Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017
Abstract The qualified presumption of safety (QPS) concept was developed to provide a harmonised generic pre‐evaluation 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...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2018-01-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2018.5131 |
| _version_ | 1831751244698353664 |
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| author | EFSA Panel on Biological Hazards (BIOHAZ) Antonia Ricci Ana Allende Declan Bolton Marianne Chemaly Robert Davies Rosina Girones Konstantinos Koutsoumanis Roland Lindqvist Birgit Nørrung Lucy Robertson Giuseppe Ru Pablo Salvador Fernández Escámez Moez Sanaa Marion Simmons Panagiotis Skandamis Emma Snary Niko Speybroeck Benno Ter Kuile John Threlfall Helene Wahlström Pier Sandro Cocconcelli Luisa Peixe Miguel Prieto Maradona Amparo Querol Juan Evaristo Suarez Ingvar Sundh Just Vlak Fulvio Barizzone Sandra Correia Lieve Herman |
| author_facet | EFSA Panel on Biological Hazards (BIOHAZ) Antonia Ricci Ana Allende Declan Bolton Marianne Chemaly Robert Davies Rosina Girones Konstantinos Koutsoumanis Roland Lindqvist Birgit Nørrung Lucy Robertson Giuseppe Ru Pablo Salvador Fernández Escámez Moez Sanaa Marion Simmons Panagiotis Skandamis Emma Snary Niko Speybroeck Benno Ter Kuile John Threlfall Helene Wahlström Pier Sandro Cocconcelli Luisa Peixe Miguel Prieto Maradona Amparo Querol Juan Evaristo Suarez Ingvar Sundh Just Vlak Fulvio Barizzone Sandra Correia Lieve Herman |
| author_sort | EFSA Panel on Biological Hazards (BIOHAZ) |
| collection | DOAJ |
| description | Abstract The qualified presumption of safety (QPS) concept was developed to provide a harmonised generic pre‐evaluation 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, considered to be ‘qualifications’ which should be assessed at the strain level by the EFSA's scientific Panels. No new information was found that would change the previously recommended QPS taxonomic units and their qualifications. The BIOHAZ Panel confirms that the QPS approach can be extended to a genetically modified production strain if the recipient strain qualifies for the QPS status, and if the genetic modification does not indicate a concern. Between April and September 2017, the QPS notification list was updated with 46 applications for market authorisation. From these, 14 biological agents already had QPS status and 16 were not included as they are filamentous fungi or enterococci. One notification of Streptomyces K‐61 (notified as former S. griseoviridis) and four of Escherichia coli were not considered for the assessment as they belong to taxonomic units that were excluded from further evaluations within the current QPS mandate. Eight notifications of Bacillus thuringiensis and one of an oomycete are pending the reception of the complete application. Two taxonomic units were evaluated: Kitasatospora paracochleata, which had not been evaluated before, and Komagataella phaffii, previously notified as Pichia pastoris included due to a change in the taxonomic identity. Kitasatospora paracochleata cannot be granted QPS status due to lack of information on its biology and to its possible production of toxic secondary metabolites. The species Komagataella phaffii can be recommended for the QPS list when used for enzyme production. |
| first_indexed | 2024-12-21T22:41:21Z |
| format | Article |
| id | doaj.art-9771a10b21954bfe983c25b4b9e27806 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-21T22:41:21Z |
| publishDate | 2018-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-9771a10b21954bfe983c25b4b9e278062022-12-21T18:47:49ZengWileyEFSA Journal1831-47322018-01-01161n/an/a10.2903/j.efsa.2018.5131Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017EFSA Panel on Biological Hazards (BIOHAZ)Antonia RicciAna AllendeDeclan BoltonMarianne ChemalyRobert DaviesRosina GironesKonstantinos KoutsoumanisRoland LindqvistBirgit NørrungLucy RobertsonGiuseppe RuPablo Salvador Fernández EscámezMoez SanaaMarion SimmonsPanagiotis SkandamisEmma SnaryNiko SpeybroeckBenno Ter KuileJohn ThrelfallHelene WahlströmPier Sandro CocconcelliLuisa PeixeMiguel Prieto MaradonaAmparo QuerolJuan Evaristo SuarezIngvar SundhJust VlakFulvio BarizzoneSandra CorreiaLieve HermanAbstract The qualified presumption of safety (QPS) concept was developed to provide a harmonised generic pre‐evaluation 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, considered to be ‘qualifications’ which should be assessed at the strain level by the EFSA's scientific Panels. No new information was found that would change the previously recommended QPS taxonomic units and their qualifications. The BIOHAZ Panel confirms that the QPS approach can be extended to a genetically modified production strain if the recipient strain qualifies for the QPS status, and if the genetic modification does not indicate a concern. Between April and September 2017, the QPS notification list was updated with 46 applications for market authorisation. From these, 14 biological agents already had QPS status and 16 were not included as they are filamentous fungi or enterococci. One notification of Streptomyces K‐61 (notified as former S. griseoviridis) and four of Escherichia coli were not considered for the assessment as they belong to taxonomic units that were excluded from further evaluations within the current QPS mandate. Eight notifications of Bacillus thuringiensis and one of an oomycete are pending the reception of the complete application. Two taxonomic units were evaluated: Kitasatospora paracochleata, which had not been evaluated before, and Komagataella phaffii, previously notified as Pichia pastoris included due to a change in the taxonomic identity. Kitasatospora paracochleata cannot be granted QPS status due to lack of information on its biology and to its possible production of toxic secondary metabolites. The species Komagataella phaffii can be recommended for the QPS list when used for enzyme production.https://doi.org/10.2903/j.efsa.2018.5131safetyQPSbacteriayeastKitasatospora paracochleataKomagataella phaffii |
| spellingShingle | EFSA Panel on Biological Hazards (BIOHAZ) Antonia Ricci Ana Allende Declan Bolton Marianne Chemaly Robert Davies Rosina Girones Konstantinos Koutsoumanis Roland Lindqvist Birgit Nørrung Lucy Robertson Giuseppe Ru Pablo Salvador Fernández Escámez Moez Sanaa Marion Simmons Panagiotis Skandamis Emma Snary Niko Speybroeck Benno Ter Kuile John Threlfall Helene Wahlström Pier Sandro Cocconcelli Luisa Peixe Miguel Prieto Maradona Amparo Querol Juan Evaristo Suarez Ingvar Sundh Just Vlak Fulvio Barizzone Sandra Correia Lieve Herman Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017 EFSA Journal safety QPS bacteria yeast Kitasatospora paracochleata Komagataella phaffii |
| title | Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017 |
| title_full | Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017 |
| title_fullStr | Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017 |
| title_full_unstemmed | Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017 |
| title_short | Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017 |
| title_sort | update of the list of qps recommended biological agents intentionally added to food or feed as notified to efsa 7 suitability of taxonomic units notified to efsa until september 2017 |
| topic | safety QPS bacteria yeast Kitasatospora paracochleata Komagataella phaffii |
| url | https://doi.org/10.2903/j.efsa.2018.5131 |
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