Registration Type

Current Decree No. 12

Article 4

Article 10

² Environmental management registration for new chemical substances is divided into regular registration, simplified registration, and filing.

² New chemical substances with an annual production or import volume of 10 tons or more must undergo regular registration; those with a volume of 1  ton or more but less than 10 tons must undergo simplified registration; and those with a volume of less than 1 ton must undergo filing.

Revised Exposure Draft

Article 4

Article 10

u The State implements an environmental management registration system for new chemical substances. Enterprises and entities that produce or import new chemical substances shall apply to the competent department of the State Council responsible for ecological environment to obtain a registration certificate prior to production or import.

u Environmental management registration for new chemical substances is divided into regular registration and simplified registration. For annual production or import volumes of 1 ton or more, an application must be filed to obtain a regular registration certificate; for volumes less than 1 ton, an application must be filed to obtain a simplified registration certificate.(The environmental management filing requirement for new chemical substances has been abolished)

Key Interpretation and Impact Analysis

l Interpretation: The filing system has been completely abolished; substances with an annual production or import volume of 1 ton or more must undergo regular registration, while those with less than 1 ton must undergo simplified registration.

l Impact: Substances that previously required only filing (which took effect automatically) for annual production or import volumes of less than 1 ton are now subject to simplified registration (a substantive approval process). This extends the approval cycle, requiring enterprises to plan their application timelines in advance.

Applicant Eligibility

Current Decree No. 12

Article 11

² 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.

² Production or trading enterprises intending to export new chemical substances to the territory of the People’s Republic of China may also serve as applicants; however, they must designate 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 to act as their agent, jointly fulfill the environmental management registration and post-registration environmental management obligations for the new chemical substances, and bear liability in accordance with the law.

² For products such as pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, and fertilizers—as defined in Article 2 of the Measures—that are classified as new chemical substances and are intended to be repurposed for other industrial uses, the manufacturer, importer, or processor of the relevant product may serve as the applicant.

² For chemical substances already listed in the “China Inventory of Existing Chemical Substances” and subject to environmental management for new uses, if such substances are intended for industrial uses other than those permitted, the producers, importers, or processors of the relevant chemical substances may all serve as applicants.

Revised Exposure Draft

Article 10

u Applicants for environmental management registration of new chemical substances shall be enterprises or institutions within the territory of the People’s Republic of China that are legally registered, capable of independently bearing legal liability, and engaged in the production or import of new chemical substances. (Delete the provisions regarding overseas enterprises and agents; delete the provisions regarding processing users)

Key Interpretation and Impact Analysis

l Interpretation: The provisions regarding “foreign enterprises + domestic agents” and “processing users” have been removed; processing users and foreign enterprises are no longer eligible to apply independently.

l Impact: Foreign manufacturers must complete registration through an importer in China or by establishing a domestic subsidiary; compliance processes for cross-border trade and processing must be restructured.

Scope of Registration Exemptions

Current Decree No. 12

Article 2

² The Measures do not apply to the following products or substances: (1) pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, animal feed, feed additives, fertilizers, and similar products—except for those repurposed for other industrial uses, as well as new chemical substances used as raw materials or intermediates for the aforementioned products; (2) radioactive substances.

² Guidance Clarification: Pharmaceuticals → Pharmaceuticals (including active pharmaceutical ingredients); Pesticides → Pesticides (including active pesticide ingredients); Veterinary Drugs → Veterinary Drugs (including active pharmaceutical ingredients)

Revised Exposure Draft

Article 2

Article 42

u The Measures apply to activities such as the application for, acceptance, review, and decision-making regarding Environmental Management Registration Certificates for New Chemical Substances, as well as the follow-up management of such certificates. (Exemptions for pharmaceuticals, pesticides, etc., have been deleted.)

u The Measures do not apply to chemical substances used for scientific research and technical services such as testing, inspection, metrology, and monitoring, nor to radioactive chemical substances. (New exemptions for scientific research, etc., have been added.)

Key Interpretation and Impact Analysis

l Interpretation: ① Remove exemptions for industries such as pharmaceuticals, pesticides, and veterinary drugs; ②Add new exemptions for scientific research, testing, inspection, metrology, and monitoring.

l Impact: All upstream raw materials for industries such as pharmaceuticals, agrochemicals, and personal care products must be included in the registration process, ensuring full regulatory coverage.

