CHINA NEW CHEMICAL SUBSTANCE REGULATORY UPDATE
China's Ministry of Ecology and Environment (MEE) issued Order No. 40, the revised Measures for the Environmental Management Registration of New Chemical Substances, on 24 October 2026. The measures took effect on that date and repealed MEE Order No. 12.
Overseas suppliers and their China-based partners should review applicant eligibility, registration routes and the implications for existing supply arrangements before manufacturing or importing new chemical substances.
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Key Takeaways
Eligible manufacturers and importers legally registered in China are the applicants; overseas suppliers should reassess their China supply arrangements.
Formality registration replaces record notification for qualifying low-volume substances and polymers and involves technical review and a registration certificate.
The measures do not provide a dedicated transition article for historical filings or certificates; their treatment requires case-specific review.
The Ecological and Environmental Code sets penalties for specified unregistered activities and breaches of registration certificate requirements.
This analysis reflects the measures and related provisions available as of 29 October 2026.
At a Glance: Order No. 12 and Order No. 40
| Issue | Order No. 12 | Order No. 40 and Business Impact |
|---|---|---|
| Applicant | An overseas manufacturer or exporter could apply through a designated Chinese agent. | The applicant must be an eligible entity registered in China that manufactures or imports the substance. Need to review importer and certificate-holder arrangements. |
| Low-volume substances and eligible polymers | Record notification was available for qualifying cases. | Formality registration requires technical review and a certificate. Leave time for review before manufacture or import. |
| Tonnage categories | Regular: 10 tonnes/year or more; Simplified: 1 to less than 10 tonnes/year; Record notification: less than 1 tonne/year and specified polymers. | The regular and simplified thresholds remain; formality registration covers less than 1 tonne/year and specified polymers. |
| Product scope | Specified product categories were outside scope, with exceptions for industrial uses and raw materials or intermediates. | The product exclusions remain, with pesticides addressed separately; need to verify the actual product, substance and use. |
| Post-registration and liability | Certificate conditions and follow-up duties applied to relevant registrations. | Order No. 40 sets follow-up duties, while the Code provides penalties for specified unregistered or non-conforming activities. |
Who Can Apply Under Order No. 40?
Article 11 of MEE Order No. 40 limits applicants to enterprises or institutions that are legally registered in China, can independently assume legal liability and manufacture or import the new chemical substance. Order No. 40 does not retain the former provision allowing an overseas manufacturer or trading company to apply through a designated Chinese agent.
An overseas supplier should therefore identify the eligible Chinese importer or manufacturer for each supply arrangement. A China-based affiliate is a potential applicant only if it meets the statutory conditions, including the relevant manufacturing or importing activity. A local service provider or agent does not automatically qualify as the applicant merely by being located in China.
Where several Chinese entities intend to import the same substance, each entity's activities and registration arrangements should be assessed. For regular and simplified registration, eligible applicants may consider a joint application in accordance with the applicable requirements. Whether and how joint applications will be available for formality registration remains subject to further implementing guidance.
Supply Chain Scenarios for Overseas Suppliers
| Scenario | Questions to Resolve Before Supply |
|---|---|
| One Chinese importer distributing domestically | Identify the entity performing the import; verify eligibility, the certificate and whether registered uses cover the supply chain. |
| Two or more Chinese importers | Map each importer and its activities. Assess the available application routes, data rights and cost allocation. Joint applications for formality registration remain subject to further guidance. |
| A Chinese affiliate imports | Confirm the affiliate is legally registered, independently liable and actually imports or manufactures the substance; check certificate conditions. |
| Changing the Chinese importer | Review the new importer's role and the status of any existing certificate or filing. Confirm the applicable transition and registration arrangements before the change. |
The appropriate approach depends on each entity's actual activities, certificate conditions and if there are any applicable transition arrangements.
Agreements between suppliers and applicants should address access to identity and test data, authorized use of studies, confidential business information (CBI), changes in suppliers or importers, and responsibilities for maintaining certificate conditions. A downstream processor considering a new use should communicate the intended use to the relevant manufacturer or importer and assess whether a new application is required.
Registration Routes: What Replaces Record Notification?
