The study described in this report was conducted with the aim of developing an unified database of ecological data and residue data to be used for the risk assessment of plant protection products for birds and mammals. The main sources of data were the information submitted in the context of approval of active substances and authorization of products and and additional information retrieved through a systematic literature review. The data were screened and organised in three Excel databases, one for birds, one for mammals and one for residue studies. The ecological information for birds and mammal risk assessment consisted of data that is used for the determination of focal species, estimation of the proportion of an animal's daily diet obtained in a treated habitat (PT) and assessment of the composition of the diet obtained from a treated area (PD). The information gathered on residues focussed on (initial) residue levels after treatment and on residue decline (the reported half‐life or DT50 and the DT90).

AbstractToday, no effective tools are proposed in ecotoxicology to diagnose and predict the accumulation and effects of chemical substances on living organisms, accounting for exposure situations that are known to be complex (routes of exposure, metabolization processes, cocktail effects, etc.). Among elaborated tools, toxicokinetic/toxicodynamic (TKTD) models are now strongly recommended to describe the exposure time-dependency on individual life-history traits from experimental data collected through standard toxicity tests. In particular, the TK part is used to relate the exposure medium concentration to the internal concentration within organisms, considering various processes such as accumulation, depuration, metabolization and excretion (ADME). Regarding plant protection products in marketing authorization applications, regulation No 283/2013 (EU) defines the data requirements for active substances with a bioaccumulation test on fish following OECD guideline 305, which consists in an accumulation phase followed by a depuration phase. The concentration of the substance within fishes is followed over time during both phases thus allowing to describe the exposure time-dependency on individual (fit of TK model) and bioaccumulation factors. On a regulation point of view, these factors are decisive criteria for further estimating the concentration of active substances present in food items of vertebrates and more particularly of piscivorous birds and mammals. This paper presents a new ready-to-use tool providing on-line the estimation of the bioaccumulation factors associated with their uncertainty to facilitate the daily work of regulators, but also of any user, by benefiting of a freely available and user-friendly interface avoiding to invest into underlying methods. This tool, MOSAICBioacc, is available from the following adress: https://mosaic.univ-lyon1.fr/bioacc, and can be used as a turn-key decision making tool in the framework of environmental risk assessment.

Today, only few ready-to-use and convenient decision-making tools are available in ecotoxicology concerning accumulation and effects of chemical substances on organisms, accounting for exposure situations that are known to be complex (routes of exposure, metabolism, mixtures, etc.). This paper presents new perspectives on the generic calculation of bioaccumulation metrics via the innovative web tool MOSAIC bioacc (http://mosaic.univ-lyon1.fr/bioacc). MOSAIC bioacc provides all kinds of bioaccumulation metrics associated with their uncertainty whatever the species-compound combination. MOSAIC bioacc expects accumulation-depuration data as inputs, even with complex exposure and clearance patterns, to quickly perform their relevant analysis. MOSAIC bioacc intends to facilitate the daily work of regulators, or any ecotoxicologist, who will freely benefit from a user-friendly online interface that automatically fits toxicokinetic models without need for users to invest in the technical aspects to get bioaccumulation metrics estimates. MOSAIC bioacc also provides all results in a fully transparent way to ensure reproducibility.

The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried ou t exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the author(s).