Japan Regulatory News

On 20 August 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MoE) jointly released draft amendmen...

On 20 August 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MoE) jointly released draft amendments to the guidelines under Chemical Substances Control Law (CSCL).

The draft notification was published on Japan’s e-GOV Public Comment Portal.

The proposed revisions aim to update the operational framework in light of the 2025 assessment of the 2017 CSCL amendment and Japan's long-term chemical substance management policy. The notification from 29 March, 2019 on the management of by-product Class I Specified Substances will also be revised. 

Key Amendments

Article 1 – Impurities containing Class I Specified Substances

Previously, the rules  applied only when Class I Specified Substances were present as by-products.

The amended rules extends the scope to include cases where these substances are present as impurities, thus broadening regulatory coverage.

Article 2 – Structural Changes and Clarifications

Restructuring: Introduces a new section "1. Common Provisions", consolidating general rules applicable throughout the guideline.

Clarifications:

Distinguishes between anhydrous and hydrated  forms of substances.

Clarifies definitions of terms for organic polymers.

Existing vs. New Substances: Certain substances previously excluded from the definition "new" will now be explicitly treated as existing chemical substances, with references to specific provisions in the law (Article 2, paragraphs 4, 5, 7).

Article 3 – Existing Chemicals: Revises the definition of "existing chemical substances" with necessary updates.

Comment Period and Enforcement Dates

Stakeholders are invited to submit comments on the draft amendment by 19 September 2025. The ministries plan to adopt the final version  in late September 2025, with enforcement taking place in phases as outlined below:

On 5 August 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MoE) jointly published draft amendments to no...

On 5 August 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MoE) jointly published draft amendments to notification norms for the Manufacture or Import of New Chemical Substances under Chemical Substances Control Law (CSCL). The draft was released on Japan’s e-GOV Public Comment Portal. The scope of the draft covers:

• New substances 
• Small-quantity new substances 
• Polymer substances
• Low-volume new substances

Key Insights from the Draft Amendment

The m inistries have included the following amendments in the draft:

I. Amendment to the Ministerial Ordinance

1. Article 1 Amendments

1. Addition of electronic filing for foreign manufacturers (Art. 3):

Foreign manufacturers of new chemical substances will now be allowed to submit electronic filing.

2. Electronic filing requirements (Arts. 11, 13, 15, 16):

• In addition to electronic signatures, a PIN (e.g., G-Biz ID Prime or Member) will be accepted.
• For certain applications, reports on confirmed new substances, applications for confirmation of small-quantity new substances, polymer substances, and low-volume new substances, the “applicant code” requirement will be abolished and replaced with the PIN system (Art. 16 to be deleted).
• Related forms (Forms 1, 11, 15–17) will be revised accordingly.

2. Article 2 Amendments

1. Principle of electronic application (Arts. 6 & 9):

Electronic filing will become the standard method for applying for confirmation of small-quantity and low-volume new chemical substances. Paper applications will only be allowed when electronic submission is extremely difficult.

II. Amendment to Related Ministerial Notification

Technical standards, designated computers, certificates, and input methods, and formats will be revised to align with the ordinance changes.

Comment Period and Enforcement Dates

Stakeholders are invited to comment on the draft amendment until 3 September 2025. Japan is expected to adopt the draft in October 2025. Enforcement dates are summarised in the table below:

On 5 August 2025, Japan’s Ministry of Economy, Trade and Industry (METI) published draft amendments to notification provisions for the manufacture or import of chemicals under Chemical Substances Co...

On 5 August 2025, Japan’s Ministry of Economy, Trade and Industry (METI) published draft amendments to notification provisions for the manufacture or import of chemicals under Chemical Substances Control Law (CSCL). The draft was released on Japan’s e-GOV Public Comment Portal. The changes apply to: 

• General chemical substances
• Priority assessment substances
• Monitoring chemical substances
• Class II specified chemical substances  

Key Insights from the Draft

METI has proposed the following revisions in the draft: 

I. Amendment to the Ministerial Ordinance

1. Cleanup of Regulations (Articles 18 & 19)

• Article 18 and 19 (previously marked for deletion) will now be formally removed.

2. Changes to Electronic Notification Requirements (Articles 20–21)

• In addition to electronic signatures, user-set passcodes (such as G Biz ID) become acceptable authentication methods.
• This applies to notifications for:
  • General chemical substances (Article 9-2)
  • Priority assessment substances (Article 9-3)
  • Monitoring chemical substances (Article 10)
  • Class II specified chemical substances (Article 15)

The notifier code requirement will be abolished and replaced with the new passcode system. As a result, Article 21 will be repealed.

