Japan Regulatory News

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 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.  

On 8 October 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) notified a draft to the World Trade Organization (WTO), proposing amendments to the list of chemicals and mixtures that requi...

On 8 October 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) notified a draft to the World Trade Organization (WTO), proposing amendments to the list of chemicals and mixtures that require mandatory labelling and safety data sheets (SDS). This update, which would amend the Enforcement Order of the Industrial Safety and Health Act and is scheduled to be adopted in December 2024. Under the provisions of the Industrial Safety and Health Act, it is mandatory to follow the Globally Harmonized System (GHS) for labelling. 

Public consultation in September 2024 

On 20 September 2024, the MHLW launched a consultation to not only add 155 substances to the classification list. but also to eliminate two substances from the list, which includes substances classified until 31 March 2024.  

Comment Period and Enforcement Dates 

Stakeholders are invited to comment on the draft proposal until 7 December 2024. The 155 chemicals are expected to be added to the list by April 2027. At the same time, sodium stearate and phosphoric acid, triphenyl ester will be eliminated from the list. 

On 19 September 2024, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly released the 2025 notification ...

On 19 September 2024, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly released the 2025 notification schedule for new chemical substances. METI published this notification schedule on its portal, along with detailed information and a manual. New chemical substances that are manufactured or imported into the Japanese market in quantities exceeding one tonne are subject to this notification. 

Annual Update of the Notification Schedule 

The Ministry updates the notification schedule every year in September. Previously, on 8 September 2023, METI revised the notification schedule for new chemicals for the year 2024. 

Notification Schedule 

For the deadlines of 7 February and 1 August 2025, there is no requirement of preliminary screening if the same substance is notified. Only notifications will be accepted on these dates.  

For preliminary materials, submissions will only be accepted until 3 pm on the respective date. If this deadline is missed, the next deadline will apply. 

Required Information  

The manual for the notification of new chemical substances lists the required information as given below and can be consulted for further information: 

• Company details 

• Name and structural formula of the new chemical substance 

• Physicochemical properties and composition 

• Uses 

• Estimated annual quantity for the manufacture or import of the new chemicals for three years 

• Details of two contact persons 

Next Announcement 

METI has not yet announced the notification schedule for the year 2026, but it is expected to be released in September 2025. 

On 27 September 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) amended the New Chemical Substances List by adding 149 new substances. This update came on the same day as the publication...

On 27 September 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) amended the New Chemical Substances List by adding 149 new substances. This update came on the same day as the publication of the notice under the Industrial Safety and Health Act (ISHA) announcing the names of these new chemical substances, which can be accessed here. 

The latest additions to the list include details such as name, ISHA official gazette serial number, chemical and structural formula for the new chemical substances, all of which are available on the MHLW’s Work Safety Portal.  

Previously Japan added 141 New Chemical Substances 

As per the notice published on 27 June 2024 under ISHA, the MHLW added 141 New Chemical Substances to the list on 30 August 2024 through the MHLW Work Safety Portal. The update can be accessed here. 

Obligations for Stakeholders 

There are currently over 72,100 substances on the Existing and New Chemical Substances (ENCS) list. Under the provisions of the Industrial Safety and Health Act, manufacturers, importers or companies must notify the MHLW before manufacturing or importing such chemicals into Japan. The notification must include the name and hazard evaluation details of the new chemical substance, as this is necessary to protect the health of workers in the industrial workplace.