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 80179 when used as a nutritional additive (amino acid) and as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The production strain is not genetically modified. No viable cells of the production strain were detected in the final product. The use of l-histidine monohydrochloride monohydrate produced by fermentation using C. glutamicum KCCM 80179 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. This conclusion would also cover the use as a sensory additive. l-Histidine HCl monohydrate produced using C. glutamicum KCCM 80179 supplemented at levels appropriate for the requirements of species and life stage is considered safe for the consumer. l-Histidine HCl monohydrate produced using C. glutamicum KCCM 80179 is not irritant to skin, is 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 80179 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. It is also considered efficacious as a feed flavouring compound under the proposed conditions of use.

Safety and efficacy of l-histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80179 for all animal species / V. Bampidis, G. Azimonti, M. de Lourdes Bastos, H. Christensen, B. Dusemund, M. Kouba, M. Kos Durjava, M. Lopez-Alonso, S. Lopez Puente, F. Marcon, B. Mayo, A. Pechova, M. Petkova, Y. Sanz, R.E. Villa, R. Woutersen, L. Costa, F. Cubadda, N. Dierick, G. Flachowsky, A. Mantovani, R.J. Wallace, P. Manini, J. Tarres-Call, F. Ramos. - In: EFSA JOURNAL. - ISSN 1831-4732. - 17:7(2019 Jul), pp. e05784.1-e05784.14. [10.2903/j.efsa.2019.5784]

Safety and efficacy of l-histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80179 for all animal species

R.E. Villa;
2019

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 80179 when used as a nutritional additive (amino acid) and as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The production strain is not genetically modified. No viable cells of the production strain were detected in the final product. The use of l-histidine monohydrochloride monohydrate produced by fermentation using C. glutamicum KCCM 80179 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. This conclusion would also cover the use as a sensory additive. l-Histidine HCl monohydrate produced using C. glutamicum KCCM 80179 supplemented at levels appropriate for the requirements of species and life stage is considered safe for the consumer. l-Histidine HCl monohydrate produced using C. glutamicum KCCM 80179 is not irritant to skin, is 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 80179 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. It is also considered efficacious as a feed flavouring compound under the proposed conditions of use.
English
amino acid; Corynebacterium glutamicum KCCM 80179; feed additive; l-histidine monohydrochloride monohydrate; nutritional additive; safety
Settore VET/07 - Farmacologia e Tossicologia Veterinaria
Articolo
Esperti anonimi
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lug-2019
Wiley
17
7
e05784
1
14
14
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Periodico con rilevanza internazionale
scopus
pubmed
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info:eu-repo/semantics/article
Safety and efficacy of l-histidine monohydrochloride monohydrate produced using Corynebacterium glutamicum KCCM 80179 for all animal species / V. Bampidis, G. Azimonti, M. de Lourdes Bastos, H. Christensen, B. Dusemund, M. Kouba, M. Kos Durjava, M. Lopez-Alonso, S. Lopez Puente, F. Marcon, B. Mayo, A. Pechova, M. Petkova, Y. Sanz, R.E. Villa, R. Woutersen, L. Costa, F. Cubadda, N. Dierick, G. Flachowsky, A. Mantovani, R.J. Wallace, P. Manini, J. Tarres-Call, F. Ramos. - In: EFSA JOURNAL. - ISSN 1831-4732. - 17:7(2019 Jul), pp. e05784.1-e05784.14. [10.2903/j.efsa.2019.5784]
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V. Bampidis, G. Azimonti, M. de Lourdes Bastos, H. Christensen, B. Dusemund, M. Kouba, M. Kos Durjava, M. Lopez-Alonso, S. Lopez Puente, F. Marcon, B. Mayo, A. Pechova, M. Petkova, Y. Sanz, R.E. Villa, R. Woutersen, L. Costa, F. Cubadda, N. Dierick, G. Flachowsky, A. Mantovani, R.J. Wallace, P. Manini, J. Tarres-Call, F. Ramos
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/752195
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