Environmental Management Measures for New Chemical Substances

Chapter I General Provisions
Chapter II Declaration Procedures
Chapter III Registration Administration
Chapter IV Tracking Control
Chapter V Legal Liability
Chapter VI Supplementary Provisions

Chapter I General Provisions

Article 1 [legislative purpose] in order to control the environmental risks of new chemical substances, protect human health and protect the ecological environment, these measures are formulated in accordance with the decision of the State Council on the establishment of administrative license for the administrative examination and approval items that really need to be retained and other relevant laws and administrative regulations.
Article 2 [Scope of Application] These Measures shall apply to the environmental management of the research, production, import, processing and use of new chemical substances within the territory of the the People's Republic of China Customs. These Measures shall also apply to the environmental management of activities related to new chemical substances in bonded areas and export processing areas.
The administration of pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, feed additives, etc. shall be governed by relevant laws and regulations; however, the environmental administration of activities related to new chemical substances as raw materials and intermediates of the above-mentioned products shall be governed by these Measures.
Articles that are designed to intentionally release new chemical substances when regular use shall be managed in accordance with these Measures.
Article 3 [Classification] According to the identification and classification standards of chemical hazard characteristics, new chemical substances are divided into general new chemical substances and dangerous new chemical substances.
The chemical substances with persistent, bioaccumulation, ecological environment and human health hazard characteristics in the hazardous new chemical substances are listed as the key environmental management hazardous new chemical substances.
The term "new chemical substances" as mentioned in these Measures refers to the chemical substances not listed in the List of Existing Chemical Substances in China.
The List of Existing Chemical Substances in China shall be formulated, adjusted and published by the Ministry of Environmental Protection.
Article 4 [Basic System] The State implements risk classification management of new chemical substances and implements a declaration, registration and follow-up control system.
Article 5 [Registration Certificate] Producers or importers of new chemical substances must declare before production or import and obtain a registration certificate for environmental management of new chemical substances (hereinafter referred to as "registration certificate").
New chemical substances that have not obtained a registration certificate are prohibited from production, import, processing and use.
New chemical substances that have not obtained a registration certificate or have not been filed for declaration shall not be used for scientific research.
Article 6 [Encouraging advanced technologies] The State supports scientific research on environmental risk and health risk assessment and control technologies for new chemical substances, promotes advanced and applicable environmental risk control technologies for new chemical substances, encourages the research, production, import, processing and use of environment-friendly alternative chemical substances, and encourages applicants to share the registration data of new chemical substances.
Article 7 [Keeping secrets] The staff engaged in the environmental management of new chemical substances shall keep trade secrets and technical secrets for the applicant.
Article 8 [Public Supervision] All units and individuals have the right to expose, report and accuse violations of the provisions of these Measures.

