Japan Regulatory News

On 31 July 2025, Japan's Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly announced the addition of 157 new subs...

On 31 July 2025, Japan's Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly announced the addition of 157 new substances to the General Chemical Substance List under the Chemical Substance Control Law (CSCL). It has been determined that six of these substances pose major risks to both human health and the environment.

Previous update in July 2024

Earlier on 31 July 2024, Japan added 164 chemicals to the general chemical substance list & identified 3 chemicals with high toxicity profile. More details can be found here.

Classification of General Chemical Substances

Chemicals that are first submitted to the government for assessment and then monitored for five years are considered new substances, according to the CSCL. Chemicals that do not pose a significant risk are added to the list as "newly announced substances" and given the designation of general chemical substances following this evaluation period.

Notification Obligations for Manufacturers and Importers

Businesses must notify METI if they produce or import general chemicals in amounts of one tonne or more throughout the year. Even after these chemicals are included to the list of general chemical substances, this requirement guarantees that they are continuously reviewed.

Addition of Highly Toxic Chemicals

Six of the recently added chemicals have been identified as extremely toxic:

• Mixture of (1-)ammonium diaquabis(oxalato-kappa(2)O,O') oxidoniobate and (1-)ammonium diaquabis(oxalato-kappa(2)O,O') oxidoniobate-water(1/n)
• Disilver ethynediide
• Bis[4-({6-[(prop-2-enoyl)oxy]hexyl}oxy)phenyl] 2-{[(1,3-benzothiazol-2-yl)(6-{[(naphthalen-1-yl)acetyl]oxy}hexyl)hydrazinylidene]methyl}-1,4-phenylene bis[(1r,4r)-cyclohexane-1,4-dicarboxylate]
• 5,11,14,17-Tetrakis[(dimethylsilyl)oxy]-1,3,5,7,9,11,14,17-octaphenyltricyclo[7.3.3.3(3,7)]octasiloxane
• 4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole
• Copolymer of 2-(dimethylamino)ethyl 2-methylprop-2-enoate / N-benzyl-N,N-dimethyl-2-[(2-methylprop-2-enoyl)oxy]ethan-1-aminium chloride (It is limited that the content of the components having molecular weight less than 1,000 is 1% or less.)

Assessment results published

Additionally METI released the assessment results of these chemicals for bioaccumulation and degradability on the same day they were added to the list. The list of added chemicals can be found here.

On 25 July 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) published draft ordinance for amending the Poisonous and Deleterious Substances List on the country’s e-Gov Public Comment Po...

On 25 July 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) published draft ordinance for amending the Poisonous and Deleterious Substances List on the country’s e-Gov Public Comment Portal. Fenazaquin has been proposed to get added, whereas formulations containing sodium chlorate or sodium bicarbonate scheduled to get removed from the list.

Poisonous and Deleterious Substances List

The Poisonous and Deleterious Substances List under Japan's Poisonous and Deleterious Substances Control Act (PDSCA) classifies chemicals based on their toxicity and health risks, categorizing them as "poisonous" or "deleterious." These substances are regulated for safe handling, storage, and transportation to prevent accidents and ensure public safety. Updated regularly by Japan's MHLW, new substances are added based on scientific evidence. The regulations include safety procedures such as labelling, record-keeping, and reporting to minimize health and environmental risks. Currently there are 587 entries present on the list.

Key Insights from the Draft Ordinance

Draft ordinance proposes the following amendments to the list of Deleterious Substances:

• 4-[2-(4-tert-Butylphenyl)ethoxy]quinazoline (Fenazaquin) (CAS: 120928-09-8) and its preparations (except from those with a concentration ≤19.4%) have been designated as a new deleterious substance.
• Taking a formulation off the list: Made with sodium bicarbonate (27–37%) (CAS: 144-55-8) and sodium chlorate (47.5–52.5%) (CAS: 7775-09–9), except powdered versions.

It was determined that fenazaquin posed a significant risk of acute toxicity upon exposure, supporting its designation as a deleterious substance. On the other hand, it was found that the sodium chlorate/sodium bicarbonate formulation had far lower toxicity, which justified its removal from the list.

Obligations for the Stakeholders

Manufacturers, importers, and distributors of the Poisonous and Deleterious Substances must register their substances with the MHLW and comply with Safety Data Sheets (SDS) and Labelling regulations.

Comment Period and Enforcement Dates

Stakeholders are requested to comment on the draft till 24 August 2025. Final ordinance will be published in late October 2025. Enforcement is scheduled to be from 1 November 2025 (Except for delisting of entries which will come into effect on the same day of ordinance publication).

On 28 July 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) published draft ordinance for public solicitation to amend provisions under Food Sanitation Act. MHLW published the draft ordin...

On 28 July 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) published draft ordinance for public solicitation to amend provisions under Food Sanitation Act. MHLW published the draft ordinance on the Japan’s e-Gov Public Comment Portal. This time MHLW emphasized on the repeated import notification for food, food additives, apparatus, or food containers/packaging.

Regulatory Background

Article 27 of the Food Sanitation Act (Japan) stipulates that any person intending to import food, food additives, apparatus, or food containers/packaging for the purpose of sale or commercial use must submit an import notification to the Ministry of Health, Labour and Welfare (MHLW) each time. This requirement ensures that imported products comply with Japan’s safety standards before they enter the domestic market. The purpose is to prevent health hazards by allowing the authorities to monitor and control the safety of imported food-related items.

Key Insights from the Draft Ordinance

MHLW has provided the amendments in the draft ordinance and which have been tabulated below:

Comment Period and Enforcement Dates

Stakeholders are allowed to submit comments till 26 August 2025. While this draft ordinance will be promulgated in early October 2025 and is scheduled to be enforced from 12 October 2025.

