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Environmental management register for new uses of new chemical substances
Overview of the law

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. It is applicable to the environmental management registration of activities engaged in the research, production, import and processing of new chemical substances in China.

Decree No. 12 stipulates that before enterprises produce or import new chemical substances in China, they must register new chemical substances that are not included in the "List of Existing Chemical Substances in China" (IECSC).

Only after obtaining the environmental management registration certificate of new chemical substances can the production or import of new chemical substances be carried out. Among them, China's new chemical substance registration can be divided into new chemical substance registration, new chemical substance simple registration, new chemical substance routine registration and new use environmental management registration.

 
Environmental Management registration for new chemical substances

1, new use of environmental management registration application:

Chemical substances in the List of Existing Chemical Substances in China that require environmental management for new uses are used for industrial purposes other than permitted uses. There is no limit on the number of applications.

2, new use of environmental management registration subject:

For highly hazardous chemical substances, the holder of the registration certificate for the proposed change of use or producers, importers or processing users other than the holder of the registration certificate for intended industrial use;

Producers, importers or process users of chemical substances with PB or PT or BT properties intended for industrial uses other than permitted uses.

3, new chemical substances new use environmental management registration material requirements:

Application form, legal person certificate or business license, agency contract or agreement (foreign applicant), authorization letter (if necessary), test report or data (if necessary), environmental exposure assessment report and environmental risk control measures for new uses, test report or data related to hazard characteristics of specific exposure routes for new uses (if necessary), Social and economic benefit analysis report (high hazard substances), qualification certificate of the testing institution, and other information about environmental and health hazard characteristics and environmental risks of the applied substances that the applicant already possesses

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
About Us
COC REACH LIMITED specializes in product registration and compliance consulting services. Leveraging its professional expertise, diverse resources, and global network, it is committed to providing regulatory consulting and environmental compliance services to pharmaceutical and chemical companies, consumer goods manufacturers, and large multinational corporations. It addresses issues related to environmental health and safety laws, product quality standards, and other challenges faced by enterprises during production, sales, and global trade processes.
Accumulated Customers
18,000+
Distributed in 35 countries and regions
15year
Industry experience
260+
Senior expert team
15+
Subsidiaries
300+
Collaboration Cases
  • Ireland Dublin
  • USA Denver
  • Korea Seoul
  • UK London
  • Qingdao
  • Beijing
  • Shanghai
  • Shenzhen
Contact Us
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.
400-115-9001
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