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Latest NewsRegulationsZMUni27/06/2022The regulatory requirements for whitening efficacy of cosmetics in different countries/regions

EU

According to the EU Cosmetics Regulation 1223/2009, whether a product is a cosmetic or not should be considered in a comprehensive manner, taking into account the product characteristics and analyzing them one by one according to the product claims, functions and mechanism of action. At the same time, it is the responsibility of the competent authorities of the EU member states to make the final judgment on whether a product belongs to the category of cosmetics. EU regulations do not distinguish between general cosmetics and special cosmetics, but focus more on the classification and management of cosmetic ingredients. The Article 7 in preface of “EU Regulation” stipulates that whitening cosmetics are categorized as cosmetics. EU guidebook further specifies, the products the purpose of which is to improve skin pigmentation disorders(such as melasma, freckles) are categorized as drugs.

 

Japan

In Japan, cosmetics are categorized as general cosmetics and quasi-drugs. Whitening products which are defined as quasi-drugs in Japan need to be reviewed and licensed by the Ministry of Health, Labor and Welfare prior to being placed on the market and can be sold only after getting approval. In relevant reports of whitening products in Japan, part of whitening components approved by the Ministry of Health, Labor and Welfare are as the followings:

NO. English name Note
1. Potassium Methoxysalicylate  
2. nicotinamide  
3. Tranexamic acid  
4. Cetyl Tranexamate HCl  
5. Arbutin  
6. disodium adenosine phosphate  
7. Chamomilla Recutita (Matricaria) Flower Extract  
8. Kojic acid  
9. Vitamin C inducer(multiple types)  
10. linoleic acid  
11. 4-Butyl-resorcinol  
12. Rhododendrol Currently removed from the list due to causing white spots on the skin
13. Tetrahydrofuranol  
14. Ellagic acid  
15. Placenta(pig) extract

 

Korea

According to Cosmetic Act in Korea, cosmetics are divided into general cosmetics and functional cosmetics. Whitening cosmetics are categorized as functional cosmetics which need to be reviewed and approved by KFDA prior to going on market. It’s Korean government’s responsibility to formulate list of “Approved Functional Ingredients” including the types and content of active ingredients used in freckle removing and whitening cosmetics. See the below sheet for details.

NO. INCI name/English name Content
1. Niacinamide 2%~5%
2. Arbutin 2%~5%
3. (-)-alpha-Bisabolol 0.5%
4. 3-o-Ethyl Ascorbic Acid 1%~2%
5. Ascorbyl Glucoside 2%
6. Oil Soluble Licorice(Glycyrrhiza) Extract 0.05%
7. Broussonetia Extract 2%
8. Magnesium Ascorbyl Phosphate 3%
9. Ascorbyl Tetraisopalmitate 2%

 

Taiwan, China

Cosmetics in Taiwan, China are divided into general cosmetics and specific purpose cosmetics based on whether the ingredients in Component Name of Specific Purpose Cosmetics and List of Use Restrictions are contained in the cosmetics. The whitening products are managed as specific-use cosmetics (formerly drug-containing cosmetics). After a period of time, if no safety risk problems are found, , they will be managed as general cosmetics. At present, there are 13 kinds of whitening components that can be used in cosmetics, as shown in the table below.

NO. INCI name/English name Content
1. Ascorbyl Glucoside 2%
2. Sodium Ascorbyl Phosphate 3%
3. Tetrahexyldecyl Ascorbate 3%
4. 3-o-Ethyl Ascorbic Acid 2%
5. Kojic Acid 2%
6. Arbutin 7%(The hydroquinone contained in the product should be below 20mg/kg)
7. Magnesium Ascorbyl Phosphate 3%
8. Ellagic Acid 0.5%
9. Matricaria Chamomilla Extract 0.5%
10. Tranexamic Acid 3%
11. Potassium Methoxysalicylate 3%
12. Tetrahydromagnolol 0.5%
13. Cetyl Tranexamate Hcl 3%

 

Mainland China

Currently, mainland China defines whitening cosmetics mainly based on the product label claims and product inner attributes. However list of whitening components has never been formally published. China NMPA has listed commonly used whitening components.

Divided according to the chemical structure and source, common whitening active components mainly include the following categories:

  1. Vitamin C and its derivatives: such as Ascorbyl Glucoside, Ascorbyl Tetraisopalmitate, 3-O-Ethyl Ascorbic Acid, Magnesium Ascorbyl Phosphate, Disodium Ascorbyl Sulfate, etc.
  2. Organic acids: Kojic acid, Tranexamic Acid, etc.
  3. Plant extract: Plant extractclaiming to have whitening effect, such as Glycyrrhiza Glabra Extract, Broussonetia Kazinoki Extract, Chamomilla Recutita Extract, etc.
  4. Others: Bisabolol, Arbutin, Nicotinamide, Potassium Methoxysalicylate, etc.

Besides, Titanium dioxide, zinc oxide, mica, talcum powder and other ingredients are commonly used as physical whitening components

In June 2020, the State Council issued Cosmetic Supervision and Administration Regulation, which stipulates that whitening cosmetics are administrated as special cosmetics and requires registration approval prior to production or import. When applying for registration, the following points should be noticed:

(1)Whitening cosmetics refer to products which help reduce or slow down skin pigmentation to achieve the effect of whitening and brightening skin, including products which improve the skin condition where acne marks result from pigmentation or products which achieve the effect of whitening and brightening skin in form of physical covering.

(2)Whitening cosmetics can’t be applied to mouth and lips and shouldn’t be used by children

(3)Efficacy products like whitening products should be tested for human efficacy evaluation trial

(4)Cosmetic products which realize whitening effect through physical covering and are labeled to have physical effect are exempted from submitting product efficacy claim evaluation materials