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Industry InsightLatest NewsMarketingRegulations24/05/2021China Registration for Children’s Products are Super Difficult?

Up to now, since the pilot of the import non-special registration system in 2017, the total number of imported non-special cosmetics has been 34,270, but only about 200 infants and children, accounting for less than 0.6%. Since the applicable objects are infants and young children, the threshold for filing children’s cosmetics is naturally high.

In China, for children’s cosmetics, there is a special declaration regulation, namely the “Children’s Cosmetics Application and Review Guidelines”, which was released in October 2012. After the publication of the guidelines, the number of successful filings of children’s cosmetics, especially imported children’s cosmetics, was very small. Compared with adult product filing, there are the following differences.

Scope of application: cosmetics used by children from 0 to 12 years old. Note: the promotion of “for family use, for family, children’s pictures”, etc. may be regarded as children’s cosmetics.

Recording data requirements: add the formula design principles of children’s cosmetics (including the overall analysis report of the formula), the selection principles and requirements of raw materials, the production process and quality control, etc. Note: The overall analysis report of the formula requires a safety analysis of each raw material and its dosage. For example: No. 6 raw material polydimethylsiloxane has been used in cosmetic formulations for many years, and its chemical properties are stable. The United States CIR commented that its maximum safe dosage in cosmetics is 24%, so it should not be used in this formula dosage (2%). There will be security risks.

Failure to provide sufficient evidence for the safety of raw materials is a common reason for the failure of the filing of children’s cosmetics. There are only 8783 types of cosmetic raw materials used in China. Not every raw material is suitable for children’s cosmetics. Among them, there are relatively few raw materials that can have sufficient safety basis. Generally, the data sources recognized by the Food and Drug Administration are CIR, SCCS, etc.

Product safety requirements: The safety of children’s cosmetics should be researched and evaluated to ensure product safety. The safety risk assessment of children’s cosmetics that use ingredients such as fragrances, ethanol and other organic solvents, cationic surfactants, and skin penetration enhancers should be strengthened in combination with the use of the product (such as whether to rinse after use). The total number of colonies should not be greater than 500CFU/mL or 500CFU/g; there should be no skin and eye irritation, no phototoxicity, and no allergic reaction.

Product filing inspection requirements: “Cosmetics Registration and Filing Inspection Work Specification”.

Formulation requirements: The types of raw materials used in the formulation should be minimized. When choosing flavors, colorants, preservatives and surfactants, the principle of less use and no use should be adhered to on an effective basis, and attention should be paid to their possible adverse reactions. Children’s cosmetics formulations should not use ingredients that have functions such as whitening, freckle removal, acne removal, hair removal, antiperspirant, deodorant, hair growth, hair dyeing, perming, bodybuilding, and beauty milk. Cosmetic raw materials with a certain history of safe use should be selected, and the use of raw materials prepared by genetic technology and nanotechnology should not be encouraged. The source, composition, impurities, physical and chemical properties, scope of application, safe dosage, precautions and other relevant information of the raw materials used in the formula should be known and available for reference.

Labeling requirements: The Chinese name of the product or the visual surface of the package should clearly indicate that it is applicable to children and other descriptive words; the warning word: “should be used under adult product supervision”.