Japan Regulatory News

Update: On 12 November 2024, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) that the amendment entered into force on 5 November 2024.     Original text: ...

Update: On 12 November 2024, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) that the amendment entered into force on 5 November 2024.  

Original text: 

On 28 August 2024, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) of the revision of food additive standards in the Food Sanitation Act. These changes include the removal of certain use standards for methyl cellulose and updates to the storage guidelines for dimethyl dicarbonate.  

Some Background  

Under Article 12 of the Food Sanitation Act 1947, designated food additives may be sold as per the Prime Minister. However, Article 13 of the Act establishes the standards for food additives in accordance with the Ministry of Health and Welfare Public Notice No. 370 of 1959, which forbids the sale of such additives unless they meet the requirements. The Committee on Food Additives of the Food Safety Standards Council in response to a request from the Prime Minister of Japan, has removed the use guidelines for methylcellulose and updated the storage guidelines for dimethyl dicarbonate.  

Removed Use Standards for the Methyl Cellulose  

Revised Storage Standards for Dimethyl Dicarbonate  

Comment Period and Enforcement Dates  

The 60-day comment period ends on 26 October 2024. The revised standards became effective on 5 November 2024.  

On 11 November 2024, Japan’s Ministry of Economy, Trade and Industry (METI) together with the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE) announced the 2025 a...

On 11 November 2024, Japan’s Ministry of Economy, Trade and Industry (METI) together with the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE) announced the 2025 application procedure for the registration of specific new chemical substances in Japan. METI has posted this application process and full details on its website. 

New Chemical Substances Covered by the 2025 Procedure 

The following categories of specific new chemical substances are covered by this application procedure:   

• Low-volume new chemical substances: This category applies to chemicals in quantities ≤ 10 t/y. The application process for these chemicals has been announced for FY 2025.  

• Small quantities of new chemical substances: This category applies to chemicals in quantities ≤ 1 t/y. The application process for these chemicals has been announced for FY 2025.  

Application Submission Methods for New Chemical Substances in Japan 

METI allows submission through the following methods: 

1. e-Gov electronic application 

2. Optical disc 

3. Written application 

October 2024 Publication of the Application Schedule 

The 2025 e-application schedule for particular new chemical substances was jointly issued by METI, MHLW and MOE of Japan on 11 October 2024. 

Annual Updates to the New Chemical Application Process 

The Ministry updates the application process for specific new chemicals every November. Last year, on 10 November 2023, METI revised the application procedure for new chemicals for 2024.  

On 5 November 2024, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) of proposed revisions to food additive standards under the Food Sanitation Act. These updates wi...

On 5 November 2024, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) of proposed revisions to food additive standards under the Food Sanitation Act. These updates will establish specifications and standards for rubber and amino acid-sugar reaction product and revise standards for cyclodextrin. The standards provide definitions, descriptions, identification methods, purity and ash or assay content. 

Background  

Under Article 12 of the Food Sanitation Act 1947, designated food additives may be sold as authorized by the Prime Minister. However, Article 13 of the Act establishes specific standards for food additives in accordance with the Ministry of Health and Welfare Public Notice No. 370 of 1959, which prohibits the sale of such additives unless they meet the requirements.  

New Food Additive Standards 

New standards for the following food additives will be established: 

Revised Standards for Cyclodextrin  

Currently, the standards for branched cyclodextrin are limited to powdered products. In addition to powdered products, liquid products will also be subject to revised standards.  

Comment Period and Enforcement Dates  

The 60-day comment period ends on 4 January 2025. The revised standards will take effect 6 months after their official publication in the gazette.  

On 7 November 2024, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and Ministry of Environment (MoE) released a draft amendment to the Chemical...

On 7 November 2024, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and Ministry of Environment (MoE) released a draft amendment to the Chemical Substances Control Law (CSCL) to add three chemicals to the list of Class I Specified Chemical Substances. The CSCL regulates these Class I Specified Chemical Substances and will be amended to include methoxychlor, dechlorane Plus and UV-328.  

