Japan Regulatory News

On 23 October 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) released the list of chemicals identified as causing skin irritation or absorption through the skin. MHLW published the list...

On 23 October 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) released the list of chemicals identified as causing skin irritation or absorption through the skin. MHLW published the list on the Japan’s Workplace Safety Site. 

Regulatory Background 

According to Article 594-2 of the Industrial Safety and Health Regulations which came into force on 1 April 2024, the use of impermeable protective equipment is mandatory when handling certain substances. This regulation ensures that workers are adequately protected from direct exposure to hazardous chemicals, thereby reducing the risk of skin irritation and other health complications. 

Obligations for chemical handlers 

Employers and workers handling chemical preparations above the specified cut-off value must use impermeable protective equipment, such as gloves and protective clothing, to prevent direct skin contact with hazardous substances.  

Key details of the updated list of skin irritants 

The updated list contains 1210 entries of chemicals with data compiled as of 9 November 2023. The list includes information about: 

• CAS number 

• Chemical name as per Japan’s GHS classification 

• Name as per Industrial Safety & Health Act 

• % Cut-off value 

• Other usage provisions 

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 27 December 2024, 131 new chemicals were added to the New Chemical chemicals List by the Japanese Ministry of Health, Labour and Welfare (MHLW) under the Industrial Safety and Health Act (ISHA). On...

On 27 December 2024, 131 new chemicals were added to the New Chemical chemicals List by the Japanese Ministry of Health, Labour and Welfare (MHLW) under the Industrial Safety and Health Act (ISHA). On the same day, an ISHA Notice was published revealing the identities of these additional substances.  

The updated list contains information about the new chemical substances listed on the MHLW's Workplace Safety Portal, including their name, ISHA official gazette serial number, and chemical and structural formula. The list can be accessed here. 

Previous Update:  149 New Chemical Substances added in September 2024  

The MHLW added 149 new chemical substances to the list via the MHLW Workplace Safety Portal in accordance with the notification published under ISHA on 27 September 2024. The update can be accessed here. 

Stakeholder Obligations under ISHA  

The list of compounds known as the Existing and New Chemical compounds (ENCS) now contains approximately 72,444 entries. Before manufacturing or importing such chemicals into Japan, manufacturers, importers, or businesses are required by the Industrial Safety and Health Act to notify the MHLW. The notification must include the name of the new chemical compound and the details of its hazard assessment in order to safeguard the health of industrial workers.  

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.