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Cited by 72Agricultural 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 8: Suitability of taxonomic units notified to EFSA until March 2018

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EFSA Panel on Biological Hazards (BIOHAZ), Ricci, Antonia, Allende, Ana, Bolton, Declan, Chemaly, Marianne, Davies, Robert, Fernández Escámez, Pablo Salvador, Girones, Rosina +23 more·2018·EFSA Journal
DOI 10.2903/j.efsa.2018.5315PMC PMC7009647
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Abstract

The qualified presumption of safety (QPS) was developed to provide a harmonised generic preevaluation procedure to support safety risk assessments of biological agents performed by EFSA's Scientific Panels.The identity, body of knowledge, safety concerns and antimicrobial resistance of valid taxonomic units were assessed.Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected by 'qualifications' which should be assessed at the strain level by the EFSA's Scientific Panels.During the current assessment, no new information was found that would change the previously recommended QPS taxonomic units and their qualifications.The Panel clarified that the qualification 'for production purpose only' implies the absence of viable cells of the production organism in the final product and can also be applied for food and feed products based on microbial biomass.Between September 2017 and March 2018, the QPS notification list was updated with 46 microorganisms from applications for market authorisation.From these, 28 biological agents already had QPS status, 15 were excluded of the QPS exercise from the previous QPS mandate (10 filamentous fungi and one bacteriophage) or from further evaluations within the current mandate (two notifications of Streptomyces spp.and one of Escherichia coli), and one was excluded where confirmatory data for the risk assessment of a plant protection product (PPP) was requested (Pseudomonas sp.).Three taxonomic units were (re)evaluated: Paracoccus carotinifaciens and Paenibacillus lentus had been previously evaluated in 2008 and 2014, respectively, and were now re-evaluated within this mandate, and Yarrowia lipolytica, which was evaluated for the first time.P. carotinifaciens and P. lentus cannot be granted QPS status due to lack of scientific knowledge.Y. lipolytica is recommended for QPS status, but only for production purpose.

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  • Absence of ARG identified by WGS does not imply absence of resistance mechanisms in probiotic lactic acid bacteria, as intrinsic or non-canonical resistance determinants may remain undetected due to database and methodological limitations.

    “The absence of ARG identified by WGS does not imply the absence of resistance mechanisms in probiotic lactic acid bacteria, as intrinsic or non-canonical resistance determinants may remain undetected due to database and methodological limitations, highlighting the need for cautious interpretation of safety assessments based on genomic data [132,133,134].”

    From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [134]

    Appendix D lists studies on resistance and safety in lactic acid bacteria, but does not report that WGS can miss resistance mechanisms. Searches for WGS, intrinsic resistance, database limitations, and genomic safety assessment found no passage in our copy addressing the claimed detection limits. (LLM, conf=0.76)

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  • Some consequences of clinical probiotic use have been attributed to poorly planned clinical studies and systematic errors in evaluation of results.

    “Some of the consequences of clinical probiotic use have been attributed to poorly planned clinical studies and systematic errors in the evaluation of results [135].”

    From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [135]

    The Assessment section on monitoring QPS safety concerns notes that one reported Lactobacillus identification used methods considered unreliable, but it does not attribute consequences of clinical probiotic use to poorly planned studies or systematic errors in evaluating results. Searches for those terms and for clinical-trial design and evaluation bias found no passage making the claimed point. (LLM, conf=0.76)

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Authors
(BIOHAZ), E. P. O. B. H., Ricci, A., Allende, A., Bolton, D., Chemaly, M., Davies, R., Fernández Escámez, P. S., Girones, R., Koutsoumanis, K., Lindqvist, R., Nørrung, B., Robertson, L., Ru, G., Sanaa, M., Simmons, M., Skandamis, P., Snary, E., Speybroeck, N., Ter Kuile, B., Threlfall, J., Wahlström, H., Cocconcelli, P. S., Peixe, L., Maradona, M. P., Querol, A., Suarez, J. E., Sundh, I., Vlak, J., Barizzone, F., Correia, S., & Herman, L.
ORCID
Venue
EFSA Journal
Publisher
Wiley
Published
2018-07
Volume
16
Issue
7
Pages
e05315-e05315
ISSN
1831-4732 (ISSN-L)
DOI
10.2903/j.efsa.2018.5315
PMC
PMC7009647
OpenAlex
W4214923348
Cited by
72
References
1
Citations by year
2026: 1 · 2025: 2 · 2024: 8 · 2023: 8 · 2022: 12 · 2021: 10 · 2020: 13 · 2019: 12 · 2018: 5 · 2017: 1
FWCI
9.62
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)
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, antimicrobial resistance, taxonomic units, Yarrowia lipolytica, filamentous fungi, bacteriophages, plant protection products, microbial biomass

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