As the Ecological Environment Code is set to take effect on 15 August 2026, the Ministry of Ecology and Environment (MEE) Order No. 12 — the Measures for the Environmental Management Registration of New Chemical Substances (hereinafter referred to as “Order No. 12”) — is also undergoing a new round of systematic revision to align with the Code.
On 11 June 2026, the Ministry of Ecology and Environment released the Measures for the Environmental Management Registration of New Chemical Substances (Revised Draft for Comments) (hereinafter referred to as the Measures (Revised Draft for Comments)), soliciting public opinions from government organs, social groups, enterprises, public institutions, and individuals. The deadline for comments is 12 July 2026.
A review of the full text of the Measures (Revised Draft for Comments) reveals that this revision is not merely a technical refinement of individual provisions of Order No. 12. Rather, it constitutes a systemic restructuring covering the registration applicant, registration type, exemption scope, polymer management logic, post-registration tracking mechanism, and legal liability. These changes are primarily driven by the fact that the legislative hierarchy and institutional logic of new chemical substance environmental management are being reshaped by the introduction of the Ecological Environment Code. The core of this revision is not only to integrate existing rules under the new Code, but also to structurally recalibrate the current system around the Code’s reformulated provisions on responsible parties, scope of activities, legal liabilities, and risk control requirements.
CIRS Group’s expert team has analysed and interpreted the significant changes in the regulations and policies for the environmental management of new chemical substances, identifying the ten most significant changes and their impact on corporate compliance work, with the aim of helping relevant enterprises quickly and accurately understand the policy changes and take response measures as soon as possible.
(I) Legislative Basis Aligned with the Ecological Environment Code
Before the revision, the regulatory foundation relied on relevant laws and regulations as well as the Decision of the State Council on Setting Administrative Licensing for Administrative Examination and Approval Items that Need to Be Retained.
After the revision, the Measures (Revised Draft for Comments) directly states: “These Measures are formulated in accordance with the Ecological Environment Code of the People’s Republic of China and other laws and regulations.”
After the revision, penalties for new chemical substance-related violations are aligned with the Ecological Environment Code. For enterprises that produce or import new chemical substances without obtaining a registration certificate or not in accordance with the registration certificate requirements, or that use new chemical substances without a registration certificate, the fine amounts have been significantly increased, with the maximum fine reaching 2,000,000 RMB. Graduated penalties for refusal to correct are even more severe. The scope of penalised parties is no longer limited to the direct production and import stages — the use of uncertified new substances to manufacture products is also explicitly included in the scope of liability, and business-related sanction measures have been notably strengthened. For other violations, the maximum fine has also been raised to 100,000 yuan.
For enterprises, this means that new chemical substance compliance is no longer merely a matter of the registration application stage, but a comprehensive legal risk issue spanning procurement, import, R&D, sales, and downstream management.
(II) Overseas Enterprises and Domestic Processing/Use Enterprises Can No Longer Serve as Registration Applicants
Before the revision, Order No. 12 allowed overseas production or trading enterprises exporting new chemical substances to China to serve as applicants, provided they designated a domestic entity lawfully registered in China and capable of independently bearing legal liability as their agent. Under certain special circumstances, such as where products already managed under other regulations were new chemical substances and were intended to be changed to other industrial uses, or where existing chemical substances were subject to new use environmental management and were intended for industrial uses beyond the permitted scope, processing users could also serve as applicants.
After the revision, the Measures (Revised Draft for Comments) provides that only domestic manufacturers or importers in China may act as registration applicants. Overseas enterprises and processing/use enterprises can no longer serve as registration applicants for new chemical substances.
This adjustment regarding new chemical substance registration applicants is consistent with the relevant wording in the Ecological Environment Code.
The inability of overseas enterprises to serve as registration certificate applicants means that regulatory responsibility will be more clearly anchored to domestic entities that can be directly enforced against and held accountable on an ongoing basis. For multinational companies, the compliance approach for new chemical substance registration will shift from a model where the overseas enterprise serves as the applicant while designating a domestic agent to jointly fulfil obligations and bear responsibility, to a new model where the domestic importing enterprise serves as the registrant and the overseas enterprise merely provides data support. Internal responsibilities, data authorisation, confidentiality arrangements, and cost-sharing mechanisms will all need to be adjusted accordingly. If there are multiple domestic importing enterprises, each will need to complete the new chemical substance registration.
