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Major Changes to China’s New Chemical Substance Environmental Management Registration System: Filing Suspended from August 15
Major Changes to China’s New Chemical Substance Environmental Management Registration System: Filing Suspended from August 15
To implement the Environmental Code of the People’s Republic of China and improve the environmental management registration system for new chemical substances, the General Office of the Ministry of Ecology and Environment (MEE) issued the Notice on Matters Concerning Environmental Management Registration of New Chemical Substances (Huan Ban Gu Ti Han [2026] No. 301) on July 31, 2026. The new policy took effect on August 15, 2026.
The key change is that environmental management filing for new chemical substances will no longer be accepted from August 15, 2026. Enterprises and public institutions that previously met the requirements for environmental management filing under the Measures on Environmental Management Registration of New Chemical Substances (MEE Order No. 12) must, before producing or importing a new chemical substance, submit an application form for environmental management registration of new chemical substances, together with supporting documents demonstrating the applicable circumstances specified in Article 10(3) of the Measures. They must also provide other available information concerning the environmental and health hazard characteristics and environmental risks of the new chemical substance. The MEE will review and approve such applications by reference to the procedures and timelines applicable to simplified registration.
This change means that low-volume new chemical substances with an annual production or import volume of less than 1 ton, which could previously enter the market through filing, will now need to proceed through the simplified registration pathway. The draft amendment proposes retaining only two administrative licensing categories—regular registration and simplified registration—while eliminating the filing route.
Meanwhile, revisions to the Measures on Environmental Management Registration of New Chemical Substances are also underway. In June 2026, the MEE initiated revisions to MEE Order No. 12 and released a draft amendment for public consultation. The draft proposes eliminating the filing system and retaining only regular and simplified registration. The threshold for regular registration would also be adjusted. Substances with an annual production or import volume of 1–10 tons, which previously fell under simplified registration, would be subject to regular registration, although the required data package would be reduced. In addition, the draft specifies that only manufacturers or importers established in China may act as registrants, representing a significant change to the existing registration model for overseas companies.
Regarding legal liabilities, under the relevant provisions of the Environmental Code of the People’s Republic of China, producing or importing a new chemical substance without obtaining a registration certificate, or failing to produce or import the substance in accordance with the requirements of the registration certificate, may result in fines of up to RMB 2 million. More severe graduated penalties may apply in cases where corrective orders are ignored. The scope of liability is also no longer limited to the direct production or import stage; using new chemical substances obtained from unauthorized sources to manufacture products is also expressly covered.
For companies in the chemical, pharmaceutical, pesticide, cosmetics, advanced materials, and related supply-chain industries, these changes may have a direct impact on registration pathways, compliance costs, market-entry timelines, and internal compliance management.
Relevant companies should therefore review their current production and import activities involving new chemical substances as soon as possible, assess the potential impact of transitioning from filing to simplified or regular registration, and prepare the required registration materials in advance to ensure continued compliance.