Article

China Seeks Public Comments on the Guidance for New Chemical Substance Registrations

Posted on: August 24, 2020

by Lily Hou, PhD, CHMM

photo of colorful test tubes - China Seeks Public Comments on the Guidance for New Chemical Substance RegistrationsOn August 17, 2020, the Ministry of Ecology and Environment of the People’s Republic of China (MEE) published the draft Guidance for New Chemical Substance Registrations for public comments.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: chem@mee.gov.cn. The public comment period for the new Measures ends on September 6, 2020.

Recommended Action Items:

Reference:

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

Key Words:

Guidance for New Chemical Substance Registrations, China New Chemical Registrations


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