TY - JOUR
T1 - Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA (2017–2019)
AU - EFSA Panel on Biological Hazards (BIOHAZ)
AU - Koutsoumanis, Kostas
AU - Allende, Ana
AU - Alvarez-Ordóñez, Avelino
AU - Bolton, Declan
AU - Bover-Cid, Sara
AU - Chemaly, Marianne
AU - Davies, Robert
AU - De Cesare, Alessandra
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 - Fernández Escámez, Pablo Salvador
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
Y1 - 2019
N2 - The qualified presumption of safety (QPS) was developed to provide a safety pre-assessment within EFSA for microorganisms. Strains belonging to QPS taxonomic units (TUs) still require an assessment based on a specific data package, but QPS status facilitates fast track evaluation. QPS TUs are unambiguously defined biological agents assessed for the body of knowledge, their safety and their end use. Safety concerns are, where possible, to be confirmed at strain or product level, and reflected as ‘qualifications’. Qualifications need to be evaluated at strain level by the respective EFSA units. The lowest QPS TU is the species level for bacteria, yeasts and protists/algae, and the family for viruses. The QPS concept is also applicable to genetically modified microorganisms used for production purposes if the recipient strain qualifies for the QPS status, and if the genetic modification does not indicate a concern. Based on the actual body of knowledge and/or an ambiguous taxonomic position, the following TUs were excluded from the QPS assessment: filamentous fungi, oomycetes, streptomycetes, Enterococcus faecium, Escherichia coli and bacteriophages. The list of QPS-recommended biological agents was reviewed and updated in the current opinion and therefore now becomes the valid list. For this update, reports on the safety of previously assessed microorganisms, including bacteria, yeasts and viruses (the latter only when used for plant protection purposes) were reviewed, following an Extensive Literature Search strategy. All TUs previously recommended for 2016 QPS list had their status reconfirmed as well as their qualifications. The TUs related to the new notifications received since the 2016 QPS opinion was periodically evaluated for QPS status in the Statements of the BIOHAZ Panel, and the QPS list was also periodically updated. In total, 14 new TUs received a QPS status between 2017 and 2019: three yeasts, eight bacteria and three algae/protists.
AB - The qualified presumption of safety (QPS) was developed to provide a safety pre-assessment within EFSA for microorganisms. Strains belonging to QPS taxonomic units (TUs) still require an assessment based on a specific data package, but QPS status facilitates fast track evaluation. QPS TUs are unambiguously defined biological agents assessed for the body of knowledge, their safety and their end use. Safety concerns are, where possible, to be confirmed at strain or product level, and reflected as ‘qualifications’. Qualifications need to be evaluated at strain level by the respective EFSA units. The lowest QPS TU is the species level for bacteria, yeasts and protists/algae, and the family for viruses. The QPS concept is also applicable to genetically modified microorganisms used for production purposes if the recipient strain qualifies for the QPS status, and if the genetic modification does not indicate a concern. Based on the actual body of knowledge and/or an ambiguous taxonomic position, the following TUs were excluded from the QPS assessment: filamentous fungi, oomycetes, streptomycetes, Enterococcus faecium, Escherichia coli and bacteriophages. The list of QPS-recommended biological agents was reviewed and updated in the current opinion and therefore now becomes the valid list. For this update, reports on the safety of previously assessed microorganisms, including bacteria, yeasts and viruses (the latter only when used for plant protection purposes) were reviewed, following an Extensive Literature Search strategy. All TUs previously recommended for 2016 QPS list had their status reconfirmed as well as their qualifications. The TUs related to the new notifications received since the 2016 QPS opinion was periodically evaluated for QPS status in the Statements of the BIOHAZ Panel, and the QPS list was also periodically updated. In total, 14 new TUs received a QPS status between 2017 and 2019: three yeasts, eight bacteria and three algae/protists.
KW - algae
KW - bacteria
KW - food and feed
KW - fungi
KW - QPS
KW - safety
KW - virus
KW - yeast
U2 - 10.2903/j.efsa.2020.5966
DO - 10.2903/j.efsa.2020.5966
M3 - Journal article
C2 - 32874212
AN - SCOPUS:85081020418
SN - 1831-4732
VL - 18
JO - EFSA Journal
JF - EFSA Journal
IS - 2
M1 - e05966
ER -