South Korea Sets Risk Levels of Recalled Cosmetics

On Dec. 12, 2019, South Korea implemented the Cosmetics Act 15157 ^[1], Enforcement Rule of Cosmetics Act 1577 ^[2] and Enforcement Decree of Cosmetics Act 30245 ^[3].

1. Cosmetics Act 15157

Compared with the previous version:

The risk levels of recalled cosmetics are newly set.
Expansion of the scope of recalled cosmetics.
Adjustment of maximum fines. When a responsible cosmetic distributor or cosmetic manufacturer is subject to suspension of business activities, the Ministry of Food and Drug Safety (MFDS) may impose penalty surcharges not exceeding one billion won in lieu of suspension.

2. Enforcement Rule of Cosmetics Act 1577

The main amendments are:
1) The risk levels of recalled cosmetics are newly set.

a) The first level: products shall be recalled within 15 days
Cosmetics containing prohibited ingredients or sunscreen agents, preservatives or colorants that are not included in the restricted ingredient list.

b) The second level: shall be recalled within 30 days.

Cosmetics do not use safety containers and packaging
The product contains restricted ingredients which do not comply with the standard (excluding the condition that the use of the functional ingredient does not comply with the standards)

c) The third level: shall be recalled within 30 days

Fully or partially deteriorated cosmetics
Cosmetics contaminated by pathogens
Cosmetics mixed with foreign substances that may cause harm to human health
The product contains restricted ingredients which do not comply with the standard (including the condition that the use of the functional ingredient does not comply with the standards)
Cosmetics with forged or falsified use-by date or best-before date (including the date of manufacture stated)
Cosmetics that manufacturers or responsible distributor found may harm public health and considered it necessary to recall
Cosmetics sold after being manufactured (including manufacturing by consignment) or imported by a person who has not been registered with MFDS
Custom cosmetics sold by a person who did not file a report
Custom cosmetics sold without employing a custom cosmetic compounding manager
Cosmetics with unqualified labeling
Sales of samples for publicity and sales promotion
Packages in which the labeling has been damaged (excluding damage necessary to sell a custom cosmetic), forged or falsified.

2) Functional cosmetics shall undergo an examination by the MFDS before manufacture and import. But two categories of functional cosmetics are exempt from examination and only require submission of a report to the National Institute of Food and Drug Safety (NIFDS). Now the scope of examination exemption expands to three categories.

Undergo an examination by the MFDS

Submission a report to the NIFDS

Single or multi-functional cosmetics with new functional ingredients, dosage form, methods of use and optimal dosage, etc.

1. Functional cosmetics whose kinds and ingredients, efficacy and effects, methods of use and optimal dosage, standards and testing methods are the same as those of any item publicly notified by the MFDS

2. Items the same as any functional cosmetics having already undergone an examination (only limited to functional cosmetics whose responsible sellers or manufacturers are one and the same) with respect to the following matters:
(a) The kinds, standards, and contents of those ingredients displaying the efficacy and effects;
(b) The efficacy and effects (if sunscreens’ measured values of SPF are within the band not exceeding minus 20%, they are deemed to have the same efficacy and effects);
(c) Standards (excluding pH-related standards) and testing methods;
(d) Methods of use and optimal dosage;
(e) The dosage form

3. (Newly added)
Multi-functional cosmetics containing skin-whitening, sunscreen and anti-wrinkle ingredients whose items the same as those products having already undergone an examination or announced by the MFDS with respect to the following matters:
(a) The kinds, standards, and contents of those ingredients displaying the efficacy and effects;
(b) The efficacy and effects (if sunscreens’ measured values of SPF are within the band not exceeding minus 20%, they are deemed to have the same efficacy and effects);
(c) Standards (excluding pH-related standards) and testing methods;
(d) Methods of use and optimal dosage;
(e) The dosage form

If an application for manufacture or import of a functional cosmetic has already been submitted then the product examination will still be conducted in accordance with the old requirements.

3) Extension of the grace period for business registration information changes due to administrative zone restructuring. The grace period was extended from the current 30 days to 90 days.

4) New labeling regulation for solid soap (effective on Dec. 31, 2019).
a) Can label both dry weight and wet weight
b) Can label all ingredients of saponification reaction products

3. Enforcement Decree of Cosmetics Act 30245

Cosmetics without price labeling will be subject to fines.