China New Chemical Substance Registration (referred to as “China Reach”) includes regular registration, simplified registration and filing.
The producer or importer of a new chemical substance shall obtain a new chemical substance environmental management regular registration certificate or a simplified registration certificate or go through a new chemical substance environmental management filing before production or import under China Reach.
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Those who meet the following conditions should apply for simplified registration:
If the annual production or import volume of new chemical substances is more than 1 ton but less than 10 tons, the simplified registration of environmental management of new chemical substances (hereinafter referred to as simplified registration) shall be applied.
Registration period:
Preliminary preparation time: 1 month
Test period: 4-10 months
Registration dossier preparation time: 10-20 working days
Competent department formal review: 5 working days (not counting the time for correction)
Technical review by the competent authority: 30 days.
If, after technical review, it is deemed that the application materials do not meet the requirements, or the necessity of information protection is not fully explained, the applicant shall supplement the relevant application materials at one time within 6 months as required by the supplementary notice.
Approval time: 20+10 working days
The total time consumption for simplified registration: 7-13 months is estimated based on the material properties and existing data.
Simplified registration application materials:
It mainly includes application forms, test reports, determination conclusions and evidence for the persistence, bioaccumulation and toxicity of the applied substances. The specific requirements of the test data need to be analyzed on a case-by-case basis based on the characteristics and purpose of the substance.
Post-registration supervisionunder China Reach:
For detailed post-registration supervision rules, please refer to Tracking Management Requirements for New Chemical Substances after Registration in Part 7 of the "Guidelines for Environmental Management Registration of New Chemical Substances.
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