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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Maximum levels of cross-contamination for 24 antimicrobial active substances in non-target feed. Part 1: Methodology, general data gaps and uncertainties. / EFSA Panel on Biological Hazards (BIOHAZ); Koutsoumanis, Konstantinos; Allende, Ana; Alvarez-Ordóñez, Avelino; Bolton, Declan; Bover-Cid, Sara; Chemaly, Marianne; Davies, Robert; De Cesare, Alessandra; Herman, Lieve; Hilbert, Friederike; Lindqvist, Roland; Nauta, Maarten; Ru, Giuseppe; Simmons, Marion; Skandamis, Panagiotis; Suffredini, Elisabetta; Andersson, Dan I; Bampidis, Vasileios; Bengtsson-Palme, Johan; Bouchard, Damien; Ferran, Aude; Kouba, Maryline; López Puente, Secundino; López-Alonso, Marta; Nielsen, Søren Saxmose; Pechová, Alena; Petkova, Mariana; Girault, Sebastien; Broglia, Alessandro; Guerra, Beatriz; Innocenti, Matteo Lorenzo; Liébana, Ernesto; López-Gálvez, Gloria; Manini, Paola; Stella, Pietro; Peixe, Luisa.
In: EFSA Journal, Vol. 19, No. 10, e06852, 26.10.2021, p. 1-57.Research output: Contribution to journal › Journal article › Research
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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 -
ID: 282610185