South Korea Implements Custom Cosmetics Regulations on Mar 14, 2020

On Mar 14, 2020, South Korea implemented the provisions related to custom cosmetics in the Cosmetics Act ^[1], Enforcement Decree of the Cosmetics Act ^[2] and Enforcement Rule of the Cosmetics Act ^[3], which clarified the definitions and categories of custom cosmetics, procedures of custom cosmetics report, contents for compounding manager test, requirements for custom cosmetics sales, etc.

1. Definition and Categories of Custom Cosmetics

According to the Cosmetics Act, custom cosmetics are products that are blended or dispensed at the sales place by a qualified cosmetic compounding manager according to the consumers' skin type and preferences for color and fragrance. It refers to any of the following:

1) A cosmetic repackaged by dividing the contents of manufactured or imported cosmetics into smaller amounts

2) A cosmetic made by mixing the contents of a manufactured or imported cosmetic with the contents of any other cosmetic or an ingredient prescribed by the MFDS

2. Requirements and Procedures for Custom Cosmetics Report

Anyone who wants to engage in a custom cosmetics sales business shall submit a Custom Cosmetics Sales Application Form to the local MFDS, and attach a copy of the qualification certificate of the compounding manager. After MFDS reviews the documents, a report certificate will be issued.

If a custom cosmetics seller changes the name, address, or compounding manager, or the custom cosmetics seller was changed, a Custom Cosmetics Sales Business Change Application Form shall be submitted to the local MFDS. The custom cosmetics report certificate and evidence of information change shall also be attached.

3. Custom Cosmetics Compounding Manager Qualification

Custom cosmetics sellers shall employ a compounding manager engaged in the mixing and division into smaller amounts of custom cosmetics. A custom cosmetic compounding manager shall pass the qualification test required by the MFDS.

MFDS will hold more than one compounding manager qualification test each year. Ninety days before the qualification test, MFDS will announce the test date, location, contents, test method, etc. on its official website. The first compounding manager test was held on Feb 22, 2020. A total of 8,837 people took the test, and a total of 2928 passed (33% of the pass). Because of the COVID-19, the following tests will be delayed.

4. Requirements for Custom Cosmetics Sales

Custom cosmetics sellers shall:

1) Inspect facilities and equipment regularly and ensure there are no health hazards

2) Comply with the safety management standards

• Before mixing and dividing cosmetics into smaller amounts, check the quality of the contents or ingredients of custom cosmetics

• Before mixing and dividing cosmetics into smaller amounts, disinfect or clean hands or wear disposable gloves

• Check-in advance whether the containers are contaminated

• Equipment used must be checked before use and cleaned after use

3) Establish and keep the sales records of custom cosmetics (both paper and electronic)

4) Explain custom cosmetics contents' and ingredients' concentration and characteristics and usage precautions to consumers when selling

5) Timely report adverse reactions to MFDS

Administrative penalties for violations:

For the detailed regulation requirements for custom cosmetics, please refer to the ChemLinked webinar presented by Tiger Kim on Mar 26, 2020.