Safety and efficacy of l‐histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal species
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 l‐histidine monohydrochloride (HCl) monohydrate produced by fermentation using Corynebacterium glutamicum KCCM 80172...
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doaj-718932a020e64532bfb631bff558928a2021-08-05T09:21:08ZengWileyEFSA Journal1831-47322019-07-01177n/an/a10.2903/j.efsa.2019.5783Safety and efficacy of l‐histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal speciesEFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMaryline KoubaMojca Kos DurjavaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaYolanda SanzRoberto Edoardo VillaRuud WoutersenLucio CostaFrancesco CubaddaNoël DierickGerhard FlachowskyBoet GlandorfLieve HermanAlberto MantovaniMaria SaarelaKettil SvenssonLuca TostiRobert John WallaceMontserrat AnguitaJordi Tarrés‐CallFernando RamosAbstract 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.https://doi.org/10.2903/j.efsa.2019.5783nutritional additiveamino acidl‐histidine monohydrochloride monohydrateCorynebacterium glutamicum KCCM 80172feed additivesafety |
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language |
English |
format |
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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 Kos Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Lucio Costa Francesco Cubadda Noël Dierick Gerhard Flachowsky Boet Glandorf Lieve Herman Alberto Mantovani Maria Saarela Kettil Svensson Luca Tosti Robert John Wallace Montserrat Anguita Jordi Tarrés‐Call Fernando Ramos |
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 Kos Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Lucio Costa Francesco Cubadda Noël Dierick Gerhard Flachowsky Boet Glandorf Lieve Herman Alberto Mantovani Maria Saarela Kettil Svensson Luca Tosti Robert John Wallace Montserrat Anguita Jordi Tarrés‐Call Fernando Ramos Safety and efficacy of l‐histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80172 for all animal species EFSA Journal nutritional additive amino acid l‐histidine monohydrochloride monohydrate Corynebacterium glutamicum KCCM 80172 feed additive safety |
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 Kos Durjava Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Lucio Costa Francesco Cubadda Noël Dierick Gerhard Flachowsky Boet Glandorf Lieve Herman Alberto Mantovani Maria Saarela Kettil Svensson Luca Tosti Robert John Wallace Montserrat Anguita Jordi Tarrés‐Call Fernando Ramos |
author_sort |
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
title |
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_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_sort |
safety and efficacy of l‐histidine monohydrochloride monohydrate produced using corynebacterium glutamicum kccm 80172 for all animal species |
publisher |
Wiley |
series |
EFSA Journal |
issn |
1831-4732 |
publishDate |
2019-07-01 |
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 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. |
topic |
nutritional additive amino acid l‐histidine monohydrochloride monohydrate Corynebacterium glutamicum KCCM 80172 feed additive safety |
url |
https://doi.org/10.2903/j.efsa.2019.5783 |
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