Children cosmetics in China are defined as "cosmetics for children aged 12 and under". The registration, notification, packaging, claims, production and operation regulations for adult cosmetics also apply to children cosmetics. But considering children have more sensitive skin than adults and are more susceptible to adverse and allergic reactions, the R&D, manufacture, safety assessment, and labeling of children cosmetics are subject to stricter supervision.
On Jun. 18, 2021, China NMPA issued the draft Supervision and Administration Provisions on Children Cosmetics. Then On Oct. 8, NMPA promulgated the finalized version of this Provisions (hereafter referred to as "Provisions").
This is the first regulation specifically for children cosmetics, indicating NMPA’s intention to further tighten the supervision for children cosmetics market. It includes 22 articles, clarifying children cosmetics' scope, formula design principles, labeling requirements, manufacture and operation requirements, post-market supervision requirements, etc. The Provisions came into force on January 1, 2022, while the labeling requirements in the Provisions took effect on May 1, 2022.
This Cosmepedia mainly talks about the additional requirements for children cosmetics. For the general requirements on the registration, notification, efficacy evaluation, packaging, claims, as well as production and operation of children cosmetics, please refer to Chinese Mainland Cosmepedia.
Part I Main Regulations for Children Cosmetics
All the cosmetic regulations in China are applicable to children cosmetics. The following table lists the regulations that have special requirements for children cosmetics.
|Practice for Cosmetics Production Licensing
The regulation stipulates the requirements, procedures, necessary dossiers for production licenses application, and provides supervision and inspection details for companies’reference.
In the production of infant and children skincare products, the air cleanliness of the filling room and clean container storage room should meet class 300,000 cleanliness requirements. The completion acceptance document of the air purification system should be provided, as a necessary dossier for the license application.
Jan. 1, 2016
The regulation stipulates the microbial limit of children cosmetics and the requirements for using specific ingredients in children cosmetics.
Dec. 1, 2016
In force, but is being revised
The regulation stipulates the permitted efficacy claims for children cosmetics. Those claiming any efficacy not listed in this regulation should be managed as cosmetics with new efficacies, which means it is defined as a special cosmetics.
May 1, 2021
The regulation stipulates the dossier requirements for registration and notification. For children cosmetics, a toxicological testing report and a safety assessment report are both required.
May 1, 2021
The safety assessment of children cosmetics should refer to the Technical Guidelines. In the safety assessment of children cosmetics, the children's physiological characteristics should be involved in the consideration of hazard identification and exposure calculation.
May 1, 2021
This is the first regulation specifically for children cosmetics promulgated by NMPA. It includes 22 articles, clarifying children cosmetics' scope, formula design principles, labeling requirements, registrant/notifier's main responsibilities, post-market supervision requirements, etc.
Jan. 1, 2022
The regulation stipulates the requirements for the manufacture and operation of cosmetics. The production license for infant and children skincare products should indicate that the licensed items include infant and children skincare products. The work area’s cleanliness shall meet the GMP requirements.
Jan. 1, 2022
The regulation contains strict environmental index requirements for the clean work area and quasi-clean work area of children cosmetics manufacture.
Jul. 1, 2022
|Technical Guidelines for Children Cosmetics
|The guidelines is formulated to provide technical guidance for the registrant, notifier, and Chinese domestic responsible person when applying for the registration and notification of children cosmetics, as well as provide the basis for the competent authorities’ technical review of special children cosmetics and post-notification review of general children cosmetics.
|Aug. 31, 2023
Part II Regulatory Requirements
Compared with adult cosmetics, National Medical Products Administration (NMPA) stipulated special requirements on formula design, ingredient use, safety assessment, labeling and testing for children cosmetics.
Children cosmetics refer to cosmetics for children aged 12 and under, and have the functions of cleansing, moisturizing, body refreshing, sunscreen, etc. In addition to age restrictions, the following two products will also be regulated as children cosmetics:
Product labeling "applicable to the whole population," "suitable for the whole family," etc.;
Product implying the target users include children by trademarks, patterns, homophones, letters, Pinyin, numbers, symbols, packaging, etc.
