Case Studies on the Safety Assessment Strategy for Botanical Extracts in Cosmetic Products

The safety assessment of botanical extracts has been the subject of extensive discussion due to the inherent challenges posed by their complex mixtures of unknown components, variations related to the raw materials and manufacturing processes, and differences arising from the plant parts and origins. These factors make safety evaluations more complicated compared to those of well-characterized chemicals. This study presents three representative botanical extracts to illustrate practical tiered approaches for assessing their safety in cosmetic products. Mauritia flexuosa fruit oil, classified as a food-derived material, allows for the waiver of systemic toxicity assessment based on its established history of safe use. Hydrolyzed Myrtus communis leaf extract is sufficiently characterized to enable a component-based risk characterization. In contrast, Chrysanthemum parthenium (feverfew) extract lacks comprehensive toxicological data and adequate chemical characterization; therefore, a weight-of-evidence approach is applied, integrating multiple lines of evidence to support safety conclusions. These case studies demonstrate the applicability of tiered assessment strategies and decision-tree approaches for botanical extracts in cosmetic safety evaluations.