On 17 March 2025, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly published the amended process for the notification procedure for new chemical substances under the Chemical Substances Control Law (CSCL). The ministries also shared the manual for preparation and submission of documents for notification on the National Institute of Technology and Evaluation (NITE) portal. 

New Chemical Substances Covered by the 2025 Notification 

The following categories of new chemical substances are covered by this notification process:    

• New chemical substances: Chemicals not listed in the Existing Chemical Substances Inventory and imported or manufactured in Japan in quantities > 1 t/y. 

• Low-volume new chemical substances: This category applies to chemicals manufactured or imported in quantities ≤ 10 t/y.  

For background on the timeline leading up to the revision, see our previous GPC news here.  

On 6 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) released the final enforcement notice for the Revised Criteria for Poisonous and Deleterious Substances and related provisions. The MHLW published the notice via Pharmaceuticals and Medical Devices Agency Notification No. 0306-6 on the notification portal of Japan’s National Institute of Health Sciences (NIHS). This enforcement took effect on the same day that the MHLW published the notice. 

For background on the draft criteria and consultation process, see the original news here.