Japan Regulatory News

Update: On 30 January 2025, the Japanese government notified the WTO that the proposed revisions to food additive standards under the Food Sanitation Act became effective on 23 January 2025.    ...

Update: On 30 January 2025, the Japanese government notified the WTO that the proposed revisions to food additive standards under the Food Sanitation Act became effective on 23 January 2025.  

Original Text: 

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 ended on 4 January 2025.   

On 10 January 2025, Japan’s National Institute of Technology and Evaluation (NITE) added ingredients used in cosmetics to the country’s Chemical Risk Information Platform (NITE-CHRIP). As a govern...

On 10 January 2025, Japan’s National Institute of Technology and Evaluation (NITE) added ingredients used in cosmetics to the country’s Chemical Risk Information Platform (NITE-CHRIP). As a government agency, NITE has been designated to provide chemical management information. NITE added cosmetic ingredients to the CHRIP for the first time in collaboration with the Japan Cosmetic Industry Association (JCIA).   

NITE-CHRIP Database 

NITE-CHRIP is a publicly available, free database that allows users or businesses to search for national and international legislation related to chemical substances. The database also provides summaries of compliance procedures along with chemical hazard or risk assessment information. NITE-CHRIP lists more than 250,000 entries, most of which include CAS data available in both Japanese and English.   

Regulatory Classification of Cosmetic Ingredients 

Standards for the use of cosmetic ingredients are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act). 

Cosmetic ingredients are classified into two lists: 

• Negative List (Appendix 1): Includes substances that are prohibited in cosmetics (excluding Class I and Class II Specified Chemical Substances under the Chemical Substances Control Law (CSCL)). 

• Positive List: Includes Appendices 2-4 with restricted ingredients, restricted ingredients of preservatives, and restricted ingredients of UV absorbers respectively. 

Obligations for Companies 

Companies dealing with such cosmetic ingredients in Japan are required to comply with the standards for cosmetics under the PMD Act. 

On 23 January 2025, Japan’s National Institute of Technology and Evaluation (NITE) published the English version of the list of 169 chemicals classified according to the provisions of the Globally ...

On 23 January 2025, Japan’s National Institute of Technology and Evaluation (NITE) published the English version of the list of 169 chemicals classified according to the provisions of the Globally Harmonized System for Classification and Labelling (GHS) on its portal. NITE released the updated list for FY 2022 on the portal on behalf of the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Environment (MOE) and the Ministry of Economy, Trade and Industry (METI) - the three ministries responsible for GHS classification in Japan. 

Previous Update 

Earlier, on 21 June 2024, NITE published the GHS list for 160 chemicals (FY 2023) on its portal. More details can be found here. 

Insights from the Update 

The FY 2022 list includes 47 entries for newly classified substances and 122 entries for revised GHS classified chemicals. This list covers classifications from 1 April 2022 to 31 March 2023. NITE also provided the detailed information of the classified chemical for: 

• Hazard Class 

• Pictogram 

• Signal Word 

• Hazard and Precautionary Statements 

• Classification Details 

• CAS and Identification Numbers 

• Reference Data 

Obligations for Companies 

Companies are advised to have updated GHS information available when preparing labels or Safety Data Sheets (SDSs). However, it’s not mandatory to use the classification provided. Companies may use alternative data or test results which are not covered by the MHLW, MoE and METI.  

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.