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CSAR Subsidiary Regulations: China Deletes One Exceptional Circumstance for Animal Testing Exemption

China is soliciting feedback on the second draft of the Instructions for Cosmetic Registration and Notification Dossiers, which made several significant amendments to the cosmetic registration and notification dossiers. The supervision over children cosmetics will be strengthened going forward. The exceptional circumstances of animal testing exemption are reduced from 4 to 3.

Less than three months after China’s National Institutes for Food and Drug Control released the draft Instructions for Cosmetic Registration and Notification Dossiers, an updated version was drafted for public comments by the NMPA on November 5, 2020 [1]. The new draft of the Instructions for Cosmetic Registration and Notification Dossiers includes a total of 6 chapters, 57 articles, and 25 attachments, with aims to further clarify and refine the provisions in the previous draft, and shift the focus of cosmetic supervision from pre-market assessment to in-and post-market management.

The second round of consultation will close at the end of November. Any suggestions can be mailed to ChemLinked (cosmetic@chemlinked.com) before November 29, 2020, and we will submit to the NMPA.

Note: Text in red indicates changes in comparison to the first draft. Strikethrough indicates a removal from first draft. 

Key Points

Compared to the first draft released on August 28, 2020, the major updates of the new draft are concerned with cosmetic pre-market application dossiers, such as product testing report, safety assessment document, product executive standard and etc.

Specifically, the new draft revises the naming of some documents, as shown below.

Cosmetic Registration and Notification Dossiers

First Draft

Second Draft

  1. Registration application form or notification information form and related documents (including information on registration applicant or notifier, production enterprise, and domestic responsible person);

  2. Information on the product name;

  3. Product formula;

  4. Product executive standard;

  5. The label sample manuscript of the registered product or the sales packaging pictures of the notified product;

  6. Product testing report;

  7. Product safety assessment documents.

  1. “Cosmetic Registration and Notification Information Form” and related documents;

  2. Naming basis of the product name;

  3. Product formula;

  4. Product executive standard;

  5. Product label sample manuscripts;

  6. Product testing report;

  7. Product safety assessment documents.

Besides, the requirements for each of the above mentioned dossiers are further modified and refined in a bid to add clarity and increase the logicality of the regulation. Among them, the following are of great significance:

1. Product Testing Report

In this new draft, China reiterates that the relevant toxicological test items of general product can be exempted provided that the production enterprise has obtained the GMP certifications from the local government, and the product safety risk assessment results can fully verify the product safety. 

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