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. 

On 3 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) notified the World Trade Organization (WTO) of draft revisions to the Industrial Safety and Health Act (ISHA) aimed at enhancing the delivery of safety data sheets (SDSs). The MHLW has made significant changes to the Safety Data Sheets content aiming to improve the safety of employees when handling hazardous chemicals.  

Background on ISHA: Delivery of Documents 

Under Article 57-2 of ISHA, the delivery of documents such as labels or safety data sheets is crucial for hazardous chemicals. Exposure to these chemicals might cause harm or side effects to employees working on-site. Transferors and suppliers are obliged to provide updated SDSs to the personnel working there. 

Key Provisions in the Draft Revision  

The MHLW has made the following three provisions in the draft notice for SDS delivery: 

1. Establishment of a punitive clause for non-compliance with hazard statement notifications for transferors/providers of chemical substances. 

2. Changes to the notification provisions for transferors and providers will become the new obligatory regulations.  

3. Allows notification using alternative names for confidential business information. Obligations to record and maintain information on ingredients, provide information to doctors, and report to labour standards inspection agencies. 

Comment Period and Enforcement Dates 

Stakeholders are invited to submit comments on this draft notice till 2 May 2025. The Ministry has not yet confirmed the adoption date of these provisions, but has released the scheduled enforcement dates.