Polymer Management

Current Decree No. 12

Article 10

² Registration is required if any of the following conditions are met: (2) The polymer contains no more than 2% of a new chemical substance as a monomer or reactant, or is classified as a low-concern polymer.

Revised Exposure Draft

Article 11

u If a new chemical substance submitted for registration is a low-concern polymer or a polymer in which the content of new chemical substance monomers or reactants does not exceed 2%, the submitter is exempt from submitting the materials specified in subparagraphs (2) through (4) of paragraph (1) of this Article; however, supporting documentation demonstrating compliance with the relevant circumstances must be submitted. (Framework carried over)

Key Interpretation and Impact Analysis

l Interpretation: The simplified management framework for polymers remains largely unchanged. Polymers of low concern and those with low reactant content continue to qualify for material exemptions, requiring only the submission of supporting documentation; data requirements remain largely consistent with the previous regulations.

l Impact: Compliance costs for companies will remain largely unchanged; however, the approval process will shift from automatic approval to substantive review, resulting in longer registration cycles. Companies should plan accordingly well in advance.

Data Requirements for those with an annual production or import volume of 1 to 10 tons

Current Decree No. 12

Article 16

² To apply for simplified registration, the following must be submitted: (1) a simplified registration application form; (2) reports or data on physical and chemical properties, as well as ecotoxicological test results regarding persistence, bioaccumulation, and aquatic toxicity; (3) a written commitment to implement environmental risk control measures.

Revised Exposure Draft

Article 11

u Applicants for regular registration shall submit the following: (1) a regular registration application form; (2) test reports or data on physicochemical properties, health toxicology, and ecotoxicology; (3) a pollution risk assessment report and corresponding pollution risk control measures; (4) for high-hazard substances, a socio-economic benefit analysis.

u If the cumulative annual production and import volume of a new chemical substance for which registration is sought is less than 10 tons nationwide, the applicant is exempt from submitting the materials specified in subparagraphs (3) and (4) of the first paragraph of this Article.

Key Interpretation and Impact Analysis

l Interpretation: Although the 1–10 tons category has been upgraded to “regular registration,” companies are exempt from submitting risk assessment reports and socio-economic benefit analysis materials, and the data requirements are essentially the same as those for the original simplified registration. However, regulatory requirements will be further refined, explicitly requiring companies to specify concrete, implementable, and verifiable pollution risk control measures.

l Impact: A smooth transition between the old and new systems, without imposing additional testing burdens on companies.

Technical Review Timeline

Current Decree No. 12

Article 25

² The technical review period for regular registration shall not exceed sixty days, and the technical review period for simplified registration shall not exceed 60 days.

Revised Exposure Draft

Article 23

Article 17/18

u The technical review period for regular registration shall not exceed forty-five working days, and the technical review period for simplified registration shall not exceed twenty working days. (The time limit is specified as working days)

u Applicants shall have no more than twenty working days to submit supplementary materials. (Previously 6 months → 20 working days)

Key Interpretation and Impact Analysis

l Interpretation: ① The timeframe for technical reviews has changed, with public holidays excluded (regular: 60 days → 45 working days; simplified: 30 days → 20 working days); ② The deadline for submitting supplementary materials has been significantly reduced from a maximum of 6 months to 20 working days.

l Impact: Technical review management has become stricter, placing higher demands on the quality of companies’ registration materials. Since technical review timelines are calculated in working days and are subject to statutory holidays, the actual review period may exceed 60 days. At the same time, the deadline for submitting supplementary materials has been further tightened, compelling companies to strictly ensure the completeness and compliance of their registration materials, submit high-quality materials on the first attempt, and improve the registration approval rate.

Items Specified on the Registration Certificate

Current Decree No. 12

Article 26

² The registration certificate shall specify: (1) the type of registration certificate; (2) the names of the applicant and its agent; (3) identification information for the new chemical substance, such as its Chinese and English names or class names; (4) the intended use; (5) the quantity applied for registration; (6) the type of activity; and (7) environmental risk control measures.

Revised Exposure Draft

Article 24

u The registration certificate shall specify: (1) the type of registration certificate; (2) the name of the registration certificate holder (deleting “agent”); (3) identification information for the new chemical substance, such as its Chinese and English names or class names; (4) pollution risk control measures, including intended uses, registration quantities, activity types, and other pollution risk control measures; and (5) environmental management requirements.

