Breaking News! The Registration System for New Chemical Substances in China Undergoes a Major Overhaul

Following the revision of the new chemical substance registration regulations, registration entities, registration types, scope of exemptions, polymer management, and supply chain responsibilities will also undergo a comprehensive overhaul. The revised Measures is set to take effect on August 15, 2026, concurrently with the Ecological Environment Code.

With the Ecological Environment Code set to take effect on August 15, 2026, MEE Order No. 12 - the Measures for the Environmental Management Registration of New Chemical Substances - is also undergoing a new round of systematic revisions to align with the Code.

On June 11, 2026, China's Ministry of Ecology and Environment released the Measures for the Environmental Management Registration of New Chemical Substances (Revised Draft for Public Comment) (hereinafter referred to as the Measures (Revised Draft for Public Comment)), soliciting public comments from government agencies, organizations, enterprises, institutions, and individuals. The deadline for public comments is July 12, 2026.

The revision this time is not merely a technical refinement of specific provisions of MEE Order No. 12, but rather a systematic restructuring covering the following aspects:

• Registration applicants,
• Registration types,
• Scope of exemptions,
• The management for polymers,
• Post-registration supervision of high-hazard substances,
• Post-registration tracking mechanisms, and legal liabilities.

These revisions are primarily driven by changes in the legislative hierarchy and institutional logic of environmental management for new chemical substances following the enactment of the Ecological Environment Code. The core of this revision is not only to align the existing rules with the Code but also to structurally recalibrate the current system in response to the Code’s reformulation of responsible entities, scope of activities, legal liabilities, and risk control requirements.

To help enterprises quickly and accurately understand the policy changes and take responsive measures as soon as possible, CIRS Group has analyzed the key changes and summarized the ten most significant changes and their impacts on enterprises as follows: 

(1) Alignment of Legislative Basis with the Ecological Environment Code

Current Regulation: The regulations were based on relevant laws and regulations, as well as the Decision of the State Council on the Establishment of Administrative Permits for Administrative Approval Items That Must Be Retained.

Revised Draft for Public Comment: the Measures (Revised Draft for Public Comment) indicates that the legal basis has been directly adjusted to: "These Measures are formulated in accordance with the Ecological Environment Code of the People’s Republic of China and other relevant laws and regulations."

CIRS Comments: Penalties for violations related to new chemical substances are to align with those in the Ecological Environment Code. For enterprises that produce or import new chemical substances without obtaining a registration certificate or fail to comply with the requirements of the registration, or for enterprises that use new chemical substances without a registration certificate, the fines will be significantly increased, with the maximum reaching 2 million yuan. The graduated penalties for refusal to rectify are even more severe. The scope of liability is no longer limited to the direct production and import stages; the act of using new substances from unlicensed sources to produce products is also explicitly included within the scope of liability, and operational sanctions have been significantly strengthened. For other violations, the maximum fine has also been raised to 100,000 yuan.

For enterprises, this means that compliance with new chemical substance regulations is no longer merely a registration stage, but rather a comprehensive legal issue spanning procurement, importation, R&D, sales, and downstream management.

(2) Overseas Enterprises and Domestic Processing and Using Enterprises May Not Serve as Registration Applicants

Current Regulation: MEE Order No. 12 permitted overseas manufacturing or trading enterprises exporting new chemical substances to China to serve as applicants, provided they designated a legally registered enterprise or institution within China capable of independently assuming legal liability as their agent. In certain special circumstances—such as when a product already regulated by other laws is classified as a new chemical substance and is intended for a different industrial use, or when environmental management of an existing chemical substance for a new use is implemented and it is intended for industrial uses beyond the permitted scope—processing and using enterprises could also serve as applicants.

Revised Draft for Public Comment: The Measures (Revised Draft for Public Comment) stipulate that only enterprises or institutions within the territory of China that produce or import new chemical substances may serve as applicants for registration. Overseas enterprises and processing users are no longer eligible to act as applicants for new chemical substances registration.

CIRS Comments: This adjustment is consistent with the relevant provisions in the Ecological Environment Code. By prohibiting foreign enterprises from acting as applicants, regulatory responsibilities will be more clearly anchored to domestic entities that can be directly enforced against and held accountable. For multinational companies, the compliance approach for new chemical substance registration will shift from a model where a foreign enterprise serves as the applicant while designating a domestic agent to jointly fulfill obligations and bear responsibility, to a new model where a domestic importer serves as the registrant and the foreign enterprise provides only data support. Internal responsibilities, data authorization, confidentiality arrangements, and cost-sharing mechanisms must all be adjusted accordingly. If there are multiple domestic importers, each must complete the new chemical substance registration.

