Application service of new chemical substance environmental management registration certificate
1、 Technical discrimination of chemical substances (check whether the chemical substances belong to new chemical substances)
| Undertaker | Solid Waste and Chemicals Management Technology Center of Ministry of Ecological Environment |
| Official Guidelines | https://www.meescc.cn/ggzc/bszn/hxwzjspb/201404/t20140403_594914.shtml |
| Event type | voluntary entrustment of the declarant |
| Charging standard | The official fee for each technical discrimination report is 3000 yuan. |
| Purpose and significance | This procedure can avoid the declarant from failing to report new chemicals as existing chemicals, thus violating the new chemical regulations [Measures for Environmental Management and Registration of New Chemical Substances (Decree No. 12 of the Ministry of Ecology and Environment)]; At the same time, it can avoid declaring existing substances as new chemical substances, thus causing huge waste of human, material and financial resources. |
| Service requirements | (1) The applicant shall provide various materials as required: ① Information of the client. Including the company name, contact person, e-mail, contact address, postal code, office telephone, office fax, and relevant description and entrustment requirements of the enterprise; ② Declared substance information. Including CAS number, Chinese name, English name, molecular formula, structural diagram (clearly visible), production and synthesis process and other relevant information.
(2) The declarer promises that all the information provided is true, reliable and complete, the source is legal, and it does not infringe the rights and interests of others. If it is not true, it shall bear all legal liabilities arising therefrom. |
| Service cycle | After the applicant submits the above materials (1) and (2) as required, the technical identification results of chemical substances issued by the undertaking unit can be obtained within 5 working days in general. For complex and difficult substances, if it is difficult to determine whether they are new chemical substances by molecular formula, structural formula, chemical substance naming or production and synthesis process, the cycle will be appropriately extended for the organizer to make a comprehensive technical determination (including searching the international chemical substance database, consulting technical experts in relevant fields, conducting comparative research on technical determination, etc.). |
| Next Steps | If the results show that it is an existing substance (listed in the List of Existing Chemical Substances in China), it is unnecessary to apply for a new chemical substance environmental management registration certificate; If the result shows that it is a new chemical substance, it shall be implemented according to the actual situation of the applicant: (1) new chemical substance filing; Or (2) Simple declaration of new chemical substances; Or (3) Routine declaration of new chemical substances. |
| Exception | For chemical substances that have been listed in the List of Existing Chemical Substances in China but are subject to environmental management for new uses, if they are used for industrial purposes other than those permitted, they shall go through environmental management registration for new uses before production, import or processing. |
| Agency service | If you need agency service, please write E-mail (caowei@jizhun.com.cn) or call (+86-20-81695425) to contact Mr. Cao Wei. |
2、 Environmental management record of new chemicals
| Undertaker | Ministry of Ecology and Environment of the People’s Republic of China |
| Official Guidelines | Log in to the website of the Government Affairs Service Hall of the Ministry of Ecology and Environment of the People’s Republic of China (Internet: http://zwfw.mee.gov.cn ）According to the path: “new chemical substances” theme → 13002 new chemical substances environmental management registration certificate issuance approval items → item declaration, enter the online registration system to handle relevant items |
| Event Type | administrative licensing |
| Charging standard | No official charge (free). |
| Corporate responsibility | Enterprises and institutions engaged in the research, production, import, processing and use of new chemical substances shall comply with the provisions of the Measures for Environmental Management and Registration of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment), take effective measures to prevent and control the environmental risks of new chemical substances, and bear responsibility for the damage caused according to law. |
| Scope of filing | The third paragraph of Article 10 of the Measures for Environmental Management and Registration of New Chemical Substances (Decree No. 12 of the Ministry of Ecological Environment) stipulates that:
If one of the following conditions is met, the environmental management of new chemical substances shall be put on record: （1） The annual production or import of new chemical substances is less than 1 ton; （2） Polymers with monomer or reactant content of new chemical substances not exceeding 2% or belonging to polymers of low concern. |
| Service requirements | For filing of environmental management of new chemical substances, the filing form and evidentiary materials conforming to the corresponding circumstances specified in Paragraph 3 of Article 10 of these Measures shall be submitted, together with other information on the environmental and health hazard characteristics and environmental risks of new chemical substances that they have mastered.
