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Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species

The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by genetically modified strains of Co...

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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, Ramos, Fernando, Sanz, Yolanda, Villa, Roberto Edoardo, Woutersen, Ruud, Costa, Lucio, Cubadda, Francesco, Dierick, Noël, Flachowsky, Gerhard, Glandorf, Boet, Herman, Lieve, Mantovani, Alberto, Anguita, Montserrat, Tarrés‐Call, Jordi
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/PMC7008832/
https://www.ncbi.nlm.nih.gov/pubmed/32626174
http://dx.doi.org/10.2903/j.efsa.2019.5886
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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
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Costa, Lucio
Cubadda, Francesco
Dierick, Noël
Flachowsky, Gerhard
Glandorf, Boet
Herman, Lieve
Mantovani, Alberto
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
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Costa, Lucio
Cubadda, Francesco
Dierick, Noël
Flachowsky, Gerhard
Glandorf, Boet
Herman, Lieve
Mantovani, Alberto
Anguita, Montserrat
Tarrés‐Call, Jordi
Ramos, Fernando
collection PubMed
description The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by genetically modified strains of Corynebacterium glutamicum (NRRL‐B‐67439 or NRRL B‐67535). They are intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains C. glutamicum strains NRRLB‐67439 or NRRL B‐67535; nor their recombinant DNA were detected in the final products. Therefore, those products do not pose any safety concern associated with the genetic modification of the production strains. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered safe for the target species, for the consumer and for the environment. l‐Lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535 is considered not irritant to skin or eyes and not a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential toxicity by inhalation of l‐lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535. Concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535, due to its high pH (10.7 and 10.9, respectively) is anticipated to be corrosive to skin and eyes and poses a risk by inhalation. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered as efficacious sources of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine 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-70088322020-07-02 Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 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 Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Costa, Lucio Cubadda, Francesco Dierick, Noël Flachowsky, Gerhard Glandorf, Boet Herman, Lieve Mantovani, Alberto Anguita, Montserrat Tarrés‐Call, Jordi Ramos, Fernando EFSA J Scientific Opinion The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by genetically modified strains of Corynebacterium glutamicum (NRRL‐B‐67439 or NRRL B‐67535). They are intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains C. glutamicum strains NRRLB‐67439 or NRRL B‐67535; nor their recombinant DNA were detected in the final products. Therefore, those products do not pose any safety concern associated with the genetic modification of the production strains. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered safe for the target species, for the consumer and for the environment. l‐Lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535 is considered not irritant to skin or eyes and not a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential toxicity by inhalation of l‐lysine HCl produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535. Concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRL B‐67439 or NRRL B‐67535, due to its high pH (10.7 and 10.9, respectively) is anticipated to be corrosive to skin and eyes and poses a risk by inhalation. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum strains NRRLB‐67439 or NRRL B‐67535 are considered as efficacious sources of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine 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. 2019-11-07 /pmc/articles/PMC7008832/ /pubmed/32626174 http://dx.doi.org/10.2903/j.efsa.2019.5886 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
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Costa, Lucio
Cubadda, Francesco
Dierick, Noël
Flachowsky, Gerhard
Glandorf, Boet
Herman, Lieve
Mantovani, Alberto
Anguita, Montserrat
Tarrés‐Call, Jordi
Ramos, Fernando
Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species
title Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species
title_full Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species
title_fullStr Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species
title_full_unstemmed Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species
title_short Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species
title_sort safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using corynebacterium glutamicum strains nrrl‐b‐67439 or nrrl b‐67535 for all animal species
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008832/
https://www.ncbi.nlm.nih.gov/pubmed/32626174
http://dx.doi.org/10.2903/j.efsa.2019.5886
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