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China Issues Guidance Framework for Environmental Risk Assessment of Chemicals

  •   12 Sep 2019
  •    Horace Wang
  •    1020
  •   Post a comment

    Takehome:

    • The guide is divided into four parts namely, Scope of Application, Basic Points, Technical Requirements and Report Preparation.
    • General requirements for the risk assessment of chemical substances are specified in the guide, such as assessment steps, assessment conclusion, uncertainty assessment, data quality assessment, risk assessment for special chemicals, etc.

    On 3rd September, 2019, China Ministry of Ecology and Environment (MEE) issued a notice [1] to publish the Framework Guide to the Technology Methods of Environmental Risk Assessment for Chemical Substances (Trial), which is an important supporting document for Environmental Risk Assessment and Control Regulation for Chemical Substances. (CL News [2]) This Guide specifies the basic framework for risk assessment, and clarifies the basic points, technical requirements, and report preparation as well. It is worthy noticing that the Guide applies to environmental risk assessments of different exposure pathways for the normal production and use of a single chemical substance, and does not apply to risk assessment under accidental exposure conditions. 

    Four basic assessment steps are specified at first in the basic points, they are Hazard Assessment, Dose (or Concentration) - Response (or Effect) Characterization, Exposure Assessment and Risk Characterization. The guide specially introduces several situations to explain that risk assessment does not always need to go through the full four steps above. For example, if the conclusions of the first and second steps indicate that the chemical is at a very low risk to ecosystem and human health, no follow-up risk assessment is required. The third part of the Guide: Technical Requirements are also carried out around these four steps, and each of them is described from two aspects: ecosystem impact and impact on human health. 

    Three possible assessment conclusions and corresponding further-step measures are specified in the Guide: 

    • If no unreasonable risks are found, risk prevention or control measures will not be required.
    • If unreasonable risk exists, further risk prevention and control measures are needed to reduce the risk.
    • If the risks are not certain, assessment will be conducted again after information of the substance is supplemented. 

    At the same time, the Guide also regulated other important risk assessment items, such as uncertainty assessment, data quality assessment, spatial scale of exposure assessment and so on. The assessment methods for PBT substances, vP/vB substances and metals and their compounds are also described in the Guide, too. According to the Guide, the risk assessment report is supposed to contain Assessment Purpose, the Scope of Assessment, Data Collection and Data Assessment, Hazard Assessment, Dose (or Concentration) - Response (or Effect) Characterization, Exposure Assessment, Risk Characterization, Uncertainty Assessment and Assessment Conclusion, etc. 

    Scientific and reasonable risk assessment for chemical substances is the basic requirement for the safe use of the substances, and the core content of the risk control of chemical substances. It is predictable that China will release a series of related documents on the risk assessment for chemical substances, Chemlinked will continue reporting the latest news for you.

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