Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 9

Suitability of taxonomic units notified to EFSA until september 2018

EFSA Panel on Biological Hazards (BIOHAZ)

Research output: Contribution to journalJournal articleResearchpeer-review

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Abstract

The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA’s Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance 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. Between April and September 2018, the QPS notification list was updated with 48 microorganisms from applications for market authorisation. Of these, 30 biological agents already had QPS status, 15 were excluded from the QPS exercise by the previous QPS mandate (five filamentous fungi) or from further evaluations within the current mandate (two notifications of Enterococcus faecium, one of Streptomyces spp. and seven of Escherichia coli). One taxonomic unit was (re)evaluated: Pseudomonas fluorescens had been previously evaluated in 2016, and was now re-evaluated within this mandate. The revision of the literature supports the previously identified safety concerns (e.g. production of biocompounds with antimicrobial activity and virulence features), preventing the inclusion of P. fluorescens in the QPS list. Mycobacterium setense and Komagataeibacter sucrofermentans were evaluated for the first time. M. setense cannot be considered for the QPS assessment because there are significant safety concerns. K. sucrofermentans (Acetobacter xylinus subsp. sucrofermentans) can be proposed for the QPS list but only for production purposes. The QPS status of Corynebacterium glutamicum is confirmed with the qualification extended to other production purposes.

Original languageEnglish
Article number5555
JournalEFSA Journal
Volume17
Issue number1
Number of pages46
ISSN1831-4732
DOIs
Publication statusPublished - 2018

Keywords

  • Bacteria
  • Corynebacterium glutamicum
  • Komagataeibacter sucrofermentans
  • Mycobacterium setense
  • Pseudomonas fluorescens
  • QPS
  • Safety
  • Yeast

Cite this

@article{6298e9218924429f8c1af2f2376aaeb9,
title = "Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 9: Suitability of taxonomic units notified to EFSA until september 2018",
abstract = "The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA’s Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance 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. Between April and September 2018, the QPS notification list was updated with 48 microorganisms from applications for market authorisation. Of these, 30 biological agents already had QPS status, 15 were excluded from the QPS exercise by the previous QPS mandate (five filamentous fungi) or from further evaluations within the current mandate (two notifications of Enterococcus faecium, one of Streptomyces spp. and seven of Escherichia coli). One taxonomic unit was (re)evaluated: Pseudomonas fluorescens had been previously evaluated in 2016, and was now re-evaluated within this mandate. The revision of the literature supports the previously identified safety concerns (e.g. production of biocompounds with antimicrobial activity and virulence features), preventing the inclusion of P. fluorescens in the QPS list. Mycobacterium setense and Komagataeibacter sucrofermentans were evaluated for the first time. M. setense cannot be considered for the QPS assessment because there are significant safety concerns. K. sucrofermentans (Acetobacter xylinus subsp. sucrofermentans) can be proposed for the QPS list but only for production purposes. The QPS status of Corynebacterium glutamicum is confirmed with the qualification extended to other production purposes.",
keywords = "Bacteria, Corynebacterium glutamicum, Komagataeibacter sucrofermentans, Mycobacterium setense, Pseudomonas fluorescens, QPS, Safety, Yeast",
author = "{EFSA Panel on Biological Hazards (BIOHAZ)} and Kostas Koutsoumanis and Ana Allende and Avelino {\'A}lvarez-Ord{\'o}{\~n}z and Declan Bolton and Sara Bover-Cid and Marianne Chemaly and Robert Davies and Friederike Hilbert and Roland Lindqvist and Maarten Nauta and Luisa Peixe and Giuseppe Ru and Marion Simmons and Panagiotis Skandamis and Elisabetta Suffredini and Cocconcelli, {Pier Sandro} and Esc{\'a}mez, {Pablo Salvador Fern{\'a}ndez} and Maradona, {Miguel Prieto} and Amparo Querol and Suarez, {Juan Evaristo} and Ingvar Sundh and Just Vlak and Fulvio Barizzone and Sandra Correia and Lieve Herman",
year = "2018",
doi = "10.2903/j.efsa.2019.5555",
language = "English",
volume = "17",
journal = "E F S A Journal",
issn = "1831-4732",
publisher = "European Food Safety Authority (E F S A)",
number = "1",

}

Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 9 : Suitability of taxonomic units notified to EFSA until september 2018. / EFSA Panel on Biological Hazards (BIOHAZ).

