China Consults on Technical Guidelines for Children Cosmetics: Stricter Ingredient Use and Labeling Requirements

China’s first regulation on children cosmetics, Supervision and Administration Provisions on Children Cosmetics (hereafter referred to as “Provisions”), came into effect on Jan. 1, 2022. Four months later, on Apr. 11, 2022, China National Institutes for Food and Drug Control released the draft of Technical Guidelines for Children Cosmetics (hereafter referred to as “Guidelines”) for public consultation. ¹ Any suggestions can be mailed to [email protected] before Apr. 28, 2022.

Main Content

The Guidelines is formulated to provide technical guidance for the registrant, notifier, and Chinese domestic responsible person when applying for the registration and notification of children cosmetics, as well as provide the basis for the competent authorities’ technical review of special children cosmetics and post-notification review of general children cosmetics. The Guidelines consists of 7 parts and an annex:

1. Basic Requirements

2. Requirements for Product Name and Related Dossiers

3. Requirements for Product Formula and Ingredient Use

4. Requirements for Product Executive Standard

5. Labeling Requirements

6. Requirements for Product Testing Report

7. Requirements for Product Safety Assessment Report

Annex: 26 Fragrance Allergens

It is worth noting that the Guidelines clarifies the specific requirements for safety assessment, products designed for the Chinese market, children sunscreens; more stringent requirements for ingredient use, labeling, and claims, etc. The Guidelines is in the process of translation and will be available on Apr. 20.

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, etc., to ensure the product safety. On the basis, the Guidelines clarifies 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 children's weight is usually lower than 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 of children cosmetics from assessment documents or published literature of 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. This is because actions such as sucking and scratching by infants may lead to increased exposure, and there are differences between the metabolic capacity of infants and adults.

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.

No.	Recognized Evidence	Simplified Safety Assessment Report	Full Safety Assessment Report
1	The use requirements of restricted ingredients, permitted preservatives, permitted sunscreens, permitted colorants, and permitted hair dyes listed in Safety and Technical Standards for Cosmetics (STSC).	√	√
2	Safety limits or conclusions published by Chinese or foreign authoritative organizations.	√	√
3	The ingredient concentration in the enterprise’s previous products with the same application method and application area that have been on the market for at least three years.	√
4	Ingredient's highest historical use concentration in Inventory of Existing Cosmetic Ingredients in China (IECIC).	√
Regarding No.4 evidence, rinse-off products can refer to the highest historical use concentration of leave-on products; the highest historical use concentration of group ingredients cannot be adopted to prove the safety of a specific ingredient; For fragrances, they cannot adopt No.4 evidence, but can use certificates such as the IFRA certificate. Those containing any of the 26 fragrance allergens should be fully assessed for safety; A complete safety assessment should be carried out for ingredients that cannot adopt the above evidence.

Stricter Ingredient Use Requirements for Children Cosmetics

The Provisions stipulates that the formula design of children cosmetics should follow the principles of “prioritizing safety, only having essential efficacies, and simplifying the formula” and lists some ingredients that are prohibited from being used in children cosmetics. The Guidelines reiterates prohibited ingredients and clarifies other ingredients not recommended for use in children cosmetics.

Prohibited Ingredients

1) Ingredients that are prohibited in children cosmetics stipulated in national mandatory standards such as STSC;

2) New ingredients under safety monitoring;

3) Ingredients whose safety to children is unknown;

4) Ingredients prepared by new technologies such as genetic technology and nanotechnology;

5) Ingredients for the purpose of freckle-removing & whitening, anti-acne, depilation, deodorization, anti-dandruff, anti-hair loss, hair dyeing, hair perming

6) Iodopropynyl butylcarbamate, salicylic acid and its salts, silver chloride deposited on titanium dioxide, etc. (prohibited for use in cosmetics for infants under three years)

Not Recommended Ingredients

1) Ingredients with potential carcinogenic risk such as formaldehyde releaser;

2) Fragrance and flavors, especially those that may contain any of the 26 fragrance allergens;

3) Colorants, preservatives, and surfactants.

For products containing more than three colorants, the enterprise should clarify the colorant types, and the scientificity and necessity of the concentration; conduct research to ensure product safety; and submit human trial data if necessary;
For leave-on products containing more than three preservatives or the concentration of the preservative is close to the limit stipulated in STSC, the enterprise should clarify the preservative types, and the scientificity and necessity of the concentration; and submit the research data for formula optimization if necessary;
For products containing cationic surfactants or dermal absorbers, the enterprise should analyze the scientificity and necessity of the use; and submit relevant safety documents.

