Draft of the Technical Guidelines for Children's Cosmetics Released in China: The Requirements become Stricter

On April 11, National Institutes for Food and Drug Control issued a notice soliciting public opinions on the draft Technical Guidelines for Children's Cosmetics.

Children's cosmetics have always been the focus of cosmetics safety supervision. To know more information about supervision of children’s cosmetics, please referred to the article Comprehensive Analysis of Compliance of Children’s Cosmetics in China prepared by Personal and Home Care Products Divisions of CIRS Group.

Provisions on Supervision and Administration of Children's Cosmetics were released on September 30, 2021, further detailing the supervision of children's cosmetics. On the premise of the above regulations and in accordance with Article 9 of Provisions on Supervision and Administration of Children's Cosmetics, National Institutes for Food and Drug Control has formulated special technical guidelines for children's cosmetics to strictly review and examine the registration materials submitted by the registration applicants or filers, so as to ensure the safety of children's cosmetics.

The main body of the Guidelines (Draft for Comments) consists of 7 parts, including the basic requirements for children's cosmetics, product name and related data requirements, product formula and raw material use requirements, product implementation standards, labeling requirements, product inspection report requirements, safety evaluation report requirements, etc. The table lists 26 allergenic components that may be present in flavors.

1. Specially Designed for the Chinese Market

Article 27 of Provisions on Supervision and Administration of Children's Cosmetics points out that: for imported products whose product formulations are specially designed for the Chinese market (except for those commissioned by domestic manufacturers to produce overseas), the descriptive materials of formulations designed for the types of skin and needs of Chinese consumers shall be submitted; If products are put in Chinese market, Chinese consumers shall be selected for researches of consumer test or human efficacy test.

The Guidelines (Draft for Comments) specify the requirements of children's cosmetics, that is imported children's cosmetics whose product formulations are specially designed for the Chinese market (except for those commissioned by domestic manufacturers to produce overseas) shall submit relevant materials on Chinese children. The data submitted should reflect the necessity of design specifically for the Chinese market and the relevant R&D work. For example, for the purposing of protecting Chinese children from UV damage, related manufacturers may need to clarify the reasons for product development and formulation design after analyzing the Fitzpatrick skin parting of Chinese Children, the ultraviolet (UV) light response characteristics and health risks, the UV intensity and its distribution characteristics, and based on China’s health needs and market research or demand analysis of aesthetic needs, etc..

In addition, it is also proposed that the efficacy claims of such cosmetics shall be evaluated by selecting adult subjects in human clinical trials, the safety evaluation data concerning Chinese children's skin exposure and the use characteristics of children's cosmetics in China should be fully considered, and related enterprises are encourage to cite the safety evaluation information of products with similar formulas that have been in international and domestic markets for many years as a supportive evidence. However, when applying for the extension of the validity period of the registration certificate for special cosmetics, the adverse reaction monitoring data from Chinese children users shall be submitted.

2. Principles of Formula Design

Article 7 of Provisions on Supervision and Administration of Children's Cosmetics emphasizes that the formula design of children’s cosmetics should follow the principle of safety first, essential efficacy and minimal formula; It is not allowed to use new raw materials that are still in the monitoring period; It is not allowed to use raw materials prepared by using new technologies such as gene technology and nanotechnology. If there is no substitute and the aforementioned raw materials must be used, the reasons for use should be explained and the safety of children's cosmetics should be evaluated; It is not allowed to use the raw materials for purposes of anti-freckle and whitening, anti-acne, hair removal, deodorization, anti-dandruff, anti-hair loss, hair dyes, hair perming, etc. If raw materials with the above effects are used for other purposes, the necessity of use should be given and the safety of children's cosmetics should be evaluated.

