1. Introduction

The Measures for Environmental Management Registration of New Chemical Substances in China (Order No.12 of the Ministry of Ecology and Environment), which was formulated to standardized the environmental management registration of new chemical substances, scientifically and effectively assess and control the environmental risks of new chemical substances, focus on new chemical substances that may cause greater risks to the environment and health, protect the ecological environment and ensure public health.

2. Scope of Application

“New chemical substances” in this “Measures” refers to chemical substances that are not listed in the Inventory of Existing Chemical Substances in China (IECSC).

Chemical listed in the IECSC but are subject to new uses environmental management used for industrial purposes other than permitted uses, are required to apply for new uses registration.

Activities such as research, manufacture, import, processing and use of new chemical substances within China are required to apply for environmental management registration of new chemical substances. However, new chemical substances stored in the special customs without being processed after exporting shall be excluded.

Note: IECSC was formulated, adjusted and published by the Ministry of Ecology and Environment of the People’s Republic of China, including the chemical substances that have been produced, sold, processed, used and imported in the territory of the People’s Republic of China before October 15, 2003, and the chemical substances listed to the IECSC after October 15, 2003, in accordance with relevant regulations on environmental management of new chemical substances. 

3. Scope of Exemption

The Measures is not applicable to the following products or substances:

1. Medicines, pesticides, veterinary medicines, cosmetics, food, food additives, feed, feed additives and fertilizers etc. However, the new chemical substances which are used for other industrial uses or used as raw materials and intermediated of the above products shall be governed by the Measures;
2. Radioactive substances;
3. Naturally occurring substances;
4. Categories for non-commercial or non-intentionally produced substances (Impurities, By-products, and Reaction Wastes, etc.)
5. Other special categories

• Materials (glass, ceramics, steel, cement, etc.)
• Alloy (excluding intermetallic compounds and metal intermixtures with defined compositions)
• Non-separable Intermediates
• Articles (excluding articles intentionally releasing new chemicals during normal use, except for the new chemicals contained therein)
• Products or formulations that are not artificially produced, imported, or sold, but generate chemicals through chemical reactions when performing their specific functions
• Mixtures artificially blended from existing chemicals and not generating new chemicals.
• Anhydrous forms of chemicals listed in IECSC or registered, their hydrates are treated equally, and vice versa.

4. Registration Bodies

• Overseas companies (should designate a representative agent when applying for the registration)
• Manufacturers in China
• Importers in China
• Processors and users in China

Enterprises intending to export new chemical substances to China must appoint a legally registered enterprise within China that can independently assume legal responsibilities as their agent to jointly fulfill relevant obligations.

Producers, importers, or processors intending to register new uses or change products already regulated by other laws and regulations for other industrial purposes can all act as applicants.

5. Registration Types

The registration types for environmental management of new chemical substances can be divided into three categories: regular registration, simplified registration, and filing.

6. Registration Procedure

7. Serial Registration and Joint Registration

Serial Registration

• If the same applicant applies for multiple new chemicals with similar molecular structures, similar or relevant uses, or similar test data, they may apply for serial registration for new chemicals environmental management.
• The quantity for registration shall be determined based on the total quantity applied for each substance.
• Upon meeting these requirements, the applicant obtains registration certificates for each new chemical substance in the serial registration.
• The number of new chemicals in serial registration shall not exceed 6.
• Health toxicology and ecotoxicology data for serial registration can be composed of test data from multiple new chemical substances in the serial registration. However, at least one set of identical health toxicology and ecotoxicology data should be submitted for all new chemical substances in the serial registration.
• For new chemical substances in serial registration, if a characteristic (such as health toxicity) cannot demonstrate similar test results for the serial substances, all health toxicology and ecotoxicology data for each substance should be submitted separately.

Joint Registration

• When two or more applicants apply for the environmental management registration of the same new chemical substance simultaneously, they can jointly submit application documents for the joint registration of the new chemical substance environmental management.
• The registration quantity is determined based on the total amount applied for by each applicant.
• If qualified, each applicant in the joint registration will receive a registration certificate separately.

9. Polymer Filing Requirements

If new chemicals meet the definition of a polymer under regulations and qualifies as a 2% polymer or polymer with low concern(PLC), and does not fall under any exclusion criteria for polymer filing, polymer filing can be conducted without limitations on the quantity of activities. For polymers that do not meet the criteria for polymer filing, regular filing applications or standard/simplified registration applications can be processed according to relevant regulations based on the quantity of activities.

Note: For the registration of polymers through regular or simplified procedures, applicants should submit additional information characterizing the polymer, including lists of monomers/reactants, molecular weight and distribution information, polymerization reaction mechanisms, residual monomer content, and the presence of metals or their cations.

