Evaluation of the endocrine-disrupting potential of a plant protection product
Case study
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”.
Literature Review Report in support of a plant protection product active substance regulatory submission
Case study
The approval or re-registration of pesticide active substances (Plant Protection Products) under Regulation (EC) No 1107/2009 Article 8(5) requires applicants to submit dossiers containing scientific peer-reviewed open literature on the active substance and its relevant metabolites and impurities, dealing with side-effects on human health, the environment and non-target species, published within ten years of the date of dossier submission.