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):e06858. doi: 10.2903/j.efsa.2021.6858. eCollection 2021 Oct.
The specific concentrations of tilmicosin, tylosin and tylvalosin 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, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were reported for tilmicosin and tylosin, whilst for tylvalosin no suitable data for the assessment were available. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these three antimicrobials.
欧洲食品安全局(EFSA)与欧洲药品管理局(EMA)合作,评估了替米考星、泰乐菌素和泰万菌素在产食用动物非靶标饲料中的特定浓度,低于该浓度不会对与人类和动物健康相关细菌的耐药性产生及/或选择产生影响,同时还评估了饲料中具有促生长/增产作用的特定抗菌药物浓度。用于该评估的方法细节、相关数据缺口和不确定性在一份单独文件中呈现。为应对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FARSC所需参数的数据,在获得进一步实验数据之前无法完成评估。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取的数据。报告了替米考星和泰乐菌素在饲料中对促生长/增产有影响的水平,而对于泰万菌素,没有可用于评估的合适数据。建议开展研究以生成填补这些缺口所需的数据,这些缺口阻碍了对这三种抗菌药物FARSC的计算。