Domestic processing and user enterprises can no longer serve as registration certificate applicants. Manufacturers or importers will be required to include all downstream processing and user enterprises in their supply chain when conducting new chemical substance registrations, complete risk assessments for all use scenarios, and implement corresponding risk control measures. If the intended industrial use differs from the use stated in the registration application, downstream processing and user enterprises are prohibited from processing or using the substance.

(3) Removal of the “Exempt for Special Products” Category and Addition of the “Research and Development” Exemption Category

Current Regulation: Products such as pharmaceuticals (including active pharmaceutical ingredients), pesticides (including pesticide active ingredients), veterinary drugs (including active ingredients), cosmetics, food, food additives, feed, feed additives, and fertilizers were exempted from MEE Order No. 12. This provision was established on the basis that these products were already regulated by other competent authorities and relevant regulations.

Revised Draft for Public Comment: The Measures (Draft for Public Comment) indicate that the aforementioned special products will also fall within the scope of new chemical substance registration, rather than having applicability determined solely by the industry to which the product belongs. If this provision is implemented, the impact on enterprises in related industrial chains—such as pharmaceuticals, pesticides, cosmetics, and food—will be particularly direct. Relevant enterprises will need to reassess their new substance registration obligations regarding product imports, the production or import of active pharmaceutical ingredients (APIs) or pesticide active ingredients, as well as the production or import of additives.

At the same time, the Measures (Revised Draft for Public Comment) proposes to add "chemical substances used for scientific research and development such as testing, inspection, metrology, and monitoring" as a category exempted from registration. This implies that future regulations will place greater emphasis on determining registration requirements based on the purpose of the activity and characteristics of risk exposure. The exemption for R&D purposes will support innovative research by relevant enterprises and institutions; however, it is recommended that these entities still establish comprehensive systems for proving intended use, controlling the flow of substances, and retaining documentation to support subsequent regulatory audits.

(4) Adjusting Registration Types and Eliminating Substance Record-Filing

Current Regulation: The types of registration for new chemical substances under MEE Order No. 12 included - regular registration (≥10 tpa), simplified registration (≥1 tpa and <10 tpa), and record-filing (＜1 tpa, or polymers meeting specific conditions). A key feature of the record-filing system is its low data requirements and short compliance cycle. After an applicant submits record-filing materials, the online registration system automatically issues a filing receipt, allowing the applicant to proceed with activities related to the new chemical substance in accordance with the filed information. However, after submitting applications for regular registration or simplified registration, both require a technical review process and await the competent authority’s approval decision, resulting in a relatively longer compliance cycle.

Revised Draft for Public Comment: the Measures (Revised Draft for Public Comment) indicate that record-filing will be abolished. New chemical substances with an annual production or import volume of less than 1 ton must undergo simplified registration, while those exceeding 1 ton will all undergo the regular registration. However, considering the number of new chemical substance registrations, the corresponding data and dossier requirements for each tonnage band remain largely consistent with the relevant requirements under MEE Order No. 12. In other words, following the revision to registration types, the key changes may not primarily manifest as a sudden surge in dossier and testing data requirements, but rather as changes in the approval process. Compliance for new chemical substances with an annual production or import volume of less than 1 ton will shift from “being able to commence activities upon submission of documentation” to requiring a wait for the results of administrative approval.

CIRS Comments: From the regulatory compliance management perspective, this will significantly impact companies’ product launch timelines, supply arrangements, and delivery commitments to customers. For companies that previously relied on record-filing to respond quickly to market demand, time costs will become a pressure point that manifests sooner than testing costs. Companies need to bring forward project start dates and reassess the alignment between registration strategies and commercial schedules.

(5) Special Provisions for Polymers

Current Regulation: MEE Order No. 12 stipulated that substances meeting the record-filing criteria for polymers and not falling under the exemption criteria for polymer record-filings could undergo record-filing, with no restrictions on the application tonnage. For polymers that do not meet the record-filing criteria, applicants were required to undergo regular or simplified registration based on the volume applied for. If a polymer met the three specified criteria, it could be exempted from submitting health and ecotoxicology data as well as environmental risk assessment reports. This system provided a highly efficient, low-intervention pathway to market access for a large number of polymers.

Revised Draft for Public Comment: The Measures (Revised Draft for Public Comment) indicate that the type of polymer registration will be determined entirely based on the application tonnage. Polymer applications for less than 1 ton require simplified registration, while those for 1 ton or more require regular registration. In terms of the requirements for registration dossiers and data, special provisions for polymers remain in place. For polymers containing no more than 2% of new chemical substance monomers or reactants, as well as low-concern polymers, exemptions or simplified requirements on registration dossiers and data will continue to be granted provided the relevant criteria are met. However, since the record-filing of polymers will be abolished, all polymers will fall under the administrative approval framework.

