China REACH Regulatory Update
China's Ministry of Ecology and Environment (MEE) has released a draft revision to the Measures for the Environmental Management Registration of New Chemical Substances. The proposal would significantly reshape China REACH by narrowing filing-based pathways, lowering registration thresholds, changing applicant eligibility, and strengthening post-registration digital management.
Quick takeaways
Record-notification pathway removed: the draft revision would retain only regular registration and simplified registration as administrative licensing categories.
Registration threshold lowered: regular registration would start from 1 ton/year, while simplified registration would apply to substances below 1 ton/year.
Applicant eligibility changed: foreign enterprises would no longer be able to act as direct applicants, and the agent system would be abolished under the draft.
Transition deadline: companies with existing record notifications would need to apply for registration certificates under the new rules by December 31, 2026.
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The General Office of the Ministry of Ecology and Environment (MEE) issued the Letter on Publicly Soliciting Opinions on the Measures for the Environmental Management Registration of New Chemical Substances (Revision Draft for Public Comment) (Huanban Bianhan [2026] No. 199) on June 11, 2026. The deadline for submitting comments is July 12, 2026. According to the draft arrangement, the revised measures are expected to take effect on August 15, 2026, together with the Ecological and Environmental Code of the People's Republic of China, at which point the current MEE Order No. 12 would be repealed.
The core rationale for the revision is to implement the relevant provisions of the Ecological and Environmental Code and further strengthen the "firewall" function of source control in the environmental management registration of new chemical substances. REACH24H has compared the Revision Draft with the current Order No. 12 and summarized the main amendments below. For wider background, see REACH24H's earlier coverage of China's new chemical substance environmental management in the era of the Environmental Code.
Key Regulatory Update: Legal Basis and Closed-Loop Enforcement
The legislative basis of the Revision Draft has been changed from "relevant laws, regulations, and the State Council's Decision on the Establishment of Administrative Permits for Administrative Approval Items That Must Be Retained" to "the Ecological and Environmental Code of the People's Republic of China and other laws and regulations." The term "environmental risk" has also been uniformly changed to "pollution risk" throughout the draft to align with the terminology used in the Code.
However, the definition of "environmental risk" in Article 52 of the current Measures, which explicitly excludes risks caused by emergencies such as production safety accidents and transportation accidents, has been deleted. No new definition of "pollution risk" has been provided in the draft. Whether risks arising from such emergencies remain excluded will require further clarification in supporting documents.
With the establishment of the overarching law, penalties for core violations are now referenced in the Code. For example, producing or importing new chemical substances in violation of registration certificate requirements, or producing or importing such substances without a certificate, would be subject to penalties under the Ecological and Environmental Code rather than the current fine range of RMB 10,000-30,000 directly stated in Order No. 12. This could substantially increase penalty exposure, with a maximum fine of RMB 2 million as indicated in the draft framework.
The draft also expands the closed-loop enforcement logic. Producing products using new chemical substances produced or imported by enterprises or public institutions without a registration certificate would similarly be subject to penalties under the Code, aligning with the information disclosure obligation requiring suppliers to provide relevant registration information.
Increased fine ranges: Fines for obtaining registration through fraud or bribery would increase from RMB 10,000-30,000 to RMB 10,000-100,000. Joint disciplinary measures for dishonesty and the three-year ban on accepting applications remain in place. For testing institutions issuing false reports, fines imposed on both the institution and directly responsible personnel would also increase from RMB 10,000-30,000 to RMB 10,000-100,000, while the provision on non-acceptance of their reports for three years remains unchanged.
Rewriting of the Scope of Application
1. Revised scope of application
The list of exempted products explicitly enumerated in Order No. 12-including pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, and fertilizers-has been entirely omitted from the Revision Draft. The accompanying provision excluding new chemical substances that are converted for other industrial uses, as well as those used as raw materials or intermediates for the aforementioned products, has also been removed. This implies that these product categories may be brought within the regulatory scope of new chemical substance registration.
For product categories no longer exempt, enterprises may face higher compliance costs across multiple regulatory regimes. Further clarification is needed on whether registration data requirements across different authorities can be integrated, how to address data generation challenges caused by animal testing restrictions in the cosmetics industry, and whether products already in circulation will need to be reassessed.
2. New exemption category
The Revision Draft introduces an exemption for "chemical substances used for scientific research and technical services such as inspection, testing, measurement, and monitoring." This exemption is favorable for research-oriented enterprises. However, the definitions of "scientific research" and "technical services" will still require clarification through supporting documents.
