South Korea to Update Enforcement Rule of Cosmetic Act

On September 24, 2024, the Ministry of Food and Drug Safety (MDFS) published the draft of Enforcement Rule of Cosmetics Act¹ for public feedback. The authority plans to establish exceptions for labeling information on cosmetics’ external packaging, ban labeling and advertising practices that extend beyond cosmetic scope, and optimize the administrative provisions. Stakeholders can send suggestions to MFDS before November 11, 2024.

The proposed modifications are as follows: 

(1)   Establishment of Exception for Labeling Information on Cosmetics’ External Packaging

According to the Cosmetics Act, expiration dates, precautions, and other labeling items should be indicated on the external packaging of cosmetics. However, the labeling information can be easily confirmed for cosmetics with packaging made of transparent boxes or films. Therefore, the authority proposes to introduce a provision to recognize the "cosmetics with packaging made of transparent boxes or films" as meeting the requirement for "labeling on external packaging" in the draft. That is to say, no labeling items are required for these cosmetic’s transparent external packaging.

(Example of cosmetic with packaging made of transparent box, source from MFDS)

Additionally, the authority proposed to simplify the current labeling requirements for specific situations. For hair dyes and depilatories that have a large number of cautionary statements, only common precautions need to be indicated on the external packaging, while the rest can be included in an attached document. For sets containing two or more cosmetics, the management number in consideration of recall, or a statement indicating the location of the manufacturing number can be labeled instead of displaying each cosmetic’s manufacturing number. As for the expiration date, enterprises can place the earliest expiration date of the cosmetic in the set on the external packaging or indicate the location of the expiration date after opening.

(Example of the expiration date of set cosmetic product, source from MFDS) 

 (2) Prohibition of Advertising and Labeling Beyond Cosmetic Scope

Provisions are to be established to prohibit labeling and advertising that suggest unsafe uses, such as injecting into the body or applying to wounds that fall outside the scope of cosmetics. MFDS also proposes new penalties for violations, including suspension of sales and advertising activities, as well as  business registration cancellation for the fourth offense. 

(3) Introduction of the Application Process for Lifting Restrictions on Prohibited Ingredients

Currently, only ingredients with usage restrictions, such as preservatives, can have their usage standards modified by manufacturers. The proposed amendment allows manufacturers to apply for lifting prohibitions on certain ingredients. The application process will be subject to the same procedures for modifying usage standards for restricted ingredients.

(4) Establishment of Legal Basis for Online Certificates Issuance

A legal basis allowing the online issuance of business registration certificate and functional cosmetic evaluation result, etc., is introduced in the draft. The authority intends to improve the current certificate issuance system and help applicants easily print and keep copies of the registration documents.