Focusing on the core scenarios of general cosmetic filing in China, CIRS Group draws on authoritative regulatory Q&As to comprehensively unpack the end-to-end compliance requirements for children's cosmetics.

This article explains in detail the key compliance rules for children's cosmetics to help cosmetic companies quickly understand the specific regulatory framework and efficiently complete children's cosmetic filing and routine quality management in a compliant manner.

Q1: What should be noted in ingredient selection and formulation design for children's cosmetics?

A: According to the Provisions on the Supervision and Administration of Children's Cosmetics, the Technical Guidelines for Children's Cosmetics, the Technical Guidelines for Safety Assessment of Cosmetics, the Safety and Technical Standards for Cosmetics, and related Q&A documents, the selection of ingredients for children's cosmetics should follow the principles of “safety first, necessity of efficacy, and formulation minimalism,” with attention to the following specific points:

1. Ingredients not permitted in formulations

(1) New ingredients under safety monitoring: cosmetic ingredients that are still within the monitoring period shall not be used.

(2) Ingredients produced using new technologies such as genetic engineering and nanotechnology: ingredients produced using genetic engineering, nanotechnology, or other new technologies are not permitted. Where there is no alternative ingredient and their use is necessary, the reasons shall be explained in the product safety-assessment documentation, including at minimum a necessity analysis demonstrating that the formula must use the ingredient and that no other ingredient can substitute; a statement that the ingredient is available only from nanotechnology or genetic-engineering sources; and a full evaluation of safety for children, providing safety-evaluation test results as supporting evidence where necessary.

(3) Ingredients explicitly prohibited for children under 3 years old under the Safety and Technical Standards for Cosmetics: for children's cosmetics whose target users include “infants and toddlers,” ingredients such as iodopropynyl butylcarbamate (except in bath products and shampoos), salicylic acid and its salts (also prohibited in shampoos from January 1, 2028), and silver chloride deposited on titanium dioxide shall not be used.

2. Ingredients not recommended for formulations

(1) Ingredients with specific safety risks: ingredients with specific safety risks (e.g., formaldehyde releasers) and ingredients listed as prohibited substances in other countries or regions are not recommended. Where their use is necessary, the reasons shall be explained in the product safety-assessment documentation, and a full evaluation of their safety for children shall be conducted.

(2) Functional ingredients: children's cosmetics shall not use ingredients intended primarily for skin whitening, anti-acne, hair removal, deodorizing, anti-dandruff, anti-hair loss, hair dyeing, hair perming, or similar purposes. Where an ingredient that may have such effects is used for other purposes, the necessity of its use and its safety for use in children's cosmetics shall be evaluated.

(3) Surfactants: quaternary ammonium cationic surfactants and similar ingredients are not recommended. Where quaternary ammonium cationic surfactants are used, the scientific basis and necessity of their use shall be analyzed, and human-safety test data shall be submitted as supporting evidence where necessary.

3. Ingredients subject to restrictions

(1) Colorants: colorants should be used rationally on the premise of safety first. When 4 or more (inclusive) colorants are used, the scientific basis and necessity of the types and amounts of ingredients used shall be explained, relevant studies shall be conducted to ensure product-use safety, and human-safety test data shall be submitted as supporting evidence where necessary.

(2) Preservatives: when the preservative amount in leave-on products approaches (90% or above) the limit in the Safety and Technical Standards for Cosmetics, or when 5 or more (inclusive) preservatives specified in the Standards are used, relevant scientific evidence shall be provided to explain the scientific basis and necessity of the types and amounts of ingredients used. Where necessary, formulation-optimization study data may be provided as supporting evidence, and human-safety test data for the final formula may also be provided as supporting evidence.

(3) UV filters: in principle, the number of chemical UV-filter types in a formula shall not exceed 5 (inclusive), and the amount used shall be below the limit in the Standards. When both titanium dioxide and zinc oxide are used, their total amount shall be ≤ 25%. The scientific basis and necessity of the ingredient amounts shall be fully substantiated in any of the following cases: 6 or more (inclusive) chemical UV filters are used in the formula; the amount of a single chemical UV filter approaches (90% or above) the limit in the Standards; or the total amount of titanium dioxide and zinc oxide exceeds 25% of the formula.

Q2: What should be noted in product form design and usage scenarios for children's cosmetics?

A: According to the Provisions on the Supervision and Administration of Children's Cosmetics, the Technical Guidelines for Children's Cosmetics, the Technical Guidelines for Safety Assessment of Cosmetics, and related Q&A documents, the following should be noted in the product form design and usage scenarios of children's cosmetics.

1. Aerosol or spray-type cosmetics: the use of spray-type cosmetics by children is not recommended; where their use is necessary, the inhalation risk shall be fully considered, and warning phrases such as “do not spray directly onto the face,” “spray onto the palm first, then apply to the face,” and “avoid inhalation” shall be indicated in the directions for use. For flammable products such as pressure-filled aerosols, fire- and explosion-prevention precautions shall be indicated in accordance with relevant Chinese laws, regulations, and technical standards, or warned in graphical form.

2. Makeup-removal and beautifying cosmetics: for children's cosmetics whose classification-code efficacy claims are makeup removal or beautifying, the usage scenario shall be clearly defined, and warning phrases such as “please rinse off promptly” and “if discomfort occurs, please stop use immediately” shall be indicated.

