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Safety and efficacy of l‐histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal species

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 l‐histidine monohydrochloride (HCl) monohydrate produced by fermentation using Corynebacterium glutamicum KCCM 80172 when used...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Kouba, Maryline, Kos Durjava, Mojca, López‐Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Sanz, Yolanda, Villa, Roberto Edoardo, Woutersen, Ruud, Costa, Lucio, Cubadda, Francesco, Dierick, Noël, Flachowsky, Gerhard, Glandorf, Boet, Herman, Lieve, Mantovani, Alberto, Saarela, Maria, Svensson, Kettil, Tosti, Luca, Wallace, Robert John, Anguita, Montserrat, Tarrés‐Call, Jordi, Ramos, Fernando
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009053/
https://www.ncbi.nlm.nih.gov/pubmed/32626390
http://dx.doi.org/10.2903/j.efsa.2019.5783
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author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Costa, Lucio
Cubadda, Francesco
Dierick, Noël
Flachowsky, Gerhard
Glandorf, Boet
Herman, Lieve
Mantovani, Alberto
Saarela, Maria
Svensson, Kettil
Tosti, Luca
Wallace, Robert John
Anguita, Montserrat
Tarrés‐Call, Jordi
Ramos, Fernando
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Costa, Lucio
Cubadda, Francesco
Dierick, Noël
Flachowsky, Gerhard
Glandorf, Boet
Herman, Lieve
Mantovani, Alberto
Saarela, Maria
Svensson, Kettil
Tosti, Luca
Wallace, Robert John
Anguita, Montserrat
Tarrés‐Call, Jordi
Ramos, Fernando
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 l‐histidine monohydrochloride (HCl) monohydrate produced by fermentation using Corynebacterium glutamicum KCCM 80172 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain is genetically modified. The production strain and its recombinant DNA were not detected in the final product. l‐Histidine HCl monohydrate manufactured by fermentation using C. glutamicum KCCM 80172 does not give rise to any safety concern regarding the genetic modification. The use of l‐histidine HCl monohydrate produced by fermentation using C. glutamicum KCCM 80172 is safe for the target species when used as a nutritional additive to supplement the diet in appropriate amounts to cover the requirements, depending on the species, the physiological state of the animal, the performance level, the environmental conditions, the background amino acid composition of the unsupplemented diet and the status of some essential trace elements such as copper and zinc. l‐Histidine HCl monohydrate produced using C. glutamicum KCCM 80172 supplemented at levels appropriate for the requirements of the target species is considered safe for the consumer. l‐Histidine HCl monohydrate produced using C. glutamicum KCCM 80172 is not irritant to skin, is a mildly irritant to eyes, and it is not a skin sensitiser. The additive does not pose a risk to users by inhalation. The use of l‐histidine HCl monohydrate produced by C. glutamicum KCCM 80172 in animal nutrition is not expected to represent a risk to the environment. l‐Histidine HCl monohydrate is considered an efficacious source of the essential amino acid l‐histidine for non‐ruminant animal species. For the supplemental l‐histidine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.
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spelling pubmed-70090532020-07-02 Safety and efficacy of l‐histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal species Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Kouba, Maryline Kos Durjava, Mojca López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Costa, Lucio Cubadda, Francesco Dierick, Noël Flachowsky, Gerhard Glandorf, Boet Herman, Lieve Mantovani, Alberto Saarela, Maria Svensson, Kettil Tosti, Luca Wallace, Robert John Anguita, Montserrat Tarrés‐Call, Jordi Ramos, Fernando 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 l‐histidine monohydrochloride (HCl) monohydrate produced by fermentation using Corynebacterium glutamicum KCCM 80172 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain is genetically modified. The production strain and its recombinant DNA were not detected in the final product. l‐Histidine HCl monohydrate manufactured by fermentation using C. glutamicum KCCM 80172 does not give rise to any safety concern regarding the genetic modification. The use of l‐histidine HCl monohydrate produced by fermentation using C. glutamicum KCCM 80172 is safe for the target species when used as a nutritional additive to supplement the diet in appropriate amounts to cover the requirements, depending on the species, the physiological state of the animal, the performance level, the environmental conditions, the background amino acid composition of the unsupplemented diet and the status of some essential trace elements such as copper and zinc. l‐Histidine HCl monohydrate produced using C. glutamicum KCCM 80172 supplemented at levels appropriate for the requirements of the target species is considered safe for the consumer. l‐Histidine HCl monohydrate produced using C. glutamicum KCCM 80172 is not irritant to skin, is a mildly irritant to eyes, and it is not a skin sensitiser. The additive does not pose a risk to users by inhalation. The use of l‐histidine HCl monohydrate produced by C. glutamicum KCCM 80172 in animal nutrition is not expected to represent a risk to the environment. l‐Histidine HCl monohydrate is considered an efficacious source of the essential amino acid l‐histidine for non‐ruminant animal species. For the supplemental l‐histidine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. John Wiley and Sons Inc. 2019-07-25 /pmc/articles/PMC7009053/ /pubmed/32626390 http://dx.doi.org/10.2903/j.efsa.2019.5783 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 Scientific Opinion
Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Costa, Lucio
Cubadda, Francesco
Dierick, Noël
Flachowsky, Gerhard
Glandorf, Boet
Herman, Lieve
Mantovani, Alberto
Saarela, Maria
Svensson, Kettil
Tosti, Luca
Wallace, Robert John
Anguita, Montserrat
Tarrés‐Call, Jordi
Ramos, Fernando
Safety and efficacy of l‐histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal species
title Safety and efficacy of l‐histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal species
title_full Safety and efficacy of l‐histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal species
title_fullStr Safety and efficacy of l‐histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal species
title_full_unstemmed Safety and efficacy of l‐histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal species
title_short Safety and efficacy of l‐histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal species
title_sort safety and efficacy of l‐histidine monohydrochloride monohydrate produced using corynebacterium glutamicum kccm 80172 for all animal species
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009053/
https://www.ncbi.nlm.nih.gov/pubmed/32626390
http://dx.doi.org/10.2903/j.efsa.2019.5783
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