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Guidance on Uncertainty Analysis in Scientific Assessments

EFSA Scientific Committee et al. EFSA J. .

Abstract

Uncertainty analysis is the process of identifying limitations in scientific knowledge and evaluating their implications for scientific conclusions. It is therefore relevant in all EFSA's scientific assessments and also necessary, to ensure that the assessment conclusions provide reliable information for decision-making. The form and extent of uncertainty analysis, and how the conclusions should be reported, vary widely depending on the nature and context of each assessment and the degree of uncertainty that is present. This document provides concise guidance on how to identify which options for uncertainty analysis are appropriate in each assessment, and how to apply them. It is accompanied by a separate, supporting opinion that explains the key concepts and principles behind this Guidance, and describes the methods in more detail.

Keywords: guidance; scientific assessment; uncertainty analysis.

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Figures

Figure 1
Figure 1
Check for uncertainties in standardised assessments. Numbered superscripts refer to text notes following the figure. Letters (A, B, C, etc.) are to facilitate reference to specific steps in the figureformula image
Figure 2
Figure 2
Assessing non‐standard uncertainties collectively in standardised assessmentformula image
Figure 3
Figure 3
Assessing non‐standard uncertainties for separate parts of the uncertainty analysis using probability boundsformula image
Figure 4
Figure 4
Assessing non‐standard uncertainties for separate parts of the uncertainty analysis using probabilities or distributionsformula image
Figure 5
Figure 5
Deciding how to handle uncertainty in a case‐specific assessment. Numbered superscripts refer to text notes following the figure. Letters (A, B, C, etc.) are to facilitate reference to specific steps in the figureformula image
Figure 6
Figure 6
Assessing uncertainties collectively in case‐specific assessmentsformula image
Figure 7
Figure 7
Combining multiple yes/no questions by expert judgemenformula image
Figure 8
Figure 8
Combining multiple yes/no questions by calculationformula image
Figure 9
Figure 9
Evaluating uncertainties separately for different parts of an assessment involving non‐variable quantities formula image
Figure 10
Figure 10
Evaluating uncertainties separately for different parts of an assessment involving variable quantities formula image
Figure 11
Figure 11
Uncertainty analysis for urgent assessments. Numbered superscripts refer to text notes following the figure. Letters (A, B, C, etc.) are to facilitate reference to specific steps in the figureformula image
Figure 12
Figure 12
Uncertainty analysis to evaluate whether a procedure in a guidance document provides adequate cover for standard uncertainties. Numbered superscripts refer to text notes following the figure. Letters (A, B, C, etc.) are to facilitate reference to specific steps in the figureformula image
Figure 13
Figure 13
Example of probability distribution, quantifying uncertainty about a non‐variable quantity X
Figure 14
Figure 14
Illustration of options for characterising overall uncertainty. See [https://doi.org/10.2903/j.efsa.2018.5122] for detailed explanation
Figure 15
Figure 15
Deciding on approach for taking account of additional uncertaintiesformula image
Figure 16
Figure 16
Revising a probability expression from earlier steps to take account of additional uncertainties
Figure 17
Figure 17
Evaluate additional uncertainties then combine with an earlier probability expression by calculation formula image

References

    1. EFSA (European Food Safety Authority), 2007a. Guidance of the Scientific Committee on a request from EFSA related to uncertainties in dietary exposure assessment. EFSA Journal 2006;5(1):438, 54 pp. 10.2903/j.efsa.2007.438 - DOI
    1. EFSA (European Food Safety Authority), 2007b. Transparency in risk assessment carried out by EFSA: guidance document on procedural aspects. EFSA Journal 2006;4(5):353, 16 pp. 10.2903/j.efsa.2006.353 - DOI
    1. EFSA (European Food Safety Authority), 2009. Guidance of the Scientific Committee on Transparency in the Scientific Aspects of Risk Assessments carried out by EFSA. Part 2: general principles. EFSA Journal 2009;7(5):1051, 22 pp. 10.2903/j.efsa.2009.1051 - DOI
    1. EFSA (European Food Safety Authority), 2014a. Guidance on expert knowledge elicitation in food and feed safety risk assessment. EFSA Journal 2014;12(6):3734, 278 pp. 10.2903/j.efsa.2014.3734 - DOI
    1. EFSA (European Food Safety Authority), 2014b. Guidance on statistical reporting. EFSA Journal 2014;12(12):3908, 18 pp. 10.2903/j.efsa.2014.3908 - DOI

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