National Service Hotline:
One-stop chemical compliance services, providing chemical compliance consulting services
Information Details
Introduction of Changes and Requirements for Registration Certificate of New Chemical Substances under Decree No.7
Release time:
2022-10-10 10:19
The Measures for the Registration of Environmental Management of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment, hereinafter referred to as the "Measures") shall come into force on January 1, 2021. The Measures clearly stipulate that if the environmental management registration of new chemical substances has been completed 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, hereinafter referred to as "Order No. 7"), the Announcement on the Connection Matters Related to the Registration of Environmental Management of New Chemical Substances also clarifies that the registration certificate of Order 7 can be changed in some cases.
The management ideas and data requirements of the new and old laws and regulations have changed to a certain extent. Compared with the changes, re-registration means spending more time and money in most cases. According to the current implementation of the laws and regulations, only substances with annual production/import volume of less than 1 meal can be directly re-applied for filing, and after submission, they can be or can be subject to filing receipt. Direct re-registration is not recommended in other cases. The specific circumstances and requirements that can be changed are as follows:
Change of Registration Certificate regular Order 7
Reason for change:
Under any of the following circumstances, the holder of the registration certificate may apply for the change of the registration certificate by reference to Article 30 of Decree No. 12:
1. The registration volume is to be reduced;
2. The type of activity is intended to change from production to import or increase imports;
3. Registration of the Chinese and English name of the new chemical substance or the identification information such as the Chemical Abstracts Service number (CAS number) to be changed;
4. The name of the applicant or agent is to be changed.
Change process:
1. Change and Material Requirements
1. Change of Name of Applicant/Agent
If the name of the applicant/agent is to be changed, the applicant and the agent shall jointly submit an application for change to the competent department of ecological environment under the State Council, explaining the reasons and specific circumstances of the change, including but not limited to the name change, merger, split, asset acquisition, merger and acquisition, etc., and submit supporting materials.
2. Replacement of registered agent
If the holder of the registration certificate intends to change his agent, the holder of the registration certificate and the new agent shall jointly submit an application for change to the competent department of ecological environment under the State Council, and provide the agreement between the holder of the registration certificate and the former agent to terminate the agency relationship, as well as the agreement with the new agent to enter into the agency relationship and other materials. The agency agreement should clearly stipulate the liability before and after the agent's replacement.
3. Changes in identification information such as English name, CAS number, molecular formula and structural formula of new chemical substances
If it is proposed to change the registration of the Chinese and English name, CAS number, molecular formula and structural formula of the new chemical substance, the holder of the registration certificate shall submit an application for the change to the competent department of ecological environment under the State Council, provide scientific reasons and evidence for the change, and fully demonstrate that the chemical substance before and after the change belongs to the same chemical substance in the certification materials.
4. The volume of registration is to be reduced, the type of activity is to be changed from production to import, or the type of activity is to be imported.
If the registration volume is to be reduced, the type of activity is to be changed from production to import, or the type of activity is to be increased, the holder of the registration certificate shall submit an application for change to the competent department of ecological environment under the State Council, explaining the reasons for the change.
2. Change Procedure
The change shall be handled in accordance with the simple registration procedure. The change application materials shall be filled and submitted through the online registration system. If the conditions for change are met, the change shall be made, the electronic registration certificate shall be renewed, and the change information shall be indicated in the registration certificate. Where it is proposed to change the Chinese and English name, CAS number, molecular formula and structural formula of the new chemical substance, the competent department of ecological environment under the State Council may organize an expert committee to conduct technical review.
Change of Summary Registration Certificate of Order 7
Reason for change:
Under any of the following circumstances, the holder of the registration certificate may apply for the change of the information contained in the registration certificate by reference to Article 30 of Decree No. 12:
1. The registered amount after the change is less than 1 ton/year;
2. If the registration certificate is obtained for the purpose of process and product research and development, the registration volume after the change is less than 10 tons, and the registration certificate is still within the validity period;
New chemical monomer content of not more than 2% of the polymer or belong to the low concern polymer.