Chapter II Declaration Procedures

Article 9 The declaration of new chemical substances is divided into regular declaration, simple declaration and scientific research filing declaration.
Article 10 [regular declaration requirements] If the annual production or import volume of new chemical substances is more than 1 ton, the new chemical substance declaration report shall be submitted to the Chemical Registration Center of the Ministry of Environmental Protection (hereinafter referred to as the "Registration Center") before production or import, and the regular declaration shall be handled; however, if the conditions for simple declaration are met, the simple declaration may be handled.
A new chemical substance declaration report shall include the following contents:
(I) a new chemical substance regular declaration form, with classification, labeling and chemical safety technical instructions in accordance with relevant national standards such as chemical classification, warning labels and warning instructions;
(II) risk assessment report, including the hazard assessment, exposure prediction assessment and risk control measures of the declared substance, as well as the conclusion of environmental risk and health risk assessment;
Test reports or data (III) physical and chemical properties, toxicological and ecotoxicological characteristics, as well as qualification certificates of relevant testing institutions. The ecotoxicological characterization test report must include test data completed in China with Chinese test organisms in accordance with the relevant standards.
Article 11 [regular Declaration Quantity Level] regular declaration follows the principle of "the higher the declaration quantity level, the higher the test data requirements. The applicant shall provide corresponding test data or information in accordance with the guidelines for the registration of new chemical substances formulated by the Ministry of Environmental Protection.
According to the number of new chemical substances declared, the regular declaration is divided into the following four levels from low to high:
The first level of (I) is the annual production or import volume of more than 1 ton but less than 10 tons;
(II) Class II is the annual production or import volume of more than 10 tons but less than 100 tons;
(III) three for the annual production or import of more than 100 tons less than 1000 tons;
(IV) four for the annual production or import volume of more than 1000 tons.
Article 12 [Basic Situation of Simple Declaration] If the annual production or import volume of new chemical substances is less than 1 ton, a simple declaration shall be made to the registration center before production or import.
To handle the summary declaration, the following materials shall be submitted:
Summary Declaration Form for (I) of New Chemical Substances;
Report of (II) ecotoxicological characterization tests performed in China with Chinese test organisms.
Article 13 [Simplified Declaration of Special Circumstances] Where a new chemical substance produced or imported has one of the following special circumstances, a simplified declaration shall be made:
(I) used as intermediates or for export only, with an annual production or import volume of less than 1 ton;
(II) for the purpose of scientific research, the annual production or import volume of more than 0.1 tons but less than 1 ton;
(III) new chemical monomer content of less than 2% of the polymer or is a low concern polymer;
(IV) for the purpose of process and product research and development, the annual production or import volume is less than 10 tons, and does not exceed two years.
For simple declaration under special circumstances, a simple declaration form for new chemical substances and supporting materials conforming to the corresponding circumstances shall be submitted.
Article 14 [requirements for filing and declaration] under any of the following circumstances, a new chemical substance scientific research filing form shall be submitted to the registration center before production or import, and the scientific research filing declaration shall be handled:
(I) for the purpose of scientific research, the annual production or import of new chemical substances is less than 0.1 tons;
(II) the import of test samples of new chemical substances for the purpose of conducting ecotoxicological characterization tests of new chemical substances with Chinese test organisms in China.
Article 15 [Series declaration, joint declaration and repeated declaration] for regular declaration, under any of the following circumstances, the declaration procedures may be handled in accordance with the following provisions:
(I) the same declarant may submit a series declaration of new chemical substances for multiple new chemical substances with similar molecular structures, the same or similar uses, and similar test data;
(II) two or more declarants declare the same new chemical substance at the same time and jointly submit the declaration materials, they may submit a joint declaration of the new chemical substance;
(III) two or more declarants declare the same new chemical substance successively, and the later declarant obtains the consent of the former declarant and uses the test data of the former declarant, the new chemical substance may be repeatedly declared. The method of sharing the cost of testing the data shall be agreed upon by the declarant.
Article 16 A declarant of a new chemical substance or its agent shall be a registered institution in China.
For those who do not declare new chemical substances for the first time, there shall be no bad record of administrative punishment for violating the environmental management regulations of new chemical substances in the past three years.
Article 17 When going through the formalities for the declaration of a new chemical substance, the applicant shall truthfully submit all known information on the hazardous characteristics and environmental risks of the new chemical substance.
Article 18 [Disclosure of Environmental Information] If a declarant requires confidentiality of trade secrets or technical secrets in the submitted declaration materials, it shall be indicated in the declaration materials.
Information that endangers human health and environmental safety shall not be required to be kept confidential.
The applicant shall inform the registration center in writing of the contents required to be kept confidential.
Article 19 [Testing Institutions] Domestic testing institutions that provide test data for the purpose of declaration of new chemical substances shall be chemical substance testing institutions announced by the Ministry of Environmental Protection and shall be subject to the supervision and inspection of the Ministry of Environmental Protection.
Domestic testing institutions shall comply with the guidelines for qualified laboratories for chemical testing issued by the Ministry of Environmental Protection, and carry out ecotoxicological property tests for new chemical substances in accordance with the guidelines for chemical testing or relevant national standards for chemical testing.
Overseas testing institutions that complete the ecotoxicological property tests of new chemical substances abroad and provide test data must pass the inspection of the competent authorities of the country where they are located or meet the qualified laboratory specifications.

