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On April 29, 2021, the Chinese Ministry of Ecology and Environment (MEE) released a notice, announcing to solicit comments on the draft Guidelines for Screening of Priority Assessment Chemical Substances [1] from a selected list of authorities, institutions and industry associations.
According to the notice, the draft Guidelines is formulated to implement the Environmental Protection Law, prevent environmental risks of chemical substances, guide the screening of chemical substances and, in particular, provide technical support for the screening of priority assessment chemical substances.
Environmental risk assessment is the premise and basis for environmental management of chemical substances. In this regard, it has been an internationally accepted practice to first screen out priority assessment chemical substances and then conduct environment risk assessment of such substances so as to identify those subject to regulation. At present, EU, US and Japan, among other countries and regions, have all put in place a technical system for screening of priority assessment chemical substances, employing risk-based methodologies to screen out chemicals with high potential environmental risks.
Therefore, based on the advanced international practices as well as China’s management and technical practices, the draft Guidelines has been developed to establish a methodology for screening of priority assessment chemicals, with its particular focus placed on chemicals which have existed in the environment and have relatively high hazards.
The draft Guidelines specifies the principles, procedures and technical requirements for the screening of priority assessment chemicals. It is designed to apply to the screening of priority assessment chemicals for environmental risk assessment and control of chemical substances in any production and living activities.
It also provides the definitions of several key terms. For example, it defines priority assessment chemical substances as “substances which have high hazards and high potential of environmental exposure and for which environmental risk assessment shall be prioritized to determine whether priority control shall be imposed”.
According to the draft Guidelines, the screening of priority assessment chemical substances generally includes three steps, including:
Ø Preparation for screening: Formulate a plan for the screening work, select chemical substances for screening, and sort out the substances by category
Ø Data collection and assessment: Comprehensively collect the hazard and exposure data of chemical substances, assess the validity of data, and determine data which can be used for screening.
Ø Determination of priority assessment chemical substances: Screen out chemical substances based on the screening conditions, and determine priority assessment chemical substances in light of comprehensive considerations.
The draft Guidelines also details technical requirements for each of the steps aforementioned. For example, in terms of data collection, the draft Guidelines provides that the data collected should include those related to the hazard, exposure, persistence, bioaccumulation, etc. of chemical substances as well as supporting information, and that they must comply with relevant requirements. Moreover, in cases where part of the data is absent, the draft Guidelines provides that read-across and QSAR models can be used for estimation to fill in the data gaps.
As for screening conditions, the draft Guidelines makes it clear that substances which meet both hazard and exposure conditions, or for which there has been evidence proving the existence of potential environmental risks, or which have led to any environmental pollution, shall be determined as priority assessment chemical substances.
