REGULATORY MEMORANDUM

China Notifies WTO of Two Draft Chemical Regulations

The Chinese Ministry of Ecology and Environment (MEE) notified the World Trade Organization (WTO) of its “Environmental Risk Assessment and Control Regulation for Chemical Substances (Notification Draft)” (the draft Regulation) and “Measures on the Environmental Management of New Chemical Substances (Notification Draft)” (the draft Measures) on September 2, 2019. The draft Regulation is a revised version of the Consultative Draft of the Regulation published on January 8, 2019, and it is now more in line with the draft Measures, especially articles related to new chemical substances. The draft Measures is the same as the Consultative Draft of the Measures published on July 9, 2019.

The draft Regulation and the draft Measures are intended to govern the environmental risk assessment and management of chemical substances and their mixtures, excluding medicines, pesticides, veterinary drugs, cosmetics, foods, food additives, feeds, feed additives, fertilizers, and radioactive materials.

The draft Regulation covers both existing and new chemical substances, including their environmental risk screening and assessment, the management of priority and high-risk chemical substances, activity reporting of chemical substances, and registration of new chemical substances. The draft Regulation requires MEE to establish rules on the environmental risk assessment of existing chemical substances and a work plan on environmental risk screening, and to conduct risk assessments of persistent, bioaccumulative, and toxic (PBT) substances. The annual reporting requirement proposed in the Consultative Draft of the Regulation is reduced in the draft Regulation to reporting every three years except for the chemical substances subject to prioritized control. Compared to the Consultative Draft of the Regulation, the draft Regulation has additional measures on risk management, including a maximum of five years of protection for confidential business information (CBI) relating to substance identity; restriction and ban of chemical substances subject to prioritized control; and additional enforcement measures. Generally, the draft Regulation is similar to the Toxic Substances Control Act (TSCA) in the United States. More information on the Consultative Draft of the Regulation is available in our January 16, 2019, memorandum, “China Publishes Chemical Environmental Risk Assessment and Control Regulation to Update MEP Order No. 7 for Public Comment.”

The draft Measures would update the “Environmental Management of New Chemical Substances” (MEP Order No. 7), which requires that new chemical substances be registered or filed to MEE. The production, importation, and processing of new chemical substances without registration or filing would be prohibited. More information and commentary on the Consultative Draft of the Measures is available in our July 12, 2019, memorandum, “China Begins Public Consultation on Draft Revision to MEP Order No. 7,” and the July 29, 2019, article, “China Drafts Changes to Chemical Registration Rules,” published in the Insights section of Bloomberg Environment.

Commentary

The draft Regulation and draft Measures will significantly change the chemical substances management regime in China. Manufacturers, processors, users, and importers of chemical substances in China will be affected. The schedule for release of the draft Regulation and draft Measures in final was not provided but is expected by the end of the year. The implementation rules and guidance documents are expected after the draft Regulation and the draft Measures are released in final.

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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