Japan Regulatory News

On 12 February 2025, Japan’s Ministry of Environment (MoE), together with the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) released a joint dr...

On 12 February 2025, Japan’s Ministry of Environment (MoE), together with the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) released a joint draft notice on its portal to amend the Priority Assessment Chemical Substances (PACS) list. This update will add 3 newly designated PACS and remove 7 PACS from the list. Following assessment of the chemicals, the three ministries have opened a public consultation on the same. In Japan, the Chemical Substances Control Law (CSCL) governs Priority Assessment Chemical Substances (PACS).

Background on PACS 

PACS are chemicals whose long-term effects on humans or the plants and animals that live in human habitats are not well understood. Therefore, in order to ensure compliance with METI laws and to encourage safety and responsibility in handling of chemicals, companies that manufacture or import these chemicals in quantities greater than 1 Tonne Per Annum (TPA) are required to file annual reports in order to protect living beings.     

Key Insights from the draft notice 

The draft notice lists the following chemicals that are proposed for addition to the PACS list because of their potential for causing long-term harm to humans or to plants and animals in the human environment is not fully understood: 

List of Newly Designated PACS 

The draft notice also lists the following chemicals whose PACS designation will be revoked due to: 

• Manufactured/imported volumes of less than 10 TPA reported for 3 consecutive years.  

• Indicated released volumes of less than 1 TPA to the environment. 

• Indication that they no longer pose a risk to living organisms. 

List of PACS to be delisted from the PACS list 

Comment Period  

Stakeholders are invited to comment on this joint draft notice till 13 March 2025. After receiving the comments, the three ministries will publicly announce further updates. 

On 7 February 2025, Japan’s Ministry of Economy, Trade and Industry (METI), in collaboration with the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE), released a ...

On 7 February 2025, Japan’s Ministry of Economy, Trade and Industry (METI), in collaboration with the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE), released a draft notice for the revision of the PAC list and monitoring procedures for FY2024. This update was published on METI’s portal on the same day. Priority Assessment Chemical Substances (PACS) are regulated under Japan’s Chemical Substances Control Law (CSCL). 

Background: PACs & Monitoring 

PACs are substances whose potential for long-term harm to humans or to plants and animals that inhabit human environments is not entirely apparent. Therefore, in order to protect living organisms, companies that manufacture or import these chemicals in amounts exceeding 1 Tonne Per Annum (TPA) must submit annual reports to assure adherence to METI regulations and to promote safety and responsibility in handling of chemicals.  

Key Insights from the draft notice 

In the draft notice, METI has proposed: 

• To delist two chemicals from the PACS list, as their annual reports for 3 consecutive years (FY 2020-2023) have indicated released volumes of less than 1 TPA to the environment, indicating that they no longer pose a risk to living organisms.  

• To monitor six chemicals from the PACS list for quantity monitoring for the coming years due to their potential environmental impact. These substances have reported manufacturing or import quantities of less than 10 TPA or environmental releases of less than 1 TPA.  

Enforcement Dates 

From the draft notice, it is evident that enforcement will be effective from April 2025. 

On 6 February 2025, Japan’s Consumer Affairs Agency (CAA) published a Q&A document on its portal to clarify the provisions of a Positive List for Food Contact Materials (FCMs). The Positive List is ...

On 6 February 2025, Japan’s Consumer Affairs Agency (CAA) published a Q&A document on its portal to clarify the provisions of a Positive List for Food Contact Materials (FCMs). The Positive List is currently in a 5-year transition period ending on 1 June 2025. At the end of the transition period, only entries on the list will be permitted in food contact applications. New materials must undergo assessment before they can be added to the list. 

Key Insights from the Q&A Document  

The main focus of the Q&A document is the Positive List of FCMs, which is governed by the Food Sanitation Act and overseen by the CAA. In general, this Act provides the basis for establishing standards for FCMs.   

The Q&A document covers topics which include following:  

• Scope and definition of the Positive List.  

• Exclusions from the list. 

• Specific product categories.  

• Provisions for polymeric substances. 

• Limits for additives. 

• Implementation guideline. 

Guidance for Stakeholders  

The Food Sanitation Act regulates FCMs in Japan, and the CAA frequently updates its portal to reflect the most recent changes to the requirements and criteria for foods and food additives. The purpose of this Q&A document is to help suppliers, importers, and manufacturers in making efficient use of the Positive List. Adhering to the list helps to prevent non-compliance in the manufacture, import and supply of FCMs. 

On February 6, 2025, the updated import customs clearance procedure for chemicals under the Chemical Substances Control Law (CSCL) was made available on the official portal of Japan's Ministry of ...

On February 6, 2025, the updated import customs clearance procedure for chemicals under the Chemical Substances Control Law (CSCL) was made available on the official portal of Japan's Ministry of Economy, Trade, and Industry (METI).  The revised process includes changes to documentation requirements and the classification of certain substances. 

Key changes to the import clearance procedure 

METI has provided the updated import customs clearance process as well as the following important information:  

• Types of chemicals and forms for importing chemicals (including those manufactured by foreign companies). 

• Documentation needed to be submitted for import clearance. 

• A list of prohibited products containing Class I Specified Chemical Substances (such as products of UV-328 and Dechlorane Plus) 

• A list of Class I Specified Chemical Substances (such as UV-328, Methoxychlor, and Dechlorane Plus) for which an import permit is required. 

Chemicals covered by the customs import clearance procedure  

The amended procedure covers the following categories of chemicals:  

• Chemicals intended for research and testing. 

• New chemical substances used as reagents. 

• General chemical substances. 

• Monitoring Chemical Substances or Priority Assessment Chemical Substances (PACS). 

• Class I and II Specified Chemical Substances. 

• New chemical substances. 

Previous Update in January 2025  

On 8 January 2025, METI released the import customs procedure for chemicals under CSCL available on its portal. Details can be found here. 

Abolishment and Enforcement Dates 

The updated import customs clearance procedure will take effect on 18 February 2025. The amended Appendix 2, which includes regulatory classification updates, will take effect on 18 June 2025. The previous procedure, published on 8 January 2025, will be revoked on 17 February 2025.

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 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. 

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.