Key Interpretation and Impact Analysis

l Interpretation: ① Delete the “Agent” information; ② Refine the “Pollution Risk Control Measures.”.

l Impact: The control measures specified on the registration certificate must be strictly implemented and may not be arbitrarily altered during information verification.

Circumstances for Amendment

Current Decree No. 12

Article 29

² For new chemical substances that have already obtained a regular registration certificate, if any of the following circumstances arise before the substance is included in the “China Inventory of Existing Chemical Substances”, the registration certificate holder shall reapply for registration: (1) The intended volume of production or import is expected to exceed the volume specified in the original registration application; (2) The intended activity type is expected to change from import to production; (3) The intended use of the new chemical substance is expected to change; (4) The environmental risk control measures are expected to change; (5) Other circumstances that result in an increased environmental risk.

Revised Exposure Draft

Article 27

u For new chemical substances that have already obtained a regular registration certificate, if any of the following circumstances apply prior to their inclusion in the "China Inventory of Existing Chemical Substances”, the registration certificate holder shall apply to amend the registration certificate: (1) a change in the name of the registration certificate holder; (2) a proposed reduction in the registration volume or a change in other pollution risk control measures to further reduce pollution risks; (3) A change in the CAS number of the new chemical substance. Except for the circumstances specified in the first paragraph, if any other information specified in the regular registration certificate changes, the registration certificate holder shall reapply for a regular registration certificate.

Key Interpretation and Impact Analysis

l Interpretation: ① Reduction in registration volume, changes to control measures (toward lower risk), and CAS numbers → amendment registration; ② Changes in activity type (e.g., from production to import) → re-registration; ③ Other changes → re-registration.

l Impact: The path for making changes is clearer, but changes in activity type require a new application, so companies need to plan ahead.

Inclusion in the Inventory

Current Decree No. 12

Article 44

² New chemical substances that have obtained a regular registration certificate shall be included in the ”China Inventory of Existing Chemical Substances” five years after the date of their initial registration.

² For high-hazard chemical substances and new chemical substances that are persistent and bioaccumulative, or persistent and toxic, or bioaccumulative and toxic, environmental management requirements other than annual reporting shall be specified upon their inclusion in the ”China Inventory of Existing Chemical Substances”（hereinafter referred to as IECSC）.

² New chemical substances subject to simplified registration or filing, as well as new chemical substances with regular registrations that have been withdrawn or revoked, shall not be included in IECSC.

Revised Exposure Draft

Article 37

u New chemical substances that have obtained a routine registration certificate shall be included in the “China Inventory of Existing Chemical Substances” five years after the date of initial registration.

u Substances shall not be included in IECSC under the following circumstances: (1) where the cumulative annual production and import volume nationwide is less than 10 tons; (2) where environmental management for new uses is implemented; (3) where the submission of materials specified in subparagraphs (2) through (4) of paragraph 1 of Article 11 is exempted; (4) where the regular registration certificate has been withdrawn or revoked in accordance with the Measures.

Key Interpretation and Impact Analysis

l Interpretation: High-hazard chemical substances that exhibit any two of the following properties—persistence (P), bioaccumulation (B), and toxicity (T)—and are subject to environmental management for new uses; substances with a cumulative national production or import volume of less than 10 tons; and substances for which no test data needs to be submitted—such as low-concern polymers, monomers, or reactants with a content not exceeding 2%—are all excluded from the IECSC.

l Impact: Even if registered, high-hazard substances will not be considered “existing substances,” and controls on their uses will be stricter. Substances already subject to new-use management must be re-registered if used for purposes other than those permitted.

Method for Conveying the Information Stated on the Registration Certificate

Current Decree No. 12

Article 38

² Producers, importers, and users of new chemical substances shall provide the following information to downstream users: (1) the registration certificate number or filing receipt number; (2) the intended uses of the new chemical substance; (3) the environmental and health hazard characteristics , measures to control environmental risks of the new chemical substance ; (4) environmental management requirements for the new chemical substance.

² Guidance Details: Information may be provided electronically or in writing, and the content and supporting documentation shall be properly archived for future reference.

Revised Exposure Draft

Article 31

u Enterprises and institutions that produce or import new chemical substances shall clearly stipulate in contracts for sales, consignment, and other arrangements that the following information specified on the registration certificate be communicated to downstream users: (1) the registration certificate number; (2) pollution risk control measures, including the registered uses of the new chemical substance; and (3) environmental management requirements for the new chemical substance.