3. Cosmetics containing strontium chloride and talc: products containing strontium chloride should not be used frequently and shall bear the marking “not for frequent use by children”; for powder cosmetics used by “infants and toddlers” containing “talc: magnesium silicate hydrate,” the powder shall be kept away from children's nose and mouth, with corresponding warning phrases indicated.

Sunscreen cosmetics: there shall be no absolute claims that encourage consumers to sunbathe or that guarantee sunscreen efficacy.

Q3: What should be noted in the labeling of children's cosmetics?

A: According to the Provisions on the Supervision and Administration of Children's Cosmetics, the Technical Guidelines for Children's Cosmetics, the Measures for the Administration of Cosmetic Labeling, the Technical Guidelines for Safety Assessment of Cosmetics, and related Q&A documents, the following should be noted in the labeling of children's cosmetics:

(1) Children's cosmetics logo marking requirements: the children's cosmetics logo (“Little Golden Shield”) stipulated by the National Medical Products Administration shall be marked on the upper left of the display panel of the sales packaging where it is easily observable. The logo shall be clear, prominent, and easy to identify.

(2) Warning-phrase marking requirements: warning phrases such as “should be used under adult supervision” shall be marked on the visible panel of the sales packaging, led by “Caution” or “Warning.” This also includes the warning-phrase marking requirements mentioned in Q2 for powder cosmetics containing talc, products containing strontium chloride, and pressure-filled aerosols.

(3) Fragrance-allergen marking requirements: where the fragrance and aromatic plant-oil ingredients used contain potentially sensitizing fragrance components published by authoritative bodies at home or abroad, and the content exceeds 0.001% in leave-on products or 0.01% in rinse-off products, the specific fragrance-component names shall be indicated in the full-ingredient list on the label or at another position on the label.

(4) Prohibited labeling content: words such as “food-grade” or “edible,” or food-related patterns, shall not be marked. The product's properties, odor, and appearance should be prevented from being confused with food, pharmaceuticals, or similar products to avoid accidental ingestion or misuse.

Q4: What are the toxicology and human-testing requirements for children's cosmetics?

A:

Q5: What should be noted in the safety assessment of children's cosmetics?

A: The formulation design of children's cosmetics should follow the three principles of safety first, necessity of efficacy, and formulation minimalism, while taking into account children's physiological and behavioral characteristics, for example:

(1) Physiological differences: considering that children have a larger body-surface-area-to-body-weight ratio, an immature skin-barrier function, and a higher absorption rate for chemical substances;

(2) Behavioral characteristics: the need to consider additional exposure risks from behaviors such as sucking and scratching (e.g., oral exposure);

(3) Usage scenarios: the need to assess risks when used on special areas such as the diaper area.

Children's cosmetics shall submit a full-version safety assessment, and the assessment report shall include a chapter corresponding to the formulation-design principles.

In addition to the general requirements, the following should also be considered in the safety assessment of ingredients and risk substances:

(1) For propellants with inhalation-toxicity risks (e.g., propane, butane, isobutane), an inhalation-toxicity safety assessment shall be conducted.

(2) Where the formula contains ingredients such as Aloe Vera (Aloe barbadensis), the risk substance anthraquinone shall be identified and assessed; the assessment may refer to conclusions of authoritative bodies.

(3) Where the formula contains cocamidopropyl betaine, cocamidopropyl dimethylamine, 3,3-dimethylaminopropylamine, and monochloroacetic acid therein shall be identified and assessed; their limits may refer to conclusions of authoritative bodies or relevant Chinese standards.

(4) Where the formula contains fragrance, plant essential oils, or flavor ingredients, the sensitizing components therein shall be identified and assessed; for example, where it contains Melaleuca alternifolia leaf oil, the risk substance methyl eugenol shall be identified and assessed, and its limit may refer to conclusions of authoritative bodies.

(5) Where the formula contains glycerin, its purity shall be ≥ 95.0%, and the identified and assessed diethylene glycol content shall be ≤ 0.1%.

CIRS Reminder

The filing requirements for children's cosmetics are more stringent. When carrying out children's cosmetic filing, companies should strictly benchmark against current regulations and the specific technical guidelines, standardize the preparation of the complete filing dossier, and precisely avoid risks such as non-compliant documentation or overdue rectification, so as to ensure compliant filing and safe market launch.

About CIRS

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The CIRS cosmetic team provides expert support to ensure that cosmetic products meet stringent global cosmetic regulations and safety standards. 

We offer comprehensive, lifecycle-based solutions for personal care products, from early-stage cosmetic ingredient development through to final product registration. Our services include:

• Cosmetic ingredient development and regulatory strategy,
• Physical/chemical and analytical tests, 
• Toxicological tests (in vivo & in vitro),
• Efficacy and claim substantiation studies (in vivo & in vitro), and
• Ingredient and product registration across global markets.

With deep expertise in cosmetic regulatory compliance and safety evaluations, our team enables brands to bring products to market efficiently and with confidence.

Our Services 

• China Cosmetics Registration and Filing
• China New Cosmetic Ingredients Registration and Filing
• China Toothpaste Filing
• Cosmetics Safety Test
• Cosmetics Efficacy Claims Test
• Micrological analysis
• Physicochemical Analysis
• Being a Domestic Responsible Person
• Safety Assessment Report
• Cosmetic Ingredient Quality and Safety Info Code Application
• Formula/Label/Ingredient Review
• Regulatory Consulting/Reporting/Training
• Custom Clearance

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.