CIRS Comments: This change has at least two practical implications. First, even if polymers meet the special requirements, the approval cycle will be extended, and companies will no longer be able to rely on the record-filing mechanism to quickly complete market access. Second, the difficulty of protecting trade secrets may increase, especially for polymers that rely on structural or compositional confidentiality; the confidentiality advantages originally achieved through the record-filing may be weakened.

(6) Abolition of Series Registration

Current Regulation: MEE Order No. 12 stipulated that a single applicant could apply for series registration when submitting applications for multiple new chemical substances with similar molecular structures, identical or similar uses, and comparable test data. In practice, this system was utilized by enterprises to control testing costs and optimize the combined registration of similar products, serving as a key mechanism to help enterprises achieve compliance for multiple similar substances in a single process.

Revised Draft for Public Comment: The Measures (Draft for Public Comment) will eliminate the series registration. It is reported that the competent authority heavily relies on expert case-by-case determinations to assess whether a group of substances meets the criteria for series registration. If a company initially opts for series registration to save costs but is ultimately deemed ineligible by experts, this may require the company to re-select a registration type and supplement test data, thereby delaying project progress.

CIRS Comments: From the regulatory perspective, this adjustment reflects the competent authority’s desire to reduce regulatory flexibility and enhance the predictability of registration pathways at an early stage. Regarding the acceptability of read-across between similar substances, further guidance from the competent authority may be required.

(7) New Circumstances for Exclusion from the IECSC

Current Regulation: MEE Order No. 12 stipulated that new chemical substances that obtained a regular registration certificate would be included in the IECSC by public announcement of the competent authority five years after the date of initial registration. For high-hazard chemical substances, as well as new chemical substances exhibiting persistence and bioaccumulation, or persistence and toxicity, or both bioaccumulation and toxicity, the permitted uses shall be indicated upon inclusion in the IECSC and environmental management for new uses shall be implemented.

Revised Draft for Public Comment: the Measures (Revised Draft for Public Comment) indicate that substances with a cumulative annual production and import volume nationwide of less than 10 tons, or those subject to environmental management for new uses, or polymers under special circumstances, will no longer be included in the IECSC even if five years have passed since obtaining a regular registration certificate; instead, they will be managed as new chemical substances on a long-term basis.

CIRS Comments: If this change is implemented, in addition to high-hazard chemicals, substances that are persistent and bioaccumulative, or persistent and toxic, or both persistent and toxic, will be treated more closely as special substances subject to continuous control. Compliance costs and regulatory intensity are expected to remain at a high level for the long term. Furthermore, given the current policy environment of continuously tightening controls on new pollutants, enterprises must reassess their commercialization expectations, applications for use extensions, and long-term compliance investments regarding new chemical substances that fall under the aforementioned categories.

(8) Digitalization and Contractualization of Post-Registration Monitoring

Current Regulation: MEE Order No. 12 already required producers, importers, and processors/users of new chemical substances to transmit information—including registration certificate numbers, intended uses, environmental and health hazard characteristics, risk control measures, and environmental management requirements—to downstream users, all the way to the final processor/user. However, there were no very specific requirements regarding the method of information transmission or the retention of evidence. It merely stated that information could be transmitted electronically or in writing, and that the content of the transmission and evidence of transmission should be properly archived for future reference.

Revised Draft for Public Comment: The Measures (Draft for Public Comment) require enterprises and institutions that produce, import, or use new chemical substances to explicitly stipulate in sales, agency, and other contracts the obligation to transmit the relevant information specified on the registration certificate to downstream users.

The Measures (Draft for Public Comment) add a new requirement mandating that enterprises and institutions producing, importing, or using new chemical substances must upload their activity records from the previous year to the New Chemical Substances Environmental Management Information System by March 31 of each year. Static regulations regarding retention periods have been abolished, replaced by dynamic oversight through system-generated records. Competent authorities at all levels will also utilize the New Chemical Substances Environmental Management Information System to conduct information sharing and supervisory spot checks entirely online.

CIRS Comments: This change implies that, in the future, regulatory scrutiny regarding the transmission of information following the registration of new chemical substances will shift from “whether a company has fulfilled its information-sharing obligations” to “whether a company can demonstrate that it has fulfilled those obligations in a complete, timely, and traceable manner.” Particularly given that the Ecological Environment Code significantly increases penalties for the illegal use of new chemical substances, the ability to provide evidence regarding the boundaries of supply chain responsibility will become a key focus of compliance management.

