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 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.

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. Furthermore, Japan notified the World Trade Organization (WTO) on August 1, 2025, of a draft designating fenazaquin as a deleterious substance.

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. While as per WTO notification, members can comment on the WTO draft till 30 September 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.