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:
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.
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