How to judge whether your product is children cosmetic in China? You may take into consideration the following aspects:
Smearing, spraying or other similar ways like rubbing
Microneedle puncture, whitening injection, whitening pill (oral administration)
Applied Body Part
Any external part of the human body, such as skin, hair, nails, lips
Oral cavity, mucosa
Cleaning, makeup removing, moisturizing, beautifying and embellishing, perfuming, hair care, sun protection, repairing, soothing and body refreshing
Prevent and treat diseases, antibacterial, anti-inflammatory, remove scar
Substance or mixture
Article (Wigs, false eyelashes)
Target User’s Age
Children cosmetics are mainly classified according to their efficacy claims. The common efficacies of children cosmetics include cleaning, moisturizing, and body refreshing. If a children cosmetics claims any efficacy outside the permitted scope stipulated by Cosmetic Classification Rules and Catalog, the product is regulated as a cosmetics with new efficacies, which means it is defined as a special cosmetics. In practice, it is difficult for children cosmetics with new efficacies to pass the NMPA technical review.
Infant cosmetics (0-3 years old, including 3)
Cleaning, moisturizing, hair care, soothing, body refreshing
NMPA or Provincial MPA entrusted by NMPA
Sunscreening, or efficacies other than the above
Children cosmetics (3-12 years old, including 12)
Cleaning, makeup removing, moisturizing, beautifying and embellishing, perfuming, hair care, repairing, soothing, body refreshing
NMPA or Provincial MPA entrusted by NMPA
Sunscreening, or efficacies other than the above
|Note: For cosmetics used by infants under 3 years old, the permitted efficacy claims do not include "beautifying and embellishing" or "makeup removing". Therefore, it is illegal to claim that makeup is suitable for infants under 3 years old.
3. R&D and Manufacture
Formula Design Principles
The formula design of children cosmetics shall follow the principle of safety prioritized, efficacy essential, and formula minimal:
1) Cosmetic ingredients with a long history of safe use shall be selected. New ingredients that are still in the monitoring period and ingredients prepared by new technologies such as genetic technology and nanotechnology shall not be used, and if they must be used due to lack of alternative ingredients, the reasons shall be explained, and assessment shall be made to the safety of its use in children cosmetics;
2) Ingredients for the purpose of freckle-removing & whitening, anti-acne, depilation, deodorization, anti-dandruff, anti-hair loss, hair dyeing, hair perming, etc., shall not be used, and the above mentioned efficacies are prohibited from claiming for children cosmetics. If ingredients that may have these efficacies are used for other purposes, assessment shall be made to the necessity of the use thereof and safety of its use in children cosmetics;
3) Children cosmetics shall be assessed of the scientificity and necessity of the ingredients used, especially the ingredients such as fragrances, colorants, preservatives and surfactants, etc., in consideration of the safety, stability, function, compatibility and other aspects thereof and in combination with the physiological characteristics of the children.
The production license of children skincare products should indicate that the licensed items include children skincare products;
Children cosmetics should be produced in accordance with Good Manufacturing Practices for Cosmetics. Children skincare products should be produced in the qualified clean work areas:
Environmental Requirements for Children Cosmetics Production Factory
Clean work area
Storage of semi-finished products, filling, storage of clean containers, tools and instruments
Static pressure difference: ≥10Pa in general production area, and ≥5Pa in quasi-cleaning work area
Quasi-clean work area
Weighing, preparation, buffering, clothes change
Total bacterial colonies in the air: ≤1,000cfu/m3
Cosmetic registrants, notifiers, and entrusted production enterprises shall conduct self-inspection on the GMP implementation situation;
Children cosmetics shall be strictly subject to the ingredient purchase inspection and recording system, and carry out related testing items when necessary. If hormones, anti-infective drugs, and other substances that may harm human health are found in the ingredients, the registrant or notifier should immediately take risk control measures and report to provincial MPA;
Cosmetic registrants, notifiers, and entrusted manufacturers shall formulate and implement annual training plans for employees and keep the training files.
Prohibited and Restricted Ingredients
The prohibited and restricted ingredients for children cosmetics are basically consistent with adult cosmetics, but some ingredients allowed in adult cosmetics are prohibited or restricted for use in children cosmetics.
