Introduction

As specified Article 22 of Reg. (EC) No. 1107/2009 (Official Journal of the European Union, 2009), botanical active substances (AS) may qualify as low-risk active substances (LRs), thereby supporting their use as an alternative to synthetically produced plant protection products (Marchand, 2017). Yet, assessing them within the EU regulatory framework remains complex (approved-LRs account for <10%) (Vekemans and Marchand, 2020). Despite being biologically sourced and expected to be lower risk, botanical LRs undergo the same data-intensive package as synthetic AS (283/2013, 284/2013), which entails high cost/time burdens and ill‑fitting test (Official Journal of the European Union, 2013a, 2013b).

Aim and methodology

This review systematically evaluates innovations in risk assessment (RA) for botanical LRs in their application as a pesticides. It focus on the integration of EFSA scientific opinions, OECD-promoted adverse outcome pathways (AOPs), and new approach methodologies (NAMs), including the read-across method, QSAR predictions, and omics (Bennekou et al., 2025; EFSA, 2025; Vrizas et al., 2026).

Results

The multifaceted nature of botanical extracts can lead to regulatory bottlenecks. Barriers to approval include perceived toxicity, limited ecotoxicological data, and the inability to apply single-molecule hazard models (Robin and Marchand, 2022). Case studies comparing botanical and chemically derived AS reveal that adopting the full synthetic-style dossier for plant-based products hinders their approval and implementation (Vekemans and Marchand, 2020). AOP-informed and NAM-based strategies effectively identify mechanistic hazards, refining exposure and risk characterization in line with EFSA uncertainty and weight-of-evidence principles to reduce reliance on vertebrate testing (Lankinen et al., 2024). These advances promote a proportionate, predictive, ethics-aligned RA process tailored to botanical LRs (Vekemans and Marchand, 2020; Acheuk et al., 2022).

Conclusion

Multiple authors call for a revised evaluation procedure for biocontrol agents and botanicals (more fit-for-purpose data; greater use of existing food/feed data; and alignment with the goals of IPM and the Green Deal) (Marchand, 2023). Toxicity thresholds still hard to meet for some botanicals (Matyjaszczyk, 2023). Embracing EFSA-guided policies is a leap forward in achieving regulatory efficiency, streamlining authorization timelines, and increasing prevalence of botanical LRs, while adhering to rigorous safety standards (Robin and Marchand, 2022).