Cosmetic Compliance
Intelligence & Solutions
China Mainland Children Cosmetics Regulation
Dec 03, 2021
Hedy He
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CONTENTS

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, 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

Guidance on Application and Review of Children's Cosmetics

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

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

Safety and Technical Standards for Cosmetics

The regulation stipulates the microbial limit of children cosmetics and the requirements for using specific ingredients in children cosmetics.

Dec. 1, 2016

In force

Cosmetic Classification Rules and Catalog

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

Technical Guidelines for Cosmetic Safety Assessment

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

To be enforced

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

To be enforced

Good Manufacturing Practices for Cosmetics (Draft)

The regulation contains strict environmental index requirements for the clean work area and quasi-clean work area of children cosmetics manufacture.

/

Draft

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 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

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.

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

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

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.

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. 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 will 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. Except for the labeling requirements, the Provisions will be implemented on January 1, 2022.

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.

Note:

  • If a product belongs to children cosmetics scope, whether it is sold separately or together with other products such as toys, the product should be supervised as children cosmetics.

  • Toy products produced by toy manufacturers that are only used for dolls and other finshing purposes should not be managed as children cosmetics. They shall be managed in accordance with the toy regulations.

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

  • Airborne particles: number of particles equal to or more than 0.5 µm ≤10,500,000/m3, number of particles equal to or more than 5 µm ≤60,000/m3

  • Airborne microbe: ≤500cfu/m3

  • Settling microbe: ≤15cfu/plate

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

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  • 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 technical 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' Logo

In addition to the common labeling items stipulated by Administrative Measures on Cosmetics Labeling, children cosmetics must additionally be labeled with NMPA designated 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.jpg

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.

Color Matching Information.jpg

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

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.

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.