An article by: Cristina Pérez
Over the last decade, K-beauty has become an undeniable global phenomenon. It is loved by many, including myself, for its unique ingredients, innovative concepts, and glass-skin results. However, behind the worldwide recognized brands and eye-catching packaging, there exists a carefully designed legal framework. Maybe you have heard of the Food and Drug Administration (FDA) in the U.S. or the European Commission in the EU. Both set rules to regulate and keep cosmetics safe. In the same way, South Korea has its own strict system. In Korea, the Cosmetic Law not only regulates what goes into the bottle, but it also defines the entire journey of a product from the labs to our homes. It establishes the institutions that ensure the safe testing and approval of cosmetics. It defines the responsible individuals for keeping products in accordance with the law. And it also dictates what ingredients can go into our cosmetics, and much more.
As someone passionate about K-beauty, I was curious to understand how products are approved and controlled. While there is a lot of information out there, finding the right sources wasn’t easy. To save you the trouble, I gathered and translated the most essential information for you. So, let’s dive into the key rules that keep K-beauty safe, effective, and trusted worldwide!
Inside South Korea’s Cosmetic Law
The primary cosmetic legislation in South Korea is the Cosmetics Act No. 2512, Oct. 22, 2024, enacted by the National Assembly. According to Article 1, its main aim is to protect public health and support the local cosmetic industry. The Act covers everything, from how companies manufacture and import products to how they label and package them. One interesting aspect is its broad definition of cosmetics. This includes typical items like moisturizers and makeup, but also certain special products such as sunscreens and anti-aging creams.
Article 2 of the legislation categorizes these products as “functional cosmetics.” This group also includes products that whiten the skin, improve wrinkles, treat acne-prone or atopic skin, and reduce hair loss. Functional cosmetics require additional safety and efficacy evaluations before entering the market, unlike regular cosmetic products.
The Key Players in K-Beauty
In South Korea, the main body in charge of enforcing the Cosmetics Act is the Ministry of Food and Drug Safety (MFDS). Any company that wants to produce or sell cosmetics there must register with the MFDS and meet facility, safety, and quality control standards. If a product falls under the functional category, it also goes through a detailed review by the National Institute of Food and Drug Safety Evaluation (NIFDS). This division, under the MFDS, handles efficacy testing and product safety.
Whether a company is local or international, it must designate a Responsible Person or Brand Holder who properly fills out required documentation, lists product ingredients, and conducts post-market surveillance. Before the company sells a product, the Responsible Person must submit documents detailing the company information, ingredient sources, and the regulatory contact person. Lastly, every February, they must submit an annual report on manufacturing volumes. For products made in Korea, companies submit this report to the Korea Cosmetic Association (KCA). For imports, they submit it to the Korea Pharmaceutical Traders Association (KPTA).
What It Takes to Sell in Korea
For most cosmetics, pre-market approval is not necessary, but functional cosmetics are a different story. The MFDS requires companies to submit extensive documentation online to the Integrated Drug Information System, proving the products’ safety and claimed effects. Which includes information on research and development, ingredient origin, SPF levels (for sunscreens), and test methods.
Imported cosmetics go through a multi-step approval process. Companies must register their business and request an examination if the product is functional. Then, they submit key documents like a free sale and manufacturing certificate. Customs checks the shipment, and once approved, the labels are translated into Korean. After a final packaging review, the product is ready for sale.
Animal Testing and Ingredients in K-Beauty?
Korea has taken a progressive stance on animal testing. Although cosmetics developed using animal testing are still classified as cosmetics under Article 15-2 of the Cosmetics Act, their sale and distribution are banned, except in specific cases. For example, animal testing is still permitted when no other alternatives exist or when it is required by a country exporting the product.
Korea uses a negative list system for ingredients, meaning it allows all ingredients unless it specifically prohibits them. This list currently includes over 1,000 banned substances like antibiotics, steroids, and radioactive materials. The MFDS maintains an extensive online database named Drug and Cosmetics Item Information for ingredient searches and product approvals. Nonetheless, most comprehensive resources are in Korean.
Customized, Natural, and Organic: A Diverse Marketplace
Apart from functional cosmetics, Korea also recognizes other product categories based on their origin and formulation. “Natural Cosmetics” are those made with ingredients derived from animals, plants, or raw materials that meet MFDS safety and quality standards. “Organic Cosmetics” go one step further by requiring those ingredients to be organically sourced and certified, again following MFDS criteria. A third and newer category, “Customized Cosmetics,” responds to consumer demand for personalization. Certified technicians in retail stores typically mix these products from existing formulations or repackage them into smaller portions to suit individual skin types, preferences, or needs.
Conclusion: Why It Matters
South Korea’s global influence in cosmetics isn’t just the result of creative branding or popular trends. A well-structured legal system supports the K-beauty industry from the inside, making sure products are safe, effective, and meet clear standards. Whether it is a Korean serum or a cream in your skincare routine, know there is a process behind it that ensures quality and transparency.
For local and international companies, knowing the rules is essential before entering the market. And for everyday consumers like me and you, it’s worth knowing that what ends up in our skincare routine has passed through a meticulous regulatory system!
If you want to learn more about South Korea’s cosmetic legislation, check out Cosmetics Regulatory Framework in Korea, an online booklet that summarizes the most important points. Otherwise, go straight to the Cosmetics Act, where you will find detailed information divided into 40 articles about everything you need to know about K-beauty regulation.
References
Korea Legislation Research Institute. (2024, October 22). Cosmetics Act. Retrieved from https://elaw.klri.re.kr/eng_service/lawView.do?hseq=68854&lang=ENG
Ministry of Food and Drug Safety, Cosmetics Regulatory Framework in Korea (2019). Retrieved from https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=71481
Ministry of Food and Drug Safety, Types, Standards, and Test Methods of Cosmetic Color Additives (2016). Retrieved from https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=69996
Ministry of Food and Drug Safety, Customized Cosmetics in Korea. (2020). Retrieved from https://www.mfds.go.kr/eng/brd/m_28/view.do?seq=71482