EFSA requested the Scientific Committee to develop a guidance document on the use of the weight of evidence approach in scientific assessments for use in all areas under EFSA's remit. The guidance document addresses the use of weight of evidence approaches in scientific assessments using both qualitative and quantitative approaches. Several case studies covering the various areas under EFSA's remit are annexed to the guidance document to illustrate the applicability of the proposed approach. Weight of evidence assessment is defined in this guidance as a process in which evidence is integrated to determine the relative support for possible answers to a question. This document considers the weight of evidence assessment as comprising three basic steps: (1) assembling the evidence into lines of evidence of similar type, (2) weighing the evidence, (3) integrating the evidence. The present document identifies reliability, relevance and consistency as three basic considerations for weighing evidence.

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Long term exposure of skylarks to a fictitious insecticide and of wood mice to a fictitious fungicide were modelled probabilistically in a Monte Carlo simulation. Within the same simulation the consequences of exposure to pesticides on reproductive success were modelled using the toxicity-exposure-linking rules developed by R.S. Bennet et al. (2005) and the interspecies extrapolation factors suggested by R. Luttik et al. (2005). We built models to reflect a range of scenarios and as a result were able to show how exposure to pesticide might alter the number of individuals engaged in any given phase of the breeding cycle at any given time and predict the numbers of new adults at the season's end.

EFSA requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not. The guidance document provides a general framework for establishing the biological relevance of observations at various stages of the assessment. Biological relevance is considered at three main stages related to the process of dealing with evidence: Development of the assessment strategy. In this context, specification of agents, effects, subjects and conditions in relation to the assessment question(s): Collection and extraction of data; Appraisal and integration of the relevance of the agents, subjects, effects and conditions, i.e. reviewing dimensions of biological relevance for each data set. A decision tree is developed to assist in the collection, identification and appraisal of relevant data for a given specific assessment question to be answered. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. SummaryThe European Food Safety Authority (EFSA) requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not.The guidance clarifies a number of definitions and concepts (such as, responses of a biological system to exposure, mode of action and adverse outcome pathways, thresholds, critical effect, modelling approaches, biomarkers), which are central to biological relevance, in order to achieve that these concepts are used in a consistent way across EFSA areas of activity.The list of generic issues (e.g. nature and size of the biological changes or differences, including the relevance of the biological systems where the effects are observed) to consider when deciding on whether an observed effect is biologically relevant should be applicable to all relevant EFSA Scientific Panels and Scientific Committee.A framework was developed in which biological relevance is considered at three main stages related to the process of dealing with evidence. Development of the assessment strategy, should specify agents, effects, subjects and conditions in relation to the assessment question(s). The collection and extraction of data should follow identification of potentially biologically relevant evidence/data as specified in the Assessment strategy. The third step should include an appraisal and an integration of the biological relevance for each data set of the agents, subjects, effects and conditions. With regard to the ag...

Abstract-For the registration procedure of pesticides it is necessary to have specific information and testing data in order to conduct an ecological hazard/risk assessment. The hazard/risk assessment for acute exposure is usually based on a quotient method, where the estimated environmental concentration is compared with the lowest available 50% lethal dose (LD50) value. Generally there are only one or two LD50s available for birds and mammals, and an underestimation of the potential hazard/risk could be a real possibility. In this article, we propose to estimate a hazardous dose for 5% of the species (HD5) for LD50 data, corresponding with the hazardous concentration for 5% of the species for the no-observed effects concentration (NOEC) data. In addition we describe a method for calculating safety factors that can be used in the case of small sample sizes, especially those smaller than 4 and including n ϭ 1. The safety factors to be applied to the geometric mean of the LD50s for a median estimate of the HD5 of birds and mammals are 5.7 and 3.8, respectively. The safety factors for the 95% confidence limit of the HD5 of birds for n ϭ 1, 2, and 3 are 33, 20, and 16, respectively. For mammals these safety factors are 15, 10, and 8.