The "New Chemical Substance Environmental Management Registration Measures" will be implemented from January 1, 2021!

The Measures for the Registration of Environmental Management of New Chemical Substances have been deliberated and adopted by the ministerial meeting of the Ministry of Ecology and Environment on February 17, 2020, and will come into force on January 1, 2021. The Measures for the Environmental Management of New Chemical Substances (Order No. 7 of the Ministry of Environmental Protection) issued by the former Ministry of Environmental Protection on January 19, 2010 shall be repealed simultaneously.

Attached:

Measures for the Registration of Environmental Management of New Chemical Substances
Chapter I General Provisions
Article 1 In order to regulate the environmental management and registration of new chemical substances, scientifically and effectively assess and control the environmental risks of new chemical substances, focus on new chemical substances that may cause greater risks to the environment and health, protect the ecological environment, and protect public health, in accordance with relevant Laws and regulations and the "Decision of the State Council on Setting Administrative Licenses for Administrative Approval Items that Really Need to Be Retained" formulate these measures.
Article 2 These Measures shall apply to the environmental management registration of the research, production, import, processing and use of new chemical substances within the territory of the People's Republic of China, except for the new chemical substances that are stored in the special customs supervision zone after import and are all exported without any processing.
The following products or substances are not subject to these Measures:
(I) medicines, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers and other products, except for new chemical substances that are changed to other industrial uses and used as raw materials and intermediates of the above-mentioned products;
(II) radioactive material.
These Measures shall apply to articles designed for the intentional release of new chemical substances contained in regular use.
Article 3 The term "new chemical substances" as mentioned in these Measures refers to the chemical substances that are not included in the List of Existing Chemical Substances in China.
Chemical substances that have been listed in the List of Existing Chemical Substances in China shall be subject to environmental management in accordance with existing chemical substances; however, chemical substances that are subject to environmental management for new uses in the List of Existing Chemical Substances in China shall be subject to environmental management in accordance with new chemical substances if they are used for other industrial purposes other than permitted uses.
The list of existing chemical substances in China is formulated, adjusted and published by the competent department of ecological environment under the State Council, including chemical substances that have been produced, sold, processed, used or imported in the People's Republic of China before October 15, 2003, and chemical substances listed in accordance with the relevant provisions on environmental management of new chemical substances after October 15, 2003.
Article 4 The State applies an environmental management registration system to new chemical substances.
The environmental management registration of new chemical substances is divided into regular registration, simple registration and filing. Producers or importers of new chemical substances shall obtain a new chemical substance environmental management regular registration certificate or a simple registration certificate (hereinafter collectively referred to as a registration certificate) or apply for a new chemical substance environmental management record before production or import.
Article 5 the environmental management and registration of new chemical substances shall follow the principles of science, efficiency, openness, fairness, impartiality and convenience for the people, adhere to source access, risk prevention and classified 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 cause 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 and registration of new chemical substances, formulating supporting documents such as policies, technical specifications and guidelines for the environmental management and registration of new chemical substances, and strengthening the information construction of environmental management and registration 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 expert committee). The expert committee is composed of experts in chemistry, chemical industry, health, environment, economy, etc., and provides technical support for the environmental management registration and review of new chemical substances.
The competent departments of ecological environment at or above the municipal level with districts shall be responsible for the environmental supervision and management of the implementation of these measures by relevant enterprises and institutions that research, produce, import, process and use new chemical substances within their respective administrative areas.
The technical institution for environmental management of chemical substances under the competent department of ecological environment under the State Council shall participate in the review of environmental management registration of new chemical substances and undertake the specific work of environmental management registration of new chemical substances.
Article 7 Enterprises and institutions engaged in the research, production, import, processing and use 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 bear responsibility for the damages caused by them.
Article 8 The State encourages and supports the scientific research, popularization and application of environmental risk assessment and control technologies for new chemical substances, and encourages the research and application of environment-friendly chemical substances and related technologies.
Article 9 All units and individuals have the right to report violations of the provisions of these Measures to the competent department of ecological environment.

