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EFSA J. 2021 Oct 26;19(10):e06852. doi: 10.2903/j.efsa.2021.6852. eCollection 2021 Oct.

Maximum levels of cross-contamination for 24 antimicrobial active substances in non-target feed. Part 1: .

EFSA journal. European Food Safety Authority

Konstantinos Koutsoumanis, Ana Allende, Avelino Alvarez-Ordóñez, Declan Bolton, Sara Bover-Cid, Marianne Chemaly, Robert Davies, Alessandra De Cesare, Lieve Herman, Friederike Hilbert, Roland Lindqvist, Maarten Nauta, Giuseppe Ru, Marion Simmons, Panagiotis Skandamis, Elisabetta Suffredini, Dan I Andersson, Vasileios Bampidis, Johan Bengtsson-Palme, Damien Bouchard, Aude Ferran, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Søren Saxmose Nielsen, Alena Pechová, Mariana Petkova, Sebastien Girault, Alessandro Broglia, Beatriz Guerra, Matteo Lorenzo Innocenti, Ernesto Liébana, Gloria López-Gálvez, Paola Manini, Pietro Stella, Luisa Peixe

PMID: 34729081 PMCID: PMC8547316 DOI: 10.2903/j.efsa.2021.6852

Abstract

The European Commission requested EFSA to assess, in collaboration with EMA, the specific concentrations of antimicrobials resulting from cross-contamination in non-target feed for food-producing animals below which there would not be an effect on the emergence of, and/or selection for, resistance in microbial agents relevant for human and animal health, as well as the levels of the antimicrobials which could have a growth promotion/increase yield effect. The assessment was performed for 24 antimicrobial active substances, as specified in the mandate. This scientific opinion describes the methodology used, and the main associated data gaps and uncertainties. To estimate the antimicrobial levels in the non-target feed that would not result in emergence of, and/or selection for, resistance, a model was developed. This 'Feed Antimicrobial Resistance Selection Concentration' (FARSC) model is based on the minimal selective concentration (MSC), or the predicted MSC (PMSC) if MSC for the most susceptible bacterial species is unavailable, the fraction of antimicrobial dose available for exposure to microorganisms in the large intestine or rumen (considering pharmacokinetic parameters), the daily faecal output or rumen volume and the daily feed intake. Currently, lack of data prevents the establishment of PMSC and/or FARSC for several antimicrobials and animal species. To address growth promotion, data from an extensive literature search were used. Specific assessments of the different substances grouped by antimicrobial classes are addressed in separate scientific opinions. General conclusions and recommendations were made.

© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Keywords: antimicrobial resistance; antimicrobial resistance selection concentration (FARSC); food‐producing animals; growth promotion; minimal selective concentration (MSC); sub‐inhibitory concentration; yield increase

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