Gel permeation chromatography (GPC) reports can provide molecular weight and distribution information, including molecular weight distribution plots, molecular weight data, conclusions regarding molecular weight distribution, etc

Definition of polymers

Polymers must meet all of the following conditions:

• Molecular weight is not a fixed value but exhibits a dispersed distribution.
• At least 50% (by weight) of the molecules contain three or more monomer units, which are covalently bonded to at least one other monomer unit or reactant.
• Molecules with the same molecular weight do not exceed 50% (by weight) of all molecules. 

2% polymer (meeting one of the following conditions):

• All weights of monomers/reactants of new chemical substances (either by feed weight ratio or content weight ratio) are ≤ 2%.
• All monomers/reactants are listed in IECSC.

PLC (Meeting one of the following conditions):

• The average molecular weight (Mn) is between 1000 and 10000, with less than 10% of oligomers with a molecular weight less than 500, and less than 25% of oligomers with a molecular weight less than 1000. Additionally, it does not contain high concern or highly reactive functional groups.
• Mn is greater than or equal to 10000. Less than 2% of oligomers have a molecular weight less than 500, and less than 5% of oligomers have a molecular weight less than 1000.
• Polyester polymers (main chain linked by ester bonds -COO-).

Exclusions of polymers

(1) Cationic Polymers

Including polymers containing covalently bonded ions such as tetraalkylammonium ions [R4P]+, tetraalkylstannyl ions [R4S]+, ammonium ions [R4N]+, or polymers expected to become cationic polymers in natural aquatic environments (e.g., polymers containing amine groups R3N, isocyanate groups R-NCO, etc.).

(2) Degradable or unstable polymers

This category includes polymers that are prone to degradation, decomposition, or depolymerization, as well as polymers that decompose after production or use. Degradation, decomposition, or depolymerization refers to chemical changes in polymers caused by oxidation, hydrolysis, heat, light, solvents, microorganisms, etc., resulting in the breakdown of the polymer into simpler, lower molecular weight substances.

(3) Hydrophilic polymers with Mn ≥ 10000

Hydrophilic polymers refer to polymers capable of absorbing water equivalent to their own weight, excluding water-soluble polymers and polymers that can be dispersed in water (including self-dispersing or already dispersed polymers).

(4) Fluorinated polymers

Polymers containing perfluoroalkyl sulfonic acid groups, perfluoroalkyl carboxylic acid groups, or fluorine-containing copolymer segments in their structure; as well as fluorinated polymers containing perfluoroalkyl segments covalently bonded to carbon or sulfur atoms in the polymer molecule.

(5) Polymers containing permissible elements (as listed below) in addition to impurities:

• Polymer components must include at least two of the following elements: C, H, N, O, S, or Si.
• F, Cl, Br, and I covalently bonded to carbon, as well as Cl-, Br-, and I- in monovalent form.
• Na+, Mg2+, Al3+, K+, and Ca2+; Li, B, P, Ti, Mn (referring to manganese here), Fe, Ni, Cu, Zn, Sn, and Zr with a weight percentage of less than 0.20%.

8. Application Materials Requirements

8.1 Registration Documents Requirements

Note: The exclusion for polymer registration may involve tests, but there are no mandatory requirements for the qualifications of testing laboratory or testing methods.

8.2 P/B/T Property and Highly Hazardous Chemicals

Highly hazardous chemicals refer to chemicals that exhibit persistence, bioaccumulation, and toxicity (PBTs) properties, those with very high persistence and very high bioaccumulation (vPvBs), or other substances that pose equivalent environmental or health hazards (such as endocrine disruptors, substances of very high concern, etc.).

Endocrine-disrupting chemicals (EDCs) or suspected EDCs shall be identified based on the existing international EDCs lists, and the existing international databases. If the substance is considered a suspected EDCs, the applicant should provide a comprehensive assessment report or test data in accordance with international technical guidelines, to assess the EDC properties of the substance. 

Substances of very high concern include, but not limited to, those classified under the “Rules for Classification and Labelling of Chemicals” (GB 30000) as Category 1- acute toxicity (oral, dermal, inhalation (gas, vapor, dust/mist)), carcinogenicity (Category 1A or 1B), germ cell mutagenicity (Category 1A or 1B), reproductive toxicity (Category 1A or 1B), specific target organ toxicity upon repeated exposure (Category 1), or aquatic chronic toxicity where NOEC or EC10<0.01mg/L.

Based on the data that may be involved in registration applications, the basic criteria for determining P/B/T properties are as follows:

8.3 Application Data Requirements

(1) Data source and data requirements
Application data include minimum data and additional data. The basic data of minimum required data should originate from test reports, and the specific data of minimum data should mainly originate from test reports. Other data should preferably come from test reports.

Non-testing data
Except for explicitly specified acceptance of non-testing data, only in special circumstances where actual testing is not feasible, non-testing data generated by QSAR, cross-referencing, authoritative publications, and authoritative databases may be accepted. However, the reasons, methods or data sources, and basis should be fully explained.

Basic data
All substances are required to submit basic information when conducting regular and simplified registration.

Special data
When conducting regular registration, substances with persistence or bio-accumulation properties are required to submit special data; substances with persistence and bio-accumulation are required to submit special date when conducting simplified registration.

Other data
These data are required to submit after technique assessment when making regular or simplified registration.

(2) Minimum data requirements 

• Specific data submission requirements are determined by factors such as registration type, substance characteristics (physical state, P and B properties, etc.), and registration quantity.
• From the perspective of substance characteristics, it is recommended to first conduct certain basic data (partition coefficients, degradation rate, hydrolysis, etc.) to determine the P and B properties of the applicant substance, and then decide whether to further conduct special data.

(3) Minimum data required ⸻ Spectrogram physiochemical

• For chiral substances, information such as specific rotation should be provided as much as possible.
• Henry’s constant can be derived from either experimental data or model calculations; for solid substances undergoing standard registration, it is recommended to conduct vapor pressure testing to combine with water solubility testing data and utilize model calculations to determine Henry’s constant.

(4) Minimum data requirements-health toxicology 

• Conclusions (typically classification) from in vitro test data on skin irritation, eye irritation, and skin sensitization are acceptable; otherwise, in vivo test data should be provided.
• Data on developmental toxicity during pregnancy, two-generation reproductive toxicity, or extended one-generation reproductive toxicity can be used as alternatives to reproductive/developmental toxicity screening tests.
• For mutagenicity, it is recommended to prioritize the submission of three in vitro test data. Unless explicitly specified, in principle, one in vivo genetic toxicity data can correspond to only one in vitro genetic toxicity data.
• Local toxicity usually refers to hazards in skin irritation, eye irritation, or skin sensitization classification.
• Toxicokinetic test data should be provided when assessing carcinogenicity.

(5) Minimum data requirement—Ecotoxicology 

• Regular registration

• Simplified registration
• More selective degradation data or degradation simulation data are optional.
• “Occurrence of toxic effects” typically refers to short-term toxicity (algae/daphnia/fish EC50 or LC50 < 100mg/L) or 21-day NOEC for reproduction of large daphnia < 10mg/L.
• All test items marked “domestic” require the use of Chinese test organisms for testing; among them, if the rapid degradation test has been completed overseas, options include conducting rapid degradation, enhanced rapid degradation, or inherent degradation within China.

(6) Data Requirements for Special Substances

(a) For chemicals whose inherent properties genuinely preclude the conduct of health or ecological toxicity testing, relevant test data may be exempted from submission. Estimated, analog-based cross-reference, or literature data may suffice, but detailed explanations of the specific reasons should be provided.

(b) Inorganic compounds and metals
Exempted from submitting biodegradability test data.

(c) Chemical substances undergoing hydrolysis/light decomposition or reaction upon contact with water (excluding substances releasing flammable gases upon contact with water)

• Submit test reports on hydrolysis/light decomposition (referring to a half-life DT50 < 12h under normal temperature and pressure) or reaction upon contact with water, analyzing and identifying the products and their contents to determine if they are new substances.
• If all products are existing substances, exemption from submitting ecological toxicity data is applicable.
• If there are new substances in the products (single substance content > 10%), ecological toxicity data corresponding to the registered quantity of the applied substance or product should be submitted. Specifically, if the application material is the object, the submitted data shall be the test data; In the case of products, the submitted data may be derived from tests, estimates, analogs cross-references, or literature.

(d) Chemicals used solely as intermediates for pesticides, pharmaceuticals, or veterinary drugs
Basic data may be submitted exclusively, along with detailed explanations of intermediate usage (production and usage units, production and usage processes, information on substances or products produced using new substances).

(e) Polymers defined under Order No.12
When applying for regular or simplified registration, health and ecological toxicity data can be exempted from being submitted if they meet all of the following conditions:

• The contained metals are limited to sodium, magnesium, potassium, and calcium.
• It is insoluble in water, n-octanol, n-hexane, tetrahydrofuran, and dimethylformamide.
• It remains stable under acidic and alkaline conditions (pH values of 4.0, 7.0, 9.0, and if physiologically relevant, also includes pH 1.2).

(7) Testing institution qualifications and testing methods 

8.4 Data Exemption and Explanation

There are about 33 items exempted from data submission in the following table: 

8.5 Information Protection

Basic requirements

• If the applicant requires protection of information involving commercial secrets in the submitted registration or filing materials, it should be raised during the process of applying for standard registration, simplified registration, or filing.
• The registration application form and filing form have corresponding checkboxes for applicants to indicate their desire for information protection. When information protection is required, the applicant should check the corresponding box. Columns without checkboxes cannot request information protection.
• Applicants who submit materials for standard, simplified registration, or filing without requesting information protection for certain columns cannot apply for information protection subsequently.
• Applicants intending to protect chemical substance identification information (including Chinese and English names, CAS numbers, molecular formulas, and structural formulas, etc.) in simplified and standard registration applications should submit necessary justifications for information protection.

Necessity for the protection of substance identification information:

a) A statement declaring the need for information protection, specifying whether the information to be protected constitutes the applicant’s trade secrets and that such information is not subject to disclosure requirements under other laws and regulations of the People's Republic of China.

b) Specific categories of information to be protected in the application and corresponding duration of protection.

c) Explanation of the information’s public awareness status, including, but not limited to:
[1] Whether the public or competitors can obtain substance identification information associated with the applicant through public channels (e.g., published materials).
[2] Whether the substance identification information has been disclosed or made public by domestic or foreign regulatory authorities, and if so, providing detailed explanations.

d) Explanation of the commercial value of the information to be protected, including, but not limited to:
[1] Whether it can be proven or reasonably anticipated that the disclosure of substance identification information will cause substantial harm to the applicant's market competitive position.
[2] Whether commercial technical information such as substance use or production processes can be inferred from the substance identification information.

e) Whether the applicant has taken and will continue to implement measures to prevent the leakage of the information to be protected, and providing specific details of such measures.

10. Acceptance and Approval Procedure

Acceptance (formal review)

• Upon receiving application materials, competent authorities shall make a decision to accept or reject the application within 5 working days.
• Once the applicant submits all materials as requested in the formal review correction notice, the formal review procedure shall restart.
• The time for material correction is excluded in the formal review deadline.

Technical review

• Regular registration: Technical review shall be conducted by the expert committee and the technical institution of the competent authority, with a maximum duration of 60 days.
• Simplified registration: Technical review shall be conducted by the technical institution of the competent authority, with a maximum duration of 30 days.
• If opinions are provided during the technical review, the applicant shall supplement the relevant application materials as per the requirements of the supplementary notice within 6 months.
• The time to supplement materials is excluded in the technical review deadline.

Approval

• A decision on whether to register shall be made within 20 working days from the date of acceptance of the application.
• If a decision cannot be made within 20 working days, with approval from the head of the competent authority, an extension of 10 working days may be granted, and the reason for the extension period shall be communicated to the applicant.
• The time to supplement materials and the technical review period are excluded in the approval deadline.

11. Re-registration and Registration Certificate Renewal

11.1 Re-registration

For new chemicals that have obtained standard registration certificates and meet one of the following conditions before being included in the IECSC, the holder of the registration certificate shall reapply for registration:

1. The intended production or import quantity exceeds the registered quantity;
2. The type of activity is intended to change from import to production;
3. The intended use of the new chemical substance is intended to change;
4. The intended change of environmental risk control measures;
5. Other circumstances leading to increased environmental risks (such as changes in domestic production and processing conditions, changes in domestic production sites, changes in environmental management requirements, etc.).

For re-registration, the holder of the registration certificate shall resubmit the following materials through the online registration system:

Registration application form and reasons for the renewal, new environmental risk assessment report, explanation of the appropriateness of the environmental risk control measures to be taken after the modification, additional test reports or data, socio-economic benefit analysis report (if required), commitment to implement or transfer environmental risk control measures and environmental management requirements, etc.

Re-registration shall be processed according to the standard registration procedure.

If the registration requirements are met, registration shall be granted, and a new registration certificate shall be issued. After obtaining the new registration certificate, the holder of the registration certificate may carry out activities according to the registration situation.

11.2 Renewal of Registration Certificate

Regular Registration Certificate

For regular registration certificates, apart from cases requiring re-registration, if there are changes in other information stated in the registration certificate before inclusion in IECSC (such as changes in applicant/agent name, replacement of agent, changing activity type from production to importation or adding importation activity type, changes in English and Chinese names of new chemical substances, CAS number, molecular formula, and structural formula), the applicant should apply for registration certificate amendment.

