Safety and efficacy of a feed additive consisting on the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella Gallinarum B/00111 (Bafasal®) for all avian species (Proteon Pharmaceuticals S.A.)
Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the feed additive consisting of four bacteriophages infecting Salmonella Gallinarum B/00111 (PCM F/00069, PCM F/00070...
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doaj-5aaf157f5d4b4d10ba21225c4acdf8132021-06-07T15:25:27ZengWileyEFSA Journal1831-47322021-05-01195n/an/a10.2903/j.efsa.2021.6534Safety and efficacy of a feed additive consisting on the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella Gallinarum B/00111 (Bafasal®) for all avian species (Proteon Pharmaceuticals S.A.)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMaryline KoubaMojca Fašmon DurjavaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenPier Sandro CocconcelliBoet GlandorfLieve HermanMiguel Prieto MaradonaMaria SaarelaNoël DierickGiovanna MartelliPaul BrantomLuca TostiKettil SvenssonMontserrat AnguitaJaume GalobartMatteo InnocentiElisa PettenatiJoana RevezRosella BrozziAbstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the feed additive consisting of four bacteriophages infecting Salmonella Gallinarum B/00111 (PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097, trade name: Bafasal®) when used as a zootechnical additive in water for drinking and liquid complementary feed for all avian species. The effects sought are the reduction of the Salmonella spp. carriage in chickens for fattening, the improvement of their performance, or both. The host strain harbours an acquired antimicrobial resistance gene. No viable cells or DNA from the host organism were found in the additive. The four phages proved to be strictly lytic and to have a machinery allowing to package a unit‐length of the viral genome. The manufacturing process excludes the presence of remnants from the propagation process in the final additive. Consequently, no concerns are expected from the nature and manufacture of the product. Considering this and the results of the tolerance study with chickens for fattening, the Panel concluded that Bafasal® is safe for all avian species. Considering the nature and manufacturing process of the additive, Bafasal® is not expected to pose a risk for consumers. The results of the subchronic oral toxicity study and genotoxicity studies provided support this conclusion. Exposure of users via inhalation is expected to be low, but Bafasal® should be considered a respiratory sensitiser. No conclusions were drawn on the irritancy of Bafasal® to skin and eyes or on its dermal sensitisation potential due to lack of data. Considering the nature and manufacturing process of the additive, Bafasal® is safe for the environment. The Panel was not in the position to conclude on the efficacy of Bafasal® for any avian species due to insufficient data.https://doi.org/10.2903/j.efsa.2021.6534Zootechnical additivebacteriophagesSalmonella enterica ser. Gallinarum B/00111Bafasal®safetyefficacy |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Maryline Kouba Mojca Fašmon Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Pier Sandro Cocconcelli Boet Glandorf Lieve Herman Miguel Prieto Maradona Maria Saarela Noël Dierick Giovanna Martelli Paul Brantom Luca Tosti Kettil Svensson Montserrat Anguita Jaume Galobart Matteo Innocenti Elisa Pettenati Joana Revez Rosella Brozzi |
spellingShingle |
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Maryline Kouba Mojca Fašmon Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Pier Sandro Cocconcelli Boet Glandorf Lieve Herman Miguel Prieto Maradona Maria Saarela Noël Dierick Giovanna Martelli Paul Brantom Luca Tosti Kettil Svensson Montserrat Anguita Jaume Galobart Matteo Innocenti Elisa Pettenati Joana Revez Rosella Brozzi Safety and efficacy of a feed additive consisting on the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella Gallinarum B/00111 (Bafasal®) for all avian species (Proteon Pharmaceuticals S.A.) EFSA Journal Zootechnical additive bacteriophages Salmonella enterica ser. Gallinarum B/00111 Bafasal® safety efficacy |
author_facet |
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Maryline Kouba Mojca Fašmon Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Pier Sandro Cocconcelli Boet Glandorf Lieve Herman Miguel Prieto Maradona Maria Saarela Noël Dierick Giovanna Martelli Paul Brantom Luca Tosti Kettil Svensson Montserrat Anguita Jaume Galobart Matteo Innocenti Elisa Pettenati Joana Revez Rosella Brozzi |
author_sort |
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
title |
Safety and efficacy of a feed additive consisting on the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella Gallinarum B/00111 (Bafasal®) for all avian species (Proteon Pharmaceuticals S.A.) |
title_short |
Safety and efficacy of a feed additive consisting on the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella Gallinarum B/00111 (Bafasal®) for all avian species (Proteon Pharmaceuticals S.A.) |
title_full |
Safety and efficacy of a feed additive consisting on the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella Gallinarum B/00111 (Bafasal®) for all avian species (Proteon Pharmaceuticals S.A.) |
title_fullStr |
Safety and efficacy of a feed additive consisting on the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella Gallinarum B/00111 (Bafasal®) for all avian species (Proteon Pharmaceuticals S.A.) |
title_full_unstemmed |
Safety and efficacy of a feed additive consisting on the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella Gallinarum B/00111 (Bafasal®) for all avian species (Proteon Pharmaceuticals S.A.) |
title_sort |
safety and efficacy of a feed additive consisting on the bacteriophages pcm f/00069, pcm f/00070, pcm f/00071 and pcm f/00097 infecting salmonella gallinarum b/00111 (bafasal®) for all avian species (proteon pharmaceuticals s.a.) |
publisher |
Wiley |
series |
EFSA Journal |
issn |
1831-4732 |
publishDate |
2021-05-01 |
description |
Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the feed additive consisting of four bacteriophages infecting Salmonella Gallinarum B/00111 (PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097, trade name: Bafasal®) when used as a zootechnical additive in water for drinking and liquid complementary feed for all avian species. The effects sought are the reduction of the Salmonella spp. carriage in chickens for fattening, the improvement of their performance, or both. The host strain harbours an acquired antimicrobial resistance gene. No viable cells or DNA from the host organism were found in the additive. The four phages proved to be strictly lytic and to have a machinery allowing to package a unit‐length of the viral genome. The manufacturing process excludes the presence of remnants from the propagation process in the final additive. Consequently, no concerns are expected from the nature and manufacture of the product. Considering this and the results of the tolerance study with chickens for fattening, the Panel concluded that Bafasal® is safe for all avian species. Considering the nature and manufacturing process of the additive, Bafasal® is not expected to pose a risk for consumers. The results of the subchronic oral toxicity study and genotoxicity studies provided support this conclusion. Exposure of users via inhalation is expected to be low, but Bafasal® should be considered a respiratory sensitiser. No conclusions were drawn on the irritancy of Bafasal® to skin and eyes or on its dermal sensitisation potential due to lack of data. Considering the nature and manufacturing process of the additive, Bafasal® is safe for the environment. The Panel was not in the position to conclude on the efficacy of Bafasal® for any avian species due to insufficient data. |
topic |
Zootechnical additive bacteriophages Salmonella enterica ser. Gallinarum B/00111 Bafasal® safety efficacy |
url |
https://doi.org/10.2903/j.efsa.2021.6534 |
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