China Implements Technical Guidelines for Children Cosmetics

On April 11, 2022, China National Institutes for Food and Drug Control (NIFDC) released a draft of the Technical Guidelines for Children Cosmetics (referred to as the "Guidelines") for public consultation. ¹ The finalized version of the Guidelines was released and implemented by NIFDC on August 31, 2023. ²

Main Content

The purpose of the Guidelines is to provide technical guidance for those seeking registration and notification of children cosmetics, as well as to serve as a basis for the technical review of special children cosmetics and the post-notification review of general children cosmetics by competent authorities. The Guidelines consists of an Overview, the main part Technical Requirements for Documents, and an annex:

The Guidelines incorporates several provisions from existing regulations, including the Supervision and Administration Provisions on Children Cosmetics, Administrative Measures on Cosmetics Registration and Notification, Provisions for Management of Cosmetic Registration and Notification Dossiers, and Administrative Measures on Cosmetics Labeling. It also introduces enhanced requirements pertaining to safety assessments and the testing of children cosmetics, children cosmetics specifically designed for the Chinese market, children sunscreens, ingredient use in children cosmetics, as well as labeling and claims associated with such products.

1. More Specific Requirements for Children Cosmetics Safety Assessment

According to Technical Guidelines for Cosmetic Safety Assessment, the safety assessment of children cosmetics should be exposure-oriented and carried out in combination with children’s physiological characteristics, product application methods, application areas, application amount, residues and other exposure levels to ensure the product safety. On the basis, the Guidelines clarifies the specific requirements on how to combine children’s physiological characteristics during the safety assessment, which is more convenient for enterprises to fulfill in the practice.

• Since systemic exposures to cosmetic products are generally higher in children than in adults, the actual safe use concentration of the same ingredient in children cosmetics is lower than that in adult cosmetics. When conducting exposure assessment, priority should be given to citing the exposure data from assessment documents or published literature specifically related to children cosmetics written by Chinese and foreign cosmetic research institutions;

• For products designed for infants under the age of three, the assessment data adopted should be as strict as possible, and the risk of oral exposure should be considered. This is because actions such as sucking and scratching by infants may lead to extra exposure, and the metabolic capacity of infants is different from that of adults;

• Certain infant cosmetics are designed for specific application scenarios, such as usage in skin folds and diaper areas. These areas are prone to skin damage due to factors like tight clothing and diapers, and infant’s inability to control urination and defecation. Consequently, safety assessments for these products should take into account the changes of skin absorption rate that may occur under such special circumstances.

Recognized Evidence for Simplified and Full Safety Assessment Report

The Guidelines also specifies the types of evidence that can be adopted to prove the ingredient safety in a safety assessment report, which has a simplified version in addition to a full version. Compared with the simplified version, the full version can use fewer types of evidence and additionally requires a product stability assessment.

2. Slightly Relaxed Requirements for Toxicological Tests and Human Skin Closed Patch Test Results

The Guidelines includes requirements for the results of toxicological tests and closed patch test on human skin. For children cosmetics,

• the results of acute eye irritation/corrosion tests should be non-irritation or slight irritation. Only when the test results show non-irritation can the product be claimed as tear-free;

• the results of skin irritation/corrosion tests should be non-irritating;

• the skin allergy test conclusion should be no sensitization;

• the skin phototoxicity test should yield no phototoxicity;

• in human skin closed patch tests conducted for sunscreen cosmetics, the occurrence of Grade 1 adverse skin reactions should be limited to one or fewer out of 30 subjects, and Grade 2 or higher adverse skin reactions should not occur.

It is worth highlighting that, in comparison to the draft version, the finalized Guidelines permits slight irritation in the results of acute eye irritation/corrosion tests. Additionally, Grade 1 skin adverse reactions are acceptable in the results of closed patch tests on human skin but with frequency limit.

3. Stricter Ingredient Use Requirements for Children Cosmetics

Supervision and Administration Provisions on Children Cosmetics (hereafter referred to as “Provisions”) stipulates that the formula design of children cosmetics should follow the principles of “safety first, essential efficacy only, and minimal formula.” Besides, the Provisions lists some ingredients that are prohibited from being used in children cosmetics.

The Guidelines reiterates prohibited ingredients and clarifies ingredients not recommended for use in children cosmetics. Additionally, the Guidelines emphasizes the importance of using certain ingredients in a rational manner.

In the finalized Guidelines, there is a relaxation in the recommended quantity of preservatives, allowing the use of no more than five preservatives compared to the previous limit of three. This adjustment acknowledges the common industry practice of utilizing more than three preservatives in cosmetic products, and helps alleviate the burden on enterprises and allows for greater flexibility in formulation choices. ³

4. More Labeling Requirements

Children cosmetics shall be labeled with the necessary contents stipulated in Administrative Measures on Cosmetics Labeling (hereafter referred to as “Measures”). The contents not filled in the label sample manuscript, which is part of the registration and notification dossiers, shall not be claimed on the label. In addition to complying with the Measures, Provisions, and STSC, the Guidelines introduces additional requirements for children cosmetics labeling.

