Taiwan's Food and Drug Administration has announced updates regarding risk assessment guidelines on cosmetics with ingredients in the nanosize. The definition refers to artificially manufactured particles that are insoluble or biopersistent (non-biodegradable) with sizes between approximately 1 and 100 nanometres. Risk assessment will involve two parts. The first one will focus on the physico-chemical properties of the nanoparticles (eg. Chemical identity solubility/dispersibility, size/size distribution and shpe, aggregation/agglomeration in relevant media, surface chemistry, surface charge and surface area, chemical composition and purity, density and pouring density, crystal structures and stability, UV absorption and catalytic activity.
The second part involves a safety assessment to evaluate: acute toxicity, irritation and corrosivity, skin sensitisation and dermal/percutaneous absorption, repeated dose toxicity, mutagenicity/genotoxicity, carcinogenicity and reproductive toxicity, photo-induced toxicity, the margin of safety (MOS) and the likelihood and extent of internal exposure via skin, lung or oral route, considering the use type (exposure assessment). The approach seeks to elucidate if the physico-chemical characteristics have an impact on the safety assessment.
The two-part sequence is used to find out if the physico-chemical characteristics of the nanomaterials have an impact on the results of the safety assessment. The guidelines also include a ban on animal testing unless special permission is granted. Information on the risk assessment must be documented in a product information file (PIF) for nano-ingredient cosmetics.