Key Interpretation and Impact Analysis

l Interpretation: The requirement for information disclosure has been upgraded from “electronic or written” to “explicitly stipulated in the contract.”

l Impact: Information disclosure has shifted from a soft requirement to a hard contractual obligation, providing a verifiable basis for enforcement and retroactive review.

Activity Records

Current Decree No. 12

Article 39

Article 41

² A system for recording activities related to new chemical substances shall be established, and such records shall be kept accurately. Materials and activity records for regular and simplified registrations shall be retained for at least 10 years, while materials and activity records for filing shall be retained for at least 3 years.

² Where the submission of an annual report is required, the registration certificate holder shall report on the previous year’s activities by April 30 of each year.

Revised Exposure Draft

Article 32

u A system for recording activities related to new chemical substances should be established to ensure accurate documentation, and activity records for the previous year should be uploaded to the Environmental Management Information System by March 31 of each year.

Key Interpretation and Impact Analysis

l Interpretation: ① Enterprises and institutions that produce or import new chemical substances must uniformly upload their activity records to the information system by March 31 of each year; ② The specific provision regarding retention periods has been removed (replaced with a requirement to retain records in the information system).

l Impact: Reporting frequency is standardized, enabling the centralization of regulatory data nationwide and facilitating dynamic risk assessment.

Protection of Commercial Information:

Current Decree No. 12

Article 13

² The protection period for identification information such as the names of new chemical substances shall not exceed 5 years from the date of initial registration or filing.

Revised Exposure Draft

Article 13

u The five-year protection period limit has been removed; only the general principle regarding the necessity of confidentiality remains.

Key Interpretation and Impact Analysis

l Interpretation: The five-year cap on the protection period has been removed.

l Impact: Protection of corporate business information is now more flexible; however, applicants must provide a more thorough justification of the need for protection and supporting materials (such as database screenshots and links). It is not recommended to file applications casually.

Series Registration

Current Decree No. 12

Article 17

² A single applicant may file a single application for environmental management registration of multiple new chemical substances that have similar molecular structures, the same or similar uses, and similar test data. The registered quantity is determined by the sum of the registered quantities for each substance.

² If two or more applicants simultaneously apply for environmental management registration of the same new chemical substance, they may jointly submit application materials to apply for joint environmental management registration of the new chemical substance. The registered quantity is determined by the sum of the registered quantities for each applicant.

Revised Exposure Draft

Article 14

u If two or more applicants simultaneously apply to register the same new chemical substance, they may jointly submit application materials to apply for a joint registration. The registered volume is determined by the sum of the volumes applied for by each applicant.

u The state encourages applicants to share registration test data.

Key Interpretation and Impact Analysis

l Interpretation: Because substances with similar structures and isomers often exhibit differences in their physicochemical and toxicological properties, the original series registration required strict matching of test data and was relatively difficult to submit. The new regulations retain only joint registration and remove the provisions for series registration.

l Impact: Following the cancellation of serious registration, companies will no longer be able to register multiple new chemical substances with similar structures and intended uses as a group. Instead, they will need to conduct testing, compile documentation, and submit separate registrations for each substance individually. This change will directly increase companies’ submission costs and significantly raise compliance expenses. At the same time, the submission process has become more detailed and cumbersome, requiring companies to plan their new substance registration strategies well in advance to avoid compliance delays and late filings.

Letter of Commitment

Current Decree No. 12

Article 15

Article 16

² When applying for simplified registration or regular registration, a written commitment to implement or communicate environmental risk control measures and environmental management requirements must be submitted. This commitment must be signed by the legal representative of the enterprise or institution, or by a person authorized by the legal representative, and bear the official seal.

Revised Exposure Draft

Article 11

Article 12

u Requirement for written commitment removed

Key Interpretation and Impact Analysis

l Interpretation: The requirement for a written commitment has been removed, and pollution risk control measures are now directly specified on the registration certificate.

l Impact: This reduces the number of required application documents by one; however, the control measures specified on the registration certificate must be strictly implemented and cannot be arbitrarily altered during information verification.

Legal Liability

Current Decree No. 12

Article 46-51

² Obtaining a registration certificate through fraud or bribery: A fine of not less than 10,000 yuan but not more than 30,000 yuan; registration applications from the entity will not be accepted for 3 years.

