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South Korea to Exempt More Functional Cosmetics from Evaluation Dossier Submission

New functional cosmetics subject to dossiers exemption are proposed. General testing institutions are to be approved for the human testing of alleviating skin itching cosmetics.

In South Korea, the Regulation on the Examination of Functional Cosmetics [1] regulates the evaluation requirements for functional cosmetics registration, including the evaluation procedure, necessary dossier, exception conditions, etc. On October 7, 2020, MFDS (Ministry of Food and Drug Safety) unveiled the draft of Regulation on the Examination of Functional Cosmetics [2] to solicit public opinion. The consultation period will last until October 28, 2020. Any suggestions can be sent to

Main amendments:

1. New Functional Cosmetics Subject to Dossiers Exemption

As stipulated under Article 4 of Cosmetics Act [3], the cosmetic manufacturer or responsible cosmetic distributor shall undergo a safety and effectiveness examination for each product and submit the dossiers necessary for the examination before selling. The competent authority intended to add new functional cosmetics subject to the dossier exemption for easing the enterprises' burden.

According to the exposure draft, the alleviating hair loss cosmetics containing either of the following two raw materials would be exempted from the evaluation dossier submission:

Raw Materials


Complex (Dexpanthenol 0.2 %, Salicylic Acid 0.25 %, and L-menthol, 0.3 %)


Complex (Niacinamide 0.3 %, Dexpanthenol 0.5 %, Biotin 0.06 %, Zinc pyrithione liquid (50%) 2.0 %)

 2. Amendments to the testing institutions

The category name of “functional cosmetics helpful in alleviating the skin dryness caused by atopy” is changed to “functional cosmetics helpful in restoring the skin barrier function to relieve the skin itching” on August 5 (Find more at ChemLinked News [4]). Therefore, the general testing institution is expected to be capable of the human testing of the alleviating skin itching cosmetics due to the name modification. In the present provisions, only a medical and pharmaceutical testing institution can conduct the human testing of an “atopy-alleviating” product for the medicine-like categorizing.

3. Provisions Updating

Certain specs such as the incorrect scientific name, redundant contents are modified to align with the amendments in the superordinate laws of Cosmetics Act [3] and Food Additive Code [5].

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