Chapter III Registration Administration

Article 20 [regular Declaration and Registration Procedures] The regular declaration and registration of new chemical substances shall be carried out in accordance with the following procedures:
After the (I) registration center accepts the regular declaration, it shall submit the new chemical substance declaration report to the Chemical Substance Environmental Management Expert Review Committee of the Ministry of Environmental Protection (hereinafter referred to as the "Review Committee"). The review committee is composed of experts in chemistry, chemical engineering, health, safety, and environmental protection.
The (II) review committee shall, in accordance with the guidelines and specifications for hazard and risk assessment of new chemical substances issued by the Ministry of Environmental Protection, as well as relevant national standards for the identification and classification of chemical hazards, conduct identification and technical review of the following contents of new chemical substances:
1. Name and identification;
2. Physical chemistry, human health, environmental and other aspects of the hazard characteristics;
Exposure levels and risks to human health and the environment;
4. Appropriateness of human health and environmental risk control measures.
If the review committee considers that the existing application materials are not sufficient to make a comprehensive evaluation conclusion on the risk of new chemical substances, the registration center shall notify the applicant in writing to supplement the application materials.
The (III) review committee shall put forward technical review opinions on the registration of new chemical substances and submit them to the Ministry of Environmental Protection. Technical review comments on registration of new chemical substances include:
1. The new chemical substances are identified as general, hazardous and whether they belong to the management category of new chemical substances in the key environmental management hazardous category;
2. Review opinions on human health and environmental risks;
3. The evaluation conclusion of the appropriateness of risk control measures;
4. Recommendations on whether to grant registration.
The Ministry of (IV) Environmental Protection shall review the technical review opinions on the registration of new chemical substances, determine the management category of new chemical substances, and make a decision according to different circumstances:
1. If there are appropriate risk control measures, register and issue a registration certificate;
2. If there is no appropriate risk control measures, it shall not be registered, and the applicant shall be notified in writing and the reasons shall be explained.
The Ministry of Environmental Protection shall publicize the contents of the registration of new chemical substances before making a registration decision.
Article 21 [Simple Declaration and Registration Procedures] The simple declaration and registration of new chemical substances shall be carried out in accordance with the following procedures:
After accepting the simplified declaration, the (I) registration center shall put forward written handling opinions and submit them to the Ministry of Environmental Protection.
If the ecotoxicological characteristics test report is submitted as required, the review committee shall conduct a technical review of the application materials, and put forward technical review opinions and submit them to the Ministry of Environmental Protection.
The Ministry of Environmental Protection of the (II) shall register those that meet the requirements and issue a registration certificate; if they do not meet the requirements, they shall not register, notify the applicant in writing and explain the reasons.
Article 22 [Procedures for Filing, Declaration and Registration] The filing of scientific research on new chemical substances shall be carried out in accordance with the following procedures:
The (I) registration center shall submit a monthly summary to the Ministry of Environmental Protection after receiving the scientific research filing declaration;
The Ministry of Environmental Protection of (II) regularly announces it on the government website.
Article 23 [Registration Announcement] The Ministry of Environmental Protection shall announce on the government website the name of the new chemical substance to be registered, the declarant, the type of declaration and the management category of the new chemical substance to be registered.
Article 24 [time limit for processing] the registration center shall, within 5 working days from the date of accepting the regular declaration, submit the declaration report of the new chemical substance to the evaluation committee; within 5 working days from the date of accepting the simple declaration, submit the written handling opinions to the Ministry of environmental protection.
The expert review time for regular declaration and registration shall not exceed 60 days, and the expert review time for simple declaration and registration shall not exceed 30 days. If the registration center notifies the supplementary declaration materials, the time required for the applicant to supplement the declaration materials shall not be included in the expert review time.
The Ministry of Environmental Protection shall make a decision on whether to register a new chemical substance within 15 working days from the date of receipt of the registration document submitted by the registration center or the review committee. If a decision cannot be made within 15 working days, it may be extended by 10 working days with the approval of the person in charge of the Ministry of Environmental Protection.
Article 25 [Contents of Registration Certificate] The registration certificate shall state the following main items:
Name of (I) declarant or agent;
(II) the name of the new chemical;
(III) purpose of registration;
(IV) registration level and quantity;
(V) management categories for new chemical substances.
The registration certificate declared by the regular shall also specify the risk control measures and administrative requirements.
Article 26 [Report and Treatment of New Characteristics] When the holder of a registration certificate discovers that a new chemical substance approved for registration has new hazardous characteristics, he shall immediately submit new information on the hazardous characteristics of the chemical substance to the registration center.
The registration center shall submit new information on the hazardous characteristics of new chemical substances approved for registration to the review committee for technical review.
The Ministry of Environmental Protection shall take the following measures according to the technical review opinions of the review committee:
If the risk can be controlled by adding risk control measures, the (I) shall add relevant risk control measures to the registration certificate and require the holder of the registration certificate to implement the corresponding new risk control measures;
If the (II) does not have appropriate measures to control its risk, it shall withdraw the registration certificate of the new chemical substance and make a public announcement.
Article 27 [Re-declaration] If a new chemical substance that has not been included in the "List of Existing Chemical Substances in China" and has been approved for registration has one of the following circumstances, the holder of the registration certificate shall re-declare it in accordance with the procedures specified in these Measures:
(I) increase the registration level;
(II) change the registered use of new chemical substances in the hazardous category of key environmental management.
New chemical substances that have been included in the "List of Existing Chemical Substances in China" and have been approved for registration of key environmental management hazardous substances can also be re-declared by the processing users of the registered new chemical substances.
Article 28 [Information Sharing] The Ministry of Environmental Protection shall notify the relevant administrative departments of the relevant information on new chemical substances that have been approved to be registered as hazardous (including new chemical substances in key environmental management hazardous categories).

