CSAR Subsidiary Regulations: China Consults on Supervision and Administration Provisions on Children Cosmetics: the Strictest Supervision Ever

On June 18, China NMPA released the draft Supervision and Administration Provisions on Children Cosmetics for public consultation. ¹ Any suggestions can be mailed to [email protected] before July 31, 2021.

Supervision and Administration Provisions on Children Cosmetics (hereafter referred to as the new Provisions) covers all aspects of children cosmetics supervision, including its definition, formula design principles, safety assessment, labeling, production and operation, registration and notification, as well as sampling inspection. Compared with the current guidance for children cosmetics, the new Provisions is stricter and more systematic.

Definition

In China, children cosmetics refer to cosmetics for children aged 12 and under. In addition to age restrictions, the following two products are also regulated as children cosmetics:

Product labeling "applicable to the whole population," "for the whole family," etc.; or
Product using trademarks, patterns, homophones, letters, Pinyin, numbers, symbols, packaging, etc. to imply that the target users include children.

Formula Design Principles

The formula design principles in the new Provisions is similar with the current guidance. But the requirement in the current guidance "not recommended to use certain functional ingredients" has been changed to "not allowed to use certain functional ingredients” in the new Provisions.

Formula Design Principles

(1) 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;

(2) Functional ingredients for freckle-removing, whitening, anti-acne, depilating, deodorant, anti-dandruff, anti-hair loss, hair dyeing, and hair perming agents 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;

(3) Ingredients with a history of safe use shall be selected. New cosmetic ingredients (NCI) that are in the monitoring period or ingredients whose safety for children is unidentified shall not be used.

Safety Assessment

During children cosmetics safety assessment, the physiological characteristics of children in aspects such as hazard identification and exposure calculation shall be considered. Detailed safety assessment requirements can refer to Technical Guidelines for Cosmetic Safety Assessment 2021.

Although China exempts general cosmetics from submitting toxicological testing reports, children cosmetics are not included in the exemption. Stakeholders are required to submit toxicological testing report and safety assessment report during registration and notification, meaning that animal testing is still mandatory for children cosmetics.

Labeling & Packaging

Children cosmetics should be labeled with NMPA designated children cosmetics’ logo (to open for the society’s contribution) 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 also take measures to avoid the confusion of product properties, appearance, etc. with food and drugs.

Registration and Notification

Regarding the management requirements for children cosmetics registration and notification,

Registration: NMPA will formulate guidelines specifically for the review of special children cosmetics, and strictly review the registration documents according to the guidelines;
Notification: The technical review of children cosmetics notification documents is retained, focusing on production safety documents. Products with non-compliant documents will be disposed severely.

Production and Operation

	Requirements for Children Cosmetics
Production	Children cosmetics should be produced in accordance with Good Manufacturing Practices for Cosmetics, and children skin care products should be produced in qualified clean plants. Cosmetic registrants, notifiers, and entrusted production enterprises shall conduct self-inspection on the GMP implementation situation; Children cosmetics must strictly implement the ingredient purchase inspection and recording system, and carry out related testing items when necessary. If hormones, anti-infective drugs and other substances that may harm human health are found in the ingredients, the registrant or notifier should immediately take risk control measures and report to provincial MPA; Cosmetic registrants, notifiers, and entrusted manufacturers shall formulate and implement annual training plans for practitioners.
Operation	Offline: Cosmetic business operators should establish and implement a purchase inspection and recording system to ensure the traceability of children cosmetics; Cosmetic business operators are encouraged to sell children cosmetics in separate areas, display children cosmetics logo in the area and prompt consumers to inquire product registration and notification information; Cosmetic business operators should check the labeling information with the corresponding product information published on the NMPA website. Online: E-commerce operators should fully, truthfully, and accurately disclose children cosmetic labels and display children cosmetics logo on the product page.
*Children cosmetics will become the key category for post-market sampling inspection and risk monitoring. Any prohibited ingredients, unregistered NCI, or ingredients that may harm human health is found in children cosmetics, severe penalties will be imposed.

Industry Comments

With the introduction of China’s two-child and three-child policy, the children cosmetics market will come to a period of rapid growth. Mintel estimates that China’s infant care products (for 0-3 years old) market will grow from 7 billion yuan in 2016 to 17.6 billion yuan in 2021. ²

The fast-growing market will also bring more non-compliance issues. At the beginning of 2021, regulatory authorities in more than 20 regions in China have launched a 7-month special inspection campaign on children cosmetics. The promulgation of children cosmetics provisions further proves that NMPA is highly concerned about children cosmetics safety. The new Provisions formulates stricter and more systematic management requirements for children cosmetics, including the use of ingredients, safety assessment, packaging design, production and operation, registration and notification, and post-market surveillance. The non-compliance in the children cosmetics market is expected to be effectively rectified in the future.