Regulatory Developments

China Publishes Final Notice on Convergence Matters Related to Transition from MEP Order No. 7 to MEE Order No. 12

November 4, 2020 PRINT

The Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), released the final Notice on Convergence Matters Related to Environmental Management Registration of New Chemical Substances on October 27, 2020. Different from the draft Notice published in early June, new chemical substance registrations submitted and accepted by MEE before December 31, 2020, will be reviewed and approved under current MEP Order No. 7 until June 30, 2021. Registrations accepted under current MEP Order No. 7 that are not approved before June 30, 2021, will have to register according to MEE Order No. 12.

The other key differences from the draft Notice are:

  • The following revisions to regular registrations obtained under MEP Order No. 7 will not require re-registration after January 1, 2021:
     
    • Reduction in the registered tonnage;
       
    • Change in the activity associated with the chemical substance from production to importation or to add import activity;
       
    • Change in chemical identity information such as name or Chemical Abstracts Service (CAS) Registry Number (RN); and
       
    • Change of the name of the registration holder or agent.
       
  • For the following scenarios, revisions to simplified registrations obtained under MEP Order No. 7 will not require re-registration after January 1, 2021:
     
    • The change will not increase the annual volume of the substance to greater than one metric ton per year;
       
    • The change to a research and development registration that is within the valid period will not increase the volume of the substance to greater than ten metric tons; and
       
    • The registered polymers are polymers comprised of less than two percent of new chemical monomers or are polymers of low concern (PLC).
       

Commentary

The final Notice includes a six-month grace period for technical review and approval of new chemical substance registrations that have been submitted and accepted by MEE before December 31, 2020. The Acta Group (Acta®) recommends that companies planning to register new chemicals for governmental approval early next year should submit them before mid-December to ensure sufficient time for completion of the completeness check by the authority before December 31, 2020, to avoid resubmitting the registration under MEE Order No. 12.

For further assistance, please e-mail or call J. Brian Xu, M.D., Ph.D., DABT®, at bxu@actagroup.com or (202) 266-5029.


 
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