1) Ingredients that are prohibited in children cosmetics stipulated in national mandatory standards such as STSC;
2) New ingredients under safety monitoring;
3) Ingredients whose safety to children is unknown;
4) Ingredients prepared through new technologies such as genetic technology and nanotechnology;
5) Ingredients for the purpose of freckle-removing & whitening, anti-acne, depilation, deodorization, anti-dandruff, anti-hair loss, hair dyeing, hair perming;
6) Iodopropynyl butylcarbamate, salicylic acid and its salts, silver chloride deposited on titanium dioxide, etc. (prohibited for use in cosmetics for infants under three years old).
Not Recommended Ingredients
1) Ingredients with specific safety risks such as formaldehyde releaser;
2) Ingredients prohibited in foreign countries or regions.
Ingredients that Need to Be Used Rationally
1) Fragrance, flavors and aromatic vegetable oil ingredients.
2) Colorants, preservatives, and surfactants.
4. Registration and Notification
For the general requirements for children cosmetics’ registration/notification process and documents, please refer to Chinese Mainland Cosmepedia. The special requirements include:
For adult cosmetics, the post-notification technical review is random. Documents submitted by companies that previously had safety problems or have records of non-compliance are reviewed more frequently. However, for children cosmetics, the notification documents submitted by each notifier are subject to technical review;
NMPA will publish the finalized Technical Guidelines for Children Cosmetics, and strictly review the registration and notification documents (especially safety documents) according to the Guidelines. Products with non-compliant documents will be punished severely.
5. Animal Testing and Safety Assessment
Although China exempts general cosmetics from submitting toxicological testing reports, children cosmetics are not included in the exemption. Toxicological testing report and safety assessment report are both required for registration and notification, meaning that animal testing is still mandatory for children cosmetics.
According to Technical Guidelines for Cosmetic Safety Assessment, the safety assessment of children cosmetics should be exposure-oriented and carried out in combination with children’s physiological characteristics, product application methods, application areas, application amount, residues and other exposure levels to ensure the product safety. On the basis, Technical Guidelines for Children Cosmetics clarifies the specific requirements on how to combine children’s physiological characteristics during the safety assessment, which is more convenient for enterprises to fulfill in the practice. The following are special requirements for children cosmetics safety assessment:
In the safety assessment of children cosmetics, the children’s physiological characteristics should be involved in the consideration of hazard identification and exposure dosage calculation;
The principles of the formula design shall be included in the safety assessment report, and the necessity of using ingredients in the formula shall be explained, especially the fragrances, colorants, preservatives and surfactants;
If the ingredients with freckle-removing and whitening, anti-acne, depilation, deodorization, anti-dandruff, anti-hair loss, hair dyeing, or hair perming efficacy are used for other purposes rather than the above-mentioned purposes, the necessity and safety of their use in children cosmetics shall be assessed;
If the ingredients are prepared by new technologies such as genetic technology or nanotechnology are used, the reason shall be explained and the safety of their use in children cosmetics shall be assessed;
Since systemic exposures to cosmetic products are generally higher in children than in adults, the actual safe use concentration of the same ingredient in children cosmetics is lower than that in adult cosmetics. When conducting exposure assessment, priority should be given to citing the exposure data from assessment documents or published literature specifically related to children cosmetics written by Chinese and foreign cosmetic research institutions;
For products designed for infants under the age of three, the assessment data adopted should be as strict as possible, and the risk of oral exposure should be considered. This is because actions such as sucking and scratching by infants may lead to extra exposure, and the metabolic capacity of infants is different from that of adults;
Certain infant cosmetics are designed for specific application scenarios, such as usage in skin folds and diaper areas. These areas are prone to skin damage due to factors like tight clothing and diapers, and infant’s inability to control urination and defecation. Consequently, safety assessments for these products should take into account the changes of skin absorption rate that may occur under such special circumstances.
6. Labeling and Packaging
The necessary labeling information for children and adult cosmetics is basically the same, but children cosmetics should be additionally labeled with children cosmetics logo and specific safety warnings. The following information shall be labeled on children cosmetics:
1. Product name, and special cosmetic registration certificate number
2. The name and address of registrant or notifier
3. The name and address of production enterprise
4. The product executive standard number
5. Full ingredients listing
6. Net content
8. Application method
9. Safety warnings
10. Children cosmetics’ logo
11. Other content prescribed by laws, administrative regulations and mandatory national standards
Children Cosmetics’ Logo
The logo shall be labeled on the upper left side of the easily-observed display panel of the sales package (hereinafter referred to as “main display panel”) in proportion to the pattern designated by NMPA, and it must be clear and easy to identify. Children cosmetics' logo is a whole pattern, and cannot be split, spliced, or replaced. Products other than children cosmetics shall not label children cosmetics' logo.
