by Lily Hou, PhD, CHMM
On August 17, 2020, the Ministry of Ecology and Environment of the People’s Republic of China (MEE) published the draft Guidance for New Chemical Substance Registrations for public comments. The new Guidance will replace the current Guidance for New Chemical Substance Notifications issued by the former Ministry of Environmental Protection in 2010.
The new Guidance refines relevant definitions and scope of new chemical registrations, and provides detailed test and non-test data requirements, as well as minimum data requirements for different registration types. It adds criteria for highly hazardous chemical substances and specifications for the newly required analysis report of socio-economic benefits for these highly hazardous chemical substances.
The Guidance contains the following seven chapters:
Chapter 1: Scope of new chemical substance registrations
Chapter 2: New chemical substance registration types
Chapter 3: New chemical substance registration procedures
Chapter 4: Requirements on registration documents
Chapter 5: Special provisions on polymers
Chapter 6: New use registration, re-registration, registration certificate change, withdrawal and cancellation
Chapter 7: Post-registration supervision and management
The following application forms and instructions are also open for public comments:
- New Chemical Substance Regular Registration Form and Instructions
- New Chemical Substance Simple Registration Form and Instructions
- New Chemical Substance Record Filing Form and Instructions and Instructions
- New Chemical Substance Regular Registration Change Form
- New Chemical Substance Simplified Registration Certificate Change Form and Instructions
- New Use Environmental Management Registration Form and Instructions
- New Hazard Report Form and Instructions
- New Chemical Substance First Activity Report Form and Instructions
- New Chemical Substance Annual Report Form and Instructions
- New Chemical Substance Environmental Management Registration Withdrawal Application Form and Instructions
- New Chemical Substance Environmental Management Registration Certificate Cancellation Application and Instructions
- Table of Chemical Use Codes
Revision suggestions can be submitted via email to: email@example.com. The public comment period for the new Measures ends on September 6, 2020.
Recommended Action Items:
- Review the Guidance document and submit your comments by September 6, 2020.
- The Guidance should be used in conjunction with the “Measures on Registrations of New Chemical Substances for Environmental Management” which will come into force on January 1, 2021. For further details on the Measures, please view our earlier blog post: China Issues Final Measures on Registrations of New Chemical Substances for Environmental Management
Draft Guidance for New Chemical Substance Registrations (新化学物质环境管理登记指南(征求意见稿), only available in Chinese): http://www.mee.gov.cn/xxgk2018/xxgk/xxgk06/202008/t20200817_793827.html
Guidance for New Chemical Substance Registrations, China New Chemical Registrations
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