Chapter IV Tracking Control

Article 29 [Pre-conditions for EIA Approval] The environmental protection department shall register new chemical substances as a condition for approving the environmental impact assessment documents for construction projects that produce or process new chemical substances.
Article 30 [Information transmission] The holder of the registration certificate declared by the regular shall specify the hazardous characteristics of the new chemical substance in the chemical safety technical specification, and transmit the following information to the processing user:
Risk control measures specified in the (I) registration certificate;
Safety technical specification of (II) chemicals;
(III) the classification results according to the chemical classification, warning labels and warning instructions safety regulations;
(IV) other relevant information.
Article 31 [General risk control measures] The holder of the registration certificate declared by the regular and the corresponding processing user shall, in accordance with the provisions of the registration certificate, take one or more of the following risk control measures:
(I) education on risk and protection of new chemical substances;
(II) strengthen personal protection for persons exposed to new chemical substances;
Safety protection such as sealing and isolation shall be set (III), and warning signs shall be arranged;
(IV) improvements in the production and use of new chemicals to reduce releases and environmental exposure;
(V) improvement of pollution prevention and control processes to reduce environmental emissions;
(VI) formulate emergency plans and emergency handling measures;
Other risk control measures are (VII).
Holders of registration certificates for hazardous new chemical substances (including hazardous new chemical substances under key environmental management) and processing users shall abide by the relevant provisions of existing laws and administrative regulations such as the Regulations on the Safety Management of Hazardous Chemicals.
Article 32 [Key risk control measures] Holders of registration certificates and processing users of key environmental management hazardous new chemical substances shall also take the following risk control measures:
During the production or processing of (I), the discharge of new chemical substances of the key environmental management hazards into the environmental medium shall be monitored or estimated. If they do not have the ability to monitor, they may entrust monitoring institutions or social testing institutions affiliated to environmental protection departments recognized by environmental protection departments at or above the prefecture level to carry out monitoring.
When (II) are transferred, they shall be equipped with corresponding equipment in accordance with relevant regulations, and appropriate measures shall be taken to prevent new chemical substances of key environmental management hazards from entering the environment in the event of an emergency, and prompt the emergency handling methods in the event of an emergency.
After the disposal of hazardous new chemical substances under key environmental management, the (III) shall dispose of them in accordance with the relevant hazardous waste disposal regulations.
Article 33 [Prohibition of Transfer] Holders of registration certificates declared by regular shall not transfer new chemical substances approved for registration to processing users who are unable to take risk control measures.
Article 34 [R & D management requirements] The scientific research activities of new chemical substances and the research and development activities of processes and products shall be carried out in special facilities and under the guidance of professionals in strict accordance with relevant management regulations.
New chemical substances produced or imported for the purpose of scientific research or research and development of processes and products shall be properly preserved and shall not be used for other purposes. If it needs to be destroyed, it shall be disposed of in accordance with the relevant regulations on hazardous waste.
Article 35 [Activity Report] The holder of the registration certificate declared by the regular shall, within 30 days of the first production activity, or within 30 days of the first import and transfer to the processing user, submit the first activity report form of the new chemical substance to the registration center.
The holder of the registration certificate of the new chemical substance of the key environmental management hazardous category shall also report the flow direction information of the new chemical substance to the registration center within 30 days from the date of each transfer of the new chemical substance of the key environmental management hazardous category to different processing users.
Article 36 [Annual Report] The holder of the registration certificate for summary declaration shall report to the registration center the actual production or import of new chemical substances approved for registration in the previous year before February 1 of each year.
The holder of the registration certificate of hazardous new chemical substances (including key environmental management hazardous new chemical substances) shall report to the registration center the following information about the new chemical substances approved for registration in the previous year before February 1 of each year:
