Japan Regulatory News

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 

On 18 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Agriculture, Forestry and Fisheries (MAFF), and Ministry of Economy, Trade and Industry (METI) released the draft...

On 18 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Agriculture, Forestry and Fisheries (MAFF), and Ministry of Economy, Trade and Industry (METI) released the draft design certification standards for plastic products. The draft has been made available for public consultation via Japan’s e-GOV Public Comment Portal. It is based on the Plastic Product Design Guidelines published under Notification 1 of 2022.  

Design Certification Standards for PET Bottle Containers for Soft Drinks 

The standards for polyethylene terephthalate (PET) containers for soft drinks outline specific requirements to improve recyclability and sustainability. 

1. Component Requirements 

Each component must meet all of the requirements listed below: 

Bottle 

1. Must be made of polyethylene terephthalate (PET) without any other added substances. However, exceptions will be made for bottles containing other materials if they are proven to be safe, hygienic, and recyclable. 

2. Must not be coloured. 

3. Handles must be made of uncoloured PET or polyethylene/polypropylene with a specific gravity of less than 1.0. 

4. No printing on the bottle, except for small markings such as expiration dates, unique manufacturing symbols, or lot numbers. 

Label 

1. Must not contain polyvinyl chloride (PVC). 

2. Must be separable from the bottle during recycling processes such as wind selection or washing. 

3. Printing ink used on labels must not adhere to the bottle. 

4. Must not use aluminium-laminated labels. 

Cap 

1. Must not use aluminium or PVC. 

2. Must be made primarily of polyethylene or polypropylene with a specific gravity of less than 1.0. 

3. If glass beads or gaskets are used, the label must include instructions for their removal. 

2. Weight Requirements 

The weight of each container (excluding labels and caps) must not exceed the values determined by the conditions are given in table below: 

3. Recycling and Sustainable Material Requirements 

At least 15% of the total weight of each container must consist of one of the following materials: 

• Recycled plastic, as specified by the Japanese Industrial Standards (JIS) Q 14021-7.8.1.1, or  

• Biomass plastic (organic material derived from plants or animals, excluding fossil resources). 

These standards are established to promote environmentally sustainable practises and efficient recycling in the production of PET bottle containers for soft drinks. 

Comment Period and Enforcement Dates  

Stakeholders are invited to submit comments on this draft standard by 16 April 2025. The ministries have not yet confirmed the adoption date of the standard, but it will take effect on the date of final publication.  

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.