In order to align the draft standards, JIS Z7252 and JIS Z7253, with GHS Rev. 9 which released on the portal, the Japanese Industrial Standards Committee (JISC) recently began a public solicitation. T...

In order to align the draft standards, JIS Z7252 and JIS Z7253, with GHS Rev. 9 which released on the portal, the Japanese Industrial Standards Committee (JISC) recently began a public solicitation. The draft updates are also included by JISC at the same time.  The Globally Harmonized System of Classification and Labelling of Chemicals (GHS), offers standardized components for communicating hazards, such as labels and Safety Data Sheets (SDS).

Regulatory Background

GHS labels and SDSs are required for chemicals governed by the three primary chemical regulations in Japan, which are the Poisonous and Deleterious Substances Control Law (PDSCL), the Industrial Safety and Health Law (ISHL), and the Pollutant Release and Transfer Register (PRTR) Law. The GHS framework in Japan consists of:

• JIS Z7252: Classification of chemicals based on Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and
• JIS Z7253: Hazard communication of chemicals based on GHS-Labelling and Safety Data Sheet (SDS)

Previous update in May 2019

Earlier Japan adopted GHS Rev. 6 through mandatory standards i.e. JIS Z7252:2019 & JIS Z7253:2019 published on 27 May 2019. More details can be found here.

Key Insights from the Draft

Comment Period and Enforcement Dates

Stakeholders are invited to provide comments on the draft till 9 August 2025. As of now there is no official announcement about the enforcement date of the standards.

Update: On 28 February 2025, MHLW published the revised list of chemicals causing skin irritation. This revised list contains updated provisions for skin irritants. More information can be found here....

Update: On 28 February 2025, MHLW published the revised list of chemicals causing skin irritation. This revised list contains updated provisions for skin irritants. More information can be found here.

 
Original Text:

On 23 October 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) released the list of chemicals identified as causing skin irritation or absorption through the skin. MHLW published the list on the Japan’s Workplace Safety Site. 

Regulatory Background 

According to Article 594-2 of the Industrial Safety and Health Regulations which came into force on 1 April 2024, the use of impermeable protective equipment is mandatory when handling certain substances. This regulation ensures that workers are adequately protected from direct exposure to hazardous chemicals, thereby reducing the risk of skin irritation and other health complications. 

Obligations for chemical handlers 

Employers and workers handling chemical preparations above the specified cut-off value must use impermeable protective equipment, such as gloves and protective clothing, to prevent direct skin contact with hazardous substances.  

Key details of the updated list of skin irritants 

The updated list contains 1210 entries of chemicals with data compiled as of 9 November 2023. The list includes information about: 

• CAS number 

• Chemical name as per Japan’s GHS classification 

• Name as per Industrial Safety & Health Act 

• % Cut-off value 

• Other usage provisions 

On 18 July 2025, The Ministry of Health, Labour, and Welfare (MHLW) in Japan released a list of substances that have been found to irritate skin or absorb through the skin. The list was made public on...

On 18 July 2025, The Ministry of Health, Labour, and Welfare (MHLW) in Japan released a list of substances that have been found to irritate skin or absorb through the skin. The list was made public on the Japan's Workplace Safety Site by MHLW. In addition with this update, MHLW also eliminated three entries from the list.

Regulatory Background

The Industrial Safety and Health Regulations, which went into effect on April 1, 2024, stipulate in Article 594-2 that using impermeable protective equipment is required when handling specific substances.  By ensuring that employees are sufficiently shielded from direct exposure to dangerous chemicals, this rule lowers the possibility of skin irritation and other health issues.

Obligations for chemical handlers

Employers and employees who handle chemical preparations above the designated cut-off value are required to wear impermeable protective equipment, such as gloves and protective clothes, to shield their skin from potentially harmful compounds.

Earlier Update in February 2025

Previously on 26 February 2025, MHLW revised the list of chemicals causing skin irritation. More information can be found here.

Key Findings from the Updated Skin Irritating List

Data obtained as of July 14, 2025, is included in 1236 entries of compounds in the updated list. The following details are included in the list:

• CAS number
• Name in accordance with the Industrial Safety & Health Act
• Chemical name in accordance with Japan's GHS classification
• Additional provisions
• % Cut-off value
• Effective date

On 4 July 2025, Japan’s Consumer Affairs Agency (CAA) released notice 437 regarding the addition of one chemical to the list of essential monomers which constitutes the base material in the Table 1,...

On 4 July 2025, Japan’s Consumer Affairs Agency (CAA) released notice 437 regarding the addition of one chemical to the list of essential monomers which constitutes the base material in the Table 1, Appendix 1 of the Standards for Food, Additives.  

3-methyl-1,5-pentanediol (CAS no 4457-71-0) has been added to the monomers list and, at the same time, removed from the optional substances list. The CAA started enforcing notice 437 from the date of publication. 

Standards and Criteria for Foods, Food Additives  

Requirements and guidelines for foods, milk and milk products, food additives, equipment, containers and packaging governed by the Food Sanitation Act and other laws are contained in the Standards and Criteria for Foods, Food Additives. The Ministry of Health, Labor and Welfare (MHLW) updates these standards on a regular basis to ensure they remain current and to safeguard the environment and public health. 

Key Insights from the Notice 

• The revision relates to Attachment 12, which governs polymers primarily composed of ester bonds. 

• The monomer “3-Methyl-1,5-pentanediol” has been reclassified: 

• Previously listed under “Optional Substances” 

• Now moved to the category of “Essential Monomers” 

• This change is in response to requests from industry stakeholders. 

Obligations for Stakeholders 

Only entries listed in the positive list (Base materials and Additives) of the Food Contact Materials (FCMs) are allowed to be used. New entities which are not listed must undergo a safety review procedure.