(August 31, 2023), the China Food and Drug Testing and Research Institute (hereinafter referred to as “CFDA”) issued a circular on the “Technical Guidelines for Children’s Cosmetics” (hereinafter referred to as the “Guidelines”), which specifies the requirements for product formulations and product implementation standards for children’s cosmetics. The regulations came into effect on the date of issuance. Some children’s cosmetics practitioners believe that “if you add the safety assessment report, this can be considered the most ‘difficult’ children’s cosmetics regulations.”
Four types of raw materials are banned
The Guiding Principles cover a total of eight major aspects, including basic information and related information, requirements for product name information, requirements for product formulations, requirements for standards to be implemented in products, requirements for product labeling, requirements for product inspection reports, requirements for product safety assessment information, and requirements for imported children’s cosmetic products with product formulations designed specifically for the Chinese market.
First of all, CIQ has made further clarification on the definition of children’s cosmetics. That is, children’s cosmetics apply to children under 12 years of age (including 12 years of age), with cleaning, moisturizing, toning, sunscreen, and other efficacy of cosmetics, mainly based on the product label claims and the use of the population to determine. The registrant/recorder of the cosmetic product is required to break it down by “infants and young children” (0 to 3 years old, including 3 years old) and “children” (3 to 12 years old, including 12 years old).
According to the Guiding Principles, the formulation design of children’s cosmetics should follow the three major principles of prioritizing safety, necessity of efficacy, and simplicity of formulation. Safety and efficacy are inseparable from the “control” of raw materials. The Guiding Principles suggest that children’s cosmetics should use cosmetic raw materials that have a history of safe use. Four types of raw materials are prohibited and restricted, as follows:
First, shall not use new cosmetic raw materials still under safety monitoring, shall not use children’s safety is not clear raw materials;
Second, the use of gene technology, nanotechnology, and other new technologies are not allowed to prepare raw materials, such as no alternative raw materials must be used, it should be in the product safety assessment information to explain the reasons, and the use of children’s safety fully evaluated, if necessary, to provide the results of the safety evaluation tests as evidence to support;
Third, “infants and young children” are not allowed to use isopropanol butyl carbamate (except bath products and shampoos), salicylic acid and its salts (except shampoos), and other raw materials;
Fourth, it is not allowed to use the main purpose of spot whitening, acne, hair removal, deodorant, anti-dandruff, anti-hair loss, hair coloring, perming, and other raw materials.
At the same time, the “Guiding Principles” also do not recommend the use of raw materials with specific safety risks (such as formaldehyde emitters), as well as other countries or regions listed as prohibited substances of raw materials, such as must be used, should be in the product safety assessment information to explain the reasons, and the use of children’s safety to carry out a full evaluation.
In this regard, some R & D engineers said, “‘do not recommend the use of other countries or regions listed as prohibited substances of raw materials,’ That is, means that children’s cosmetics not only comply with China’s raw material regulations but also to understand the changes in other countries’ raw material regulations. This is a higher requirement for children’s cosmetics R&D engineers and formulators.”
It is worth mentioning that the “Guiding Principles” also highlight that product formulations designed specifically for the Chinese market for imported children’s cosmetics (except for domestic commissioned overseas production), should be designed for the Chinese children’s consumer skin type, consumer demand, etc., the formula submitted to the description of the information should be able to reflect the necessity of designing specifically for the Chinese market, as well as the relevant research and development work carried out. Some industry sources believe that “this is also undoubtedly for the import of children’s cosmetics added a threshold.”
It is worth noting that the “Guiding Principles” also emphasize the requirements of sunscreen children’s cosmetics.
First of all, the “Guiding Principles” clearly pointed out that “sunscreen children’s cosmetics should be designed to take into account the safety of the formulation as well as the effect of sunscreen”. In principle, the formulation of chemical sunscreen agent types shall not be more than five (including five) and the amount used should be lower than the “Cosmetic Safety Technical Specification” limit; the simultaneous use of titanium dioxide, zinc oxide, the total amount used should be ≤ 25%.
In addition, when the formula “uses more than 6 (including 6) chemical sunscreen agents”; or “the use of a single chemical sunscreen agent is close to the “Cosmetic Safety Technical Specification” limit (more than 90%)”; or there is a “total use of titanium dioxide, zinc oxide, titanium dioxide, zinc oxide”. Titanium dioxide, and zinc oxide total use of more than 25% of the amount of formula” situation, the enterprise should be fully confirmed the amount of raw materials used in science and necessity.
For SPF value is higher for sunscreen class children’s cosmetics, the “Guiding Principles” requires, “should be used by children to fully assess the safety. If necessary, submit human trial test safety evaluation data as evidence to support”.
The introduction of the “Guiding Principles” also clearly put forward, “Children are not recommended to use spray-type sunscreen cosmetics, such as must be used, should be fully considered the risk of inhalation, in the use of the label ‘Do not spray directly on the face’ ‘avoid inhalation ‘ and other similar warning terms.”
In this regard, Li Jincong, the developer of CosmeticBannedWords.com, expressed his views, claiming that the State Drug Administration attaches great importance to the safety of children’s cosmetic makeup is evident. In his opinion, “At present, China’s regulatory system for children’s cosmetics is parallel to that of foreign countries in Europe and the United States, and some of the requirements in the Guiding Principles this time have already surpassed those of other countries and regions, and can be considered the strictest regulations.”