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.
This Cosmepedia mainly talks about the additional requirements for children cosmetics. For the general requirements on the registration, notification, 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 |
The guidance clearly defines children cosmetics in China: cosmetics used for children aged 12 and under. Stakeholders involved in the production of children cosmetics should refer to this guidance. The main content consists of the applicable scope, formula design principles, safety assessment of finished products and ingredients, registration/notification requirements, and key points for technical review. | Feb. 1, 2013 | In force | |
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 | |
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 (Draft) | This is the first regulation specifically for children cosmetics promulgated by NMPA. Compared with the current guidance for children cosmetics, this Provisions specifies the responsibilities of each entity; formula design principles; and requirements for safety assessment, production, operation, adverse reaction monitoring, labeling, and sampling inspection. | / | Draft |
Supervision and Administration Measures on Cosmetics Manufacture and Operation (Draft) | 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. | / | Draft |
The regulation contains strict environmental index requirements for the clean work area and quasi-clean work area of children cosmetics manufacture. | / | Draft |
Part II Current 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.
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 | |
Children cosmetics (under 3 years old) | Cleaning, moistening, moisturizing, relieving, body refreshing | General cosmetics | Notification | Provincial MPA |
Sunscreening, or efficacies other than the above | Special cosmetics | Registration | NMPA | |
Children cosmetics (3-12 years old) | Cleaning, makeup removing, moistening, moisturizing, beautifying and embellishing, hair styling, fragrant, hair care, repairing, relieving, oil-control, exfoliating, body refreshing, hair break prevention | General cosmetics | Notification | Provincial MPA |
Sunscreening, or efficacies other than the above | Special cosmetics | Registration | NMPA | |
R&D and Manufacture
Formula Design Principles
The formula design of children cosmetics should follow these principles:
The number of ingredient categories should be kept to the minimum level;
Restrict the use of fragrance, colorant, preservative, and surfactant to the minimum as long as it is sufficient to maintain function;
Not recommend using ingredients with the efficacy of whitening, freckle-removing, anti-acne, depilation, anti-perspirant, deodorization, hair dyeing, hair perming, slimming, breast beauty;
The ingredients selected should have a safe use record during a certain period. Ingredients manufactured through genetic technology or nanotechnology are not recommended to use;
The source, composition, impurities, physical and chemical properties, applicable scope, safe usage, and precautions of the ingredients used should be recognized and available for reference.
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 |
Tetraborates | Prohibited to use in cosmetics for children under 3 (except hair perming products) | |
2 | Salicylic acid | Prohibited to use in cosmetics for children under 3 (except shampoos) |
3 | Strontium chloride | Children should not use cosmetics containing strontium chloride 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 | These ingredients should be kept out of children’s reach |
5 | Talc: hydrated magnesium silicate | 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 bath products and shampoos) |
7 | Silver chloride deposited on titanium dioxide | Prohibited to use in cosmetics for children under 3 |
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 three 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 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.
Labeling and Packaging
Children cosmetics are subject to the following additional labeling requirements:
The Chinese name or the visible panel of the package should indicate that the product is suitable for children;
Children cosmetics should be marked with warning words such as “should be used under adult supervision” on the product label and in the instructions;
Cosmetics without a clear indication for use by children shall not bear any images of children or imply in any way that these are children cosmetics on the packages.
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.
Part III Future Regulatory Requirements
On Jun. 18, 2021, China NMPA issued the draft Supervision and Administration Provisions on Children Cosmetics. This is the first regulation specifically for children cosmetics, indicating NMPA will further tighten the supervision for children cosmetics market. Compared with the current guidance, the draft Provisions contains regulatory requirements for every step of children cosmetics production and operation from R&D to post-market sales.
Notes: The following content is written based on the draft regulation. The future regulatory requirements for children cosmetics are subject to the finalized regulation.
Definition
Children cosmetics refer to cosmetics for children aged 12 and under. In addition to age restrictions, the following two products will also be regulated as children cosmetics:
Product labeling "applicable to the whole population," "for the whole family," etc.;
Product implying the target users include children by trademarks, patterns, homophones, letters, Pinyin, numbers, symbols, packaging, etc.
R&D and Manufacture
Formula Design Principles
The formula design principles in the new Provisions are similar to the current guidance. But the requirement in the current guidance "not recommended to use certain functional ingredients" has been changed to “not allowed to use certain functional ingredients”.
1) Children cosmetics should reduce the number of ingredients used in formulas and assess the scientificity and necessity of ingredients (especially fragrances, colorants, preservatives, and surfactants) from the aspects of safety, stability, function, and compatibility;
2) Functional ingredients for freckle-removing, whitening, anti-acne, depilating, deodorant, anti-dandruff, anti-hair loss, hair dyeing, and hair perming agents are not allowed to use. If the above ingredients are used for other purposes rather than the above-mentioned purposes, the necessity and safety of their use in children cosmetics should be accessed;
3) Ingredients with a history of safe use can be used. New cosmetic ingredients in the monitoring period or ingredients whose safety for children is unidentified shall not be used.
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.
Registration and Notification
Registration: NMPA will formulate guidelines specifically for the review of special children cosmetics and strictly review the registration documents according to the guidelines;
Notification: The technical review of children cosmetics notification documents is retained, especially focusing on safety documents. Products with non-compliant documents will be punished severely.
Labeling and Packaging
Children cosmetics should be labeled with NMPA designated children cosmetics’ logo (the logo design is to open for the society’s contribution) in a prominent position on the display surface, with the executive standard number directly below the logo. Adult cosmetics shall not be labeled with the children cosmetics’ logo.
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.
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, severe penalties will be imposed.