A substance not listed in the Inventory of Existing Chemical Substances in China (IECSC) is considered new under the measures. The applicable requirements depend on the substance, its intended use and the planned manufacturing or import activity. The route depends on the planned annual manufacture or import quantity and, for qualifying polymers, the substance's characteristics.
| Route | Conditions under Order No. 40 | Application Focus |
|---|---|---|
| Regular registration | Annual manufacture or import of 10 tonnes or more. | Application form, hazard data covering physicochemical, ecotoxicological, and toxicological data, environmental risk assessment and commitments; additional information applies for high-hazard substances. |
| Simplified registration | Annual manufacture or import of at least 1 tonne but less than 10 tonnes. | Application form, specified physicochemical and ecotoxicological data and risk-control commitment. |
| Formality registration | Less than 1 tonne/year, or a polymer containing no more than 2% new chemical substance monomers or reactants, or a polymer of low concern. | Application form; evidence of the applicable polymer condition where relevant; other environmental and health hazard and risk information already held by the applicant. |
Under Order No. 12, qualifying low-volume substances and polymers could apply for record notification. Order No. 40 replaces that route with formality registration, also described as nominal registration in some English-language materials. The technical institution reviews substance identity, applicable polymer criteria and the need to protect commercial secrets. The authority issues a formality registration certificate if the statutory conditions are met. The manufacturer or importer must obtain the applicable registration certificate before manufacturing or importing the new chemical substance.
MEE stopped processing record notifications on 15 August 2026 under a separate interim notice and introduced an application process pending new rules. The notice provided for its automatic expiry when new registration rules were issued. Order No. 40 now provides the applicable registration framework.
For planning, Article 28 of Order No. 40 sets a technical review limit of 60 days for regular registration and 30 days for simplified and formality registration. Time taken by the applicant to supply requested supplementary materials is excluded from the review period. The authority must decide within 20 working days after acceptance, extendable by 10 working days with approval; technical review time is excluded from that decision period. These statutory stages are not a guaranteed end-to-end project duration.
Product Scope: Check the Substance and Its Intended Use
Order No. 40 applies to environmental management registration for the manufacture or import of new chemical substances in China. An exception applies to substances imported into a customs special supervision area, stored there and exported in full without any processing. New substances intentionally released from articles during normal use fall within the measures.
| Scenario | How to Assess It |
|---|---|
| Finished products in listed categories | Products such as drugs, veterinary drugs, cosmetics, food, food additives, feed, feed additives and fertilizers are excluded. Check the specific product and use. |
| Raw materials or intermediates | New chemical substances used as raw materials or intermediates for the listed products fall within the measures; assess their registration route. |
| Change to another industrial use | Where a listed product is changed to another industrial use, assess whether the exception to the product exclusion applies and identify the new chemical substance concerned. |
| Pesticides | New chemical substances used in pesticide products follow pesticide laws and regulations; the measures apply when they are changed to other industrial uses or used as pesticide raw materials or intermediates. |
| Radioactive substances | Excluded from the measures. |
A product-level exclusion does not automatically exclude a new chemical substance supplied separately as a raw material or intermediate. Suppliers should assess the substance's identity, intended use and position in the supply chain.
Data, Testing and Protection of Confidential Information
Regular and simplified registrations require different data. Both require relevant ecotoxicological test reports to include data generated using Chinese test organisms in accordance with applicable standards. The regular dossier also requires an environmental risk assessment and, for high-hazard substances, an analysis supporting the necessity of the proposed activity. Applicants must also provide other environmental and health hazard and risk information already in their possession.
Article 14 requires Chinese testing institutions to follow relevant chemical testing standards; institutions conducting health toxicology or ecotoxicology tests must also comply with good laboratory practice (GLP). Overseas institutions providing health toxicology or ecotoxicology data must meet internationally recognized GLP requirements. Testing institutions are responsible for the authenticity and reliability of their testing results.
Order No. 40 no longer expressly repeats Order No. 12's wording on qualification accreditation for domestic testing institutions. This textual change alone does not establish that all qualification requirements have been relaxed. Relevant parties need to verify the applicable standards, accreditation, testing scope and data quality for each study, and assess the suitability of overseas data for the Chinese submission.
