From Vision to Reality: Five Years of the Botanical Safety Consortium

Botanicals, including products derived from plants, fungi, and algae, are increasingly consumed worldwide. Their complex compositions and variable phytochemical profiles present significant challenges for safety assessment. Traditional toxicology methods are time and resource intensive, and the variability of botanicals makes it difficult to test one lot as representative.

The Botanical Safety Consortium (BSC), launched in 2019, was established to advance fit-for-purpose toxicity testing strategies for botanicals. This manuscript summarizes the progress of the BSC, with emphasis on the activities of its Working Groups.

The BSC Working Groups evaluate established new approach methodologies (NAMs), including in vitro assays, in silico models, and non-protected whole organisms such as C. elegans, for their applicability to botanical hazard assessment. Case studies of botanicals were selected based on known toxicity profiles to test assay performance and determine whether botanicals behave differently from single chemicals in these systems.

The evaluations address toxicological endpoints such as hepatotoxicity, genotoxicity, developmental and reproductive toxicity, neurotoxicity, cardiotoxicity, and dermal toxicity. Early findings have identified fit-for-purpose screening tools that can generally be applied to botanical testing, with some nuances and considerations.

Future work will focus on refining and enhancing the tool-kit through assay refinement, filling endpoint gaps with additional assays, and incorporating ADME data and in silico modeling approaches. This collaborative, science-driven framework aims to modernize botanical safety evaluation, address regulatory needs, and ultimately protect public health while supporting the global demand for botanical-based dietary supplements, cosmetics, and other products.