[EN] 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.SI: The BIOHAZ Panel, leading Panel in charge of the adoption of the scientific opinion and assessment of Term of Reference 1 (ToR1, antimicrobial resistance) wishes to thank the following for the support provided to this scientific output: EFSA Panel on Animal Health and Welfare (AHAW Panel), who supported ToR1 assessments development and endorsement of those sections under their remit (animal production, main use of antimicrobials); EFSA Panel for Additives and Products or Substances used in Animal Feed (FEEDAP), in charge of the assessment and endorsement of ToR2, and providing advice and data needed for ToR1 assessments; European Medicines Agency (EMA), who was represented by an external expert and EMA secretariat as members of the Working Group (WG); Valeria Bortolaia, who was member of the WG until 17 April 2020; EFSA staff members: Angelica Amaduzzi, Gina Cioacata, Pilar Garc ıa-Vello, Michaela Hempen, Rita Navarrete, Daniel Plaza and Anita Radovnikovic; EMA staff members: Barbara Freischem, Zoltan Kunsagi, Nicholas Jarrett, Jordi Torren, and Julia Fabrega (currently EFSA staff). The BIOHAZ Panel wishes also to acknowledge the EMA Committee for Medicinal Products for Veterinary Use (CVMP) and their experts
