In 2017, the Global Industry Analyst reported that the  global skin-whitening market was valued at US $4.8 billion and anticipated that it would double to US $8.9 billion by 2027.  Freckle and whitening cosmetics are mainly used to reduce skin epidermal pigmentation or help skin whitening and whitening. In China, woman have been reported to spend as much as 30 percent of income on different skin whitening products. Its popularity has been both controversial and, in some cases, dangerous. The use of ingredients of dangerous substances such as mercury have led individuals to experience some serious adverse effects (SAE).

It only has been until relatively recently that governments have paid more attention to the cosmetic adverse effects reported by customers. For example, on June of 2020, China’s  State Council issued the “Regulations on the Supervision and Administration of Cosmetics,” which regulates the management of freckle and whitening cosmetics as special cosmetics, their registration requirements and post-market surveillance requirements.

How do they work?

Anti-freckle and whitening cosmetics can be divided into two different mechanism of action in which they can achieve the desired outcome: chemical whitening and physical whitening.

Chemical Whitening:

Chemical whitening cosmetics refer to the effect of whitening the skin by inhibiting the production of melanin and blocking the transportation of melanin.

Potential chemical Mechanism of Actions include:

  • Inhibition of the activity of tyrosinase: The catalytic action of tyrosinase is inhibited by the skin whitening agent.
  • Preventing the transfer of melanosomes to keratinocytes.
  • Directly destroying existing melanin/ melanocytes

Physical Whitening:

Cosmetics with physical whitening, refers to the use of physical covering agents, such as titanium dioxide, zinc oxide, talcum powder, etc. or similar white powders, which are applied to the skin surface to cover the spots on the skin to achieve the whitening effect , But it does not change the original appearance of the skin.

Commonly used ingredients:

The commonly used anti-freckle and whitening active ingredients mainly include the following categories:

  • Vitamin C and its derivatives
  • resorcinol  
  • Organic acids: kojic acid, tranexamic acid, etc.
  • Plant extracts: GLYCYRRHIZA GLABRA root extract, BROUSSONETIA KAZINOKI root extract, CHAMOMILLA RECUTITA flower extract, etc.
  • Other substances: bisabolol, arbutin, nicotinamide, potassium methoxysalicylate, etc.

Regulatory requirements:

The “Regulations on the Supervision and Administration of Cosmetics,” which regulates the management of freckle and whitening cosmetics as special cosmetics. 

All special cosmetics  such as,  whitening cosmetics, must be registered with the State Drug Administration before they can be marketed. If the registrant or filer is an overseas enterprise, a corporate legal person in the territory of China shall be designated as the domestic responsible person to handle cosmetics/new ingredient registration and filing, market the products and assist in monitoring of cosmetics adverse reactions and implementation of product recalls.

Cosmetics that claim quick-acting whitening or produce freckle and whitening effects immediately after use is suspected to be an illegal claim . Additionally,  banned substances such as hormones and heavy metals requires a high degree of vigilance. These regulations shall come into force on January 1, 2021

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com


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