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 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.