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Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH)
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 zearalenone hydrolase (ZenA) produced by Escherichia coli DSM 32731 when used as a feed additive for all terrestrial animals....
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8867527/ https://www.ncbi.nlm.nih.gov/pubmed/35233253 http://dx.doi.org/10.2903/j.efsa.2022.7157 |
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author | Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Fašmon Durjava, Mojca Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Bories, Georges Glandorf, Boet Svensson, Kettil Anguita, Montserrat Brozzi, Rosella Galobart, Jaume Gregoretti, Lucilla Innocenti, Matteo L Pettenati, Elisa Pizzo, Fabiola Tarrés‐Call, Jordi Vettori, Maria Vittoria López‐Gálvez, Gloria |
author_facet | Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Fašmon Durjava, Mojca Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Bories, Georges Glandorf, Boet Svensson, Kettil Anguita, Montserrat Brozzi, Rosella Galobart, Jaume Gregoretti, Lucilla Innocenti, Matteo L Pettenati, Elisa Pizzo, Fabiola Tarrés‐Call, Jordi Vettori, Maria Vittoria López‐Gálvez, Gloria |
collection | PubMed |
description | 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 zearalenone hydrolase (ZenA) produced by Escherichia coli DSM 32731 when used as a feed additive for all terrestrial animals. The production strain E. coli DSM 32731 is genetically modified and harbours a kanamycin resistance gene. No viable cells of the production strain were detected in the final product, but uncertainty remains on the presence of recombinant DNA in the final product. The ZenA contained in the additive is safe for all terrestrial animal species up to the maximum use levels of (in U/kg complete feed): 100 U/kg in chickens for fattening; 150 U/kg in laying hens, turkeys for fattening and rabbits; 200 U/kg in pigs; 250 U/kg in dairy cows; 400 U/kg in veal calf (milk replacer), cattle for fattening, sheep, goats, horses and cats; and 450 U/kg in dogs. Based on the ADME and toxicological data, the FEEDAP Panel considers that the use of the ZenA contained in the additive in animal nutrition is safe for the consumers. The endotoxin content in the additive poses a risk by inhalation for users handling the additive. The additive is not a skin/eye irritant nor a skin sensitiser. Due to its proteinaceous nature, the additive should be considered as a potential respiratory sensitiser. The ZenA contained in the additive and the resulting breakdown products of its enzymatic activity do not represent a safety concern for the environment. The production strain harbours an antimicrobial resistance gene and uncertainties remain on the possible presence of its recombinant DNA in the final product; therefore, the FEEDAP Panel cannot conclude on safety of the additive for the target species, the consumer, the user and the environment. |
format | Online Article Text |
id | pubmed-8867527 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-88675272022-02-28 Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH) Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Fašmon Durjava, Mojca Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Bories, Georges Glandorf, Boet Svensson, Kettil Anguita, Montserrat Brozzi, Rosella Galobart, Jaume Gregoretti, Lucilla Innocenti, Matteo L Pettenati, Elisa Pizzo, Fabiola Tarrés‐Call, Jordi Vettori, Maria Vittoria López‐Gálvez, Gloria EFSA J Scientific Opinion 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 zearalenone hydrolase (ZenA) produced by Escherichia coli DSM 32731 when used as a feed additive for all terrestrial animals. The production strain E. coli DSM 32731 is genetically modified and harbours a kanamycin resistance gene. No viable cells of the production strain were detected in the final product, but uncertainty remains on the presence of recombinant DNA in the final product. The ZenA contained in the additive is safe for all terrestrial animal species up to the maximum use levels of (in U/kg complete feed): 100 U/kg in chickens for fattening; 150 U/kg in laying hens, turkeys for fattening and rabbits; 200 U/kg in pigs; 250 U/kg in dairy cows; 400 U/kg in veal calf (milk replacer), cattle for fattening, sheep, goats, horses and cats; and 450 U/kg in dogs. Based on the ADME and toxicological data, the FEEDAP Panel considers that the use of the ZenA contained in the additive in animal nutrition is safe for the consumers. The endotoxin content in the additive poses a risk by inhalation for users handling the additive. The additive is not a skin/eye irritant nor a skin sensitiser. Due to its proteinaceous nature, the additive should be considered as a potential respiratory sensitiser. The ZenA contained in the additive and the resulting breakdown products of its enzymatic activity do not represent a safety concern for the environment. The production strain harbours an antimicrobial resistance gene and uncertainties remain on the possible presence of its recombinant DNA in the final product; therefore, the FEEDAP Panel cannot conclude on safety of the additive for the target species, the consumer, the user and the environment. John Wiley and Sons Inc. 2022-02-24 /pmc/articles/PMC8867527/ /pubmed/35233253 http://dx.doi.org/10.2903/j.efsa.2022.7157 Text en © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://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 | Scientific Opinion Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Fašmon Durjava, Mojca Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Bories, Georges Glandorf, Boet Svensson, Kettil Anguita, Montserrat Brozzi, Rosella Galobart, Jaume Gregoretti, Lucilla Innocenti, Matteo L Pettenati, Elisa Pizzo, Fabiola Tarrés‐Call, Jordi Vettori, Maria Vittoria López‐Gálvez, Gloria Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH) |
title | Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH) |
title_full | Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH) |
title_fullStr | Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH) |
title_full_unstemmed | Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH) |
title_short | Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH) |
title_sort | safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by escherichia coli dsm 32731 for all terrestrial animal species (biomin gmbh) |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8867527/ https://www.ncbi.nlm.nih.gov/pubmed/35233253 http://dx.doi.org/10.2903/j.efsa.2022.7157 |
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