Japan Regulatory News

On 1 August 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) jointly released a notice to designate p...

On 1 August 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) jointly released a notice to designate perfluorohexane sulfonic acid (PFHxS)-related chemicals as Class I Specified Chemical Substances. In addition, the notice also specifies a ban on the import of 10 products containing PFHxS-related chemicals. Although there is no deadline for implementation, the ministry stated that more talks will take place after 2025. 

PFHxS designated as Class I Specified Chemical Substances 

The manufacture, import and use of PFHxS-related chemicals will be banned unless deemed needed. PFHxS,,characterised by a branched structure with 6 carbon atoms i.e. perfluoro (hexane-1-sulfonic acid) or perfluoro (alkanesulfonic acid) are derived from compounds with a (tridecafluoroalkyl) sulfonyl group and six carbon atoms. A license is required to manufacture or import these chemicals. 

The Notice provides specific details on the chemicals listed, identified by their CAS numbers: 

Ministry bans import of 10 products containing Class I Specified Chemical Substances 

The following products containing PFHxS-related chemicals will be banned from import: 

1. Fire extinguishers, extinguishing agents for fire extinguishers, and foam extinguishing agents 

2. Etching agents used in metal processing  

3. Surface treatment agents for plating and additives for their preparation 

4. Fabrics treated to impart water- or oil-repellent properties  

5. Clothing treated to impart water- or oil-repellent properties  

6. Floor coverings treated to impart water- or oil-repellent properties  

7. Water-repellent agents, oil-repellent agents, and textile protective agents  

8. Antireflective agents used in semiconductor manufacturing  

9. Etching agents used in semiconductor manufacturing  

10. Resist for semiconductors 

Regulations on the use of Class I Specified Chemical Substances 

According to the Chemical Substances Control Law (CSCL), the use of chemicals is prohibited except for essential use or for testing and research purposes.  

Technical Standards for Handling of Class I Specified Chemicals 

When handling the following products that use Class 1 Specified Chemical Substances, follow the separately prescribed technical handling standards: 

• Fire extinguishers,  

• Extinguishing agents for fire extinguishers 

• Foam extinguishing agents 

Manufacturing Permit 

According to the Notice, manufacturers need to obtain a permit to produce such Class I Specified Chemicals and shall seek permission from the Ministry of Economy, Trade and Industry (METI). The application must include the following details: 

• Name or trade name and address, and in the case of a corporation, the name of its representative 

• Location of business establishment 

• Name of the Class 1 Specified Chemical Substance   

• Structure and capacity of the manufacturing facility. 

After approval of the permit, the manufacturer must immediately notify the Ministry of Environment (MOE). 

Import Permit 

For importers, an import permit is required from the Ministry of Economy, Trade and Industry, with an application containing the following details:  

• Name or trade name and address, and in the case of a corporation, the name of its representative. 

• Name of the Class 1 Specified Chemical Substance. 

• Import quantity 

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 Orde...

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 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 (WT...

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: October 2024
• Date of Entry into Force: April 2025
• Deadline for Comments: 60 days from notification

Companies are encouraged to review the proposed regulations and provide feedback within the specified comment period. This proactive step is critical to ensuring that the regulations are comprehensive and effective in achieving their intended protective measures.

On 21 June 2024, Japan took a significant step in chemical safety management by releasing an updated list of new and revised Globally Harmonized System (GHS) classifications for 160 chemical substance...

On 21 June 2024, Japan took a significant step in chemical safety management by releasing an updated list of new and revised Globally Harmonized System (GHS) classifications for 160 chemical substances. This update was published by the National Institute of Technology and Evaluation (NITE) on behalf of the Ministry of Health, Labour and Welfare (MHLW), the Ministry of the Environment (MOE) and the Ministry of Economy, Trade and Industry (METI).

This GHS classification was performed based on the information sources and guidance for classification and evaluation which are described in the GHS Classification Guidance for the Japanese Government etc.

Details of the Update:

• New Classifications: The update includes 48 newly classified substances such as Oxiran-2-ylmethyl neodecanoate (CAS 26761-45-5) and Cycloaliphatic epoxy resin (CAS 2386-87-0).
• Revised Classifications: It also revises the classifications for 112 existing substances, including 1,2-Dichloropropane (CAS 78-87-5) and Cellosolve acetate (CAS 111-15-9).

Comprehensive Information:

The detailed list is available in both Japanese and English. It includes the following critical information for each substance:

• Hazard Class
• Pictogram
• Signal Word
• Hazard and Precautionary Statements
• Classification Rationale
• CAS Numbers
• Reference Materials

The classifications were finalized during the fiscal year 2023, from 1 April 2023, to 31 March 2024.

Implications for Companies:

While companies are encouraged to use this updated list as a reference when preparing GHS-based labels or Safety Data Sheets (SDS), it is not mandatory. Companies may choose to use other test results and information sources to support their labels and SDS content.

Japan follows the sixth revised edition of the UN Globally Harmonized System of Classification and Labelling of Chemicals. Currently, Japan's GHS list includes a total of 3376 substances. This update reinforces Japan's commitment to chemical safety and aligns with global standards for chemical classification and labelling. Companies involved in the production, handling or use of these substances should review the new classifications to ensure compliance and safety.

Japan’s Ministry of Economy, Trade and Industry (METI) has proposed significant amendments to the procedures related to the manufacture of Class I Specified Chemical Substances under the Enforcement...

