Cited by 169Agricultural safety and regulationsGenetically Modified Organisms ResearchProbiotics and Fermented Foods

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 12: suitability of taxonomic units notified to EFSA until March 2020

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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 +19 more·2020·EFSA Journal

Abstract

The qualified presumption of safety (QPS) was developed to provide a generic safety evaluation for biological agents to support EFSA's Scientific Panels.It is based on an assessment of the taxonomic identity, the body of knowledge, safety concerns and antimicrobial resistance.Safety concerns identified for a taxonomic unit (TU) are where possible to be confirmed at strain or product level, reflected by 'qualifications'.No new information was found that would change the previously recommended QPS TUs of the 39 microorganisms notified to EFSA between October 2019 and March 2020, 33 were excluded, including five filamentous fungi, five Escherichia coli, two Enterococcus faecium, two Streptomyces spp.and 19 TUs already evaluated.Six TUs were evaluated.Akkermansia muciniphila was not recommended for QPS status due to safety concerns.Clostridium butyricum was not recommended because some strains contain pathogenicity factors.This TU was excluded for further QPS evaluation.Galdieria sulphuraria and Pseudomonas chlororaphis were also rejected due to a lack of body of knowledge.The QPS status of Corynebacterium ammoniagenes (with the qualification 'for production purposes only') and of Komagataella pastoris (with the qualification 'for enzyme production') was confirmed.In relation to the taxonomic revision of the Lactobacillus genus, previously designated Lactobacillus species will be reassigned to the new species and both the old and new names will be retained in the QPS list.

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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 [41]

    The Assessment section reports bacteraemia linked to probiotic strains in premature infants and ICU patients, rather than treating probiotic use in hospitals as safe. The Methodologies section also says that living microorganisms used as human food supplements fall outside the remit of its QPS safety assessment; QPS status therefore does not establish safety for hospital patients. Page numbers are unavailable in our copy. (LLM, conf=0.85)

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  • Bacillus probiotics are classified as generally regarded as safe (GRAS) by the FDA and by EFSA.

    “Bacillus probiotics are classified as generally regarded as safe (GRAS) by the Food and Drug Administration [40] and by the European Food Safety Authority (EFSA) [41].”

    From Profiling the resistome and virulome of Bacillus strains used for probiotic-based sanitation: a multicenter WGS analysis (2025) · cites this paper as [41]

    Appendix F identifies Bacillus subtilis as already having EFSA QPS status. But the Introduction describes QPS as a qualified, species-level safety pre-assessment, not a GRAS classification of Bacillus probiotics generally. The FDA portion is attributed to a different citation and is not assessed here. (LLM, conf=0.88)

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Research works printed but not linked: 2

  1. Ali R, Hameed ZH, Hussain AF and Hamu A, 2019 Evaluation effectiveness of fluconazole and mirabilis jalapa extract against some pathological fungi. Biochemistry and Cellular Archives, 19, 2467– 2473. 10.35124/bca.2019.19.s1.2467 · DOI
  2. Palleroni N, 2005 In: Garrity George M (ed.). “Genus I. Pseudomonas”. In Bergey's Manual of Systematic Bacteriology, Volume 2: The Proteobacteria. Springer, US pp. 323– 379.

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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., Maradona, M. P., Querol, A., Suarez, J. E., Sundh, I., Vlak, J., Barizzone, F., Hempen, M., & Herman, L.
Affiliations
Technical University of Denmark (DK)
Corresponding author
EFSA Panel on Biological Hazards (BIOHAZ)
Venue
EFSA Journal
Publisher
Wiley
Published
2020-07
Volume
18
Issue
7
Pages
e06174-e06174
ISSN
1831-4732 (ISSN-L)
OpenAlex
W4205461514
Cited by
169
References
127
Citations by year
2026: 6 · 2025: 23 · 2024: 17 · 2023: 29 · 2022: 32 · 2021: 34 · 2020: 13 · 2019: 4 · 2018: 5 · 2017: 5
FWCI
17.52
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)
  • 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)
  • Technical University of Denmark, DTU Orbit (Technical University of Denmark, DTU) (submittedVersion, other-oa)
  • 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 › Plant Science › Genetically Modified Organisms Research
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
Keywords
qualified presumption of safety, biological agents, taxonomic units, nomenclature, food safety

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