Japan Regulatory News

On 8 January 2025, Japan’s Ministry of Economy, Trade and Industry (METI) released the revised import customs procedure for chemicals under the Chemical Substances Control Law (CSCL) on its official...

On 8 January 2025, Japan’s Ministry of Economy, Trade and Industry (METI) released the revised import customs procedure for chemicals under the Chemical Substances Control Law (CSCL) on its official portal.  

METI has provided the revised import customs procedure along with the following key details:

• definitions of types of chemicals, forms for importing chemicals (including overseas manufacturers)
• documents required for submission at the import clearance
• list of prohibited products containing Class I Specified Chemical Substances 
• list of Class I Specified Chemical Substances requiring a permit 

Chemicals covered under the import customs procedure 

The revised procedure applies to the following types of chemical substances: 

• Chemical substances for research and testing 
• New chemical substances as reagents 
• General chemical substances 
• Monitoring Chemical Substances or Priority Assessment Chemical Substances 
• Specified chemical substances (Class I & II) 
• New chemical substances 

Previous Update in August 2024  

METI previously published the import customs procedure for chemicals under CSCL on its portal on 9 August 2024.  

Abolishment and Enforcement Dates 

The revised import customs procedure came into effect on 10 January 2025. The older procedure, published on 9 August 2024, was revoked on 9 January 2025.

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 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 1149 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 

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 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.