The Ministry of Environmental Protection (MEP) of China has recently published two drafts for the Guidelines for Risk Assessment of Chemicals and Guidelines for Hazard Identification of New Chemical Substances. The consultations are open to the Environmental Research Institutes, CPCIF, CCCMC, China chemical industry associations, European Union Chamber of Commerce, American Chamber of Commerce in China etc. Comments are welcome and should be sent to the MEP in written or electronic form by 30th October 2011.
These documents are essential standards that provide guidance to enable fulfillment of the regular notification requirements of "China REACH" - Measures on Environmental Management of New Chemical Substances. In line with the guidance of "China REACH", the minimum requirements for regular notification include physicochemical, toxicological and eco-toxicological test reports and a risk assessment report.
The released draft guidelines for risk assessment of chemicals (hereinafter “RA guideline”) have similar core concept to REACH CSA guidance. However, substantial difference exists in consideration of China current status. For example, it is only necessary to qualitatively characterize the potential risk to human health irrespective of the tonnage volume under China regular notification. However, the qualitative methods are extremely different. Under RA guideline, the toxicological test results and levels of exposure will be given individual scores and the combination of scores corresponds to a human health qualitative risk characterisation phrase.
The draft guidelines for hazard identification of new chemical substances are important supplement to RA guideline. Its main aim is to help notifiers to identify the new chemical substances’ hazard. Except some necessary data requirements in new chemical substance notification guidance document (hereinafter “Guidance”), two points should be paid more attention.
1) It clarifies identification methods of the general new chemical substance, the hazardous new chemical substance, and hazardous new chemical substances of prior environmental concern which are ambiguous in China REACh and Guidance. Different substances properties will directly lead to different post-notification obligations under regular notification.
2) Some other eco-toxicity classification methods have newly been proposed, e.g. activated sludge respiration inhibition toxicity, acute earthworm toxicity which are different from CLP regulation. The new added classifications make environmental hazard assessment more complex in process of risk assessment.