Restructuring of Registration Categories: Filing Abolished and Thresholds Lowered
This is one of the most significant proposed changes. The current three-track system-regular registration for 10 tons/year or more, simplified registration for 1-10 tons/year, and record notification for less than 1 ton/year, certain 2% rule polymers, and polymers of low concern-would be adjusted into two categories of administrative licensing.
| Item | Current Order No. 12 | Revised Draft |
|---|---|---|
| Regular Registration | Annual production/import volume of 10 tons or more | Annual production/import volume of 1 ton or more |
| Simplified Registration | 1 ton or more but less than 10 tons | Annual production/import volume of less than 1 ton |
| Record Notification | Less than 1 ton; polymers subject to the 2% rule; low-concern polymers | Abolished |
The "series registration" category has been removed, while joint registration remains. Since the Code explicitly stipulates a registration system for new chemical substances, the original filing mechanism would no longer meet the requirement for "registration" and would be converted into simplified registration. Substances previously falling within the 1-10-ton bracket would need to apply for regular registration, while substances previously subject to filing would be upgraded to registration certificate management.
Important notes
Data requirements for 1-10-ton substances remain uncertain: Article 11 states that for new chemical substances with cumulative annual production and import volume nationwide below 10 tons, submission of certain materials is exempted. However, Article 2 still requires test reports or data on physicochemical, health toxicological, and ecotoxicological properties. Whether 1-10-ton registrations will require additional health toxicological testing remains to be clarified in supporting documents.
Existing filings have a short transition window: For substances already filed under Order No. 12, filing applicants must apply for a registration certificate under the new rules by December 31, 2026. The conversion window would be approximately four and a half months from the planned effective date of August 15, 2026.
The shift from filing to simplified or regular registration would also introduce administrative approval procedures. Companies would no longer benefit from the flexibility of automatic filing receipt issuance. As the number of registration applications increases, the registration cycle may lengthen. In addition, converting a filing into simplified or regular registration would require a statement on the necessity of information protection. If the request for confidential business information protection is not approved, substance information may be disclosed, potentially creating trade secret risks.
Adjustments to Registration Entities: Overseas Applicant and Agent System Removed
Article 10, Paragraph 4 of the Revision Draft stipulates that the applicant "shall be an enterprise or public institution legally registered within the territory of the People's Republic of China that is capable of independently bearing legal liability and engaged in the production or import of new chemical substances."
This implies that foreign enterprises would no longer be able to act as direct applicants. Compliance obligations in China would shift to domestic importers or domestic affiliated entities. How to isolate and transmit formulation information involving trade secrets within the supply chain has become a key issue for multinational enterprises to plan in advance. Since foreign enterprises would no longer qualify as applicants, the agent system would also be abolished.
Foreign enterprises should promptly optimize trade chain arrangements, such as by establishing or using subsidiaries in China to centralize distribution and reduce the total number of registration certificates required. They should also coordinate with domestic importers to redefine the registration entity and clearly allocate responsibilities for confidential business information (CBI), data sharing, and post-registration monitoring and management.
Adjustments to Review Timelines and Public Notice
Regular registration review: Under the current system, applicants have six months to supplement test reports or materials. The Revision Draft specifies that "the time for the applicant to supplement materials shall not exceed twenty working days." This compression from six months to 20 working days means that the strategy of submitting data while the application is under review would essentially disappear; all test data should be fully prepared before submission.
Scope of public notice narrowed: Public notice prior to a registration decision would be changed from applying to all registration types to applying only before a regular registration decision. As a result, simplified registration would no longer be subject to public notice.
Approval time limits: The technical review period for regular registration would be reduced from 60 days to 45 working days, while simplified registration would be reduced from 30 days to 20 working days. The total duration is roughly equivalent when calculated in working days, but the wording is more standardized.
Comprehensive Digitalization of Follow-up Management
Activity records and annual uploads: The record-keeping system is retained, with "researchers" removed from the list of entities. A new universal obligation would require enterprises and public institutions that produce, import, or use new chemical substances to upload the previous year's activity records to the New Chemical Substances Environmental Management Information System by March 31 each year. This expands the reporting obligation beyond certificate holders subject to annual reporting requirements and moves the deadline one month earlier than the current annual reporting deadline of April 30.
The current statutory retention period provision-requiring regular and simplified registration materials and activity records to be kept for at least ten years, and filing materials for at least three years-has been deleted. Retention requirements would be transferred into systematic online uploads.
Information disclosure: The obligation for enterprises producing or using regular-registered new chemical substances to disclose the implementation status of measures through official websites or other means remains in place.