² Testing agencies engaging in fraud: A fine of not less than 10,000 yuan but not more than 30,000 yuan (both the agency and the responsible person shall be penalized); test reports issued by the agency will not be accepted for 3 years.

² Unlicensed production, import, or processing and use: A fine of not less than 10,000 yuan but not more than 30,000 yuan; in serious cases, registration applications from the entity will not be accepted for 1 year.

Revised Exposure Draft

Article 38-41+

"Ecological and Environmental Code of the People’s Republic of China"

u Obtaining a registration certificate through fraud or bribery: A fine of not less than 10,000 yuan and not more than 100,000 yuan; registration applications from the entity will not be accepted for 3 years. (The maximum fine has been increased.)

u Testing agencies engaging in fraud: A fine of not less than 10,000 yuan and not more than 100,000 yuan (both the agency and the responsible individuals shall be penalized); test reports issued by such agencies shall not be accepted for 3 years. (The maximum fine has been increased.)

u production, import, or processing and use without a registration certificate: Penalties shall be imposed in accordance with the relevant provisions of the "Ecological and Environmental Code of the People’s Republic of China".

Key Interpretation and Impact Analysis

l Interpretation:  ① Obtaining a registration certificate through fraud or bribery: The maximum fine has been increased from 30,000 yuan to 100,000 yuan, while the “refusal to accept applications” period remains unchanged at 3 years; ② Fraud by testing institutions: The maximum fine has been increased from 30,000 yuan to 100,000 yuan, and the dual-penalty system and the provision that “test reports will not be accepted for 3 years” remain in effect; ③ Unlicensed production, import, or processing and use: The legal basis for penalties has shifted from Decree No. 12 to the "Ecological and Environmental Code of the People’s Republic of China", and the range of fines has been significantly increased.

l Impact: Pursuant to Article 1206 of the “Ecological and Environmental Code of the People’s Republic of China” (Production or Importation in Violation of Registration Certificate Requirements): For a first-time violation, the entity shall be ordered to rectify the violation and shall be fined not less than 200,000 yuan but not more than 1,000,000 yuan; if the entity refuses to rectify the violation, it shall be fined not less than 1,000,000 yuan but not more than 2,000,000 yuan, and ordered to restrict production or suspend production for rectification; in serious cases, the registration certificate shall be revoked, and the entity shall be ordered to suspend operations or close down. Article 1207 (Production without a license, importation without a license, or use of unlicensed new chemical substances to produce products): For a first-time violation, the entity shall be ordered to rectify the violation and shall be fined between 200,000 yuan and 1,000,000 yuan; if the entity refuses to rectify the violation, it shall be fined between 1,000,000 yuan and 2,000,000 yuan and ordered to restrict production or suspend operations for rectification; in serious cases, the entity shall be ordered to suspend business or close down. The cost of noncompliance has jumped from a previous maximum of 30,000 yuan to a maximum of 2 million yuan, creating a powerful legal deterrent.

Transition Period

Current Decree No. 12

Article 53

Article 55

² Any environmental management registrations for new chemical substances that have already been filed shall remain valid after the Measures take effect.

² The Measures shall take effect on January 1, 2021, and Decree No. 7 is hereby repealed.

Revised Exposure Draft

Article 44

Article 45

Article 47

u For cases that have already been filed in accordance with the current Decree No. 12, the filing applicant shall apply for a registration certificate in accordance with the relevant provisions of the Measures by December 31, 2026.

u For registration applications that were accepted pursuant to Decree No. 12 prior to the effective date of the Measures, the processing may continue in accordance with the provisions of Decree No. 12 after the Measures take effect.

u Where a registration certificate has already been obtained, it shall remain valid after the implementation of these Measures; however, if there are changes to the information specified therein, a new application must be filed.

u The Measures shall take effect on August 15, 2026, and Decree No. 12 shall be repealed simultaneously.

Key Interpretation and Impact Analysis

l Interpretation: ① Substances that have been filed must be registered by December 31, 2026; ② Registration certificates for substances that have already been registered remain valid; ③ Applications that have been accepted but not yet processed may continue to be processed in accordance with Decree No. 12.

l Impact: Under the new regulations, the filing requirement will be eliminated, and approval will no longer be automatic. Companies required to apply for registration should plan accordingly; given the tight timeline, they should prepare in advance.