Safety and efficacy of a feed additive consisting of l‐arginine produced with Corynebacterium glutamicum KCCM 80393 for all animal species (Daesang Europe BV)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐arginine produced with a genetically modified strain of Corynebacterium glutamicum (KCCM 80393) when used as a nutritional additive in feed and water for drinking...

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Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Ilen Röhe, Katerina Theodoridou, Lieve Herman, Montserrat Anguita, Nicole Bozzi Cionci, Matteo L. Innocenti, Jordi Tarrés‐Call
Format: Article
Language:English
Published: Wiley 2025-05-01
Series:EFSA Journal
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Online Access:https://doi.org/10.2903/j.efsa.2025.9453
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author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Roberto Edoardo Villa
Giovanna Azimonti
Eleftherios Bonos
Henrik Christensen
Mojca Durjava
Birgit Dusemund
Ronette Gehring
Boet Glandorf
Maryline Kouba
Marta López‐Alonso
Francesca Marcon
Carlo Nebbia
Alena Pechová
Miguel Prieto‐Maradona
Ilen Röhe
Katerina Theodoridou
Lieve Herman
Montserrat Anguita
Nicole Bozzi Cionci
Matteo L. Innocenti
Jordi Tarrés‐Call
author_facet EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Roberto Edoardo Villa
Giovanna Azimonti
Eleftherios Bonos
Henrik Christensen
Mojca Durjava
Birgit Dusemund
Ronette Gehring
Boet Glandorf
Maryline Kouba
Marta López‐Alonso
Francesca Marcon
Carlo Nebbia
Alena Pechová
Miguel Prieto‐Maradona
Ilen Röhe
Katerina Theodoridou
Lieve Herman
Montserrat Anguita
Nicole Bozzi Cionci
Matteo L. Innocenti
Jordi Tarrés‐Call
author_sort EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
collection DOAJ
description Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐arginine produced with a genetically modified strain of Corynebacterium glutamicum (KCCM 80393) when used as a nutritional additive in feed and water for drinking for all animal species and categories. The Panel concluded that the product under assessment does not give rise to any safety concern with regard to the genetic modification of the production strain. No DNA of the production strain was detected in the final product. l‐Arginine produced by fermentation with C. glutamicum KCCM 80393 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of l‐arginine in water for drinking. The use of l‐arginine produced by fermentation with C. glutamicum KCCM 80393 in animal nutrition is considered safe for the consumers and for the environment. Regarding the user safety, in the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes, or to be a dermal or respiratory sensitiser. The additive l‐arginine produced by fermentation with C. glutamicum KCCM 80393 is regarded as an efficacious source of the essential amino acid l‐arginine for non‐ruminant nutrition. For the supplemental l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.
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spelling doaj-art-a4c4e4f35b4a4440990e9b0e63ad5b5b2025-08-20T03:21:38ZengWileyEFSA Journal1831-47322025-05-01235n/an/a10.2903/j.efsa.2025.9453Safety and efficacy of a feed additive consisting of l‐arginine produced with Corynebacterium glutamicum KCCM 80393 for all animal species (Daesang Europe BV)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Roberto Edoardo VillaGiovanna AzimontiEleftherios BonosHenrik ChristensenMojca DurjavaBirgit DusemundRonette GehringBoet GlandorfMaryline KoubaMarta López‐AlonsoFrancesca MarconCarlo NebbiaAlena PechováMiguel Prieto‐MaradonaIlen RöheKaterina TheodoridouLieve HermanMontserrat AnguitaNicole Bozzi CionciMatteo L. InnocentiJordi Tarrés‐CallAbstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐arginine produced with a genetically modified strain of Corynebacterium glutamicum (KCCM 80393) when used as a nutritional additive in feed and water for drinking for all animal species and categories. The Panel concluded that the product under assessment does not give rise to any safety concern with regard to the genetic modification of the production strain. No DNA of the production strain was detected in the final product. l‐Arginine produced by fermentation with C. glutamicum KCCM 80393 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of l‐arginine in water for drinking. The use of l‐arginine produced by fermentation with C. glutamicum KCCM 80393 in animal nutrition is considered safe for the consumers and for the environment. Regarding the user safety, in the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes, or to be a dermal or respiratory sensitiser. The additive l‐arginine produced by fermentation with C. glutamicum KCCM 80393 is regarded as an efficacious source of the essential amino acid l‐arginine for non‐ruminant nutrition. For the supplemental l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.https://doi.org/10.2903/j.efsa.2025.9453amino acidCorynebacterium glutamicum KCCM 80393efficacyl‐argininenutritional additivesafety
spellingShingle EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Roberto Edoardo Villa
Giovanna Azimonti
Eleftherios Bonos
Henrik Christensen
Mojca Durjava
Birgit Dusemund
Ronette Gehring
Boet Glandorf
Maryline Kouba
Marta López‐Alonso
Francesca Marcon
Carlo Nebbia
Alena Pechová
Miguel Prieto‐Maradona
Ilen Röhe
Katerina Theodoridou
Lieve Herman
Montserrat Anguita
Nicole Bozzi Cionci
Matteo L. Innocenti
Jordi Tarrés‐Call
Safety and efficacy of a feed additive consisting of l‐arginine produced with Corynebacterium glutamicum KCCM 80393 for all animal species (Daesang Europe BV)
EFSA Journal
amino acid
Corynebacterium glutamicum KCCM 80393
efficacy
l‐arginine
nutritional additive
safety
title Safety and efficacy of a feed additive consisting of l‐arginine produced with Corynebacterium glutamicum KCCM 80393 for all animal species (Daesang Europe BV)
title_full Safety and efficacy of a feed additive consisting of l‐arginine produced with Corynebacterium glutamicum KCCM 80393 for all animal species (Daesang Europe BV)
title_fullStr Safety and efficacy of a feed additive consisting of l‐arginine produced with Corynebacterium glutamicum KCCM 80393 for all animal species (Daesang Europe BV)
title_full_unstemmed Safety and efficacy of a feed additive consisting of l‐arginine produced with Corynebacterium glutamicum KCCM 80393 for all animal species (Daesang Europe BV)
title_short Safety and efficacy of a feed additive consisting of l‐arginine produced with Corynebacterium glutamicum KCCM 80393 for all animal species (Daesang Europe BV)
title_sort safety and efficacy of a feed additive consisting of l arginine produced with corynebacterium glutamicum kccm 80393 for all animal species daesang europe bv
topic amino acid
Corynebacterium glutamicum KCCM 80393
efficacy
l‐arginine
nutritional additive
safety
url https://doi.org/10.2903/j.efsa.2025.9453
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