Chapter II Basic Requirements
Article 10 Where the annual production or import volume of new chemical substances is more than 10 tons, the environmental management regular registration of new chemical substances (hereinafter referred to as regular registration) shall be handled.
If the annual production or import volume of new chemical substances is more than 1 ton but less than 10 tons, a simple registration for environmental management of new chemical substances (hereinafter referred to as simple registration) shall be handled.
If one of the following conditions is met, the environmental management of new chemical substances shall be filed (hereinafter referred to as filing):
The annual production or import of new (I) chemical substances is less than 1 ton;
(II) new chemical monomer or reactant content of not more than 2% of the polymer or is a low concern polymer.
Article 11 An applicant for the environmental management registration of new chemical substances shall be an enterprise or institution engaged in the production or import of new chemical substances that is legally registered within the territory of the the People's Republic of China and can independently bear legal responsibilities.
A production or trading enterprise that intends to export new chemical substances to the People's Republic of China may also act as an applicant, but it shall designate an enterprise or institution that is legally registered within the territory of the People's Republic of China and can independently assume legal responsibilities as an agent to jointly perform the environmental management registration of new chemical substances And environmental management obligations after registration, and assume responsibility according to law.
If the medicines, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers and other products specified in Article 2 of these Measures belong to new chemical substances and are to be changed to other industrial uses, the producers and importers of the relevant products Or processing users can be the applicant.
For chemical substances that have been listed in the "List of Existing Chemical Substances in China" and are subject to environmental management for new uses, if they are intended to be used for other industrial uses other than permitted uses, the producers, importers or processing users of the relevant chemical substances can be the applicant.
Article 12 Where an applicant applies for the registration of the environmental management of new chemical substances, 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 for environmental management of new chemical substances.
Article 13 If the applicant believes that the registration application or filing materials submitted involve trade secrets and require information protection, it shall submit it when applying for registration or filing, and submit materials explaining the necessity of applying for trade secret protection. For information that may have a significant impact on the environment, health and public interests, the competent department of ecological environment under the State Council may not protect trade secrets in accordance with the law. The applicant may withdraw the information protection request in writing.
The protection period of the identification information such as the name of the new chemical substance shall not exceed five years from the date of the first registration or filing.
Staff and relevant experts engaged in the environmental management and registration of new chemical substances shall not disclose trade secrets that shall be protected in accordance with the law.
Article 14 the People's Republic of China domestic testing institutions that provide test data for the environmental management registration of new chemical substances shall obtain the qualification of inspection and testing institutions in accordance with the law, and carry out testing work in strict accordance with the relevant standards for chemical substance testing; health toxicology and ecotoxicology testing institutions shall also comply with good laboratory management practices. The testing institution shall be responsible for the authenticity and reliability of the test results issued by it, and shall be liable according to law.
The competent department of ecological environment under the State Council shall organize the supervision and random inspection of the testing conditions and conditions of the ecotoxicology testing institutions for chemical substances.
the People's Republic of China overseas testing institutions that issue health toxicology or ecotoxicology test data shall comply with the internationally accepted requirements for good laboratory management.

Chapter III regular Registration, Summary Registration and Filing
Section 1 Application and Acceptance of regular Registration and Summary Registration
Article 15 To apply for regular registration, the applicant shall submit the following materials:
(I) regular registration application form;
(II) new chemical substance physicochemical properties, health toxicology and ecotoxicology characteristics test report or data;
(III) the environmental risk assessment report of new chemical substances, including the assessment of the environmental risks that may be caused by the new chemical substances to be registered, the environmental risk control measures to be taken and their appropriateness analysis, and the assessment conclusion of whether there are unreasonable environmental risks;
(IV) the letter of commitment to implement or transmit environmental risk control measures and environmental management requirements, the letter of commitment shall be signed by the legal representative of the enterprise or institution or its authorized person, and stamped with the official seal.
