Japan Amends Notification Rules for New Chemical Substances Under CSCL

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: