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China - Regulation

In 2003, Chinese Ministry of Ecology and Environment (MEE) introduced the regulation on the registration of New Chemical Substances (MEP Order No.7). In 2010, this regulation was revised for the first time and the Inventory (IECSC) was introduced under Order No.7.

After 9 years’ implementation of Order No.7, MEE called for the second revision of Measures for the Environmental Management Registration of New Chemical Substances, which was finally approved on February 12, 2020 (MEE Order No.12). This new regulation has come into force on January 1, 2021 and replaced the previous regulation (Order No.7).

Under the provisions of this regulation, companies shall submit registration application if manufactured/imported substance is not listed in the Inventory. All activities including research, production, importation and processing have to comply with the regulation requirements as long as the chemical substances are under the scope of this regulation. Business activities are not allowed until a certificate is granted.

Persistent Organic Pollutants (POPs), also referred to as “emerging contaminants”, include a range of chemical substances from diverse applications, ranging from medicines, personal care, household cleaning products, lawn care, agricultural products, among others.

The toxicity of POPs has been long investigated, and researchers found that these chemicals may have long-range mobility and long-lasting duration, leading to environmental contamination and pollution. POPs are often classified as Substance of Very High Concern (SVHC) with hormone disruption consequences, bioaccumulation and biomagnification through the food chain. The presence of POPs in the environment and in human health can lead to several complications, from mild effects to more serious consequences, for example, reproductive disruptions and immunological disorders.

Since POPs are not easily broken down, a characteristic that guarantees its continuation in the environment, the contaminant consequences are still being investigated. In other words, the emerging contaminants are mainly not from new pollutants that recently entered the environment. Instead, there is a good understanding of contaminants, but the consequences of their exposure are still being discovered.

Countries have created a set of rules and regulations to regulate, control, and mitigate POPs use and its effects on the environment and on human health. The essence of these legislations is to eliminate the production, trading, and use of such chemicals, including storage and waste management.

International effort in addressing POPs starts in the late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parties to reduce their emissions below 1990 levels.

The Stockholm Convention is an international conference specifically for POPs proposed in May 2001 in Sweden (complementing the Aarhus Protocol), entering into force in 2004. Among the objectives, the Stockholm Convention aims to:

  • Prohibit, eliminate, and restrict several POPs in the production, use, import, and export.
  • Ensure that waste containing POPs is managed safely and in an environmentally sound manner.
  • Promote tools for information exchange, public access, awareness and education, research, development and monitoring, reporting, and implementation of plans to fight POPs pollution.

The Stockholm Convention is considered the main international instrument to address POPs. Most countries adhere to the Stockholm Convention.

China signed the Stockholm Convention on its launch in 2001 and ratified the Convention in 2004. Since then, the initial list of 12 POPs listed in the Stockholm Convention entered the government agenda. For example, the Regulation for Pesticide Management, issued by the State Council in 1997 and amended in 2002, is a comprehensive law that strengthened the import and export, registration, production, utilization, management, and transportation of pesticides, especially those of POPs. The Regulation for Pesticide Management forbids enterprises or individuals to produce, utilize, or trade products such as Hexachlorobenzene (HCB), Bexachloridge (HCH), and Dichlorodiphenyltrichloroethane (DDT).

In 2007, the Chinese government issued the National Implementation Plan for the Stockholm Convention on Persistent Organic Pollutants, dividing the implementation goals by stages (2010, 2010-2015, and after 2015), by region, and type of industry. The overall objective, as expected, is to reduce or eliminate the environmental and health risks posed by the POPs through the effective implementation of several action plans.

  • By 2010
    • Eliminate the production, use, import, and export of certain pesticide POPs
    • Control of PCBs used in PCBs-containing equipment in use
    • Reduce or eliminate releases of unintentionally produced POPs
    • Reduce or eliminate releases of POPs from stockpiles and wastes
  • By 2015
    • Eliminate the use of PCBs in currently used equipment containing PCBs
    • Reduce or eliminate releases of unintentionally produced POPs
    • Reduce or eliminate releases originating from POPs stockpiles and wastes
    • Manage POPs contaminated sites
  • After 2015 (long-term aims)
    • Complete the identification of currently used equipment containing PCBs and eliminate uses of PCBs by 2025
    • Promote the Best Available Techniques and Best Environmental Practices in all relevant areas for maximum reduction of Dioxin releases
    • Improve the inventories of POPs wastes and contaminated sites, pursuing their gradual recovery

The overall steps for the National Implementation Plan for POPs are depicted below:

Currently, China’s legislation addresses phasing-out, reduction, control, and disposal of POPs or contaminated articles with POPs, specifically with alpha hexachlorocyclohexan, beta hexachlorocyclohexane, chlordecone, hexabromobiphenyl, hexabromodiphenyl ether, heptabromodiphenyl ether, lindane, pentachlorobenzene, perfluorooctane sulfonic acid, tetrabromodiphenyl ether, pentabromodiphenyl ether, endosulfan, and hexabromocyclododecane.

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The Measures for the Registration of Environmental Management of New Chemical Substances were approved by the Ministry of Ecological Environment on February 17, 2020 and are hereby promulgated, effective January 1, 2021. The Measures for the Environmental Management of New ChemicalSubstances (Decree No. 7 of the Ministry of Environmental Protection) issued by the former Ministry of Environmental Protection on 19 January 2010 were repealed at the same time.

Article 1 These Measures are formulated in accordance with relevant laws and regulations and the Decision of the State Council on the Establishment of Administrative Permits for Administrative Approval Projects that are necessary to retain new chemical sishists, scientifically and effectively assess and control the environmental risks of new chemical substances, focus on new chemical substances that may pose greater risks to the environment and health, protect the ecological environment and safeguard public health.

Article 2 These Measures shall apply to the registration of environmental management for the research, production, import and processing of new chemical substances within the territory of the People's Republic of China, except for new chemical substances stored in the special customs area after import and exported in their entirety without any processing.

The following products or substances do not apply to these Measures:

(1) medicines, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers and other products, except for new chemical substances that are changed for other industrial uses, as well as raw materials and intermediates of the above-mentioned products;

(2) Radioactive substances.

Article 3 The term "new chemical substances" as mentioned in these Measures refers to chemical substances that are not included in the List of Existing Chemical Substances in China.

Chemical substances that have been included in the List of Existing Chemicals in China shall be environmentally called for environmental management according to existing chemical substances, but those chemical substances that are provided for in the List of Existing Chemicals in China for the implementation of environmental management for new uses shall be environmentally managed in accordance with new chemicals for industrial purposes other than those permitted.

The List of Existing Chemical Substances in China shall be formulated, adjusted and published by the competent department of ecological environment under the State Council, including chemical substances that have been produced, sold, processed or imported in the territory of the People's Republic of China before October 15, 2003, and chemical substances included after October 15, 2003 in accordance with the relevant regulations on environmental management of new chemical substances.

Article 4 The State shall implement a system of environmental management and registration of new chemical substances.

The registration of environmental management of new chemical substances is divided into routine registration, simple registration and filing. The producer or importer of a new chemical substance shall obtain a routine registration certificate for environmental management of new chemical substances or a simple registration certificate (collectively, a registration certificate) before production or before importing it, or handle the record of environmental management of new chemical substances.

Article 5 The registration of environmental management of new chemical substances shall follow the principles of science, efficiency, openness, fairness, fairness and convenience, adhere to source access, risk prevention and classification management, and focus on the control of new chemical substances that are persistent, bioaccumulative, harmful to the environment or health, or may exist in the environment for a long time and may pose greater risks to the environment and health.

Article 6 The competent department of ecological environment under the State Council shall be responsible for organizing and carrying out the national environmental management registration of new chemical substances, formulating supporting documents such as policies, technical norms and guidelines for the registration of new chemical substances, as well as the rules for registration and evaluation, and strengthening the construction of the registration and informationization of new chemical substances.

The competent department of ecological environment under the State Council shall organize the establishment of an expert committee on environmental risk assessment of chemical substances (hereinafter referred to as the committee of experts). The expert committee is composed of experts in chemistry, chemical, health, environment, economy, etc., and provides technical support for the registration and evaluation of environmental management of new chemical substances.

The competent local ecological environment departmentats at or above the municipal level of the district shall be responsible for the environmental supervision and management of the implementation of these Measures by the relevant enterprises and institutions that study, produce, import and process the use of new chemical substances in their respective administrative areas.

The technical institution sundered by the competent department of ecological environment under the State Council shall participate in the registration and evaluation of the environmental management of new chemical substances and undertake the specific work of the registration of new chemical environmental management.

Article 7 Enterprises and institutions engaged in the research, production, import and processing of new chemical substances shall abide by the provisions of these Measures, take effective measures to prevent and control the environmental risks of new chemical substances, and shall be responsible for the damage caused by them.

Article 8 The State encourages and supports the scientific research and application of environmental risk assessment and control technologies for new chemical substances, and encourages the research and application of environmentally friendly chemical substances and related technologies.

Article 9 All units and individuals shall have the right to report any violation of the provisions of these Measures to the competent department of ecological environment.

Article 10 Where the annual production of new chemical substances or the import volume of more than 10 tons, the general registration of environmental management of new chemical substances shall be conducted (hereinafter referred to as the regular registration).

If the annual production of new chemical substances or the import volume of more than 1 ton is less than 10 tons, the environmental management of the new chemical substances shall be subject to a simple registration (hereinafter referred to as the simple registration).

If one of the following conditions is met, the new chemical environmental management shall be filed (hereinafter referred to as the record):

(1) The annual production of new chemical substances or the import volume is less than 1 ton;

(2) A polymer with a content of no more than 2% of the new chemical substance monomer or reaction body or a polymer of low concern.

Article 11 An applicant for the registration of environmental management of new chemical substances shall, in accordance with the law within the territory of the People's Republic of China, be able to bear legal responsibility independently, and engage in the production or import ation of new chemical substances.

A production or trading enterprise that intends to export new chemical substances to the territory of the People's Republic of China may also act as an applicant, but shall designate enterprises and institutions registered in the territory of the People's Republic of China who can independently assume legal liability as agents, jointly fulfill their obligations for environmental management after registration and registration of new chemical substances, and assume responsibility in accordance with the law.

If the products of medicine, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers, etc. as stipulated in Article 2 of these Measures belong to new chemical substances and are to be changed for other industrial purposes, the producers, importers or processing users of the relevant products may be eligible as applicants.

Producers, importers or processing users of chemical substances that have been included in the List of Existing Chemicals in China and have implemented environmental management for new uses may be used for industrial purposes other than those permitted.

Article 12 Where an application is made for registration of new chemical environmental management, the applicant shall submit the registration application or filing materials to the competent department of ecological environment under the State Council and shall be responsible for the authenticity, completeness, accuracy and legality of the registration application or filing materials.

The State encourages applicants to share registration data on environmental management of new chemicals.

Article 13 If the applicant believes that the registration application or filing materials submitted by him involve trade secrets and requires information protection, it shall submit it at the time of application for registration or filing, and submit the materials on the necessity of applying for the protection of trade secrets. The competent department of ecological environment under the State Council may not protect trade secrets in accordance with the law for information that may have a significant impact on the environment and the public interest of health. The applicant may withdraw the request for information protection that has been made in writing.

The period of protection of marking information, such as the name of a new chemical substance, shall not exceed five years from the date of first registration or filing.

Staff members and relevant experts engaged in the registration of environmental management of new chemical substances shall not disclose trade secrets which should be protected according to law.

Article 13 If the applicant believes that the registration application or filing materials submitted by him involve trade secrets and requires information protection, it shall submit it at the time of application for registration or filing, and submit the materials on the necessity of applying for the protection of trade secrets. The competent department of ecological environment under the State Council may not protect trade secrets in accordance with the law for information that may have a significant impact on the environment and the public interest of health. The applicant may withdraw the request for information protection that has been made in writing.

The period of protection of marking information, such as the name of a new chemical substance, shall not exceed five years from the date of first registration or filing.

Staff members and relevant experts engaged in the registration of environmental management of new chemical substances shall not disclose trade secrets which should be protected according to law.

Article 14 The domestic testing institutions of the People's Republic of China that provide test data for the registration of new chemical substances for environmental management shall, in accordance with law, obtain the qualification of the inspection and testing institutions and carry out testing work in strict accordance with the relevant standards of chemical substance testing; The testing institution shall be responsible for the authenticity and reliability of the test results it has issued and shall be held responsible in accordance with the law.

The competent department of ecological environment under the State Council shall organize supervision and spot checks on the testing conditions and toxicology testing institutions.

The testing institutions outside the People's Republic of China that produce data on health toxicology or ecotoxicology testing shall comply with the internationally accepted requirements for good laboratory management.

Article 15 Where an application is made for routine registration, the applicant shall submit the following materials:

(1) The application form for regular registration;

(2) The physical and chemical properties of new chemical substances, health toxicology and ecological toxicology characteristics test report or data;

(iii) Environmental risk assessment reports on new chemical substances, including an assessment of the possible environmental risks of new chemicalsubstances to be applied for registration, the proposed environmental risk control measures and their appropriateness analysis, and the assessment of the existence of unreasonable environmental risks;

(4) A commitment letter to implement or transmit environmental risk control measures and environmental management requirements shall be signed by the legal representative of an enterprise or institution or its authorized person and sealed.

The relevant test reports and data as stipulated in ARTICLE 14 shall meet the needs of the environmental risk assessment of new chemical substances, and the ecotoxicology test report shall include test data completed using the test organisms of the People's Republic of China in accordance with the relevant standards.

For those belonging to highly hazardous chemical substances, the applicant shall also submit the social and economic benefits of the new chemical activities, including a description of whether the new chemical substance has a considerable or obvious advantage in the use of chemical substances in terms of performance and environmental friendliness, and fully demonstrate the necessity of the application activity.

In addition to the application materials set out in the preceding three paragraphs of this article, the applicant shall also submit other information on the environmental and health hazards of the new chemical substances he has acquired and other information on environmental and environmental risks.

Article 16 Where an application is made for a simple registration, the applicant shall submit the following materials:

(1) The application form for simple registration;

(ii) The physicochemical properties of new chemicalsubstances, as well as ecotoxicological test reports or data such as persistence, bioaccumulation and aquatic environmental toxicity;

(3) The commitment letter of commitment to implement or transmit environmental risk control measures shall be signed by the legal representative of an enterprise or institution or its authorized person and sealed with a public seal.

The ecological toxicology test report stipulated in ARTICLE 14 shall include the test data completed by the test organisms of the People's Republic of China in accordance with the relevant standards.

In addition to the application materials specified in the preceding paragraph, the applicant shall also submit other information on the environmental and health hazards of the new chemicalsubstances he has acquired and other information on environmental hazards and environmental risks.

Article 17 The same applicant may apply for registration for environmental management of new chemical substances with similar molecular structures, similar uses or similar test data. The number of applications for registration is determined by the sum of the registrations for each substance.

If two or more applicants apply for the same new chemical environmental management registration at the same time, they may jointly submit the application materials for joint registration of the new chemical environmental management. The number of applications for registration is determined on the basis of the sum of the number of applications for registration per applicant.

Article 18 After receiving the application materials for environmental management registration of new chemical substances, the competent department of ecology and environment under the State Council shall deal with them according to the following circumstances:
   (1) If the application materials are complete and conform to the legal form, or the applicant submits all the correction application materials as required, it will be accepted;
   (2) If there are errors in the application materials that can be corrected on the spot, the applicant is allowed to make corrections on the spot;
   (3) If the applied substance does not need to carry out environmental management registration of new chemical substances, or there are other circumstances in the application materials that are not accepted by laws and regulations, it shall make a decision of non-admission on the spot or within five working days;
   (4) If there are situations where the applicant and its agent do not comply with the provisions of these Measures, the application materials are incomplete, and other legal forms are not met, the applicant shall be notified on the spot or within five working days of the entire content that needs to be corrected. If the application is not notified within the time limit, it will be accepted as of the date of receipt of the application materials

Article 19 After accepting the application for routine registration, the competent department of ecological environment under the State Council shall organize an expert committee and the technical institution for the environmental management of chemical substances to conduct a technical evaluation. The technical review should focus on the following:

(1) the name and identification of the new chemical substances;

(2) the quality of the test report or information on new chemical substances;

(3) the environmental and health hazard characteristics of new chemical substances;

(4) Environmental exposure and environmental risks of new chemical substances;

(5) Whether to implement new-use environmental management when included in the List of Existing Chemical Substances in China;

(6) whether environmental risk control measures are appropriate;

(7) The necessity of applying for high-hazard chemical substances;

(8) The necessity of the protection of trade secrets.

The technical review should include the conclusions of the review of the content of the preceding paragraph, as well as the recommendations on whether registration should be granted and recommendations on environmental management requirements.

If the application materials submitted by the applicant are found to be not in accordance with the requirements or are not sufficient to make a comprehensive assessment of the environmental risks of new chemical substances, the competent department of ecological environment under the State Council may request the applicant to provide additional test reports or information.

Article 20 After accepting the application for simple registration, the competent department of ecological environment under the State Council shall organize the technical institution for the environmental management of chemical substances to which it belongs to conduct a technical evaluation. The technical review should focus on the following:

(1) the name and identification of the new chemical substances;

(2) the quality of the test report or information on new chemical substances;

(3) the persistence, bioaccumulation and toxicity of new chemical substances;

(4) The cumulative environmental risks of new chemical substances;

(5) The necessity of the protection of trade secrets.

The technical review opinion sits on the evaluation of the content seamount in the preceding paragraph and the recommendation on whether registration should be granted.

If the application materials submitted by the applicant are found to be not in accordance with the requirements, the competent department of ecological environment under the State Council may request the applicant to provide additional relevant test reports or information.

Article 21 The competent department of ecological environment under the State Council shall examine the technical evaluation opinions of the regular registration and make a decision on the following circumstances:

(1) If unreasonable environmental risks are not found, they shall be registered and a conventional registration certificate for environmental management of new chemical substances shall be issued to the applicant (hereinafter referred to as the regular registration certificate). The issuance of a conventional registration certificate for high-hazard chemical substances shall also meet the requirements of the necessity of the application activities;

(2) If there is an unreasonable environmental risk found, or does not meet the requirements for the necessity of applying for a high-hazard chemical substance, it shall not be registered, and the applicant shall be notified in writing and the reasons shall be explained.

Article 22 The competent department of ecological environment under the State Council shall examine the technical evaluation opinions on simple registration and make a decision on the following circumstances:

(1) If no one has been found to be persistent, bioaccumulative and toxic, and no cumulative environmental risk sourcing is found, and a simple registration certificate for environmental management of new chemical substances is issued to the applicant (hereinafter referred to as a simple registration certificate);

(2) If it does not meet the registration conditions stipulated in the preceding paragraph, it shall not be registered, and the applicant shall be notified in writing and the reasons given.

Article 23 If any of the following circumstances occur, the competent department of ecological environment under the State Council shall not register, notify the applicant in writing and explain the reasons:

(1) using deception such as concealment or providing false materials in the course of registration application;

(2) failing to provide the relevant test reports or information within six months if the relevant test reports or information are not provided in accordance with the requirements of Article 19 (3) or Article 20, paragraph 3, of these Measures;

(3) Other circumstances in which the laws and regulations provide for non-registration.

Article 24 Before making a registration decision, the competent department of ecological environment under the State Council shall make public the names or types of new chemical substances to be registered, the applicant and his agent, the type of activity and the requirements for environmental management for new uses. The period of publicity shall not be less than three working days.

Article 25 After accepting the application for registration of new chemical sisanother environmental management, the competent department of ecological environment under the State Council shall initiate the technical evaluation work in a timely manner. The technical review time of the regular registration shall not exceed 60 days, and the technical evaluation time of the simple registration shall not exceed 30 days. Where the competent department of ecological environment under the State Council notifies the supplementary provision of relevant test reports or materials, the time required for the applicant to supplement the relevant materials shall not be included in the time limit for technical evaluation.

The competent department of ecological environment under the State Council shall, within twenty working days from the date of acceptance of the application, make a decision on whether to register it. If a decision cannot be made within twenty working days, it may be extended by ten working days with the approval of the person in charge of the ecological environment department under the State Council, and the applicant shall be informed of the reasons for the extension.

The time for technical evaluation shall not be included in the time limit for approval as specified in the second paragraph of this article.

Article 26 The registration certificate shall specify the following items:
   (1) Type of registration certificate;
   (2) The name of the applicant and its agent;
   (3) Identification information such as Chinese and English names or class names of new chemical substances;
   (4) Application purpose;
   (5) Number of applications for registration;
   (6) Types of activities;
   (VII) Environmental risk control measures.
   For high-hazard chemical substances and new chemical substances with persistence and bioaccumulation, or with persistence and toxicity, or with bioaccumulation and toxicity, the regular registration certificate should also specify one or more of the following environmental management requirements:
   (1) Limit the discharge amount or concentration of new chemical substances;
   (2) Requirements for implementing new-use environmental management when listed in the "Inventory of Existing Chemical Substances in China";
   (3) Submit annual report;
   (4) Other environmental management requirements.
   Article 27 After the application for registration of environmental management of new chemical substances is accepted, the applicant may withdraw the registration application according to law before the decision of the competent department of ecology and environment under the State Council.
Article 28 After the competent department of ecology and environment under the State Council makes a decision on the environmental management registration of new chemical substances, it shall disclose the environmental management registration of new chemical substances within 20 working days, including the name or class name of the registered new chemical substance, and the applicant Information about its agents, types of activities, and environmental management requirements for new uses.

Article 29 Before a new chemical substance that has obtained a regular registration certificate is listed in the "Inventory of Existing Chemical Substances in China" in accordance with Article 44 of these Measures, the holder of the registration certificate shall have one of the following circumstances Should apply for registration again:
   (1) The quantity of production or import intends to exceed the amount applied for registration;
   (2) The type of activity to be converted from import to production;
   (3) To change the application purpose of the chemical substance;
   (4) Plan to change environmental risk control measures;
   (5) Other circumstances that lead to increased environmental risks.
When re-applying for registration, the applicant shall submit re-registration application materials, explain the reasons for the change of relevant matters, re-compile and submit an environmental risk assessment report, and focus on explaining the environmental risk control measures to be taken after the change and their appropriateness, and whether they exist Unreasonable environmental risks.
Article 30 Before new chemical substances that have obtained regular registration certificates are included in the "Inventory of Existing Chemical Substances in China" in accordance with the provisions of Article 44 of these Measures, except for the circumstances specified in Article 29 of these Measures, If any other information stated in the registration certificate changes, the holder of the registration certificate shall apply for the change of the registration certificate.
   For new chemical substances that have obtained a simple registration certificate, if the information stated in the registration certificate changes, the holder of the registration certificate shall apply for the change of the registration certificate.
  Applying for the change of the registration certificate, the applicant shall submit the reason for the change and relevant certification materials. Among them, if it is proposed to update the Chinese and English names of chemical substances or the CAS number (CAS) and other identification information, the certification materials should fully demonstrate that the chemical substances before and after the change belong to the same chemical substance.
  The State Council department in charge of ecology and environment accepts and organizes technical reviews with reference to the simple registration procedure and time limit, and makes a decision to change the registration certificate. Among them, for the proposed updating of Chinese and English names of chemical substances or chemical abstract service number (CAS) and other identification information, the competent department of ecology and environment of the State Council may organize an expert committee to conduct a technical review; for those who cannot determine whether the chemical substances belong to the same chemical substance before and after the change , The change will not be approved.
   Article 31 The following chemical substances listed in the "Inventory of Existing Chemical Substances in China" in accordance with Article 44 of these Measures shall be subject to new-use environmental management:
   (1) Highly hazardous chemical substances;
   (2) Chemical substances with persistence and bioaccumulation, or with persistence and toxicity, or with bioaccumulation and toxicity.
If the holder of the registration certificate changes the use of a high-hazard chemical substance, or if someone other than the holder of the registration certificate uses it for industrial purposes, it shall report to the competent department of ecology and environment under the State Council before production, import or processing. Apply for new environmental management registration.
For the chemical substances listed in Paragraph 2 of Paragraph 1 of this Article, if they are intended to be used for industrial purposes other than the permitted uses stipulated in Article 44 of these Measures, they shall apply to the competent department of ecology and environment of the State Council before production, import or processing. Go through the registration of environmental management for new purposes.

  Article 31 The following chemical substances listed in the "Inventory of Existing Chemical Substances in China" in accordance with Article 44 of these Measures shall be subject to new-use environmental management:
   (1) Highly hazardous chemical substances;
   (2) Chemical substances with persistence and bioaccumulation, or with persistence and toxicity, or with bioaccumulation and toxicity.
If the holder of the registration certificate changes the use of a high-hazard chemical substance, or if someone other than the holder of the registration certificate uses it for industrial purposes, it shall report to the competent department of ecology and environment under the State Council before production, import or processing. Apply for new environmental management registration.
For the chemical substances listed in Paragraph 2 of Paragraph 1 of this Article, if they are intended to be used for industrial purposes other than the permitted uses stipulated in Article 44 of these Measures, they shall apply to the competent department of ecology and environment of the State Council before production, import or processing. Go through the registration of environmental management for new purposes.
   Article 32 For an application for new-use environmental management registration, the applicant shall submit a new-use environmental management registration application form and the environmental exposure assessment report and environmental risk control measures of the chemical substance for new use and other materials. For high-hazard chemical substances, socio-economic benefit analysis materials should also be submitted to fully demonstrate the necessity of the substance for the application for registration.
  After receiving the application materials, the department in charge of ecology and environment under the State Council accepts and organizes the technical review in accordance with the normal registration procedures, processes them according to the following circumstances, and notifies the applicant in writing:
   (1) If no unreasonable environmental risks are found, they shall be registered. For high-hazard chemical substances, it should also meet the requirements for the necessity of the application;
   (2) If there is an unreasonable environmental risk or does not meet the requirements for the use of high-hazard chemical substances, the application shall not be registered.
After making an environmental management registration decision for a new purpose, the competent department of ecology and environment under the State Council shall, within 20 working days, disclose the name of the applicant and its agent, the name or class name of the chemical substance involved, the new use registered, and the corresponding Environmental risk control measures and environmental management requirements. Among them, those that do not belong to high-hazardous chemical substances will be added to the "Chinese Inventory of Existing Chemical Substances" for which new permitted uses have been registered; those that belong to high-hazardous chemical substances will be listed in the "Chinese Existing Chemical Substances List 》The scope of the new-use environmental management remains unchanged.

 Article 33 After obtaining the registration certificate, the applicant may apply to the State Council department in charge of ecology and environment to cancel the registration certificate.
  Article 34 In one of the following situations, for the sake of public interest, the State Council department in charge of ecology and environment may change or withdraw the registration certificate in accordance with the relevant provisions of the Administrative License Law of the People’s Republic of China:
   (1) It needs to be changed or withdrawn in accordance with Article 42 of these Measures;
   (2) The content of environmental management registration of new chemical substances does not comply with the national industrial policy;
   (3) Changes in relevant laws, administrative regulations or mandatory standards;
   (4) The content of environmental management registration of new chemical substances conflicts with the requirements of international treaties concluded or participated in by the People's Republic of China;
   (5) Other circumstances that should be changed or withdrawn as required by laws and regulations.
  Article 35 In one of the following circumstances, the competent department of ecology and environment under the State Council may revoke the registration certificate in accordance with the relevant provisions of the Administrative License Law of the People’s Republic of China:
   (1) The applicant or its agent obtains the registration certificate by fraud, bribery or other improper means;
   (2) A staff member of the State Council department in charge of ecology and environment abuses his power, neglects his duties, or violates the legal procedures to issue a registration certificate;
   (3) Other circumstances that should be revoked as required by laws and regulations.

Article 36 For handling the environmental management filing of new chemical substances, the filing form and supporting materials that meet the corresponding circumstances specified in Article 10, paragraph 3 of these Measures shall be submitted, and the environmental and health status of the new chemical substances already in its possession shall be submitted together.

Article 37 After receiving the filing materials for the environmental management of new chemical substances, the competent department of ecological environment under the State Council shall file the complete and complete filing materials and send a receipt for the record. After the applicant submits the filing materials, he or she may carry out the activities related to the new chemical substances in accordance with the contents of the filing.

When the filing of new chemical sisphons or related information changes, the applicant shall promptly change the filing information.

The competent department of ecological environment under the State Council shall regularly publish the record of environmental management of new chemical substances.

Article 38 Producers, importers and processing users of new chemical substances shall convey the following information to downstream users:

(1) the registration certificate number or the record receipt number;

(2) The application for use of new chemical substances;

(3) the environmental and health hazard characteristics of new chemical substances and environmental risk control measures;

(4) Environmental management requirements for new chemical substances.

Users of new chemicals may request the supplier to provide information about the new chemicalsubstances specified in the preceding paragraph.

Article 39 Researchers, producers, importers and processing users of new chemical substances shall establish a system for recording the activities of new chemical substances, truthfully record the time, quantity and use of the activities of new chemical substances, and implement environmental risk control measures and environmental management requirements.

Relevant information such as routine and simple registration materials and records of the activities of new chemical substances shall be kept for at least 10 years. Relevant materials such as filing materials and records of the activities of new chemical substances shall be kept for at least three years.

Article 40 Producers and processing users of the regular registration of new chemical substances shall implement environmental risk control measures and environmental management requirements and disclose the implementation of environmental risk control measures and environmental management requirements through their official websites or other means that are easily known to the public.

Article 41 The holder of the registration certificate shall report the first activity of the new chemical substance to the competent department of ecological environment under the State Council within 60 days from the date of the first production or within 60 days from the date of the first import and transfer to the processed user.

If the environmental management requirements as set out in the regular registration certificate stipulate that the requirements for the submission of annual reports, the holder of the registration certificate shall, from the following year of registration, report to the competent department of ecological environment under the State Council on the actual production or import of new chemical substances approved for the previous year, the discharge to the environment, and the implementation of environmental risk control measures and environmental management requirements by April 30 of each year.

Article 42 If researchers, producers, importers and processing users of new chemical substances discover that new chemical substances have new environmental or health hazard characteristics or environmental risks, they shall promptly report them to the competent department of ecological environment under the State Council; if they may lead to an increase in environmental risks, they shall take timely measures to eliminate or reduce environmental risks.

The competent department of ecological environment under the State Council may request relevant researchers, producers, importers and processing users to further submit relevant environmental or health hazard and environmental exposure data information on new chemical substances that may continue to increase in environmental risks, in accordance with the national registration of new chemical sisphons, actual production or import, discharge to the environment, and newly discovered environmental or health hazard characteristics.

After receiving the relevant information, the competent department of ecological environment under the State Council shall organize the technical institution situated in the environmental management of chemical substances and the expert committee to conduct technical evaluation;

Article 43 The competent department of ecological environment under the State Council shall inform the competent department of ecological environment at the provincial level of the registration of environmental management of new chemical substances, environmental risk control measures and environmental management requirements, first activities and annual reports; the competent department of ecological environment at the provincial level shall inform the municipal ecological environment department in the district.

The competent department of ecological environment at or above the municipal level of the district shall conduct a supervision and spot check on whether the producers, importers and processing users of new chemical substances shall, as required, handle the registration of the environmental management of new chemical substances, the authenticity of the registration matters, the matters specified in the registration certificate and the implementation of other relevant provisions of these Measures.

Researchers, producers, importers and processing users of new chemical substances shall truthfully provide relevant information and be subject to supervision and spot checks by the competent ecological environment department.

  Article 44 If a new chemical substance that has obtained a regular registration certificate has reached five years from the date of its first registration, the State Council department in charge of ecology and environment shall include it in the "Inventory of Existing Chemical Substances in China" and make an announcement.
   For new chemical substances that are persistent and bioaccumulative, or persistent and toxic, or bioaccumulative and toxic, when they are listed in the "Inventory of Existing Chemical Substances in China", their permitted uses should be indicated.
For high-hazard chemical substances and new chemical substances with persistence and bioaccumulation, or persistence and toxicity, or bioaccumulation and toxicity, when listed in the "Inventory of Existing Chemical Substances in China", it shall be stipulated that in addition to the annual report Environmental management requirements.
   The provisions of the first three paragraphs of this article apply to the routine registration of new chemical substances that apply for cancellation in accordance with Article 33 of these Measures.
   New chemical substances for simple registration and filing, as well as routinely registered new chemical substances that are withdrawn or withdrawn in accordance with Articles 34 and 35 of these Measures, are not included in the "Inventory of Existing Chemical Substances in China".
Article 45. New chemical substances that have obtained regular declaration registration certificates in accordance with the "Administrative Measures on Environmental Protection of New Chemical Substances" (Ministry of Environmental Protection Order No. 7), if they have not been listed in the "Inventory of Existing Chemical Substances in China", they shall be included in the "Inventory of Existing Chemical Substances in China" Five years from the date of the first production or import activity or five years from the date of implementation of these Measures.
According to the "Administrative Measures on New Chemical Substances" (Decree No. 17 of the State Environmental Protection Administration), new chemical substances that have been registered for environmental management and have not been listed in the "Inventory of Existing Chemical Substances in China" shall be subject to these Measures Within six months from the date of implementation, be included in the "Inventory of Existing Chemical Substances in China".
   If these measures have been included in the "Inventory of Existing Chemical Substances in China" and the protection of identification information such as substance names is implemented before the effective date of this method, the protection period of the identification information shall be up to December 31, 2025.

Article 46 Anyone who, in violation of the provisions of these Measures, obtains the registration of environmental management of new chemical substances by improper means such as deception or bribery shall be ordered by the competent department of ecological environment under the State Council to make corrections, impose a fine of 10,000 yuan to 30,000 yuan or less, and carry out joint punishment for breach of trust in accordance with the law, and shall no longer accept its application for the registration of new chemical environmental management within three years.

Article 47 If any of the following acts are violated by these Measures, the competent department of ecological environment under the State Council shall order the correction and impose a fine of not more than 10,000 yuan; if the circumstances are serious, joint disciplinary action for breach of trust shall be carried out in accordance with the law, and the application for registration of environmental management of new chemical substances shall not be accepted within one year:

(1) failing to report the first activity of new chemical substances as required or being allowed to register the actual production or import of new chemical substances in the previous year, as well as the implementation of environmental risk control measures and environmental management requirements;

(2) failing to report new environmental or health hazard characteristics or environmental risk information of new chemical substances as required, or failing to take measures to eliminate or reduce environmental risks, or failing to submit information on environmental or health hazards or environmental exposure data.

Article 48 If any of the following acts are committed in violation of the provisions of these Measures, the competent department of local ecological environment at or above the municipal level of the district shall order the correction and impose a fine of not less than 10,000 yuan and 30,000 yuan; if the circumstances are serious, joint disciplinary action for breach of trust shall be carried out in accordance with the law, and the application for registration of environmental management of new chemical substances shall not be accepted within one year:

(1) producing or importing new chemical substances without a registration certificate, or processing and using new chemical substances without a registration certificate;

(2) failing to re-register the production or import of new chemical substances in accordance with the provisions;

(3) The chemical substances that have not been approved after the registration of environmental management for new uses by the competent department of ecological environment under the State Council shall be used for industrial purposes other than those permitted.

Article 49 If any of the following acts are committed in violation of the provisions of these Measures, the competent department of local ecological environment at or above the municipal level of the district shall order it to make corrections within a time limit and impose a fine of not less than 10,000 yuan and not more than 30,000 yuan; if the circumstances are serious, joint disciplinary measures for breach of trust shall be carried out in accordance with the law, and the application for registration of environmental management of new chemical substances shall not be accepted within one year:

(1) failing to file a record, or producing or importing new chemical substances in accordance with the information for the record, or processing and using new chemical substances that have not been filed;

(2) failing to produce, import or process the use of new chemical substances in accordance with the provisions of the registration certificate;

(3) failing to register changes, or producing or importing new chemical substances in accordance with the changes;

(4) failing to implement the relevant environmental risk control measures or environmental management requirements, or failing to disclose the relevant information in accordance with the provisions;

(5) failing to transmit the required information to the downstream users, or refusing to provide relevant information on the new chemical substances;

(6) failing to establish a system for recording the activities of new chemical substances, or failing to record the activities of new chemical substances or keeping relevant information;

(7) Failure to implement the environmental management requirements set out in the List of Existing Chemical Substances in China.

Article 50 If a member of the Expert Committee cheats in the registration and evaluation of the new chemical environmental management, or has other acts of dereliction of duty, resulting in serious infact of the evaluation results, the competent department of ecological environment under the State Council shall cancel its membership of the expert committee and make it public to the public.

Article 51 If a testing institution that provides test data for a new chemical substance application issues a false report, the competent department of ecological environment under the State Council shall impose a fine of 10,000 yuan or less on the testing institution, a fine of 10,000 yuan to 30,000 yuan or less for the person in charge and other persons directly responsible for the testing institution, and shall carry out joint disciplinary punishment for breach of trust in accordance with the law, and shall not accept the test report issued by the testing institution or the relevant responsible person to participate in the test report within three years.

Chapter VI Supplementary Provisions
   Article 52 The meaning of the following terms in these measures:
(1) Environmental risk refers to the degree and probability of harmful effects on the environment and health after chemical substances with environmental or health hazard properties enter or may enter the environment during production, processing, use, disposal. Risks caused by emergencies such as production safety accidents and transportation accidents.
(2) High-hazard chemical substances refer to chemical substances that are both persistent, bioaccumulative, and toxic, as well as chemical substances that are both highly persistent and bioaccumulative, or other chemical substances with equivalent environmental or health hazards. .
   (3) Processing and use of new chemical substances refers to the use of new chemical substances for production and operation activities such as packaging, preparation, or manufacturing. It does not include trading, warehousing, transportation and other business activities and the use of articles containing new chemical substances.
Article 53 The environment for new chemical substances has been handled in accordance with the provisions of the “Administrative Measures for New Chemical Substances” (Order No. 7 of the Ministry of Environmental Protection) and the “Administrative Measures for New Chemical Substances (Order No. 17 of the State Environmental Protection Administration) For management registration, the relevant registration will continue to be effective after the implementation of these measures.
   Article 54 The Measures shall be interpreted by the competent department of ecology and environment under the State Council.
   Article 55 These Measures shall come into force on January 1, 2021, and the "Administrative Measures on New Chemical Substances" issued by the former Ministry of Environmental Protection (Ministry of Environmental Protection Order No. 7) shall be repealed at the same time.

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