Public Consultation in September 2024 

On 19 September 2024, Japan’s MHLW, METI and MoE jointly notified the World Trade Organization (WTO) of a draft proposal to designate three chemicals as Class I Specified Chemical Substances. The consultation ended on 18 November 2024. 

Class I Specified Chemical Substances List  

Class I Specific Chemical Substances are compounds with a high potential for bioaccumulation, persistence, and long-term toxicity to humans or higher trophic level predator animals. There are currently 35 chemicals on the list.  

 
Exemptions  

The draft includes exemptions for the use of Dechlorane Plus in certain applications, such as defence uses for insulation materials which are allowed until 26 February 2030.  

Comment Period and Enforcement Dates  

Stakeholders are invited to comment on the draft amendment until 6 December 2024. The enforcement order will be promulgated in December 2024 and come into force in February 2025. From June 2025, Japan will ban the import of products containing Dechlorane Plus and UV-328 as listed in the table below.  

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...

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. 

On 27 September 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved amendments to the Standards and Criteria for Foods, Food Additives. This amendment revises the positive list of f...

On 27 September 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved amendments to the Standards and Criteria for Foods, Food Additives. This amendment revises the positive list of food contact materials (FCMs) under the Food Sanitation Act. 

This amendment will revise the usage provisions of 4 polymers in Table 1 and add 13 new additives to Table 2 of the FCM positive list. There are now 840 entries on the list.    

Public Consultation in May 2024 

Before approving the amendment, the MHLW held a public consultation from 24 May 2024 to 22 June 2024 to gather feedback on the proposed changes to the FCM positive list. This consultation specifically addressed revisions to the polymer use provisions and the addition of new additives, which were included in the final amendment. 

Standards and Criteria for Foods, Food Additives 

The Standards and Criteria for Foods, Food Additives contain requirements and guidelines for foods, milk and milk products, food additives, apparatus, and containers and packaging regulated by the Food Sanitation Act and other laws. The MHLW regularly revises these standards to keep them up to date and to protect human health and the environment. 

Japan’s Positive List of FCMs 

For synthetic resins used as primary materials in food utensils, containers, and packaging, the amended Food Sanitation Act introduced a positive list system on 1 June 2020. Only materials deemed safe and specifically included in the Positive List are permitted for use, which by default forbids the use of synthetic resin materials. 

The MHLW released the Japanese version of FCM Positive List (containing 827 entries) on 30 November 2023, followed by the English version on 25 December 2023. Details can be found here.  

Enforcement Date 

The amendment came into effect on promulgation. The revised FCM positive list will be enforceable from 1 June 2025, although existing materials may continue to be used until the end of the five-year transition period, which is 31 May 2025. 

On 11 October 2024, Japan’s Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE) jointly released the 2025 e-applic...

On 11 October 2024, Japan’s Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE) jointly released the 2025 e-application schedule for specific new chemical substances. METI published this application schedule along with detailed information on its portal. In addition, the schedule for the electronic submission of information for the manufacture and import of new chemical substances and low-volume new chemical substances, as well as the manufacture and import of intermediates, was released. 

New chemical substances that are manufactured or imported into the Japanese market in low quantities are subject to this notification as follows: 

• Low-volume new chemical substances: For the year 2025, the application schedule (notice) for the manufacture and import of low-volume new chemical substances, i.e. ≤ 10 t/y, has been released. 

• Small quantities of new chemical substances: The 2025 application schedule (notice) for the manufacture and import of small amounts of new chemical substances i.e. ≤ 1 t/y has been released. 

Annual Update of the Application Schedule 

Every year in October, the Ministry revises the application schedule for e-submission. METI has already updated the new chemical application schedule for the year 2024 on 13 October 2023. The application schedule for the year 2026 is expected to be released in October 2025, but METI has not yet made it official.