News Details
Japan amends notification rules for New Chemical Substances under CSCL
Update: On 17th September 2025, Japan’s MHLW, METI and MoE jointly released the promulgation date for the order on the e-GOV Public Comment Portal. As per the information from the portal, the final order will be promulgated on 8 October 2025.
Original Text:
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 the draft amendments to notification norms for Manufacture or Import of New Chemical Substances under Chemical Substances Control Law (CSCL). Ministry released the draft on the Japan’s e-GOV Public Comment Portal. Chemicals covered under the scope of this draft are:
- New substances
- Small-quantity new substances
- Polymer substances
- Low-volume new substances
Key Insights from the Draft Amendment
Ministry has included following amendments in the draft and are summarised below:
I. Amendment to the Ministerial Ordinance
1. Article 1 Amendments
1. Addition of electronic filing for foreign manufacturers (Art. 3):
Allow foreign manufacturers of new chemical substances to use electronic filing.
2. Electronic filing requirements (Arts. 11, 13, 15, 16):
- In addition to electronic signatures, allow use of a PIN (e.g., G-Biz ID Prime or Member).
- For certain applications (reports on confirmed new substances, applications for confirmation of small-quantity new substances, polymer substances, and low-volume new substances), replace the “applicant code” requirement with the PIN system, and abolish the applicant code (delete Art. 16).
- Revise related forms (Forms 1, 11, 15–17).
2. Article 2 Amendments
1. Principle of electronic application (Arts. 6 & 9):
- Make electronic filing the principle method for applications for confirmation of small-quantity and low-volume new chemical substances.
- Paper applications allowed only if electronic filing is extremely difficult.
II. Amendment to Related Ministerial Notification
- Revise technical standards, designated computers, certificates, and input methods, including format adjustments, in line with the ordinance changes.
Comment Period and Enforcement Dates
Stakeholders are invited to comment on the draft amendment by 3 September 2025. While Japan will adopt the draft in October 2025. Enforcement dates are summarised in below table:
Particulars | Enforcement Dates |
I-(1) and II above | 1 July 2026 |
I-(2) above | 1 January 2029 |
We acknowledge that the above information has been compiled from e-GOV Public Comment Portal - Japan.
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