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Easy registration of new chemical substances
Legal overview

The Ministry Decree No. 12 officially implemented on January 1, 2021, namely the New Environmental Management Registration Measures for Chemical Substances, is a new management standard for new chemical substances in China. The environmental management registration applicable to the research, production, import and processing and use of new chemical substances in China 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 activities 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.

 
Registration scope
Where the annual production or import volume of new chemical substances is more than 1 ton and less than 10 tons, the simple registration of environmental management of new chemical substances shall be handled (hereinafter referred to as simple registration).
 
Registration period:

Preparation time: 1 month

Test period: 4-10 months

Registration file preparation time: 10-20 working days

Formal review by competent authorities: 5 working days (excluding correction time)

Competent department technical review: 30 days.

If the technical review finds that the application materials do not meet the requirements, or the necessity of information protection is insufficient, the applicant shall supplement the relevant application materials within 6 months as required by the supplementary notice.

Approval time: 20+10 working days

 
Handling of hazardous chemicals business license:

Hazardous Chemicals business license acceptance scope:

The State implements a licensing system for the operation of hazardous chemicals. An enterprise dealing in hazardous chemicals shall, in accordance with these Measures, obtain a license for the operation of hazardous chemicals (hereinafter referred to as the operation license). No unit or individual shall handle hazardous chemicals without obtaining a business license.

Conditions for hazardous chemicals production and operation enterprises:

According to Article 34 of the Regulations on the Safety Administration of Hazardous Chemicals, enterprises engaged in the operation of hazardous chemicals shall meet the following conditions:

1, there are business premises that meet national standards and industry standards, and storage of hazardous chemicals, there shall also be storage facilities that meet national standards and industry standards;

2. The employees have received professional and technical training and passed the examination;

3, there are sound safety management rules and regulations;

4, there are full-time safety management personnel;

5. Having emergency plans for hazardous chemical accidents in accordance with the provisions of the State and necessary emergency rescue equipment and equipment;

6. Other conditions stipulated by laws and regulations.

 
Simple registration application materials:

Mainly contains the application form, test report, as well as the durability of the application substance, bioaccumulation and toxicity of the judgment conclusions and basis. The specific requirements of its test data need to be analyzed on a case-by-case basis according to the characteristics and uses of the substance.

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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