Japan Regulatory News

On 31 July 2024, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE) jointly announced the addition of 164 new...

On 31 July 2024, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE) jointly announced the addition of 164 new chemicals to the General Chemical Substance List under the Chemical Substance Control Law (CSCL). Of these chemicals, three have been identified as posing significant risks to both human health and the environment.

Classification of General Chemical Substances

Under the CSCL, new substances are chemicals which are first submitted to the government for evaluation and are monitored for a period of 5 years. Substances that do not pose a significant risk after this evaluation period are classified as general chemical substances and made publicly available on the list and classified as 'newly announced substances'. These substances are further divided into two groups: those notified before 1 April 2011 and those notified after that date.

The list is updated every July, with the latest revision published at the end of the month. The General Chemical Substances List includes all chemicals, except following:

1. Priority Assessment Chemicals (PACs),
2. Class I and Class II Specified Substances
3. Monitoring and exempted substances.

Notification Requirements for Manufacturers and Importers

Companies that manufacture or import general chemical substances in quantities equal to or greater than 1 tonne per annum are required to notify METI. This requirement ensures that these substances are kept under review, even after they are added to the list of general chemical substances.

Highly Toxic Chemicals Added

Among the newly added chemicals, the following three have been classified as highly toxic:

• (eta(5)-cyclopentadienido) tris (n-methylmethanaminido-kappaN) zirconium
• 2-(4-aminophenyl)-1,3-benzoxazol-5-amine
• Reaction products of hydrogen peroxide and 1,4-bis{[(prop-2-en-1-yl)oxy]methyl}cyclohexane, which consists of 80% or more of 2,2'-[cyclohexane-1,4-diylbis(methyleneoxymethylene)]bis(oxirane).

Publication of Assessment Results

On the same day they were added to the list, METI also published the results of the assessment of the degradability and bioaccumulation of these chemicals. The list of added chemicals can be found here (in Japanese).

Japan Revises Food Additive Standards in the Food Sanitation Act   On 28 August 2024, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) of the revision of food a...

Japan Revises Food Additive Standards in the Food Sanitation Act  

On 28 August 2024, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) of the revision of food additive standards in the Food Sanitation Act. These changes include the removal of certain use standards for methyl cellulose and updates to the storage guidelines for dimethyl dicarbonate. 

Some Background 

Under Article 12 of the Food Sanitation Act 1947, designated food additives may be sold as per the Prime Minister. However, Article 13 of the Act establishes the standards for food additives in accordance with the Ministry of Health and Welfare Public Notice No. 370 of 1959, which forbids the sale of such additives unless they meet the requirements. The Committee on Food Additives of the Food Safety Standards Council in response to a request from the Prime Minister of Japan, has removed the use guidelines for methylcellulose and updated the storage guidelines for dimethyl dicarbonate. 

Removed Use Standards for the Methyl Cellulose 

Revised Storage Standards for Dimethyl Dicarbonate 

Comment Period and Enforcement Dates 

The 60-day comment period ends on 26 October 2024. The revised standards will take effect 6 months after their official publication in the gazette. 

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.