The declarer promises that all the information provided is true, reliable and complete, the source is legal, and it does not infringe the rights and interests of others. If it is not true, it shall bear all legal liabilities arising therefrom. |
| Service cycle | The applicant shall complete the filing work within 10 working days after submitting various materials as required. |
| Next Steps | After receiving the filing materials for environmental management of new chemical substances, the competent ecological environment department 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 according to the filing contents. |
| change | In case of any change in the filing matters or relevant information of environmental management of new chemical substances, the applicant shall change the filing information in a timely manner. |
| Agency service | If you need agency service, please write（ caowei@jizhun.com.cn ）Or call (020-81695425).
After both parties sign the confidentiality agreement (optional), the applicant shall provide the legal person certificate or business license (duplicate, affixed with official seal) of his/her unit, fill in the “New Chemical Substance Filing Form” or provide all the information listed in the form, and other information that the applicant has mastered about the characteristics of environmental and health hazards and environmental risks. If the declared substance is a polymer, the applicant shall submit the “Polymer Filing Explanatory Materials”; Both parties sign agency contract or agreement and issue legal power of attorney. |
3、 Simple registration of environmental management of new chemicals
| Undertaker | Ministry of Ecology and Environment of the People’s Republic of China |
| Official Guidelines | Log in to the website of the Government Affairs Service Hall of the Ministry of Ecology and Environment of the People’s Republic of China (Internet: http://zwfw.mee.gov.cn ）According to the path: “new chemical substances” theme → 13002 new chemical substances environmental management registration certificate issuance approval items → item declaration, enter the online registration system to handle relevant items |
| Event Type | administrative licensing |
| Charging standard | No official charge (free). |
| Corporate responsibility | Enterprises and institutions engaged in the research, production, import, processing and use of new chemical substances shall comply with the provisions of the Measures for Environmental Management and Registration of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment), take effective measures to prevent and control the environmental risks of new chemical substances, and bear responsibility for the damage caused according to law. |
| Scope of registration | The second paragraph of Article 10 of the Measures for Environmental Management and Registration of New Chemical Substances (Decree No. 12 of the Ministry of Ecological Environment) stipulates that:
If the annual production or import of new chemical substances is more than 1 ton but less than 10 tons, a simple registration for environmental management of new chemical substances shall be handled. |
| applicant | (1) Enterprises and institutions within the territory of China: engaged in the production or import of new chemical substances, registered according to law, and able to bear legal liabilities independently;
(2) Enterprises exporting to China: may act as applicants, but shall appoint agents to jointly perform the obligations of registration and post registration environmental management, and assume responsibilities according to law; (3) To be changed to other industrial uses: producers, importers or processing users can all be applicants; (4) For those who implement environmental management for new purposes: producers, importers or processing users can all be applicants. |
| Data submission | Where an applicant applies for environmental management registration of new chemical substances, the applicant shall submit an application for registration to the competent ecological environment department under the State Council, and shall be responsible for the authenticity, integrity, accuracy and legitimacy of the registration application materials. In case of any inaccuracy, bear all legal liabilities arising therefrom. Encourage registration data sharing. |
| Information protection | (1) It shall be submitted at the time of application for registration or filing, and the materials explaining the necessity of applying for protection of trade secrets shall be submitted; For information that may have a significant impact on the environment and public health interests, trade secrets may not be protected according to law; The applicant may withdraw its request for information protection in writing at any time.
(2) The term of protection for the identification information such as the name of new chemical substances shall not exceed five years from the date of initial registration or filing. (3) The staff and relevant experts engaged in the environmental management and registration of new chemical substances shall not disclose the trade secrets that should be protected according to law. |
| Testing agency | (1) Domestic testing institutions: they shall obtain the qualification certification of inspection and testing institutions according to law, and carry out testing in strict accordance with relevant standards for chemical substance testing; Health toxicology and ecotoxicology testing institutions shall also comply with good laboratory management practices; They shall be responsible for the authenticity and reliability of the test results issued by them, and shall be liable according to law.
