The European Food Safety Authority (EFSA) has concluded that 90-day oral toxicity studies in dogs can be waived for pesticide active substance approval when a tiered assessment strategy demonstrates they provide no added value for human health hazard assessment. In a scientific opinion published on 29 July 2026, the EFSA Panel on Plant Protection Products and their Residues (PPR Panel) found that in 97% of cases for acceptable daily intake (ADI) and 95% for acceptable operator exposure level (AOEL), observed interspecies differences between dogs and other species were not due to genuine dog-specific sensitivity but to experimental variability, study design, or allometric scaling.
The opinion, adopted on 18 June 2026, updates a retrospective analysis of 461 active substances registered in Europe. Among these, dog studies were considered relevant for setting health-based guidance values in 288 cases. The analysis showed that in only a small fraction of cases did the dog exhibit unique sensitivity that could not be explained by other factors. Based on this evidence, the PPR Panel developed a tiered assessment strategy comprising two preliminary phases and a flowchart. Preliminary phase 1 evaluates in vitro comparative metabolism and toxicological mode of action, allowing early waiving if the dog shows a dissimilar metabolite profile compared to humans or if the substance belongs to a chemical class with sufficient mode-of-action data. Preliminary phase 2 assesses whether the rat is an adequate test species for internal exposure based on in vivo ADME studies and in vitro human Caco-2 permeability data. If waiving cannot be concluded in these phases, a flowchart using physiologically based kinetic (PBK) modelling compares internal exposure across species.
The strategy was tested on four active substances, demonstrating with medium to high confidence that hazard assessment could be performed without dog toxicity data in three cases. The opinion recommends the use of New Approach Methodologies (NAMs), aligning with EFSA's Strategy 2027 and the European Commission's roadmap to phase out animal testing. The proposal is expected to reduce animal testing while maintaining protective health-based guidance values, though uncertainties remain regarding the availability of PBK models and in vitro data for all substances. The European Commission and Member States will consider the opinion in future revisions of data requirements under Regulation (EU) No 283/2013.