Japan’s MHLW Drafts Revised Criteria for Poisonous and Deleterious Substances – Comments Due by 27 January 2025

On 28 December 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) released a draft notice to revise the criteria for determining poisonous and deleterious substances under the Poisonous and Deleterious Substances Control Act. MHLW has published this consultation draft on the e-GOV public comment portal.  

Poisonous and Deleterious Substances Control Act 

The Act specifically outlines a registration system for companies that deal in toxic and dangerous materials, including container labelling, sale (transfer) procedures, safeguards against theft, loss, and leakage, transportation and disposal standards, and measures to control the prevention of improper distribution and leakage of toxic and hazardous materials. 

Previous revision in 2017   

The MHLW last revised the criteria in June 2017. The draft notice for revising the criteria was released in February 2017 and was enforced on 13 June 2017. 

Revised Criteria 

The draft notice has information about the criteria for adding or excluding chemicals from the Poisonous and Deleterious Substances list along with endpoints. Evaluations will consider acute toxicity (via oral, dermal, or inhalation exposure), local toxicity (such as skin corrosion and eye damage), and relevant human data. Substances with extreme toxicity and a high potential for misuse may be classified as Specific Poisonous Substances. 

The criteria also provide exemptions for certain tests where the properties of the substance make evaluation impractical (e.g. extreme pH values). Additionally, the exclusion of certain formulations from the list is addressed, with thresholds based on toxicity levels and concentration limits. 

Comment Period and Enforcement Dates  

Stakeholders are invited to comment on this consultation notice until 27 January 2025. The MHLW will issue the final draft after the end of the comment period. The Ministry has not yet confirmed the enforcement date.