Special Requirements for Safety Assessment of Children’s Cosmetics

Children’s cosmetics are subject to stringent and unique safety assessment requirements due to their specific user group. This article delves into the special requirements for children’s cosmetics in formula design, safety evaluation data, and labeling rules to help enterprises swiftly mitigate compliance risks.

Definition and Classification of Children’s Cosmetics

Children’s cosmetics refer to products intended for children aged 12 or below, serving functions such as cleansing, moisturizing, soothing, and sun protection.

According to Appendix 3 of the Cosmetics Classification Rules and Classification Catalogue,

Infants (0–3 years old, inclusive): Permitted efficacy claims are limited to cleansing, moisturizing, hair care, sun protection, soothing, and refreshing.

Children (3–12 years old, inclusive): Efficacy claims only include cleansing, makeup removal, moisturizing, cosmetic enhancement, fragrance, hair care, sun protection, repair, soothing, and refreshing.

Core Safety Principles in Formula Design

Ingredient Selection

Prohibited Ingredients: Cosmetics for children under 3 years old must avoid high-risk ingredients such as salicylic acid, boric acid, and their salts. New ingredients under safety monitoring, genetically modified ingredients, or nanomaterials are prohibited. If there are no alternative ingredients and their use is unavoidable, an explanation must be attached with a safety evaluation specific to children’s use.

Simplified Formulas: Minimize non-essential additives, like fragrances, colorants, preservatives. Prioritize ingredients with a long history of safe use.

Toxicological Testing Requirements

Mandatory Tests: All children’s products must pass tests confirming no skin and no eye irritation, no phototoxicity, and no sensitization. Microbial limits must not exceed 500 CFU/mL or 500 CFU/g.

No Exemptions: Toxicological testing cannot be waived for children’s cosmetics, even if manufacturers hold quality management certifications.

* Article 33(2) of the Regulations on the Administration of Cosmetic Registration and Filing Information stipulates that if the general cosmetic manufacturer has obtained quality management certifications issued by the government authority of its country (region) and the product safety risk assessment sufficiently confirms product safety, the submission of toxicological test reports may be exempted, except in the following cases:  1. Products labeled for infants and children. 2. Products using new ingredients under safety monitoring. 3. When the filer, domestic responsible person, or manufacturer is classified as a key regulatory target based on quantitative risk grading.

Key Stages of Safety Assessment

According to the Cosmetic Safety Assessment Document Submission Guidelines, cosmetics are divided into two categories. Infant and children's cosmetics belong to the first category. Like special cosmetics and new raw materials in the safety monitoring period, they are required to submit a complete safety assessment report when registering and filing.

Exposure and Scenario Assessment

Key differences in safety assessment of children’s cosmetics vs. adult products:

The safety assessment of children's cosmetics needs to be exposure-oriented, taking into account the physiological characteristics of children's thin skin and fast absorption, as well as the product usage scenarios and exposure levels. Due to the large surface area to body weight ratio and high systemic exposure of children, the safe use concentration of raw materials is, in principle, lower than that of adult products. Priority should be given to citing exposure data from assessment documents by domestic and international cosmetic research institutions or published literature on exposure studies specific to children’s cosmetics. For children's cosmetics, the high exposure risks caused by special behaviors such as sucking and scratching, as well as metabolic differences, should be considered, and more stringent assessment data should be used when necessary.

Ingredient Data Citation

Safety limits from the Safety and Technical Standards for Cosmetics, conclusions by international authorities (e.g., SCCS, CIR), or publicly available safety data on ingredients from regulatory agencies can be prioritized as data sources.

The “highest historical usage of raw materials announced by the cosmetics regulatory authorities” cannot be used as complete safety assessment evidence.

Stability and Microbial Evaluation

The complete safety assessment report for children's cosmetics must include physical and chemical stability evaluations such as product stability and packaging material compatibility, as well as product microbiological evaluation (i.e. product preservative challenge test).

Key Compliance Points and Marking

In the label of children's cosmetics, if the words "suitable for all people" or "for the whole family" are marked, or if trademarks, patterns, homophones, letters, Chinese pinyin, numbers, symbols, packaging forms, etc. are used to imply that the product's user group includes children, the product shall be managed as children's cosmetics.

Mandatory Labeling Content

According to the Regulations on Supervision and Administration of Children's Cosmetics, children's cosmetics shall be marked with the children's cosmetics logo on the display surface of the sales packaging. That is, the "Little Golden Shield", the logo must be placed on the upper left of the packaging and clearly identifiable.

A warning statement for children’s cosmetics, prefaced by “Caution” or “Warning”, must appear on the visible surface of the packaging, e.g., “Should be used under adult supervision.”

Prohibited Misleading Designs

Children’s cosmetics shall not be designed to resemble food, drugs, or other products in texture, scent, appearance, or packaging to prevent accidental ingestion or misuse. Labels must not include terms like “food-grade”, “edible”, or food-related imagery.

Non-children’s products should not use patterns or other forms to imply suitability for children. For example, the package front is printed with baby bear graphics, but this cosmetic is not suitable for children.

The formula design, safety assessment, and labeling rules for children’s cosmetics demonstrate that Children’s Cosmetic Safety Assessment is by no means an easy task. Manufacturers must adopt a rigorous and prudent attitude to fully guarantee the safety of children's cosmetics.

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