The relevant test reports and data specified in the second paragraph of the preceding paragraph shall meet the needs of the environmental risk assessment of new chemical substances; the ecotoxicological test report shall include the test data completed by the test organism using the the People's Republic of China in accordance with the provisions of the relevant standards.
For highly hazardous chemical substances, the applicant shall also submit the social and economic benefit analysis materials of the new chemical substance activity, including the explanation of whether the new chemical substance has considerable or obvious advantages over the chemical substance in use for the same purpose in terms of performance and environmental friendliness, so as to fully demonstrate the necessity of the application activity.
In addition to the application materials specified in the first three paragraphs of this article, the applicant shall also submit other information on the environmental and health hazard characteristics and environmental risks of the new chemical substance that it already has.
Article 16 To apply for simple registration, the applicant shall submit the following materials:
(I) summary registration application form;
(II) new chemical substance physicochemical properties, and persistence, bioaccumulation and aquatic environment toxicity and other ecotoxicological test report or data;
(III) the letter of commitment to implement or transmit environmental risk control measures, the letter of commitment shall be signed by the legal representative of the enterprise or institution or its authorized person, and stamped with the official seal.
The ecotoxicological test report provided for in item 2 of the preceding paragraph shall include test data completed in accordance with the provisions of the relevant standards using the the People's Republic of China test organism.
In addition to the application materials specified in the preceding paragraph, the applicant shall also submit other information on the environmental and health hazard characteristics and environmental risks of the new chemical substance.
Article 17 The same applicant may apply for the environmental management registration of new chemical substances for multiple new chemical substances with similar molecular structures, the same or similar uses, and similar test data. The application registration amount is determined according to the sum of the application registration amount of each substance.
If two or more applicants apply for the same new chemical substance environmental management registration at the same time, they can jointly submit the application materials and handle the joint registration of new chemical substance environmental management. The application registration amount is determined based on the sum of the application registration amount of each applicant.
Article 18 After receiving the application materials for the environmental management registration of new chemical substances, the competent department of ecological environment under the State Council shall handle them according to the following circumstances:
(I) the application materials are complete and conform to the legal form, or the applicant submits all the application materials for correction as required, it shall be accepted;
If there are errors in the (II) application materials that can be corrected on the spot, the applicant is allowed to correct them on the spot;
(III) the substance applied for does not need to be registered for the environmental management of new chemical substances, or if the application materials are not accepted under other circumstances stipulated by laws and regulations, a decision of inadmissibility shall be made on the spot or within five working days;
(IV) the applicant and his agent do not comply with the provisions of these measures, the application materials are incomplete and other circumstances do not conform to the legal form, the applicant shall be informed of all the contents that need to be supplemented and corrected on the spot or within five working days. Failure to inform within the time limit shall be accepted from the date of receipt of the application materials.
Section II Technical Review and Decision on regular Registration and Simplified Registration
Article 19 after accepting an application for regular registration, the competent department of ecology and environment under the State Council shall organize an expert committee and its subordinate technical institution for environmental management of chemical substances to conduct technical evaluation. The technical review shall mainly focus on the following:
(I) new chemical substance names and labels;
(II) the quality of new chemical substance test reports or data;
(III) the environmental and health hazard characteristics of new chemicals;
(IV) environmental exposure and environmental risks of new chemicals;
Whether environmental management for new uses is implemented when the (V) is listed in the List of Existing Chemical Substances in China;
(VI) whether environmental risk control measures are appropriate;
Necessity of (VII) application activities for highly hazardous chemical substances;
(VIII) the need for trade secret protection.
The technical review opinions shall include the review conclusions on the contents specified in the preceding paragraph, as well as recommendations on whether to approve registration and recommendations on environmental management requirements.
If the technical review finds that the application materials submitted by the applicant do not meet the requirements, or are insufficient to make a comprehensive assessment of the environmental risks of the new chemical substances, the competent department of ecological environment under the State Council may require the applicant to provide additional relevant test reports or materials.
