The Ministry of Food and Drugs issued the frequently asked questions (FAQs) of cosmetic industry in 2021. ChemLinked compiled the essential questions about importation, functional cosmetic, natural and organic cosmetic, and labeling for enterprises' reference.
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.