Japan Regulatory News

Update: On 27 December 2024, Japan’s METI and MOE published the promulgated order prohibiting the manufacture of the 10 mercury-containing products in Japan’s Kanpo Official Gazette.     ...

Update: On 27 December 2024, Japan’s METI and MOE published the promulgated order prohibiting the manufacture of the 10 mercury-containing products in Japan’s Kanpo Official Gazette.  

Original Text: 

On 4 July 2024, Japan’s Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) jointly notified the World Trade Organization (WTO) of a revision of the Enforcement Order of the Act on Preventing Mercury Pollution of the Environment. This revision updates the list of mercury-added products under Annex A of the Minamata Convention on Mercury. Following the phase-out dates specified in Article 4 of the Minamata Convention, the manufacture of 10 newly added products will be prohibited.   

Currently the draft is open for public comment until 2 September 2024. The revised order will be adopted in October 2024.  

Background on Enforcement Order   

The Enforcement Order which was originally enacted on 11 November 2015 categorizes certain mercury-containing products as specialized goods that require stringent control in accordance with Article 2, Paragraph 1 of the Act on Preventing Mercury Pollution of the Environment. The use of these products as raw materials for the manufacture of other commodities will be restricted.  

Enforcement Dates  

The revised Enforcement Order will come into effect in three phases, starting on 1 January 2026, 1 January 2027 and 1 January 2028 respectively as per the phase-out dates of the Minamata Convention.  

The following products will be subject to the manufacturing ban:  

Rationale  

This strategy will implement the Minamata Convention on Mercury and reduce the risks posed by mercury to human health and the environment. The government will monitor the implementation of the policy and evaluate the long-term effects of these products on the environment and public health. To further contribute to the industry's green transition, the phased prohibition on the manufacture of 10 items will encourage the development and use of low- or no-mercury technology.  

On 28 December 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) released a draft notice to revise the criteria for determining poisonous and deleterious substances under the Poisonous and...

On 28 December 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) released a draft notice to revise the criteria for determining poisonous and deleterious substances under the Poisonous and Deleterious Substances Control Act. MHLW has published this consultation draft on the e-GOV public comment portal.  

Poisonous and Deleterious Substances Control Act 

The Act specifically outlines a registration system for companies that deal in toxic and dangerous materials, including container labelling, sale (transfer) procedures, safeguards against theft, loss, and leakage, transportation and disposal standards, and measures to control the prevention of improper distribution and leakage of toxic and hazardous materials. 

Previous revision in 2017   

The MHLW last revised the criteria in June 2017. The draft notice for revising the criteria was released in February 2017 and was enforced on 13 June 2017. 

Revised Criteria 

The draft notice has information about the criteria for adding or excluding chemicals from the Poisonous and Deleterious Substances list along with endpoints. Evaluations will consider acute toxicity (via oral, dermal, or inhalation exposure), local toxicity (such as skin corrosion and eye damage), and relevant human data. Substances with extreme toxicity and a high potential for misuse may be classified as Specific Poisonous Substances. 

The criteria also provide exemptions for certain tests where the properties of the substance make evaluation impractical (e.g. extreme pH values). Additionally, the exclusion of certain formulations from the list is addressed, with thresholds based on toxicity levels and concentration limits. 

Comment Period and Enforcement Dates  

Stakeholders are invited to comment on this consultation notice until 27 January 2025. The MHLW will issue the final draft after the end of the comment period. The Ministry has not yet confirmed the enforcement date. 

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.