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China Publishes Draft Notice on Convergence Matters Related to Transition from MEP Order No. 7 to MEE Order No. 12
The Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), released a Notice on Convergence Matters Related to Environmental Management Registration of New Chemical Substances (Draft for Consultation) on June 3, 2020. The deadline to submit comments to MEE regarding the draft Notice is June 20, 2020. Comments can be submitted to MEE via e-mail (chem@mee.gov.cn). The key points in the draft Notice are summarized below:
- After January 1, 2021, new chemical substances that have completed regular registration under MEP Order No. 7 but that have not yet been added to the Inventory of Existing Chemical Substances in China (IECSC) will be managed as follows:
- Annual reporting of the registered new chemical substances will follow the requirements under MEE Order No. 12;
- New chemical substances registered with classification of priority management of environmental risk will be added to IECSC with a use restriction five years after the approval date of regular registration; and
- Any changes of information in the registration certificate will require re-registration.
- Annual reporting of the registered new chemical substances will follow the requirements under MEE Order No. 12;
- After January 1, 2021, new chemical substances with simplified registration under MEP Order No. 7 will be managed as follows:
- Simplified registration for research and development of process and product will be valid for two years from the date of the first activity; and
- Any changes of information in the registration certificate will require new record filing or simplified registration.
- Simplified registration for research and development of process and product will be valid for two years from the date of the first activity; and
- Registrations submitted under current MEP Order No. 7 for which technical review and approval are not completed before January 1, 2021, will have to register according to MEE Order No. 12.
Commentary
According to the draft Notice, revisions to existing registrations, such as changes of tonnage within the registered volume level, registration holder name, and chemical identity information, will require re-registration after January 1, 2021. The Acta Group (Acta®) recommends that all registration holders check all existing new chemical substance registration certificates to ensure that any changes of the registrations will be filed at least three months before the end of this year to avoid re-registration obligations.
Companies planning to register new chemicals with governmental approval this year or early next year should submit them as soon as possible to ensure sufficient time for completion of the technical review and approval process by the authority before January 1, 2021, to avoid resubmitting the registration under MEE Order No. 12.
Although the draft Notice may be issued in final with some revision, Acta suggests that all registration holders review all existing and ongoing registrations and take necessary actions to mitigate potential risks related to the regulatory process changes and uncertainties surrounding the implementation of MEE Order No. 12, including those associated with possible revisions of the current draft Notice.
For further assistance, please e-mail or call J. Brian Xu, M.D., Ph.D., DABT®, at bxu@actagroup.com or (202) 266-5029.