On March 26, 2025, the Ministry of Food and Drug Safety (MFDS) of South Korea issued Notice No. 2025-17, which revises regulations concerning the lifting and change of the prohibition on the use of cosmetic ingredients and the designation or alteration of use standards. This revision aims to establish a clear process for the evaluation and approval of raw materials in cosmetics, ensuring that safety and efficacy standards are upheld. The revised regulation effective as of the notification date, March 26, 2025.
The Revised document provides following chapters:
Chapter 1: General Provisions
Article 1 (Purpose): The regulation establishes guidelines for cosmetic manufacturers, distributors, and research institutes applying for the cancellation or modification of prohibited ingredients. It also sets out the procedure for establishing use standards for ingredients with undefined usage limits.
Article 2 (Definition): ""Standards for use"" refers to restrictions on the concentration, application, and type of raw materials that must adhere to safety standards.
Article 3 (Subject of Examination): Those eligible to apply for an examination include:
Ingredients subject to cancellation or modification from Schedule 1 of the Cosmetics Safety Standards.
Preservatives, sunscreen ingredients, and other substances not listed in Schedule 2.
Pigments not covered in the ""Pigment Types and Standards of Cosmetics.""
Changes to the use standards of materials listed in either Schedule 1 or 2.
Chapter 2: Handling of Examinations
Article 4 (Types of Submitted Materials): Applicants must provide:
Summary of all submitted materials.
Data on raw material origins, development, use standards, and safety evaluations.
Safety evaluation data including tests for skin irritation, toxicity, genotoxicity, reproductive toxicity, and more.
Test reports on raw material standards and methods.
Article 5 (Requirements for Submitted Materials): The application must include:
A summary of the application, including reasons for lifting or modifying the prohibition on raw materials.
Data on the raw material’s origin, development, and usage status both domestically and internationally.
Comprehensive safety and efficacy data.
Test reports based on established scientific methods.
Article 6 (Supplementation of Submitted Data): Applicants may be required to supplement or provide additional data if requested by the MFDS.
Article 7 (Notification of Nonconformity and Appeal): Applicants can appeal if the submitted materials do not meet the necessary criteria.
Chapter 3: Supplementary Provisions
Article 8 (Expert Advice): The MFDS may consult external experts for opinions on lifting or modifying the prohibition on the use of raw materials.
Article 9 (Notification of Ingredients Lifted from the Prohibition of Use): The MFDS will announce the approved ingredients and their corresponding usage standards on its website.
Article 10 (Deadline for Review): The regulations specify timelines for reviewing and processing applications.
Source:
News Region:
ASEAN
News Market:
South Korea