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China Consults on Technical Guidelines for Special Cosmetics with Freckle-removing and Whitening Efficacy

The Guidelines integrates the regulatory requirements for “freckle-removing and whitening cosmetics” in CSAR and its subsidiary regulations, including product definition, scope, requirements for using freckle-removing and whitening agents, prohibited claims, safety assessment, and efficacy evaluation. It provides the basis for registrants to prepare registration documents, and the technical review department to review registration documents.

On August 1, 2022, China National Institutes for Food and Drug Control (NIFDC) released the draft Technical Guidelines for Special Cosmetics with Freckle-removing and Whitening Efficacy (Guidelines) for public consultation. 1 Any suggestions can be sent to before August 16.

Main Content

The Guidelines consists of three parts:

  • Basic Principles of Freckle-removing and Whitening

  • Definition of Freckle-removing and Whitening Cosmetics

  • Technical Requirements for Freckle-removing and Whitening Cosmetics (including product’s basic information, product name, product formula and ingredient use, product’s executive standard, labeling and packaging, product’s testing report, and safety assessment report)

Applicable Scope

Freckle-removing and whitening cosmetics are classified as special cosmetics and subject to registration management in China. The Guidelines is to provide:

The Guidelines does not apply to cosmetics that achieve freckle-removing and whitening effect through physical covering, nor does it apply to general cosmetics.

Definition of Freckle-removing and Whitening Cosmetics

To clarify the scope of freckle-removing and whitening cosmetics, the Guidelines specifies the product definition, and distinguishes them from sunscreen, cleansing, and exfoliating products.


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