South Korea Finalizes New Guidelines for Lifting Bans on Prohibited Ingredients

The amended Cosmetics Act of February 6, 2024, permits cosmetic companies to apply for the lifting or modification of bans on prohibited ingredients. To facilitate the implementation of this change, South Korea's Ministry of Food and Drug Safety (MFDS) officially released and implemented the Regulations on the Lifting or Modification of Bans on Cosmetic Ingredients and the Designation or Change of Cosmetic Ingredient Standards on March 26, 2025, providing guidance to support companies in submitting such applications.

The new regulations clarify that "prohibited ingredients" refer to those listed in Appendix 1 of the "Regulations on Cosmetic Safety Standards, etc.". They also define the following required document types for applications to lift or modify bans on prohibited ingredients and specify the detailed requirements for each type.

No.	Type	Details
1	A summary of all submitted materials
2	Data on the origin and development of raw materials, domestic and international usage standards, and usage status
3	Data on the characteristics of the raw materials
4	Information on safety and efficacy	A. Safety evaluation data (can be exempt from submission for reasonable reasons) Single-dose toxicity tests Skin irritation tests Skin sensitivity tests Mucosal irritation tests Phototoxicity and photosensitivity tests Repeated-dose toxicity tests Reproductive, developmental, genetic toxicity, and carcinogenicity tests Inhalation toxicity tests Human skin irritation tests Skin absorption tests B. Evaluation data on validity (can be exempt from submission for reasonable reasons), including: Data on intended use and function Usage data C. Data for establishing usage criteria
5	Test reports on the standards and testing methods of raw materials