Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 13: Diaminopyrimidines: trimethoprim

Abstract

The specific concentrations of trimethoprim 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. The FARSC for trimethoprim was estimated. Uncertainties and data gaps associated to the levels reported were addressed. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. No suitable data for the assessment were available. It was recommended to perform further studies to supply more diverse and complete data related to the requirements for calculation of the FARSC for trimethoprim.

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.…”

“…“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 ).…”

“…Appendix B.1 , Table B.1 presents the general uncertainties associated with the model proposed and data gaps identified. The uncertainties associated with specific substances for which the data available allowed the application of the model are presented in the specific assessments (Scientific Opinions Part 7 – EFSA BIOHAZ Panel, 2021f , Part 12 – EFSA BIOHAZ Panel, 2021k , and Part 13 – EFSA BIOHAZ Panel, 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 ).…”