Initial activity report: The reporting entity would be explicitly limited to holders of regular registration certificates. Holders of simplified registration certificates would no longer need to submit an initial activity report. The reporting channel would be the New Chemical Substances Environmental Management Information System.
Supervision and management: Local ecological and environmental authorities would be required to promptly upload the results of supervisory spot checks within their administrative regions to the same information system, incorporating regulatory supervision into the digital management loop.
Tightened Rules for Inclusion in the IECSC
Article 37 of the Revision Draft retains the principle that substances subject to regular registration for five years shall be included in the Inventory of Existing Chemical Substances in China (IECSC) and announced. However, four new scenarios would be exempted from inclusion:
Substances with a cumulative annual production and import volume of less than 10 tons nationwide;
Substances subject to environmental management for new uses;
Substances exempt from submitting test reports and other materials, such as substances eligible for simplified polymer registration;
Substances for which the regular registration certificate has been withdrawn or revoked.
Even if low-volume substances and data-exempt substances obtain a regular registration certificate, they would not be included in the IECSC after five years. Their status as "new chemical substances" would be retained indefinitely, and subsequent enterprises would still need to register these substances individually. Formal inclusion in the IECSC would be explicitly linked to registration based on sufficient and complete data.
Adjustment of the Environmental Management Approach for New Uses
The Revision Draft removes the management requirements and provisions concerning registration for environmental management of new uses. After the revision, "registration for environmental management of new uses" would no longer exist as a separate registration category. Substances meeting the requirements for new use management would no longer be included in the List and would continue to be managed as new chemical substances.
For chemical substances in the inventory that were subject to environmental management for new uses, if they are used for purposes other than permitted uses, an application must be submitted to obtain a registration certificate for the new use of that chemical substance. In practice, substances previously subject to environmental management for new uses would no longer be included in the inventory and would be uniformly managed as new chemical substances.
Transitional Arrangements
Registration certificates obtained under Order No. 7 and Order No. 12 would remain valid after the new Measures take effect. However, if the information stated on the registration certificate changes, a new registration certificate must be applied for under the new Measures.
For substances that have been filed under Order No. 12, the filing applicant must apply for a registration certificate under the new rules by December 31, 2026. Based on the planned effective date of August 15, the conversion window would be approximately four and a half months.
Registration applications accepted before the effective date of the new rules may continue to be processed under Order No. 12 after the new rules take effect.
The planned effective date is August 15, 2026, coinciding with the implementation of the Ecological and Environmental Code, at which time Order No. 12 would be repealed.
REACH24H's Perspective: Recommendations for Enterprises
Taking into account the proposed amendments, this revision shows five key characteristics: lowered thresholds, tiered documentation requirements, streamlined procedures, fully online processing, and strengthened accountability. REACH24H recommends that relevant companies take the following actions:
Immediately conduct an inventory of existing notified substances. Substances subject to record notification below 1 ton and polymer notifications must apply for a registration certificate under the new rules by December 31, 2026. Companies should initiate substance list reviews and pathway assessments early to avoid a year-end rush.
Assess the application strategy for substances in the 1-10-ton bracket. These substances would shift from simplified registration to regular registration. Although a risk assessment report may not be required if the cumulative quantity is below 10 tons, biological test data from China may still be mandatory, and testing schedules should be secured in advance.
Plan for a domestic compliance entity. Following the abolition of the agent system, foreign manufacturers would need to fulfill registration obligations through a domestic importer or by establishing a domestic entity. A secure mechanism for trade secret transfer should be designed at the same time.
Strengthen supplier verification and contract clauses. Downstream user companies should establish mechanisms for verifying suppliers' registration certificates and include information transfer clauses in procurement contracts. Producing products using unregistered substances is explicitly subject to penalties under the draft framework.
Conversion assessment for existing filings and polymer notifications;
Registration strategy development based on tonnage, use, polymer status, and supply chain role;
Data gap analysis, testing strategy, and laboratory coordination;
Dossier preparation, submission support, and authority communication where applicable;
Post-registration follow-up management, including activity records, reporting, CBI strategy, and supplier communication.
CRAC Italy 2026: China's New Chemical Substance Management in the Environmental Code Era
China REACH: New Chemical Substance Registration under MEE Order No. 12
Guide to China GHS (Classification, SDSs & Labels) for Chemical Safety
Managing New Pollutants in China: Pollutant Regulations and Enterprise Compliance Strategies
How REACH24H Can Help
REACH24H has specialized in environmental management and registration of new chemical substances in China for over a decade. Our China REACH compliance team supports companies in assessing how the Revision Draft may affect their substance portfolios and supply chain responsibilities.
