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As the enhanced requirements of custom cosmetics in Cosmetics Act1 came into effect on February 18, 2022, the amendments on facility standards, material reporting, and other administrative provisions in its downstream laws are updated as well on the same day.
The relevant downstream laws include:
Enforcement Decree of Cosmetics Act2
Enforcement Rule of Cosmetics Act3
Regulation for Notification of Cosmetics Manufacturing & Import Amount and Lists of Ingredients4
Regulation on the Management of Safety Information for Cosmetics5
Requirement on Operating Custom Cosmetics Compounding Manager Qualification Test6
The detailed amendments are as below:
1. Detailing New Penalty Standards in Enforcements Decree of Cosmetics Act
Violations | Penalty |
Utilizing the name of the "custom cosmetic compounding manager" or any name similar to the "custom cosmetic compounding manager" improperly. | 1 million KR won (about 837 US dollars) |
Failing to complete the compulsory education stipulated forthe responsible cosmetic distributor and compounding managers | 5 hundred thousand KR won (about 418 US dollars) |
Failing to report the raw material list (applicable to the custom cosmetic sales business entity) | 5 hundred thousand KR won (about 418 US dollars) |
2. Specifying Custom Cosmetic Facility Standards and Material Reporting Methods in Enforcement Rule of Cosmetics Act
Amendments | Details |
Custom Cosmetic Facility Standard | The person who intends to apply for the custom cosmetic sales business shall conduct the mixing or division into smaller amounts of custom cosmetics in a place that is separated from the places for conducting other business. |
Raw Material List Reporting | A cosmetic responsible distributor shall report to the Minister of Food and Drug Safety by the end of February every year through the Korea Cosmetic Association. |
Other Administrative Requirements
(1) A new document is required for applying the custom cosmetic compounding manager certificate:
A doctor's note to prove the applicant is not a mental patient or an addict to narcotics.
(2) Cosmetics simulating food’s form or container is designated as cosmetics subject to recall with risk grade B.
(3) The label of a solid soap can be placed either on the primary or secondary package of the product.
3. Updating Provisions in the Administrative Regulations Following the Upstream Acts
The main amendments adopted in the Regulation for Notification of Cosmetics Manufacturing & Import Amount and Lists of Ingredients4, Regulation on the Management of Safety Information for Cosmetics5, and Requirement on Operating Custom Cosmetics Compounding Manager Qualification Test6 are:
(1) Newly adding the custom cosmetic sales business operator as the person subject to report raw material list. The method to report the raw material list is outlined as well.
(2) The custom cosmetic sales business operator is designated as the person to report the cosmetic's side effect voluntarily.
(3) Additionally, the requirements for operating the custom cosmetic test are optimized.
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