Assessment of the application for renewal of authorisation of l‐histidine monohydrochloride monohydrate produced with Escherichia coli NITE SD 00268 for salmonids and its extension of use to other fin fish
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 Escherichia coli NITE SD 00268 in the...
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doaj-8c40f26c555a4288bc0a0e3de6d2d4ed2021-05-02T21:37:03ZengWileyEFSA Journal1831-47322020-04-01184n/an/a10.2903/j.efsa.2020.6072Assessment of the application for renewal of authorisation of l‐histidine monohydrochloride monohydrate produced with Escherichia coli NITE SD 00268 for salmonids and its extension of use to other fin fishEFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria deLourdes BastosHenrik ChristensenBirgit DusemundMojca Kos DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaYolanda SanzRoberto Edoardo VillaRuud WoutersenLucio CostaFrancesco CubaddaNoël DierickBoet GlandorfLieve HermanAlberto MantovaniMaria SaarelaKettil SvenssonLuca TostiMontserrat AnguitaElisa PettenatiJordi 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 Escherichia coli NITE SD 00268 in the context of the renewal of the authorisation for salmonids when used as a nutritional additive. In addition, the applicant requested the extension of use of the additive for other fin fish. The applicant has provided evidence that the composition of the additive currently in the market complies with the conditions of authorisation. The production strain has been modified by conventional mutagenesis and it does not raise safety concerns. The use of l‐histidine HCl monohydrate produced by fermentation using E. coli NITE SD 00268 is safe for salmonids and other fin fish when used as a nutritional additive to supplement the diet in appropriate amounts to cover the nutritional 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. The FEEDAP Panel considers the maximum total concentration of 1.7% histidine in feed for salmonids proposed by the applicant as safe. For other fin fish species, the level of 1.7% appears to cause adverse effects. Therefore, it is not possible to define a maximum concentration of histidine in fish other than salmonids as it depends on histidine nutritional requirements in the different fish species. The use of the authorised additive in salmonids production does not pose a risk for consumers, and the proposed maximum total concentration of 1.7% histidine in feed is considered safe for the consumer. l‐Histidine HCl monohydrate produced using E. coli NITE SD 00268 supplemented at levels appropriate to cover the nutritional requirements of fish other than salmonids is considered safe for the consumer. The additive under assessment is not a skin irritant. In the absence of data, it is not possible to conclude on the potential of the additive to be toxic by inhalation, irritant to eyes or a skin sensitiser. The amino acid l‐histidine is a natural component of plants and animals. The use of the additive under assessment in animal nutrition does not represent a risk to the environment. The additive is considered an efficacious source of the amino acid l‐histidine for fish species.https://doi.org/10.2903/j.efsa.2020.6072nutritional additiveamino acidl‐histidine monohydrochloride monohydrateEscherichia coli NITE SD 00268safety |
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English |
format |
Article |
sources |
DOAJ |
author |
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria deLourdes Bastos Henrik Christensen Birgit Dusemund Mojca Kos Durjava Maryline Kouba 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 Boet Glandorf Lieve Herman Alberto Mantovani Maria Saarela Kettil Svensson Luca Tosti Montserrat Anguita Elisa Pettenati Jordi Tarrés‐Call Fernando Ramos |
spellingShingle |
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria deLourdes Bastos Henrik Christensen Birgit Dusemund Mojca Kos Durjava Maryline Kouba 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 Boet Glandorf Lieve Herman Alberto Mantovani Maria Saarela Kettil Svensson Luca Tosti Montserrat Anguita Elisa Pettenati Jordi Tarrés‐Call Fernando Ramos Assessment of the application for renewal of authorisation of l‐histidine monohydrochloride monohydrate produced with Escherichia coli NITE SD 00268 for salmonids and its extension of use to other fin fish EFSA Journal nutritional additive amino acid l‐histidine monohydrochloride monohydrate Escherichia coli NITE SD 00268 safety |
author_facet |
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria deLourdes Bastos Henrik Christensen Birgit Dusemund Mojca Kos Durjava Maryline Kouba 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 Boet Glandorf Lieve Herman Alberto Mantovani Maria Saarela Kettil Svensson Luca Tosti Montserrat Anguita Elisa Pettenati Jordi Tarrés‐Call Fernando Ramos |
author_sort |
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
title |
Assessment of the application for renewal of authorisation of l‐histidine monohydrochloride monohydrate produced with Escherichia coli NITE SD 00268 for salmonids and its extension of use to other fin fish |
title_short |
Assessment of the application for renewal of authorisation of l‐histidine monohydrochloride monohydrate produced with Escherichia coli NITE SD 00268 for salmonids and its extension of use to other fin fish |
title_full |
Assessment of the application for renewal of authorisation of l‐histidine monohydrochloride monohydrate produced with Escherichia coli NITE SD 00268 for salmonids and its extension of use to other fin fish |
title_fullStr |
Assessment of the application for renewal of authorisation of l‐histidine monohydrochloride monohydrate produced with Escherichia coli NITE SD 00268 for salmonids and its extension of use to other fin fish |
title_full_unstemmed |
Assessment of the application for renewal of authorisation of l‐histidine monohydrochloride monohydrate produced with Escherichia coli NITE SD 00268 for salmonids and its extension of use to other fin fish |
title_sort |
assessment of the application for renewal of authorisation of l‐histidine monohydrochloride monohydrate produced with escherichia coli nite sd 00268 for salmonids and its extension of use to other fin fish |
publisher |
Wiley |
series |
EFSA Journal |
issn |
1831-4732 |
publishDate |
2020-04-01 |
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 Escherichia coli NITE SD 00268 in the context of the renewal of the authorisation for salmonids when used as a nutritional additive. In addition, the applicant requested the extension of use of the additive for other fin fish. The applicant has provided evidence that the composition of the additive currently in the market complies with the conditions of authorisation. The production strain has been modified by conventional mutagenesis and it does not raise safety concerns. The use of l‐histidine HCl monohydrate produced by fermentation using E. coli NITE SD 00268 is safe for salmonids and other fin fish when used as a nutritional additive to supplement the diet in appropriate amounts to cover the nutritional 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. The FEEDAP Panel considers the maximum total concentration of 1.7% histidine in feed for salmonids proposed by the applicant as safe. For other fin fish species, the level of 1.7% appears to cause adverse effects. Therefore, it is not possible to define a maximum concentration of histidine in fish other than salmonids as it depends on histidine nutritional requirements in the different fish species. The use of the authorised additive in salmonids production does not pose a risk for consumers, and the proposed maximum total concentration of 1.7% histidine in feed is considered safe for the consumer. l‐Histidine HCl monohydrate produced using E. coli NITE SD 00268 supplemented at levels appropriate to cover the nutritional requirements of fish other than salmonids is considered safe for the consumer. The additive under assessment is not a skin irritant. In the absence of data, it is not possible to conclude on the potential of the additive to be toxic by inhalation, irritant to eyes or a skin sensitiser. The amino acid l‐histidine is a natural component of plants and animals. The use of the additive under assessment in animal nutrition does not represent a risk to the environment. The additive is considered an efficacious source of the amino acid l‐histidine for fish species. |
topic |
nutritional additive amino acid l‐histidine monohydrochloride monohydrate Escherichia coli NITE SD 00268 safety |
url |
https://doi.org/10.2903/j.efsa.2020.6072 |
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