South Korea Issues the Guideline on Reporting Functional Cosmetic

On December 1, 2022, the Ministry of Food and Drug Safety (MFDS) released the official version of the Guideline. 

On November 21, Korean Cosmetic Association (KCA) unveiled a notice¹ to solicit public opinion on the new Guideline on Submission of Reporting Functional Cosmetic.

As per Article 4 of Cosmetics Act², functional cosmetic enterprises shall undergo an examination by Ministry of Food and Drug Safety (MFDS) or submit a report to MFDS for the safety and effectiveness of each product. In line with the provisions in Enforcement Rule of Cosmetics Act³, three kinds of functional cosmetics are subject to the submission of a report in lieu of the examination:

1. Functional cosmetics whose kinds and ingredients, efficacy and effects, methods of use and optimal dosage, standards and testing methods are the same as the items publicly notified by MFDS in Standards and Testing Methods of Functional Cosmetics (Korean Functional Cosmetics Codex, KFCC)⁴.

2. Functional cosmetics whose following items are the same as any functional cosmetics having already undergone an examination concerning the following matters:

1. The kinds, standards, and contents (densities in cases of liquids) of those raw materials performing the efficacy and effects;

2. The efficacy and effects (in cases of tanning products or sunblocks, if their measured values of sun protection factor (SPF) are within the band not exceeding minus 20 percent, they are deemed to have the same efficacy and effects);

3. Standards (excluding pH-related standards) and testing methods;

4. Methods of use and optimal dosage;

5. Dosage forms.

Note, that the above-mentioned "any functional cosmetics having already undergone an examination” refers to the functional cosmetics whose cosmetic responsible distributors are one and the same, functional cosmetics whose cosmetic manufacturers are one and the same, or functional cosmetics whose research institutes that have undergone an examination of functional cosmetics are one and the same. This applies to the situation in the following subparagraph 3.

3. Functional cosmetics whose following items are the same as any functional cosmetics having already undergone an examination and publicly notified by MFDS (limited to the situation of mixing a functional ingredient of tanning products or sun blocks with a functional ingredient of skin-whitening or anti-wrinkle products):

1. The kinds, standards, and contents of those raw materials performing the efficacy and effects;

2. The efficacy and effects (in cases of tanning products or sunblocks, if their measured values of sun protection factor (SPF) are within the band not exceeding minus 20 percent, they are deemed to have the same efficacy and effects);

3. Standards (excluding pH-related standards) and testing methods;

4. Methods of use and optimal dosage;

5. The dosage forms.

The guideline drafts the procedure to submit the report and the instructions for filling in the report for the three situations.

The report submission procedure is as follows:

The instructions for filling in the report via MFDS platform are also detailed in the guideline (Figure 1). 

(Figure 1. Instructions for filling in the general information)

Read More

• Quasi-drug compliance: South Korea Quasi-Drug Regulation

• Functional cosmetic compliance: South Korea Functional Cosmetic Regulation