1. What is the general principle of children's cosmetic formula design?
The formula design of children's cosmetics should follow the principles of safety priority, efficacy necessity, and formula minimalism. The scientific nature and necessity of the ingredients used should be evaluated from the aspects of safety, stability, function, and compatibility, in combination with the physiological characteristics of children, especially flavors and fragrances, colorants, preservatives, surfactants, and other ingredients.
2. What are the requirements for pH indicators of children's cosmetics?
In principle, children's cosmetics should set the pH range (except for the dosage form whose pH cannot be measured), the pH range of leave-on cosmetics should be 4.5~7.5 (including 4.5 and 7.5); the pH range of rinse-off cosmetics should be 4.5~8.5 (including 4.5 and 8.5).
Considering the physiological characteristics of specific areas of use (such as diaper area for infants and young children), a scientific and reasonable explanation should be provided, and safety assessment should be fully conducted when the pH range is set to meet any of the following circumstances: (1) set the lower limit of the pH range ≥ 3.5 but <4.5; leave-on cosmetics set the upper limit of the pH range > 7.5 but ≤ 10.5; (3) rinse-off cosmetics set the upper limit of the pH range >8.5 but ≤10.5.
3. What are the requirements for toxicology program results of children's cosmetics?
Toxicology test items should be consistent with the requirements of the Work Specifications for Cosmetics Registration and Record-filing Inspection. The acute eye irritation/corrosivity test results should be non-irritation or slight irritation. Only when the test results are non-irritation, can the tear-free formula be claimed. The skin irritation/corrosivity test results should be non-irritation, the skin allergy test conclusion should be non-allergenic, and the skin phototoxicity test results should be non-phototoxic.
4. What are the requirements for children's cosmetic labels?
(1) Children's cosmetics shall mark the exclusive logo (Small Golden Shield) stipulated by NMPA on the display surface of the sales package.
(2) Children's cosmetics shall use "attention" or "warning" as guide words, and mark warning words such as "should be used under adult supervision" on the visible surface of the sales package.
(3) When the flavor and aromatic plant oil ingredients used contain potentially allergenic flavor components published by domestic and foreign authorities, and the amount in leave-on products >0.001% or the amount in rinse-off products >0.01%, the specific flavor component name should be marked in the full ingredients of the label or in other places on the label.
(4) The labeling of use conditions and precautions should be in accordance with the requirements of the Technical Specification for the Safety of Cosmetics. For example, when using strontium chloride, it should be labeled with "not suitable for children to use frequently"; Powder cosmetics used for infants and young children containing "talc: hydrated magnesium silicate" should be labeled with warning phrases such as "keep the powder away from the nose and mouth of children".
(5) When using spray sunscreen cosmetics, the use method should be marked with such warning phrases as "Do not spray directly on the face", "Please spray on the palm first, then apply on the face", "Avoid inhalation", etc.
5. What are the requirements for the formula design of children's cosmetics?
(1) Flavors and fragrances: The scientific nature and necessity of the types and amounts of ingredients used should be explained. When the potential allergenic fragrance components in the leave-on cosmetics > 0.001%, in the rinse-off cosmetics 0.01%, the safety of children's use should be fully evaluated and marked on the product label.
(2) Colorants: When using more than 4 types (including 4) of colorants, the scientific and necessary nature of the types and amounts of raw materials used should be explained, and relevant research should be conducted to ensure the safety of product use.
(3) Preservatives: When the amount of preservatives used in leave-on products is close to the limit specified in the Technical Specification for the Safety of Cosmetics (over 90%), or when using more than 5 types (including 5 types) of preservatives specified in the Technical Specification for the Safety of Cosmetics, relevant scientific basis should be provided to explain the scientific and necessary nature of the types and amounts of raw materials used.
(4) Surfactants: It is not recommended to use quaternary ammonium salt cationic surfactants and other raw materials. If quaternary ammonium cationic surfactants are used, their scientific and necessary use should be analyzed.
(5) Sunscreens: The types of chemical sunscreen agents in the formula should not exceed 5 (including 5), and the amount of use should be lower than the limit specified in the Technical Specification for the Safety of Cosmetics; When using titanium dioxide and zinc oxide simultaneously, the total amount of use should be ≤ 25%.
When one or more of the following situations are met, the scientific nature and necessity of the amount of used ingredients should be fully confirmed: (1) the use of more than six (including six) chemical sunscreens in the formula; (2) the use of single chemical sunscreen is close to the limit specified in the Technical Specification for the Safety of Cosmetics (over 90%); (3) The total use of titanium dioxide and zinc oxide exceeds 25% of the formula amount. If necessary, provide research data on formula optimization as supporting evidence.
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