Statement on the use and interpretation of the margin of exposure approach
Suzanne Hougaard Bennekou, Ana Allende, Angela Bearth, Josep Casacuberta, Laurence Castle, Tamara Čoja, Amélie Crépet, Þórhallur I. Halldórsson, Laurentius Ron Hoogenboom, Helle Katrine Knutsen, Claude Lambré, Søren Saxmose Nielsen, Dominique Turck, Antonio Vicent Civera, Roberto Edoardo Villa, Pikka Jokelainen, Holger Zorn, Diane Benford, Rex FitzGerald, Bette Meek, Alicja Mortensen, Salomon Sand, Emanuela Testai, Paola Manini, Alicia Paini, Dieter Schrenk
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.