China Officially Releases Revised Measures for Environmental Management Registration of New Chemical Substances

The Ministry of Ecology and Environment (MEE) published the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 40) on October 24, 2026. The Measures took effect on the date of publication, and Order No. 12 was repealed simultaneously. This marks the conclusion of the systematic revision of the new chemical substance registration regime under the Ecological Environment Code, with exemptions maintained for pharmaceuticals, veterinary drugs, cosmetics, food, and other fields. Drawing on an article-by-article comparison of the provisions before and after the revision, the new chemical substance registration team of CIRS Group has sorted out the changes that companies most need to note and the key response points for industry reference.

The revision of the Measures for the Environmental Management Registration of New Chemical Substances (hereinafter referred to as the “Measures”) went through three stages: public consultation, deliberation, and promulgation. On June 11, 2026, the MEE released the Measures for the Environmental Management Registration of New Chemical Substances (Revised Draft for Comments) to solicit public comments. During the consultation period, the competent authority stopped processing environmental management filings for new chemical substances from August 15, 2026, to prepare for the regime transition. On October 15, 2026, the 4th executive meeting of the MEE deliberated and adopted the revised Measures. Finally, the newly revised Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 40; hereinafter referred to as the new Measures or Order No. 40) were officially released on October 24, 2026, took effect on the date of publication, and repealed the former Order No. 12.

With the release of the new Measures, this round of revision of China's environmental management regulations for new chemical substances has officially been finalized. To help companies quickly and accurately understand the final policy changes and take compliance response measures as soon as possible, this article focuses again on the final core changes to the new chemical substance environmental management registration regime, accompanied by an analysis of corporate impacts and professional compliance recommendations, helping companies concerned grasp the key points and clarify their actions in the shortest possible time.

Scope of Application

Order No. 40 retains the exemptions for pharmaceuticals, veterinary drugs, daily chemical products, food, feed, and other products, which is a plus for the industry. In particular, pesticides are now listed separately: they are merely governed by reference to the relevant pesticide management laws and regulations, rather than being entirely excluded from the Measures. This means that the MEE has retained its authority over the environmental risk control of pesticides and is expected to participate in management reviews at the pesticide registration and re-evaluation stages, reducing the burden of duplicate registration.

In addition, Order No. 40 deletes “research” and “processing use” from the scope of covered activities, so enterprises engaged in these two types of activities will no longer be subject to new chemical substance registration.

Significantly Heavier Penalties under the Ecological Environment Code

After the revision, the legal basis of the new chemical substance registration regime has been elevated from a “State Council administrative licensing decision” to a “law (the Ecological Environment Code)”. Violations will be penalized directly under the Code, with the maximum fine raised to “RMB 2,000,000”; depending on the severity of the circumstances, restrictions on production, suspension of production for rectification, and even cessation of business or closure may also be imposed.

For companies, new chemical substance compliance will be a comprehensive legal risk issue running through procurement, import, R&D, sales, and downstream management, and it has a direct bearing on the survival of the company.

Neither Overseas Enterprises nor Domestic Processing Use Enterprises May Act as Registration Applicants

The fact that overseas enterprises can no longer act as registration certificate applicants will significantly affect the compliance pathways of overseas companies exporting new chemical substances to China. Compliance for new chemical substance registration will shift from the previous model in which overseas enterprises acted as applicants to a new model in which domestic importing enterprises act as registrants while overseas enterprises only provide data support. Where there are multiple domestic importing enterprises, each of them will need to complete the new chemical substance registration.

As domestic processing use enterprises can no longer act as registration certificate applicants, enterprises producing or importing new chemical substances will, when carrying out new chemical substance registration, be required to cover the uses of all downstream processing use enterprises in their supply chain, complete risk assessments for all use scenarios, and take corresponding risk control measures. Where the planned industrial use is inconsistent with the use in the registration application, downstream processing use enterprises must not process or use the substance.

