China's Revised Measures for Environmental Management Registration of New Chemical Substances Now in Effect: Core Changes, Industry Impacts, and Compliance Strategies

At a Glance: On October 24, 2026, China’s Ministry of Ecology and Environment (MEE) published the revised Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 40). Taking effect immediately, Order No. 40 officially repeals Order No. 12, marking the completion of a systematic overhaul aligned with China's overarching Ecological and Environment Code. Key product exemptions—including pharmaceuticals, veterinary drugs, cosmetics, and food—remain in full effect.

Background & Legislative Timeline

The revision of the Measures for the Environmental Management Registration of New Chemical Substances (hereinafter referred to as the Measures) underwent three key legislative stages:

• June 11, 2026: Draft issued for public comment. To prepare for the system transition, authorities paused record-keeping on August 15, 2026.
• October 15, 2026: Final measures formally approved during the MEE’s 4th executive meeting of 2026.
• October 24, 2026: MEE Order No. 40 officially published and enacted, completely superseding MEE Order No. 12.

To help related enterprises navigate this shift, CIRS Group's New Chemical Registration Team has prepared a clause-by-clause analysis of the updated rules, highlighting key updates and practical compliance steps.

Key Regulatory Changes & Article Comparisons

Scope of Application

Regulatory Comparison

CIRS Key Takeaways

MEE Order No. 40 maintains key exemptions for pharmaceuticals, veterinary drugs, cosmetics, food, and animal feed—a welcome relief for the industry. While pesticides are now listed separately, they are governed by pesticide management regulations rather than being fully exempt. This means the MEE retains authority over environmental risk controls for pesticides, likely participating in reviews during pesticide registration and re-evaluation to minimize duplicate filing burdens.

In addition, Order No. 40 narrows its scope by removing "research" and "processing/using" from covered activities. As a result, entities engaged solely in R&D or processing are no longer subject to new chemical substance registration.

2. Stricter Penalties

Regulatory Comparison

CIRS Key Takeaways

Under the revised measures, the legal foundation for the new chemical substance registration system elevates from a State Council administrative decree to statutory law—the Ecology and Environment Code. Non-compliance penalties will now be enforced directly under the Code, pushing maximum fines up to RMB 2 million. Depending on the severity of the offense, violators may face production restrictions, mandatory operational suspension for remediation, or even complete business closure.

For businesses, compliance is no longer a mere administrative hurdle—it is a critical legal risk spanning procurement, import, R&D, sales, and downstream supply chain management that directly impacts corporate survival.

3. Applicant Eligibility Restrictions: Overseas Enterprises and Domestic Processers Cannot Act as Registration Application

Regulatory Comparison

CIRS Key Takeaways

Impact on Overseas Exporters: Foreign companies exporting new chemical substances to China must adjust their compliance models. Registrations must now be completed by the domestic Chinese importer, with the overseas supplier providing data support. If multiple Chinese importers are involved, each importer must hold a valid registration.

Impact on Downstream Users: Downstream processors and users cannot act as the certificate applicant any more. When submitting a registration, producers or importers must now cover every downstream application across their supply chain, conduct risk evaluations for each exposure scenario, and implement corresponding risk mitigation measures. Downstream users cannot process or use a new substance for any industrial purpose outside the registered scope.

4. Transition from Record-Keeping to Registration

Order No. 40 restructures application types, bringing all new chemical substance submissions under mandatory administrative approval.

CIRS Key Takeaways

Under Order No. 12, the primary advantage of the Record-Keeping system was its minimal data burden and rapid timeline. Once an applicant submitted their materials, the online portal automatically generated an instant receipt, allowing activities to begin immediately. By replacing Record-keeping with Registration, low-volume substances (<1 tpa) and qualifying polymers are now subject to a mandatory 30-day technical review and formal administrative approval, significantly extending compliance lead times.

This procedural shift will directly affect product launch timelines, supply chain logistics, and customer delivery commitments. Companies that previously relied on fast-track record-keeping to respond quickly to market demand must now kick off compliance planning much earlier and align regulatory strategies with commercial plans.

Despite the administrative changes, the core data and testing requirements within corresponding tonnage bands remain essentially identical to those under Order No. 12, meaning companies will not face an increased data-gathering burden when preparing applications.

5. Qualification Adjustments for Domestic Testing Laboratories

Regulatory Comparison

CIRS Key Takeaways

While CMA accreditation is no longer mandatory under MEE Order No. 40, testing institutions must still comply with relevant chemical testing standards and Good Laboratory Practice (GLP) guidelines, retaining full legal liability for their test results.

While this change suggests a potential easing of entry barrier requirements for testing providers, applicants must take greater care when sourcing laboratory partners. Beyond managing costs, companies will need to independently verify a lab’s GLP compliance and technical adherence to testing standards. Specific qualification criteria for testing facilities remain subject to further clarification in forthcoming official registration guidelines.

Actionable Compliance Strategies for Enterprises

1. Screen your chemical substances and start to prepare registrations immediately: With both the Ecological and Environment Code and MEE Order No. 40 now in effect, companies should immediately screen their chemical portfolios against the Inventory of Existing Chemical Substances in China (IECSC). If any manufactured or imported substances are unlisted, initiate the registration process right away to avoid severe non-compliance penalties (fines up to RMB 2 million).

2. Adjust Commercial & Supply Chain Timelines: Replacing instant record-keeping with Registration brings all low-volume substances (<1 tpa) and qualifying polymers under mandatory administrative review. Because approval timelines will lengthen significantly, companies must kick off compliance planning much earlier, aligning registration schedules with procurement, sales, and product launch roadmaps to prevent delivery delays or market access bottlenecks.

3. Overseas Enterprises Restructure Compliance Models: Foreign exporters can no longer serve as registration applicants and must proactively coordinate with Chinese importers to clearly define registration roles, data ownership, and cost-sharing arrangements. Overseas companies can either designate a single primary importer to register the substance for downstream redistribution or have each Chinese importer file an independent registration.

4. Integrate Compliance into Lifecycle Management: Establish inter-departmental workflows across EHS, R&D, Procurement, and Legal to embed new substance screening into early product development.

It is worth mentioning that the new measures do not clarify whether existing record-keeping receipts issued under Order No. 12 must be converted into the Registration.

Next Steps

With the revised Measures for the Environmental Management Registration of New Chemical Substances now in Effect, the Ministry of Ecology and Environment is expected to publish transition rules alongside updated technical specifications and registration guidance documents. These supplementary materials will provide specific operational details regarding the practical implementation of Order No. 40.

How CIRS Group Can Help

CIRS Group will closely monitor the rollout and enforcement of China’s new chemical regulations. Our regulatory team remains dedicated to delivering expert guidance, strategic compliance consulting, and tailored solutions to ensure your business navigates China’s evolving regulatory landscape seamlessly.

What Can CIRS Do for You

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services, from regulatory compliance and laboratory testing to R&D and data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

Our Services

• China new chemical substance registration;
• Only Representative (OR);
• IECSC Enquiry and Inventory Adding;
• Chemical Safety Report (CSR) Compilation;
• Testing Coordination/Supervision;
• Alternative methods (QSAR, Read-Across, In-vitro, Waiver, Evaluation);
• Post-registration (Annual Report, Certificate Renewal)
• China REACH Training Service;

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.