Korea Newly Designated Functional Cosmetics---More information on Registration

  •   14 Aug 2017
  •    Jo Zhou

    Take home:

    In H1 2017, Korean cosmetic authorities newly designated 4 quasi-drug categories as functional cosmetics (see news on CL). Now Korea Cosmetic Association released more instructions on how to register these new functional cosmetics in a Q&A format.

    On Technical review

    Q1:If I want to use new ingredients in a hair dye product, what special documents should I submit?

    A: The product should first comply with cosmetic distribution standard, and if ingredients are listed the International Cosmetics Ingredients Dictionary (ICID) (published by Cosmetic, Toiletry, and Fragrance Association), the safety data can be exempted. Otherwise the product requires submission of safety data and hair dye efficacy data.

    Q2: For hair loss products which are undergoing re-evaluation, can product name be changed? How long will it take for re-evaluation if product information is changed?

    A: Because hair loss products have been changed from quasi drug to functional cosmetics, the data submitted should be re-evaluated. Before the re-evaluation is complete, product information can be changed. The length of re-evaluation depends on what information has been changed:

    1. Change name of the product -- 15 days for re-evaluation process;

    2. Change ingredients or proportion of each component in the formula. Amendment of additives should comply with cosmetic rules. Product form should remain unchanged – 2 weeks;

    3. Change other information– 60 days.

    Q3: For product to relieve acne and product to relieve hair loss, does Korea provide guidelines for related human body testing methods?

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    Hi Jo, Some ingredients approved to use in Quasi-drugs (such as hair dye products) previously, but are prohibited in cosmetics regulation. As the products are classified as functional cosmetics, is it still allowed to use these ingredients? for how long? Do you know whether or not MFDS is going to revise the current cosmetics regulation for adopting these ingredients with certain conditions? Thanks.
    Thank you for your comments. The MFDS has revised its ingredients standards for functional cosmetics. Take hair dye products for example, the revised standards include those permitted ingredients for hair dye but only exclusive to use in hair dye products. Chemlinked has updated this news, you may refer to https://cosmetic.chemlinked.com/news/cosmetic-news/summary-korea-recent-ingredients-requirement-changes. Hope this will help. Regards.