The major development in the China New Chemical Substance Notification (China NCSN) enacted in 2010 as compared with its 2003 version lies in the shift from hazard-oriented to the risk-oriented assessment. Accordingly, the original Guidelines for the Hazard Evaluation of New Chemical Substances (HJ/T 154-2004) is revised into two separate documents, the Guidelines for Risk Assessment of Chemicals and the Guidelines for Hazard Identification of New Chemical Substances.
The draft proposals of the above two guidelines have been released for public consultation from 30 September to 30 October 2011. The final drafts have been completed and submitted to the Institute of Standards and Technology under the MEP for evaluation in May 2012 and are expected to be published soon, introduced by Ms. Wang Hong from the Chinese Research Academy of Environmental Sciences (CRAES) who has participated in the compilation of the two guidelines.
The first step of hazard identification of new chemical substances is based on the 26 national GHS classification standards, according to which the new chemical substances can be classified into hazardous and general. After that, the hazardous new chemical substances can be further divided into hazardous new chemical substance of environmental concern and general new chemical of environmental concern, according to the environmental management categories. The hazardous new chemical substances of priority environmental concern are screened out based on risk assessment outcome.
The Guidelines for Risk Assessment of Chemicals (draft) specifies the technical methods and procedures for the environmental and health risk assessment of chemical substances, details are displayed in the figure below.
When the result of the hazard characterization shows that the chemicals substance is hazardous, the exposure assessment need be conducted to see whether the risk is controllable. When the risk characterization demonstrates that the risk is uncontrollable, iteration would be recommended, more detailed information supplied or more advanced risk management measures could relieve the risk characterization outcome (control the risk ratio to be less than 1).
However, the current risk assessment strategy proposed in the guideline draft is rudimentary framework without elaborate technical details, considering that China is still in its initial period in the risk assessment practice. It should be noted that the current health risk assessment is only a qualitative grading system, which is not internationally adopted practice.
