TY - JOUR

T1 - Maximum levels of cross-contamination for 24 antimicrobial active substances in non-target feed. Part 1: Methodology, general data gaps and uncertainties

AU - EFSA Panel on Biological Hazards (BIOHAZ), null

AU - Koutsoumanis, Konstantinos

AU - Allende, Ana

AU - Alvarez-Ordóñez, Avelino

AU - Bolton, Declan

AU - Bover-Cid, Sara

AU - Chemaly, Marianne

AU - Davies, Robert

AU - De Cesare, Alessandra

AU - Herman, Lieve

AU - Hilbert, Friederike

AU - Lindqvist, Roland

AU - Nauta, Maarten

AU - Ru, Giuseppe

AU - Simmons, Marion

AU - Skandamis, Panagiotis

AU - Suffredini, Elisabetta

AU - Andersson, Dan I

AU - Bampidis, Vasileios

AU - Bengtsson-Palme, Johan

AU - Bouchard, Damien

AU - Ferran, Aude

AU - Kouba, Maryline

AU - López Puente, Secundino

AU - López-Alonso, Marta

AU - Nielsen, Søren Saxmose

AU - Pechová, Alena

AU - Petkova, Mariana

AU - Girault, Sebastien

AU - Broglia, Alessandro

AU - Guerra, Beatriz

AU - Innocenti, Matteo Lorenzo

AU - Liébana, Ernesto

AU - López-Gálvez, Gloria

AU - Manini, Paola

AU - Stella, Pietro

AU - Peixe, Luisa

PY - 2021/10/26

Y1 - 2021/10/26

N2 - 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.

AB - 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.

KW - antimicrobial resistance

KW - antimicrobial resistance selection concentration (FARSC)

KW - minimal selective concentration (MSC)

KW - sub-inhibitory concentration

KW - growth promotion

KW - yield increase

KW - food-producing animals

U2 - 10.2903/j.efsa.2021.6852

DO - 10.2903/j.efsa.2021.6852

M3 - Journal article

C2 - 34729081

VL - 19

SP - 1

EP - 57

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 10

M1 - e06852

ER -