Taiwan FDA revised Safety Guidelines on Children’s Cosmetics!


On Aug. 17, 2022, FDA of Taiwan, China issued NO.1111608018 Announcement on revisions on Safety Guidelines on Children’s Cosmetics. Though there is no little golden shield(a logo representing the product is children’ s cosmetic product in China mainland)in Taiwan, the administration on children’ s cosmetics is also strict. Many cosmetic components are not allowed to be used in children's cosmetics. Let’s have a quick look.

 

1.In order to ensure the safe use of children’s cosmetics, this guideline has been established.

 

2.Where cosmetics express or imply that the target users are children, the following items should be noted:

◆ Under normal use, directions for use and dosage and foreseeable circumstances, the cosmetic products should be healthy and safe for children.

◆ Ingredients with safe use history should be used with priority, and reduce using fragrance, flavour, colors and preservatives.

◆ Where the product is used by children aged below 3 years old, the number of microbial organisms should be below 100 CFU/g or CFU/mL and escherichia coli, pseudomonas aeruginosa, staphylococcus aureus and candida albicans should not be detected.

◆ Its appearance, odor, color, packaging, labeling and capacity should be noted, and cosmetic products should be clearly distinguished from food and related products to avoid that children accidentally ingest them and their health is endangered.

◆To prevent children from using the product in an inappropriate manner, it is recommended to label it with the words "For the safety of children, use under adult supervision" or words of the same meaning.

◆ When the product is contained in a pressurized container, it is recommended to label it with the words "Please avoid spraying it into eyes. Don’t damage the container or burn the product. Avoid direct sunlight. It’s appropriate to store it in a cool place. Avoid being close to fire or heat sources " or words of the same meaning.

◆ When the product contains components such as Salicylic acid, Calcium salicylate, Magnesium salicylate, MEA-salicylate, Sodium salicylate, Potassium salicylate, TEAsalicylate, cautions like “Not for use by children under 3 years old” should be labeled (Hair wash cosmetics excluded).

◆ When the product contains components such as Hydrogen peroxide, Urea peroxide, cautions like “It is not recommended for use by children under 12 years old” should be labeled.

◆ Cosmetics containing fruit acids and related ingredients should be marked with the precaution "This product is not suitable for use by infants and children".

◆ When the product contains Camphor, Menthol, Methyl Salicylate,“It is not recommended for use by children under 2 years old”should be marked on product label or packaging.

◆ Nail cosmetic products containing Toluene should be labeled with precautions to avoid contact with children.

◆ Cosmetics containing components like Thioglycolic acid, Potassium hydroxide, Sodium hydroxide should be labeled with precautions like “Should be stored in places out of reach of children”.

◆ For non-drug use toothpaste the fluorine content of which is from 0.1% to 0.15%, and not labeled with words like “The use by children is forbidden”, it should be marked with “The maximum amount of each use is the size of a rice grain for children under 3 years old. It is recommended for use by children’s aged 3~6, and the maximum amount of each use is the size of a pea. Avoid ingestion as much as possible”

Non-drug use toothpaste and mouthwash containing Strontium compound should be labeled with precautions like “It is not recommended for frequent use by children”.

◆ For cosmetics containing Talc, it is recommended to label: “Keep away from the mouth and nose when used by children”.

◆ Cosmetics containing Indopropynyl butylcarbamate should be labeled with precautions like “Not for use by children under 3” (Bath and shampoo products are exempted from labeling this caution).

◆ Mouth, lip and eye cosmetics containing Silver chloride should be labeled with cautions like “Not for use by children under 3”.

◆ Cosmetics containing Butylparaben, Propylparaben, Propylparaben, Sodium propylparaben, Sodium butylparaben, Potassium butylparaben, Potassiumpropylparaben should be labeled with precautions “Not for use by children under 3 for products that are not immediately flushable in the diaper area” (Immediately flushable products can be exempted from labeling this precaution).

 

For other provisions please refer to the previous guideline: https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637964372955707858


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ZMUni Chinese Cosmetic Regulation Compliance Centre 中贸合规中心

Contact us: info@zmuni.com

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