Filing Converted to Nominal Registration, Registration Types Restructured, and All Placed under Administrative Approval

Under Order No. 12, the distinctive features of the filing regime were low documentation requirements and a short compliance cycle. After the applicant submitted the filing documents, the online registration system automatically issued a filing receipt, and the applicant could then carry out new chemical substance related activities in accordance with the filed content. With filing now converted into nominal registration, both new chemical substances with an annual production or import volume of less than 1 tonne and polymers meeting special requirements must go through the technical review procedure and await the approval decision of the competent authority, significantly lengthening the compliance cycle.

The adjustment of registration types and approval procedures will markedly affect companies' market launch pace, supply arrangements, and customer delivery commitments. Companies that previously relied on filing to respond quickly to market demand must move the start-up point of project compliance forward, and re-examine how their registration compliance strategy links with their commercial schedules.

However, after the adjustment of registration types, taking the corresponding registration tonnage bands into account, the documentation and data requirements for registration applications are essentially the same as under Order No. 12, and will not increase the burden on companies of preparing registration application documents.

Adjusted Qualification Requirements for Domestic Testing Institutions

Under Order No. 40, domestic testing institutions providing test data for the environmental management registration of new chemical substances are no longer required to obtain CMA accreditation, but they must still carry out testing in accordance with the relevant chemical substance testing standards and GLP, and bear responsibility for the results.

This change may mean that the entry qualification standards for testing institutions will be relaxed in the future, but applicant companies will need to assess compliant testing resources more broadly, verifying GLP and standards compliance while controlling costs. As for the specific qualification requirements for testing institutions, attention should be paid to the further elaboration in the forthcoming registration guidelines, including whether separate requirements will be set.

Compliance Recommendations for Enterprises

1. Conduct a comprehensive screening and initiate registration as soon as possible. Both the Ecological Environment Code and the new Measures have taken effect. Enterprises should immediately conduct a comprehensive screening of new chemical substances and identify substances not yet registered against the Inventory of Existing Chemical Substances in China (IECSC); wherever production or import of new chemical substances exists, the registration procedure should be initiated as soon as possible, to avoid unlicensed production or import that could incur heavy penalties (up to RMB 2 million).
2. Prepare for compliance in advance as approval cycles lengthen. With filing converted into nominal registration and all registrations placed under administrative approval, the compliance approval cycle for new chemical substances with an annual production or import volume of less than 1 tonne and for polymers meeting special requirements has been markedly extended. Enterprises should move the start of compliance registration forward to the early stage of business planning and coordinate it with sales and procurement schedules, so that compliance not in place in time does not affect customer delivery and market access.
3. Shift compliance strategies for overseas enterprises. As overseas enterprises no longer qualify as registration applicants, they should clarify with domestic importers as early as possible the registering entity, data ownership, and the allocation of responsibilities. Options include having one importer complete the registration as the registrant and then distribute the substance, or having each domestic importer carry out its own registration.
4. Embed new chemical substance compliance registration into whole life-cycle management. Enterprises should set up a cross-departmental working group covering regulatory affairs, R&D, procurement, sales, and EHS, update internal new substance compliance procedures, and embed compliance requirements into the entire process of product initiation, formulation, procurement, and market launch.

It should be noted that the new Measures do not address whether filings already completed under Order No. 12 need to be converted into nominal registrations.

Notes on Follow-up Transitional Arrangements

With this revision of the Measures for the Environmental Management Registration of New Chemical Substances formally finalized, the MEE is expected to successively release regulatory transitional documents and revise supporting documents such as technical specifications and registration guidelines. The operational details of the revised content of the Measures remain to be further clarified in the above supporting documents.

CIRS Group will continue to monitor the implementation of new chemical substance regulations, provide professional regulatory interpretations for clients, and offer consulting services for new chemical substance compliance in China together with optimal solutions.

Please stay tuned to the CIRS Group website and ChemRadar for professional regulatory analyses and compliance recommendations. You are also welcome to follow and attend the seminar series on the revision of the new chemical substance regulations hosted by CIRS Group.

Query the Inventory of Existing Chemical Substances in China (IECSC): https://hgt.cirs-group.com/tools/cis/inv/62aaaae3bc9325535f80a837

Further information

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