Introduction
With the release of China's "Technical Guidelines on Children's Cosmetics" in August 2023, the regulatory landscape for children's cosmetics has become more stringent. Brands and manufacturers must now navigate an intricate framework of registration, ingredient selection, and labeling requirements.
This article provides a comprehensive guide on ensuring compliance with these new regulations, integrating insights from relevant regulatory documents such as the Cosmetic Registration and Filing Management Measures, Children’s Cosmetic Supervision and Management Regulations, and Safety and Technical Standards for Cosmetics (STSC).
Scroll down to gain a clear understanding of registration and filing requirements, ingredient selection and formulation rules, mandatory labeling and packaging requirements, and more.
What Are Children's Cosmetics?
Children’s cosmetics refer to products designed for individuals aged 12 years and below. These products typically serve functions such as cleansing, moisturizing, body-refreshing, and sunscreen. Any product explicitly marketed toward children or indirectly suggesting its suitability for them (e.g., labeled as "for all ages" or "family use") must adhere to children's cosmetics regulations.
Unique Considerations for Children's Makeups: Physiological Differences in Children
Infants (0–1 year): Thinner skin, underdeveloped sebaceous glands, higher surface area-to-body ratio, and weaker moisture retention make their skin more vulnerable.
Toddlers (1–3 years): Although their skin structure is more developed, their barrier function remains immature, making them prone to skin irritation and contact dermatitis.
Behavioral Aspects: Infants and toddlers are more likely to ingest products due to behaviors such as sucking and scratching. Safety assessments should consider potential oral exposure.
Specific Application Areas: Products used in diaper areas or skin folds must account for prolonged skin contact and increased sensitivity due to exposure to urine and feces.
Here are Key Compliance Aspects for Children's Cosmetics.
Registration and Filing Requirements for Children's Cosmetics
Children’s cosmetics are categorized into:
For infants and toddlers (0–3 years): Limited to cleansing, moisturizing, hair-care, sunscreen, soothing, and body-refreshing functions..
For children (3–12 years): Limited to cleaning, makeup-removing, moisturizing, beauty and embellishment, perfuming, hair-care, sunscreen, repairing, soothing, and body-refreshing functions.
Products with new efficacy claims beyond these categories require registration.
Ingredient Selection and Formulation for Children's Makeups
Prohibited Ingredients
Ingredients under safety monitoring.
Ingredients lacking safety verification for children.
Genetically modified or nanotechnology-based ingredients unless no alternatives exist, with rigorous safety evaluation.
Ingredients banned under national cosmetic safety standards.
Specific preservatives, such as formaldehyde releasersand salicylic acid and its salts(except for shampoos).
Restrictions on Functional Ingredients
No freckle-removing and whitening, acne-removing, depilating, deodorant, anti-dandruff, anti-hair loss, hair dyeing, hair perming functions..
Colorants: Using more than four types requires safety justification.
Preservatives: Preservatives at >90% STSC limit in leave-on products, or ≥5 STSC preservatives used, require safety studies.
Surfactants: Avoid quaternary ammonium cationic surfactants; if used, provide safety assessments.
Sunscreens: No more than five chemical UV filterswith the usage amount lower than the STSC limits, with total titanium dioxide and zinc oxide content ≤25%.
Microbiological and Physicochemical Standards
Total bacterial count:≤500 CFU/mL or CFU/g.
pH Value:
Leave-on products: 4.5–7.5
Rinse-off products: 4.5–8.5
Exceptions require justification based on safety evaluations.
Labeling and Packaging Requirements
Essential Labeling Elements
Mandatory Children’s Cosmetics Logo: A distinct emblem must be displayed on the top-left corner of the primary display panel.
Safety Warnings: Labels must include cautionary statements such as “For use under adult supervision.”
SPF and PA Ratings: Sun protection products must include SPF values based on human efficacy testing.
Warnings for Mist Sprays: Avoid direct facial application, with advisories such as “Spray onto hands before applying to face.”
Prohibition on Misleading Claims: Labels must not suggest edible properties (e.g., "food-grade," "edible") or resemble food packaging to prevent accidental ingestion.
Additional Labeling for Imported Products
Imported children's cosmetics claiming SPF value, PA level, water resistance, or sweat resistance must submit corresponding efficacy test reports. Modifying labels to bypass testing requirements is prohibited.
Safety Testing and Evaluation
Toxicological Test Results
Eye irritation tests: Products must be non-irritating or slightly irritating, and can claim "tear-free" only with non-irritating test results.
Skin irritation and sensitization tests: Products must be non-irritating and non-sensitizing.
Skin phototoxicity tests: Products must be non-phototoxic.
Human Safety and Efficacy Trials
Skin Patch Testing: Conducted on 30 participants, with strict criteria for adverse reaction thresholds.
SPF and PFA Testing:
SPF Testing: Children's cosmetics that claim to have a sunscreen efficacy shall be tested for the SPF value.
PFA Testing: Products labeled with the UVA protection index (PFA value) or PA+ to PA++++: Must be tested for the PFA value.
Products claiming to have a UVA protection effect or broad-spectrum sunscreen efficacy shall be tested for the cosmetic anti-UVA ability parameter - critical wavelength or the PFA value.
Water Resistance Tests: SPF reduction post-bathing should not exceed 50% for products claiming water resistance.
Conclusion
The stringent regulatory framework surrounding children’s cosmetics underscores the importance of prioritizing safety, efficacy, and transparency. Compliance with these standards ensures consumer trust and enhances product credibility. As the regulatory landscape continues to evolve, companies should proactively update their formulations, labeling practices, and safety evaluations to meet the highest industry standards.
For more information or service inquiries, please feel free to contact us at customer@reach24h.com!
