National Institute of Environmental Research Public Notice No. 2024-55
This notice outlines the regulations for preparing risk assessment information within the registration documents of chemical substances. It is based on the "Act on Registration and Evaluation of Chemical Substances" and its enforcement rules. The regulations describe the methodology for creating documents related to the risks and hazards of chemical substances.
The key points of the regulations include defining concepts such as "biodegradability" and "lowest observed adverse effect level (LOAEL)." It also specifies how to evaluate exposure scenarios, the acceptable daily intake (ADI), and provisional tolerable weekly intake (PTWI) for chemicals. Moreover, it provides detailed guidance on calculating and assessing chemical exposure risks to both humans and the environment, including direct and indirect exposure.
Finally, the notice mandates that risk assessment results must be reviewed periodically (every three years starting from January 1, 2025) to ensure they remain accurate and up to date.