Japan Regulatory News

On 5 December 2024, Japan’s Ministry of Economy, Trade and Industry (METI) circulated a draft notice to add methoxychlor, dechlorane plus, UV-328 and their products to the country’s Export Trade C...

On 5 December 2024, Japan’s Ministry of Economy, Trade and Industry (METI) circulated a draft notice to add methoxychlor, dechlorane plus, UV-328 and their products to the country’s Export Trade Control Order, imposing new restrictions on exporters. METI has published this consultation notice on the e-GOV public comment portal. 

New Export Restrictions under Japan’s Export Trade Control Order 

Under the provisions of the Export Trade Control Order, exporters are obliged to obtain approval from the METI to ship these chemicals or products containing them. However, the Ministry has not yet published the enforcement date. 

Background: METI’s Cabinet Order and Chemical Classifications 

On 13 December 2024, the Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MoE) published an enforcement Cabinet Order designating UV-328, methoxychlor, and dechlorane plus as Class I Specified Chemical Substances. 

Class I Specific Chemical Substances List 

Compounds classified as Class I Specific Chemical Substances have a high potential for bioaccumulation, persistence, and long-term toxicity to humans or higher trophic-level predator species. The list currently contains 35 compounds.  

Exemptions for Specific Applications 

According to the draft, dechlorane plus may be used in specific applications, such as defence applications for insulation materials, which are permitted until 26 February 2030.  

Comment Period and Enforcement Dates    

Stakeholders are invited to comment on this draft notice until 6 January 2025. This designation will come into force on 18 February 2025. From 18 June 2025, Japan will ban the import of products containing dechlorane plus and UV-328 as listed in the table below while the promulgation is expected to occur on 18 December 2025.  

Update: On 13 December 2024, Japan’s MHLW, METI and MOE released an enforcement Cabinet Order designating methoxychlor, dechlorane plus and UV-328 as Class I Specified Chemical Substances on the Jap...

Update: On 13 December 2024, Japan’s MHLW, METI and MOE released an enforcement Cabinet Order designating methoxychlor, dechlorane plus and UV-328 as Class I Specified Chemical Substances on the Japan’s e-GOV public comment portal. This designation will come into force from February 2025.    

Original Text: 

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.   

Update: On 5 December 2024, Japan’s MHLW, METI and MOE notified the World Trade Organization (WTO) of the adoption of the Cabinet Order designating NPE as a Class II Specified Chemical Substance. ...

Update: On 5 December 2024, Japan’s MHLW, METI and MOE notified the World Trade Organization (WTO) of the adoption of the Cabinet Order designating NPE as a Class II Specified Chemical Substance. This designation will come into force on 1 April 2025.   

Original Text: 

On 21 June 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) notified the World Trade Organization (WTO) of the designation of NPE (polyoxyethylene nonylphenyl ether) as a Class II Specified Chemical Substance under the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (hereinafter referred to as the Act). 

Class II Specified Chemical Substances are substances that are specified by Cabinet Order (Order for enforcement of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.), and that are believed to pose a risk of causing harm to humans or damage to flora and fauna in the human living environment, and a significant amount of the substance remains in the environment over a substantially extensive area, or it is reasonably likely that such a situation will arise in the near future. 

Regulatory Requirements 

This designation necessitates several regulatory requirements: 

1. Notification Requirement: 

• Manufacturers and importers of NPE must notify the planned quantity of NPE to be manufactured or imported, as stipulated in Article 35, paragraphs 1 and 6 of the Act. 

2. Technical Guidelines: 

• The handling of NPE and NPE-added water-based cleaning agents must comply with the measures outlined in the technical guidelines, as per Article 36, paragraph 1 of the Act. 

3. Labelling Requirements: 

• Containers and packaging of NPE and NPE-added water-based cleaning agents must display labels indicating compliance with the prescribed measures, in accordance with Article 37, paragraph 1 of the Act. 

Objective and Rationale: 

The primary objective of this designation is to protect animal and plant life, ensure public health, and protect the environment. This action reflects Japan's extensive efforts to protect the environment and ensure public health. 

Proposed Dates: 

• Date of Adoption: 1 October 2024 

• Date of Entry into Force: 1 April 2025 

• Deadline for Comments: 19 August 2024 

Companies are encouraged to review the proposed regulations. This proactive step is critical to ensuring that the regulations are comprehensive and effective in achieving their intended protective measures. 

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 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 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.