Cited by 143Agricultural safety and regulationsProbiotics and Fermented FoodsMycotoxins in Agriculture and Food

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 15: suitability of taxonomic units notified to EFSA until September 2021

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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Kostas, Allende, Ana, Alvarez‐Ordóñez, Avelino, Bolton, Declan, Bover‐Cid, Sara, Chemaly, Marianne, Davies, Robert +20 more·2022·EFSA Journal

Abstract

The qualified presumption of safety (QPS) approach was developed to provide a generic pre-evaluation of the safety of biological agents. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’. The QPS list was updated in relation to the revised taxonomy of the genus Bacillus, to synonyms of yeast species and for the qualifications ‘absence of resistance to antimycotics’ and ‘only for production purposes’. Lactobacillus cellobiosus has been reclassified as Limosilactobacillus fermentum. In the period covered by this statement, no new information was found that would change the status of previously recommended QPS taxonomic units (TU)s. Of the 70 microorganisms notified to EFSA, 64 were not evaluated: 11 filamentous fungi, one oomycete, one Clostridium butyricum, one Enterococcus faecium, five Escherichia coli, one Streptomyces sp., one Bacillus nakamurai and 43 TUs that already had a QPS status. Six notifications, corresponding to six TUs were evaluated: Paenibacillus lentus was reassessed because an update was requested for the current mandate. Enterococcus lactis synonym Enterococcus xinjiangensis, Aurantiochytrium mangrovei synonym Schizochytrium mangrovei, Schizochytrium aggregatum, Chlamydomonas reinhardtii synonym Chlamydomonas smithii and Haematococcus lacustris synonym Haematococcus pluvialis were assessed for the first time. The following TUs were not recommended for QPS status: P. lentus due to a limited body of knowledge, E. lactis synonym E. xinjiangensis due to potential safety concerns, A. mangrovei synonym S. mangrovei, S. aggregatum and C. reinhardtii synonym C. smithii, due to lack of a body of knowledge on its occurrence in the food and feed chain. H. lacustris synonym H. pluvialis is recommended for QPS status with the qualification ‘for production purposes only’.

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  • Most Bacillus species, including the B. subtilis group, B. pumilus, B. megaterium, B. velezensis, and other Bacillus species, meet the QPS requirements.

    “Most Bacillus species, including the B. subtilis group, B. pumilus, B. megaterium, B. velezensis, and other Bacillus species, meet these requirements for QPS [43].”

    From Profiling the resistome and virulome of Bacillus strains used for probiotic-based sanitation: a multicenter WGS analysis (2025) · cites this paper as [43]

    Table 3 in ‘Taxonomic changes in bacilli included in the QPS list’ lists B. subtilis, B. pumilus, B. megaterium (now Priestia megaterium), and B. velezensis among QPS-listed species. It does not establish that most Bacillus species meet QPS requirements, and the table notes qualifications for some listed species. Page numbers are unavailable in our copy. (LLM, conf=0.86)

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  • Probiotics in the hospital environment are considered safe for humans.

    “The use of probiotics in the hospital environment relies on the fact that they are considered safe for humans [41, 43]”

    From Profiling the resistome and virulome of Bacillus strains used for probiotic-based sanitation: a multicenter WGS analysis (2025) · cites this paper as [43]

    The Introduction describes QPS as a safety-assessment approach for selected microorganisms used in food and feed, which supports a qualified safety presumption for those organisms. The Data and methodologies section says human food-supplement use falls outside the QPS assessment and notes occasional infections in people with predisposing conditions. The paper therefore does not establish that probiotics generally are safe for humans in a hospital environment; page numbers were not available in our copy. (LLM, conf=0.87)

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  1. Moss ST, 1986. Biology and phylogeny of the Labyrinthulales and Thraustochytriales. In: Moss ST (ed.). Cambridge University Press, Cambridge UK, pp. 105–131.

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Authors
(BIOHAZ), E. P. O. B. H., Koutsoumanis, K., Allende, A., Alvarez‐Ordóñez, A., Bolton, D., Bover‐Cid, S., Chemaly, M., Davies, R., De Cesare, A., Hilbert, F., Lindqvist, R., Nauta, M., Peixe, L., Ru, G., Simmons, M., Skandamis, P., Suffredini, E., Cocconcelli, P. S., Fernández Escámez, P. S., Prieto‐Maradona, M., Querol, A., Sijtsma, L., Evaristo Suarez, J., Sundh, I., Vlak, J., Barizzone, F., Hempen, M., & Herman, L.
Corresponding author
EFSA Panel on Biological Hazards (BIOHAZ)
Venue
EFSA Journal
Publisher
Wiley
Published
2022-01
Volume
20
Issue
1
Pages
e07045-e07045
ISSN
1831-4732 (ISSN-L)
OpenAlex
W4210307247
Cited by
143
References
66
Citations by year
2026: 20 · 2025: 42 · 2024: 43 · 2023: 18 · 2022: 19 · 2021: 1
FWCI
16.22
Type
journal article
Language
en
Open access
Licence
cc-by-nd
Locations
  • EFSA Journal (publishedVersion, cc-by-nd)
  • PubMed Central (publishedVersion, cc-by-nd)
  • PubMed (publishedVersion)
  • Epsilon Open Archive (Sveriges lantbruksuniversitet biblioteket (Swedish University of Agricultural Sciences)) (acceptedVersion)
  • HAL (submittedVersion, cc-by-nd)
  • Buleria (Universidad de León) (submittedVersion, cc-by-nd)
  • Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion, cc-by-nd)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • IRTA (Institut de Recerca i Tecnologia Agroalimentaries) (submittedVersion, cc-by-nd)
Topics
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
  • Life Sciences › Agricultural and Biological Sciences › Plant Science › Mycotoxins in Agriculture and Food
Keywords
qualified presumption of safety, biological agents, taxonomic units, Enterococcus lactis, Schizochytrium, Chlamydomonas reinhardtii, Haematococcus lacustris, filamentous fungi, oomycete, Clostridium butyricum, Enterococcus faecium, Escherichia coli, Streptomyces, Lactobacillus cellobiosus, Lactobacillus fermentum

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