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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
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7328880/ https://www.ncbi.nlm.nih.gov/pubmed/32626100 http://dx.doi.org/10.2903/j.efsa.2019.5555 |
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author | Koutsoumanis, Kostas Allende, Ana Álvarez‐Ordóñez, Avelino Bolton, Declan Bover‐Cid, Sara Chemaly, Marianne Davies, Robert Hilbert, Friederike Lindqvist, Roland Nauta, Maarten Peixe, Luisa Ru, Giuseppe Simmons, Marion Skandamis, Panagiotis Suffredini, Elisabetta Cocconcelli, Pier Sandro Fernández Escámez, Pablo Salvador Maradona, Miguel Prieto Querol, Amparo Suarez, Juan Evaristo Sundh, Ingvar Vlak, Just Barizzone, Fulvio Correia, Sandra Herman, Lieve |
author_facet | Koutsoumanis, Kostas Allende, Ana Álvarez‐Ordóñez, Avelino Bolton, Declan Bover‐Cid, Sara Chemaly, Marianne Davies, Robert Hilbert, Friederike Lindqvist, Roland Nauta, Maarten Peixe, Luisa Ru, Giuseppe Simmons, Marion Skandamis, Panagiotis Suffredini, Elisabetta Cocconcelli, Pier Sandro Fernández Escámez, Pablo Salvador Maradona, Miguel Prieto Querol, Amparo Suarez, Juan Evaristo Sundh, Ingvar Vlak, Just Barizzone, Fulvio Correia, Sandra Herman, Lieve |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7328880 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-73288802020-07-02 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 Koutsoumanis, Kostas Allende, Ana Álvarez‐Ordóñez, Avelino Bolton, Declan Bover‐Cid, Sara Chemaly, Marianne Davies, Robert Hilbert, Friederike Lindqvist, Roland Nauta, Maarten Peixe, Luisa Ru, Giuseppe Simmons, Marion Skandamis, Panagiotis Suffredini, Elisabetta Cocconcelli, Pier Sandro Fernández Escámez, Pablo Salvador Maradona, Miguel Prieto Querol, Amparo Suarez, Juan Evaristo Sundh, Ingvar Vlak, Just Barizzone, Fulvio Correia, Sandra Herman, Lieve EFSA J Statement 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. John Wiley and Sons Inc. 2019-01-24 /pmc/articles/PMC7328880/ /pubmed/32626100 http://dx.doi.org/10.2903/j.efsa.2019.5555 Text en © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
spellingShingle | Statement Koutsoumanis, Kostas Allende, Ana Álvarez‐Ordóñez, Avelino Bolton, Declan Bover‐Cid, Sara Chemaly, Marianne Davies, Robert Hilbert, Friederike Lindqvist, Roland Nauta, Maarten Peixe, Luisa Ru, Giuseppe Simmons, Marion Skandamis, Panagiotis Suffredini, Elisabetta Cocconcelli, Pier Sandro Fernández Escámez, Pablo Salvador Maradona, Miguel Prieto Querol, Amparo Suarez, Juan Evaristo Sundh, Ingvar Vlak, Just Barizzone, Fulvio Correia, Sandra Herman, Lieve 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Statement |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7328880/ https://www.ncbi.nlm.nih.gov/pubmed/32626100 http://dx.doi.org/10.2903/j.efsa.2019.5555 |
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