Regulatory Developments

China Publishes Long-Awaited Revised MEP Order No. 7

May 8, 2020 PRINT

The Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), issued the long-awaited revision of MEP Order No. 7 in final, “Measures on the Environmental Management of New Chemical Substances” (MEE Order No. 12), on April 29, 2020, which will become effective January 1, 2021.

MEE Order No. 12 is generally the same as the Notification Draft that MEE notified to the World Trade Organization (WTO) on September 2, 2019, except that the exclusion for new chemical substances used for research with annual production or import volumes of less than 100 kilograms (kg) is removed.

The regulations on new chemical substances were first introduced in 2003 and revised in 2010 as MEP Order No. 7. MEE Order No. 12 will replace the current MEP Order No. 7, strengthening the management of new chemical substances with persistent (P), bioaccumulative (B), and toxic (T) potential, including some concepts similar to the ones under the U.S. Toxic Substances Control Act (TSCA), reducing some registration burdens for new chemical substances, particularly for new chemical substances with annual production or import volume of less than ten metric tons. The key provisions in the final revision are summarized below:

  • New chemical substances with annual production or import volumes of less than one metric ton and polymers with less than two percent of new chemical monomers or polymers of low concern (PLC) will only require a record filing, which does not require premarket approval. Companies can begin production, import, or use as soon as they have submitted the necessary information and documents and passed the completeness check;
     
  • Regular registration is required only for new chemical substances with annual production or import volumes of ten metric tons and above. New chemical substances with annual production or import volumes of one to ten metric tons will only require a simplified registration, which does not require toxicology tests related to health hazards. Substances that meet all three criteria -- P, B, and T -- and with cumulative environmental risk will not be eligible for the simplified registration;
     
  • New chemical substances with regular registration will be added to the Inventory of Existing Chemical Substances in China (IECSC) five years from the date of approval and PB, PT, or BT substances will include a use restriction;
     
  • Substances on the IECSC with a use restriction will require new use registration, similar to the significant new use rule (SNUR) under TSCA;
     
  • Introduces a maximum five-year protection period for confidential information on the identity of new chemical substances; and
     
  • Annual reporting will only be required for highly hazardous, PB, PT, or BT substances with regular registration, which will be specified in the registration certificate.
     

Commentary

MEE Order No. 12 will reduce some registration burdens of new chemical substances in China. It removed the low volume (<100 kg/year) exclusion from the Notification Draft, however. MEE is currently working on supporting documents and guidance. The full revision of “Guidance for New Chemical Substance Notification and Registration” is expected, which will provide more information on data requirements and detailed notification procedures. The schedule for release of the supporting documents and guidance was not provided, but is expected to be before the end of this year.

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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