China enforces technical guideline for children’s cosmetics to ensure safety based on efficacy labels

02 Oct 2023 --- The National Institutes for Food and Drug Control (NIFDC) China has published the “Technical Guiding Principles for Children’s Cosmetics,” which details trade name, formula, labeling and safety assessment requirements. The document aims to guide registrants and cosmetics filing for children under 12.

The guideline was published on Aug 31 this year and came into effect upon publication.

Children’s cosmetics are recognized as having cleaning, moisturizing, toning and sun protection functions. They are identified based on user group and labels, such as whether it indicates, in words, if it applies to the whole population or family use or via Chinese pinyin, numbers, symbols and packaging formats.

“In principle, imported children’s cosmetics should be classified according to the efficacy claims, parts of action, user groups, product dosage forms, usage methods, etc., in the sales package label (including instructions) of the country (region) where the cosmetics registrant or filing person is located or the country (region) of production. The coding and declaration category cannot be changed at will,” reads the guideline.

Cosmetic registrants and filers should submit materials according to the “Regulations on the Management of Cosmetics Registration and Filing Materials” and fulfill the technical requirements outlined in the new guideline, according to the NIFDC.

Divided efficacy claims cosmetics
Children’s cosmetics are divided into infants, zero to three years and children, three to 12 years.

NIFDC limits efficacy claims for cosmetics for infants to cleaning, moisturizing, hair care, sun protection, soothing and refreshing.

For children, efficacy claims are limited to cleansing, makeup removal, moisturizing, beautification, fragrance, hair care, sun protection, repair, soothing and refreshing.Children’s cosmetics are identified based on user group and labels.

Moreover, the two sub-categories have different raw material formulas, labeling, product execution and safety requirements.

Immature skin requirements
NIFDC justifies the division between infants and children based on differing physiological characteristics. 

They highlight that infant skin (zero to one year) is thinner than adults, has fewer sebaceous glands, and has poor skin moisturizing and buffering abilities. Although the skin structure is complete, the skin barrier function is immature and cannot entirely resist microbial contamination.

“Adverse reactions such as contact dermatitis are more likely to occur, and it takes longer to recover,” underlines the guideline. 

“Therefore, the product formula design of children’s cosmetics should give priority to safety and necessary efficacy, use relatively simple product formulas, and reduce the use of raw materials that may contain allergenic components or strong irritants, such as flavors, fragrances, and colorings agents, preservatives, cationic surfactants, chemical sunscreens, etc.”

Attention to particular behavior and applications
The guideline outlines that infant and children cosmetics that claim to be tear-free will undergo more stringent toxicological testing. Children have “immature lacrimal glands, blink less frequently,” and can not protect their eyes.

Moreover, since children explore by mouth and scratch themselves, the risk of oral exposure should be considered when necessary.

“Some infant cosmetics also have special application scenarios, such as being used on specific skin folds and diaper areas. Due to factors such as tight clothing and diapers, uncontrolled urination and defecation, skin damage may occur,” notes the guideline.

“Therefore, changes in skin absorption rates caused by special circumstances should be considered when conducting safety assessments of such products.”

Product name and formula checks
The requirement under product name information has three parts: trademark name, common name and attribute name.

“Imported children’s cosmetics should submit both the foreign name and the Chinese name of the product, and explain the corrChildren’s cosmetics are divided into infants and children.espondence between the Chinese name and the foreign name (except those designed specifically for the Chinese market without foreign names); if there is no clear correspondence, a scientific and reasonable explanation should be provided,” outlines the guideline.

Furthermore, raw materials need to be tabled by domestic responsible persons according to the “Catalog of Used Cosmetic Raw Materials” with the Chinese name and international name or English name.

Contested ingredients, raw materials produced by genetic technology and nanotechnology are not allowed in childrens cosmetics, unless there are no alternatives. 

“Infant cosmetics must not use raw materials such as iodopropynyl butylcarbamate (except for bath products and shampoos), salicylic acid and its salts (except for shampoos), silver chloride deposited and titanium dioxide,” details the guideline.

Raw materials that remove freckles, acne, hair and dandruff, along with those intended to whiten, deodorize, dye, perm and prevent hair loss, will be inspected.

Further safety measures
Microbial indicators must align with the “Technical Specifications for Safety of Cosmetics,” “Cosmetic Registration and Filing Inspection Work Specifications” and mandatory national standards.

Moreover, microbial and physical and chemical indicators need to consider changes in children’s skin in various age ranges.

On labeling requirements, children’s cosmetics must include safety warnings and clear usage instructions. The NIFDC notes that it is not recommended for children to use spray-type sunscreen cosmetics, and if spray is used, then it must come with specific instructions, for instance, not to spray on face – due to inhalation risk.

To prevent children from accidentally eating and misusing cosmetics, the smell and appearance should not resemble food or medicine.

In related news last week, the EU and China agreed to establish a working group that will “lower the administrative burden and far-reaching disclosure requirements” on EU cosmetic products sold in China. 

By Venya Patel