(2) Overseas testing institutions: overseas testing institutions of the People’s Republic of China that issue health toxicology or ecotoxicology test data shall meet the internationally prevailing requirements for good laboratory management. |
| Time limit for handling | (1) Time limit for technical review: 30 days. The time required for the applicant to supplement relevant materials is not included in the time limit for technical review;
(2) Time limit for examination and approval: Within 20 working days from the date of acceptance of the application, the decision on whether to register shall be made. Under special circumstances, ten working days may be extended upon approval. The time of technical review is not included in the approval time limit. |
| Agency service | If you need agency service, please write（ caowei@jizhun.com.cn ）Or call (020-81695425).
Both parties sign a confidentiality agreement (optional), sign an agency contract or agreement, and issue a legal power of attorney; The applicant shall provide the legal person certificate or business license (duplicate, affixed with official seal) of his/her unit, fill in the “Application Form for Simple Registration of New Chemical Substances” or provide all the information, test reports or data listed in the form, the determination conclusion and basis for the persistence, bioaccumulation and toxicity of the applied substance, the explanation materials for the necessity of information protection, the commitment letter for implementing or transferring the environmental risk control measures, and the conditions of the testing institution Other information about the characteristics of environmental and health hazards and environmental risks that the applicant has mastered. |
4、 Routine registration of environmental management of new chemicals
| Undertaker | Ministry of Ecology and Environment of the People’s Republic of China |
| Official Guidelines | Log in to the website of the Government Affairs Service Hall of the Ministry of Ecology and Environment of the People’s Republic of China (Internet: http://zwfw.mee.gov.cn ）According to the path: “new chemical substances” theme → 13002 new chemical substances environmental management registration certificate issuance approval items → item declaration, enter the online registration system to handle relevant items |
| Event Type | administrative licensing |
| Charging standard | No official charge (free). |
| Corporate responsibility | Enterprises and institutions engaged in the research, production, import, processing and use of new chemical substances shall comply with the provisions of the Measures for Environmental Management and Registration of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment), take effective measures to prevent and control the environmental risks of new chemical substances, and bear responsibility for the damage caused according to law. |
| Scope of registration | The first paragraph of Article 10 of the Measures for Environmental Management and Registration of New Chemical Substances (Decree No. 12 of the Ministry of Ecological Environment) stipulates that:
If the annual production or import volume of new chemical substances is more than 10 tons, the routine registration for environmental management of new chemical substances shall be handled. |
| applicant | (1) Enterprises and institutions within the territory of China: engaged in the production or import of new chemical substances, registered according to law, and able to bear legal liabilities independently;
(2) Enterprises exporting to China: may act as applicants, but shall appoint agents to jointly perform the obligations of registration and post registration environmental management, and assume responsibilities according to law; (3) To be changed to other industrial uses: producers, importers or processing users can all be applicants; (4) For those who implement environmental management for new purposes: producers, importers or processing users can all be applicants. |
| Data submission | Where an applicant applies for environmental management registration of new chemical substances, the applicant shall submit an application for registration to the competent ecological environment department under the State Council, and shall be responsible for the authenticity, integrity, accuracy and legitimacy of the registration application materials. In case of any inaccuracy, bear all legal liabilities arising therefrom. Encourage registration data sharing. |
| Information protection | (1) It shall be submitted at the time of application for registration or filing, and the materials explaining the necessity of applying for protection of trade secrets shall be submitted; For information that may have a significant impact on the environment and public health interests, trade secrets may not be protected according to law; The applicant may withdraw its request for information protection in writing at any time.
