Japan Regulatory News

Update: On 10 September 2025, Japan’s Consumer Affairs Agency (CAA) published the revised manual of standards for substances in food contact materials (FCMs.) The update includes changes to Append...

Update: On 10 September 2025, Japan’s Consumer Affairs Agency (CAA) published the revised manual of standards for substances in food contact materials (FCMs.) The update includes changes to Appendix 1, which outlines the information required for the addition of new additives to the Positive List (PL).

Applicants must now provide detailed data on the substance's identity, physicochemical properties, migration into food, safety assessment, intended purpose and use, as well as draft standards for inclusion in the PL. The previous manual which was issued on 28 May 2025 has been abolished with the publication of this revised edition.

Original Text:

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: On 17 September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MoE) jointly announced the promu...

Update: On 17 September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MoE) jointly announced the promulgation date for the order on the e-GOV Public Comment Portal. According to the information provided, the final order will be promulgated on 8 October 2025.

Original Text:e-GOV Public Comment Portal    draftand are given below:    2. Changes to Electronic Notification Requirements (Articles 20–21)In addition to electronic signatures,  (e.g.,...

On 16 September 2025, Japan released a draft Cabinet Order proposing amendments to the Enforcement Order of the Chemical Substances Control Law (CSCL). If adopted, this change would align with the d...

On 16 September 2025, Japan released a draft Cabinet Order proposing amendments to the Enforcement Order of the Chemical Substances Control Law (CSCL). If adopted, this change would align with the decision at the 10th Conference of the Parties (COP10) to the Stockholm Convention on Persistent Organic Pollutants in June 2022 to eliminate Perfluorohexane sulfonic acid (PFHxS)-related substances.

The draft, developed by the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of the Environment (MoE), proposes that PFHxS-related chemicals be designated as Class I Specified Chemical Substances under CSCL. This status would impose bans on their manufacture, import, and use, as well as the import of products containing them.

Previous update in August 2024

On 1 August 2024, MHLW, METI and MoE jointly released an earlier draft to designate PFHxS-related substances as Class I Specified Chemicals under CSCL. That version also included import bans on the products containing PFHxS-related substances. More information can be found here.

Key Proposals in the New Draft

The provisions which are proposed in the draft are:

• PFHxS-related substances designated as Class I Specified Chemicals → Manufacture, import, and use banned.
• Import bans on products containing these substances.
• Exemption removed for 8:2 Fluorotelomer Alcohol (no longer considered “difficult to substitute”).
• Technical standards and labelling rules updated accordingly.
• Transitional provisions included.

Obligations for Stakeholders

Once the final Cabinet Order is adopted, manufacture, import, and use, a of PFHxS-related substances, and the import of products containing them, will be prohibited.

Stakeholders are expected to identify safer alternatives to PFHxS or apply for a specific permit to continue their activities.

Comment Period and Enforcement Dates

The public comment period is open until 15 October 2025. According to the draft, partial enforcement is planned for December 2025, coinciding with the promulgation of the Cabinet Order, while full enforcement will follow in June 2026.

On 10 September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) amended the list of GHS-compliant model Safety Data Sheet (SDS) information for chemical substances. The amended list wa...

On 10 September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) amended the list of GHS-compliant model Safety Data Sheet (SDS) information for chemical substances.

The amended list was published on the MHLW Workplace Safety Site on the same day and inlcudes 135 newly added chemicals and 140 revised entries. CAS numbers and chemicals name are available on the official portal.

List of GHS-Compliant Model SDS Information

The GHS-compliant model SDS informations serves as a guide for preparing SDSs in line with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Companies can use this data when preparing SDSs and related documentation to ensure consistency and accuracy. Following the latest update, the model list now covers 3,622 chemicals.

Previous update in October 2024

On 1 October 2024, the MHLW added model SDS information for 68 new chemicals and revised 104 existing entries. More details can be found here.

Obligations for Stakeholders

Under Japan's Industrial Safety and Health Act (ISHA) manufacturers, importers, suppliers, and employers are required to provide SDSs for applicable chemical substances. Other literature, test findings, and supporting information may also be used when preparing SDSs.

On 1 September 2025, Japan’s Ministry of Economy, Trade and Industry (METI) released draft amendment to the Export Trade Control Order, revising provisions related to export approval for chemical...

On 1 September 2025, Japan’s Ministry of Economy, Trade and Industry (METI) released draft amendment to the Export Trade Control Order, revising provisions related to export approval for chemical substances. The consultation notice was published on Japan’s e-GOV Public Comment Portal.

The Export Trade Control Order (Cabinet Order No. 378 of 1949) is a key regulation under the Foreign Exchange and Foreign Trade Act, establishing the legal basis for Japan’s export control system. The framework requires prior authorization for exports of hazardous chemicals and substances that could pose environmental or health risks, in line with Japan’s commitments under the Rotterdam Convention, the Stockholm Convention, and the Chemical Substances Control Law (CSCL).

Key Provisons in the  Drafted Amendment

The revised provisions are summarised in the table below:

Consultation and Next Steps

Stakeholders are invited to submit comment  by 2 October 2025. The enforcement date of the ameded Order has not yet been announced.

On 20 August 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MoE) jointly released draft amendm...

On 20 August 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MoE) jointly released draft amendments to the guidelines under Chemical Substances Control Law (CSCL). 

The draft notification was published on Japan’s e-GOV Public Comment Portal.

The proposed revisions aim to update the operational framework in light of the 2025 assessment of the 2017 CSCL amendment and Japan's long-term chemical substance management policy. The notification from 29 March, 2019 on the management of by-product Class I Specified Substances will also be revised.   

Key Amendments 

Article 1 – Impurities containing Class I Specified Substances

• Previously, the rules  applied only when Class I Specified Substances were present as by-products.
• The amended rules extends the scope to include cases where these substances are present as impurities, thus broadening regulatory coverage.

Article 2 – Structural Changes and Clarifications

• Restructuring: Introduces a new section "1. Common Provisions", consolidating general rules applicable throughout the guideline.
• Clarifications:
• Distinguishes between anhydrous and hydrated  forms of substances.
• Clarifies definitions of terms for organic polymers.
• Existing vs. New Substances: Certain substances previously excluded from the definition "new" will now be explicitly treated as existing chemical substances, with references to specific provisions in the law (Article 2, paragraphs 4, 5, 7).

Article 3 – Existing Chemicals: Revises the definition of "existing chemical substances" with necessary updates.

Comment Period and Enforcement Dates