The Guidelines (Draft for Comments) specifies that the principle of minimal formula is of relativity. It does not limit the quantity of raw materials. Furthermore, according to the requirements of Safety and Technical Standards for Cosmetics, raw materials that are clearly prohibited to use in children’s cosmetics under the Safety and Technical Standards for Cosmetics and other mandatory national standards shall not be used in children’s cosmetics; It is not suitable to use raw materials that are potentially carcinogenic, such as Formaldehyde emitter; It is not allowed to use Iodopropargyl Butyl Carbamate (except for bath products and shampoos), Salicylic Acid and its salts (except for shampoos), Silver Chloride deposited on Titanium Dioxide, etc. in children’s cosmetics when infants are available to use such children’s cosmetics; When certain restricted ingredients are used, corresponding use conditions and precautions should be marked on the products label. For example, mark "not suitable for children" when Strontium Chloride is used and mark "keep away from children's nose and mouth" when Use Talc ( Hydrated Magnesium Silicate) is used, etc.

According to Article 7 of Provisions on Supervision and Administration of Children's Cosmetics, the scientific nature and the necessity of use of ingredients applied in children’s cosmetics, in particular, the flavors, colorants, preservatives and surfactants, should be evaluated, based on the safety, stability, function, compatibility of ingredients and taking into consideration of children's physiological characteristics.

The specific requirements are given in the Guidelines (Draft for Comments) as following:

• Do not use or use flavor or fragrance as little as possible. It is not recommended to use complex ingredients that may contain 26 allergenic components as fragrances. If used, a full safety evaluation should be carried out and related information should be labeled to inform consumers if the content of allergenic component content is ≥0.001% in leave-on products and ≥0.01% in the rinsed product.
• Do not use or use colorant as little as possible. When more than three kinds of colorants are used (excluding three kinds), the scientific nature and necessity of use of the type and dosage of ingredients used shall be explained, and relevant research shall be carried out to ensure product safety.
• Use preservatives as little as possible. The amount of preservatives used in rinsing products should be lower than the limit requirements under the Safety and Technical Standards for Cosmetics. When the amount of preservatives in leave-on products is close to the limit (such as more than 90%), or when more than three preservatives are used (excluding three), relevant scientific evidence shall be provided to explain the scientific nature and necessity of the type of raw materials used and the amount of preservatives.
• Use as little surfactant as possible. For products using raw materials such as cationic surfactants and transdermal absorbents, the scientific nature and necessity of their use should be analyzed and relevant safety information should be provided.

3. Implementation Standards

The microbial and physical and chemical indexes of children's cosmetics should meet the requirements under Safety and Technical Standards for Cosmetics, that is, the total number of bacterial colonies in the microbial indexes should not exceed 500CFU/mL or 500CFU/g and the limit value of harmful substances in the physical and chemical indexes must not exceed the threshold. The Guidelines (Draft for Comments) upgrade the requirements of physical and chemical indicators: the control indicators of restricted and quasi-used components in physical and chemical indicators should be controlled within a reasonable error range (generally not more than ±20%) on the basis of meeting the requirements of Safety and Technical Standards for Cosmetics.

Under the Guidelines (Draft for Comments), the pH value of physical and chemical indexes of children's cosmetics is clarified at the regulatory level for the first time. In principle, PH value of children's cosmetics should range from 4.5~7.0 (including 4.5 and 7.0) (except for dosage forms whose pH value cannot be measured); Scientific explanations should be provided and adequate safety assessments carried out if the PH values of products shall range from 7.0~9.0 (7.0 excluded) when taking into consideration of the physical characteristics of specific parts of use (e.g., infant diaper areas), product properties (e.g., cleaning classes), as well as material stability.

In terms of warning words, children's cosmetics should be labeled with safety warning terms in accordance with the Provisions on Supervision and Administration of Children's Cosmetics and other relevant laws and regulations. "Attention" or "warning" should be used as the guide language and "should be used under adult supervision" should be labeled. The Guidelines (Draft for Comments) specify that the requirements for inflammable products such as pressure-filled sol and the use of perfume or fragrance products containing 26 allergenic components.

