South Korea publishes the Animal Testing Method Guidelines for Cosmetics

The South Korean Ministry of Food and Drug Safety (MFDS) announced a new guideline for animal testing on October 18, 2023, entitled Guideline of Alternative Animal Testing Methods for Cosmetics: Eye Irritation (Acute Eye Damage or Irritation) Test using Reconstructed Human Cornea-like Epithelium (RhCE).

Animal testing

Many countries prohibit animal testing. Since 2013, South Korea has also been a pioneer in the protection of animal rights. According to the South Korean Cosmetics Act, no cosmetics or cosmetic materials that have been tested on animals may be supplied in the country. The ban on animal testing also applies to imported cosmetics.

The MFDS has previously issued twenty-nine recommendations previously on alternative animal testing methods to help cosmetic companies conduct safety tests efficiently.

RhCE model

The reconstructed human corneal-like epithelial model (RhCE) is a model created by culturing immortalized human-derived corneal epithelial cells that have a lamellar structure and a highly differentiated squamous epithelium. It consists of at least four living cell layers and measures survival after topical exposure to a test substance. RhCE tissue viability measures the extent to which the bioluminescent dye MTT is converted to formazan dye by living cells and predicts the overall ocular damage/irritation response to chemicals.

Guidelines

The recently published guidelines explain alternative testing methods for eye irritation in cosmetics using the RhCE model. It describes the position of the Food and Drug Administration (FDA) and is based on scientific evidence and laws in effect as of October 18, 2023. It may be applied differently depending on recent amendments.

"Eye damage or irritation" refers to adverse effects such as damage or irritation caused by the test chemical coming into contact with the eyes. The RhCE eye irritation test technique is anticipated to assist companies in developing safer cosmetic products without the use of animal testing.

This test guideline applies to single substances, mixtures, solids, liquids, semi-solids, and waxes. It is applicable to water-soluble or water-insoluble liquids and highly soluble or insoluble solids. It is not appropriate to apply this guideline to gases and aerosols, and scientifically meaningful results should be considered when testing difficult-to-test substances or mixtures not covered by this guideline.