Whitening products regulatory status in Chinese Mainland, China Taiwan, Korea and Japan

	Chinese Mainland	Taiwan of China	Japan	Korea
Classification	Special Use Cosmetics	General Cosmetics (except products containing Ascorbyl Tetraisopalmitate)	Quasi Drugs	Functional Cosmetics
Obligation	Registration	Products containing Ascorbyl Tetraisopalmitate: registration	Registration	Registration
Permitted ingredients	No list	13	No official list	9

China

Whitening products with active whitening ingredients were classified as special use cosmetics since December 2013, which require registration with CFDA. Certain categories of whitening products are defined under Chinese regulations as "products which make people look white by physical covering". Although they are regulated as special-use cosmetics these whitening products (in contrast to whitening products which alter the actual appearance of the skin) are subject to more relaxed registration requirements and shorter duration.

CFDA hasn't defined any permitted or prohibited whitening ingredients. For some common whitening ingredients, such as Arbutin, there is also no limit in the Safety and Technical Standards for Cosmetics. CFDA reviews the registration only based on the claims and active whitening agents in the submitted formula. The technical expert panel will determine the safety and efficacy of the ingredient.

Test Item	Test Category
Microbiological Test	Microbiological Test
Mercury	Hygienic Chemical Test
Lead	Hygienic Chemical Test
Arsenic	Hygienic Chemical Test
*Phenol and Hydroquinone	Hygienic Chemical Test
*PH value	Hygienic Chemical Test
Repeated Dermal Irritation Test	Toxicological Test
*Skin Sensitisation Test	Toxicological Test
*Skin Phototoxicity Test	Toxicological Test
*Human Patch Test	Human Trial

*: not needed for physical whitening products.

Compared to physical-covering whitening products, other whitening products need more testing and require submission of efficacy data and thus require more time to obtain the license. Generally it takes 6-8 months for physical-covering whitening products to obtain approval while other whitening products take 10-12 months.

Taiwan

Taiwan regulates whitening products based on the ingredients used in the product. TFDA has released a list named "Legal Whitening Ingredients in Cosmetics" to determine the classification and obligation of whitening products.

Ingredients	Limit or Maximum Permissible Concentration	Use
Magnesium Ascorbyl Phosphate	3%	Whitening
Kojic acid	2%	Whitening
Ascorbyl Glucoside	2%	Whitening
Arbutin	7%	Whitening (Hydroquinone should be less than 20ppm in the finished product)
Sodium Ascorbyl Phosphate	3%	Whitening
Ellagic Acid	0.50%	Whitening
Chamomile ET	0.50%	Preventing black spots and freckles
5,5’-Dipropyl-Biphenyl-2,2’-diol	0.50% (Maximum Permissible Concentration)	Inhibiting melanin and preventing skin pigment spot; whitening skin
Cetyl Tranexamate HCl	3% (Maximum Permissible Concentration)	Inhibiting melanin and preventing skin pigment spot; whitening skin
Tranexamic acid	2.0%-3.0% (Maximum Permissible Concentration)	Inhibiting melanin and preventing skin pigment spot;
Potassium Methoxysalicylate (Potassium 4-Methoxysalicylate) (Benzoic acid, 2-Hydroxy-4-Methoxy-, Monopotassium Salt)	1.0%-3.0% (Maximum Permissible Concentration)	Inhibiting melanin and preventing skin pigment spot; whitening skin
3-O-Ethyl Ascorbic Acid (L-Ascorbic Acid,3-O-Ethyl Ether)	1.0%-2.0% (Maximum Permissible Concentration)	Inhibiting melanin and preventing skin pigment spot; whitening skin
Ascorbyl Tetraisopalmitate	3% (Maximum Permissible Concentration)	Inhibiting melanin (Medicated Cosmetics)

Products containing the above ingredients (except for Ascorbyl tetraisopalmitate) within limits are general cosmetics that are subject to no registration. Cosmetics containing Ascorbyl tetraisopalmitate are managed as medicated cosmetics which require pre-market registration. Like EU, Taiwan permits the use of ingredients excluded from the list or exceeding the limits but require registration prior to use.

Korea

Whitening products are regulated as functional cosmetics in Korea. There are total 9 ingredients approved for use in whitening products.

Ingredients	Concentration
Broussonetia Extract Powder	2.0%
Arbutin	2.0%~5.0%
Ethyl Ascorbyl Ether	1.0%~2.0%
Oil Soluble Licorice(Glycyrrhiza)Extract	0.05%
Ascorbyl Glucoside	2.0 %
Magnesium Ascorbyl Phosphate	3.0 %
Niacinnamide	2.0%~5.0%
Alpha-bisabolol	0.5%
Ascorbyltetraisopalmitate	2.0%

The concentration (%) should be exactly as above for whitening products.

According to the regulation, there is no need to provide clinical data or efficacy test reports to MFDS if products use the listed whitening ingredient within the limitation, which just takes 7 day to get approval. Otherwise, clinical data and efficacy reports are necessary and it will take 4-6 months to be approved.

Japan

Japan legally defines whitening products as quasi drugs and must contain active whitening agents. Such products are permitted to claim whitening efficacy only after obtaining MHLW's approval.

Compared with Taiwan and Korea, no specific whitening ingredient list is published by MHLW. Some companies collected some active whitening ingredients approved by MHLW (Click here to see the list collected by Shiseido). Ingredients in the list are exempted from active ingredient registration, but registration as quasi drugs is unavoidable. It can take around 10 years for a new active whitening ingredient to be approved starting from initial ingredient discovery, through to R&D study to final approval by MHLW.