On December 26, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE) announced a plan to revise the list of Chemical Substances Designated by the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment as Not Falling Under Any Item of Paragraph 2 or 3 of Article 2 of the Chemical Substances Control Law (CSCL) and as Not Requiring Assessment Under Paragraph 5 of the Same Article. The revision will add 90 chemical substances, including β-aminoethylsulfonic acid (taurine), inositol, and sodium N-(α,γ-dihydroxy-β,β-dimethylbutyryl)-β-alaninate (calcium pantothenate).
List of newly added substances:
https://public-comment.e-gov.go.jp/pcm/download?seqNo=0000304470
According to Article 8, Paragraph 1 of the CSCL, businesses that manufacture or import general chemical substances above a certain quantity are required to submit an annual report to the Minister of Economy, Trade and Industry regarding the manufacturing or import volume from the previous year.
However, under Paragraph 3 of the same article, chemical substances designated by the Ministers of Health, Labour and Welfare, Economy, Trade and Industry, and the Environment as not being Class I or Class II Specified Chemical Substances and not requiring risk assessment under Article 2, Paragraph 5 of the law (hereinafter referred to as non-notifiable substances) are exempt from this reporting obligation.
This revision is based on the said provision and aims to add the attached list of 90 chemical substances to the list published in the relevant public notice, officially designating them as non-notifiable substances.
Summary of Relevant Legal Definitions
- Class I Specified Chemical Substances (CSCL Article 2, Paragraph 2)
Refers to chemical substances designated by cabinet order that meet the following criteria:
- Not readily transformed by natural processes and prone to bioaccumulation; and
- Likely to harm human health or interfere with the survival or reproduction of top predators through continuous intake.
- Class II Specified Chemical Substances (CSCL Article 2, Paragraph 3)
Refers to chemical substances designated by cabinet order that meet one of the following criteria (excluding Class I Specified Chemical Substances):
- Likely to harm human health through continuous intake, or substances formed by its natural transformation possess such hazard; or
- Likely to interfere with the habitation or reproduction of flora and fauna in the living environment through continuous intake or exposure, or substances formed by its natural transformation possess such hazard;
and the substance is already present or is expected to become present in the environment over a considerably wide area to a considerable extent, posing a potential risk to human health or the habitation/reproduction of flora and fauna.
- Priority Assessment Chemical Substances (CSCL Article 2, Paragraph 5)
Refers to chemical substances designated by the three ministers that satisfy all of the following conditions:
- It cannot be clearly determined that they do not fall under any item for Class II Specified Chemical Substances;
- Based on their manufacturing, import, etc., they are recognized as being already present in the environment to a considerable extent or are expected to reach such a state;
Therefore, it cannot be concluded that environmental pollution caused by them poses no possibility of harming human health or the habitation/reproduction of flora and fauna in the living environment, making it necessary to prioritize the collection of information on their properties and usage status to assess the existence of such risks.
Public Comment
Comments may be submitted to MHLW, METI, and MOE via the contact information provided on their official websites from today until January 25, 2026.
Expected Schedule
Notice issuance date: Late March 2026 (planned)
Effective date: The date of the notice issuance
