South Korea Updates Regulation on the Examination of Functional 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] for public opinion, and soon after announced its implementation ^[3] on December 30, 2020.

Main amendments:

1. 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 capable of the human testing of the alleviating skin itching cosmetics due to the name modification. In the last version, only a medical and pharmaceutical testing institution can conduct the human testing of an “atopy-alleviating” product for the medicine-like categorizing.

2. Human Skin Application Test

The standards about human skin application tests are specified as following the requirements under Regulations on the Demonstration of Labeling and Advertisement for Cosmetic Products ^[5].

The definition of human skin application data:

Paragraph 3 of Article 2 of Regulations on the Demonstration of Labeling and Advertisement for Cosmetic Products

The standard of human skin application data:

Paragraph 2 of Article 4 of Regulations on the Demonstration of Labeling and Advertisement for Cosmetic Products

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 ^[6] and Food Additive Code ^[7].

ChemLinked Note

The updating of Regulation on the Examination of Functional Cosmetics optimized many provisions. However, the new functional cosmetics subject to dossiers exemption were not brought out as clarified in the draft. The authority didn't indicate the reason. We will pay close attention to the regulation updates and publish news. Please stay tuned to ChemLinked Cosmetic News.