Some Cosmetics Should not Claim Whitening Efficacy

Whitening has always been an immediate need for Chinese women, so how can cosmetics properly promote whitening under Chinese cosmetic regulations?

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The National Institutes for Food and Drug Control has issued two announcements, Technical Guidelines for Research on Whitening Cosmetics (Draft for Comments) and Technical Guidelines for Research on Efficacy of Whitening Cosmetics and Whitening Ingredients (Draft for Comments). The two announcements regulate and guide the general principles of the preliminary research phase of whitening cosmetics and whitening ingredients, intending to encourage and support the industry to carry out cosmetic research and innovation.

According to a senior industry source, "After nearly three years of comprehensive regulation, the industry's next phase of development may focus on the high-quality level. The recent release of several guidelines for special cosmetic research may be the first step taken."

Whitening cosmetics belong to special cosmetics in China and are managed under a registration system. In 2021, the Cosmetic Supervision and Administration Regulation (CSAR) (hereinafter referred to as "the new regulations") came into force. Then China established a new regulatory and technical system with relevant supporting regulatory documents released. At the same time, in order to encourage and support cosmetic research and innovation, higher requirements were placed on the quality, safety and supervision of cosmetics.

The National Medical Products Administration believes that it is necessary to conduct systematic research and discussion on relevant technical issues and to develop special technical guidelines for regulating and guiding the research and evaluation of whitening cosmetics. It aims to meet the needs of high-quality development of the industry and regulation in the context of the new conditions. Therefore, The National Medical Products Administration and The National Institutes for Food and Drug Control drafted The Technical Guidelines for the Research of Whitening Cosmetics (Draft for Comments) (hereinafter referred to as the Guidelines for the Research of Whitening Cosmetics).

The Guidelines for the Research of Whitening Cosmetics consists of eight parts, which summarise the technical points and technical principles that need to be paid attention to, mainly around the general principles of whitening cosmetics, product attributes, formulation design, product safety assessment, production process and quality control, evaluation of efficacy claims and product labeling. It is clearly stated that in the research process, the first thing that should be done is to position the whitening cosmetic, clarify its product attributes, develop and design around the product attributes and carry out corresponding research. In addition, the applying body part of the cosmetic that can be used for whitening should not include "lips and mouth". The group of people who can use it should not include "infants" or "children".

In addition, products to improve acne marks caused by pigmentation are classified as blemish-whitening cosmetics according to the Cosmetic Classification Rules and Catalogs. Products that only improve skin brightness or accelerate the renewal of keratin by increasing hydration, cleansing and exfoliation are not spot-whitening cosmetics because they are different from the main mechanism of whitening cosmetics.

For ingredients with whitening efficacy, The Guidelines for the Research of Whitening Cosmetics state that the focus should be on possible risk substances, as well as information on the quality of ingredients. For non-single ingredients such as plant extracts used as whitening ingredients, the safety information should generally include characteristic control indicators that indicate the quality of the ingredients, such as quantitative requirements for specific efficacy ingredients, to ensure long-term stability and reliability of product safety and efficacy.

The Guidelines for the Research of Whitening Cosmetics then required that claims about the efficacy, mechanism of ingredients and others should be consistent with the basis for the efficacy of the ingredients in question. "Medical terminology or words that imply the cosmetics have medical efficacy shall not be used, such as removing melasma, removing freckles, removing pigmented moles, anti-inflammatory, etc. Exaggerated or absolute claims shall not be used, such as whitening immediately, eliminating melanin, blocking melanin transport, going straight to the bottom of the skin, and intelligently targeting to suppress darkness, etc."

The Guidelines for the Research of Whitening Cosmetics defines ingredients with whitening efficacy for the first time. Ingredients with whitening efficacy are those ingredients that are reported in the product formulations of whitening special cosmetic products as "spotting agents", "whitening agents" or the ingredients that have the whitening efficacy. They do not include ingredients that work by physical masking, and new cosmetic ingredients with spot-lighting and whitening functions. In addition, ingredients that are filled in the form of compounding in the formula refer to the ingredients that specifically play a role in spot-removal and whitening.

In other words, if an ingredient has multiple efficacies but the filer doesn’t register the ingredient as a whitening agent, it can be added to ordinary cosmetics even if it comes with a whitening efficacy. For example, niacinamide has whitening, emollient, antioxidant and acne-fighting efficacy and can be added to ordinary cosmetics. However, ingredients like Symwhite 377, which are mainly used as a whitening agent, cannot be added to ordinary cosmetics.

It is worth mentioning that The Guidelines for the Research of Whitening Cosmetics state that confusion with other purposes of use should also be avoided through the mechanism of action studies. For example, sun protection, which reduces external UV damage and the corresponding skin response, may ultimately also have some preventive/reducing efficacy on skin darkening or sun spots. But it should be a secondary result of sun protection and should not be a direct spot whitening efficacy. The use of "exfoliators" may help to promote the removal of melanin-containing stratum corneum from the skin surface. But there is a difference between this method and the primary mechanism of spot whitening action. To avoid confusion, the relevant ingredients should not be used as spot-whitening agents. Products that can improve skin brightness by improving hydration, and cleansing still have a difference between this and whitening efficacy.

In other words, sunscreen, exfoliation, cleansing and other related products are not allowed to claim whitening efficacy.

A cosmetic ingredients professional, who did not want to be named, said, "In general, this is a guiding refinement document for the development, safety and efficacy evaluation, manufacturing and quality supervision of whitening and spot-removing cosmetics. It also focuses on answering questions about whether whitening efficacy can be claimed if it relies on moisturizing, exfoliating, sun protection and other means to obtain whitening efficacy."