On December 24th, 2020, the Chinese Ministry of Ecology and Environment (MEE) unveiled the official version of three technical guidelines, including Technical Guidelines for Environmental and Health Hazard Assessment of Chemical Substances (Trial) [1], Technical Guidelines for Environmental and Health Exposure Assessment of Chemical Substances (Trial) [2] and Technical Guidelines for Environmental and Health Risk Characterization of Chemical Substances (Trial) [3], seven days before the MEE Order No. 12 [4] takes effect.
MEE Order No.12 requires that applicants for regular registration shall submit an environmental risk assessment report of new chemical substances along with other application materials. Therefore, the following three Technical Guidelines are thus put forward to, in conjunction with the Guidance on Environmental Management Registration of New Chemical Substances [5], provide instructions for enterprises on the environmental risk assessment of new chemicals and to specify relevant technical requirements.
Technical Guidelines for Environmental and Health Hazard Assessment of Chemical Substances (Trial)
The Technical Guidelines makes clear that the procedures of environmental and health hazard assessment consist of three parts, including: data collection, environmental and health hazard identification and environmental and health hazard characterization. The document provides technical requirements for each part: for example, for the part of environmental and health hazard identification, it lays out the methodologies for determining critical endpoint data, persistence/bioaccumulation/toxicity of substances, and endocrine-disrupting chemicals.
Technical Guidelines for Environmental and Health Exposure Assessment of Chemical Substances (Trial)
The Technical Guidelines clarifies the content of environmental and health exposure assessment which covers the entire lifecycle of chemical substances, from production to waste disposal. It also sets out methodologies and tools for specific assessment needs, including the application requirements for different methods, as well as models, parameters and even estimation software which can be used in exposure assessment.
Technical Guidelines for Environmental and Health Risk Characterization of Chemical Substances (Trial)
The Technical Guidelines specifies the scope and methodologies of risk characterization and, notably, proposes basic requirements for uncertainty analysis, including: factors which may contribute to the generation of uncertainties; uncertainty analysis requirements; and requirement that measures be taken to reduce uncertainties when they are overwhelmingly large.
A new exposure assessment tool called CET will be published very soon. Please stay tuned.
