Data from China’s National Bureau of Statistics shows that the population of children under 14 in China exceeds 253 million, accounting for 17.95% of the country’s total population. This substantial number of children creates significant demand for children cosmetics, driving continuous growth in the children cosmetics market.
In comparison to adults, children have more sensitive skin, and are more susceptible to adverse reactions, allergies, and other potential negative impacts. As the fast-growing market also brings forth more non-compliance issues, regulatory authorities in China have placed a pronounced emphasis on the quality and safety of children cosmetics. To ensure their safe use, the regulatory system for children cosmetics has undergone continuous improvements over the past decade, with supervision gradually strengthening.
A Decade of Regulatory Changes for Children Cosmetics
On October 12, 2012, the former cosmetic competent authority in China, the State Food and Drug Administration (SFDA, now National Medical Products Administration (NMPA)), released the Guidance on Application and Review of Children Cosmetics. This guidance marked the first instance of addressing the individualized regulatory treatment of children cosmetics. However, the voluntary nature of this guidance undermined its effectiveness in deterring violators and unscrupulous manufacturers of children cosmetics. Released in December 2015, the Safety and Technical Standards for Cosmetics sets distinct hygienic standards for children and adult cosmetics, while the requirements for ingredient use, particularly for heavy metals, are essentially the same for both.
Later in 2016, the competent authority at that time, the China Food and Drug Administration (CFDA), conducted a study on cosmetic classification, underscoring the need for separate listing and differential management of children cosmetics. On this basis, the draft Standard for Cosmetic Classification, issued in January 2018, outlined differentiated research, manufacturing, and supervision processes for children cosmetics compared to those for adults. This focus on differential treatment is further evident in the release of the finalized Cosmetic Classification Rules and Catalog in April 2021. Additionally, starting from May 1, 2021, the Provisions for Management of Cosmetic Registration and Notification Dossiers makes it mandatory for children cosmetics to submit toxicological testing reports and safety assessment reports for the registration and notification application.
Furthermore, on October 8, 2021, NMPA promulgated the finalized Supervision and Administration Provisions on Children Cosmetics (the Provisions), marking the first regulation specifically tailored for children cosmetics. The Provisions provides clarity on the scope of children cosmetics, defining them as cosmetics intended for children aged 12 and under, with functions of cleaning, moisturizing, body refreshing, sunscreen, etc. In addition to age restrictions, products labelled as “applicable to the whole population” or “suitable for the whole family”, as well as products implying their target users include children through trademarks, homophones, letters, symbols and other means, will also be regulated as children cosmetics. Regarding compliance requirements, the existing regulatory framework for registration/notification, packaging, claims, production, and operation regulations for adult cosmetics also apply to children cosmetics. On this basis, the Provisions outlines special requirements for formula design, safety assessment, efficacy claims and labelling. A comprehensive examination of these crucial compliance aspects will be elaborated in the following paragraphs.
Compliance in Formula Design
Given the physiological differences between adults and children, the formulation of adult cosmetics cannot be directly applied to children cosmetics. The safety of these products shall be strictly observed, starting from the selection of ingredients to the formulation process. The Provisions outlines fundamental principles for the design of children cosmetics’ formula, namely prioritizing safety, ensuring essential efficacy, and utilizing minimal formulas. To be specific,
(1) Ingredients with a long history of safe use shall be selected. New cosmetic ingredients in the monitoring period, or those prepared using emerging technologies such as genetic or nanotechnology shall not be used. In cases where their usage is necessary due to the absence of alternative ingredients, justifications should be provided along with a thorough assessment of their safety for use in children cosmetics;
(2) Functional ingredients for freckle-removing, whitening, anti-acne, depilating, deodorant, anti-dandruff, anti-hair loss, hair dyeing, and hair perming are not permitted for use. If these ingredients are used for purposes other than those mentioned, their necessity and safety in children cosmetics shall be assessed;
(3) The scientificity and necessity of ingredients used in the formula of children cosmetics, especially fragrances, colorants, preservatives and surfactants, should be assessed from the aspects of safety, stability, function, and compatibility, and in alignment with children’s physiological characteristics.