Article 20 after accepting the application for simple registration, the competent department of ecological environment under the State Council shall organize its subordinate technical institutions for environmental management of chemical substances to conduct technical evaluation. The technical review shall mainly focus on the following:
(I) new chemical substance names and labels;
(II) the quality of new chemical substance test reports or data;
(III) the persistence, bioaccumulation and toxicity of new chemicals;
Cumulative environmental risks from (IV) new chemicals;
(V) the need for trade secret protection.
The technical review opinions shall include the review conclusions on the contents specified in the preceding paragraph and the recommendations on whether to approve the registration.
If the technical review finds that the application materials submitted by the applicant do not meet the requirements, the competent department of ecological environment under the State Council may require the applicant to provide relevant test reports or materials.
Article 21 the competent department of ecological environment under the State Council shall examine the technical evaluation opinions of regular registration and make decisions according to the following circumstances:
If the (I) does not find unreasonable environmental risks, it shall register and issue a new chemical substance environmental management regular registration certificate (hereinafter referred to as the regular registration certificate) to the applicant. The issuance of regular registration certificates for highly hazardous chemical substances shall also meet the requirements of the necessity of the application activities;
If the (II) finds that there are unreasonable environmental risks, or does not meet the requirements of the necessity of high-hazard chemical substance application activities, it shall not register, notify the applicant in writing and explain the reasons.
Article 22 The competent department of ecology and environment under the State Council shall review the technical review opinions on simple registration and make decisions according to the following circumstances:
The (I) shall register those that are not found to have persistence, bioaccumulation and toxicity at the same time, and no cumulative environmental risks are found, and issue a simple registration certificate for environmental management of new chemical substances (hereinafter referred to as the simple registration certificate) to the applicant;
If the (II) does not meet the conditions for registration specified in the preceding paragraph, the registration shall not be granted, and the applicant shall be notified in writing and the reasons shall be given.
Article 23 under any of the following circumstances, the competent department of ecological environment under the State Council shall not register, notify the applicant in writing and explain the reasons:
(I) use deceptive means such as concealing information or providing false materials in the process of registration application;
The (II) fails to refuse or fail to provide relevant test reports or materials within six months in accordance with the requirements of the third paragraph of Article 19 or the third paragraph of Article 20 of these Measures;
Other circumstances where registration is not permitted (III) to laws and regulations.
Article 24 Before making a registration decision, the competent department of ecology and environment under the State Council shall publicize the name or class name of the new chemical substance to be registered, the applicant and his agent, the type of activity, and the environmental management requirements for new uses. The period of publicity shall not be less than three working days.
Article 25 After accepting an application for environmental management registration of new chemical substances, the competent department of ecological environment under the State Council shall start the technical evaluation work in a timely manner. The technical review time for regular registration shall not exceed 60 days, and the technical review time for simple registration shall not exceed 30 days. If the competent department of ecological environment under the State Council notifies the supplementary provision of relevant test reports or materials, the time required by 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 make a decision on whether to register or not within 20 working days from the date of acceptance of the application. If a decision cannot be made within 20 working days, it may be extended for 10 working days with the approval of the person in charge of the competent department of ecological environment under the State Council, and the applicant shall be informed of the reasons for the extension.
The time for technical review shall not be included in the time limit for examination and approval provided for in paragraph 2 of this Article.
Article 26 The registration certificate shall state the following:
Type of (I) registration certificate;
Name of the (II) applicant and its agent;
Identification information such as name or class name in English and Chinese of (III) new chemical substance;
(IV) application purposes;
(V) the number of applications for registration;
Type of (VI) activity;
(VII) environmental risk control measures.
For highly hazardous chemical substances and new chemical substances that are persistent and bioaccumulative, or persistent and toxic, or bioaccumulative and toxic, the regular registration certificate shall also specify one or more of the following environmental management requirements:
(I) limits on emissions or concentrations of new chemical substances;
Requirements for implementing environmental management for new uses when (II) are included in the List of Existing Chemical Substances in China;
(III) submission of annual reports;
(IV) other environmental management requirements.
Article 27 after the application for environmental management registration of new chemical substances is accepted, and before the competent department of ecological environment under the State Council makes a decision, the applicant may withdraw the application for registration according to law.
