4.4 Article

Maximum levels of cross-contamination for 24 antimicrobial active substances in non-target feed. Part 8: Pleuromutilins: tiamulin and valnemulin

Journal

EFSA JOURNAL
Volume 19, Issue 10, Pages -

Publisher

WILEY
DOI: 10.2903/j.efsa.2021.6860

Keywords

tiamulin; valnemulin; antimicrobial resistance; sub-inhibitory concentration; growth promotion; yield increase; food-producing animals

Funding

  1. EFSA Panel on Animal Health and Welfare (AHAW Panel)
  2. EFSA Panel for Additives and Products or Substances used in Animal Feed (FEEDAP)
  3. European Medicines Agency (EMA)

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The study evaluated the specific concentrations of tiamulin and valnemulin in non-target feed for food-producing animals and their effects on antimicrobial resistance and growth promotion. A model called FARSC was developed to address antimicrobial resistance, but the lack of data hindered the assessment. Further research is recommended to generate the necessary data to fill the gaps for these two antimicrobials.
The specific concentrations of tiamulin and valnemulin 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 tiamulin, while for valnemulin 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 two antimicrobials. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

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