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China’s MEE published on Jul 9th the draft revision of the Measures for the Environmental Management of New Chemical Substances (MEP Order 7), with public comments accepted until Aug 16th, 2019.
The current new chemical management system has been in effect since Oct 15th, 2010. The research and discussion on the revision of the MEP Order 7 has been underway for several years. The newly drafted Regulation on environmental risk assessment and control of chemical substances has outlined potential pending changes of China’s new substances management regime in Jan this year. The MEP Order 7 will be a subordinate measure of the regulation (CL news).
There are two overriding principles shaping the revision of the MEP Order 7.
Streamline administration: adjust registration types, reduce data requirements, optimize reporting mechanism, improve listing procedures for qualified chemicals into IECSC, quicken steps to the international practice and promote the green chemistry innovation in China under the premise of ensuring the environmental risk is controllable
Problem-orientated: solve practical problems during implementation, prioritize new chemicals of high environmental concern, strengthen corporate responsibilities and public transparency and give full play to the role of social supervision.
Below are the major changes introduced in the draft.
Registration Type
The draft offered exemptions for new substances imported or manufactured in very low volume below 100kg per year. Under the current practical regulation, companies can apply for simplified notifications for low volume substances (under 1 tonne per year) or for PLC or for polymers with low new chemical substance concentration of monomer which are (<2 % w/w) . As proposed, these three cases will be subject to a record notification and the companies can directly operate after submitting the required materials (no testing requirements). The current regular notification (Tier one: 1-10 tonne per year) will be adjusted to simplified registration with reduced data requirements.
As for the revised regular registration (＞10 tonne per year), the data requirements will no longer be simply classified according to tonnage bands. Instead, the data requirements will be considered based on hazards of the new substance and the exposure situations. For example, the chronic toxicity test data is required only for new persistent or bioaccumulative substances with exposure concern.
Approval Criteria
The draft specified criteria for approving and rejecting registration applications. In the future, regular registration can be approved if there is no unreasonable risks detected with appropriate risk control measures. In addition, for new substances of high hazards, the necessity for their activities should be acceptable. For a simplified registration, it will be approved if the new substance does not have persistent, bioaccumulative and toxic properties at the same time, and no cumulative environmental risk is found. The simplified registration rejected can submit more data to further assess the risks and apply for regular registration.
Post-registration supervision
The draft removed the provisions for submitting the every time activity report and five-year activity report. Only the annual report and the activity report for the first time have been kept. The deadline for annual reporting will be extended from Feb 1st to Apr 30th in the future. However, only regular registrations that have stipulated on the registration certificate that annual reporting is required should submit the annual report.
As for listing registered new chemicals into the IECSC, the qualified substance will be listed into the IECSC after 5 years from the first date of registration by the MEE. There will be no need to carry out a revaluation on the substance by the evaluation committee.
The new draft underlined the importance of strengthening responsibilities of enterprises for research, production, import, processing and use of new chemical substances. In addition, they should disclose risk control measures and the implementation details on the website or other public channels and transfer such information to the downstream users.
The draft revisions reflected the MEE’s intention to intensify the regulation of new chemical substances of great hazards. Their environmental management will focus on the requirements of emissions or discharge concentration limit, annual reporting, uses restriction when listed into the IECSC, etc. In addition, requirements of risk tracking and assessment after registration for these new chemical substances are added. The issued registration certificate will be modified or even withdrawn based on the tracking results.
The State and local ecology and environment departments will be responsible for random inspection of new chemical substances activities, which will mainly focus on assessing if they have completed registration or record notification, the authenticity of registration and record notification, the implementation of MEP Order 7 provisions and the items stipulated on the registration certificate, etc. Enterprises with a track record of problems will be subject to more frequent random checks.