Article 28 after making a decision on the environmental management registration of new chemical substances, the competent department of ecology and environment under the State Council shall, within 20 working days, disclose the environmental management registration of new chemical substances, including the name or class name of the new chemical substance, the applicant and its agent, the type of activity, the environmental management requirements for new uses, and other information.
Section 3 Alteration, Withdrawal and Revocation of regular Registration and Summary Registration
Article 29 For new chemical substances that have obtained a regular registration certificate, before they are included in the "List of Existing Chemical Substances in China" in accordance with Article 44 of these Measures, the holder of the registration certificate shall apply for registration again:
The (I) production or import quantity is intended to exceed the quantity applied for registration;
Where the type of (II) activity is to be changed from import to production;
The (III) intends to change the application use of the new chemical substance;
The (IV) intends to change the environmental risk control measures;
(V) other situations that result in increased environmental risk.
In case of re-application for registration, the applicant shall submit the application materials for re-registration, explain the reasons for the change of relevant matters, prepare and submit the environmental risk assessment report again, and highlight the environmental risk control measures to be taken after the change and their appropriateness, and whether there are unreasonable environmental risks.
Article 30 For new chemical substances that have obtained a regular registration certificate, before they are included in the "List 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 other information stated in the registration certificate changes, the holder of the registration certificate shall apply for a change in the registration certificate.
For a new chemical substance that has 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.
Where an application is made for changing the registration certificate, the applicant shall submit the reasons for the change and relevant supporting materials. Among them, if it is proposed to change the Chinese and English name of the new chemical substance or the identification information such as the Chemical Abstracts Service number (CAS), the certification materials shall fully demonstrate that the chemical substance before and after the change belongs to the same chemical substance.
The competent department of ecological environment under the State Council shall, with reference to the simple registration procedure and time limit, accept and organize technical review, and make a decision on the change of the registration certificate. Among them, if it is proposed to change the Chinese and English name of the new chemical substance or the identification information such as the Chemical Abstracts Service number (CAS), the competent department of ecological environment under the State Council may organize an expert committee to conduct a technical review; if it is impossible to judge that the chemical substance before and after the change belongs to the same chemical substance, the change shall not be approved.
Article 31 The following chemical substances listed in the List of Existing Chemical Substances in China in accordance with Article 44 of these Measures shall be subject to environmental management for new uses:
(I) of highly hazardous chemicals;
(II) chemicals that are persistent and bioaccumulative, or persistent and toxic, or bioaccumulative and toxic.
For highly hazardous chemical substances, if the holder of the registration certificate changes their use, or if someone other than the holder of the registration certificate uses them for industrial purposes, they shall apply to the competent department of ecological environment under the State Council for environmental management registration of new uses before production, import or processing.
For the chemical substances listed in item 2 of the first paragraph of this article, if they are intended to be used for other industrial purposes other than the permitted uses specified in Article 44 of these Measures, they shall apply to the competent department of ecological environment under the State Council before production, import or processing. Go through the registration of environmental management for new uses.
Article 32 To apply for registration of environmental management for new uses, the applicant shall submit an application form for registration of environmental management for new uses, as well as materials such as an environmental exposure assessment report and environmental risk control measures for the use of the chemical substance for new uses. For high-hazard chemical substances, social and economic benefit analysis materials should also be submitted to fully demonstrate the necessity of the substance for the purpose of registration.
After receiving the application materials, the competent department of ecological environment under the State Council shall accept and organize technical evaluation in accordance with the regular registration procedures, deal with them according to the following circumstances, and notify the applicant in writing:
If the (I) does not find unreasonable environmental risks, it shall be registered. For highly hazardous chemical substances, it shall also meet the requirements of the necessity of the application;
If the (II) finds that there are unreasonable environmental risks, or does not meet the requirements of the necessity of the application for the use of high-hazard chemical substances, it shall not be registered.
