China Ends New Chemical Filing
Important Regulatory Update
Effective August 15, 2026, China's Ministry of Ecology and Environment stopped processing environmental management filings for new chemical substances.
Substances that previously qualified for filing are not automatically exempt from regulatory requirements. Companies must still submit the required environmental management registration application before manufacturing or importing the substance in China.
If your substance previously qualified for filing because the annual manufacture or import volume was below 1 metric ton or because it met specific polymer criteria, Regulix can help determine the current regulatory pathway, evaluate documentation requirements, and prepare the registration application.
This page reflects the transitional requirements currently in effect. When the Ministry of Ecology and Environment issues new provisions, those provisions will apply and the current notice will automatically cease to be effective. Regulix will update this page as China's environmental authorities issue new requirements.
Which Cases Previously Qualified for Filing?
Before China stopped processing filings on August 15, 2026, certain low-volume new chemical substances and substances meeting specified conditions were eligible for the filing pathway under Article 10, paragraph 3 of the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12). The criteria below help determine whether a substance previously fell within that pathway.
- New chemical substances with an annual manufacture or import volume below 1 metric ton.
- Polymers with a new chemical substance monomer or reactant content of no more than 2%, or polymers of low concern.
Polymer eligibility must be evaluated based on composition, monomer or reactant content, polymer characteristics, and the applicable regulatory criteria. A substance should not be treated as eligible solely because it is described as a polymer. Other special uses or circumstances require a review of the relevant regulatory basis and scope; research use alone should not be treated as a former filing condition.
Review the former eligibility criteria in Article 10 of MEE Order No. 12. These historical criteria do not mean that filing remains available today.
How Are Cases Previously Eligible for Filing Handled After August 15, 2026?
Before manufacture or import, companies whose substances previously met the filing criteria must submit an environmental management registration application form, documentation demonstrating the applicable condition under Article 10, paragraph 3 of the Measures, and available information on environmental and human health hazard characteristics and environmental risks to the competent environmental authority under the State Council. Applications are handled under the current transitional requirements, with acceptance, review, and approval conducted by reference to simplified registration procedures and timelines.
This transitional arrangement should not be interpreted as meaning that all former filing cases have simply been converted into simplified registrations. Submitting an application does not by itself authorize manufacture or import.
Determine Whether the Substance Is a New Chemical Substance
Check the Inventory of Existing Chemical Substances in China (IECSC) and relevant regulatory information to confirm substance identity, inventory status, applicable regulatory scope, and new-use management requirements.
Determine Whether the Substance Previously Qualified for Filing
Review annual manufacture or import volume, substance composition, polymer criteria, monomer or reactant composition, polymer of low concern criteria, and other applicable conditions to establish the previous regulatory pathway.
Determine the Current Registration Pathway
Filing is no longer processed. Determine the appropriate pathway under the transitional requirements effective August 15, 2026. Cases that do not fall within the former filing criteria should be evaluated for simplified registration, regular registration, or other applicable requirements based on volume and substance characteristics.
Prepare the Registration Application
Compile the environmental management registration application form, documentation demonstrating the applicable qualifying condition, available environmental hazard information, human health hazard information, environmental risk information, and other supporting documentation required for the application.
Submit the Application and Follow the Review Process
Submit the application under the current transitional framework, monitor acceptance and review, respond to requests for corrections or supplemental information where necessary, and proceed with manufacture or import only in accordance with the approval outcome and applicable management requirements.
Comparison of the Previous and Current Requirements
| Item | Before August 15, 2026 | Effective August 15, 2026 |
|---|---|---|
| Cases previously eligible for filing | Filing available under the applicable rules | Filing no longer processed |
| Regulatory submission still required | Yes | Yes |
| Primary mechanism | Filing | Environmental management registration application |
| Key documentation | Filing documentation | Registration application form, qualifying-condition documentation, and available hazard and risk information |
| Review mechanism | Filing procedure | Current transitional process, with acceptance, review, and approval conducted by reference to simplified registration procedures and timelines |
Registration Application Documentation
Prepare the following documentation for the circumstances of the application and check the current submission requirements:
Application Form
Eligibility Evidence
Hazard & Risk Information
Supporting Documents
How Regulix Can Help
Regulix supports manufacturers, importers, traders, and overseas suppliers based on their substances and business activities:
- New chemical substance identity verification, IECSC searches, and review of CAS numbers and substance composition.
- Assessment of cases previously eligible for filing, annual tonnage assessment, polymer eligibility assessment, monomer and reactant composition review, and polymer of low concern assessment.
- SDS review, environmental and human health hazard data review, data gap analysis, and preparation of documentation checklists for overseas suppliers.
- Registration application preparation, submission support, and follow-up during regulatory review.
We evaluate substance composition, annual volume, intended use, and available documentation to determine the applicable pathway, identify data gaps, and develop a registration preparation plan.
We support application preparation and submission, track acceptance and review progress, and assist with responses to requests for corrections or supplemental information.
We track new rules and implementation requirements issued by the relevant authorities and help companies assess their impact on existing registration plans and adjust their documentation and preparation accordingly.