APAC’s regulatory portal, Chemlinked, has reported that the country’s Cosmetics Act, which is governed and overseen by Ministry of Food and Drug Safety (MFDS), has amended the act to change the status of four categories of quasi-drugs to functional cosmetics.
The change, which will take effect from 30th May 2017, marks Korea’s efforts to maximise product safety and consumer confidence.
Cosmetics status and definitions
The act, which became effective as of 31st July 2014, regulates the manufacture, import and sale of cosmetics and cosmetic ingredients. It also provides comprehensive guidance on product labelling and advertising to ensure this product safety is achieved and that ingredients are clearly communicated to consumers upon purchase.
Quasi-drugs refer to products marketed for use in disinfection, insecticide or other similar purposes to prevent infectious diseases.
Chemlinked states that in Korea, functional cosmetics are defined as products that support skin brightening, wrinkle improvement, gentle tanning or protection from ultraviolet radiation.
As of 30th May 2017, hair dye, decolorant, bleach agent; epilating agent; anti-hair loss agent; and the preparation of relieving acne in bath solvents will be removed from the list of quasi-drugs and reassigned to functional cosmetics. Bath solvent products that have not been designed to reduce the effects of acne will be classified as general cosmetics.
Changing the status of these products to functional cosmetics places more stringent regulations on manufacturers than those that are in place for general cosmetics. As a result, moving forward, all anti-ageing, whitening and sunscreens products are subject to closer scrutiny.
These newly-assigned functional cosmetics will undertake safety and efficacy evaluation before manufacturing and import can take place. Once registered, these developers will receive the categorisation of “cosmetic manufacturers” or “marketing authorisation holder”, which then enables them to manufacture and import these items.
Under Article 30 of the Cosmetic Act, this evaluation is not applicable to those products that are exclusively developed for export purposes. Existing products that have a quasi-license will need to submit license information and supporting documentation to accompany the process to assist the change in status from quasi-cosmetics to functional cosmetics.
To support improved cosmetics safety and efficacy in Korea, the country will strengthen claims requirements for functional cosmetics including those that relate to acne, allergy, rhagadia and cavities.
Product packaging will change from typical and original wording such as “ help relieve acne”, “help relieve dryness for hypersensitive skin”, “help relieve red lines caused by rhagadia” and “help relieve calvities phenomena” to read “this product is not a drug to prevent or cure disease”.
A public consultation relating to this policy is open until 13th June 2017.