Taiwan Tightens the Labeling Requirements for Children Cosmetics

On August 17, 2022, TFDA released the updated Guidelines for Safety of Children Cosmetics. Compared to the previous version, the updated Guidelines amends the labeling requirements and microbiological specification for children cosmetics.

In October 2016, Taiwan Food and Drug Administration (TFDA) implemented the Guidelines for Safety of Children Cosmetics (Guidelines), setting a series of requirements to ensure the safety of children cosmetics. As a further refinement to the Guidelines, TFDA included 10 new requirements in the Guidelines and implemented the updated version on August 17, 2022. ¹

New Requirements for Cosmetics Labeling

Compared to adults, children appear to have more sensitive skin and are more susceptible to allergic reactions. Therefore, the previous Guidelines laid down particular labeling requirements for children cosmetics containing specific ingredients, such as Salicylic Acid, Camphor, Menthol and Methyl Salicylate. On this basis, TFDA adds new labeling requirements for products containing any of the following 24 ingredients, including:

Ingredient	CAS No.	Warnings Must Be Printed on the Label	Product Categories that Need to Be Marked with the Required Warning Information
Silver chloride	7783-90-6	Not to be used for children under 3 years of age.	Oral products, eye and lip products
Calcium salicylate	824-35-1		All cosmetic products, excluding shampoos
Magnesium salicylate	18917-89-0
MEA-salicylate	59866-70-5
Sodium salicylate	54-21-7
Potassium salicylate	578-36-9
TEA-salicylate	2174-16-5
Iodopropynyl butylcarbamate	55406-53-6		All cosmetic products, excluding bath products and shampoos
Ethyl Lauroyl Arginate HCl	60372-77-2	Not to be used for children under 10 years of age.	All cosmetic products
Hydrogen peroxide	7722-84-1	Not to be used for children under 12 years of age.	All cosmetic products
Urea peroxide	124-43-6	Not to be used for children under 12 years of age.	All cosmetic products
Butylparaben	94-26-8	Not to be used on nappy area of children under 3 years of age	Leave-on products
Propylparaben	94-13-3
Sodium propylparaben	35285-69-9
Sodium butylparaben	36457-20-2
Potassium butylparaben	38566-94-8
Potassium propylparaben	84930-16-5
Toluene	108-88-3	Must be kept out of the reach of children.	Nail products
Thioglycolic acid	68-11-1		All cosmetic products
Potassium hydroxide	1310-58-3
Sodium hydroxide	1310-73-2
Talc	14807-96-6	Must be kept away from children's nose and mouth when being used.	All cosmetic products
Fluorine compounds	/	When using the product, the maximum amount per time is: - For children under 3: a rice-size amount; - For children from 3 to 6: a pea-size amount (avoid swallowing).	Non-medicated toothpastes whose fluoride concentration reaches 0.1% to 0.15%, except if they are already labeled with "prohibited for use by children"
Strontium compounds	/	Frequent use by children is not recommended.	Non-medicated toothpastes and mouthwashes

In addition, the updated Guidelines revises the labeling requirement for cosmetics containing Camphor, Menthol and Methyl Salicylate. The warning must be labeled on these products is revised from "for children under 2 years of age, the product shall be used under the guidance of doctors or pharmacists" to "use for children under 2 years of age is not recommended".

Update on Microbiological Specification

Exposure to Candida albicans can cause infections in the bloodstream or internal organs. To enhance the safe use of cosmetics, TFDA released the amended List of Micro-organisms Limits in Cosmetic Products on September 7, 2021, in which Candida albicans was included as a micro-organism that shall not be detected in cosmetics. Consistent with this amendment, TFDA updated the microbiological specification in Guidelines as:

3. In cosmetics designed for children under 3 years of age, the total bacteria count shall be less than 100 CFU/g(ml). Besides, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus or Candida albicans shall not be detected.