Overseas data owners should agree with the Chinese applicant how identity information, study reports and supporting records will be made available and protected. Under Article 13, an applicant requesting protection for commercial secrets must make the request when applying and explain why protection is necessary. Insufficient reasons for protection or information that could materially affect public interests relating to the environment or human health may lawfully be denied for protection. Protection for identifying information, such as the substance name, may not exceed five years from the date of first registration. The protection of other information should be assessed under the applicable requirements.
Existing Certificates, Historical Filings and Pending Applications
Order No. 40 does not set out a dedicated transition article explaining how Order No. 7 or Order No. 12 certificates, historical record notifications and applications already accepted under the former regime should be handled. The measures do not themselves determine the transition outcome for each legacy certificate, historical filing or pending application. Their status and any required action must be assessed against applicable subsequent arrangements and the facts of each case.
Companies should compile the relevant certificate or filing receipt, applicant and agent details, substance identity, registered use, quantities and importers. For pending applications and changes in entity, importer, use or ownership, companies should verify the applicable treatment with the competent authority and monitor any implementing guidance.
Post-Registration Duties and Enforcement
Manufacturers and importers must pass specified information to downstream users, including the certificate number, registered use, environmental and health hazard properties, risk-control measures and environmental management requirements. Manufacturers and importers that have obtained a registration certificate must maintain records of activity dates, quantities, uses and implementation of applicable measures. Regular and simplified registration materials and activity records must be retained for at least 10 years; the corresponding period for formality registration is at least three years.
Under Article 42 of Order No. 40, registration certificate holders must report the first activity within 60 days after the first manufacture, or within 60 days after the first import and transfer to a processor or user. The provision does not expressly exclude formality registration certificate holders. The practical reporting procedure for formality registration should be confirmed against subsequent official guidance and the registration system. An annual report is required where a regular registration certificate specifies that obligation, by 30 April each year starting in the year following registration.
Changes to Registration Certificates
For a regular registration before IECSC inclusion, certain changes—including an increase beyond the registered quantity, a change from import to manufacture, a change of use or risk-control measures, or other circumstances leading to increased environmental risks—require a new application. Other changes to certificate information require an amendment.
For simplified and formality certificates, changes to certificate information require an amendment; a higher-category certificate must be obtained where legally required.
New Uses of IECSC-Listed Substances
Certain IECSC-listed substances are subject to new-use environmental management. Article 34 distinguishes high-hazard substances from substances with specified combinations of persistence, bioaccumulation and toxicity: the registration trigger depends on the substance category, the actor and the proposed use. IECSC listing alone should not be assumed to authorize every industrial use.
Penalties for Non-Compliance
Under Articles 1206 and 1207 of the Ecological and Environmental Code, manufacturing or importing contrary to certificate requirements, manufacturing or importing without the required certificate, and using a new chemical substance produced or imported by an entity that does not hold the required new chemical substance registration certificate to manufacture products can each trigger an order to correct and a fine of RMB 200,000 to RMB 1 million. Refusal to correct can trigger a fine of RMB 1 million to RMB 2 million and an order to restrict production or suspend production for rectification. Serious cases may lead to further measures, including closure subject to the required approval; Article 1206 also provides for certificate revocation in serious cases.
Practical Checklist for Overseas Suppliers and China Importers
Map each substance and intended use: confirm identity, IECSC status, polymer characteristics, intended activity and annual quantity.
Identify the China-based importer or manufacturer and confirm that it qualifies as an applicant; map each importer and assess the available application arrangements.
Review existing certificates, filing receipts and pending dossiers. Record the responsible entity, permitted uses, quantity and unresolved transition questions.
Review available testing data, study ownership, authorizations and CBI protection before information is exchanged or submitted.
Build the project schedule around the applicable route, technical review, possible requests for supplementary information and the registration decision.
Assign responsibilities for certificate conditions, downstream communication, activity records, reporting and changes in use, volume or supply structure.
Frequently Asked Questions
How REACH24H Can Help
REACH24H supports overseas suppliers and China-based businesses with IECSC screening, registration pathway assessment, applicant strategy and data-gap analysis. Our team can review how a particular substance and supply arrangement may be affected by Order No. 40 and help identify the next steps for China market access.
Assess Your China New Chemical Registration Requirements
Discuss your substance, intended use and China supply arrangement with REACH24H to identify the applicable registration pathway and next steps.
Recommended Reading
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