After the competent department of ecology and environment under the State Council has made a decision on the registration of environmental management for new uses, it shall, within 20 working days, disclose the names of the registered applicants and their agents, the names or class names of the chemical substances involved, the registered new uses, and the corresponding environmental risk control measures and environmental management requirements. Among them, if it is not a highly hazardous chemical substance, the registered permitted new use of the chemical substance shall be added to the List of Existing Chemical Substances in China; if it is a highly hazardous chemical substance, the environmental management scope of the new use of the chemical substance in the List of Existing Chemical Substances in China shall remain unchanged.
Article 33 After obtaining the registration certificate, the applicant may apply to the competent department of ecological environment under the State Council for cancellation of the registration certificate.
Article 34 Under any of the following circumstances, in order to meet the needs of the public interest, the competent department of ecological environment under the State Council may change or withdraw the registration certificate in accordance with the relevant provisions of the the People's Republic of China Administrative Licensing Law:
The (I) needs to be changed or withdrawn in accordance with the provisions of Article 42 of these Measures;
(II) new chemical substance environmental management registration content does not conform to the national industrial policy;
Changes in relevant (III) laws, administrative regulations or mandatory standards;
(IV) the contents of the environmental management registration of new chemical substances conflict with the requirements of the international treaties concluded or acceded to by the the People's Republic of China;
Other circumstances that should be changed or withdrawn (V) to the provisions of laws and regulations.
Article 35 Under any 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 the People's Republic of China Administrative Licensing Law:
(I) the applicant or his agent to obtain the registration certificate by deception, bribery or other improper means;
(II) the staff of the competent department of ecological environment under the State Council abuse their power, neglect their duties or issue registration certificates in violation of legal procedures;
Other circumstances that should be revoked (III) to the provisions of laws and regulations.
Section IV Filing
Article 36 For the filing of the environmental management of new chemical substances, the filing form and the certification materials that meet the corresponding circumstances specified in the third paragraph of Article 10 of these Measures shall be submitted, and the environmental and health hazards of new chemical substances that they have mastered shall be submitted together. Other information on the characteristics and environmental risks.
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 filing materials for future reference and send the filing receipt. After submitting the filing materials, the applicant can carry out activities related to new chemical substances in accordance with the contents of the filing.
When the environmental management record of new chemical substances or related information changes, the applicant shall change the record information in a timely manner.
The competent department of ecological environment under the State Council shall regularly publish the record of environmental management of new chemical substances.

Chapter IV Tracking Management
Article 38 Producers, importers and processing users of new chemical substances shall transmit the following information to downstream users:
(I) registration certificate number or record receipt number;
(II) new chemical substance applications;
(III) environmental and health hazard characteristics of new chemical substances and environmental risk control measures;
(IV) environmental management requirements for new chemical substances.
The processing user of a new chemical substance may request the supplier to provide information on the new chemical substance specified in the preceding paragraph.
Article 39 Researchers, producers, importers and processing users of new chemical substances shall establish a new recording system for the activities of new chemical substances, truthfully record the time, quantity and purpose of the activities of new chemical substances, as well as the implementation of environmental risk control measures and environmental management requirements.
regular registration and summary registration materials and new chemical activity records and other relevant information should be kept for at least ten years. Record materials and relevant information such as records of new chemical substance activities shall be kept for at least three years.
Article 40 The producers and processing users of new chemical substances registered by the regular 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 methods that are convenient for the public to know.
Article 41 the holder of the registration certificate shall, 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 processing user, report the first activity of the new chemical substance to the competent department of ecological environment under the State Council.
If the environmental management requirements specified in the regular registration certificate stipulate the requirements for the submission of annual reports, the holder of the registration certificate shall report to the competent department of ecological environment under the State Council before April 30 of each year from the following year of registration the actual production or import of new chemical substances approved for registration in the previous year, the discharge into the environment, and the implementation of environmental risk control measures and environmental management requirements.
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 to the competent department of ecological environment under the State Council; if it may lead to an increase in environmental risks, measures shall be taken in a timely manner to eliminate or reduce environmental risks.
