Statement on how to interpret the QPS qualification on ‘acquired antimicrobial resistance genes’
Author
EFSA Panel on Biological Hazards (BIOHAZ)
Koutsoumanis, Konstantinos
Allende, Ana
Alvarez-Ordóñez, Avelino
Bolton, Declan
Bover-Cid, Sara
Chemaly, Marianne
De Cesare, Alessandra
Hilbert, Friederike
Lindqvist, Roland
Nauta, Maarten
Nonno, Romolo
Peixe, Luisa
Ru, Giuseppe
Simmons, Marion
Skandamis, Panagiotis
Suffredini, Elisabetta
Cocconcelli, Pier Sandro
Evaristo Suarez, Juan
Noriega Fernández, Estefania
Istace, Frédérique
Aguillera, Jaime
Brozzi, Rosella
Liébana, Ernesto
Guerra, Beatriz
Correia, Sandra
Herman, Lieve
Publication date
2023-10-31ISSN
1831-4732
Abstract
The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of microorganisms intended for use in the food or feed chains. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’ which should be assessed at strain and/or product level by EFSA's Scientific Panels. The generic qualification ‘the strains should not harbour any acquired antimicrobial resistance (AMR) genes to clinically relevant antimicrobials’ applies to all QPS bacterial TUs. The different EFSA risk assessment areas use the same approach to assess the qualification related to AMR genes. In this statement, the terms ‘intrinsic’ and ‘acquired’ AMR genes were defined for the purpose of EFSA's risk assessments, and they apply to bacteria used in the food and feed chains. A bioinformatic approach is proposed for demonstrating the ‘intrinsic’/’acquired’ nature of an AMR gene. All AMR genes that confer resistance towards ‘critically important’, ‘highly important’ and ‘important’ antimicrobials, as defined by the World Health Organisation (WHO), found as hits, need to be considered as hazards (for humans, animals and environment) and need further assessment. Genes identified as responsible for ‘intrinsic’ resistance could be considered as being of no concern in the frame of the EFSA risk assessment. ‘Acquired’ AMR genes resulting in a resistant phenotype should be considered as a concern. If the presence of the ‘acquired’ AMR gene is not leading to phenotypic resistanc
Document Type
Article
Document version
Published version
Language
English
Subject (CDU)
663/664 - Food and nutrition. Enology. Oils. Fat
Pages
13
Publisher
Wiley Open Access
Is part of
EFSA Journal
Citation
Koutsoumanis, Konstantinos, Ana Allende, Avelino Alvarez-Ordóñez, Declan Bolton, Sara Bover‐Cid, Marianne Chemaly, Alessandra De Cesare et al. 2023. " Statement on how to interpret the QPS qualification on ‘acquired antimicrobial resistance genes’". EFSA Journal 21 (10). doi:10.2903/j.efsa.2023.8323.
Program
Funcionalitat i Seguretat Alimentària
This item appears in the following Collection(s)
- ARTICLES CIENTÍFICS [2838]
Except where otherwise noted, this item's license is described as http://creativecommons.org/licenses/by-nd/4.0/