The inability of domestic processing/use enterprises to serve as registration certificate applicants will require production or importing enterprises, when conducting new chemical substance registration, to cover the uses of all downstream processing and use enterprises in their supply chain, complete risk assessments for all use scenarios, and adopt corresponding risk control measures. Where the intended industrial use is inconsistent with the registered application use, downstream processing and use enterprises shall not process or use the substance.
(III) Removal of the Exemption for Special Products, Addition of Research Use Exemption
Before the revision, pharmaceuticals (including active pharmaceutical ingredients), pesticides (including active ingredients), veterinary drugs (including active ingredients), cosmetics, food, food additives, feed, feed additives and fertilisers were exempted from Order No. 12. This provision was based on the fact that the products involved were already managed by other competent authorities and relevant regulations.
After the revision, the Measures (Revised Draft for Comments) provides that the above products will also fall within the scope of new chemical substance registration management. If this revision is implemented, the impact on enterprises in the pharmaceutical, pesticide, cosmetic, and food-related companies will be particularly effected. Relevant enterprises will need to re-examine their new substance registration obligations concerned products, APIs and additives.
At the same time, the Measures (Revised Draft for Comments) proposes to add “chemical substances used for scientific research and inspection, testing, metrology, monitoring and other technical services” as a exemption category. This means that future rules will place greater emphasis on identifying whether registration is required based on activity purpose and risk exposure characteristics. The exemption for research use will support the innovative research of relevant enterprises and public institutions, but it is recommended that relevant entities still establish complete proof of use, flow control, and document retention to support subsequent regulatory verification.
(IV) Adjustment of Registration Types, Elimination of the Record-filing Type
Before the revision, under Order No. 12, the new chemical substance registration types included: regular registration (≥10 tonnes/year), simplified registration (≥1 tonne/year and <10 tonnes/year), and record-filing (<1 tonne/year, or polymers meeting specific conditions). The most notable feature of the record-filing system was its low documentation requirements and short compliance cycle. After the applicant submitted the record-filing materials, the online registration system would automatically issue a record-filing receipt, and the applicant could then carry out new chemical substance-related activities in accordance with the filed content. However, after submitting regular or simplified registration documents, applicants both undergo a technical review process and await the competent authority’s approval decision, resulting in a relatively longer compliance cycle.
After the revision, the Measures (Revised Draft for Comments) provides that the record-filing type is deleted. New chemical substances with an annual production or import volume of less than 1 tonne shall be subject to simplified registration, and those of 1 tonne or above shall all be subjected to regular registration. However, considering the registration volume of new chemical substances, the documentation and data requirements for the corresponding tonnage bands are largely consistent with the relevant requirements under Order No. 12. In other words, after the adjustment of registration types, the key change may not first manifest as a surge in registration documentation and data requirements, but rather as a change in the approval procedure. New chemical substances with an annual production or import volume of <1 tonne/year will shift from “submit materials and commence activities” to the administrative approval result.
From a compliance management perspective, this will significantly affect enterprises’ time-to-market schedules, supply arrangements, and delivery commitments. For enterprises that previously relied on record-filing for rapid market response, time will emerge as a pressure point earlier than costs. Enterprises will need to advance project start dates and re-evaluate the alignment between registration strategy and commercial scheduling.
(V) Special Provisions for Polymers
Before the revision, Order No. 12 stipulated that polymers meeting the record-filing conditions and not falling under the polymer record-filing exclusion criteria could undergo polymer record-filing, with no tonnage limit. Polymers not meeting the record-filing conditions required regular or simplified registration depending on the applied registration volume. If a polymer could satisfy three specified criteria, it could also be exempted from submitting health toxicology, ecotoxicology data, and environmental risk assessment reports. This system provided an efficient, low-intervention access pathway for the compliance of a large number of polymers.
After the revision, the Measures (Revised Draft for Comments) provides that polymer registration types will also be determined entirely by the applied volume. Polymers with an applied volume of less than 1 tonne require simplified registration, and those of 1 tonne or above require regular registration. Regarding registration documentation and data requirements, special provisions are still retained for polymers. For polymers where the content of new chemical substance monomers or reactants does not exceed 2%, and for polymers of low concern (PLC), exemptions or simplifications in registration documentation and data requirements continue to be granted provided the specified criteria are met. However, since the record-filing type for polymers has been eliminated, all polymers will enter the administrative approval framework in terms of registration procedures.
