CSAR Subsidiary Regulations: China to Implement the First Children Cosmetics Regulation in 2022

Implementation Date

Except for labeling requirements, other requirements in the finalized Provisions will come into force on Jan. 1, 2022;
Children cosmetics that apply for registration/notification after May 1, 2022, must be labeled in accordance with the finalized Provisions;
For children cosmetics that have applied for registration/notification before May 1, 2022, the registrant/notifier shall update the product label before May 1, 2023.

Main Revisions

Compared with the draft provisions, there are few changes in the finalized Provisions. Most of them are adjustments to the order or expressions of articles. The main revisions to regulatory requirements are as follows (the underlined texts are the revisions):

Items	The Finalized Provisions	The Draft Provisions	Remarks
Definition	Children cosmetics refer to cosmetics for children aged 12 and under, and have the functions of cleansing, moisturizing, body refreshing, sunscreen, etc.	Children cosmetics refer to cosmetics for children aged 12 and under.	Add children cosmetics functions in the definition. The function of “makeup" is not listed in the definition, which may indicate that NMPA encourages children cosmetic companies to focus more on cleansing and skincare functions.
Formula Design Principles	The formula design of children cosmetics should follow the principle of safety first, essential efficacy, and minimal formula: Ingredients with a long history of safe use shall be selected. New ingredients in the monitoring period, ingredients prepared by new technologies such as genetic technology or nanotechnology shall not be used. If they must be used (no alternative ingredients), the reasons should be explained and the safety of their use in children cosmetics should be accessed; Functional ingredients for freckle-removing, whitening, anti-acne, depilating, deodorant, anti-dandruff, anti-hair loss, hair dyeing, and hair perming are not allowed for use. If the above ingredients are used for other purposes, the necessity and safety of their use in children cosmetics should be accessed; The scientificity and necessity of ingredients used in formulas of children cosmetics (especially fragrances, colorants, preservatives, and surfactants) should be assessed from the aspects of safety, stability, function, and compatibility, combined with children's physiological characteristics.	The formula design of children cosmetics should follow the following principles: Children cosmetics should reduce the number of ingredients used in formulas and assess the scientificity and necessity of ingredients (especially fragrances, colorants, preservatives, and surfactants) from the aspects of safety, stability, function, and compatibility; Functional ingredients for freckle-removing, whitening, anti-acne, depilating, deodorant, anti-dandruff, anti-hair loss, hair dyeing, and hair perming are not allowed to use. If the above ingredients are used for other purposes, the necessity and safety of their use in children cosmetics should be accessed; Ingredients with a history of safe use shall be selected. New ingredients in the monitoring period or ingredients whose safety for children is unidentified shall not be used.	Add prohibited ingredients for children cosmetics. i.e., the ingredients prepared by new technologies such as genetic technology and nanotechnology.
Labeling Requirements	Children cosmetics should be labeled with NMPA designated children cosmetics’ logo (to be released separately) on the display panel of the sales package. Adult cosmetics shall not be labeled with the children cosmetics’logo. Children cosmetics should be labeled with warning words such as “Used under adult supervision” on the visual surface of the sales packaging, with“Caution” or “Warning” as the guiding word. Cosmetic registrants, notifiers, and entrusted production enterprises shall take measures to avoid the confusion of product properties, smell, appearance, etc. with food and drugs. Children cosmetics shall not be labeled with words such as "food grade," "edible," or food-related patterns.	Children cosmetics should be labeled with NMPA designated children cosmetics' logo in a prominent position on the display surface, and the executive standard number directly below the logo. Adult cosmetics shall not be labeled with the children cosmetics' logo. Cosmetic registrants, notifiers, and entrusted production enterprises shall take measures to avoid the confusion of product properties, appearance, etc. with food and drugs.	Add labeling requirements for warning and prohibited words.
Sampling Inspection	Medical products administration (MPA) departments shall include children cosmetics as a key category for annual sampling inspection and risk monitoring. If any ingredients that may harm human health are found in children cosmetics, local MPA may take emergency control measures (i.e., suspension of production and operation), and issue safety warning information. If unqualified children cosmetics are found to be imported, they shall be suspended from import.	Medical products administration (MPA) departments shall include children cosmetics as a key category for annual sampling inspection and risk monitoring. If any ingredients that may harm human health are found in children cosmetics, local MPA may take emergency control measures (i.e., suspension of production and operation), and issue safety warning information.	Strengthen the supervision of imported children cosmetics.
Children Toothpastes	Children toothpastes shall be managed with reference to the finalized Provisions.	/	Clarify the regulatory requirements for children toothpastes.

For detailed analysis of the draft provisions, please refer to "China Consults on Supervision and Administration Provisions on Children Cosmetics: the Strictest Supervision Ever."