Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 1: Methodology, general data gaps and uncertainties

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, res...

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Autores principales:	EFSA Panel on Biological Hazards (BIOHAZ), 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
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	antimicrobial resistance antimicrobial resistance selection concentration (FARSC) minimal selective concentration (MSC) sub‐inhibitory concentration growth promotion yield increase Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
Acceso en línea:	https://doaj.org/article/f6f88172fa794c8fb1b77c908b17de06
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spelling	oai:doaj.org-article:f6f88172fa794c8fb1b77c908b17de062021-11-23T08:30:51ZMaximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 1: Methodology, general data gaps and uncertainties1831-473210.2903/j.efsa.2021.6852https://doaj.org/article/f6f88172fa794c8fb1b77c908b17de062021-10-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6852https://doaj.org/toc/1831-4732Abstract 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.EFSA Panel on Biological Hazards (BIOHAZ)Konstantinos KoutsoumanisAna AllendeAvelino Alvarez‐OrdóñezDeclan BoltonSara Bover‐CidMarianne ChemalyRobert DaviesAlessandra De CesareLieve HermanFriederike HilbertRoland LindqvistMaarten NautaGiuseppe RuMarion SimmonsPanagiotis SkandamisElisabetta SuffrediniDan I AnderssonVasileios BampidisJohan Bengtsson‐PalmeDamien BouchardAude FerranMaryline KoubaSecundino López PuenteMarta López‐AlonsoSøren Saxmose NielsenAlena PechováMariana PetkovaSebastien GiraultAlessandro BrogliaBeatriz GuerraMatteo Lorenzo InnocentiErnesto LiébanaGloria López‐GálvezPaola ManiniPietro StellaLuisa PeixeWileyarticleantimicrobial resistanceantimicrobial resistance selection concentration (FARSC)minimal selective concentration (MSC)sub‐inhibitory concentrationgrowth promotionyield increaseNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 10, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	antimicrobial resistance antimicrobial resistance selection concentration (FARSC) minimal selective concentration (MSC) sub‐inhibitory concentration growth promotion yield increase Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
spellingShingle	antimicrobial resistance antimicrobial resistance selection concentration (FARSC) minimal selective concentration (MSC) sub‐inhibitory concentration growth promotion yield increase Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185 EFSA Panel on Biological Hazards (BIOHAZ) 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 Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 1: Methodology, general data gaps and uncertainties
description	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.
format	article
author	EFSA Panel on Biological Hazards (BIOHAZ) 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
author_facet	EFSA Panel on Biological Hazards (BIOHAZ) 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
author_sort	EFSA Panel on Biological Hazards (BIOHAZ)
title	Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 1: Methodology, general data gaps and uncertainties
title_short	Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 1: Methodology, general data gaps and uncertainties
title_full	Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 1: Methodology, general data gaps and uncertainties
title_fullStr	Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 1: Methodology, general data gaps and uncertainties
title_full_unstemmed	Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 1: Methodology, general data gaps and uncertainties
title_sort	maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. part 1: methodology, general data gaps and uncertainties
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/f6f88172fa794c8fb1b77c908b17de06
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Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 1: Methodology, general data gaps and uncertainties

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