BEIJING, 2 November 2026 — China is replacing the notification procedure for low-volume new chemicals and certain polymers with mandatory registration approval, potentially extending market-entry timelines despite largely unchanged technical data requirements. The revised rules also eliminate the option for overseas manufacturers to register chemicals through authorized Chinese representatives, raising concerns about protecting trade secrets and maintaining control over registrations.
The Ministry of Ecology and Environment (MEE) published the revised Measures for the Environmental Management Registration of New Chemical Substances under Order No. 40 on 26 October 2026, replacing Order No. 12. The changes follow transitional arrangements introduced on 15 August 2026.
The final regulation still retains the existing exemptions for cosmetics, pharmaceuticals, food, and other regulated products, despite a proposal to eliminate these exclusions in the June 2026 draft. These products are already governed by other separate regulations.
Low-volume chemicals and polymers now require approval
Under the previous rules, new chemicals manufactured or imported below one metric tonne annually and certain polymers—including polymers of low concern and polymers containing no more than 2% new monomers or reactants—were eligible for a simpler notification procedure.
Order No. 40 replaces notification with formal registration, a reduced-requirement process involving government review and issuance of a registration certificate.
The principal change is the requirement for approval, not additional chemical testing. According to the MEE, technical information requirements remain largely unchanged. However, companies must now obtain a registration certificate before manufacturing or importing these substances.
Formal registration applications are subject to technical review of up to 30 days, introducing additional lead time for specialty chemical suppliers, polymer manufacturers, and companies developing customized materials.
Companies can reduce delays by preparing applications earlier or considering existing chemicals listed in China's Inventory of Existing Chemical Substances in China (IECSC). However, early registration increases upfront costs, while substitution may require reformulation and additional product qualification.
The MEE stopped accepting new notifications on 15 August 2026, before incorporating the new procedure into Order No. 40.
Foreign suppliers face registration and confidentiality challenges
Order No. 40 restricts registration to eligible Chinese manufacturers and importers, ending the previous option for foreign companies to register through authorized representatives.
Foreign suppliers can rely on Chinese importers, avoiding the expense of establishing local operations. However, this may require disclosing confidential chemical identities, formulations, or trade secrets to commercial partners. It also creates dependence on individual importers and may complicate distribution through multiple customers.
Alternatively, foreign manufacturers can register through an eligible Chinese subsidiary that conducts import activities, retaining greater control over registrations and proprietary information but incurring additional operating costs and legal responsibilities.
Confidentiality agreements can help protect sensitive information but cannot eliminate disclosure risks. Companies should also verify whether proprietary data can be submitted separately to Chinese authorities without disclosure to importers. Regulatory consultants can assist with applications but cannot hold registrations solely as authorized representatives.
Existing registration thresholds remain unchanged
China retains its existing tonnage thresholds despite a June 2026 proposal to lower the regular registration threshold from 10 tonnes to one tonne annually.
Regular registration: 10 tonnes or more
Simplified registration: 1 to less than 10 tonnes
Formal registration: Less than 1 tonne or certain qualifying polymers
Implications for chemical suppliers
China's revised framework introduces an additional approval step for low-volume chemicals and qualifying polymers without substantially increasing their technical data requirements. The main consequences are longer potential market-entry timelines and greater administrative costs.
For overseas suppliers, restrictions on registration eligibility create a separate challenge: maintaining commercial flexibility and protecting proprietary information while relying on eligible Chinese applicants.
Although the government retains existing tonnage thresholds, manufacturers and importers must now account for registration approval, applicant eligibility, and confidentiality risks earlier when planning chemical introductions into China.
