Because of its influence on trends and its constant industry innovation, Korea is one of the world most attractive markets for cosmetics. It is not surprising that some of the most popular trends these past years have been born there.
For instance, Korea has been one on the first countries in the world with men keen on using cosmetics whereas Korean Beauty (K-beauty) and anti-pollution skincare are very fashionables today. Some of the trends in this country may influence all Asia and then the world.
Not to forget, the importation of cosmetics products in Korea is on a regular growth every year with an average of 4 % estimated on the last 5 years. In 2016, South Korea has imported for more than 1.6 billion dollars of cosmetics (source: international trade center).
At the moment, facial masks, BB and CC products and natural products are very popular in Korea. But before manufacturing or importing products in this country, it is very important to be aware of the regulation of cosmetics.
A stringent regulation
There are several laws which regulate the manufacturing and importation of cosmetics in Korea. Manufacturers and importers have therefore to stay up to date on cosmetics regulation and its subtleties. At COSMED, regulatory affairs department answers several questions per week regarding cosmetic regulation in Korea.
One of the particularities in Korea is that it relies on 3 categories of products that can be classified as cosmetics in Europe.
- cosmetics designate the products whose aim is to purify, embellish, add attraction, and illuminate the appearance, maintain or improve the skin or hair health by application, friction, spraying or any other similar action with superficial effects on the human body.
- functional cosmetics are classified as cosmetics which help whitening the skin or help reducing wrinkles or help protecting from UV ray. These products are cosmetics but with a stronger and proven action on the human body (not a superficial effect).
Functional cosmetics are regulated more strictly by MFDS (Ministry of Food and Drug Safety in Korea) because the Korean authorities want consumers to purchase cosmetics with demonstrated benefits and safety.
- quasi-drugs are products with a low pharmaceutical action or not acting directly on the human body, preparations used to prevent infectious diseases, sterilisation, insecticidal or similar applications. For example, deodorants, antiperspirants, toothpastes, oral care products are classified as quasi-drugs.
The registration process in Korea will be different depending on the category. Whereas limited documentation will have to be sent for cosmetics, data on efficacy, safety and specifications will be asked for registration of functional cosmetics.
As for the registration of quasi-drugs, every aspect of the product will be evaluated by the MFDS; the process takes 3 months minimum but can be much longer.
Evolution is on the way
On May 2016, via an amendment of the Cosmetic Act, some quasi-drugs have been reclassified as functional cosmetics. During the end of 2016, Korean MFDS adapted the other laws regulating cosmetics to be in line with these changes.
In February 2017, the new categories of functional cosmetics were defined more specifically in an amendment of the text “Enforcement Rules of Cosmetic Act”.
- cosmetics changing the colour of the hair, including bleaching (but excluding temporary hair dying)
- depilatories (chemical action only)
- cosmetics preventing hair loss and cosmetics increasing the thickness of the hair (coating excluded)
- cosmetics preventing acne, limited to rinsed-off products with a cleaning action
- cosmetics preventing the dryness of the skin, specifically for atopic or irritated skin
- cosmetics helping to thicken stretch marks
A big change is expected as the new regulation will enter into force on May 30, 2017. The registration for Korean manufacturers and importation from oversea for these products will be considerably easier.
Nevertheless, some explanations are still awaited from the Korean Authorities which are currently composing guidelines for formulation, tests and registration under the new classification.
These changes, made partly to align to the global trend of regulation, will also help to increase innovation in a country were active skin care products are very popular and watched by the whole world.
To know more on classification of products in the world and particularly in Korea, COSMED is organizing on Friday, June 9th 2017, in Paris, an International cosmetic meeting devoted to international regulation, on “Cosmetic claims around the world” More information here.
COSMED counts 725 SMEs members. It is an industry stakeholder in the European Commission for the development of cosmetic regulation, as well as in national and international standardization bodies. Its contributions and regulatory and scientific views are internationally recognized. Furthermore, COSMED provide a regulatory monitoring to institutions and enterprises.