Japan Regulatory News

On 10 September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) amended the list of model SDS information of chemical substances. Amended list was published on the Japan’s Workplace...

On 10 September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) amended the list of model SDS information of chemical substances. Amended list was published on the Japan’s Workplace Safety Site on the same day. This time MHLW added 135 new chemicals and revised 140 existing chemicals to the list. Also CAS numbers and chemicals name are published on the portal.

List of GHS-compliant model SDS information

As a guide for creating SDSs based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), the GHS-compliant model SDS information was developed. Consequently, companies use this knowledge about chemical substances as a guide when creating SDSs and other documents. Currently model list has 3,622 chemicals information available for SDS.

Previous update in October 2024

On 1 October 2024, MHLW added model SDS information for 68 new chemicals while 104 existing chemicals were revised. More details can be found here.

Obligations for Stakeholders

The Industrial Safety and Health Act (ISHA) of Japan imposes SDS delivery requirements on the manufacturers, importers, suppliers, and employers. Other literature, test findings, etc., can be used in addition to the material in this list.

On 1 September 2025, Japan’s Ministry of Economy, Trade and Industry (METI) released draft to amend provisions of Export Approval for Chemical Substances under Export Trade Control Order. Consult...

On 1 September 2025, Japan’s Ministry of Economy, Trade and Industry (METI) released draft to amend provisions of Export Approval for Chemical Substances under Export Trade Control Order. Consultation notice was published on the Japan’s e-GOV Public Comment Portal. The Japanese Export Trade Control Order is a key regulation under the Foreign Exchange and Foreign Trade Act.

Export Trade Control Order

Under the Japanese Export Trade Control Order (Cabinet Order No. 378 of 1949), the export of certain chemical substances is strictly regulated through an export approval system administered by the Ministry of Economy, Trade and Industry (METI). This framework aligns Japan with international obligations under the Rotterdam and Stockholm Conventions and the Chemical Substances Control Law (CSCL). Exporters must obtain prior authorization when shipping hazardous chemicals such as pesticides, persistent organic pollutants (POPs), mercury compounds, asbestos, and PFAS, including mixtures, formulations, and even finished products containing these substances. The system ensures that Japan fulfills its role in safeguarding human health, the environment, and international security by preventing the uncontrolled transfer of dangerous chemicals.

Provisions drafted under Consultation Notice

Revised provisions are summarised in below table:

Comment Period and Enforcement Dates

Stakeholders are informed to submit comment on this draft provisions by 2 October 2025. While METI has not published the enforcement dates yet.

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 the draft a...

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 the draft amendments to guidelines under Chemical Substances Control Law (CSCL). Ministry released the draft notification on the Japan’s e-GOV Public Comment Portal. The ministries plan to update these operational guidelines in light of the 2025 assessment of the 2017 CSCL amendment and plans for chemical substance management in the future. The March 29, 2019 notification on managing by-product Class I Specified Substances will also be revised.   

Key Amendments from draft notification

Article 1 – Impurities containing Class I Specified Substances:

• Previously, rules only applied when Class I Specified Substances were present as by-products.
• Now, rules will also apply when they are present as impurities (broader definition, including by-products).

Article 2 – Structural Changes and Clarifications:

1. Restructuring:
• Establish a new section "1. Common Provisions" to consolidate rules that apply across the entire guideline.
2. Clarifications:
• Clarify treatment of anhydrous vs. hydrated substances.
• Clarify definitions of terms for organic polymers.
3. Existing vs. New Substances:
• Some substances previously excluded from being treated as "new" will now be explicitly treated as existing chemical substances, with reference to specific provisions in the law (Article 2, paragraphs 4, 5, 7).

Article 3 – Existing Chemicals:

• Revision of the definition of "existing chemical substances" with necessary updates.

Comment Period and Enforcement Dates 

e-GOV Public Comment Portal    draftand are given below:    2. Changes to Electronic Notification Requirements (Articles 20–21)In addition to electronic signatures, (e.g., G Biz ID) will no...

e-GOV Public Comment Portal  Small-quantity new substances  Low-volume new substancesKey Insights from the Draft AmendmentMinistry has included following amendments in the   Amendment to the Mi...

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.