China Proposes Overhaul Of New Chemical Substance Registration Rules Under Environmental Code

The revised framework would replace the current MEE Order No. 12 and strengthen source-level controls on substances that may pose environmental or human health risks. The consultation was circulated to government departments, industry associations, academic institutions and regional environmental authorities.

New Chemical Substance Registration Requirements

Under the draft, a new chemical substance remains any substance not listed in China's Inventory of Existing Chemical Substances, as well as substances subject to new use environmental management requirements. Companies intending to manufacture or import such substances must obtain registration before commencing activities.

The proposal simplifies registration categories into:

• Regular registration for substances manufactured or imported at one tonne per year or more.
• Simplified registration for substances below one tonne per year.

Applicants seeking regular registration would generally need to submit physicochemical, toxicological and ecotoxicological data, environmental risk assessments and risk management measures. Additional socio-economic justification would be required for high-hazard substances.

Stronger Focus on High-Hazard Chemicals

A key feature of the draft is its emphasis on substances exhibiting persistence, bioaccumulation and toxicity characteristics. The MEE proposes enhanced controls for chemicals considered high hazard or capable of posing long-term environmental and health risks.

Registration certificates for such substances may include restrictions on emissions, new use environmental management requirements and other risk-control measures. The draft defines high-hazard chemicals as substances possessing persistent, bioaccumulative and toxic properties, highly persistent and highly bioaccumulative characteristics, or equivalent environmental or health hazards.

Supply Chain Reporting and Compliance Duties

The revised rules would impose broader post-registration obligations throughout the supply chain.

Manufacturers, importers and users would be required to communicate registration numbers, approved uses and environmental management requirements to downstream customers. Annual activity records would need to be maintained and uploaded to the national information system by 31 March each year.

Companies must also report newly identified environmental or health hazards and take immediate action where risks increase. Authorities would gain powers to require additional data and potentially amend or revoke registrations following reassessment.

Implications for Industry

The changes are likely to affect chemical manufacturers, importers, formulators, consumer goods producers, testing laboratories, logistics providers and compliance teams. Businesses currently relying on filing mechanisms under the existing framework should note that previously filed substances must obtain registration certificates by 31 December 2026.

Organisations operating in China or supplying the Chinese market should review portfolios, assess registration strategies and evaluate data requirements well before the proposed implementation date.

Summary

China's proposed revision of its new chemical substance registration regime represents a significant strengthening of environmental risk management. By aligning with the new Environmental Code, the draft increases scrutiny of hazardous chemicals, expands supply chain responsibilities and introduces new compliance obligations that industry participants should begin preparing for now.