China Finalizes Dossier Requirements for Registration and Notification of Cosmetics and New Cosmetic Ingredients

Provisions for Management of Cosmetic Registration and Notification Dossiers (Click here to read the interpretations of the second draft)

1. The detailed documents for cosmetic registration and notification are finalized:

• “Cosmetic Registration and Notification Information Form” and related documents

• Information on the product name

• Product formula

• Product executive standard

• Product label sample manuscripts

• Product testing report

• Product safety assessment documents

2. Imported general cosmetics can be exempted from animal testing from May 1, 2021, under certain conditions. (Click here to see the details)

3. The regulation clarifies the information required for annual reports of general cosmetics, which includes:

• General situation of product production and import, and the suspension of production during the period

• Self-inspection status of product compliance with laws and regulations, mandatory national standards, and technical norms

4. For imported products that are specifically designed for the Chinese market, the following documents shall be submitted:

• Explanatory documents for formula design according to skin types and consumer demands of Chinese consumers.

• Documents of consumer testing research or human trials conducted on selected Chinese consumers in China

*Click here to visit webinar interpreting cosmetic products registration and notification documentation requirements.

Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers (Click here to read the interpretations of the second draft)

1. The detailed documents for new cosmetic ingredients (NCI) registration and notification are finalized:

• The name, address, and contact information of the registrant, notifier, and domestic responsible person;

• New cosmetic ingredient R&D report;

• Research documents on the NCI preparation techniques, stability, and quality control standards;

• Safety assessment documents for NCI;

• Technical requirements (available for public).

2. Three additional toxicological tests are required for high-risk, relative high-risk NCI and NCI with high biological activity first used at home and abroad.

• Teratogenicity test

• Chronic toxicity/carcinogenicity combined test

• Long-term human trial safety test

3. Animal testing alternative method data for NCI registration/notification can be conditionally accepted.

If the animal testing alternative methods (not included in the Safety and Technical Standards for Cosmetics but is validated by an international authoritative alternative method validation agency) are used for toxicological tests for NCI, the evidence proving that the method can accurately predict the toxicological endpoint should be submitted.

Appropriate Integrated Approaches to Testing and Assessment (IATA) should be selected according to the ingredient's structural characteristics and specific toxicological endpoints to evaluate the NCI safety.

*Click here to visit webinar interpreting new cosmetic ingredients registration and notification documentation requirements.