4. Label Content

Children's cosmetics marks shall be stuck on the upper left side of the display surface of the sales package where the mark can be easily observed in accordance with the requirements under the NMPA Notice regarding the Issuance of Children's Cosmetics Marks (No. 143, 2021). Safety warning terms shall be marked on the main display surface with "notice" or "warning" as the guide language.

According to the Cosmetic Classification Rules and Classification Catalogue, if the target users are "infants" (0-3 years old, including 3 years old), the efficacy claim is limited to cleaning, moisturizing, hair protection, sunscreen, soothing, refreshing body; if the target users are children (3-12 years old, including 12 years old), the efficacy claim is limited to cleaning, makeup removal, moisturizing, beauty modification, fragrance, hair care, sunscreen, repair, soothing and refreshing. It is further pointed out in the Guidelines (Draft for Comments) that children's products whose functions are claimed to be makeup removal, beauty modification, fragrance and hair care are not recommended for daily use. The application scenarios and the frequency of use, etc. should be clearly indicated in the usage part.

5. Testing Report

The product testing report shall be issued by the cosmetics registration and filing inspection institution, and shall meet the requirements of relevant laws, regulations and technical standards such as the Safety and Technical Standards for Cosmetics and the Inspection Work Standards for the Registration and Filing of Cosmetics. According to the Provisions on the Management of Cosmetic Registration and Filing Data, toxicology test reports cannot be exempted if products claim to be used by infants and children.

Guidelines (Draft for Comments) requires that the results of acute eye irritation/corrosion test for children's cosmetics should be non-irritating, the results of skin irritation/corrosion test should be non-irritating, the results of skin allergy test should be no sensitization, and the results of skin phototoxicity test should be no phototoxicity.

6. Safety Evaluation

The safety evaluation of children's cosmetics should be conducted based on the principles and requirements under the Technical Guidelines for Cosmetics Safety Assessment. The safety of products should be evaluated with exposure oriented and taking into consideration of children's physiological characteristics and the use method, use part, amount, residue and other exposure levels of the products.

Guidelines (Draft for Comments) emphasize that children's cosmetics should be evaluated on the basis of all ingredients and risky substances, and the correct evaluation conclusions should be obtained. The weight of children is usually lower than that of adults. According to the habit of daily use of cosmetics, the systematic exposure risks of children are higher than that of adults. Therefore, the actual safe concentration of one raw material in children's cosmetics is lower than that in adult cosmetics. Considerations should be given to the characteristics of infants' physical and behavioral development, such as the possibility of increased exposure due to certain behaviors (sucking, scratching, etc.), as well as differences in infants' metabolic capacity compared with adults. When conducting the exposure assessment, the exposure data of children's cosmetics in the evaluation documents of domestic and foreign cosmetic research institutions or publicly published literatures shall be preferentially cited.

7. Sunscreen Products for Children

Sunscreen products have always been the core of regulation. In the Guidelines (Draft for Comments), sunscreen products for children have to meet the general requirements as well as additional rules.

• Both safety and sun protection effects should take into account in formula design, and benefit risk analysis should be performed if necessary. In principle, there should be no more than 3 types of chemical sunscreen agents and the amount should be less than that for adult use. When titanium dioxide and zinc oxide are used simultaneously as sunscreen or for other purposes, the total amount of should not exceed 25%, and the SPF value should not be higher than 30.
• Sunscreen effect claims should be consistent with the results of the product efficacy test. It is not allowed for children's cosmetics to claim "high SPF sunscreen", and it is not recommended to encourage exposure to sun, such as effective resistance to XX hours of ultraviolet radiation, effectively reduce XX% ultraviolet damage, provide XX times protection ability.
• It is not recommended to use spray sunscreen cosmetics on children. If it is necessary to use, the risk of inhalation should be fully considered, and the use method should be marked with "do not spray directly on the face", "spray on the palm first, then on the face", "avoid inhalation" and other similar warning words.
• According to the requirements of Safety and Technical Standards for Cosmetics, the closed human skin patch test should be carried out, and the test result should be 0 cases of skin adverse reactions.

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