China MEP Consults on Two Guidelines for Risk Assessment and Hazard Identification of ChemicalsThese 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.
REACH24H encourages our clients, partners and any interested parties to comment on the recently published guidelines. We are glad to collect your comments to these guidelines and deliver to China MEP before Oct 28 2011. We will hold a seminar and invite technical experts of RA guidelines to face to face communicate with any interested parties on 28th Nov. 2011 in Hangzhou. Welcome any interested party or person to attend the seminar.
The Guidelines for Risk Assessment of Chemical Substances for consultation are:
- Guidelines for Risk Assessment of Chemicals; (Download PDF, Chinese - MEP site)
- Supporting Document for Guidelinse for Risk Assessment of Chemicals; (Download PDF, Chinese - MEP site)
- Guidelines for Hazardous Identification of New Chemical Substances; (Download PDF, Chinese - MEP Site)
- Supporting Document for Guidelines for Hazardous Identification of New Chemical Substances; (Download PDF, Chinese - MEP Site)
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News from China MEP:
http://www.mep.gov.cn/gkml/hbb/bgth/201109/t20110930_217940.htm
Further information on the two guidelines from REACH24H experts: