On May 7, 2020, the Chinese Ministry of Ecology and Environment (MEE) published the final version of revised legislation regulating new chemical substances in the country. News provider Chemical Watch published an article reviewing the revision, which will come into effect on January 1, 2021. It reports that the updated text focuses on the management of persistent (P), bioaccumulative (B), and toxic (T) substances, including defining scenarios in which substances meeting the set PBT criteria will not be approved. It further reduces set requirements for polymers considered of low concern as well as for the registration of substances that are manufactured or imported in volumes less than ten metric tons per year. A new process for notifying uses of previously registered substances has also been introduced. New substances will require either a regular, simplified, or record filing notification with different requirements for each depending on the annual volume manufactured or imported.

New substances registered under the revised regulation can now be kept confidential for a maximum of 5 years, and no extensions can be granted. This means that all existing substances registered previously within the national chemicals inventory will become public beginning on January 1, 2026. Annual reporting requirements under the revision have been reduced, and companies will only need to submit annual reports for new substances that meet the criteria of being either PB, PT, or BT or considered highly hazardous. The agency is reported to be developing further guidance documentation that will specify the data requirements and detail the steps within the notification procedure.

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Ellen Daliday (May 7, 2020). “China publishes final text of regulation governing new chemicals.” Chemical Watch

Chemical Watch (May 13, 2020). “China adds 156 substances to existing chemical inventory.”

Ellen Daliday (May 14, 2020). “China: start preparing now for changes to new chemicals registration, experts advise.” Chemical Watch

Heng Li (May 20, 2020). “Expert Focus: What changes has China’s revised law on new chemical substances introduced?Chemical Watch

Ellen Daliday (June 4, 2020). “China consults on transitional rules for MEE Order 12.” Chemical Watch

Nhat Nguyen (June 15, 2020). “Comparison Analysis: How does China’s MEE Order 12 concerning the introduction of new chemical substances compare with MEP Order 7?Chemical Watch

David Macfarlane (October 28, 2020). “‘Inconsistencies’ in China’s draft hazardous chemicals safety law need reworking, says industry.” Chemical Watch

David Ettinger and Chen Hu (November 2, 2020). “Expert Focus: What will be required under China’s draft guidelines for new chemical registration?Chemical Watch


MEE (May 7, 2020). “New Chemical Substance Environmental Management Registration Measures.”