On April 29, 2020, China's Ministry of Ecology and Environment (MEE) published the Measures on Environmental Management Registration of New Chemical Substances (MEE Order 12). The amendment will come into force on January 1, 2021 and replace the current MEP Order 7. The updated text focuses on the management of persistent (P), bioaccumulative (B), and toxic (T) substances, including defining scenarios in which substances meeting the PBT criteria will not be approved. MEE Order 12 introduces Simplified Registration as well as post-registration management.
Depending on annual tonnage, new chemical substances will be subject to three types of registrations: Regular Registration, Simplified Registration, and Filing.
New substances with annual volumes between 1 and 10 tons will be subject to the Simplified Registrations under MEE Order 12. Registrants should provide following information: (1) the application form; (2) physicochemical properties, and ecotoxicological study reports or materials regarding persistency, bioaccumulation, and aquatic environmental toxicity; and (3) a commitment letter on implementation or transmission of environmental risk control measures.
For New Substances of more than 10 tons, registrants should submit Regular Registration, including following information: (1) the application form; (2) physicochemical, toxicological and ecotoxicological test reports or materials; (3) an environmental risk assessment report; and (4) a commitment letter on implementation or transmission of environmental risk control measures.
The first-activity report is required for both Simplified Registrations and Regular Registrations and should be submitted within 60 days since the first manufacture or the first transfer to customers after import.
CBI Protection: CBI protection for substances currently in the IECSC will be abolished by 31 December 2025. The maximum time applicable for CBI protection of new substances added to the inventory of existing chemicals in China (IECSC) will be 5 years.
For further details, please click on the link to the official announcement
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MEP Order NO.7 has been China’s main chemical regulation since 2010 and it only controls new chemicals. The regulation has been revised by the Ministry of Ecology and Environment (MEE) and the revision of MEP Order No.7, Measures on the Environmental Management of New Chemical Substances (MEE Order No. 12), published on 29 April 2020, is expected to be effective from 1 January 2021. Obligations and challenges under China’s new and revised chemical laws have been a major concern for companies.
See our Regulatory Manager Chia-Sui Hsu's insights on the revision in Chemical Watch’s annual Global Service Providers Guide (2020) (p.58-59).