On November 6, 2025, the Korean Ministry of Food and Drug Safety (MFDS) announced draft amendments to the Regulation on the Review of Functional Cosmetics and the Standards and Test Methods for Functional Cosmetics.
These two regulations are expected to be revised to add solid agents to the scope of exemptions from submission requirements for functional cosmetics review, based on product formulation.
The key points of the proposed amendments are as follows:
1) Regulation on the Review of Functional Cosmetics
- Conditional approval for the sale of manufactured products prior to the completion of functional cosmetics review
- Expansion of the scope of exemptions from data submission for functional cosmetics review, for example, allowing omission of submission for formulations of whitening, wrinkle-improving, and acne-relief products when adding solid agents
2) Standards and Test Methods for Functional Cosmetics
- Addition of the definition of solid agents to cosmetic formulation definitions
- Addition of nine standards and test methods for whitening and wrinkle-improving solid ingredients
- Addition of eleven analytical methods (Method 2) for quantifying whitening, wrinkle-improving, and UV-filtering ingredients, among others
These amendments aim to support the prompts market launch of functional cosmetics by adding solid agents to the types of functional cosmetics for which submission of safety, efficacy, or functional data may be omitted during the review process.
Please refer to the attached documents below.
< Regulation on the Review of Functional Cosmetics>
< Standards and Test Methods for Functional Cosmetics>
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