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.
Regulation | Remark | Effective Date | Status |
| 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 | In force |
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 | In force | |
Provisions for Management of Cosmetic Registration and Notification Dossiers | 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 | In force |
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 | In force | |
Supervision and Administration Provisions on Children Cosmetics | 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 | In force |
Supervision and Administration Measures on Cosmetics Manufacture and Operation | 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 | In force |
The regulation contains strict environmental index requirements for the clean work area and quasi-clean work area of children cosmetics manufacture. | Jul. 1, 2022 | In force | |
| Technical Guidelines for Children Cosmetics (Draft) | 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. | / | Draft |
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.
1. Definition
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:
Aspects | Yes | No (examples) |
Application Method | 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 |
Use Purpose | 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 |
Product Status | Substance or mixture | Article (Wigs, false eyelashes) |
Target User’s Age | 0-12 | Above 12 |
Notes:
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2. Classification
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.
Product Efficacy | Category | Obligation | Competent Authority | |
Infant cosmetics (0-3 years old, including 3) | Cleaning, moisturizing, hair care, soothing, body refreshing | General cosmetics | Notification | NMPA or Provincial MPA entrusted by NMPA |
Sunscreening, or efficacies other than the above | Special cosmetics | Registration | NMPA | |
Children cosmetics (3-12 years old, including 12) | Cleaning, makeup removing, moisturizing, beautifying and embellishing, perfuming, hair care, repairing, soothing, body refreshing | General cosmetics | Notification | NMPA or Provincial MPA entrusted by NMPA |
Sunscreening, or efficacies other than the above | Special cosmetics | Registration | NMPA | |
| 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.
Manufacture Requirements
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 | |||
Level | Working Procedure | Environmental Indicators | |
Hygienic indicators | Other indicators | ||
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 Ingredients
The prohibited and restricted ingredients for children cosmetics are basically consistent with adult cosmetics, but some ingredients allowed in adult cosmetics are prohibited in children cosmetics under three years old.
No. | Ingredients | Requirements |
1 | Boric acid, borates and tetraborates | Prohibited to use in cosmetics for children under 3 |
2 | Salicylic acid | Prohibited to use in cosmetics for children under 3 (except for shampoos) |
3 | Strontium chloride | Cosmetics containing strontium chloride should be labeled with "Children should not use this product frequently" |
4 | Calcium hydroxide, Lithium hydroxide, Thioglycollic acid and its salts, Thioglycollic acid esters, Alkali sulfides, Alkaline earth sulfides, Strontium hydroxide, Potassium hydroxide, Sodium hydroxide | Cosmetics containing these ingredients should be labeled with "be kept out of children’s reach” |
5 | Talc: hydrated magnesium silicate | Powdered cosmetics containing talc (for children under 3) should be labeled with "The powder should be kept away from children’s nose and mouth" |
6 | Iodopropynyl butylcarbamate | Prohibited to use in cosmetics for children under 3 (except for bath products and shampoos) |
7 | Silver chloride deposited on titanium dioxide | Prohibited to use in cosmetics for children under 3 |
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
Animal Testing
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.
Safety Assessment
The safety assessment of children cosmetics should refer to Technical Guidelines for Cosmetic Safety Assessment. 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.
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
7. Durability
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
Children cosmetics shall be labeled with warnings such as “shall be used under adult supervision”, guided by “Caution” or “Warning”, on the sales package.
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.
Children cosmetics shall not be marked with words such as “food grade”, “edible”, or food-related patterns on the label.
Cosmetic registrants and notifiers are encouraged to adopt anti-counterfeiting technologies, etc., on labels to facilitate consumers’ identification and selection of legal products.
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.
Children cosmetics that apply for registration/notification after May 1, 2022, must be labeled in accordance with Supervision and Administration Provisions on Children Cosmetics and Administrative Measures on Cosmetics Labeling. For children cosmetics that have applied for registration/notification before May 1, 2022, the registrant/notifier shall update the product label before May 1, 2023.
7. Efficacy Evaluation and Claims
Efficacy Evaluation
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.
Efficacy Claims | Evaluation Principles | Evaluation Methods | Evaluation Institutions |
Sun protection | Human trial | Methods prescribed in mandatory national standards and technical norms | NMPA accredited labs in China |
Repairing | Human trial |
| Both Chinese and international institutions are acceptable |
Soothing |
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Moisturizing, hair care |
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Cleaning, body refreshing, makeup removing, beautifying and embellishing, perfuming | Exempt from efficacy evaluation | ||
Prohibited Claims
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
8. Testing
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 to the skin and eyes, 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
Offline
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.
Online
E-commerce operators should fully, truthfully, and accurately display children cosmetic labels and children cosmetics logo on the product page.
Post-market Surveillance
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 cosmetic@chemlinked.com.
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