Children Cosmetics' Logo Published by NMPA
Notes: The logo’s name is “Little Golden Shield” (in Chinese is “小金盾”). It is intended to express the hope of NMPA to continuously improve children cosmetic's quality and safety, provide a good growth environment and protect the healthy growth of children through the joint efforts of all parties in the society. The logo uses a golden color scheme and a shield shape. The gold color reflects the healthy, lively, optimistic, and positive state of children; the shield represents the protection and care of children, the resistance to illegal products, and also to increase the recognition of the logo; the center of the shield is an image of children with open hands, emphasizing the firm determination of all parties in the society to protect the healthy growth of children.
For children cosmetics whose main display panel:
Has a surface area greater than 100 square centimeters, the width of the widest part of children cosmetics' logo shall not be less than 2 centimeters;
Has a surface area less than or equal to 100 square centimeters, the width of the widest part of children cosmetics' logo shall not be less than 1 centimeter.
NMPA also provided recommended color matching information. Children cosmetics companies can fine-tune the color according to the actual packaging.
C:38 M:49 Y:81 K:0
C:20 M:31 Y:66 K:0
C:1 M:16 Y:34 K:0
Color Matching Information Recommended by NMPA
Safety Warnings and Other Labeling Requirements
1. Children cosmetics shall be labeled with warnings such as “shall be used under adult supervision”, guided by “Caution” or “Warning”, on the sales package;
2. Cosmetic registrants, notifiers, and entrusted production enterprises shall also take measures to avoid the confusion of product properties, appearance, and other attributes with food and drugs;
3. Children cosmetics shall not be marked with words such as “food grade”, “edible”, or food-related patterns on the label;
4. Cosmetic registrants and notifiers are encouraged to adopt anti-counterfeiting technologies, etc., on labels to facilitate consumers’ identification and selection of legal products;
5. Companies that produce and sell toys and utensils for minors should indicate precautions on the packaging and take measures to prevent the products from being misused as children cosmetics;
6. Flammable products, such as pressure-filled sols, should include warning words like "Fire and Explosion Hazard" or warning icons on the label;
7. Leave-on products containing fragrance allergens at a concentration not less than 0.001% or rinse-off products with a concentration of fragrance allergens not less than 0.01% should be labeled with the specific names of the fragrance allergens;
8. Children cosmetics claiming "makeup removing" or "beautifying and embellishing" functions should specify the use scenario. The product should be labeled with warnings such as "Clean in Time" and "If you experience discomfort during use, please discontinue immediately."
9. For imported children cosmetics:
The information related to efficacy claims, application methods, application areas, target users, and product dosage forms on the Chinese label should be consistent with the corresponding information on the original label;
The safety warning contents (including precautions) on the Chinese label should be equal to or more comprehensive than the corresponding contents on the original label;
The SPF value and PA grade information on the Chinese label should be consistent with the corresponding information on the original label. If not, the enterprise should provide a sales package specifically designed for the Chinese market.
7. Efficacy Evaluation and Claims
Starting from 2022, cosmetics registrants and notifiers shall evaluate the cosmetic efficacy claims and upload the evaluation summary on the website specified by the NMPA. The content necessary in the evaluation summary and report can refer to Chinese Mainland Cosmepedia.
For children cosmetics, most of their permitted efficacies, such as cleansing, makeup-removing, beautifying and embellishing, perfuming, body refreshing, can be directly recognized by the senses and exempted from efficacy evaluation. Only 5 kinds of efficacy claims of children cosmetics require evaluation. The detailed requirements are listed in the following table.
Methods prescribed in mandatory national standards and technical norms
NMPA accredited labs in China
Both Chinese and international institutions are acceptable
Moisturizing, hair care
Cleaning, body refreshing, makeup removing, beautifying and embellishing, perfuming
Exempt from efficacy evaluation
Children cosmetics are not allowed to make the following five types of claims.
