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China Consults on Three Technical Guidelines Supporting MEE Order No. 12

China MEE is consulting on three technical specifications, with an aim of facilitating the upcoming implementation of MEE Order No. 12.

On September 29th, 2020, the Chinese Ministry of Ecology and Environment (MEE) opened a public consultation on the drafts 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].

The Measures for the Environmental Management Registration of New Chemical Substances [4], also known as MEE Order No.12, will take effect on January 1st, 2021. It 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 drafted in order to provide guidance 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)

According to the draft Technical Guidelines, the procedures of environmental and health hazard assessment consist of three parts, including: data collection, hazard identification and hazard characterization. The document provides technical requirements for each part: for example, for the part of 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 of Chemical Substances (Trial)

The draft 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 draft 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.

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