Updated list of QPS-recommended biological agents for safety risk assessments carried out by EFSA

  • Annamaria Rossi (Bijdrager)
  • Friederike Hilbert (Bijdrager)
  • Fulvio Barizzone (Bijdrager)
  • Alessandra De Cesare (Bijdrager)
  • Panagiotis Skandamis (Bijdrager)
  • Konstantinos Koutsoumanis (Bijdrager)
  • Maarten Nauta (Bijdrager)
  • Frédérique Istace (Bijdrager)
  • Miguel Prieto Maradona (Bijdrager)
  • Wolfgang Gelbmann (Bijdrager)
  • Sara Bover-Cid (Bijdrager)
  • Just Vlak (Bijdrager)
  • EFSA BIOHAZ Panel (Bijdrager)
  • Margarita Aguilera-Gomez (Bijdrager)
  • Rosella Brozzi (Bijdrager)
  • Patricia Romero (Bijdrager)
  • Jaime Aguilera (Bijdrager)
  • Leng Heng (Bijdrager)
  • Elisabetta Suffredini (Bijdrager)
  • Pier Sandro Cocconcelli (Bijdrager)
  • Ana Allende (Bijdrager)
  • Luisa Peixe (Bijdrager)
  • Roland Lindqvist (Bijdrager)
  • Katrin Bote (Bijdrager)
  • Avelino Alvarez-Ordonez (Bijdrager)
  • Marianne Chemaly (Bijdrager)
  • Declan Bolton (Bijdrager)
  • Lolke Sijtsma (Bijdrager)
  • Ingvar Sundh (Bijdrager)
  • Malcolm Richardson (Bijdrager)
  • Giuseppe Ru (Bijdrager)
  • Amparo Querol (Bijdrager)
  • Marion Simmons (Bijdrager)
  • Michaela Hempen (Bijdrager)
  • Lieve Herman (Bijdrager)
  • Robert Davies (Bijdrager)
  • Juan Evaristo Suarez (Bijdrager)
  • Pablo Salvador Fernández Escámez (Bijdrager)



The European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) to deliver a scientific Opinion on the maintenance of the list of qualified presumption of safety (QPS) biological agents. The QPS approach was developed by the EFSA Scientific Committee to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents intentionally introduced into the food and feed chain, in support of the concerned scientific Panels and Units in the frame of market authorisations. The taxonomic identity, body of knowledge, the safety concerns in relation to pathogenicity and virulence, and the safety for the environment of those microbiological agents are assessed. Safety concerns identified for a respective taxonomic unit (TU) are, where possible and reasonable in number, reflected as ‘qualifications’ that are assessed at the strain level by the EFSA’s scientific Panels. The “list of microorganisms with QPS status” first established in 2007, has been revised and updated annually until 2014 via QPS Opinions; since 2014 the updates are carried out and published every 3 years. If new information is retrieved from extended literature searches (ELS) that would change the QPS status of a TU or its qualifications, this is also published in the Panel Statement covering the previous 6-months period. The ELS protocol can be found at https://doi.org/10.5281/zenodo.3607190 and the Search strategies are available at: https://doi.org/10.5281/zenodo.3607193.   The QPS Panel Statement also includes the evaluation of microbiological agents notified to EFSA within the 6-month period for an assessment for feed additives, food enzymes, food additives and flavourings, and novel foods or plant protection products for a possible QPS status. The new QPS status recommendations are incorporated into the 2019 updated “list of microorganisms with QPS status” is available in this upload. The list of “Microbiological agents as notified to EFSA” from 2007, in the context of technical dossiers to EFSA Units, for intentional use in feed and/or food or as sources of food and feed additives, enzymes and plant protection products (PPPs) for safety assessment can be found at https://doi.org/10.5281/zenodo.3607184.   Useful links on EFSA QPS EFSA topic on QPS: https://www.efsa.europa.eu/en/topics/topic/qualified-presumption-safety-qps Link to the virtual issue on QPS on Wiley Online Library: https://efsa.onlinelibrary.wiley.com/doi/toc/10.1002/(ISSN)1831-4732.QPS Versions history: Versions 1 and 2 were substituted by version 3 – all are associated with the QPS Panel statement EFSA 7: suitability of taxonomic units notified to EFSA until September 2017: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5131   Version 4 is associated with the QPS Panel statement EFSA 8: suitability of taxonomic units notified to EFSA until March 2018: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5315   Versions 5 and 6 were substituted by version 7 – all are associated with the QPS Panel statement EFSA 9: suitability of taxonomic units notified to EFSA until September 2018: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5555   Version 8 is associated with the QPS Panel statement EFSA 10: suitability of taxonomic units notified to EFSA until March 2019: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5753   Version 9 is associated with the QPS Panel statement EFSA 11: suitability of taxonomic units notified to EFSA until September  2019: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.5965 and with the Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA (2017-2019):  https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.5966   Version 10: updates version 9 following the update of the qualification of Bacillus velezensis as: ‘absence of toxigenic potential and absence of aminoglycoside production ability’ - applied in the QPS Statement part 11 (ON-5965) and in the 2019 Scientific Opinion (ON-5966). Version 11: updates version 10 following the addition of the Bacillus circulans ‘for production purposes only’ - applied in the QPS Statement part 13 (ON-6377) and in the 2019 Scientific Opinion (ON-5966). Version 12 updates version 11 following the addition of the Bacillus paralicheniformis with the qualifications 'absence of toxigenic activity’ and ‘absence of genetic information to synthesize bacitracin'; and adding Schizochytrium limacinum, which is a synomym for Aurantiochytrium limacinum, - applied in the QPS Statement part 14 (ON-6689) and in the 2019 Scientific Opinion (ON-5966). Version 13 updates version 12 following the addition of Haematococcus lacustris synonym Haematococcus pluvialis, recommended for QPS status with the qualification ‘for production purposes only’. Some other changes related to taxonomy and qualifications are described in the QPS Statement part 15 (ON-7045). Note: As of January 2022 the updated list is provided only as excel file format.
Datum ter beschikking27-jan-2022

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