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Analysis of the Technical Guidelines for Children's Cosmetics

Children Cosmetic Guideline

On August 31, China NIFDC issued an announcement on the Technical Guidelines for Children's Cosmetics, which shall be effective as of August 31, 2023. EnterCo has analyzed the Guidelines and sorted out the following main contents:

Definition and Efficacy of Children's Cosmetics

Children's cosmetics refer to cosmetics that are applicable to Children under the age of 12 (including 12 years old) with the functions of cleansing, moisturizing, refreshing, and sun protection.

Infants (0-3 years old, including 3 years old): Efficacy claims are limited to cleansing, moisturizing, hair care, sun protection, soothing, and refreshing.

Children (3-12 years old, including 12 years old): Efficacy claims are limited to cleansing, makeup remover, moisturizing, beauty modification, fragrance, hair care, sun protection, repair, soothing, and refreshing.

Requirements for the Use of Cosmetic Product Ingredients

Children's cosmetics should use cosmetic product ingredients with a history of safe use, and new cosmetic product ingredients that are still under safety monitoring should not be used. Ingredients that are not yet clear about the safety of children should not be used. It is not allowed to use new technologies such as gene technology and nanotechnology to prepare ingredients used in children's cosmetics. If there is no alternative ingredient and the above ingredient must be used, the reasons should be explained in the product safety assessment, at least including an analysis of the necessity of using the ingredient that cannot be replaced by other ingredients in the product formula, providing a description that the ingredient only can be prepared by gene technology or nanotechnology, and conducting a full evaluation on the safety of children's use.

It is not recommended to use raw materials with specific safety risks (such as formaldehyde emitters) and raw materials listed as prohibited substances in other countries or regions.

The cosmetics for infants shall not use raw materials such as iodopropylenol butyl carbamate (excluding bath products and shampoos), salicylic acid and its salts (excluding shampoos), and silver chloride deposited on titanium dioxide.

Children's cosmetics are not allowed to use cosmetic raw materials with the main purpose of anti-spot and whitening, anti-acne, hair removal, deodorant, anti-dandruff, anti-hair loss, hair dye, hair perm, etc.

Product Implementation Standard

The sensory index should be consistent with the product formula. Formula with flavors should be described as having a fragrance or a characteristic odor of raw materials.

Microbiological index in the total number of colonies ≤ 500CFU/mL (CFU/g);

Children's cosmetics should set the pH range (except for dosage forms for which pH cannot be measured), the pH range of leave-on cosmetics should be 4.5~7.5 (including 4.5 and 7.5); the pH range of rinse-off cosmetics should be 4.5~8.5 (including 4.5 and 8.5).

Cosmetic Inspection Report

Product inspection reports should be issued by the cosmetic registration and filing inspection agency, and product information contained in the product inspection report should be consistent with the relevant information in the "cosmetic registration and filing information form". Microbiological and Physicochemical test reports, toxicology test reports, and human safety test reports should be consistent with the Work Specifications for Cosmetics Registration and Record-filing Inspection, and the Technical Specification for the Safety of Cosmetics.

The acute eye irritation/corrosivity test results for children's cosmetics should be non-irritation or slight-irritation. Only when the test results are non-irritation, can the tear-free formula be claimed. The skin irritation/corrosivity test results should be non-irritation, the skin allergy test conclusion should be non-allergenic, and the skin phototoxicity test results should be non-phototoxic.

Sunscreen cosmetics for children require conducting a closed patch test on the human skin. Among the 30 subjects, the number of people experiencing Level 1 skin adverse reactions should be less than or equal to 1, and there should be no Level 2 or above skin adverse reactions.

Sunscreen cosmetics for children claiming "waterproof", "sweatproof" or "suitable for swimming and other outdoor activities" and other contents, should test waterproof performance according to the prescribed method based on its claimed degree or time of resistance to water. If the product waterproof test shows that the SPF value decreases by more than 50% after bathing, the waterproof effect shall not be claimed.

Cosmetic Product Safety Assessment

Colorants: When using more than 4 types (including 4) of colorants, the scientific and necessary nature of the types and amounts of raw materials used should be explained, and relevant research should be conducted to ensure the safety of product use.

Preservatives: When the amount of preservatives used in leave-on products is close to the limit specified in the Technical Specification for the Safety of Cosmetics (over 90%), or when using more than 5 types (including 5 types) of preservatives specified in the Technical Specification for the Safety of Cosmetics, relevant scientific basis should be provided to explain the scientific and necessary nature of the types and amounts of raw materials used.

Surfactants: It is not recommended to use quaternary ammonium salt cationic surfactants and other raw materials. If quaternary ammonium cationic surfactants are used, their scientific and necessary use should be analyzed.

Sunscreen agents: The types of chemical sunscreen agents in the formula should not exceed 5 (including 5), and the amount of use should be lower than the limit specified in the Technical Specification for the Safety of Cosmetics; When using titanium dioxide and zinc oxide simultaneously, the total amount of use should be ≤ 25%. When the SPF value of sunscreen cosmetics for children is relatively high, the safety of use for children should also be fully evaluated.

Fragrance and flavor: Submit the materials on the types and contents of all flavor components contained in the fragrance issued by the raw material manufacturer, and conduct a safety assessment on each flavor component. Calculate the content of potentially allergenic flavor components in the product. If it is>0.001% in leave-on products and>0.01% in rinse-off products, the safety of children's use should be fully evaluated and marked on the product label.

Products using paste and mask as carrier materials: Conduct a thorough safety assessment of the stability of carrier materials (whether they degrade, whether risk substances are generated, and whether risk substances migrate to the content).

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