actual production or import of (I);
Implementation of (II) risk control measures;
Exposure and release in (III) environment;
(IV) the actual impact on the environment and human health;
(V) other information related to environmental risks.
The holder of the registration certificate of the new chemical substances in the key environmental management hazardous category shall also report to the registration center the production or import plan of the new chemical substances registered this year, as well as the preparation for the implementation of risk control measures.
Article 37 [Data Preservation] The holder of the registration certificate shall save the declaration materials of the new chemical substance and the actual situation of the production and import activities for more than ten years.
Article 38 [Supervision Notice] The Ministry of Environmental Protection shall, within 30 days after receiving the report form on the first activity of new chemical substances or the information on the flow direction of new chemical substances submitted by the registration center, send a new chemical substance supervision notice to the provincial environmental protection department where the producers and processing users of hazardous new chemical substances (including key environmental management hazardous new chemical substances) are located.
The provincial environmental protection department is responsible for sending the supervision notice to the municipal or county-level environmental protection department where the chemical substance producer or processing user is located.
The contents of the regulatory notice include: the name of the new chemical substance, the management category, the risk control measures and administrative management requirements as stated in the registration certificate, and the main points of supervision and inspection.
Article 39 [Supervision and Inspection] The local environmental protection department responsible for supervision and management shall, in accordance with the requirements of the new chemical substance supervision notice and in accordance with the new chemical substance supervision and management inspection specifications formulated by the Ministry of Environmental Protection, supervise and inspect the production, processing and use of new chemical substances.
If it is found that the production or processing of new chemical substances causes or is likely to cause immediate or cumulative environmental pollution hazards, the producers and processing users shall be ordered to take immediate measures to eliminate the hazards or dangers, and the relevant situation shall be reported to the Ministry of environmental protection step by step.
The Ministry of Environmental Protection may, according to the report, require the holder of the registration certificate to provide information on the new hazard characteristics that may exist in the new chemical substance approved for registration, and deal with it in accordance with the provisions of these Measures on the report and handling of the new hazard characteristics of the new chemical substance.
Article 40 [Cancellation of Registration] If the holder of the registration certificate fails to carry out production or import activities or stops production or import activities, he may submit an application for cancellation to the registration center, explain the situation, and return the registration certificate.
If the Ministry of Environmental Protection confirms that there is no production or import activity or no environmental hazard in the circumstances of the preceding paragraph, it shall cancel the registration and announce the information on the cancellation of the registration of new chemical substances.
Article 41 [Procedures for inclusion in the list of existing chemical substances] General new chemical substances shall be listed in the List of Existing Chemical Substances in China by the Ministry of Environmental Protection for five years from the date of the first production or import activities of the registration certificate holder.
The holder of the registration certificate of hazardous new chemical substances (including key environmental management hazardous new chemical substances) shall submit a report on the actual activities to the registration center six months before the expiration of five years from the date of the first production or import activities.
The Ministry of Environmental Protection organized the experts of the review committee to conduct a retrospective assessment of the actual activity report, and based on the assessment results, the announcement of hazardous new chemical substances (including key environmental management hazardous new chemical substances) was included in the "List of Existing Chemical Substances in China."
New chemical substances that are simply declared for registration and scientific research are not included in the List of Existing Chemical Substances in China.
Article 42 The Ministry of Environmental Protection shall organize the investigation of new chemical substances every five years.
For chemical substances legally produced or imported within the territory of the People's Republic of China before October 15, 2003, the Ministry of Environmental Protection shall include them in the List of Existing Chemical Substances in China.
The environmental protection department shall impose penalties on those who produce, import or process new chemical substances without obtaining a registration certificate.

