After over a year of review and revision, on January 8, 2019, the Chinese Ministry of Ecology and Environment (MEE) published the "Chemical Environmental Risk Assessment and Control Regulation (Draft)" (Regulation) for public comment. The draft Regulation would update the “Environmental Management of New Chemical Substances” (MEP Order No. 7). The deadline to submit comments to MEE regarding the Regulation is February 20, 2019. Comments should be submitted to MEE via e-mail (chem@mee.gov.cn).

Background

Since "Provision on the Environmental Administration of New Chemical Substances" became effective on October 15, 2003, China revised the Provision through the MEP Order No. 7 on January 19, 2010, which came into effect on October 15, 2010. The intent of the draft revision of MEP Order No. 7 is to provide an update based on the effectiveness of the revision of the Environmental Protection Law on January 1, 2015; the release of Water Pollution Control Plan on April 2, 2015; and practical experiences and lessons learned since the implementation of MEP Order No. 7. As with all documents issued by the MEE, the document is available in Chinese. We provide a brief summary of key elements in English, below.

What Is New?

The current MEP Order No. 7 came into effect on October 15, 2010. The draft Regulation includes risk assessment and management of new and existing chemical substances; the key provisions are summarized below:

• Scope:
  • The scope of the Regulation is expanded from new chemical substances to all chemical substances, including both existing and new chemical substances.
• Inventory and Lists:
  • Risk assessment and control of chemical substances are managed under the lists based on priority and risk, which includes:
    • Inventory of Chemical Substances in China;
    • List of Priority Control Chemical Substances;
    • List of Chemical Substances Strictly Restricted;
    • List of Chemical Substances Restricted for Import and Export; and
    • List of Prohibited Chemical Substances.
• Registration of New Chemical Substances:
  • Exemption: New chemical substances used for research in laboratories or reference standards with annual production or import volume of less than 100 kilograms;
  • New Chemical Substance Record: New chemical substances with annual production or import volume of less than one metric ton; polymers with less than two percent of new chemical monomer or polymers of low concern (PLC); and new chemical substances used for research and development (R&D) with annual production or import volume of less than ten metric tons for no more than two years; and
  • New Chemical Substance Registration: New chemical substances with annual production or import volume of more than one metric ton that meet criteria for New Chemical Substance Record.
• Risk Assessment and Reporting of Chemical Substances:
  • MEE shall establish technical guidance, procedures, and database for environmental impact assessment of chemical substances;
  • Producers, processors/users, or importers of chemical substances shall annually report identity, quantity, and uses of the chemical substances to MEE;
  • MEE shall publish work plans for risk assessment of priority control chemical substances, which are persistent, bioaccumulative, or relatively high risk to environment or human health, and conduct risk assessment of the priority control chemical substances; and
  • Producers, processors/users, or importers of chemical substances on the List of Priority Control Chemical Substances shall report emission data, local environment impact, and necessary physicochemical properties, toxicology, and ecotoxicology data of the chemicals. MEE can request the enterprises to conduct additional tests if the existing information is insufficient for risk assessment.

Commentary

The revisions to MEP Order No. 7 will significantly change the registration process for new chemical substances in China. Unfortunately, exactly how the process will change is unclear because the details are not provided in the draft Regulation. The new process suggests that simplified registration will be replaced with the record filing, which will not require premarket approval, for new chemical substances with an annual volume of less than one metric ton or used for R&D and polymers with less than two percent of new chemical monomer or PLC. Import and export licenses will be required for chemical substances strictly restricted. The schedule for release of this revision in final was not provided. The full revision of “Guidance for New Chemical Substance Notification and Registration” is expected after the Regulation is released in final.