In: EFSA Journal, Vol. 17, No. 1, 5555, 2018.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 9

T2 - Suitability of taxonomic units notified to EFSA until september 2018

AU - EFSA Panel on Biological Hazards (BIOHAZ)

AU - Koutsoumanis, Kostas

AU - Allende, Ana

AU - Álvarez-Ordóñz, Avelino

AU - Bolton, Declan

AU - Bover-Cid, Sara

AU - Chemaly, Marianne

AU - Davies, Robert

AU - Hilbert, Friederike

AU - Lindqvist, Roland

AU - Nauta, Maarten

AU - Peixe, Luisa

AU - Ru, Giuseppe

AU - Simmons, Marion

AU - Skandamis, Panagiotis

AU - Suffredini, Elisabetta

AU - Cocconcelli, Pier Sandro

AU - Escámez, Pablo Salvador Fernández

AU - Maradona, Miguel Prieto

AU - Querol, Amparo

AU - Suarez, Juan Evaristo

AU - Sundh, Ingvar

AU - Vlak, Just

AU - Barizzone, Fulvio

AU - Correia, Sandra

AU - Herman, Lieve

PY - 2018

Y1 - 2018

N2 - The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA’s Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance 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. Between April and September 2018, the QPS notification list was updated with 48 microorganisms from applications for market authorisation. Of these, 30 biological agents already had QPS status, 15 were excluded from the QPS exercise by the previous QPS mandate (five filamentous fungi) or from further evaluations within the current mandate (two notifications of Enterococcus faecium, one of Streptomyces spp. and seven of Escherichia coli). One taxonomic unit was (re)evaluated: Pseudomonas fluorescens had been previously evaluated in 2016, and was now re-evaluated within this mandate. The revision of the literature supports the previously identified safety concerns (e.g. production of biocompounds with antimicrobial activity and virulence features), preventing the inclusion of P. fluorescens in the QPS list. Mycobacterium setense and Komagataeibacter sucrofermentans were evaluated for the first time. M. setense cannot be considered for the QPS assessment because there are significant safety concerns. K. sucrofermentans (Acetobacter xylinus subsp. sucrofermentans) can be proposed for the QPS list but only for production purposes. The QPS status of Corynebacterium glutamicum is confirmed with the qualification extended to other production purposes.

AB - The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA’s Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance 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. Between April and September 2018, the QPS notification list was updated with 48 microorganisms from applications for market authorisation. Of these, 30 biological agents already had QPS status, 15 were excluded from the QPS exercise by the previous QPS mandate (five filamentous fungi) or from further evaluations within the current mandate (two notifications of Enterococcus faecium, one of Streptomyces spp. and seven of Escherichia coli). One taxonomic unit was (re)evaluated: Pseudomonas fluorescens had been previously evaluated in 2016, and was now re-evaluated within this mandate. The revision of the literature supports the previously identified safety concerns (e.g. production of biocompounds with antimicrobial activity and virulence features), preventing the inclusion of P. fluorescens in the QPS list. Mycobacterium setense and Komagataeibacter sucrofermentans were evaluated for the first time. M. setense cannot be considered for the QPS assessment because there are significant safety concerns. K. sucrofermentans (Acetobacter xylinus subsp. sucrofermentans) can be proposed for the QPS list but only for production purposes. The QPS status of Corynebacterium glutamicum is confirmed with the qualification extended to other production purposes.

KW - Bacteria

KW - Corynebacterium glutamicum

KW - Komagataeibacter sucrofermentans

KW - Mycobacterium setense

KW - Pseudomonas fluorescens

KW - QPS

KW - Safety

KW - Yeast

U2 - 10.2903/j.efsa.2019.5555

DO - 10.2903/j.efsa.2019.5555

M3 - Journal article

VL - 17

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 1

M1 - 5555

ER -