Takehome:
- MFDS require clarifications on claims of functional cosmetics;
- This amendment was put into the Enforcement Rules of the Cosmetic Act and has been effective since 2017.11.17.
MFDS require newly designated functional cosmetics used for skin allergy, acne, striae gravidarum (pregnancy stretch marks) and hair removal to add a claim: "can't prevent or treat disease"on the label. Because these functional cosmetics have just been converted from quasi-drug category, the new requirement aims at helping consumers to differentiate between these products and pharmaceutical drugs.
To make the new requirements mandatory, MFDS revised its Enforcement Rules of the Cosmetic Act and include the requirement into the Act as follow:
- Article 19 No.7 (4): the functional cosmetics described in Article 2 No.8 to No.11 can’t prevent or treat disease;
- Attachment 4, Item 7 “Functional Cosmetic Specification and Claim”: According to the requirement of Article 19 No.7 (4), the claims should be put below the label of the product;
- The amendment enters into force immediately after the publication on Nov. 17 2017.
MFDS also allowed a grace period of 6 months for already marketed products, after 6 months, all the designated functional cosmetics should change their labels.