Winnie Xu,Chen Ye

ChemLinked,China

On November 30,2021,a notice from China NMPA implied that products containing SymWhite 377 (a whitening cosmetic ingredient) must be registered as special cosmetics.Many products containing SymWhite 377,which used to be notified as general cosmetics rather than registered as special cosmetics,were removed from shelves later.This notice also made many industry practitioners worry that there will be further inspection on other whitening ingredients.In response to the chaos,China NMPA later issued a new article to explain.

On November 30,2021,China National Medical Products Administration (NMPA) issued a notice,announcing that the addition of whitening ingredient SymWhite 377 in general cosmetics is suspected of violating the relevant provisions in the Cosmetic Supervision and Administration Regulation(CS AR) and Administrative Measures on Cosmetics Registration and Notification and will be investigated and dealt with by the provincial medical products administrations.All provincial medical products administration shall report the investigation and handling progress of the general cosmetics added with SymWhite 377 to NMPA by December 20 this year.This announcement sent shockwaves across the whole cosmetic industry and sound an alarm over the whitening beauty products in the market.

1 What happened?

In the latest overarching cosmetic regulation,Cosmetic Supervision and Administration Regulation(CSAR),cosmetics are classified as general and special cosmetics.While the former kind only requires notification,the latter needs registration,which takes more money and extended time than notification.Whitening products belong to special cosmetics.

However,in practice,many skincare products that have the whitening function have been notified as general cosmetics in the market because they have other functions besides whitening,so that they could argue that other functions are their products’ main functions.The market is chaotic,and it is troublesome for the regulatory authorities to distinguish these products from actual whitening products,so some companies take a loophole here,which is also why the whole market is shocked by this notice.Many industry practitioners worry that all products that have the whitening function will be required to be registered as special cosmetics in the future,which can be a crackdown on many brands in the industry.

Two questions emerge.First,why did SymWhite 377 become the first target of this regulatory inspection? The main reason is that SymWhite 377 has only one function,whitening.Second,will other ingredients with whitening function be regulated as SymWhite 377 in the future,such as nicotinamide,arbutin,VC? It depends on whether whitening is the primary function of these ingredients.Unlike SymWhite 377,most of these ingredients have other functions.For example,nicotinamide can repair skin barriers,and VCis good at antioxidants.If all beauty products with these ingredients need to be registered as special cosmetics,there won't be as many general cosmetics as we currently see in the market.China NMPA is working on a list of whitening cosmetic ingredients in the future.Products using ingredients on the list will be required to be registered as special cosmetics.

As consumers are gaining more professional knowledge about cosmetic ingredients and their functions in recent years,they start to make buying decisions based on ingredients rather than brands.SymWhite 377 is one of the most popular whitening ingredients in the market.Some brands were eager to follow the trend and promote their SymWhite 377 products as soon as possible,so they chose to notify their products as general cosmetics.At present,there are nearly 7,000 general cosmetics containing SymWhite 377 in the market,so we can see that this notice has a widespread impact on the industry.After the statement’s release,many brands,including BIOHYALUX,PURID,John Jeff,etc.,have taken action to remove products containing this ingredient from shelves and asked their distributors to carry out clearance.

One interesting thing to notice is that such regulations will benefit large companies.When large companies use SymWhite 377 in their products,they register these products as special cosmetics at the beginning because they have higher standards for compliance,and they can afford more time and more money.For example,Dr.Ci Labo,L’Oreal,Lancome,and Arden all have registered their SymWhite 377 products as special cosmetics,so they are not affected by this event.

After the SymWhite 377 event,another cosmetic ingredient,bisabolol,is suspected of being banned in general cosmetics on the Internet.Bisabolol is widely used in skin care products because of its good stability,safety,and skin compatibility.Current researches on bisabolol focused more on antiinflammatory,antibacterial,and repairing rather than whitening.Therefore,bisabolol is different from SymWhite that only has one function.Later,regulatory authorities also confirmed that products containing bisabolol would not be required to be registered as special cosmetics.

2 Further development

In response to the buzz on the ban of SymWhite377 in general cosmetics,China NMPA issued an article to answer questions on December 16,2021,expounding the reasons for the ban as well as the definition,judging principles,safety risks,supervision requirements,etc.of whitening cosmetics.Here are the highlights.

2.1 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.

2.2 What are whitening cosmetics?

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.”

2.3 An authoritative list of whitening agents is on the way

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 to avoid the SymWhite 377 issue repeating caused by ignoring the properties of some specific ingredients and the attributes of the products applied.

2.4 Commonly used whitening agents

At present,commonly used whitening agents in China,Japan,and South Korea includ e Arbutin,Niacinamide,Glabridin,Phenylethy l 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 oilsoluble 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.

2.5 Safety assessment issue

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.

2.6 False or exaggerated claims of whitening efficacies will be cracked down

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.CDC