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Beijing MPA FAQs on Children’s Cosmetic Filing

Children’s Cosmetic Filing

1. What is the children’s cosmetic?

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.

Products that use words such as "适用于所有人群 (applicable to all people)", "全家使用 (available for all family members)" or use trademarks, patterns, homophonic expressions, letters, Chinese Pinyin, numbers, symbols, packaging forms, etc. to imply that the use group includes children shall be managed as children's cosmetics.

2. What are the requirements for formula design principles in the safety assessment report of children's cosmetics?

According to Article 7 of the Provisions for the Supervision and Administration of Children's Cosmetics, the principle of formula design should include the principles of safety priority, efficacy necessity, and formula minimalism. The scientificity and necessity of the ingredients used should be evaluated from the aspects of safety, stability, function, and compatibility, in combination with the physiological characteristics of children, especially flavors and fragrances, colorants, preservatives, surfactants, and other ingredients. The principle of formula minimalism here is relative, not simply limiting the quantity of raw materials used, nor is it better to have fewer types of raw materials, but rather strictly following the principle of necessity.

3. What are the requirements for children's cosmetics in the Technical Specification for the Safety of Cosmetics?

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

If the formula uses the substances listed in the Cosmetic Restricted Ingredients (Table 3) in the "Specification", the use requirements should be in accordance with the provisions of the table. If the formula uses preservatives, sunscreens, colorants, and other approved cosmetic ingredients in the "Specification" (Table 4-6), the use requirements should comply with the provisions of the table.

For example, Iodopropynyl Butylcarbamate (except bath products and shampoos), Salicylic Acid and its salts (except shampoos) shall not be used in products for children under three years old, and the label shall be marked with warnings such as "Do not use for children under three years old" and "Contains salicylic acid, do not use for children under three years old" according to the "Specification".

4. What are the requirements for children's cosmetic labels?

Children's cosmetics shall mark the exclusive logo (Small Golden Shield) stipulated by NMPA on the display surface of the sales package. Children's cosmetics shall use "attention" or "warning" as guide words, and mark warning words such as "should be used under adult supervision" on the visible surface of the sales package.

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.

In order to enable consumers to choose children's cosmetics accurately, the filer should specify whether it is for infants, children, or both in the label "Use Group", based on the efficacy claims and safety assessment results.

5. What are the requirements for the inspection report of children's cosmetics?

According to the Provisions for the Registration or Filing Dossier of Cosmetics, and the NMPA Announcement on Optimizing the Management Measures for Filing Inspection of General Cosmetics (No. 13 of 2023), cosmetics that claim to be used by infants and children are not exempt from submitting toxicology test reports for the product. The inspection report for children's cosmetics must be issued by the inspection agency for cosmetic registration and filing, and cannot be conducted by self-inspection and issued by cosmetic filers or entrusted production enterprises in accordance with the requirements of the cosmetic technical specifications.

6. What are the requirements for ingredients used in children's cosmetics?

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.

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. If ingredients that may have the above efficacy are used for other purposes, the necessity and safety of their use in cosmetic products for children shall be evaluated.

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