China to Release a List of Permitted Cosmetic Whitening Ingredients

In response to the recent industry buzz on the ban of whitening ingredient phenethyl resorcinol (commonly known as SymWhite 377 in the industry) in general cosmetics, China National Medical Products Administration (NMPA) issued a popular science article on 16 December 2021, expounding the reasons for the ban as well as the definition, judging principles, safety risks, supervision requirements, etc. of whitening cosmetics. ¹

Explanations of the 377 Issue

The article pointed out SymWhite 377 is currently approved for the sole purpose of "whitening the skin and restraining the formation of melanin by inhibiting the activity of tyrosinase." From the perspective of ingredient usage, using this ingredient's other efficacy besides whitening efficacy in general cosmetics exceeds its approved use purpose, which shall be registered or notified per the new cosmetic ingredient registration or notification regulations before it can be used. From the perspective of product formula, adding the ingredient approved solely for use as whitening agent to general cosmetics implies that the product has whitening function, so the product shall be managed as the freckle removing (whitening) cosmetics and is only allowed to be marketed after registration.

Based on these two points, products added with SymWhite 377 should not be registered as general cosmetics. Otherwise, they are suspected of violating the relevant provisions in the Cosmetic Supervision and Administration Regulation and shall be investigated and dealt with by the provincial medical products administrations.

Other Highlights of the Article

1. Whitening cosmetics in China include products that can achieve skin whitening effects through physical covering, and products that reduce or slow down skin pigmentation through whitening agents. The judgment of whitening cosmetics is mainly based on the label claims and the intrinsic attributes of the product.

   Notably, for freckle-removing (whitening) cosmetics that achieve skin whitening effects by physical covering, in addition to registration licenses, the labels of such products also need to be clearly marked as "have physical covering effects only."

2. At present, commonly used whitening agents in China, Japan, and South Korea include Arbutin, Niacinamide, Glabridin, Phenylethyl Resorcinol, Ascorbic Acid (Vitamin C), Ascorbyl Glucoside, 3-o-Ethyl Ascorbic Acid, Magnesium Ascorbyl Phosphate, Tranexamic Acid, Potassium Methoxysalicylate, Bisabolol, etc. Plant ingredients with whitening effect mainly include oil-soluble Glycyrrhiza Uralensis (Licorice) Extract, Broussonetia Papyrifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, etc. Commonly used physical whitening ingredients include Titanium Dioxide, Zinc Oxide, Mica, Talc, etc.

3. Relevant departments are preparing to draft a list of cosmetic whitening agents, which is expected to influence the definition of whitening cosmetics in China.

   NMPA reminds cosmetics companies that before the whitening ingredient list is issued, they should rationally select the use purpose of the ingredient according to its source and characteristics and apply it to products, so as to avoid the SymWhite 377 issue repeating caused by ignoring the properties of some specific ingredients and the attributes of the products applied.

4. Given the safety risks of whitening products, manufacturers should pay attention to the safety assessment information of whitening agents at home and abroad, carry out a comprehensive safety assessment when developing whitening cosmetics and strictly implement the main responsibility, so as to effectively ensure the safety of such products.

5. The implementation of Standards for Cosmetic Efficacy Claim Evaluation and Administrative Measures on Cosmetics Labeling will, to a certain extent, crack down on the false or exaggerated claims of whitening efficacies by non-compliant enterprises, the conceptual addition^* of functional ingredients, and other irregularities that may mislead consumers.

   *Conceptual addition: some cosmetics companies widely advertise that the product contains a certain ingredient, but the actual amount of the ingredient is negligible and far from achieving the corresponding effect.