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
EFSA J. 2021 Oct 26;19(10):e06854. doi: 10.2903/j.efsa.2021.6854. eCollection 2021 Oct.
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.
欧洲食品安全局(EFSA)与欧洲药品管理局(EMA)合作,评估了用于生产食品动物的非目标饲料中氨丙啉的特定浓度,低于该浓度不会对与人类和动物健康相关的细菌的耐药性产生和/或选择产生影响,以及饲料中具有促生长/增产作用的特定抗菌浓度。本次评估所采用方法的详细信息、相关的数据缺口和不确定性在一份单独的文件中呈现。为解决抗菌药物耐药性问题,应用了专门为该评估开发的饲料抗菌药物耐药性选择浓度(FARSC)模型。然而,由于缺乏计算氨丙啉FARSC所需参数的数据,无法完成评估。为解决促生长问题,使用了通过广泛文献综述从科学出版物中获得的数据。报告了饲料中显示对促生长/增产有影响的氨丙啉水平。氨丙啉在临床相关浓度下缺乏抗菌活性,这表明与细菌耐药性相关的进一步研究并非优先事项。