In the past few days we’ve looked at sunscreen regulations in the USA and EU; today we will examine Asia. As I mentioned in part 1, there is no continuity in regulating sunscreen around the world. As a continent, Asia’s various countries have different regulations, SPF ratings and registration requirements and guidelines to bring sunscreens to market. This information was presented by Alain Khaiat, Ph.D. of Seers Consulting during a very informative half day scientific seminar I attended at In-Cosmetics Barcelona. Let’s break things down by specific countries, taking a look at maximum SPF, how sunscreens are classified, and the process of bringing product to market:
1. In China, sunscreens fall under the category of specialty cosmetics. They have capped the maximum allowed SPF rating at 30+. The process to bring a new sunscreen to market takes about a year, which includes testing at a Chinese government recognized lab. China requires a final product formulation, specs, manufacturing process and claim support documents for SPF and clinical testing reports to be on file with the government. They also require a safety assessment on any product that is considered to contain a risky substance as well as 3 dozens of product samples provided for testing. The product must have a Chinese name, and all artwork on the packaging must also be in Chinese.
2. Korea classifies sunscreen as “Functional Cosmetics” and caps the maximum SPF at 50+. Korea requires a product sample for registration, and reports on tests methods for both active ingredients and finished product. This includes the background of origin, development and final formulation. In addition, Korea requires any SPF or efficacy data and testing info to be provided by a test supervisor with more than 5 years experience in a respective field. If the manufacturer is introducing a new sunscreen active ingredient, they must provide additional safety data for any and all new actives. In Korea the manufacturer must also provide all fragrance information, including a components list of the fragrance. The registration process is 6 months.
3. In Taiwan, sunscreens are “Medicated Cosmetics” with a maximum SPF of 50+. The registration lead time is 4 months and requires a “Free Sales Certificate” which needs to be notarized by a cosmetic association. This notarization is not necessary if the certificate was issued by the FDA. The final formulation must include percentages by INCI name. They do not require any product samples for registration, only a photocopy of the primary packaging. All artwork on the packaging must be in Chinese with a Chinese product name.
4. In Japan and ASEAN* (Association of Southeast Asian Nations), there is “notification” rather than a registration process to bring a sunscreen to market. This notification process entails a 2 week lead time where companies must provide specific information on product formulation, including ingredients, name, level and function, along with their stability testing and a special certificate if amy animal derived material* is used in the formula. Japan allows a maximum SPF of 50+.
*ASEAN is similar to Japan, but there is not a special certificate required for animal derived materials, and they do not have a maximum allowed SPF rating.
Hong Kong has no regulations for bringing sunscreen to market or limits on maximum SPF ratings.
In the fourth and final post in this series, we’ll be wrapping up and shining the spotlight on Sun Protection in Australia and India.
Scientific seminar presentation at In-Cosmetics Barcelona by Alain Khaiat, Ph.D., Seers Consulting