The competent department of ecological environment under the State Council may require relevant researchers, producers, importers and processing users of new chemical substances that may continue to increase environmental risks according to the national environmental management registration of new chemical substances, actual production or import, discharge to the environment, and newly discovered environmental or health hazard characteristics, Further submit relevant environmental or health hazard and environmental exposure data information.
After receiving the relevant information, the competent department of ecological environment under the State Council shall organize its subordinate technical institutions and expert committees for environmental management of chemical substances to conduct technical review; if necessary, it may change or withdraw the corresponding registration certificate according to law according to the review results.
Article 43 the competent department of ecological environment under the State Council shall notify 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, annual reports and other information; the competent department of ecological environment at the provincial level shall notify the competent department of ecological environment at the municipal level divided into districts of the above-mentioned information.
The competent department of ecological environment at or above the municipal level divided into districts shall supervise and spot check whether the producers, importers and processing users of new chemical substances have gone through the environmental management registration of new chemical substances as required, the authenticity of the registration items, the items 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 accept the supervision and random inspection of the competent department of ecological environment.
Article 44: If a new chemical substance that has obtained a regular registration certificate has been registered for five years from the date of first registration, the competent department of ecology and environment under the State Council shall include it in the "List of Existing Chemical Substances in China" and announce it.
For new chemical substances that are persistent and bioaccumulative, or persistent and toxic, or bioaccumulative and toxic, their permitted uses shall be indicated when they are listed in the List of Existing Chemical Substances in China.
For highly hazardous chemical substances and new chemical substances with persistence and bioaccumulation, or persistence and toxicity, or bioaccumulation and toxicity, when they are included in the "List of Existing Chemical Substances in China", environmental management requirements other than annual reports shall be stipulated.
The provisions of the first three paragraphs of this article shall apply to the new chemical substances registered in accordance with the application for cancellation of the regular registration in accordance with the provisions of Article 33 of these Measures.
New chemical substances that are simply registered and filed, as well as new chemical substances that have been withdrawn or revoked in accordance with the provisions of Articles 34 and 35 of these Measures, shall not be included in the regular List of Existing Chemical Substances in China.
Article 45 If a new chemical substance that has obtained a regular declaration and registration certificate in accordance with the Environmental Management Measures for New Chemical Substances (Order No. 7 of the Ministry of Environmental Protection) has not been included in the List of Existing Chemical Substances in China, it shall be listed in the List of Existing Chemical Substances in China after five years from the date of first production or import activities or five years from the date of implementation of these Measures.
According to the provisions of the Measures for the Environmental Management of New Chemical Substances (Order No. 17 of the State Environmental Protection Administration), new chemical substances that have obtained normal environmental management registration and have not been included in the List of Existing Chemical Substances in China shall be included in the List of Existing Chemical Substances in China within six months from the date of implementation of these Measures.
If these Measures have been listed in the "List of Existing Chemical Substances in China" before the entry into force of the Measures and the protection of identification information such as substance names is implemented, the longest protection period of identification information shall end on December 31, 2025.

Chapter V Legal Liability
Article 46 whoever, in violation of the provisions of these measures, obtains the registration of environmental management of new chemical substances by deception, bribery and other improper means shall be ordered by the competent department of ecological environment under the State Council to make corrections and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan. and carry out joint punishment for breach of faith in accordance with the rules and regulations, and will no longer accept its application for environmental management registration of new chemical substances within three years.
Article 47 whoever, in violation of the provisions of these measures, commits one of the following acts shall be ordered by the competent department of ecological environment under the State Council to make corrections and impose a fine of not more than 10,000 yuan; if the circumstances are serious, joint punishment for breach of trust shall be carried out in accordance with the rules and regulations, and its application for environmental management registration of new chemical substances shall not be accepted within one year:
The (I) fails to report the first activity of new chemical substances or the actual production or import of new chemical substances approved for registration in the previous year, as well as the implementation of environmental risk control measures and environmental management requirements;
(II) 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 environmental or health hazard or environmental exposure data information.
