China New Chemical Substance Registration
Regular Registration
2025-01-19 visibility

The environmental management registration of new chemical substances includes full registration, simplified registration and notification. 
The producer or importer of a new chemical substance shall obtain a full registration certificate or a simplified registration certificate for the environmental management of the new chemical substance or apply for the notification of the environmental management of the new chemical substance before production or importation. 


If the following conditions are met, full registration shall be carried out:

If the annual production or import volume of a new chemical substance is more than 10 tons, the full registration of a new chemical substance (hereinafter referred to as full registration) shall be completed. 
 
Full registration timeline of new chemical substances:

Preliminary preparation time: 1-2 months

Test period: 9-36 months

Registration dossier preparation time: 1-2 months

Formal examination by the competent department: 5 working days (excluding the time for supplementation and correction)

Expert technical review: 60 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 at one time within 6 months according to the requirements of the supplementary notice

Approval time: 20+10 working days

Full registration of the total timeline: 14-40 months is appropriate according to the substance property, PBT property, available data and use.
 
Full registration application materials
Mainly include the application form, test report, environmental risk assessment report, and social and economic benefit analysis report (pertaining to high-hazard new chemical substances). The specific requirements for the test data need to be analyzed on a case-by-case basis according to the characteristics and uses of the substance.
 
Post-registration supervision:

  1. The holder of the registration certificate shall carry out activities in accordance with the matters specified in the registration certificate.
  2. Processing users shall not process or use new chemical substances that have not obtained a registration certificate or have not been recorded.
  3. The registration certificate is non-transferable.
  4. The validity of the fulll registration certificate is from the date of issuance until the date the new chemical substance is included in the IECSC list.
  5. Producers, importers, and processing users of new chemical substances shall transmit information related to new substances to downstream users and properly preserve evidence of information transmission.
  6. The holder of the registration certificate shall submit a report on the first activity of the new chemical substance within 60 days from the date of the first production activity or the date of the first import and transfer to the processing user.
  7. If the environmental management requirements on the full registration certificate stipulate the requirements for the submission of annual reports, the holder of the registration certificate or their designated agent shall submit an annual report on the new chemical substance by April 30 of each year starting from the year following the date of registration.
  8. Registration materials and records of the activities of new chemical substances and other relevant materials shall be kept for at least 10 years.

For detailed post-registration regulatory details, please refer to Part VII of the "Guidelines for Environmental Management and Registration of New Chemical Substances" - Post-registration Follow-up Management Requirements for New Chemical Substances.
 
Friendly Reminder:

  1. The full registration of new chemical substances applies to special forms such as 'serial registration' and 'joint registration';
  2. The specified ecological tests must be conducted using Chinese test organisms;
  3. The preliminary assessment of the basic properties, uses, declared amounts, accumulation, degradability, and toxicity of substances is crucial for the project's deployment, and it is necessary to analyze the characteristics and uses of the substances to provide the most efficient combination of testing solutions. BoardingCard has compiled the following for your reference. If you encounter any issues during the self-assessment, you can call our consultation number or email us for inquiries.
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