As the saying goes, "a white complexion hides a hundred imperfections." Among Chinese female consumers, the pursuit of fair skin is also one of the important demands when they use cosmetics. Therefore, whitening cosmetics are very popular among consumers in China and even in Asia. Cosmetics companies are also very optimistic about this market and have launched their own whitening products. 1. What are whitening cosmetics? Whitening cosmetics generally refer to cosmetics that help reduce or slow down skin pigmentation and achieve skin whitening and brightening effects. As the risk level of such products is relatively high, the "Regulations on the Supervision and Administration of Cosmetics" clearly stipulates that they belong to the category of special cosmetics and are subject to registration management. (Image source: Pexels) At present, the judgment of whitening cosmetics in my country is mainly based on the product label claims and the intrinsic properties of the product. In addition, relevant departments are preparing to draft a list of cosmetic whitening agents, which is expected to have a further impact on the definition of whitening cosmetics in my country after its release. Consumers should be reminded that in my country, products that achieve skin whitening and brightening effects through physical covering are also classified as freckle-removing and whitening cosmetics. However, the number of such products is relatively small. The product category on the license is printed with the words "freckle-removing and whitening (only with physical covering effect)". The labels of such products also need to be clearly marked with "only with physical covering effect" to distinguish them. Such products only have a temporary covering and whitening effect and will not really whiten the original skin color. Therefore, when purchasing freckle-removing and whitening cosmetics, you should pay special attention to the difference between these two types of products. 2. What are the commonly used whitening agents? From the composition point of view, cosmetics are generally the product of physical mixing of various raw materials. The efficacy of cosmetics can be regarded as a concentrated reflection of the functions of the raw materials used. In other words, the whitening effect of whitening cosmetics depends on the type and amount of whitening agent added to the product. In addition to products that achieve whitening and brightening effects through physical covering, the current mechanisms of action of whitening cosmetics mainly include: inhibiting the production of melanin, blocking the transport of melanin, reducing melanin, promoting the shedding of epidermal melanin, etc. Depending on the specific whitening agents used in the formula, the whitening effect of the product is usually reflected through one or more mechanisms and raw material combinations. (Image source: Pexels) Commonly used whitening agents in cosmetics in my country, 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. Among them, whitening plant ingredients mainly include oil-soluble licorice extract, paper mulberry leaf extract, chamomile flower extract, etc. Raw materials such as titanium dioxide, zinc oxide, mica, talc, etc. are commonly used physical whitening ingredients. 3. Are there safety risks associated with whitening products? Everything has two sides. While companies pursue the whitening effects of whitening cosmetics, they cannot ignore the possible safety risks. The production of melanin is actually a manifestation of the normal physiological function of the human body. It is produced by a series of complex biochemical metabolic transformations of tyrosine, an important amino acid in melanocytes, and is affected by many factors. For example, ultraviolet radiation can cause melanocytes to synthesize more melanin, making the skin darker and protecting skin cells from damage by ultraviolet rays. Therefore, whitening cosmetics should appropriately inhibit the synthesis of melanin. If the effect is too strong, it may seriously interfere with the production of melanin and have an adverse effect on the normal physiological function of the human body. In addition, since tyrosine and tyrosinase are also involved in the metabolism of catecholamine hormones in the body, excessive action of whitening agents may also have an adverse effect on the metabolism of catecholamine hormones. The incident in which whitening products containing rhododendrol caused "white spots" on the users' skin is a typical case of such products causing skin damage to consumers. Therefore, this also requires our manufacturers to strictly implement their principal responsibilities and conduct comprehensive safety assessments when developing whitening cosmetics to ensure the safety of such products. The international community has also paid continuous attention to the potential safety risks brought about by the use of whitening agents, and has continuously gained new insights into the safety of related raw materials. In November 2021, the European Union Scientific Committee on Consumer Safety (SCCS) issued a preliminary assessment draft opinion SCCS/1637/21 on the cosmetic whitening ingredient kojic acid, concluding that kojic acid has potential endocrine disrupting properties, and the current maximum concentration of 1% allowed in EU cosmetics will no longer be considered safe. Kojic acid has been included in the SCCS priority reassessment list. Information on the safety assessment of whitening agents at home and abroad deserves the attention of our relevant companies. 4. What are the new changes in the supervision of whitening cosmetics in my country? In my country, whitening cosmetics are classified as special cosmetics and strictly regulated because of the high safety risks of this category of products. It is also an international practice to impose stricter management on whitening products. Japan divides cosmetics into ordinary cosmetics and quasi-drugs. Whitening products are defined as quasi-drugs in Japan and must be reviewed and approved by the Ministry of Health, Labor and Welfare before they can be sold. According to the Korean Cosmetics Act, cosmetics are divided into general cosmetics and functional cosmetics. Whitening cosmetics are functional cosmetics and must be reviewed and approved by the Korean Food and Drug Safety Administration before they can be put on the market. Nowadays, cosmetics have become an indispensable product in people's daily life. One of the main ways for consumers to understand the efficacy of cosmetics is to read the label claims. The content on the label, especially the efficacy claims, will have a direct impact on consumers' behavior in purchasing