Article

China Releases Amended Data Requirements for New Chemical Notifications

Posted on: September 28, 2017

by Lily Hou, PhD, CHMM

On August 31, 2017, China’s Ministry of Environmental Protection (MEP) published Announcement No. 42 of 2017: Regarding Amendment to the Data Requirements Under the “Guidance for New Chemical Substance Notification”.

Background

MEP submitted a Technical Barrier to Trade (TBT) notification on the first draft revision of the “Guidance for New Chemical Substance Notification” to the World Trade Organization (WTO) in March 2016. The draft version introduced substantial changes to the Guidance covering scope, data requirements and risk assessment, etc. MEP hasn’t been able to finalize the Guidance, yet. But, they decided to announce the new data requirements for regular notifications first so that chemical companies can refer to the new requirements when developing testing strategies for new chemical notifications.

What’s changed?

The Announcement revised the minimum data requirements and exemption conditions for Regular Notifications under China REACH, including the following five categories:

  • Minimum toxicological data requirements;
  • Minimum eco-toxicological data requirements;
  • Exemption conditions of physico-chemical data;
  • Exemption conditions of toxicology testing data;
  • Exemption conditions of eco-toxicology testing data.

Compared to the current data requirements, the new requirements reduced the test data requirements for regular notifications, especially for lower tonnage levels. For example, a 28-day repeated dose toxicity test is no longer required for level 1 notifications and a 90-day repeated dose toxicity test and a 14-day prolonged toxicity test to fish are no longer required for level 2 notifications.

New chemical notifications will need to comply with the new data requirements on October 15, 2017.

{ Recommended Action Items }

  • Review your company’s new chemical substance notification dossier for China to determine if your testing data follow the new data requirements under MEP Announcement No. 42 of 2017.
  • Watch for the publication of the finalized “Guidance for New Chemical Substance Notification.”

Reference:

MEP Announcement No. 42 of 2017: Regarding Amendment to the Data Requirements Under the “Guidance for New Chemical Substance Notification”

 


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