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The change takes effect alongside China's new Ecological and Environmental Code and replaces the ministry's existing Order No. 12 framework.
Under the outgoing system, new substances produced or imported below a one-tonne annual threshold, along with certain lower-concern polymers, could use a lightweight record-filing pathway.
The revised measures remove that pathway entirely, retaining only two administrative categories – regular registration and simplified registration – with simplified registration now applying to substances below one tonne a year and regular registration to everything above it.
The revision also narrows who can apply. From 15 August, the ministry will no longer accept new chemical substance registration applications submitted directly by enterprises based outside China, nor applications to amend existing registration certificate information from overseas entities.
Only importers of new chemical substances located within China may act as applicants going forward – a change that effectively ends direct registration by foreign manufacturers and pushes them towards in-country importers or agents.
The ministry first floated the changes in a June consultation draft, with a public comment period that closed on 12 July.
Existing registration certificates issued under the current Order No. 12 regime remain valid, and applications already accepted before the new measures take effect may continue to be processed under the old rules – but the window for new simplified filings closes on 15 August, and enterprises with substances in the pipeline for that route need to have filed before the cutoff.
The documentation burden under the fuller registration categories is substantially heavier than under record notification.
Registrants must submit physicochemical, toxicological and environmental fate data proportionate to tonnage band and hazard profile, rather than the largely self-declared information that sufficed under the simplified route.
For substances meeting persistence, bioaccumulation or toxicity criteria, additional non-approval criteria apply, meaning some borderline substances that previously cleared record notification may now face a substantively harder registration bar.
The shift places China's system on a broadly similar trajectory to EU REACH and UK REACH, both of which have progressively tightened data requirements and narrowed lower-tier registration routes for new and existing substances over the past decade, though the compressed six-week gap between confirmation and implementation here is notably shorter than the multi-year transition periods typically built into EU or UK regulatory changes of comparable scope.
For laboratories and analytical service providers supporting China-facing petrochemical and chemical supply chains, the practical effect is a heavier testing and documentation burden per substance, and a shift in where compliance work sits within the supply chain – increasingly with in-country importers rather than with the originating manufacturer overseas.
Firms currently relying on the record-notification route for lower-volume specialty or intermediate chemicals should treat the 15 August cutoff as the point at which that route is no longer available for new filings, not simply 'restricted' – testing and registration budgets built around the simplified pathway will need to move to the fuller regular or simplified registration categories under the new rules well before the deadline.
PIN 27.3 June/July 2026
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