Regulatory Developments

China Begins Public Consultation on Draft Revision to MEP Order No. 7

July 12, 2019 PRINT

On July 9, 2019, the Ministry of Ecology and Environment (MEE, formerly the Ministry of Environmental Protection (MEP)) issued a notice of public consultation on the draft revision to the “Environmental Management of New Chemical Substances” (MEP Order No. 7). The deadline to submit comments to MEE regarding the draft revision is August 16, 2019. Comments should be submitted to MEE via e-mail (chem@mee.gov.cn).

What Is New?

The “Provision on the Environmental Administration of New Chemical Substances” was first introduced in 2003, and last revised through MEP Order No. 7 in 2010. This draft revision will replace the current MEP Order No. 7, reducing some registration burdens for new chemical substances, particularly for new chemical substances without persistent, bioaccumulative, and toxic (PBT) potential and with annual production or import volume of less than ten metric tons. The key provisions in the draft revision are summarized below:

  • New chemical substances used for research with annual production or import volumes of less than 100 kilograms (kg) are excluded;
     
  • 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 monomer or polymers of low concern (PLC) will only require a record filing;
     
  • 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 file a simplified registration, which does not require that toxicological tests related to health hazards be conducted. PBT substances will not be eligible for the simplified registration;
     
  • New chemical substances with regular registration will be included in the Inventory of Existing Chemical Substances in China (IECSC) after five years and PBT substances will include a use restriction;
     
  • PBT substances on the IECSC with a use restriction will require new use registration; and
     
  • Annual reporting will only be required for regular registration and the report date is changed from February 1 to April 30 each year.
     

Commentary

The draft revision to MEP Order No. 7 will reduce some registration burdens of new chemical substances once it becomes effective in China and thus is welcomed news by some. Importantly, the draft revision includes a low volume (<100 kg/year) exclusion, addressing a major shortcoming in the current MEP Order No. 7. Additionally, current simplified registrations for substances with an annual volume of less than one metric ton and polymers with less than two percent of new chemical monomer or PLC will be replaced with a record filing process, which will not require premarket approval. Current level 1 regular registration will be replaced with the simplified registration, a process that will not require toxicology tests related to health hazards.

The draft revision also introduces a new use rule for PBT substances. Registration will be required for new uses of PBT substances listed on the IECSC with use restriction. The full revision of “Guidance for New Chemical Substance Notification and Registration” is expected after the draft revision is released in final. The schedule for release of this revision in final was not provided, however.

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


 
BERGESON & CAMPBELL, P.C.
2200 Pennsylvania Avenue, NW, Suite 100W
Washington, D.C. 20037
202-557-3800 • 202-557-3836 (fax) | lawbc.com
Contact • Twitter
 
Privacy Policy | Terms of Use | Cookie Policy | Attorney Advertising | Trademarks
©2019 Bergeson & Campbell, P.C.
All Rights Reserved.