cosmetics. The efficacy of a cosmetic is mainly determined by factors such as the type, amount, specifications, and product usage of the functional raw materials added to its formula. According to the "Specifications for the Evaluation of Cosmetic Efficacy Claims", starting from January 1, 2022, newly registered anti-freckle and whitening cosmetics must be subject to human efficacy evaluation tests and reports issued by cosmetics registration and filing inspection agencies in accordance with the requirements of mandatory national standards and technical specifications. The cosmetics registrants must upload a summary of the basis for the product efficacy claims on a special website designated by the State Food and Drug Administration. At the same time, the "Regulations on the Management of Cosmetics Labels" which came into effect on May 1, 2022 stipulates that the full ingredient labeling requirements for cosmetics labels require that all ingredients not exceeding 0.1% (w/w) in the cosmetic formula should be introduced and labeled separately with "other trace ingredients" as an introductory phrase. The above two regulations also show that the national regulatory authorities attach great importance to the management of cosmetic efficacy claims and pay attention to consumers' right to know. After their implementation, they will certainly combat the false and exaggerated claims of whitening efficacy by bad companies and the conceptual addition of efficacy ingredients, which mislead consumers and other illegal practices. It will guide companies and even the entire industry to pay more attention to research and development, focus on improving the quality of their own products, and promote the high-quality and healthy development of the entire industry. 5. How should consumers choose whitening cosmetics? First of all, whitening cosmetics should be purchased through formal channels, and the product labels must have the product approval number of the National Medical Products Administration, that is, for example, domestic freckle removal and whitening products approved in 2021 are "Guozhuang Te Zi G2021XXXX", and imported products are "Guozhuang Te Jin Zi J2021XXXX". You can also check the consistency of product registration information with the actual label information through the official website of the National Medical Products Administration or the "Cosmetics Supervision" APP of the National Bureau. When purchasing, pay attention to distinguish products with only physical covering in the freckle removal and whitening category. Avoid buying products with obvious illegal claims on the labels, such as "quick whitening", "seven-day whitening", "medical whitening", etc., because some counterfeit and shoddy products stimulate consumers' desire to buy through these false claims. Behind the above claims, there are often suspected cases of illegal additives, such as illegal addition of hormones and banned substances such as lead and mercury. Repeated use of hormone products will make the skin abnormally sensitive, turning it into a "hormone face" and causing dependent dermatitis, and severe cases will cause harm to the nervous system. Choose products that suit your skin type according to seasonal characteristics. For consumers with sensitive skin, try it on a local area before use. Read the product instructions carefully before use, especially some warning words. If you experience skin redness, swelling, itching, etc. after use, stop using it immediately. If the symptoms are serious, seek medical attention in time. When using whitening cosmetics, you must try to reduce the impact of sunlight on the skin, especially the long-wave ultraviolet rays UVA that cause the skin to tan. Otherwise, it will affect the whitening effect of the product. It is recommended to use sunscreen cosmetics when going out in spring and summer. 6. How do you view the “377” in ordinary products? Not long ago, the State Food and Drug Administration discovered during a quality spot check on domestically produced ordinary products that some companies added benzoylresorcinol (trade name SymWhite®377, commonly known as 377), a raw material with only whitening effect, to their ordinary products. This raw material was a new cosmetic raw material approved by the former State Food and Drug Administration in 2012, and the only approved purpose of use was "whitening the skin and inhibiting the formation of melanin by inhibiting the activity of tyrosinase." From the perspective of raw material use, the use of this raw material in ordinary cosmetics for functions other than whitening exceeds the approved purpose of use of the raw material, and it should be registered or filed in accordance with the regulations on registration and filing of new raw materials before it can be used. From the perspective of product formula, adding a raw material with the only purpose of whitening agent to the formula of ordinary products, and the raw material has no other functions, means that the product adding this raw material should have whitening function, or the company's practice implies that the product has whitening function, and the product should be managed as freckle removal and whitening cosmetics, and the product can be put on the market after registration. The above-mentioned registered ordinary products containing benzoylresorcin are suspected of violating relevant provisions of the Regulations on the Supervision and Administration of Cosmetics, and the provincial drug regulatory authorities have begun to deal with them in accordance with the law. Whitening agents are a type of raw material with relatively high risks. It is recommended that companies should fully understand their sources, properties, scope of application, conditions of use, regulatory requirements, etc. when using such raw materials, and complete a comprehensive safety assessment before using them to ensure their safe use. Many raw materials in cosmetics have multiple functions at the same time. For example, ascorbic acid and its derivatives have antioxidant effects in addition to whitening effects; bisabolol has both certain whitening effects and certain soothing effects. Many formulators first know this raw material based on its soothing effect. Before the whitening list is released, cosmetic companies should reasonably select the raw materials according to their sources and their own characteristics and apply them to their products, so as to avoid repeating the mistakes of "377" due to ignoring the properties of some specific raw materials and the properties of the products they are used in. (Source: China Pharmaceutical News, National Drug Administration website) |
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