(2) The term of protection for the identification information such as the name of new chemical substances shall not exceed five years from the date of initial registration or filing. (3) The staff and relevant experts engaged in the environmental management and registration of new chemical substances shall not disclose the trade secrets that should be protected according to law. |
| Testing agency | (1) Domestic testing institutions: they shall obtain the qualification certification of inspection and testing institutions according to law, and carry out testing in strict accordance with relevant standards for chemical substance testing; Health toxicology and ecotoxicology testing institutions shall also comply with good laboratory management practices; They shall be responsible for the authenticity and reliability of the test results issued by them, and shall be liable according to law.
(2) Overseas testing institutions: overseas testing institutions of the People’s Republic of China that issue health toxicology or ecotoxicology test data shall meet the internationally prevailing requirements for good laboratory management. |
| Time limit for handling | (1) Time limit for technical review: 60 days. The time required for the applicant to supplement relevant materials is not included in the time limit for technical review;
(2) Time limit for examination and approval: Within 20 working days from the date of acceptance of the application, the decision on whether to register shall be made. Under special circumstances, ten working days may be extended upon approval. The time of technical review is not included in the approval time limit. |
| Agency service | If you need agency service, please write（ caowei@jizhun.com.cn ）Or call (020-81695425).
Both parties sign a confidentiality agreement (optional), sign an agency contract or agreement, and issue a legal power of attorney; The applicant shall provide the legal person certificate or business license (duplicate, with official seal affixed) of his/her unit, fill in the “Application Form for Conventional Registration of New Chemical Substances” or provide all the information, test reports or data, environmental risk assessment reports, social and economic benefit analysis reports, explanation materials on the necessity of information protection, letter of commitment to implement or transmit environmental risk control measures, and conditions of testing institutions Other information about the characteristics of environmental and health hazards and environmental risks that the applicant has mastered. |
5、 Environmental management registration for new use
| Undertaker | Ministry of Ecology and Environment of the People’s Republic of China |
| Official Guidelines | Log in to the website of the Government Affairs Service Hall of the Ministry of Ecology and Environment of the People’s Republic of China (Internet: http://zwfw.mee.gov.cn ）According to the path: “new chemical substances” theme → 13002 new chemical substances environmental management registration certificate issuance approval items → item declaration, enter the online registration system to handle relevant items |
| Event Type | administrative licensing |
| Charging standard | No official charge (free). |
| Corporate responsibility | Enterprises and institutions engaged in the research, production, import, processing and use of new chemical substances shall comply with the provisions of the Measures for Environmental Management and Registration of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment), take effective measures to prevent and control the environmental risks of new chemical substances, and bear responsibility for the damage caused according to law. |
| Scope of registration | The second paragraph of Article 3 of the Measures for Environmental Management and Registration of New Chemical Substances (Decree No. 12 of the Ministry of Ecological Environment) stipulates that:
The chemical substances that have been listed in the List of Existing Chemical Substances in China shall be managed according to the existing chemical substances; However, if the chemical substances specified in the Directory of Existing Chemical Substances in China are used for industrial purposes other than the permitted ones, the environmental management shall be carried out according to the new chemical substances.
The following chemicals shall be subject to environmental management for new uses: (1) Highly hazardous chemicals (PBT, vPvB or other equivalent environmental or health hazardous chemicals); (2) Persistent and bioaccumulative (PB) or persistent and toxic (PT), or bioaccumulative and toxic chemicals (BT). |
| Registration procedure | Where an applicant applies for environmental management registration for a new use, the applicant shall submit the application form for environmental management registration for a new use, the environmental exposure assessment report and environmental risk control measures for the new use of the chemical substance. For highly hazardous chemical substances, social and economic benefit analysis materials shall also be submitted to fully demonstrate the necessity of using the substance for the purposes for which registration is applied. |
| applicant | Producers, importers or processing users can all be applicants. |
| Data submission | Where an applicant applies for environmental management registration of new chemical substances, the applicant shall submit an application for registration to the competent ecological environment department under the State Council, and shall be responsible for the authenticity, integrity, accuracy and legitimacy of the registration application materials. In case of any inaccuracy, bear all legal liabilities arising therefrom. Encourage registration data sharing. |
| Information protection | (1) It shall be submitted at the time of application for registration or filing, and the materials explaining the necessity of applying for protection of trade secrets shall be submitted; For information that may have a significant impact on the environment and public health interests, trade secrets may not be protected according to law; The applicant may withdraw its request for information protection in writing at any time.