Consequently, companies urgently need to establish a standardized information transfer system that spans multiple functions—including sales, procurement, legal, EHS, and customer service—encompassing templates, acknowledgments, training records, and procedures for handling exceptions.

(9) Registration Requirements for 1–10 Ton Substances Will Depend on Total National Registration Volume

The Measures (Revised Draft for Public Comment) indicate that for regular registrations with an application tonnage of 1–10 tpa, the requirements for registration dossiers and data will depend on the total volume of registration applications for the same substance nationwide that have already been completed. If the cumulative annual production and import tonnage of the new chemical substance being registered is less than 10 tons, the applicant is exempted from submitting a pollution risk assessment report and corresponding pollution risk control measures. Even if the substance is classified as a high-hazard chemical, the applicant is not required to submit a socio-economic benefit analysis of the new chemical substance activity.

CIRS Comments: If this change is ultimately implemented, it will have a direct impact on market entry sequencing, competitor intelligence assessments, and project budget planning. Before submitting an application, enterprises must not only evaluate their own annual tonnage but also, to the extent possible, determine whether other enterprises have already registered the same substance and the tonnage range they may have allocated.

(10) The transition period between the old and new systems is tight

The Measures (Revised Draft for Public Comment) stipulate that for substances already filed in accordance with the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12), the filers must apply for and obtain a registration certificate in accordance with the relevant provisions of these Measures by December 31, 2026.

According to statistics, the number of new substances filed under MEE Order No. 12 exceeds 170,000. All new substances filed under MEE Order No. 12 must reapply for either a simplified registration or a regular registration, which will pose a significant challenge to both company's compliance works and the efficiency of regulatory authorities. Companies are suggested to promptly check whether their existing new substances filings fall under the exemption category for research & development purposes, thereby reducing the registration burden.

The Measures (Revised Draft for Public Comment) stipulate that for substances that have already obtained registration certificates in accordance with the Measures for the Environmental Management of New Chemical Substances (Order No. 7 of the former MEP) and the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12), such registration certificates shall remain valid after the implementation of the Measures (Revised Draft for Public Comment). For registration applications accepted prior to the effective date of the Measures (Revised Draft for Public Comment) in accordance with the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12), such applications may continue to be processed in accordance with the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12) after the Measures (Revised Draft for Public Comment) take effect. This provides support for a smooth transition in enterprises’ registration work.

The Measures (Revised Draft for Public Comment) stipulate that the revised Measures will take effect on August 15, 2026, concurrently with the Ecological Environment Code. Given the tight timeline, enterprises should comprehensively review their existing new chemical substance registration projects and develop compliance plans.

Key Practical Issues and Recommendations for Enterprises

First, complete the review of existing projects as soon as possible. Existing projects should be categorized by substance type, tonnage band, project stage, applicant, registration certificate status, and intended use to identify which projects are most likely to be affected by the changes.

Second, companies should redefine their polymer compliance strategies. For companies relying on the low-concern polymer, 2% polymer, or sub-1-ton polymer compliance pathways, they should promptly assess the time costs, data gaps, and trade secret protection plans under the trend toward approval-based registration.

Third, overseas companies should plan their compliance strategies in advance. Once the new regulations take effect, overseas companies will no longer be eligible to act as registrants. They may either select an importer to complete the registration before distributing the product to downstream processing and user companies, or have the downstream processing and user companies conduct their own registrations.

Fourth, improve supply chain information sharing and evidence retention. It is recommended to establish standardized templates for communicating information on new substances and a confirmation receipt system, integrating Safety Data Sheets (SDS), sales contracts, service agreements, and customer notification mechanisms.

Fifth, the Measures (Revised Draft for Public Comment) stipulate that if additional information is requested following a technical review, the applicant must submit the supplementary materials within 20 working days. This places high demands on the applicant’s response efficiency, particularly regarding the quality of test reports. Given the lengthy testing cycles, if test reports are challenged or studies need to be repeated, the time required for corrections will be significantly longer.

Sixth, around the time the final regulations are published, companies should prepare internal impact assessments covering topics such as the registration applicant, registration types, polymers, the transition between old and new registration certificates, environmental management of new uses, and cumulative tonnage management, in order to promptly adjust their China market entry and product portfolio strategies.

As the implementation date of the Ecological Environment Code approaches, CIRS Group anticipates that revisions to the regulatory framework for the registration and management of new chemical substances will be rapidly implemented. We recommend that companies involved in new substance registration pay close attention to these developments and set aside sufficient time and budget for compliance costs. CIRS Group will continue to monitor revisions to the regulations, if you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

About CIRS

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, laboratory testing, R&D to 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.