Jun 25, 2015 saw the official release of the draft of the revised China New Chemical Substance Notification Guidance after more than 1 year of deliberation. The draft is now open for public consultation until 31 July, 2015.
Primary changes in the revised draft focus on the applicable scope, management policy, data requirements and waiving, notification procedures, requirements of risk assessment report and post-notification requirements. Compared to the current guidance, when promulgated the new one will impose a more comprehensive management on new chemical substance notification in China.
The revision draft contains 6 Chapters and 5 Annexes.
Chapter 1. Applicable scope
Chapter 2. Notification types and submission format
Chapter 3. Notification procedure
Chapter 4. Notification material requirements
Chapter 5. Special provisions for polymers
Chapter 6. Post-notification supervision and management of new chemical substances
Annex 1. Format requirements of risk assessment report
Annex 2. Use code list of chemicals
Annex 3. Each-activity report of new chemical substances
Annex 4. Annual report of new chemical substances
Annex 5. Five-year actual activity report of notified new chemical substances