- The data requirements in the revised Guidance were published individually.
- MEP Order 7 will be revised before the publication of its revised Guidance.
- Amendments on minimum data requirements are summarized.
The amendments on data requirements in China’s New Substance Notification Guidance were published on Aug 28th 2017 as an individual announcement (MEP Announcement No.42 of 2017), rather than being published as part of the full document of the revised Guidance. The amendments will take effect from Oct 15th 2017.
China MEP notified the WTO on the revised draft of the new substance notification guidance on Mar 8th 2016 (CL news). The WTO version was updated last October (CL news) based on the feedback received during the public consultation period. Since there are some discrepancies between the amendments and MEP Order 7 (the Measures for the Environmental Management of New Chemical Substances), China MEP recommended an initial revision of MEP Order 7 first and then the subsequent publication of revised Guidance. However, considering the revision of MEP Order 7 is a large undertaking and there are major amendments on data requirements in China’s new substance notification guidance, China MEP finally decided to publish the revised data requirements separately. A draft copy of the MEP announcement attached with the proposed amendments on data requirements was circulated to a limited number of associations in July 2017 for soliciting comments. The final publication was recently relased to facilitate effective planning and utilization of the test programs according to the new requirements.
The revised data requirements consist of the following part:
- Annex 1. Minimum requirements of toxicological data
- Annex 2. Minimum requirements of eco-toxicological data
- Annex 3. Exemption conditions of physico-chemical data
- Annex 4. Exemption conditions of toxicology testing data
- Annex 5. Exemption conditions of eco-toxicology testing data
For minimum data requirements, the major amendments are summarized in ChemLinked Expert Article. Please click here to read more.
A new translation (Annex 1~5) is in ChemLinked stock now. Compared with the 2010 version updates have been highlighted in yellow, which will facilitate effective planning and utilization of the test programs according to the new requirements. This document is free during ChemLinked 5-year Anniversary Celebration till Oct 10. After that this would be only free for premium members in chemical portal. Click here to have a free copy now.