SOUTH KOREA LEGAL FRAMEWORK ON COSMETIC PRODUCTS
In South Korea, the Cosmetics Act represents the main legal regulatory framework for cosmetics. There are other regulations, standards and guidance documents that support this Act and which allow the country to have a comprehensive framework to manage this type of products. The Cosmetics Act provides standards for the manufacture, importing and sale of cosmetics and cosmetic ingredients, including detailed requirements for the labelling and advertising of products. The Ministry of Food and Drug Safety (MFDS) is the competent authority that enacts and executes cosmetic regulations in South Korea, including the register of functional products. The South Korean Pharmaceutical Traders Association (KPTA) is responsible for issuing importing cosmetic approvals and supervising cosmetic trading.
According to the Cosmetics Act, cosmetic products are defined as “products/articles intended to be applied to the human body by friction, spraying or other means, in order to cleanse it, beautify it, make it more attractive, improve its appearance, maintain or improve the state of health of the skin or hair, and which has surface effects“.
Cosmetics are divided into general cosmetics and functional cosmetics. Functional cosmetics are products that aid in functionally improving or changing the condition of skin and hair. Examples of functional cosmetics are: whitening products; anti-wrinkle products; sunscreens; hair dyes; epilating agent; acne products; etc.
General cosmetics are subject to a post-market surveillance and can be manufactured/imported without registration. On the other hand, functional cosmetics must undergo a complex registration process to obtain an approval letter from the MFDS before manufacturing or importing processes can be made. Additionally, importers of cosmetic products also have to obtain approval from the South Korean Pharmaceuticals Traders Association (KPTA).
A company must register for the type of cosmetic business that its products entails before conducting any commercial operations related to cosmetics. If a company wants to manufacture cosmetics, it must register itself as a “manufacturer”. But if it wants to import cosmetic products, it needs to be registered as a “marketing authorization holder” (MAH). When a company wishes to conduct activities associated with functional cosmetics, it needs to be registered as MAH. The MAH has several responsibilities: product registration, safety, quality, labelling, advertising, cosmetic claims, custom clearances, among other regulatory activities. A cosmetic supervisor (with specific qualifications and training) needs to be designated by the MAH and registered at MFDS.
LABELLING, CLAIMS AND TESTING
Safe containers and packaging must be used with the intention of preventing children poisoning due to misuse. The information required to appear on the label depends on the category of the cosmetic and its volume, among other determinants. The product’s name, the name of the MAH, the expiry date and the lot number are mandatory to appear on the label of all products.
The MFDS lays down some strict requirements for claims made for functional cosmetics. For example, if a product is approved as an “anti-wrinkle”, it may make claims like “anti-wrinkle”, “fine lines” and such, but it can not claim “anti-aging”. “Whitening” claims can be made if a cosmetic gets approval as whitening product. If a product does not get approved as a functional “whitening” product, it may only make claims such as “lightening” or “brightening”.
Some ingredients have been already approved by the MFDS to be used in certain functional cosmetics (with limitations). This means that if a manufacturer or importer wants to make available on the market a functional cosmetic which contains only ingredients approved (for that specific type of functional cosmetic), he does not need to provide clinical and efficacy data. The approval of these products will take about 7 days (“submission procedure”). If, on the contrary, the manufacturer/importer wishes to use unapproved ingredients, he must submit clinical and efficacy data, identifying the active ingredients, when applying for approval from the MFDS. This “approval process” may take 4-6 months to be concluded.
After approval from MFDS (and KPTA for imported products) and according to the type of cosmetic product, it needs to be submitted to lab testing in an institution located in South Korean territory.
NATURAL MATERIALS CERTIFICATION IN SOUTH KOREA
In July 2019, the MFDS implemented the Regulations on the Standards of Natural and Organic Cosmetic Products. This Regulation specified “organic” and “natural” definitions, permitted ingredients, manufacturing processes and requirements for the business entity. For example, natural raw materials concentration should exceed 95% in a natural cosmetic. Organic cosmetics, besides the 95% concentration in natural raw materials, have to contain over 10% organic ingredients.
In January 2021, South Korea has introduced a new certification mechanism, which inspects raw materials instead of the final products. The preparation required for documents is reduced and, consequently, the work of the industry gets easier.
Besides South Korean natural and organic certification, companies can choose to follow other standards/certifications, such as COSMOS (see our post about natural and organic cosmetics).
2021 UPDATES ON SOUTH KOREA COSMETICS REGULATION
The MFDS has recently updated the cosmetics regulation. The addition of some product categories (e.g., beauty soap bars, hair removal wax) and the simplification of the registration process of some functional cosmetics (whitening, anti-wrinkle, hair loss and hair dye products that contain certain ingredients) are two examples of the changes introduced. Additionally, functional products can no longer make any claims on atopic skin, as the term ‘atopic’ now can only be used in the pharmaceutical product category.
Although both South Korean and European Union cosmetics regulation primarily aim the safety of consumers, they still have striking differences. For example, some cosmetic products in the EU do not meet the definition of cosmetic products in South Korea and vice-versa. As this country represents a popular emerging market for EU brands, new opportunities for manufacturers and importers arise . It is essential to be up-to-date and understand the South Korean cosmetic regulations before entering this highly competitive market.
Our company has a team of regulatory experts that can help you place cosmetic products in the South Korean market. Do not hesitate to contact us at info@criticalcatalyst.com.
References:
- Cosmetics Act 17250 (Apr 7, 2020). Ministry of Food and Drug Safety. South Korea. Available at: https://cosmetic.chemlinked.com/database/view/1008
- South Korea Cosmetic Regulation. Chemlinked. Aug 07, 2020. Available at: https://cosmetic.chemlinked.com/cosmepedia/south-korea-cosmetic-regulation
