Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed.
Part 3: Amprolium

Abstract

The specific concentrations of amprolium 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 bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC for amprolium, it was not possible to conclude the assessment. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels of amprolium in feed that showed to have an effect on growth promotion/increased yield were reported. The lack of antibacterial activity at clinically relevant concentrations for amprolium suggests that further studies relating to bacterial resistance are not a priority.

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

“…A summary of all the assessments done applying the FARSC model (complementing Scientific Opinions Parts 2–13, EFSA BIOHAZ Panel, 2021a , 2021b , 2021c , 2021d , 2021e , 2021f , 2021g , 2021h , 2021i , 2021j , 2021k , 2021l – see also the Virtual Issue ) is presented in Annex F , Table F.1. The FARSC was obtained for florfenicol, tetracycline, chlortetracycline, oxytetracycline, doxycycline and trimethoprim, but it was not possible to estimate it for other substances.…”

“…A summary of the assessments done (complementing Scientific Opinions Parts 2–3, EFSA BIOHAZ Panel, 2021a , 2021b , 2021c , 2021d , 2021e , 2021f , 2021g , 2021h , 2021i , 2021j , 2021k , 2021l , – see also the Virtual Issue ) is presented in Annex F , Table F.2.…”

“…“AMR”, selection), horizontal gene transfer, virulence and/or mutagenesis and with the different antimicrobial classes or single substances under assessment were performed. Examples of the hits retrieved were included in the different assessments (see the complementing Scientific Opinions Parts 2–13, EFSA BIOHAZ Panel, 2021a , 2021b , 2021c , 2021d , 2021e , 2021f , 2021g , 2021h , 2021i , 2021j , 2021k , 2021l , and also the Virtual Issue ).…”

“…Each study meeting one or more of the aforementioned excluding criteria was removed from the evaluation. The full list of studies excluded and the respective criteria for the exclusion from further evaluation is reported in the Appendices of the complementing Scientific Opinions Parts 2–13, EFSA BIOHAZ Panel, 2021a , 2021b , 2021c , 2021d , 2021e , 2021f , 2021g , 2021h , 2021i , 2021j , 2021k , 2021l (see also the Virtual Issue ).…”

“…The assessments of the specific substances belonging to the different antimicrobial classes are presented in the Scientific opinions as regards maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed (see the complementing Scientific Opinions Parts 2–13, EFSA BIOHAZ Panel, 2021a , 2021b , 2021c , 2021d , 2021e , 2021f , 2021g , 2021h , 2021i , 2021j , 2021k , 2021l , and also the Virtual Issue ).…”