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 - 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 - 2019/1
Y1 - 2019/1
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 - Article
AN - SCOPUS:85063639323
SN - 1831-4732
VL - 17
JO - EFSA Journal
JF - EFSA Journal
IS - 1
M1 - 5555
ER -