Requirements for Safety Assessment
According to Technical Guidelines for Cosmetic Safety Assessment, the safety assessment of children cosmetics should be exposure-oriented, and conducted in consideration of children’s physiological characteristics, product application methods, application areas, application amount, residues, and other relevant factors to ensure product safety. Building upon this foundation, the Technical Guidelines for Children Cosmetics further clarifies specific requirements on how to incorporate children’s physiological characteristics during the safety assessment:
- Since children typically weigh less than adults, the safe concentration of the same ingredient in children cosmetics is generally lower than that in adult cosmetics. When conducting exposure assessment, priority should be given to referencing exposure data of children cosmetics from assessment documents or published literature of Chinese and foreign cosmetic research institutions;
- For products designed for infants under the age of three, the assessment data adopted should adhere to the highest level of stringency possible. This is due to the fact that actions such as sucking and scratching by infants can result in increased exposure, and there are differences in metabolic capacity between infants and adults.
Besides, while China provides exemptions for general cosmetics from submitting toxicological testing reports under certain conditions, children cosmetics are not included in these exemptions. Both a toxicological testing report and a safety assessment report are required to register/notify children cosmetics, indicating that animal testing is still mandatory for these products.
Limitations on Efficacy Claims
Cosmetic Classification Rules and Catalog introduces a total of 27 categories of allowable efficacy claims for cosmetics. Considering the different needs of children and adults, limitations have been established for the efficacy claims that can be made for children cosmetics and toothpaste. Following the specifications laid out, the allowable claims for children cosmetics are categorized into two groups based on different age groups (table 1).
With regard to toothpaste, subject to the draft Instructions for Toothpaste Notification Dossiers, the allowable efficacy claims for children toothpaste are limited to basic cleaning and caries prevention.
| Age Group | Allowable Efficacy Claims |
|---|---|
| Infants and toddlers (0-3 years) | ● Cleaning ● Moisturizing ● Hair care ● Sunscreen ● Soothing ● Body refreshing |
| Children (3-12 years) | ● Cleaning ● Moisturizing ● Hair care ● Sunscreen ● Soothing ● Body refreshing ● Makeup removing ● Perfuming ● Repairing ● Beautifying and embellishing |
Essentials for Labelling
In addition to the required labelling information for cosmetics, children cosmetics shall be labelled with the NMPA-designated children cosmetics’ logo on the sales packaging. The logo should be placed on the upper left side of the easily-observed display panel of the packaging, following the proportion specified by NMPA. It must be clear and easily identifiable. The children cosmetics’ logo is a complete pattern, and should not be split, spliced, or replaced. Starting from May 1, 2022, children cosmetics that apply for registration/notification shall bear the logo.
It is noteworthy that the “Little Golden Shield” logo solely indicates that the product is a children cosmetic, distinguishing it from adult cosmetics, children’s toys, and other products. It does not imply that the product has been approved by the regulatory authority, or certified for quality and safety.
Additionally, children cosmetics shall be labelled with warnings such as “shall be used under adult supervision”, guided by “caution” or “warning”, on the visual surface of the sales packaging. To prevent confusion between product properties, smell, appearance, etc., with food items, words such as “food-grade”, “edible”, or food-related patterns shall not appear on children cosmetics. Furthermore, companies manufacturing and selling toys and utensils for minors should provide precautionary information on the packaging, and take measures to prevent the products from being misused as children cosmetics.
Conclusions
With the introduction of two-child and three-child policy, the future children cosmetics market in China holds significant prospects for development. However, as stricter regulations and supervision are implemented, children cosmetics enterprises should adhere to higher requirements for product development, production, sales and other aspects of the production chain to maintain a competitive edge. In terms of compliance, enterprises should select ingredients with a safe use history and comprehensive toxicological data to develop children cosmetics tailored to their physiological characteristics, and conduct thorough safety assessments. It is crucial for children cosmetics to make claims that align with regulations while refraining from exaggerated efficacy and false advertising. Additionally, enterprises should prominently display the children cosmetics’ logo on the packaging during sales.
Staying updated on laws and regulations, conducting regular self-examinations and inspections, as well as maintaining rigorous production and operational practices are essential for enterprises operating in the children cosmetics market. By prioritizing compliance and safety, enterprises can not only enhance their credibility but also capitalize on the vast opportunities present in this market.
