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The major revision of China's Measures on the Environment Management of New Chemical Substances came into force in October 2010, (hereinafter “Measures”) has significantly impacted manufacturers and importers of new chemicals in China as well as manufacturers outside China.
In accordance with the Measures, prior to actual manufacture or importation activities of the new chemical substances, the manufacturer or importer should notify the Chemical Registration Centre of MEP (CRC-MEP). The notification of new chemical substances can be classified into three types: Regular Notification, Simplified Notification and Scientific Research Record Notification (SRRN). Simplified notification can be classified into two sub-types: General Case and Special Case. The General Case of Simplified Notification will be focused in this article.
What is General Case of Simplified Notification?
In accordance with the Measures, the applicant should apply for simplified notification with the CRC for new substances below 1 tonne per year.
What are the Requirements of General Case of Simplified Notification?
In accordance with the Measures, the applicant who applies for general case of Simplified Notification should submit the following documents:
(1) Simplified notification form of the new chemical substance
There are three parts in the Simplified notification form.
Part I is Information of the notifier.
Part II is general information, such as the notified tonnage, uses and the information about the downstream users in China.
Part III is Information of the notified substance, including chemical name in Chinese and English, structure information, properties, process flow chart, exposure and use method of the notified substance. The properties of the notified substance, physical state, melting point, water solubility, octanol-water partition coefficient and eco-toxicity results are normally required in Part III.
(2) The eco-toxicological testing reports from China testing laboratories performed on Chinese organisms
In accordance with New Chemical Substance Notification Guidance Document, if the notified substance is organic, the ready biodegradability data is required. If the substance is not readily biodegradable, an acute aquatic organism toxicity test (fish preferred) is required.
If the substance is an inorganic substance, an acute aquatic organism toxicity test (fish preferred) is required.
If the solubility of a new chemical substance in water is less than 100mg/l, and the substance is toxic to aquatic organisms under saturated conditions, the LC50 will be required. If the substance is not toxic to aquatic organisms under saturated conditions, the acute terrestrial organisms toxicity (earthworm preferred) is required.
Apart from the above environmental toxicity data, melting point, water solubility and octanol-water partition coefficient are also required in the Simplified notification form. However, test reports are not compulsory for the physical –chemical data and data from QSAR or literature will be acceptable.
What is the Notification Process of General Case of Simplified Notifcation?
The CRC will initiate a submission review to evaluate the notification materials (which is similar to the Technical Completeness Check in EU REACH) upon receipt of the notification dossier and inform the notifier(s) of the review result within 5 working days. If the notification dossier passes the submission review, the notification materials will be submitted to the evaluation committee for a technical review. The evaluation committee will evaluate the technical parts in the notification material, identify any potential environmental hazards of the new chemical substance, provide a technical review report and subsequently submit the relevant documents to the MEP within 30 days. The review report provided will include preliminary evaluation conclusions of the eco-toxicological testing (including the rationality of the experiment design and test organism, etc.), as well as the decision on whether the notification should be granted.
Current Status
Since limited information and no risk assessment report are required for General Case of Simplified Notification, it is usually considered to be simple and easy to pass the technical review. Nevertheless, more and more cases of general case of simplified notification turn out to be rejected or required to provide additional information by the CRC-MEP. For example, for notified substance which is not readily biodegradable and has high eco-toxicity, it is very likely that the panel expert will consider the notified substance as highly hazardous to the environment and suggested the MEP to reject the simplified notification if more biodegradation or long-term eco-toxicological data and detailed exposure information fail to be submitted. This might lead to huge business loss since the notifiers will not be allowed to import or manufacture the notified substance without the valid notification certificate.
Suggestions
Although only several eco-toxicity studies are required and there is no requirement for hazard assessment and risk characterization for General Case of Simplified Notification, the notifiers are recommended to justify the substance’s potential hazard based on the available data before submitting the notification materials. If the notified substance has been classified as hazardous new chemical substance of priority environmental concern according to the Guidelines for Hazard Identification of New Chemical Substances, notifers are suggested to provide detailed exposure prediction and appropriate Risk Management Measure (RMMs) to justify the safety use of the notified substance. For general case of simplified notification, biodegradation and eco-toxicological data are generally considered. Once the notified substance is not readily biodegradable, or/and the acute fish toxicity or earthworm toxicity is very high, more information are needed to justify that the notified substance is safe to environment. Two aspects are suggested in the following, which will be helpful to justify whether the notified substance is hazardous to environment or not.
Collect all the available data. Additional data will increase the weight of evidence and help to reduce the overestimated environmental hazard, such as long-term aquatic toxicity data, inherent biodegradation and etc.
Collect specific information on manufacture and use, which will include process flow chart, exposure and use method of the notified substance. Risk management measures (RMMs) should be treated with more care. More specific information will be helpful to determine the potential exposure concentration of the notified substance exactly.
