Review of available criteria for non-aquatic organisms within PBT/vPvB frameworks: Part II: Toxicity assessment

Abstract

Aquatic and non-aquatic ecosystems differ with regards to metabolism as well as exposure and uptake routes. Current international and European regulatory criteria for Persistence, Bioaccumulation, and Toxicity (PBT) assessment of chemical substances are mainly based on toxicity and bioaccumulation data in aquatic species. In the literature, there is evidence that several persistent organic chemicals, which are not classified as bioaccumulative and/or toxic in aquatic organisms according to existing criteria, can biomagnify in non-aquatic food chains up to the top predators (including humans) and exert their toxicity. Therefore, the regulatory frameworks may fail to identify a number of substances that are bioaccumulative and/or toxic in non-aquatic organisms and related food chains (exposed through soil and food), but not in aquatic species. Based on these considerations, two reports were prepared on available criteria for non-aquatic organisms within PBT/vPvB frameworks: one on bioaccumulation assessment (Part I) and one on toxicity assessment (Part II). Specifically, the present document illustrates and discusses the outcomes of a regulatory and literature review on available criteria for toxicity assessment in non-aquatic organisms at international and European level (Part II). This report could be used to support an eventual revision of guidance documents, e.g. for REACH (EU Regulation 1907/2006), as well as to promote the harmonisation of regulatory criteria for PBT/vPvB assessment.