Biopesticides such as biochemicals are generally regarded as of lower risk to humans and the environment while facing the same extensive EU data requirements (Regulations 283/2013 and 284/2013), limiting their potential for sustainable agriculture. Busschers et al. have published a data decision tree for natural substances when used in plant protection (Biocontrol Science and Technology, 33(7), 597–629). The present peer-review paper is adding concrete testing strategies by proposing a Scheme for Safety Testing and Assessment of Biochemicals under the EU Plant Protection Products Regulation (BiochemPPP-STAS). The BiochemPPP-STAS offers a flexible, science-based scheme to tailor safety testing, justify study waivers, and ensure ‘fit-for-purpose’ dossiers. It emphasizes use of existing data, iterative collaboration between applicants and authorities, building a base dataset to determine triggers of concern that require follow-up in vertebrate animal studies as last resort.
Aligned with EU legislations but adaptable globally, the scheme provides a case-by-case approach to characterise exposure, identify the toxicological, environmental fate and ecotoxicological endpoints and studies relevant for the safety assessment under the PPP Regulation. A follow-up publication with case studies to show how the testing scheme can be applied is in development.
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