Simplified registration Certificate

If there are changes in the information stated in the simplified registration certificate (such as changes in applicant/agent name, replacement of agent, changes in registered quantity, activity type, intended use, environmental risk control measures, and changes in the identification information of new chemical substances), the holder of the registration certificate should apply for registration certificate amendment.

Requirements for registration certificate renewal:

• The applicant should submit the reason for the amendment along with relevant supporting documents.
• If the applicant intending to change the identification information of the new chemical substance, the supporting documents should adequately demonstrate that the chemical substance before and after the change belongs to the same chemical substance.
• Registration certificate amendment should be processed according to the simplified registration procedure.

12. Application Withdraw and Revocation of Registration Certificate 

Withdrawal of Application

• After the application is accepted, the applicant may submit a written withdrawal of the registration application, explaining the reasons for withdrawal, before obtaining approval.
• If the applicant designates an agent, the withdrawal of the registration application should be jointly submitted by the applicant and the agent; for joint registrations, the withdrawal of the registration application should be jointly submitted by all applicants.

Revocation of Registration Certificate

• After obtaining a standard registration certificate or simplified registration certificate, the applicant may apply to the ecological and environmental competent authority for revocation of the registration certificate. The holder of the registration certificate should submit a written revocation application, explaining the reasons for revocation, and return the registration certificate.
• If the applicant designates an agent, the revocation application should be jointly submitted by the holder of the registration certificate and the agent.
• The original holder of the revoked registration certificate shall not reapply for registration of the same new chemical substance within three years after revocation.

13. New Use Registration

• For chemicals with PB, PT, or BT properties already listed in the IECSC, if they are intended for industrial uses other than permitted uses, all applicants shall apply for new use registration to the competent authority.
• For chemicals with high hazard properties already listed in the IECSC, new applicants intending to use them for any purpose must also apply for new use registration.

The form requirements for submitting application materials for new uses shall be in accordance with standard registration applications and processed according to the standard registration procedure.

14. Activity Record and Data-keeping

Activity record

Researchers, producers, importers, and processors of new chemicals shall establish a system for recording activities of new chemicals, truthfully documenting the time, quantity, usage, implementation of environmental risk control measures, and environmental management requirements.

Data-keeping

For standard registration and simplified registration materials, as well as related documents such as records of activities of new chemicals, they should be retained for at least ten years. For filing materials and related documents such as records of activities of new chemicals, they should be retained for at least three years.

15. Activity Report

16. New Hazard Characteristics Reporting

Researchers, producers, importers, and processors of new chemicals who discover new environmental or health hazard characteristics or environmental risks associated with new chemicals shall promptly report to the competent authority; measures shall be taken promptly to eliminate or reduce environmental risks if they may increase.

• Based on the national registration status of new chemicals for environmental management, actual production or importation, environmental discharge conditions, as well as newly discovered environmental or health hazard characteristics, competent authorities may require relevant researchers, producers, importers, and processors to further submit relevant environmental or health hazard and environmental exposure data information for new chemicals for which environmental risks may continue to increase.

• Upon receiving relevant information, the competent authority shall organize its affiliated technical institution for chemical environmental management and expert committee to conduct a technical review; when necessary, based on the review results, corresponding registration certificates may be legally amended or revoked.

17. Post-registration Obligations

18. Inclusion to IECSC

Before implementing the new chemical substance environmental management registration system, the chemical substances are supplemented into the Inventory of Existing Chemical Substances in China (IECSC).

Chemical substances that were produced, sold, processed, used, or imported within the territory of the People’s Republic of China before October 15, 2003, relevant production, import, processing and usage enterprises, related industry associations, and other relevant units can apply to be added to the IECSC (Inventory of Existing Chemical Substances in China). Applicants should provide proof materials including sales invoices of the chemical substances, import and export customs declarations, industry statistical materials, chemical industry yearbooks, documents issued by management departments, public publications, or other evidence proving that the chemical substance was produced, sold, processed, used, or imported within the territory of the People’s Republic of China before October 15, 2003.

• New chemical substances that have obtained a regular registration certificate will be added to the IECSC and announced by the competent authority after five years from the date of their first registration.
• New chemical substances on regular registration certificates that are voluntarily revoked by the applicant will be normally added to the IECSC; however, new chemical substances that are subject to simplified registration and filing will not be added to the IECSC.
• New chemical substances that have obtained a regular declaration registration certificate under Order No. 7 and have not yet been added to the IECSC will be included in the IECSC after five years from the date of the first activity or by December 31, 2025, at the latest.

Inventory Search:

Inventory of Existing Chemical Substances in China (IECSC)