On August 17, 2022, the Taiwan FDA issued Circular No. 1111608018, revising the safety guidelines for children’s cosmetics. The supervision of children’s cosmetics in Taiwan is also very rigorous and many cosmetic ingredients are not allowed to be used in children’s cosmetics.
Details are as follows:
Ⅰ The guidelines are specially formulated to ensure the safety of children’s use of cosmetics.
Ⅱ When cosmetics are expressly or implicitly intended for use by children, the following matters shall be noted:
1. The product is safe for children under normal use, usage and dosage or in foreseeable circumstances.
2. Ingredients with safe use history should be prioritized and the use of essence, fragrance, colors and preservatives should be reduced.
3. If the products can be used by children under 3 years old, the microbial count should be below 100 CFU/g or CFU/mL, and Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans shall not be detected.
4. The appearance, smell, color, package, label and capacity of related cosmetic products shall be clearly distinguished from that of food and related products, so as to prevent children from eating by mistake.
5. In order to prevent children from using in an inappropriate way, it is recommended to mark with “For the safety of children, please use it under the supervision of an adult” or words with the same meaning.
6. When it is packed in a pressurized container, it is recommended to label “Please avoid spraying into eyes. Do not damage the container or incinerate it. Avoid direct sunlight and store in a cool place. Avoid close to fire or heat” or the words with the same meaning.
7. Cosmetics containing Salicylic acid, Calcium salicylate, Magnesium salicylate, MEA-salicylate, Sodium salicylate, Potassium salicylate, TEAsalicylate should be marked with the precaution “Not for use by children under 3 years old” (except shampoo cosmetics).
8. Cosmetics containing Hydrogen peroxide, Urea peroxide shall be marked with the precaution “Not recommended for children under 12”.
9. Cosmetics containing fruit acid and related ingredients should be marked with the precaution “This product shall not be used by infants and children”.
10. Cosmetics containing Camphor, Menthol, Methyl Salicylate should be indicated on the label or package “Not recommended for children under 2 years old”.
11. Nail cosmetic products containing Toluene shall be marked with the precautions to keep out of reach of children.
12. Cosmetics containing Thioglycolic acid, Potassium hydroxide, Sodium hydroxide should be marked with the precaution “It should be stored out of the reach of children”.
13. If the fluoride content of non-medicinal toothpastes reaches 0.1 to 0.15% and there is no label prohibiting children from using, it should make it clear that “The maximum amount of use for children under 3 years old should not be larger than a rice each time; for children aged 3 to 6 years, no larger than a pea each time and avoid swallowing”.
14. Non-medicinal toothpastes and mouthwashes containing Strontium should be marked with the precaution “Not recommended for frequent use by children”.
15. It is recommended that cosmetics containing Talcum power (Talc) shall be marked with the precaution “Keeping away from mouth and nose when using by children”.
16. Cosmetics containing Indopropynyl butylcarbamate should be marked with the precaution “Not for use by children under 3 years old (bath and shampoo products are exempt from the precautions)”.
17. Oral, lip and eye cosmetics containing Silver chloride should be marked with the precaution “Not for use by children under 3 years old”.
18. Cosmetics containing Butylparaben, Propylparaben, Propylparaben, Sodium propylparaben, Sodium butylparaben, Potassium butylparaben and Potassiumpropylparaben ingredients should be marked with the precaution “Non-immediate rinse-off product and not be used in the diapers for children under 3 years old (immediate rinse-off products can be exempted from indicating this precaution).
19. Cosmetics containing Ethyl lauroyl arginate and HCl shall be marked with the precaution “Not for use by children under 10 years old”.
Other provisions still follow the previous guideline.
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