Japan’s Ministry of Economy, Trade and Industry (METI) has proposed significant amendments to the procedures related to the manufacture of Class I Specified Chemical Substances under the Enforcement Regulations of the Law Concerning the Examination and Regulation of Manufacture, etc. of Chemical Substances. The proposed changes which aims to facilitate the transition to an electronic application system, were announced in a consultation notice on 25 May 2024. The public consultation period is set to conclude on 23 June 2024.

Class I and II Specified Chemical Substances

Under Japan's Chemical Substances Control Law (CSCL), Class I Specified Chemical Substances are those that have been assessed as being persistent, highly bioaccumulative, or posing a risk of long-term toxicity to human health and the environment. Manufacturers and importers of these substances must obtain a permit prior to manufacture and import. Class II Specified Chemical Substances are characterized by a risk to human health and/or the environment due to long-term toxicity, with a substantial amount remaining in the environment over large areas.

Details of the Proposed Changes

METI has clarified the conditions under which 'minor changes' notifications are required. Licensed manufacturers of Class I Specified Chemical Substances will be exempt from notifying METI if changes to manufacturing equipment do not pose a risk of leakage and do not change manufacturing capacity.

Additionally, METI's proposed amendments include the adoption of the existing annual reporting format for e-submissions, which includes monthly manufacturing, inventory, use, and storage volumes.

The transition to an online application system will require the use of electronic signatures for applications and notifications, including those related to Class II Specified Chemical Substances and the products in which they are used.

The proposed amendments are set to come into force upon promulgation, which is expected in July.

Japan will implement a ban on 21 products containing perfluorooctanoic acid (PFOA) isomers, their salts and PFOA-related compounds, as announced on 26 April 2024. This significant move by the Ministry...

Japan will implement a ban on 21 products containing perfluorooctanoic acid (PFOA) isomers, their salts and PFOA-related compounds, as announced on 26 April 2024. This significant move by the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI) and the Ministry of Environment (MOE) is a crucial step towards protecting the environment and public health.

Amendments to Chemical Substance Regulations

The proposal will amend the Order for Enforcement of the Act on the Evaluation of Chemical Substances and Regulation of their Manufacture to designate certain substances as Class I Specified Chemical Substances:

• PFOA with a branched structure and eight carbon atoms and its salts.

• PFOA-related compounds, including perfluorooctyl iodide (PFOI) and 8:2 fluorotelomer alcohol (8:2 FTOH).

• Compounds (with seven carbon atoms) containing a pentadecafluoroalkyl group directly bonded to a carbon atom and containing perfluorooctanoic acid or perfluoroalkane acid with a branched structure and eight carbon atoms as a result of a natural chemical reaction.

When a substance is designated as a Class 1 Specified Chemical Substance its manufacture, import, and use are generally prohibited in accordance with the provisions of the Cabinet Order.

Import Bans

The proposed ban will specifically prohibit the import of the following:

Transitional Measures

In order to facilitate a smooth transition, the proposal includes several measures:

• Medical Devices: The use of 8:2 FTOH for the manufacture of invasive and implantable medical devices will be allowed until 3 December 2025.

• Pharmaceutical Products: Use of PFOI for the manufacture of perfluorooctyl bromide (PFOB) allowed until 31 December 2036.

• Manufacturing Permits: Companies can apply for permits to manufacture PFOI and 8:2 FTOH before the enforcement date, effective upon approval.

• Permit the temporary use of fire extinguishers, fire extinguishing agents and fire extinguishing foam that contain PFOA isomers and salts.

Technical Standards and Environmental Protection

The proposal also stipulates technical standards for manufacturing facilities that handle PFOI and related substances. Additionally, companies will have to include environmental protection information on containers, packaging or invoices for these substances.

Consultation and Enforcement Timeline

The authorities plan to review feedback from Council members and other organizations before finalizing the draft Order for PFOA-related compounds. This review will take place after June but before the enforcement date.

Consultation Period: Ended on 25 May 2024

Public Notice Announcement: Expected in July

Enforcement Date: January 2025 for the general ban; September 2024 for PFOA with a branched structure and eight carbon atoms as a Class I Specified Chemical Substance.

Japan’s Ministry of the Environment (MOE) has allocated funding for three pioneering projects dedicated to understanding the health effects associated with per- and polyfluoroalkyl substances (PFAS)...

Japan’s Ministry of the Environment (MOE) has allocated funding for three pioneering projects dedicated to understanding the health effects associated with per- and polyfluoroalkyl substances (PFAS). The three projects were selected by the PFAS Research Steering Committee from a pool of 14 submissions received by the MOE following a call for proposals from 26 December 2023 to 5 February 2024.

Under the overarching theme of Comprehensive Research on PFAS, the selected projects are as follows:

1. Hyogo Medical University: This project aims to conduct experimental validation to shed light on the immunosuppressive and immune-promoting effects of PFAS in the context of immunological diseases.
2. National Institute of Health Sciences (NIHS): Focused on innovation, this project endeavors to develop a hazard assessment methodology grounded in gene expression analysis. Such an approach seeks to facilitate prioritization and holistic evaluation in the context of PFAS regulation.
3. Hokkaido University: Embarking on a multidimensional exploration, this comprehensive initiative aims to elucidate the health effects of PFASs, taking into account toxicological impacts, mechanisms of toxicity development and interspecies variations. This integrated study merges environmental epidemiology and toxicology to provide a deeper understanding of the subject matter.