1) Flammable products, such as pressure-filled sols, should include warning words like "Fire and Explosion Hazard" or warning icons on the label.

2) Leave-on products containing fragrance allergens at a concentration not less than 0.001% or rinse-off products with a concentration of fragrance allergens not less than 0.01% should be labeled with the specific names of the fragrance allergens.

This is the first time that China has stipulated the labeling of fragrance allergens. Compared to the draft Guidelines released in April 2022, the finalized Guidelines removed the requirement to label fragrance allergens in the "safety warning" part. The name of the fragrance allergens can now be labeled in the "full ingredient" part or other places on the label.

3) Children cosmetics claiming "makeup removing" or "beautifying and embellishing" functions should specify the use scenario. The product should be labeled with warnings such as "Clean in Time" and "If you experience discomfort during use, please discontinue immediately."

4) For imported children cosmetics:

• The information related to efficacy claims, application methods, application areas, target users, and product dosage forms on the Chinese label should be consistent with the corresponding information on the original label;

• The safety warning contents (including precautions) on the Chinese label should be equal to or more comprehensive than the corresponding contents on the original label;

• The SPF value and PA grade information on the Chinese label should be consistent with the corresponding information on the original label. If not, the enterprise should provide a sales package specifically designed for the Chinese market.

5. Key Supervision Categories

1. Imported Children Cosmetics with Formula Specifically Designed for the Chinese Market

The Guidelines provides clear requirements for imported children cosmetics that have formulas specifically tailored for the Chinese market. These cosmetics require stringent management as there are no equivalent products available abroad. Accordingly, the Guidelines stipulates the following:

• The formula design should be based on the specific skin type and consumption needs of Chinese children. The accompanying explanatory documents should demonstrate the necessity of and relevant research and development efforts involved in designing the formula for the Chinese market;

• Enterprises should conduct consumer testing research or human clinical trials on Chinese adult consumers in China, and the data will be used for efficacy evaluation;

• The safety assessment should comprehensively consider skin exposure data and the usage characteristics of Chinese children. It is encouraged to provide safety assessment data from products with similar formulas that have been marketed internationally or in China for several years as the supporting evidence;

• When applying for the registration renewal for special children cosmetics, adverse reaction monitoring data from child consumers in China should also be submitted.

2. Children Sunscreens

As special cosmetics, sunscreen products have always been the core category of supervision. The Guidelines stipulates additional requirements for children sunscreens in details.

1) Ingredient Use

In principle, there should be no more than five types of chemical sunscreen agents in children sunscreens, and the concentration should be lower than that of adult sunscreens. The total concentration of titanium dioxide and zinc oxide in children sunscreens shall not exceed 25%.

Compared to the draft, the number of permissible types of sunscreen agents in children cosmetics has been expanded from “no more than three” to “no more than five” in the finalized Guidelines. This change provides greater flexibility for companies in formulating their products.

Moreover, the finalized Guidelines has eliminated the provisions in the draft that set a maximum SPF value of 30 for children sunscreens and prohibited claim of "high sun protection." Instead, the finalized Guidelines no longer imposes a specific restriction on the maximum SPF value. It emphasizes that when the SPF value is high, enterprises should undertake a thorough safety assessment. If required, they may submit human trial data as supporting evidence.

2) Claims

• The efficacy claims of sunscreen products should align with the results obtained from the product's efficacy evaluation report. Claims for children sunscreens should not encourage sun exposure or make absolute guarantees about the effectiveness of sun protection;

• Children sunscreens with claims of "waterproof," "sweatproof," and/or "suitable for outdoor activities such as swimming" should undergo testing to verify the claimed water resistance degree and/or time. The claims should be consistent with the results of water-resistance testing. If the testing shows that the SPF value decreases by more than 50% after bathing, the waterproof efficacy should not be claimed.

3) Labeling

• The labeled SPF value and PA level should be consistent with the results obtained from the human efficacy test report and comply with China's requirements for sunscreen effect labeling management;

• For children sunscreen sprays, the product should include warning labels such as "do not spray directly on the face," "please spray on the palm before applying to the face," and "avoid inhalation."

Industry Comments

The finalized Guidelines made many changes compared to the draft version, aiming to facilitate the better development of enterprises while prioritizing the safety of children cosmetics. It is important to note that these changes should not be perceived as mere "relaxation" but rather as a comprehensive approach to ensuring the safety of children products. With the help of Guidelines, the oversight and regulation of the industry is expected to be enhanced, resulting in a higher level of consumer protection and fostering the growth and development of safer children cosmetics.

ChemLinked expects to assist companies in registering/notifying cosmetics in China. If you have any further cosmetic compliance consultation needs, please contact us at [email protected].

Further Reading

• China Mainland Children Cosmetics Regulation

• Webinar | Introduction of China's First Children Cosmetics Regulation

• China to Implement the First Children Cosmetics Regulation in 2022