Change process:
1. Change and Material Requirements
1. Change of Name of Applicant/Agent
If the name of the applicant/agent is to be changed, the applicant and the agent shall jointly submit an application for change to the competent department of ecological environment under the State Council, explaining the reasons and specific circumstances of the change, including but not limited to the name change, merger, split, asset acquisition, merger and acquisition, etc., and submit supporting materials.
2. Replacement of registered agent
If the holder of the registration certificate intends to change his agent, the holder of the registration certificate and the new agent shall jointly submit an application for change to the competent department of ecological environment under the State Council, and provide the agreement between the holder of the registration certificate and the former agent to terminate the agency relationship, as well as the agreement with the new agent to enter into the agency relationship and other materials. The agency agreement should clearly stipulate the liability before and after the agent's replacement.
3. Changes in identification information such as English name, CAS number, molecular formula and structural formula of new chemical substances
If it is proposed to change the registration of the Chinese and English name, CAS number, molecular formula and structural formula of the new chemical substance, the holder of the registration certificate shall submit an application for the change to the competent department of ecological environment under the State Council, provide scientific reasons and evidence for the change, and fully demonstrate that the chemical substance before and after the change belongs to the same chemical substance in the certification materials.
4. The type of activity proposed to change from production to import or the type of activity proposed to increase imports
If the type of activity is to be changed from production to import or the type of activity is to be increased, the holder of the registration certificate shall submit an application for change to the competent department of ecological environment under the State Council, explaining the reasons for the change.
2. Change Procedure
The change shall be handled in accordance with the simple registration procedure. The change application materials shall be filled and submitted through the online registration system.
If the conditions for change are met, the change shall be made, the electronic registration certificate shall be renewed, and the change information shall be indicated in the registration certificate. Where it is proposed to change the Chinese and English name, CAS number, molecular formula and structural formula of the new chemical substance, the competent department of ecological environment under the State Council may organize an expert committee to conduct technical review.
Our services:
Comprehensive consultation on 1. and regulations and substance novelty search service
(1) Professional regulatory advisory services
(2) New chemical substance search service (IECSC open database query, entrusted new search)
2. New Chemical Substance Registration Agency Services
(1) Registered Agent Services
(2) New chemical substance registration service (filing/simple registration/regular registration)
(3) Registration of the overall program customization
(4) Substance data assessment/gap analysis/exemption analysis
(5) Laboratory test supervision service
(6) Preparation of risk assessment report
(7) Competent department/expert communication and consultation
(8) Translation of regulatory documents and registration materials
3. Registration Agent Maintenance Service
(1) Post-registration services for new chemical substances
(2) Regulatory training services
New Anrun Chemical Regulations Advisory Services:
Declaration of new domestic chemical substances
Registration of hazardous chemicals and business license for hazardous chemicals
SDS/GHS Labeling
Declaration of cosmetic finished products and raw materials
EU REACH, Taiwan REACH, South Korea K-REACH Registration
Pharmaceutical, food contact materials regulatory consultation
Compliance services in countries where epidemic prevention materials are exported
Laboratory Testing Services
Environmental regulations consulting services
Including carbon sink consulting, solid waste hazardous waste integrated solution design, etc.
Contact: Miss Ann
Mobile phone number: 15801695345 (WeChat with the same number)
QQ: 1798064165
Electronic E-mail: nar@china-reach.net
National Service Hotline:
Beijing Headquarters: D10, Floor 4, Block A, Borui Building, No.26, Dongsanhuan North Road, Chaoyang District, Beijing, China
Tel: 86-010-6471 0683
Shanghai: Room D308, Zhongyi International Building, Puxing Highway 800, Minhang District, Shanghai
Tel: 86-021-3478 3993
Guangzhou: Room 201, Xinying Technology Park, No. 313 Jinxin Avenue, Panyu District, Guangzhou
Tel:400 660 1329
E-mail：nar@china-reach.net
Copyright: New Anrun (Beijing) Consulting Co., Ltd.
