Comprehensive Analysis of Compliance of Children’s Cosmetics in China

Provisions on Supervision and Administration of Children's Cosmetics (hereinafter referred to as Provisions) were officially launched on October 8, 2021. Except for the labeling requirements, other regulations on children’s cosmetics came into force on January 1, 2022. Children’s toothpaste shall be also administered according to Provisions.

State Administration for Market Regulation issued Measures for the Supervision and Administration of Cosmetics Production and Operation on August 6, 2021, pointing out the key points of supervision of children’s cosmetics.

National Medical Products Administration (NMPA) created a children’s cosmetics label called “Little Gold Shield” on December 1, 2021.

(Little Gold Shield)

Besides, there are many other cosmetics regulatory documents that also address the requirements for children’s cosmetics, such as Cosmetic Classification Rules and Classification Catalogue, Safety and Technical Standards for Cosmetics and so on. NMPA also issued a number of popular science articles to regulate the children’s cosmetics industry, such as Do Not Use Toys as Children’s Cosmetics, Correct Understanding of Children’s Cosmetics Logo little Gold Shield and so on.

How should enterprises comprehensively meet the pre-market and post-market regulatory requirements for children’s cosmetics?

The Main Responsibility

Cosmetics registrants and filers are responsible for the quality safety and efficacy claims of children’s cosmetics.

Definition, Classification Management and Efficacy Claims

According to the Provisions, Children’s cosmetics refer to cosmetics that are suitable for children under 12 years old (including 12 years old) and have the functions of cleaning, moisturizing, refreshing and sunscreen. Products with labels such as “applicable to the whole population” and “used by the whole family” or using trademarks, patterns, homonyms, letters, Chinese pinyin, numbers, symbols, packaging forms, etc, to indicate that the users of products include children are subject to the management of children’s cosmetics. According to Cosmetic Classification Rules and Classification Catalogue, cosmetics claiming that they can be used by infants and children shall implant corresponding serial number in their classification codes, and shall be managed according to the safety and efficacy claims of cosmetics for “infants” and “children”. Efficacy claims for infant (0-3 years old, including 3 years old) cosmetics are limited to cleaning, moisturizing, hair care, sunscreen, soothing and refreshing body, while the efficacy claims for children (3-12 years old, including 12 years old) cosmetics are limited to cleaning, makeup removal, moisturizing, beauty modification, fragrance, hair care, sunscreen, repair, soothing and refreshing body. In other words, cosmetics used by children under the age of 3 do not include the category of “makeup”. Therefore, it is illegal for cosmetics labels to claim that they can be used for children under 3 years old.

In addition, toy decorative products produced exclusively for the makeup and decoration of toys by toy manufacturers shall not be managed as cosmetics. There is certain risk when children misuse this kind of toy as cosmetics. “Lipstick toys”, “blush toys” and other products produced according to general toy product standards may contain substances that are not suitable for use as cosmetic materials, including colorants with relatively high safety risks, which may irritate children’s skin if used.

Label Requirements

• Children’s cosmetic marks stipulated by the NMPA shall be marked on the display surface of sales package, and shall not be marked on non-children’s cosmetics；
• “Caution” or “warning” should be used as the guide language, and warning words including “use under adult supervision” should be marked on the visible surface of the sales package；
• Cosmetics registrants and filers are encouraged to adopt anti-counterfeiting technology and other means on labels to facilitate consumers’ identification and selection of legitimate products；
• Avoid confusion with food and drugs, and prevent accidental eating and misuse. Words such as “food grade” and “edible” or food related patterns shall not be marked.

Description on updates to labels

New application for registration or filing of children’s cosmetics

>> Since May 1, 2022 , children’s cosmetics must be labeled according to the Provisions;

Registered/ Filed children’s cosmetics

>> Before May 1, 2023 , the product label should be updated according to the Provisions.

“Little Gold Shield”

From May 1, 2022 , children’s cosmetics that apply for registration or filing must be labeled with "Little Gold Shield"; All children’s cosmetics manufactured or imported after May 1, 2023 , must be labeled with "Little Gold Shield." It is worth noting that the label "Little Gold Shield" on the cosmetic package only indicates that the product belongs to children’s cosmetics, and does not mean that the product has been approved by regulatory authorities or its quality and safety have been certified.

Formula Design Principles: Safety First, Essential Efficacy, Minimal Formula

• Cosmetics raw materials with a long history of safe use shall be selected, and new raw materials still in the monitoring period shall not be used;
• Raw materials prepared by new technologies such as gene technology and nanotechnology are not allowed to be used. If there is no substitute raw material and the aforementioned raw materials have to be used, reasons should be given and the safety of the children’s cosmetics should be evaluated；
• It is not allowed to use the raw materials for the purpose of anti-freckle and whitening, acne removal, hair removal, deodorization, anti-dandruff, hair loss prevention, hair color, hair perming, etc. If the raw materials with the aforementioned functions are used for other purposes, the necessity of use should be given and the safety of children’s cosmetics should be evaluated；
• Evaluate the scientific nature and necessity of raw materials, especially spices and flavors, colorants, preservatives, etc, from the aspect of safety, stability, function, compatibility and other aspects, with a combination of children’s physiological characteristics.