More Labeling Requirements

Children cosmetics shall label the necessary contents stipulated in Administrative Measures on Cosmetics Labeling (hereafter referred to as “Measures”). The contents not filled in the label sample manuscript when applying for registration and notification, shall not be claimed on the label. In addition to complying with the Measures, Provisions, and STSC, the Guidelines adds special requirements for children cosmetics labeling.

1) Children cosmetics shall be labeled with warnings such as "shall be used under adult supervision," guided by "Caution" or "Warning";

2) For flammable products such as pressure-filled sols, warnings words such as "Fire and Explosion Hazard" or warning icons should be labeled;

3) For leave-on products containing fragrance allergens not less than 0.001% or rinse-off products with a concentration of fragrance allergens not less than 0.01%, the name of specific fragrance allergens should be labeled, guided by "Contains Allergens";

This is the first time that China has proposed labeling 26 fragrance allergens. The regulatory authorities add this requirement to children cosmetics first, which shows the importance attached to the safety supervision for children cosmetics. ²

4) For children cosmetics claiming "makeup removing," "beautifying and embellishing," "perfuming," or "hair care," in principle, the use scenario and frequency should be identified. The product should be labeled with warnings such as "Not Recommended for Daily Use," "Not Recommended for Long-term Use," "Clean in Time," or "If you feel uncomfortable during the use, please stop using it immediately.”

5) For imported children cosmetics,

the contents related to efficacy claims, application methods, application areas, target users, safety warnings (including precautions) in the Chinese label should be consistent with the corresponding contents on the original label;
if the fragrance allergens are marked on the original label, they shall be marked in the safety warning part on the Chinese label;
The SPF value and PA grade marked on the Chinese label shall comply with China’s requirements for sunscreen efficacy labeling.

Key Supervision Categories

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

The Guidelines clarifies specific requirements for imported children cosmetics whose formula is specifically designed for the Chinese market. This type of cosmetics requires stricter management because there are no same kind of products on the market abroad. Therefore, the Guidelines stipulates,

The formula design should be based on Chinese children's skin type and consumption needs. The explanatory documents submitted should reflect the necessity and the relevant R&D work for designing a formula for the Chinese market;
Enterprises shall invite Chinese adult consumers to join human clinical trial research, and the data will be used for efficacy evaluation;
The safety assessment should fully consider the skin exposure data and the use characteristics of Chinese children. It is encouraged to cite the safety assessment data of products with similar formula that have been marketed in the international or Chinese markets for many years as evidence.

2. Children Sunscreens

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

Ingredient Use

In principle, there should be no more than three 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%. The SPF value should not be higher than 30.

Claims

The claim of sunscreen efficacy shall be consistent with the results in the product efficacy evaluation report. Children sunscreens shall not claim "strong sun protection" and are not recommended to have claims that encourage exposure to the sun, such as “effectively resisting XX hours of UV radiation," “effectively reducing XX% UV damage," or “providing XX times sun protection."

For children sunscreens that claim to be "waterproof," "sweatproof," or "suitable for outdoor activities such as swimming," the waterproof performance shall be tested according to the claimed water resistance degree or time. Claims should be consistent with the water-resistance testing results. If the testing results show that the SPF value decreases by more than 50% after bathing, the waterproof efficacy shall not be claimed.

Labeling

For children sunscreen spray, the product should be labeled with warnings such as "do not spray directly on the face," "please spray on the palm before applying to the face," and "avoid inhalation."

The Guidelines also clarifies the allowed pH value range of children cosmetics, which should be between 4.5 and 7.0. If the pH value of the product used in a specific part of the body is between 7.0 and 9.0, an explanatory document should be provided, and a safety assessment should be conducted. Industry insiders believe that the pH range is reasonable, and most companies can meet the standard.

In addition, according to the Guidelines, the toxicological test results for children cosmetics should be non-irritant to the skin and eyes, non-phototoxic, and non-allergic. This is consistent with the requirements in the previous Guidance on Application and Review of Children Cosmetics promulgated in October 2012.

As a blue ocean market in the beauty industry, the children cosmetics market is gradually emerging. The introduction of the Guidelines and the Provisions are responses to several non-compliance cases of children cosmetics that occurred before. The regulatory authorities intend to strengthen the supervision for the children cosmetics market and ensure product safety.