of 50 carcinogenic chemicals on the ASEAN-Japan Chemical Safety Database portal. The update was also released on the country’s National Institute of Technology and Evaluation - Chemical Risk Information Platform (NITE-CHRIP) portal.  

Background 

In Japan, carcinogenic substances are subject to strict obligations under the Industrial Safety and Health Act (ISHA), which requires records to be kept for up to 30-years. 

Previous update in December 2022 

Earlier, in December 2022, the MHLW classified 200 chemicals as carcinogenic and started enforcement in a phased manner starting from April 2023. More details can be found here.  

Obligations for Stakeholders 

From 1 April 2027, the following will be mandatory for stakeholders: 

• Mandatory GHS-compliant labelling and provision of Safety Data Sheets (SDS). 

• Risk assessment before use, implementation of exposure control measures, and health monitoring for workers.  

• Employers must conduct regular medical examinations, particularly for substances classified as Group 1 or 2A carcinogens, maintain detailed exposure and health records, and notify authorities when required.  

• Additional regulations, such as the Chemical Substances Control Law (CSCL) and PRTR Law, also apply to environmental reporting and emissions control. 

On 29 May 2025, Japan’s Ministry of Environment (MoE), launched a public consultation to collect toxicity data on chemical substances regulated under the Chemical Substances Control Law (CSCL). The ...

On 29 May 2025, Japan’s Ministry of Environment (MoE), launched a public consultation to collect toxicity data on chemical substances regulated under the Chemical Substances Control Law (CSCL). The MoE has requested this data to further accelerate and optimize the risk assessment of Priority Assessment Chemicals (PACs) and general chemicals under the CSCL.  

Background 

The MoE periodically reviews the toxicity information of chemicals to help protect human health and the environment. It also revises the classification accordingly and makes this information publicly available through the Ministry’s portal. 

Chemicals covered under the consultation  

The consultation covers two classes of chemicals under the CSCL: 

• PACs: 53 entries  

• General Chemicals: 81 entries 

Information to be submitted 

The MoE requests companies to submit toxicity information for the following endpoints: 

• Acute or chronic toxicity to algae 

• Acute or chronic toxicity to crustaceans 

• Acute or chronic toxicity to fish 

The Ministry has also shared guidance on assessment methods and the preparation of documents for submission, which is available in detail through the consultation notice. 

Consultation Period 

Stakeholders are invited to submit the required toxicity information to the MoE by 31 July 2025. 

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.