JNM Global

Global Approval Partner

JNM Global/Cosmetic

Korea MFDS, Revises Guidelines for Testing Methods for Cosmetic Labeling and Advertising Claims

JNM Global 제이엔엠글로벌 2024. 12. 13. 13:12

On November 29, 2024, the Korean Ministry of Food and Drug Safety (MFDS) revised the Guidelines for Testing Methods for Cosmetic Labeling and Advertising Claims by adding a new section (Chapter 11) on temporary reduction of pore size and similar claims. This revision aims to provide testing methods necessary to substantiate labeling and advertising claims, protecting consumers from false or exaggerated advertisements and enhancing the credibility of cosmetics.

 

The revised guidelines present testing methods to substantiate claims related to temporary reduction in pore size, in addition to other claims such as skin moisturizing, elasticity improvement, sebum regulation, and dark circle reduction. This helps protect consumers from false or exaggerated advertising and enhances the credibility of cosmetics.

 

The revised guidelines provide general requirements, testing conditions, methods, and reporting for testing temporary reduction in pore size and similar claims.

 

1) Test Subjects

 Male and female participants aged 19 years and older with visibly noticeable pores on the check area (pore grade 3* or higher) *Pore Grade 3: Pores are enlarged and easily visible to the naked eye.

 

2) Evaluation

 If the comparison results before and after the use of the test substance show a decrease in the evaluation values, it indicates an improvement in pore size. Statistical significance is determined when the p-value is less than 0.05 (p<0.05), indicating that the test substance has a temporary effect on reducing pore size and similar parameters. The primary efficacy evaluation variables include the number of pores, pore area, and pore depth (first efficacy evaluation variables), as well as survey items from the test subjects (secondary efficacy evaluation variables).

 

3) Judgement

 The product should be applied for at least 4 weeks, and comparison tests before and after use must show statistically significant effects across all primary efficacy evaluation variables. No adverse reactions should occur. The survey results from test subjects serve as supplementary date to the primary efficacy evaluation results.

 

Please refer to the attached document below.

화장품+표시광고+실증을+위한+시험방법+가이드라인(민원인+안내서).pdf
2.13MB


If you have any questions about medical device,

please contact us with the below.

ra@jnmglobal.net

info@jnmglobal.net