Chapter V Legal Liability

Article 43 [false declaration] whoever, in violation of the provisions of these measures, conceals the relevant information or provides false materials in the process of declaration, shall be ordered by the Ministry of Environmental Protection to make corrections, announce its violations, record its bad records, and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan; if it has been registered, its registration certificate shall be revoked.
Article 44 [Penalties of the Ministry of Environmental Protection] Anyone who violates the provisions of these Measures and commits one of the following acts shall be ordered by the Ministry of Environmental Protection to make corrections and impose a fine of less than 10,000 yuan:
The (I) fails to submit the updated environmental risk information of the new chemical substance approved for registration in time;
The (II) fails to submit the first activity report form of the new chemical substance or the information on the flow direction of the new chemical substance as required;
The (III) fails to report the production or import of new chemical substances in the previous year as required;
The (IV) fails to submit the actual activity report as required.
Article 45 [Local Penalties 1] Anyone who violates the provisions of these Measures and commits one of the following acts shall be ordered by the local environmental protection department responsible for supervision and management to make corrections, impose a fine of 10,000 yuan up to 30,000 yuan, and report to the Ministry of Environmental Protection to announce his violations and record his bad records:
(I) refusing or hindering the supervision and inspection by the environmental protection department, or practicing fraud when accepting supervision and inspection;
(II) producing or importing new chemical substances without obtaining a registration certificate or failing to comply with the provisions of the registration certificate;
(III) processing and using new chemical substances for which no registration certificate has been obtained;
The (IV) fails to take risk control measures in accordance with the provisions of the registration certificate;
(V) transfer of registered new chemical substances to process users who do not have the capacity to take risk control measures.
Article 46 [Local Penalties 2] Anyone who violates the provisions of these Measures and commits one of the following acts shall be ordered by the local environmental protection department responsible for supervision and management to make corrections and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan:
The (I) fails to transmit risk control information to the processing users as required;
The (II) fails to keep the declaration materials of new chemical substances and the actual situation of production and import activities as required;
(III) use new chemical substances produced or imported for the purpose of scientific research and research and development of processes and products for other purposes or fail to manage them in accordance with regulations.
Article 47 [Punishment for Violation of Evaluation Experts] If the experts of the evaluation committee practice fraud or dereliction of duty in the evaluation of new chemical substances, resulting in serious inaccuracy of the evaluation results, the Ministry of Environmental Protection shall disqualify them from being selected into the evaluation expert database and make a public announcement.
Article 48 [Punishment for Violation of Testing Institutions] If a domestic testing institution that provides test data for the declaration of new chemical substances forges, tampers with data or has other fraudulent acts during the testing of new chemical substances, the Ministry of Environmental Protection shall remove the name from the list of testing institutions and make a public announcement.
Article 49 [Punishment for Abuse of Power] If a staff member who violates the provisions of these Measures and engages in the environmental management of new chemical substances abuses his power or neglects his duty, he shall be punished according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.

Chapter VI Supplementary Provisions

Article 50 [Terms] The meanings of the following terms in these Measures:
(I) general new chemical substance refers to the new chemical substance whose hazard characteristics have not been found or whose harmfulness is lower than the value specified in the relevant standards for the identification and classification of the hazard characteristics of chemical substances;
(II) hazardous new chemical substances refer to the new chemical substances that have physical and chemical, human health or environmental hazard characteristics, and meet or exceed the value specified in the relevant standards for the identification and classification of the hazard characteristics of chemical substances.
Article 51 [Document Format] The following document formats of these Measures shall be uniformly formulated by the Ministry of Environmental Protection:
(I) new chemical substance regular declaration form;
Summary Declaration Form for (II) of New Chemical Substances;
(III) new chemical substance scientific research record form;
(IV) new chemical substance environmental management registration certificate;
(V) new chemical substance first activity report form;
(VI) new chemical substance regulatory notice.
Article 52 [Effective Date] These Measures shall come into force on October 15, 2010.
On September 12, 2003, the former State Environmental Protection Administration issued the "new chemical substances environmental management approach" repealed simultaneously.