This change brings at least two practical implications. First, even if a polymer can meet the special requirements, the approval cycle will be extended, and enterprises can no longer rely on the record-filing mechanism for rapid market access. Second, trade secret protection may become more difficult, especially for polymers that rely on structural or compositional confidentiality — the confidentiality advantages previously achieved through the record-filing pathway may be weakened.
(VI) Elimination of Series Registration
Before the revision, Order No. 12 provided that where the same applicant applied for multiple new chemical substances with similar molecular structures, identical or similar uses, and comparable test data, they could apply for series registration for new chemical substance environmental management. In practice, this system was used by applicant enterprises to control testing costs and optimise the grouped registration of similar products, serving as an important pathway for enterprises to complete the compliance of multiple similar substances at one time.
After the revision, the Measures (Revised Draft for Comments) eliminates the series registration type. It is understood that the competent authority considered that whether a group of substances meets the conditions for series registration relies heavily on expert case-by-case judgement. Enterprises may initially choose series registration to save costs, but ultimately the experts may determine that the series conditions are not met, which could lead to the enterprise having to re-select the registration type and supplement test data, thereby delaying the project timeline.
From an institutional logic perspective, this adjustment reflects the competent authority’s intention to reduce system flexibility and improve the upfront certainty of the registration pathway. The acceptability of read-across between similar substances may require further guidance from the competent authority.
(VII) New Circumstances for Non-inclusion in the Inventory
Before the revision, Order No. 12 stipulated that new chemical substances that had obtained a regular registration certificate would be announced by the competent authority for inclusion in the Existing Inventory upon the expiry of five years from the date of initial registration. For highly hazardous chemical substances and new chemical substances with persistency and bioaccumulation, or persistency and toxicity, or bioaccumulation and toxicity, their permitted uses would be noted upon inclusion in the Inventory of Existing Chemical Substances in China, and they would be subject to new use environmental management.
After the revision, the Measures (Revised Draft for Comments) provides that where the cumulative national annual production and import volume is less than 10 tonnes, or where new use environmental management is implemented, or for special-case polymers, even if a regular registration certificate has been issued for five years, the substance will no longer be included in the Inventory of Existing Chemical Substances in China and will continue to be managed as a new chemical substance on a long-term basis.
If this change is implemented, in addition to highly hazardous chemical substances, substances with persistency and bioaccumulation, or persistency and toxicity, or bioaccumulation and toxicity will also be assigned to a specially controlled substance category. Moreover, under the current policy trend of continuously strengthening new pollutant control, enterprises will need to re-evaluate their commercialisation expectations, use expansion, and long-term compliance investments for new chemical substances falling under the above circumstances.
(VIII) Informatisation and Contractualisation of Post-registration Tracking Management
Before the revision, Order No. 12 already required producers, importers, and processing users of new chemical substances to transmit information such as registration certificate numbers, applied uses, environmental and health hazard characteristics, risk control measures, and environmental management requirements to downstream users, extending to the final downstream user. However, there were no very specific requirements regarding the method of information transmission and evidence retention. It merely mentioned that information transmission could be in electronic or written form, and that the transmitted content and transmission evidence should be properly archived for inspection.
After the revision, the Measures (Revised Draft for Comments) requires enterprises that produce, import and use new chemical substances to clearly transmit the information specified on the registration certificate to downstream users in sales, consignment and other contracts.
It newly requires enterprises that produce, import, and use new chemical substances to upload their activity records for the previous year to the new chemical substance environmental management information system by 31 March each year. The static retention period requirement is removed, replaced by system-based record-keeping for dynamic supervision. Competent authorities at all levels will also use the new chemical substance environmental management information system to achieve fully online information notification and supervisory inspection.
This change means that the regulatory focus for post-registration information transmission will extend from “whether the enterprise has fulfilled its information transmission obligation” to “whether the enterprise can prove that it has fulfilled its information transmission obligation completely, in a timely manner, and in a traceable manner.” Particularly in the context of the Ecological Environment Code’s significant increase in penalties for the illegal use of new chemical substances, the evidentialisation of supply chain responsibility boundaries will become a priority in compliance management.
Therefore, enterprises urgently need to simultaneously build a standardised information transmission system covering sales, procurement, legal, EHS, and customer service functions, including templates, receipts, training records, and exception handling procedures.