3. Revision of Article 19

A new Article 19 will clarify name/identity declaration requirements in line with Article 6(4) of the Act on Advancement of Utilizing Information and Communication Technology in Administrative Procedures (Law No. 151 of 2002).

4. Other Related and Formatting Amendments:

Additional revisions will be made to: Articles 5-2, 9-2, 9-3(2), 10(2), 15(2), and Article 22 (renumbered as Article 20),as well as to the Supplementary Provisions on transitional measures.

II. Amendment to METI Notification Related to Technical Standards

The notification specifying the technical standards for computers and electronic certificates under Articles 20 and 20-2 will be updated to reflect the regulatory changes mentioned above .

Comment Period and Enforcement Dates 

Stakeholders are invited to comment on the draft by 3 September 2025. METI plans to publish the final draft in October 2025, while enforcement is scheduled to begin on 1 April 2026.

Update: On 29 July 2025, Japan's MHLW released the revised enforcement notice to remove the chemicals from the list of mandatory safety data sheets (SDS) and labelling. The notice was published on the...

Update: On 29 July 2025, Japan's MHLW released the revised enforcement notice to remove the chemicals from the list of mandatory safety data sheets (SDS) and labelling. The notice was published on the Japanese e-GOV Public Comment Portal by MHLW. The enforcement date was rescheduled by the government from April 1, 2027, to late September 2025. This notice will take effect on the day it is promulgated, as two chemicals i.e. sodium stearate and phosphoric acid, triphenyl ester will be removed from the list. The deadline for stakeholder comments on this draft is August 28, 2025.

Original Text:

On 8 October 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) notified a draft to the World Trade Organization (WTO), proposing amendments to the list of chemicals and mixtures that require mandatory labelling and safety data sheets (SDS). This update, which would amend the Enforcement Order of the Industrial Safety and Health Act and is scheduled to be adopted in December 2024. Under the provisions of the Industrial Safety and Health Act (ISHA), it is mandatory to follow the Globally Harmonized System (GHS) for labelling.

Public consultation in September 2024

On 20 September 2024, the MHLW launched a consultation to not only add 155 substances to the classification list, but also to eliminate two substances from the list, which includes substances classified until 31 March 2024.

Comment Period and Enforcement Dates

Stakeholders are invited to comment on the draft proposal until 7 December 2024. The 155 chemicals are expected to be added to the list by April 2027. At the same time, sodium stearate and phosphoric acid, triphenyl ester will be eliminated from the list.

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 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.

The Japanese Industrial Standards Committee (JISC) has launched a public consultation on draft standards JIS Z7252 and JIS Z7253, to bring Japan’s chemical communication framework into line with the...

The Japanese Industrial Standards Committee (JISC) has launched a public consultation on draft standards JIS Z7252 and JIS Z7253, to bring Japan’s chemical communication framework into line with the ninth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS Rev. 9) The draft revisions were recently published on the JISC portal. The GHS provides standardized components for communicating hazards, such as labels and Safety Data Sheets (SDS).

Regulatory Background

In Japan, GHS-compliant labels and SDSs are required for chemicals governed by the three primary chemical regulations: 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 implementation of GHS in Japan is based on the following two key JIS standards:

• 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

In 2019, Japan adopted GHS Rev. 6 through the mandatory standards JIS Z7252:2019 and JIS Z7253:2019 published on 27 May 2019. More details can be found here.

Key Insights from the Draft 

JIS Z7252 (Classification)

• Explosives: The classification will shift from transport-based (1.1–1.6) to use-based (Divisions 1, 2A, 2B, and 2C).
• Flammable gases: Category 1B is added (lower flammability); current Category 1 becomes 1A; pyrophoric and chemically unstable gases become subcategories of 1A.
• Aerosols: Adds "chemicals under pressure" as a new class between high-pressure gases and aerosols.
• Skin corrosion/irritation: Classification methods for in vitro/ex vivo testing are added to support non-animal testing approaches.

JIS Z7253 (Labelling and SDS)

• Standard title updated to: "Hazard communication of chemicals based on GHS - Labelling and Safety Data Sheet (SDS)".
• Annexes A, B, C are  revised to reflect updated hazard/toxicity statements from the UN GHS. New columns added to show revisions.
• Precautionary statements flexibility expanded; Annex C.4 updated accordingly.
• Transport information (Annex D.15) is revised to include solids and liquefied gases, in line with the UN GHS update.
• Annex D updates (D.2, D.4, D.9, etc.) are made to align with revised Industrial Safety and Health Act ordinances and current SDS practices.

Comment Period and Enforcement Dates

Stakeholders are invited to submit comments on the draft standards till 9 August 2025. There is currently no official announcement regarding the enforcement date of the standards.