General Inspection Requirements

There are corresponding provisions on various indicators of children's cosmetics in the Safety and Technical Standards for Cosmetics. The microbiology indicators show that the total number of bacterial colonies in children’s cosmetics should not be more than 500 CFU/mL or 500 CFU/g.

According to Provisions on the Management of Cosmetic Registration and Filing Data, ordinary and special cosmetics that can be used by infants and children shall not be exempt from animal testing.

Safety Assessment Requirements

According to Technical Guidelines for Cosmetics Safety Assessment (2021), safety assessments and necessary toxicology tests shall be carried out for children’s cosmetics. When evaluating the safety of children's cosmetics, children’s physiological characteristics should be considered in hazard identification and exposure calculation.

Raw Material Inspection Requirements

Cosmetics registrants, filers and entrusted manufacturers shall strictly implement the material purchase inspection record system, carry out inspection of relevant items when necessary, and avoid bringing hormones, anti-infection-related drugs and other forbidden materials or substances that may harm human health into cosmetics through raw materials or packaging materials that directly contact cosmetics.

Business Requirements

Cosmetics operators shall establish and implement the purchase inspection record system, check the direct supplier’s market subject registration certificate, special cosmetics registration certificate or ordinary cosmetics record information, children’s cosmetics marks, product quality inspection certificate and keep relevant certificates. Accurately record information of cosmetics, including special cosmetics registration certificate number or ordinary cosmetics record number, use period, net content, purchase quantity, supplier’s name, address, contact information, purchase date.

Cosmetics operator shall compare the information recorded in labels of children's cosmetics with that published on the NMPA official website, to make sure information from the above two sources remain consistent. The information cover name of cosmetics, special cosmetics registration certificate number or ordinary cosmetics record number, name of cosmetics registrants or filers, entrusted producers, name of the domestic responsible person.

Cosmetics operators are encouraged to display children’s cosmetics in different areas, and make public the signs of children’s cosmetics in sales areas. Cosmetics operators are also encouraged to take the initiative to prompt consumers to inquire product registration or record information when selling children’s cosmetics.

Online Business Requirements

Information including the cosmetics labels information that are consistent with that on the registration certification or the record information shall be completely, authentically and accurately disclosed on the home page for the business activities. Children’s cosmetic marks shall be continuously displayed in a prominent position on the product display page

Post-Mortem Supervision

Cosmetics registrants and filers shall analyze and evaluate the collected or acquired reports on adverse reactions of children’s cosmetics, and investigate the possible causes of adverse reactions by themselves. If the quality and safety problems of children’s cosmetics are found by sampling inspection, the cosmetics registrant, the filer or the entrusted manufacturer shall immediately stop the production, conduct self-inspection on the implementation status of the cosmetics production quality management standards, and report to the provincial pharmaceutical supervisory and administrative departments.

Key Points of Production and Operation Supervision: Measures for the Supervision and Administration of Cosmetics Production and Operation

1. Clarify that children’s skin care cosmetics should be produced under strict production conditions, and make special notes on the cosmetics production license.
2. Label it as children’s cosmetics clearly.
3. Avoid misusing children’s toys as children’s cosmetics when producing and selling toys
4. Illegal addition of substances that may harm human health in children’s cosmetics is a serious violation of the law and will be given a severe punishment according to law.

The requirements for restricted components in children’s cosmetics under the Safety and Technical Standards for Cosmetics

Restricted Cosmetics Components
Number	Name of Raw Materials	Relevant Restrictions and Requirements	Label
1	Salicylic Acid	Shall not be used in products for children under three years of age, except for shampoos	Not for children under three years old *
2	Strontium chloride		should not be used frequently by children
3	Calcium hydroxide、Lithium hydroxide、Mercaptoacetic acid and its salts、Mercaptoacetic acid lipids、Sulphides of alkali metals、Sulphides of alkaline earth metals、Strontium hydroxide、Potassium hydroxide (or Sodium hydroxide		Prevent children from grabbing **
4	Talc: Magnesium Silicate Hydrate		Powder products for children under 3 years of age: Keep powder away from children's mouth and nose
Cosmetic Preservatives
1	Iodopropynyl butylcarbamate	Shall not be used in products for children under three years of age, (except for bath products and shampoos)	Not for children under three years old ***
2	Salicylic Acid and its salts	Shall not be used in products for children under three years of age, except for shampoos	Not for children under three years old *
3	Silver chloride deposit on titanium dioxide	Shall not be used in products for children under three years of age

* This information shall be marked if the product is likely to be used by children under three years of age and in long-term contact with skin.

** Some types of cosmetics need to be marked in this way.

*** This information shall be marked only if the product is likely to be used by children under three years of age, except for bath products and shampoos.

The draft of the technical standards for children's cosmetics has also been released for public comments, please click here to know more information about the draft technical guidelines for childrens cosmetics

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