Safety of Botanical/Natural Substances in cosmetic products – an industry perspective

The safety assessment of Botanical/Natural Substances (B/NS) to be used in cosmetic products can be a complex undertaking. Data requirements can be extensive. B/NS are complex mixtures of phytochemical constituents. To start, it is important to know the genus, species, part of the plant/animal and processing steps, including any concentration or dilution factors. Quality will be assessed at supplier qualification and may need to become part of the ingredient specification (ex. analysis of marker chemicals or physicochemical properties). The B/NS must be sustainably sourced. The safety assessment (hazard + exposure) focuses on three areas: systemic exposure, site of contact exposure and Type 1 Allergy. Systemic toxicity potential can be readily assessed if the B/NS is used at very low levels in products or is a common food B/NS. For cosmetic products, exposure to B/NS used as herbal medicines must be well below therapeutic levels. If a history of safe human use cannot be documented, an analytical characterization is necessary and the phyto-chemical constituents must be assessed individually. Site of contact effects must be assessed if the cosmetic product is applied dermally or exposure is via a spray/inhalation. Protein is analyzed (content & molecular weight) for Type 1 Allergy Assessment. When all three areas of the safety assessment are favorable, the B/NS can be used in the cosmetic product.