Japan’s Ministry of Health Labour and Welfare MHLW Ministry of Economy Trade and Industry METI and Ministry of the Environment MoE jointly issued amendments on September 18 2025 to the Chemical Substances Control Law CSCL notification procedures The amendments will be officially promulgated on October 8 2025 and aim to digitize and streamline the submission process for new chemical substance notifications
Background and Scope
The CSCL regulates the manufacture and import of chemical substances in Japan to protect human health and the environment The latest amendments modernize notification requirements particularly for:
• New chemical substances
• Small quantity new substances
• Polymer substances
• Low volume new substances
Key Amendments to the Ministerial Ordinance
Article 1 Changes – Electronic Filing and Form Revisions
Electronic Filing for Foreign Manufacturers Art 3
Foreign manufacturers are now allowed to submit CSCL notifications electronically replacing the traditional paper based system
Electronic Signature Alternatives Arts 11 13 15 16
i. Applicants can now authenticate submissions using PIN based systems such as G Biz ID Prime or Member
ii. The “applicant code” requirement is abolished and Article 16 is deleted accordingly
Revised Forms for Notification
The following forms have been updated to reflect electronic procedures
• Form 1 General new substance notification
• Form 11 Confirmation of new substance status
• Forms 15–17 For small quantity polymer and low volume substance notifications
Article 2 Changes – Digital First Filing
Default to Electronic Submissions Arts 6 and 9
Electronic application becomes the principle method for
• Confirmation of small quantity new substances
• Confirmation of low volume new substances
Paper Filing Exception
Paper submission is only allowed in cases where electronic filing is extremely difficult
Timeline of Key Milestones Draft Published 5 August 2025
Official Promulgation: 8 October 2025
Enforcement Begins: To be announced
Implications for Industry Stakeholders
Benefits
• Faster processing through digital workflows
• Global accessibility for foreign entities
• Stronger security via PIN based authentication
• Elimination of outdated applicant code system
Challenges
• Transition to electronic notification systems
• Need for updated SOPs and staff training
• Compliance with new digital form requirements
Recommendations for Compliance Teams
• Audit existing processes to identify digital gaps
• Register for G Biz ID or a suitable PIN authentication method
• Revise SOPs and templates based on new digital form structure
• Monitor official channels from METI MHLW and MoE for final guidance
Reference: Japan Ministry of Health Labour and Welfare – CSCL Amendments (e Gov Public Comment)
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