China New Chemical Substance Registration
Regulatory Introduction
The Measures for Environmental Management and Registration of New Chemical Substances: Refers to the Ministry of Ecology and Environment Order No. 12, promulgated on April 29, 2020 and officially implemented on January 1, 2021, abbreviated as the Measures or China REACH. Before the production or import of new chemical substances in China, it is necessary to first apply for the registration of new chemical substances and obtain the Environmental Management Registration Certificate for New Chemical Substances (referred to as the "Registration Certificate").
The Measures apply to the registration of environmental management activities engaged in research, production, import, and processing of new chemical substances within China. It is stipulated that before enterprises produce or import new chemical substances into China, they must register new chemical substances that are not listed in the Existing Chemical Substances List of China (IECSC) in accordance with regulations. Only after obtaining the Environmental Management Registration Certificate for New Chemical Substances can they carry out production or import activities of new chemical substances.
Registered enterprise entity
● Domestic enterprises and institutions engaged in the production or import of new chemical substances；
● Overseas enterprises intending to engage in new chemical substance trade activities within China should entrust agents within China to handle them；
● Pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers, and other products belong to new chemical substances and are intended to be changed to other industrial uses by relevant producers, importers, or processing users；
● Producers, importers, or processing users of chemical substances related to the implementation of environmental management for new uses
Note: Exporters from the Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan region are considered overseas declarants。
Scope of substance registration
◆ New chemical substances not included in the List of Existing Chemical Substances in China
(1) General new chemical substances
(2) Substances contained in products or formulations with specific functions such as surfactants, plasticizers, preservatives, dispersants, flame retardants, etc
(3) Substances contained in items that are intentionally released during regular use
(4) UVCB substances, intermetallic compounds, and polymers
(5) Intermediates other than non separated intermediates
(6) Medicines (including active pharmaceutical ingredients), pesticides (including pesticide raw materials), veterinary drugs (including active pharmaceutical ingredients), cosmetics, food, food additives, feed, feed additives, fertilizers, and other products that are changed to other industrial uses, as well as raw materials or intermediates used in the production of the aforementioned products
Chemical substances included in the "List of Existing Chemical Substances in China"
(1) Implementing environmental management for new uses, for chemical substances used for industrial purposes other than those permitted
Registration type
The types of environmental management registration for new chemical substances can be divided into three categories: conventional registration, simplified registration, and filing<
· Regular registration:
For new chemical substances with an annual production or import volume of more than 10 tons
· Simple registration:
For new chemical substances with an annual production or import volume of 1 ton or more but less than 10 tons
· Filing:
1. If the annual production or import volume of new chemical substances is less than 1 ton< 2. Polymers with a monomer or reactant content of no more than 2% for new chemical substances; Or belongs to low attention polymers and does not meet the exclusion criteria for polymer filing;
Zhongbang Consulting has 12 years of experience in responding to new substances, a top-notch team of toxicologists, a sound project management mechanism, abundant laboratory resources, and a series of related work on behalf of new chemical substance declaration, including novelty search, filing, simplified declaration, routine declaration, SDS preparation and labeling, risk assessment report preparation, chemical classification and hazard identification.
The benefits of certification
1 Provide convenient services for enterprises and institutions to handle the registration of new chemical substance environmental management.
2 Further enhance the standardization, standardization, and informatization level of environmental management registration for new chemical substances。
3 Simplify the process of determining health toxicology protocols, which is more conducive to the determination of protocols and saves testing cycles。
4 Specific conditions and requirements have been established for the protection of trade secret information that enterprises are very concerned about。
Services provided
Zhongbang provides one-stop solutions and compliance services for the declaration of new chemical substances：
- • New chemical substance novelty search service
- • Environmental risk assessment report production service
- • New chemical substance registration service
- • Socio economic benefit analysis report production service
- • New use environmental management registration service
- • Existing Chemical Substance List Supplement Service
- • Gap analysis/experimental supervision services
- • Training services for new chemical substance registration regulations
- • PPORD notification service
- • Supplier REACH compliance review service
- • PBT substance analysis and judgment service
- • QSAR/Read Across/Expert Statement Service
Zhongbang is one of the earliest institutions in China to engage in compliance consulting services. It has a senior expert team composed of PhDs, Masters, and Bachelor's degrees, and has established branches in the UK, the United States, South Korea, Beijing, Shanghai, Suzhou, Fuzhou, Shenzhen, and other places, forming a global service network layout.
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Strong technical strength：
A strong team composed of mid to senior technical personnel with professional backgrounds in chemistry, food nutrition and health, medicine, biology, toxicology, environment, and other fields
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International service level：
A business elite team with multiple languages including English, Japanese, German, and Chinese, efficiently serving international customers
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Rich compliance experience：
With years of experience in global product and regulatory research in multiple fields, we are able to provide comprehensive and high-level compliance consulting support to various customers
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Localized service capabilities：
Having multiple branch offices in the UK, USA, South Korea, Beijing, Shanghai, Suzhou, Fuzhou, Shenzhen, etc., we can provide you with services nearby
Service Hotline ：400-115-9001
Zhongbang Consulting (Shandong Zhongbang North Management Consulting Co., Ltd.) focuses on product registration and compliance consulting services. With its professional technology, diverse resources, and global network, we are committed to providing regulatory consulting and environmental regulation response services for pharmaceutical, chemical, consumer goods production enterprises, and large multinational corporations. To solve the environmental, health and safety laws and regulations, product quality standards, and other issues faced by enterprises in production, sales, and global trade processes.
Accumulated Customers
15,000+
Distributed in 35 countries and regions
12year
Industry experience
260+
Senior expert team
15+
Subsidiaries
300+
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The choices and trust of over 15000 customers are the driving force for Zhongbang to continuously improve its services. We are willing to grow together with these excellent enterprises
Service Hotline：400-115-9001
Consultation
400-115-9001