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

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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, De Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Fernández Escámez, Pablo Salvador, Prieto‐Maradona, Miguel, Querol, Amparo, Sijtsma, Lolke, Evaristo Suarez, Juan, Sundh, Ingvar, Vlak, Just, Barizzone, Fulvio, Hempen, Michaela, Herman, Lieve·2022·EFSA Journal

DOI 10.2903/j.efsa.2022.7045PMC PMC8792879

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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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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)
ORCID: Allende, Ana
Bolton, Declan
Bover‐Cid, Sara
Chemaly, Marianne
Hilbert, Friederike
Lindqvist, Roland
Nauta, Maarten
Ru, Giuseppe
Skandamis, Panagiotis
Suffredini, Elisabetta
Cocconcelli, Pier Sandro
Querol, Amparo
Sijtsma, Lolke
Sundh, Ingvar
Vlak, Just
Hempen, Michaela
Venue: EFSA Journal
Publisher: Wiley
Published: 2022-01
Volume: 20
Issue: 1
Pages: e07045-e07045
ISSN: 1831-4732 (ISSN-L)
DOI: 10.2903/j.efsa.2022.7045
PMC: PMC8792879
OpenAlex: W4210307247
Cited by: 143
References: 66
Citations by year: 2026: 20 · 2025: 42 · 2024: 43 · 2023: 18 · 2022: 19
FWCI: 16.22
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)
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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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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