(IX) Documentation Requirements for 1–10 Tonnes Will Depend on National Cumulative Registration Volume
The Measures (Revised Draft for Comments) provides that for regular registration of new chemical substances with a registration application volume of 1–10 tonnes, the registration documentation and data requirements will depend on the total registration application volume of the same substance already completed nationwide. If the cumulative national annual production and import volume of the new chemical substance applied for registration is less than 10 tonnes, the applicant is exempted from submitting a new chemical substance pollution risk assessment report and the corresponding pollution risk control measures, and even if it is classified as a highly hazardous chemical substance, there is no need to submit a socio-economic analysis report of the new chemical substance.
If this change is ultimately implemented, it will directly affect market entry timing, competitive intelligence assessment, and project budgeting. Before submitting, enterprises will need to assess not only their own annual demand but also endeavour to understand whether the same substance has already been registered by other enterprises and the tonnage band it may occupy.
(X) Tight Timeline for Transition Between Old and New Systems
The Measures (Revised Draft for Comments) provides that for substances that have already undergone record-filing under the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12), the record-filing applicant shall apply for and obtain a registration certificate in accordance with the relevant provisions of these Measures by 31 December 2026.
According to statistics, the number of new substances that have completed record-filing under Order No. 12 exceeds 170,000. All existing record-filed new substances under Order No. 12 will need to re-apply for either a simplified registration certificate, posing a significant challenge for both enterprise compliance efforts and the competent authority’s approval efficiency. Enterprises should promptly review their record-filed new chemical substances and determine whether they qualify for the research use exemption, so as to reduce the pressure of registration compliance.
The Measures (Revised Draft for Comments) provides that for substances that have already obtained registration certificates under the Measures for the Environmental Management of New Chemical Substances (former Ministry of Environmental Protection Order No. 7) and the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12), the relevant registration certificates shall remain valid after the implementation of these Measures. For registration applications according to MEE Order No. 12 that have been accepted before the effective date of the Measures (Revised Draft for Comments), processing may continue in accordance with MEE Order No. 12 after the Measures (Revised Draft for Comments) take effect. This provides support for the smooth transition of enterprise registration compliance work.
The Measures (Revised Draft for Comments) provides that the revised Measures will be implemented on 15 August 2026, simultaneous with the Ecological Environment Code. The timeline is tight, and enterprises should comprehensively review their existing new chemical substance registration projects and prepare compliance plans.
Key Practical Issues and Recommendations for Enterprises
First, complete the review of existing projects as soon as possible. Projects should be classified by substance category, tonnage band, project stage, registration applicant, registration certificate status, and use flow direction to identify which projects are most likely to be affected by changes in the registration applicant, elimination of record-filing, or polymer registration pathway adjustments.
Second, rebuild polymer compliance strategies. For enterprises relying on the polymer of low concern, 2% polymer, or sub-1-tonne polymer pathways, they should promptly assess the time costs, data gaps, and CBI plans under the trend towards approval-based processes.
Third, overseas enterprises should propose new chemical substance compliance strategies in advance. Under the new regulations, overseas enterprises can no longer serve as registration applicants. They may choose one importer to complete the registration and then distribute to downstream processing and use enterprises, or downstream processing and use enterprises each conduct their own registration.
Fourth, improve supply chain information transmission and evidence retention. It is recommended to establish a standardised new substance information transmission template and confirmation receipt system, integrating SDS, sales contracts, consignment agreements, and customer notification mechanisms.
Fifth, the new regulations stipulate that where supplementary materials are required after technical review, the applicant’s supplementary material submission time shall not exceed twenty working days. This places high demands on applicant enterprises’ response efficiency, particularly regarding the quality of test reports. Testing cycles are long, and if a test report is questioned, it may even require re-conducting the study, which would make the correction period even longer.
Sixth, around the time of the formal version’s release, enterprises should prepare internal impact assessments on topics including the registration applicant, registration type, polymer, new and old registration certificate transition, new use environmental management, and tonnage accumulation management, so as to timely adjust their China market entry and product portfolio strategies.
As the implementation date of the Ecological Environment Code approaches, CIRS Group expects that the revision of the new chemical substance registration management regulations and system will be rapidly advanced and implemented. Enterprises involved in new substance registration are advised to pay close attention and allocate time and compliance budget reserves for the possible institutional adjustments. CIRS Group will continue to monitor the revision status of relevant regulatory documents, provide professional regulatory interpretations for clients, and offer China new chemical substance compliance consulting and optimal solutions.
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