A regulatory and toxicology consultancy.
The Plant Protection Products Regulation (EC) No 1107/2009 is amended by Regulation (EU) 2018/605, requiring that information on the potential endocrine-disrupting properties of such products must be collated and evaluated. The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have published “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009”, detailing the performance of such hazard identification, together with an Excel spreadsheet to be used as a template for gathering the necessary information on “human and animal health” and “non-target organisms”.
The aim of the project was to evaluate the endocrine-disrupting properties of a plant protection product active substance following the ECHA/EFSA guidance.
Approach & Outcome
Bibra was provided with details of the toxicity studies included in the Human Health section of the client’s previously-submitted plant protection product active substance dossier. In addition, study reports describing in vitro reporter gene assays were also provided. Comprehensive searches were conducted in a wide range of online databases with the aim of identifying any pertinent published literature on the active substance. From all of these sources, those studies considered relevant to the evaluation of endocrine disruption, and also reliable, were selected for inclusion in the ECHA/EFSA template, Appendix E1 (“Excel template for reporting effects”), following the instructions in Appendix E2 (“Guidance to fill in the ‘Data’ sheet template”). The “Lines of Evidence” for adversity and endocrine activity were assembled for each EATS (estrogenic, androgenic, thyroidal, steroidogenic) modality, using the macros embedded within the Excel workbook. An expert evaluation was provided, working through the flowchart illustrating the endocrine disruption assessment strategy that is provided in the ECHA/EFSA guidance. A justification for each response was provided, cross-referencing to the studies summarised in Appendix E1. It was established that the current data set was insufficient to conclude on the endocrine-disrupting properties of the active substance, and that there was a need to obtain new information. Two proposed options for the generation of new data were provided to the client, one involving level 5 (in vivo) studies, and the other involving level 2 (in vitro) studies followed by level 3 (in vivo) studies if needed (depending on the level 2 results)