To enhance the toxic substance management, the Ministry of Health, Labour and Welfare (MHLW) of Japan recently proposed significant revisions to the standards under the Poisonous and Deleterious Substances Control Law (PDSCL). The revisions aim to optimize the existing toxicity assessment processes to ensure environmental and public health safety.
Revisions
- Criteria for systemic and local toxicity: The proposal more clearly distinguishes between systemic acute toxicity and local toxicity criteria, while reducing reliance on animal testing.
- Specificity in toxicity assessments: The proposal clarifies the criteria for acute toxicity assessment of substances and outlines procedures when formulation information is lacking, including additional tests for other health hazards.
- Local toxicity evaluation: Enhances assessment of skin corrosivity and severe damage to mucous membranes such as eyes, promoting alternative testing methods.
- Exemptions from animal testing: Based on OECD guidelines, new standards for exempting animal testing are added, covering oral, dermal, and inhalation exposure tests.
Revisions to the criteria for formulations not considered poisonous and deleterious
- It defines acute systemic toxicity and local toxicity, and provides detailed descriptions of the methods used to determine that a formulation is not considered toxic or harmful.
- It deletes examples of benchmark compounds that could lead to erroneous results in alternative method testing.
- It specifies that these standards will serve as reference points in discussions about designated toxic and harmful substances at meetings of the Pharmaceutical Affairs Committee.
Compliance Requirements
Companies involved in the manufacture, import, storage, sale, or handling of these substances must notify the MHLW and comply with relevant transportation and storage regulations. Additionally, companies are required to provide Safety Data Sheets (SDS) and label containers and/or packaging appropriately, ensuring proper waste management.
The public comment period ended on January 27, 2025. The MHLW plans to finalize the documents swiftly after reviewing public feedback. These revisions are expected to be further discussed and adopted in upcoming Pharmaceutical Affairs Committee meetings to ensure the implementation of the regulations.
