Taiwan FDA, Update the Risk Assessment Guideline for Cosmetics Containing Nanomaterials

 

On November 8, 2024, the Taiwan Food and Drug Administration (TFDA) updated the risk assessment guidelines for cosmetics containing nanomaterials to strengthen cosmetic regulation.

 

The guidelines define cosmetics containing nanomaterials as those made with artificially manufactured, insoluble or non-degradable nanomaterials. These products may have characteristics that differ from those of general cosmetics, and the guidelines emphasize the importance of ensuring their safety during use. The required submission items for the physicochemical properties and safety information of nanomaterials, according to the guidelines, are as follows:

 

items		Submission requirement (O: submission, △: as applicable)
Physical and Chemical Properties	Chemical identity	O
	Solubility/Dispersibility	O
	Size/Size distribution	O
	Shape	O
	Aggregation/Agglomeration in relevant media	O
	Surface chemistry	O
	Surface charge	O
	Surface area	O
	Chemical composition	O
	Purity	O
	Density and Pour density	O
	Crystal structures	O
	Stability	O
	UV Absorption	△
	Partition coefficient	O
	Catalytic activity	△
Safety Assessment information	Acute toxicity	O
	Irritation and corrosivity	O
	Skin sensitization	O
	Dermal/Percutaneous absorption	O
	Repeated dose toxicity	O
	Mutagenicity/Genotoxicity	O
	Carcinogenicity	△
	Reproductive toxicity	△
	Toxicokinetic	O
	Photo-induced toxicity	O
	Margin of Safety; MoS	O
	Likelihood and extent of internal exposure via skin, lung or oral route considering the use type	O

 

Please refer to the link below. 

https://www.fda.gov.tw/TC/siteListContent.aspx?sid=1894&id=13597

-衛生福利部食品藥物管理署

 

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