Statement on the use and interpretation of the margin of exposure approach

The margin of exposure (MOE) is a risk assessment tool used to evaluate the safety of substances in food and feed. Adopted by the European Food Safety Authority (EFSA) in 2005, the MOE is calculated as the ratio between a Reference Point (RP) and the estimated exposure. While some regulatory bodies use 'margin of safety' (MOS) interchangeably with MOE, others define it differently, leading to inconsistencies in interpretation. To address this, EFSA has standardised its terminology, establishing MOE as a primary metric for safety assessments across human and animal health evaluations. In addition, the meaning and interpretation of terms used to qualify a 'concern' is elaborated. The EFSA definitions will come into force from when this statement is published. By refining these definitions and ensuring consistent terminology across sectors, EFSA aims to improve clarity and transparency in its risk assessments, facilitating effective communication.

Authors

Publication Details

Journal
EFSA Journal
Published
2025-08-01
DOI
https://doi.org/10.2903/j.efsa.2025.9606
Citations
10
Primary Topic
Agricultural safety and regulations
Type
article
Field-Weighted Citation Impact
11.62
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article

Statement on the use and interpretation of the margin of exposure approach

Þórhallur I. Halldórsson, Dieter Schrenk, Alicia Paini, Roberto Edoardo Villa et al.
10 citations
EFSA Journal
Agricultural safety and regulations
11.62
article

Statement on the use and interpretation of the margin of exposure approach

Þórhallur I. Halldórsson, Dieter Schrenk, Alicia Paini, Roberto Edoardo Villa, Amélie Crépet, Pikka Jokelainen, Claude Lambré, Helle Katrine Knutsen, Josep Casacuberta, Rex FitzGerald, Holger Zorn, Susanne Hougaard Bennekou, Angela Bearth, Bette Meek, Søren Saxmose Nielsen, Alicja Mortensen, Dominique Turck, Emanuela Testai, Diane Benford, Laurentius Ron Hoogenboom, Salomon Sand, Tamara Čoja, Antonio Vicent Civera, Laurence Castle
article en
10 citations

Abstract

The margin of exposure (MOE) is a risk assessment tool used to evaluate the safety of substances in food and feed. Adopted by the European Food Safety Authority (EFSA) in 2005, the MOE is calculated as the ratio between a Reference Point (RP) and the estimated exposure. While some regulatory bodies use 'margin of safety' (MOS) interchangeably with MOE, others define it differently, leading to inconsistencies in interpretation. To address this, EFSA has standardised its terminology, establishing MOE as a primary metric for safety assessments across human and animal health evaluations. In addition, the meaning and interpretation of terms used to qualify a 'concern' is elaborated. The EFSA definitions will come into force from when this statement is published. By refining these definitions and ensuring consistent terminology across sectors, EFSA aims to improve clarity and transparency in its risk assessments, facilitating effective communication.

EFSA JournalVol. 23(8)
Openalex Percentile: Top 1%
Agricultural safety and regulations
11.62
DOIOpen Access PDFOpenAlex
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