Japan Regulatory News

On 6 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) released the final enforcement notice for the Revised Criteria for Poisonous and Deleterious Substances and related provisions....

On 6 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) released the final enforcement notice for the Revised Criteria for Poisonous and Deleterious Substances and related provisions. The MHLW published the notice via Pharmaceuticals and Medical Devices Agency Notification No. 0306-6 on the notification portal of Japan’s National Institute of Health Sciences (NIHS). This enforcement took effect on the same day that the MHLW published the notice. 

For background on the draft criteria and consultation process, see the original news here. 

On 3 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) notified the World Trade Organization (WTO) of draft revisions to the Industrial Safety and Health Act (ISHA) aimed at enhancin...

On 3 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) notified the World Trade Organization (WTO) of draft revisions to the Industrial Safety and Health Act (ISHA) aimed at enhancing the delivery of safety data sheets (SDSs). The MHLW has made significant changes to the Safety Data Sheets content aiming to improve the safety of employees when handling hazardous chemicals.  

Background on ISHA: Delivery of Documents 

Under Article 57-2 of ISHA, the delivery of documents such as labels or safety data sheets is crucial for hazardous chemicals. Exposure to these chemicals might cause harm or side effects to employees working on-site. Transferors and suppliers are obliged to provide updated SDSs to the personnel working there. 

Key Provisions in the Draft Revision  

The MHLW has made the following three provisions in the draft notice for SDS delivery: 

1. Establishment of a punitive clause for non-compliance with hazard statement notifications for transferors/providers of chemical substances. 

2. Changes to the notification provisions for transferors and providers will become the new obligatory regulations.  

3. Allows notification using alternative names for confidential business information. Obligations to record and maintain information on ingredients, provide information to doctors, and report to labour standards inspection agencies. 

Comment Period and Enforcement Dates 

Stakeholders are invited to submit comments on this draft notice till 2 May 2025. The Ministry has not yet confirmed the adoption date of these provisions, but has released the scheduled enforcement dates. 

On 26 February 2025, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) of a proposed revision to water quality standards under the Food Sanitation Act. This revis...

On 26 February 2025, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) of a proposed revision to water quality standards under the Food Sanitation Act. This revision aims to establish specifications for sterilized or filter sterilized mineral water. At the same time, the CAA published this notice on Japan’s e-GOV Public Comment Portal.  

Background 

According to Article 12 of the Food Sanitation Act 1947, the Prime Minister may allow the sale of specific food additives. However, the Health and Welfare Public Notice No. 370 of 1959 prohibits the sale of food additives unless they comply with the regulations, as set out in Article 13 of the Act.  

The Food Safety Commission of Japan (FSCJ) has reviewed specifications and standards for mineral water and assessing the health effects of synthetic organofluorine chemical compounds, particularly per- and polyfluoroalkyl substances (PFAS), in food. As a result, Japan will establish water quality standards for perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) in sterilized or filter sterilized mineral waters under the Water Supply Act. 

New Standards for Mineral Water  

The following new standards for PFOS and PFAS in mineral water will be established: 

Comment Period and Enforcement Dates 

The 60-day comment period will end on 27 April 2025. The newly established standards are expected to be enforced from 1 April 2026.   

On 17 February 2025, Japan released a document entitled "J4CE 2024 Noteworthy Cases", which highlights key circular economy initiatives, led by businesses and local governments under the Japan Circula...

On 17 February 2025, Japan released a document entitled "J4CE 2024 Noteworthy Cases", which highlights key circular economy initiatives, led by businesses and local governments under the Japan Circular Economy Partnership (J4CE).  

Background: Japan Partnership for Circular Economy (J4CE) 

In March 2021, the Ministry of the Environment, the Ministry of Economy, Trade, and Industry, and the Japan Business Federation (Keidanren) launched the Japan Circular Economy Partnership (J4CE), a public-private project in Japan. It aims to advance the principles of circular economy by encouraging cooperation between companies, governmental bodies, and trade associations. In order to promote sustainable resource management, waste reduction, and recycling innovations in Japan, J4CE facilitates policy discussions, business networking, and knowledge exchange. This collaboration is critical to coordinating Japan's activities with international circular economy projects, such as those outlined by the G7.  

