,"On August 5, 2025, a draft Ministerial Ordinance was released for public comment regarding partial amendments to the Ministerial Ordinance on Notification of Manufacture or Import of New Chemical Substances. The amendments focus on improving electronic notification procedures under the Act on the Examination of Chemical Substances and Regulation of Their Manufacture, etc.
Public comment deadline is September 3, 2025.
Key Points:
1.Purpose of Amendments:
-Amend provisions related to electronic notifications under the Ministerial Ordinance.
-Add additional identification codes to electronic filing alongside existing electronic signatures.
2.Electronic Notification Improvements:
-Overseas manufacturers allowed to submit notifications electronically.
-Submission now requires a preset personal identification code along with an electronic signature.
-Applicant code system Article 16 abolished and replaced with a preset PIN for:
-Reports on confirmed new chemical substances.
-Applications for confirmation of low-volume new chemical substances.
-Applications for high-molecular-weight compounds.
-Applications for low-production-volume new chemical substances.
3.Electronic Submission as General Rule:
-Electronic submission mandatory for notifications concerning low-volume and low-production-volume new chemical substances.
-Paper submission allowed only if electronic submission is extremely difficult.
4.Technical and Formatting Updates:
-Amendments include necessary changes to notification formats and technical standards for computers used in electronic filings.
-Cosmetic and formatting changes accompany the ordinance amendment.
5. Governance:
Relevant offices involved include:
-Chemical Substance Safety Office, Ministry of Health, Labour and Welfare.
-Chemical Substance Management Division, Ministry of Economy, Trade and Industry.
-Chemical Substance Safety Division, Ministry of the Environment.
6. Future Schedule (Planned)
Publication Date: Around October 2025
Effective Date: July 1, 2026 (Amendments to 2.I.(1) and 2.II.
January 1, 2029 (Amendments to 2.I.2
"
Consumer News Region