Draft Guidelines for China’s Chemical Risk Assessment and Hazard Identification: Request for Comments from Industry
Since the introduction of China’s new chemical substance notification (commonly known as 'China REACH') system in October last year, research on a series of detailed technical standards have been progressing.
Later last month, the Ministry of Environmental Protection (MEP) issued two draft Guidelines concerning, respectively, Risk Assessment of Chemicals and Hazard Identification in order to better regulate the hazard identification methods and categorization of environmental management under China REACH.
The MEP urges all interested parties and potential China REACH notifiers to comment on the 2 Guideline drafts before October 30, 2011 so that the legislators can incorporate the opinions of industry into the draft revision and finalised documents.
Since the issuing of the two guidelines, REACH24H Consulting Group has received several company inquires from flavouring and cosmetic industries, expressing their concerns on the qualitative assessment scoring system, which is irrespective of the tonnage band of the substance. They also questioned the required data tests and expressed a wish that the national authorities propose some policies that would be favourable to SMEs.
China NCSN Risk Assessment Report VS EU REACH CSA Guidance
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.
Draft Guidelines for Hazard identification of New Chemical Substance
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, 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.
Applicable Scope of the Guidelines of Risk Assessment and Hazard Identification
Guidelines | Applicable Scope |
Risk Assessment | For China REACH expert panel review |
For potential China REACH notifiers in need of compiling Risk Assessment Reports | |
For the risk assessment of China’s all existing chemicals | |
Hazard Identification | For China REACH expert panel review |
For China REACH notifiers self-review |
Chemicals Risk Assessment Procedure
Risk Assessment program is divided into four steps: 1) hazard identification, 2) hazard characterization, 3) exposure assessment and 4) risk characterization. The procedure chart is shown as below.
Qualitative Health Risk Assessment
This section includes 1) hazard identification, which determines the hazards caused to human health by the inherent chemical properties of the substance, and 2) qualitative hazard characterization (hazard classification), which makes a qualitative prediction on the hazard level reached.
Hazards to human health are divided into very high hazard, high hazard, medium hazard and low hazard - four categories. This section supplies all toxic classifications and their corresponding scoring system in an indicator called HAZARDhealth. Each toxic classification is aligned with a distinct score from 1 to 4 for hazard Levels. For instance, LD50 (mg/kg) acute toxicity by Oral Class 1 is scored at 4 as very high hazardous; and respiratory sensitization Class 1 is scored at 3 as high hazardous. The guideline specifies 8 tables of toxic classification and their hazard level scoring:
Table 12-Acute Toxicity by Oral, Dermal and Inhalation scoring from 1-4
Table 13- Skin Irritation scoring from 1-3
Table 14- Eye Irritation scoring from 1-3
Table 15- Acute Toxicity by Respiration and Dermal Sensitization scoring from 2-3
Table 16- Mutagenicity scoring from 3-4
Table 17- Reproduction/Development Toxicity scoring from 3-4
Table 18- Repeated Poisoned and Chronic Toxicity scoring from 2-3
Table 19- Carcinogenicity scoring from 3-4
Human Body Exposure Classification
As a result of a combined assessment on exposure factors and quantitative factors, the guideline specifies the classification of human body exposure respectively as very high exposure, high exposure, medium exposure and low exposure. And it is recorded in an indicator called EXPOSUREhealth.
Qualitative Risk Characterization
On the basis of hazard class scoring and exposure class scoring, a comprehensive indicator of Health Risk Class (RChealth) is calculated according to the below formula.
RChealth = HAZARDhealth x EXPOSUREhealth
Health Risk Class Scores
Hazard Class | Health Risk Class Scores |
Very High Risk | 16-12 |
High Risk | 11-8 |
Medium Risk | 7-4 |
Low Risk | 3-1 |