Key Highlights from the “J4CE 2024 Noteworthy Cases” Report 

The report highlights a wide range of initiatives across multiple sectors: 

• Plastic Recycling and Repurposing: In order to produce new goods, creative projects focus on collecting and recycling used domestic plastics, industrial plastic waste, and plastic packaging (e.g. Aeon Co., Ltd). 

• Construction Waste Management: Initiatives include recycling glass and plastic waste from construction sites, reusing construction materials, and implementing digital tracking systems (e.g. Taisei Corporation). 

• Household Waste and Consumer Engagement: Programs encourage the recycling of consumer goods and used packaging, including small gadgets and diapers often use digital platforms to provide incentives for participation (e.g. Mercari Co Ltd.).  

• Automotive and Industrial Recycling: To reduce landfill waste and carbon emissions, programs concentrate on recovering and recycling plastic materials from end-of-life automobiles and industrial by-products (e.g. Mitsui and Co., Ltd.).  

• Technological Innovation: To maximize resource recovery and boost recycling effectiveness, businesses are using digital technologies and AI-driven analytics.  

Other Initiatives Supporting Japan’s Circular Economy 

With an emphasis on resource efficiency, waste reduction, and sustainable business models, Japan has created a number of frameworks to move towards a circular economy. Among the crucial frameworks are: 

1. Basic Act for Establishing a Sound Material-Cycle Society (2000) 

2. Plastic Resource Circulation Act (2022) 

3. Circular Economy Roadmap (2021) 

4. Japan Circular Economy Partnership (J4CE, 2021) 

5. Extended Producer Responsibility (EPR) Policies 

These frameworks, along with the efforts of J4CE, highlight Japan's commitment to sustainable resource management and its proactive approach to addressing environmental challenges through collaborative and innovative solutions. 

Update: On 18 February 2025, Japan designated three POPs as Class I Specified Chemical Substances, in line with the scheduled notice. As of this date, there are a total of 39 chemicals on the list.  ...

Update: On 18 February 2025, Japan designated three POPs as Class I Specified Chemical Substances, in line with the scheduled notice. As of this date, there are a total of 39 chemicals on the list. 

Original Text: 

On 19 September 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MoE) jointly notified the World Trade Organization (WTO) of a draft proposal to designate three chemicals as Class I Specified Chemical Substances. The three chemicals which were mentioned in the draft are Methoxychlor, Dechlorane Plus and UV-328. 

The Act on the Regulation of Manufacture and Evaluation of Chemical Substances regulates these Class I Specified Chemical Substances, which will be amended to add these three chemicals to the list of Class I Specified Chemical Substances. 

The three Class I Specified Chemical Substances are as follows. 

Background 

Earlier in May 2023, at the 11th Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants (POPs) these three chemicals were added to Annex A of the Convention which can be accessed here. In reply to this, a consultation regarding these designations was held by the three ministries in December 2023. 

Class I Specified Chemical Substances 

Class I Specified Chemical Substances are defined under Japan's Chemical Substances Control Law (CSCL) as substances that have been determined to be persistent, extremely bioaccumulative, or potentially hazardous to the environment and human health over an extended period of time. Manufacturers and importers are required to obtain a permit before manufacturing or importing certain compounds.   

Exemptions 

This order includes some exemptions for the use of Dechlorane Plus in certain applications. 

Comment Period and Enforcement Dates 

Stakeholders are invited to comment on this draft proposal until 18 November 2024. The enforcement order will be adopted in December 2024 and come into force in February 2024. In addition, the importation of products containing Dechlorane Plus and UV-328 (as listed in the table below) will be banned from June 2025. 

Update: On 18 February 2025, the updated import customs clearance procedure became effective, in line with the scheduled notice.    Original Text:  On February 6, 2025, the updated import ...

Update: On 18 February 2025, the updated import customs clearance procedure became effective, in line with the scheduled notice. 

Original Text: 

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.

Update: On 18 February 2025, Japan officially designated the three chemicals as Class I Specified Chemical Substances, in line with the scheduled notice.    Original Text:  On 5 December ...

Update: On 18 February 2025, Japan officially designated the three chemicals as Class I Specified Chemical Substances, in line with the scheduled notice. 

Original Text: 

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.