China's Ministry of Ecology and Environment (MEE) has released a draft revision of its rules governing the registration of new chemical substances for public consultation.
The draft Measures for the Environmental Management Registration of New Chemical Substances set out several major changes, such as greater regulatory control, removal of exemptions, stricter enforcement and increased downstream accountability.
These changes are expected to have significant impacts on the country's chemical industry, including potentially higher costs for overseas companies seeking to enter the Chinese market and the need to appoint local Chinese importers.
The move reflects recent trends in China's environmental governance, such as the strengthening of lifecycle chemical management and the alignment of MEE Order 12 with the Ecological and Environmental Code.
The main changes include:
- increased fines for non-compliance (operating without a certificate, violating conditions, or downstream usage of uncertified substances);
- legal liability extended downstream to cover use of unlicensed substances;
- only domestic manufacturers or importers within China will be able to apply for registration, with overseas entities and downstream users no longer eligible as registration holders;
- removal of exemptions for chemical substances already subject to other regulations, including cosmetics, food and additives;
- an exemption for chemical substances used strictly for scientific research and development (testing, inspection, metrology and monitoring);
- change in registration types, with elimination of the record-filing tier for <1 tonne/year (t/y) or polymer of low concern, meaning that substances <1t/y must now undergo simplified registration, while substances ≥1t/y will require regular registration;
- removal of serial registration for structurally similar substances; and
- introduction of cumulative national tonnage triggers for regular registrations in the 1-10t/y tier, meaning data requirements will depend on the total volume already registered nationwide for that substance.
Additional post-registration supervision, with information including hazard traits and risk controls, will need to be included in supply contracts to further inform supply chains. Downstream users will also be required to submit annual reports for new substances.
The notice was published on 11 June and the deadline for public comments is 12 July.