Japan Regulatory News

Japan has recently scheduled a public consultation to update the list of chemicals and mixtures which require labelling and safety data sheets (SDS). Under the provisions of the Industrial Safety and ...

Japan has recently scheduled a public consultation to update the list of chemicals and mixtures which require labelling and safety data sheets (SDS). Under the provisions of the Industrial Safety and Health Act, it is mandatory to follow the Globally Harmonized System (GHS) for labelling.

This public consultation is scheduled for 20 September 2024. Non-Japanese manufacturers and importers doing business in Japan are encouraged to participate by submitting comments on the draft proposal. Stakeholders have to register to participate in this consultation.

Classification List Update

Japan’s Ministry of Health, Labour and Welfare (MHLW) has proposed to add 155 substances to the classification list, which currently includes substances listed until 31 March 2024. In addition, the draft proposes to eliminate 2 substances from the list. Previously, substances classified till 31 March 2021 were added to the list.

Enforcement Dates

The 155 chemicals are expected to be added to the list by April 2027. However, the MHLW has not yet announced the date for the elimination of the following 2 substances from the list:

1. Sodium stearate

2. Phosphoric acid, triphenyl ester

On 30 August 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) amended the New Chemical Substances List by adding 141 new substances. This update follows the Ministry’s previous notice u...

On 30 August 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) amended the New Chemical Substances List by adding 141 new substances. This update follows the Ministry’s previous notice under the Industrial Safety and Health Act (ISHA) which was published on 27 June 2024 and announced the names for these new chemical substances.

The latest additions to the list include details such as the name, ISHA official gazette serial number, chemical and structural formula for the new chemical substances all of which are available on the MHLW Work Safety Portal. Under the Industrial Safety and Health Act, manufacturers, importers or companies must notify the MHLW before manufacturing or importing such chemicals into Japan. The notification, must include the name and hazard evaluation details of the new chemical substance as this is necessary to safeguard the health of workers at the industrial workplace.

The Role of the Industrial Safety and Health Act (ISHA)

An important part of legislation that aims to protect workers' health, safety, and well-being at work is Japan's Industrial Safety and Health Act (ISHA). The Act, which was established in 1972, uses a variety of safety precautions, rules and employer requirements to prevent workplace accidents and health problems.

New Chemical Substances List

The Existing and New Chemical Substances (ENCS) List covers chemicals imported, manufactured and used in the Japanese market. New substances are those approved after 1974 by the regulatory authorities. These new substances are not yet listed on the ENCS database. There are currently over 72,000 compounds on the list.

On 5 September 2024, Japan’s Consumer Affairs Agency (CAA) proposed to delete 32 food additive entries from the Existing Food Additives List, as specified in the Ministry of Health and Welfare (MHLW...

On 5 September 2024, Japan’s Consumer Affairs Agency (CAA) proposed to delete 32 food additive entries from the Existing Food Additives List, as specified in the Ministry of Health and Welfare (MHLW) Public Notice No. 120, 1996. The same draft was notified on 10 September 2024 to the World Trade Organization (WTO). 

Since 1 April 2024, the Consumer Affairs Agency (CAA) has been in charge of the publication and assessment of food standards.  

Background on the Existing Food Additives List 

Under Article 2-3 of the supplementary provisions to the Food Sanitation Act and the Nutrition Improvement Act (Act No. 101 of 1995), the CAA has the authority to amend the list of Existing Food Additives. This deletion of entries generally depends on factors such as sale, manufacturing, import, processing, use, storage, and display of the additives. 

A survey conducted and reviewed by the MHLW during the period June 2023 to June 2024, concluded that 32 entries were no longer distributed in Japan. Therefore, the CAA has recommended their removal from the list as of 4 September 2025. A list of the 32 food additives to be removed can be found here. 

Comment Period and Enforcement Dates 

Currently, the CAA has invited interested stakeholders to comment on this draft until 4 March 2025. Once the entries are ready to be eliminated, the CAA will delete the entries from the list and this will be enforced from 4 September 2025. 

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.