China Replaces Its New Chemical Registration Rules

China's Ministry of Ecology and Environment has issued Order No. 40, replacing its measures for environmental management registration of new chemical substances. The order was promulgated on 24 October 2026 and took effect that day. Producers and importers must obtain the appropriate registration certificate before producing or importing a covered substance.

Registration Routes

Article 10 sets three routes according to annual production or import volume and polymer status:

• Conventional registration applies at 10 tonnes or more.
• Simplified registration applies from 1 tonne to less than 10 tonnes.
• Formal registration applies below 1 tonne, to polymers containing no more than 2% new-substance monomers or reactants, or to low-concern polymers.

The measures define new substances as those absent from the Inventory of Existing Chemical Substances in China. Specified inventory substances also fall under new-use management when used for industrial purposes outside their permitted uses.

Scope And Exceptions

Article 2 excludes listed finished products, including medicines, cosmetics, food and fertilisers, but preserves coverage for relevant raw materials, intermediates and changes to other industrial uses. It also excludes new substances stored in special customs-supervision areas and wholly re-exported without processing.

Reporting And The Earlier Framework

Article 48 repeals the earlier Order No. 12. The replacement measures require first-activity reporting within 60 days of first production, or first import followed by transfer to a processing user. Annual reporting applies where a conventional registration certificate requires it. Those reports are due by 30 April, starting in the year after registration.