Reduced regulatory testing of biochemical plant protection products: an evaluation using three case studies

Biochemicals are increasingly used in plant protection strategies due to their generally favorable safety profiles and rapid environmental degradation and are currently subject to the same extensive data requirements as conventional synthetic chemicals in Europe. The BiochemPPP-STAS framework was developed to consider these differences and to provide a concept for reduced and triggered information requirements. Here, we report on three case studies to compare the outcome of the BiochemPPP-STAS concept with the traditional information requirements for regulatory human health and environmental risk assessment. Three biochemicals, gibberellic acid (GA3), Lysate of Willaertia magna C2c Maky lysate (LWm) and tea tree oil (TTO) were retrospectively assessed using regulatory authority evaluations. For all three case studies, BiochemPPP-STAS adequately identified hazard profiles and supported derivation of reference values comparable to those obtained using full conventional data packages, while substantially reducing resources and in particular animal testing. For GA3 and LWm, the base dataset was sufficient to characterize toxicity and support low-risk conclusions. For TTO, reproductive toxicity signals were identified in base studies and triggered higher-tier testing, demonstrating the responsiveness of the tiered approach. Quantitative differences in reference values compared with classical assessments were generally small and did not alter regulatory outcomes. Environmental assessments similarly showed that base data requirements captured ecotoxicological concerns. The assessments on environmental safety were not different than using the full data set. Although conclusions are limited by the small number of case studies, and additional evaluations are necessary, the findings support, as a proof of concept the scientific adequacy of the BiochemPPP-STAS.