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South Korea Proposes New Guidelines for Lifting Bans on Prohibited Ingredients

On February 21, 2025, South Korea's Ministry of Food and Drug Safety (MFDS) sought feedback on proposed revisions to the Regulations on the Designation and Change of Cosmetic Ingredient Standards. Stakeholders wishing to provide their opinions on the draft revisions must submit their comments by March 13, 2025.

This update responds to the revised Cosmetics Act of February 6, 2024, which allows cosmetic companies to apply for the lifting or modification of bans on prohibited ingredients. The key revisions in this update include:

  • The regulation's name is updated to the " Regulations on the Lifting or Modification of Bans on Cosmetic Ingredients and the Designation or Change of Cosmetic Ingredient Standards." This name change reflects the expanded scope of the regulations, which now cover both restricted and prohibited ingredients.

  • It clarifies that "prohibited ingredients" refer to those listed in Appendix 1 of the "Regulations on Cosmetic Safety Standards, etc."

  • The amended regulations outline the types of documents required for applications to lift or modify bans on prohibited ingredients (see Table 1). The types and corresponding requirements align with those for changing the usage standards of restricted ingredients.

Table 1: Required Document Types

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 omitted for valid 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 omitted for valid 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


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