Claims indicating medical effects implicitly or explicitly
Claims indicating misleading information implicitly or explicitly
Claims including absolute/exaggerated/false descriptions
Other claims that are contrary to law, cosmetic regulations, public order or good customs
Efficacies of freckle-removing & whitening, anti-acne, depilation, deodorant, anti-dandruff, anti-hair loss, hair dyeing, hair perming
Like adult cosmetics, children cosmetics must be tested in NMPA approved testing institutions. The testing items shall comply with Working Rules for Cosmetic Registration and Notification Testing. In addition, the children cosmetics shall be non-irritant or slight irritant to the eyes, non-irritant to the skin, non-phototoxic, and non-allergic. The total bacteria count in children cosmetics shall be no more than 500 CFU/mL or 500 CFU/g.
9. Post-market Sales
Cosmetic business operators should establish and implement a purchase inspection and recording system to ensure the traceability of children cosmetics;
Cosmetic business operators are encouraged to sell children cosmetics in a separate area, display children cosmetics logo in the area and prompt consumers to inquire product registration and notification information;
Cosmetic business operators should check the product labeling information with the corresponding product information published on NMPA website.
E-commerce operators should fully, truthfully, and accurately display children cosmetic labels and children cosmetics logo on the product page.
Children cosmetics is the key category subject to post-market sampling inspection and risk monitoring. If any prohibited ingredients, unregistered NCI, or ingredients that may harm human health are found in children cosmetics, it shall be deemed as a serious circumstance and severe penalties will be imposed.
ChemLinked expects assist companies in registering and notifying cosmetics in China. If you have any further cosmetic compliance consultation needs, please contact us at firstname.lastname@example.org.
10. Key Supervision Categories
1. Imported Children Cosmetics with Formula Specifically Designed for the Chinese Market
The Guidelines provides clear requirements for imported children cosmetics that have formulas specifically tailored for the Chinese market. These cosmetics require stringent management as there are no equivalent products available abroad. Accordingly, the Guidelines stipulates the following:
The formula design should be based on the specific skin type and consumption needs of Chinese children. The accompanying explanatory documents should demonstrate the necessity of and relevant research and development efforts involved in designing the formula for the Chinese market;
Enterprises should conduct consumer testing research or human clinical trials on Chinese adult consumers in China, and the data will be used for efficacy evaluation;
The safety assessment should comprehensively consider skin exposure data and the usage characteristics of Chinese children. It is encouraged to provide safety assessment data from products with similar formulas that have been marketed internationally or in China for several years as the supporting evidence;
When applying for the registration renewal for special children cosmetics, adverse reaction monitoring data from child consumers in China should also be submitted.
2. Children Sunscreens
As special cosmetics, sunscreen products have always been the core category of supervision. The Guidelines stipulates additional requirements for children sunscreens in details.
1) Ingredient Use
In principle, there should be no more than five types of chemical sunscreen agents in children sunscreens, and the concentration should be lower than that of adult sunscreens. The total concentration of titanium dioxide and zinc oxide in children sunscreens shall not exceed 25%.
Compared to the draft, the number of permissible types of sunscreen agents in children cosmetics has been expanded from “no more than three” to “no more than five” in the finalized Guidelines. This change provides greater flexibility for companies in formulating their products.
Moreover, the finalized Guidelines has eliminated the provisions in the draft that set a maximum SPF value of 30 for children sunscreens and prohibited claim of "high sun protection." Instead, the finalized Guidelines no longer imposes a specific restriction on the maximum SPF value. It emphasizes that when the SPF value is high, enterprises should undertake a thorough safety assessment. If required, they may submit human trial data as supporting evidence.
The efficacy claims of sunscreen products should align with the results obtained from the product's efficacy evaluation report. Claims for children sunscreens should not encourage sun exposure or make absolute guarantees about the effectiveness of sun protection;
Children sunscreens with claims of "waterproof," "sweatproof," and/or "suitable for outdoor activities such as swimming" should undergo testing to verify the claimed water resistance degree and/or time. The claims should be consistent with the results of water-resistance testing. If the testing shows that the SPF value decreases by more than 50% after bathing, the waterproof efficacy should not be claimed.
The labeled SPF value and PA level should be consistent with the results obtained from the human efficacy test report and comply with China's requirements for sunscreen effect labeling management;
For children sunscreen sprays, the product should include warning labels such as "do not spray directly on the face," "please spray on the palm before applying to the face," and "avoid inhalation."