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The difficulties in China new chemical substance notification (China NCSN, a.k.a China REACH) and management of new chemical substances were discussed and debated during the 2013 Seminar on Environmental Management of New Chemical Substances held by the Working Committee on Collaboration & Promotion of Industry, College and Institute under Chinese Chemical Society (CCS). The workshop provided an ideal communication platform for industry stakeholders and staff from the Chemical Registration Centre of MEP, (hereinafter ‘CRC-MEP’) during which problems relating to testing strategy and risk assessment were discussed.
Exemption not Made Available from RA Outcome
The process of China NCSN is governed by the principle of ‘the higher tonnage band, the more testing data required’. However, under EU REACH, for the registration of more than 100 tons, some data can be exempted based on the results of risk assessment, namely if the results of risk assessment show that the risk of a target substance can be controlled, some tests listed in Annex IX do not need to be carried out. However this proposal was not accepted by the authority at this meeting. As such it is still required to conduct compulsory testing and to submit the test reports which meet the minimum data requirements based on the tonnage band of China NCSN.
Potential of Overestimation
When the aquatic eco-toxicological tests are carried out in accordance with the requirements of testing guideline, the exposure concentration of the test substance needs to be measured and it will affect the validity of the test report. Usually, the actual exposure concentrations will directly decide the final results of test reports. For example, in the limit test of short-term toxicity testing on fish, for substances with relatively poor stability with a nominal concentration of 100 mg/l, measured concentrations may be less than 80% of the nominal concentration. However in the test report, you can only use the measured concentration to represent the final LC50 result. Since the classification limit for hazard to the aquatic environment is 100 mg/l, when such a test report is used for the hazard classification, according to National Safety Rules for Classification, Precautionary Labeling and Precautionary Statements of Chemicals (hereinafter referred to as "Safety Rules "), the “aquatic environment, acute toxicity category 3” should be considered instead of “no hazard” to the aquatic environment, which overestimates the risk. Even if the results of other hazard classifications are “not classified”, the notified substance will still be supervised as hazardous instead of substance without hazard classification. According to New Chemical Substance Notification Guidance Document (short as "Guidance"), when the new substance is notified without hazard classification, only the basis and results of classification and simple exposure description in the risk assessment report should be submitted. However, for the chemical substances with hazard classification, the qualitative or (semi-) quantitative risk assessment should be conducted. Therefore, if the qualitative or (semi-) quantitative risk assessment is necessary based solely on the results of these test reports, it is a waste of resources.
Concerns Expressed by the Review Committee
For the exposure description and risk management measures in the risk assessment reports, the experts from the review committee listed some common points easily overlooked:
The amount of notified substance used to produce per unit of output. The estimated amount of emissions (waste gas) of the notified substance in the processing procedure. The amount of residual notified substance in the gas containers should be provided;
Measures taken to treat the sludge from sewage treatment plant in the risk management measure should be provided;
For the application of domestic production (especially in the case of hazardous new chemical substance and hazardous new chemical substance of priority environmental concern). The measures taken to treat the sewage and hazardous waste (sludge). The qualification certificates of the institution, contracts of the treatment should be provided;
Measures used to treat the accidental leakage dispersion in the risk management measures should be provided.
In addition, for the quantitative environmental risk assessment, the experts from the committee expressed concern about the following:
The calculation of Predicted Environmental Concentration (PEC), including whether the emissions scenarios are left out; whether they are reasonable; whether the assumed conditions in calculation formula are satisfied; whether the default risk management measures for emission reduction and waste treatment are used with their default effects;
When the calculated Risk Characterization Ratio (RCR)value is far less than 1, it may be appropriate to relax on the detailed description of risk management measures;
When the RCR value is close to 1 and a large uncertainty of the risks exists (such as in the PEC calculation process, multiple parameter are set without sufficient basis), the details in the production process (production and discharge of the waste) and the operating parameters during the waste treatment process should be provided.
REACH24H Recommendations
Thus, experts evaluate the risk assessment report based on the risk assessment results of specific notified substances and, if necessary, will request the applicant to provide more detailed information (such as new testing and exposure parameters) to further assess the risks of notified uses. Therefore, when conducing testing and risk assessments, we recommend the following:
When conducting the aquatic eco-toxicological tests, if the measured concentrations is less than 80% of the nominal concentration, the experimental solutions should be prepared to ensure the maximum measured concentration is no less than the upper limit of classification criteria;
In the risk assessment reports, the detailed exposure information and risk management measures should be provided to meet the requirements for risk assessment from evaluation experts;
The efficiency of risk management measures should be reasonable, thus any exaggeration of the efficiency in order to ensure the risk is controllable is not permissible;
When the RCR value is close to 1, it can be considered to carry out tests beyond the minimum data requirements. It will help to have a more rational understanding on the risk of the notified substance.
To sum up, unlike EU REACH, under “China REACH” certain tests can’t be exempted based on the results of risk assessment. However, the official also pointed out that the ranking of different tonnage bands is a means to simplify assessment of exposure. If there is a more accurate way to determine the exposure values, test strategies based on the results of the risk assessment will be adopted.
