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South Korea Requires Establishment of Product Safety Data on Cosmetics for Children

Jan 20, 2020
Hedy He
Responsible distribution managers of infant and children cosmetics use shall establish and keep product safety data.

On Jan. 16, 2020, South Korea implemented the Cosmetics Act (No. 16298) [1]. The main amendments are as follows:

1. Responsible distribution managers of cosmetics for children and infant shall establish and keep product safety data. Product safety data includes:

Documents RequiredDetails [2]
Product description and manufacture method

  • Product management standard

  • Product standard (for imported products, import management record including manufacture method explanation shall be provided)

Cosmetics safety evaluation data

  • Ingredient safety assessment report such as toxicity assessment

  • Abnormal information collection, inspection, assessment and treatment

Proof of product efficacyProof of product efficacy claimed in label or advertised

*The safety data of each product shall be kept in paper or electronic form, and backup files shall be kept

2. South Korean Ministry of Food and Drug Safety (MFDS) shall conduct regular inspections of cosmetics claiming or advertising to be infant and children cosmetics. The inspection items include cosmetics safety data, consumer usage status and adverse reaction information.

Tags : South KoreaChildren CosmeticsPre-market Approval
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