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Routine registration of new chemical substances
Legal overview

The Measures for the Registration of the Environmental Management of New Chemical Substances, that is, the Ministry Order No. 12, is a brand new management standard for new chemical substances in China.

Before the production of new chemical substances in China or the import of new chemical substances into China, for chemical substances not included in the "List of Existing Chemical substances in China" (that is, IECSC), it is necessary to register new chemical substances in accordance with the regulations, after obtaining the environmental management registration certificate of new chemical substances, the production or import of new chemical substances can be carried out.

China's new chemical substance registration is divided into new chemical substance filing registration, new chemical substance simple registration, new chemical substance routine registration and new use environmental management registration.

 
Routine registration of new chemical substances

1, new chemical substances routine registration application:

Annual production or import of new chemical substances of 10 tons or more.

2, new chemical substances routine registration subject:

Domestic production enterprises/import enterprises and overseas enterprises exporting to China (must entrust domestic agents).

3, new chemical substances routine registration material requirements:

Application form, legal person certificate or business license agent contract or agreement (overseas applicant), authorization letter (if required), test report or information, environmental risk assessment report, social and economic benefit analysis report (high hazard substances), Necessary information protection materials (if required), commitment to implement or transmit environmental risk control measures and environmental management requirements, qualification certificate of testing organization, other information already in the possession of the applicant about the environmental and health hazard characteristics and environmental risks of the applied material

4, the routine registration cycle of new chemical substances: 14~24 months

5. Obligations after routine registration of new chemical substances:

Information transfer, data preservation, information disclosure, first activity report, annual report, new hazard information and environmental risk tracking, subject to environmental supervision spot checks.

The services we provide
  • Domestic Agent Annual Service
  • New Chemical Discovery Service
  • New Simple Registration Service for chemical substances
  • Registration overall plan development
  • Data evaluation/Gap analysis/Exemption analysis/PBT attribute identification
  • QSAR/ Cross-reference and other non-testing report production
  • Competent authorities/Expert consultation communication
  • Translation of regulatory documents and application materials
Service Advantages
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.
  • 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
  • International service level:
    A business elite team with multiple languages including English, Japanese, German, and Chinese, efficiently serving international customers
  • 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
  • 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
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About Us
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.
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If you have any issues related to environmental health and safety laws and regulations, product quality standards, etc. that need to be resolved in import and export trade, you can contact us for assistance.
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