(2) The term of protection for the identification information such as the name of new chemical substances shall not exceed five years from the date of initial registration or filing. (3) The staff and relevant experts engaged in the environmental management and registration of new chemical substances shall not disclose the trade secrets that should be protected according to law. |
| Testing agency | (1) Domestic testing institutions: they shall obtain the qualification certification of inspection and testing institutions according to law, and carry out testing in strict accordance with relevant standards for chemical substance testing; Health toxicology and ecotoxicology testing institutions shall also comply with good laboratory management practices; They shall be responsible for the authenticity and reliability of the test results issued by them, and shall be liable according to law.
(2) Overseas testing institutions: overseas testing institutions of the People’s Republic of China that issue health toxicology or ecotoxicology test data shall meet the internationally prevailing requirements for good laboratory management. |
| Time limit for handling | (1) Time limit for technical review: 60 days. The time required for the applicant to supplement relevant materials is not included in the time limit for technical review;
(2) Time limit for examination and approval: Within 20 working days from the date of acceptance of the application, the decision on whether to register shall be made. Under special circumstances, ten working days may be extended upon approval. The time of technical review is not included in the approval time limit. |
| Agency service | If you need agency service, please write（ caowei@jizhun.com.cn ）Or call (020-81695425).
Both parties sign a confidentiality agreement (optional), sign an agency contract or agreement, and issue a legal power of attorney; The applicant shall provide the legal person certificate or business license (duplicate, affixed with official seal) of his/her unit, fill in the “Application Form for Registration of Environmental Management for New Use” or provide all the information listed in the form, environmental exposure assessment report and environmental risk control measures, social and economic benefit analysis report, and hazard characteristics test report or data. |
6、 Application for change of registration certificate
| NO. | Change | Name of submitted materials | Material issuing unit | medium | Number of copies | requirement |
| 1 | Name change of applicant/agent | Application form and supporting materials for change of routine/simple registration certificate of new chemical substances | Applicant and agent | Electronics | 1 | The application form is filled in, output, signed and sealed through the online registration system, and then uploaded to the online registration system after color scanning (ensuring sufficient clear resolution) |
| 2 | Replacement of agent | Application Form for Change of Conventional/Simple Registration Certificate of New Chemical Substances, Agreement on Termination of Agency Relationship between Registration Certificate Holder and Former Agent, and Agreement on Signing Agency Relationship with New Agent | Registration certificate holder and new agent | Electronics | 1 | The application form is filled in, output, signed and sealed through the online registration system, and then uploaded to the online registration system after color scanning (ensuring sufficient clear resolution) |
| 3 | The type of regular registration activity is planned to change from production to import or the type of activity is planned to increase imports | Application Form for Change of New Chemical Substance Routine Registration Certificate | Registration certificate holder | Electronics | 1 | The application form is filled in, output, signed and sealed through the online registration system, and then uploaded to the online registration system after color scanning (ensuring sufficient clear resolution) |
| 4 | Change of Chinese and English name, CAS number, molecular formula, structural formula and other identification information of new chemical substances | Application form and supporting materials for change of routine/simple registration certificate of new chemical substances | Registration certificate holder | Electronics | 1 | The application form is filled in, output, signed and sealed through the online registration system, and then uploaded to the online registration system after color scanning (ensuring sufficient clear resolution)
The certification materials shall fully demonstrate that the chemical substances before and after the change belong to the same chemical substance. |
| 5 | Change in the amount of simple registration application, activity type, application purpose and environmental risk control measures | Application Form for Change of Simple Registration Certificate of New Chemical Substances and Supporting Materials | Registration certificate holder | Electronics | 1 | The application form is filled in, output, signed and sealed through the online registration system, and then uploaded to the online registration system after color scanning (ensuring sufficient clear resolution)
The certification materials shall fully demonstrate that the chemical substances before and after the change belong to the same chemical substance. |