Consultation open on proposed revision of cosmetics safety standards in South Korea

On  August 2, 2024, the Ministry of Food and Drug Safety (MFDS) of South Korea announced a proposed amendment to its ‘Regulations on Cosmetic Safety Standards’, which aims to strengthen public health by revising safety standards for cosmetic ingredients. The MFDS is seeking public comments on these amendments until October 3, 2024, and the revised regulations will come into effect six months after their announcement.

Updates and New Ingredient Limits

The amended regulations remove a combination of lawson and dihydroxyacetone from the list of UV-blocking ingredients and introduce a new UV-blocking ingredient, tris-biphenyl triazine, with specific limits on its use in aerosol products and requirements for particle size and purity. The amendment also specifies new or revised limits for several raw materials. This amendment reflects ongoing efforts to enhance cosmetic safety, particularly concerning UV-blocking agents and raw materials with potential health risks.

Proposed Amendment

The proposed amendment to the "Regulation on Safety Standards etc. of Cosmetics" is as follows:

1) Impose restrictions on some cosmetic substances

• 2,6-Dihydroxyethylaminotoluene (hair dye substance):

  • No restrictions up to 1.0%.

  • Not to be used with nitrosating agents.

  • Total nitrosamine content must not exceed 50 ppb.

• Nonoxynol-9: No restrictions up to17.2%.

• Butylphenyl Methylpropional: No restrictions up to 0.14%.

• Cyclotetrasiloxane: No restrictions up to 8.7%.

• Cyclopentasiloxane: No restrictions up to 19.7%.

2) Changes to restrictions on maximum concentration of UV filters in cosmetics

• Addition: Tris-biphenyl triazine

  •  Permitted up to 10%.

  • Not to be used in aerosols.

  • If used in nanoparticles the particle size must be greater than 80 nm and the purity must be at least 98%.

• Deletion: Compounds of lawsone and dihydroxyacetone

• Reduction of allowable concentrations for benzophenone-3(oxybenzone):

  • Allowed up to 2.4% for general use

  • Allowed up to 5% in the face, hand, and lip products)

A partial amendment notice has been sent to the Ministry of Food and Drug Safety seeking feedback on the use of six chemicals in cosmetics, including benzophenone-3. The notification asks for an opinion for or against the use the substances, along with the organization or group's name, address, and phone number. The notice also mentions the addition of one UV-blocking component to the list of raw ingredients that require limits on cosmetics use.