Since the release and implementation of the Technical Guidelines for Children's Cosmetics (hereinafter as Guidelines) on August 31, 2023, official statistics as of April 7, 2024, show that only 22 children's sunscreen products have successfully passed registration. The distribution of these products by type is as follows:
|
Type |
Number |
|
Chemical + Physical Sunscreen |
2 |
|
Chemical Sunscreen |
5 |
|
Physical Sunscreen |
15 |
ZMUni Compliance Centre makes a summary of key points to note in the registration process of children's sunscreen cosmetics for your reading:
Requirements for Formula
The Guidelines stipulates that the formula of children's sunscreen should not use ingredients whose safety is not yet clear. Ingredients prepared by genetic technology, nanotechnology, and other new technologies are not allowed to be used in children’s sunscreen; if no alternative ingredients are available and such ingredients must be used, the reasons shall be explained in the product safety assessment documentation.
The Guidelines stipulates that the formula of children's sunscreen should only use ingredients whose safety has yet to be clarified. Ingredients prepared by genetic technology, nanotechnology, and other new technologies are not allowed in children's sunscreen; if no alternative ingredients are available and such ingredients must be used, the reasons shall be explained in the product safety assessment documentation.
1. Reduce the use of ingredients containing allergens or having irritant solid properties, such as fragrances, colorants, preservatives, cationic surfactants, chemical sunscreen agents, etc.
2. The number of chemical sunscreen agents in the formula should not exceed 5 (including 5), and the amount used should be lower than the limit specified in the Safety and Technical Standards for Cosmetics(STSC). At the same time, when using titanium dioxide and zinc oxide, the total amount used should be equal to or less than 25%.
3. When the SPF value of children's sunscreen is high, the safety of use on children should also be thoroughly assessed. If necessary, submit human patch test safety evaluation data.
4. For fragrance components that may cause allergies, leave-on products with concentrations greater than 0.001%, and rinse-off products with concentrations greater than 0.01%, a thorough safety assessment for children's use must be conducted.
5. The pH range of leave-on cosmetics should be between 4.5 and 7.5 (including 4.5 and 7.5).
Requirements for Labeling
1. Directions for Use: Children's cosmetics should have clear instructions for consumers to use them correctly. The usage instructions for children's sunscreen products should ensure consumers can achieve the expected sunscreen effects. This includes specifying the amount to be used, the time required before exposure, reapplication recommendations, etc. The content should be scientific and reasonable.
2. Safety Warning Statements: Use "Caution" or "Warning" as introductory phrases, and include statements such as "Used under adult supervision."
3. Label the allergenic fragrance components the product contains on the packaging.
4. The efficacy claims, target areas, target users, product types, and usage instructions on the Chinese label should correspond consistently with the information on the sales packaging label (including the instructions) of the cosmetics registrant's country (region) or production country (region). Safety warning statements (including precautions) should be at least the relevant content on the original sales packaging label (including instructions).
Requirements for Safety Assessment
1. Toxicology Test Requirements: For children's cosmetics, the results of acute eye irritation/corrosion tests should be non-irritating or mildly irritating. It can be claimed as a tear-free formula only when the test results show no irritation. Skin irritation/corrosion test results should be non-irritating. The conclusion of the skin sensitization test should be non-allergenic, and the phototoxicity test results should be non-phototoxic.
2. Human Testing Requirements: Sunscreen products for children should conduct human skin closed patch tests by the STSC. Among 30 test subjects, the number of individuals with Grade 1 skin adverse reactions should be less than or equal to one, and there should be no Grade 2 or higher skin adverse reactions.
Registration Process
