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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
Open accessAbstract
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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“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]
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“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]
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Metadata
- 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)
- ORCID
- Venue
- EFSA Journal
- Publisher
- Wiley
- Published
- 2020-07
- Volume
- 18
- Issue
- 7
- Pages
- e06174-e06174
- ISSN
- 1831-4732 (ISSN-L)
- PMC
- PMC7331632
- OpenAlex
- W4205461514
- Cited by
- 169
- References
- 127
- Citations by year
- 2026: 6 · 2025: 23 · 2024: 17 · 2023: 29 · 2022: 32 · 2021: 34 · 2020: 13
- FWCI
- 17.52
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- 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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