Abstract
The transition toward more sustainable crop protection under the European Green Deal has accelerated the adoption of biopesticides, which are widely considered safer alternatives to synthetic pesticides. Botanical biopesticides derived from plant extracts, essential oils, and secondary metabolites are increasingly used in both conventional and organic agriculture. However, their growing use raises important questions regarding human health risks. Botanical biopesticides are complex mixtures of bioactive compounds whose composition and toxicological profiles can vary substantially depending on plant chemotype, extraction method, and manufacturing processes. This review critically examined the toxicological properties of botanical biopesticides and evaluated their regulatory assessment within the European Union (EU) framework. Particular attention is paid to scientific uncertainties, gaps in toxicological data, challenges in hazard characterization of complex mixtures, and limitations of current human exposure assessments. The review also considered how regulatory practices, user behavior, and risk perception may influence real-world exposure and potential health outcomes. By integrating experimental toxicology studies, EU risk assessment documents, and evidence on agricultural use patterns, this review assessed whether reduced intrinsic toxicity of botanical biopesticides translates into lower human health risk under current regulatory frameworks and agricultural practices. The findings underscore the need for strengthened toxicological evidence, harmonized regulatory approaches, and improved risk communication to ensure that the use of botanical biopesticides remains aligned with good agricultural practice and human health protection.