China Issues Final Guidance for Environmental Management Registration of New Chemical Substances
The Chinese Ministry of Ecology and Environment (MEE) Order No. 12, “Measures on the Environmental Management Registration of New Chemical Substances,” will replace the Ministry of Environmental Protection (MEP) Order No. 7, “Measures of Environmental Management of New Chemical Substances,” on January 1, 2021. To implement MEE Order No. 12, the MEE issued in final its “Guidance for Environmental Management Registration of New Chemical Substances” (Guidance) on November 17, 2020, which will replace the “Guidance for New Chemical Substances Notification and Registration” under MEP Order No. 7 on January 1, 2021.
The final Guidance is generally the same as the draft Guidance that was reported in our August 20, 2020, memorandum, “China Publishes Draft Guidance for Environmental Management Registration of New Chemical Substances.” There are, however, some significant changes on confidential information protection and the data requirements for regular registration of new chemical substances with the potential for persistence (P) and/or bioaccumulation (B).
The key changes in the final Guidance are summarized below:
- Physiochemical properties test data generated in laboratories outside of China will be acceptable if the laboratory complies with the administrative requirements applicable in the country in which it operates; compliance with the requirements of the International Organization for Standardization (ISO) 17025 will no longer be required;
- The five-year protection period for confidential information is limited to the identity information of new chemical substances and can be extended for a maximum of five additional years;
- In vitro dermal and eye irritation test data will be accepted if the results are conclusive, i.e., clearly positive or clearly negative;
- The toxicology data requirements for regular registrations are classified into three categories based on the substance’s P and/or B potential. Only substances with both P and B potential will require extensive toxicology tests;
- Sediment-water chironomid toxicity testing will be required only for regular registration of substances that have both P and B potential; and
- Intermediates of pharmaceuticals, pesticides, and/or veterinary drugs that have P and/or B potential are exempt from the additional data requirements for regular registrations of all other new chemical substances that have P and/or B potential.
On the whole, the final Guidance is good news. It addresses some of industry’s major concerns with the status quo and reduces the data requirements for the regular registration of new chemical substances with either P or B potential, although the data requirements are still hazard oriented and test results-based, not risk-based.
For further assistance, please e-mail or call J. Brian Xu, M.D., Ph.D., DABT®, at firstname.lastname@example.org or (202) 266-5029.