Since the pilot program of the import non-special filing system in 2017, the total number of imported non-special cosmetics has been reached 34,270 products, but only about 200 infants and children’s products been approved, less than 0.6% in total. But on the bright side is that the registration of children’s cosmetics is quite difficult but it is not impossible.
I have worked in several successful cases to help brands to register children’s cosmetics in China. I would like to share with you my experiences with analyzing the current laws and regulations of children’s cosmetics in China. And also give suggestions on how you can design your baby/infant/children cosmetics in compliance in China.
China Children’s Cosmetics Regulatory Requirements-“Guidelines for the Application and Evaluation of Children’s Cosmetics”
In China, there are special regulations for children’s cosmetics, namely the “Guidelines for the Application and Evaluation of Children’s Cosmetics”, which were released in October 2012. After the release, the number of successfully registered children’s cosmetics, especially imported children’s cosmetics, is very small.
⏩Scope of application: cosmetics used by children from 0 to 12 years old will be categorized as Children’s cosmetics.
Note: The claims on the labels such as “for family use, children’s pictures”, etc. may be regarded as Children’s cosmetics.
⏩Additional Documents for registration: Except for the normal registration documents of adult cosmetics, there are additional materials are required.
1. Formula design principles of children’s cosmetics
2. The overall analysis report of the formula *
3. The selection principles and requirements of raw materials
4. 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 similar to EU CPSR.
Example of ingredients analysis: No. 6 raw material polydimethylsiloxane has been used in cosmetic formulations for many years, and its chemical properties are stable. The US CIR commented that its maximum safe dosage in cosmetics is 24%, so it should be safe to use forthe ingredients dosage is 2% in this formula.
Roger: 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 a sufficient safety basis. Generally, the data sources recognized by the NMPA recognized institutions include CIR, SCCS, etc.
⏩Product safety requirements:
● The safety of children’s cosmetics should be researched and evaluated to ensure product safety. It should carefully perform the safety evaluation of Children cosmetics based on the use types of the product (such as whether to rinse after use) to strengthen the safety of fragrances, ethanol, and other organic solvents, cationic surfactants, and skin penetration enhancers use in the products.
● 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.
⏩Formulation Suggestions:
Principle: The types and numbers of raw materials used in the formulation should be minimized as much as possible.
● When selecting flavors, colorants, preservatives, and surfactants, the principle is to use less or even don’t use on the basis of effectiveness, and it should be paid attention to the 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 breast. The above claims are all belongs to the special cosmetics category, so It also means Children cosmetics almost not be registered as special cosmetics except for sunscreen products.
● 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 is discouraged.
● The source, composition, impurities, physical and chemical properties, the 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 Suggestions:
● The Chinese name of the product or the visual surface of the package should indicate the products applicable to children;
● Should put the warning term: “should be used under adult supervision.”
Case Study about Children Cosmetics Registration
I sorted out 10 review opinions of typical failure of children’s cosmetics registration from the NMPA Database as follows:
Case 1: The formula contains flavors and pigments “CI 15985, CI 14700“. It does not provide sufficient basis for adding these ingredients and the explanation of the necessity, as well as the conclusions of toxicological research and its literature (including toxicology Research report on experimental data and conclusions) and other materials.
Case 2: In the formula, MACADAMIA INTEGRIFOLIA seed oil and sunflower (HELIANTHUS ANNUUS) seed oil did not provide the basis for evaluating the safe dosage for use in cosmetics, nor calculate and provide the daily exposure of these two raw materials and Basis for infants weight calculation. The Chinese label of the product is not marked with warning words such as “should be used under adult supervision” as required.
Case 3: Did not analyze the necessity of using and rationality of each ingredients, such as of p-hydroxyacetophenone, bisabolol, carbomer, etc.
Case 4: The product packaging adopts the cartoon image”Little Penguin Pok Lele”. It is suspected of children’s cosmetics. The packaging should be designed in accordance with relevant Chinese regulations and registered as Children cosmetics.
Case 5: The foreign name of the product is “Little Body Moisturizing Lotion“. Please clearly indicate the warning word on the Chinese label: This product is not a cosmetic for children.
Case 6: The formula design principles of children’s cosmetics did not provide cyclopentadimethylsiloxane and did not provide the quality specification certificate containing cyclotetrasiloxane (D4) control indicators.
Case 7: The name of the product was changed from “boy” to “child”, the applicable population has changed, and no special and effective description has been made.
Case 8: Assessment of safety risk substances: The raw material formula“carbomer” may bring in the harmful solvent “benzene”. Please provide the quality specifications of the raw material, and make a safety evaluation analysis for this ingredient in the overall analysis report.
Case 9: Potassium sorbate is a preservative, which has not been analyzed according to the “Cosmetics Safety Technical Standards”.
Case 10: The safety assessment of the fragrance does not meet the requirements, and the ratio analysis certificate issued by the fragrance manufacturer that may contain allergenic fragrance components (26 EU allergens) in the fragrance is not provided.
In conclusion, the main problems are that the formulation design principles do not meet the requirements and the raw material safety basis is insufficient. Highly suggest that the safety of the raw materials and their dosage are fully considered when the product formula is designed.
