China Issues Guideline for Environmental Risk Assessment of Chemical Substances

On September 3, 2019, the Chinese Ministry of Ecology and Environment (MEE) and National Health Commission (NHC) jointly issued a final Technical Framework Guideline for Environmental Risk Assessment of Chemical Substances (Trial). This Trial Guideline provides a basic framework, including evaluation steps, technical requirements, and report preparation, for the environmental risk assessment of a single chemical substance under standard production and uses. The Trial Guideline does not apply to mixtures or exposures due to accidents or leakages. The “four-step” evaluation includes hazard identification, dose-response assessment, exposure assessment, and risk characterization. It also outlines uncertainty analysis, data quality assessment, spatial scale of exposure assessment, risk assessment of persistent, bioaccumulative, and toxic (PBT) and very persistent and very bioaccumulative (vPvB) chemical substances, and consideration for risk assessment of metals and their compounds.

Commentary

This Trial Guideline outlines the process to conduct risk assessments of chemicals under standard production and uses and will be part of implementation guidance documents to the Environmental Risk Assessment and Control Regulation for Chemical Substances (Notification Draft) and the Measures on the Environmental Management of New Chemical Substances (Notification Draft) that were notified to the World Trade Organization (WTO) last week. The Trial Guideline intends to strengthen the environmental management of chemicals to establish a sound technical method system and to standardize the environmental risk assessment of chemicals in China. More information on the Environmental Risk Assessment and Control Regulation for Chemical Substances (Notification Draft) and the Measures on the Environmental Management of New Chemical Substances (Notification Draft) is available in our September 9, 2019, memorandum, “China Notifies WTO of Two Draft Chemical Regulations.”

For further assistance, please e-mail or call J. Brian Xu, M.D., Ph.D., DABT^® at bxu@actagroup.com or (202) 266-5029.