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How does South Korea regulate cosmetic ingredients?

South Korea mainly regulates cosmetic ingredients in accordance with seven lists in the three regulations:

1) Regulation on Safety Standards, etc. for Cosmetics

2) Standards and Test Methods of Cosmetic Color Additives

3) Standards and Testing Methods of Functional Cosmetics

The manufacturer shall not add prohibited ingredients to cosmetics, and shall use the restricted preservatives, restricted UV-filters, restricted hair dyes, permitted colorants, and other restricted ingredients only under specific conditions given in relevant requirements due to safety problems.

Can enterprises use preservatives, UV filters, hair dyes, or colorants that are not in the restricted ingredient lists above or that exceed the specified usage standards?

Yes, but they need to apply to Ministry of Food and Drug Safety (MFDS) for approval. The application dossiers contain:

1) Application letter;

2) A summary of all submitted documents;

3) The origin, development process, usage standard, and usage situation of the ingredient;

4) Properties of the ingredient;

5) Safety and efficacy documents (if necessary);

6) Data of the ingredient standard and test method.

Information about the application procedures can be found here.

What does it mean if an ingredient is included in the List of Approved Ingredients for Functional Cosmetics?

To register a functional cosmetic in South Korea, the manufacturer or seller should apply to MFDS for an evaluation.

However, for functional cosmetics whose functional ingredients are included in the List of Approved Ingredients for Functional Cosmetics, the evaluation can be exempted. The relevant enterprises only need to submit a report illustrating the product efficacy, functional ingredients, precautions, etc. to MFDS. When the report passed MFDS' review, enterprises can download the report as a certificate document.

Can enterprises use functional ingredients that are not on the List of Approved Ingredients for Functional Cosmetics?

Yes. If the functional ingredient is not listed in the List of Approved Ingredients for Functional Cosmetics, the product should undergo an evaluation conducted by MFDS. Enterprises shall submit the dossiers about ingredient’s origin and development, safety data, efficacy data, etc. MFDS will evaluate the dossiers and notify the result to the enterprises.

The report or evaluation result of the functional cosmetic is essential for the entry notice of imported products when selling functional cosmetics to South Korea.

Which products are prohibited from being added with the microbeads included in the List of Prohibited Ingredients in Cosmetics?

The microbeads included in the List of Prohibited Ingredients in Cosmetics are prohibited from being used in products listed in Annex 3 of Enforcement Rule of the Cosmetics Act:

1. Baby products, including baby shampoo and hair conditioner, body cleansing products for baby, bath products for baby

2. Bath products

3. Body cleansing products

4. Hair care products, including hair conditioner, shampoo, hair rinse, other hair-care products (only rinse-off products)

5. Men's talcum (only rinse-off products), shaving cream, shaving foam, other shaving products (only rinse-off products)

6. Facial mask (only rinse-off products), hand and foot skin softening products (only rinse-off products), cleansing water, cleansing oil, cleansing lotion, cleansing cream, etc., make-up remover, other basic make-up products (only rinse-off products)

What are the ingredient use requirements for natural and organic cosmetics in South Korea?

On March 13, 2018, MFDS introduced new cosmetic categories: "natural cosmetics" and "organic cosmetics". The approved ingredients for natural and organic cosmetics are as follows:

1. Natural Ingredients;

2. Natural Derived Ingredients;

3. Water;

4. Other Permitted Ingredients;

5. Permitted Synthetic Preservatives and Denaturants;

6. Ingredients containing both natural and petrochemical moiety.

Detailed information of the above ingredients: ChemLinked Cosme-List: Permitted Ingredients in Natural and Organic Cosmetics

Are limits for toxic ingredients and microorganisms included in the regulatory database of South Korean cosmetic ingredients?

Toxic ingredients and microorganisms are not included in the South Korean cosmetic ingredients regulatory database. But in the production process of cosmetics, there are restrictions on these substances. Please refer to the information in Cosme-list and Cosmepedia for more details about these limit requirements.

How to import chemicals used for manufacturing cosmetics in South Korea? Are cosmetic products exempt from Korea REACH?

According the Article 3 of Act on Registration and Evaluation of Chemicals (K-REACH), cosmetic products are not subject to K-REACH registration. If the chemicals are used for manufacturing cosmetics in South Korea, these chemical substances can be exempted from K-REACH registration. Enterprises can import the chemicals following the import procedure of cosmetic ingredients.

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