Article 48 whoever, in violation of the provisions of these measures, commits one of the following acts shall be ordered by the competent department of ecological environment at or above the municipal level divided into districts to make corrections and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan; if the circumstances are serious, joint punishment for breach of faith shall be carried out in accordance with the law, and its application for environmental management registration of new chemical substances shall not be accepted within one year:
(I) producing or importing new chemical substances without obtaining a registration certificate, or processing and using new chemical substances without obtaining a registration certificate;
The (II) fails to re-register the production or import of new chemical substances in accordance with the provisions;
(III) use chemical substances that have not been examined by the competent department of ecological environment under the State Council for new uses or have not been approved after examination for industrial purposes other than the permitted uses.
Article 49 whoever, in violation of the provisions of these measures, commits one of the following acts shall be ordered by the competent department of ecological environment at or above the municipal level divided into districts to make corrections within a time limit and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan; if the circumstances are serious, joint punishment for breach of faith shall be carried out in accordance with the rules and regulations, and its application for environmental management registration of new chemical substances shall not be accepted within one year:
The (I) fails to file, or fails to produce or import new chemical substances in accordance with the filing information, or processes and uses new chemical substances that have not been filed;
The (II) fails to produce, import or process and use new chemical substances in accordance with the provisions of the registration certificate;
The (III) fails to register the change, or does not produce or import new chemical substances in accordance with the content of the change;
The (IV) fails to implement relevant environmental risk control measures or environmental management requirements, or fails to disclose relevant information in accordance with regulations;
The (V) fails to transmit the prescribed information to the downstream user, or refuses to provide the relevant information of the new chemical substance;
The (VI) has not established a record system for the activities of new chemical substances, or has not recorded the activities of new chemical substances, or has not kept relevant information;
(VII) failing to implement the environmental management requirements listed in the List of Existing Chemical Substances in China.
Article 50 If the members of the expert committee practice fraud in the environmental management review of new chemical substances, or have other dereliction of duty, resulting in serious inauthenticity of the review results, the competent department of ecology and environment under the State Council shall cancel the membership of the expert committee and make it public.
Article 51 Where 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 not less than 10,000 yuan but not more than 30,000 yuan on the testing institution, impose a fine of not less than 10,000 yuan but not more than 30,000 yuan on the person in charge directly responsible for the testing institution and other persons directly responsible, and carry out joint punishment for dishonesty in accordance with laws and regulations, the test report issued by the testing institution or the test report issued by the relevant responsible personnel shall not be accepted within three years.

Chapter VI Supplementary Provisions
Article 52 The meanings of the following terms in these Measures:
(I) environmental risk refers to the degree and probability of harmful effects on the environment and health caused by chemical substances with environmental or health hazard properties entering or possibly entering the environment in the process of production, processing and use, waste and disposal, excluding the risks caused by emergencies such as production safety accidents and traffic and transportation accidents.
(II) high-hazard chemical substances refer to chemical substances that are persistent, bioaccumulative and toxic at the same time, chemical substances that are highly persistent and bioaccumulative at the same time, or other chemical substances that are equally hazardous to the environment or health.
(III) the processing and use of new chemical substances refers to the use of new chemical substances for sub-packaging, preparation or manufacturing and other production and business activities, excluding trade, storage, transportation and other business activities and the use of articles containing new chemical substances.
Article 53 Where the environmental management of new chemical substances has been registered in accordance with the provisions of the Measures for the Environmental Management of New Chemical Substances (Order No. 7 of the Ministry of Environmental Protection) and the Measures for the Environmental Management of New Chemical Substances (Order No. 17 of the State Environmental Protection Administration), the relevant registration shall continue to be valid after the implementation of these Measures.
Article 54 The competent department of ecological environment under the State Council shall be responsible for the interpretation of these Measures.
Article 55 These Measures shall come into force on January 1, 2021, and the Measures for the Environmental Management of New Chemical Substances (Order No. 7 of the Ministry of Environmental Protection) issued by the former Ministry of Environmental Protection shall be repealed at the same time.

Note: If you need to download the regulations, please go to our website download center to download, thank you!