Government Response: FAQs of South Korea Cosmetic Industry

As stipulated in Article 35 (4) of the Comprehensive Notification, when importing cosmetics (including raw materials), an "entry notice of imported products" shall be submitted to Korea Pharmaceutical Traders Association (KPTA).

Therefore, the applicant needs to fill in the “entry notice of imported products” for both final cosmetic products and cosmetic raw materials and get approval from KPTA.

As per the Article 4 of Cosmetic Act, a cosmetic manufacturer, a responsible cosmetic distributor, or a university/ research institute, etc., prescribed by Ordinance of the Prime Minister that intends to engage in the sale, etc., of a recognized functional cosmetic shall undergo an examinationor submit a report to the Minister of Food and Drug Safety for safety and effectiveness of each product."

Therefore, either of a cosmetic manufacturer, a responsible cosmetic distributor, or a university/research institute as stipulated in Article 6 (1) and Article 14 (2) of the Basic Research Promotion and Technology Development Support Act can apply for the functional cosmetic examination.

The Cosmetic Act regulates that "cosmetic manufacturing business" refers to the business of manufacturing (excluding the process of secondary packaging or labeling only) all or part of the cosmetics.

Furthermore, the term "manufacture" is stipulated as "a series of work from weighing raw materials to mixing, filling (primary packaging), secondary packaging, labeling, etc." under Regulations on Cosmetic Good Manufacturing and Quality Control Practices.

Therefore, the business of filling and packing the bulk products is sorted as the "cosmetic manufacturing business". The relevant final products shall be labeled following the Korean cosmetics labeling requirements. Instead of the country of origin, the business entity's name and address shall be labeled on the products.

According to the Guidelines for Management of Cosmetic Labelling and Advertisements, when the scientific and objective demonstration data, such as human application test data, etc., is prepared, the body wash products can be labeled with the "antimicrobial(항균)".

In this case, "antimicrobial" refers to the "antimicrobial effect" resulting from the physical cleaning. The product should be labeled and advertised according to the demonstration data. Besides, enterprises should avoid using claims similar to drug, such as disinfectant (소독), sterilizing (살균), etc.

First and foremost, only the cosmetics certified as "natural cosmetic" by MFDS can place the "natural cosmetic mark" in accordance with Article 14-4 of the Cosmetics Act. Enterprises need to make sure the products are the official certified natural cosmetics.  

The Attached table 5-2 of Enforcement Rule of Cosmetics Act gives out the logo of natural cosmetics. It also stipulates that the logo can be proportionally modified according to the cosmetic packaging.

Considering the above provisions, the natural cosmetic mark's color can be changed. Please note that the logo should be recognized easily by consumers. 

(1) Manufacturing process:

As per the Regulations on the Standards of Natural and Organic Cosmetic Products, the manufacturing process shall follow the below requirements:

The raw materials' manufacturing process should be simple without creating pollution. The materials' characteristics should not be modified. The proper and prohibited manufacturing processes of raw materials are specified in the Attached Table 5 of Regulations on the Standards of Natural and Organic Cosmetic Products.

The prohibited manufacturing processes of natural and organic cosmetics are:

a. Prohibited manufacturing processes under the Attached Table 5 of Regulations on the Standards of Natural and Organic Cosmetic Products;

b. Mixing genetically modified raw materials;

c. Mixing nanometer-sized components or using any processes that could generate nanometer-sized components;

d. Mixing an insoluble or biologically durable material (size range from 1-100 nm) so as to generate a single-faceted or multi-faceted external or internal structure;

e. Using propellant besides air, oxygen, nitrogen, carbon dioxide, and argon gas.

(2) Packaging

The Article 6 of Regulations on the Standards of Natural and Organic Cosmetic Products specifies that the container and packaging of a natural or organic cosmetic is forbidden from using Polyvinyl chloride (PVC) or Polystyrene foam.