Third draft of China’s new substance notification guidance expected soon

China’s Environmental Protection Ministry may issue draft proposals for revising the guidance on new substance notification soon. And they will focus on data requirements. A draft copy of an MEP notice announcing the proposed changes has been circulated to industry. The text indicates that instead of revising all of the guidance provisions, the ministry will limit changes to the data requirements because it will deal with other issues by revising the law on the control of new substances, MEP Order 7. The MEP has been working on the new guidance for more than 18 months. Following comments from industry, a second draft issued last October made the proposals less onerous, and the latest draft is expected to be similar to this second document. Some of the key points from this were:

  • registrations of 1-10 tonnes per year substances will require only one exposure route of acute toxicity studies, rather than three. Oral studies will be preferred and 28-day repeated dose toxicity studies are no longer needed. For genotoxicity testing, only an Ames test (using bacteria to test carcinogens) is needed;
  • registrations of 10 to 100 tonnes per year substances will no longer require 90-day repeated dose toxicity and toxicokinetics studies; and
  • registrations of 100 to 1,000 tonnes per year, or above, substances will no longer require a full toxicokinetics study.

Chemical Watch, 23 August 2017 ;