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Safety and efficacy of l‐lysine sulfate produced by fermentation using Corynebacterium glutamicum KFCC 11043 as a feed additive for all animal species.

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Title: Safety and efficacy of l‐lysine sulfate produced by fermentation using Corynebacterium glutamicum KFCC 11043 as a feed additive for all animal species.
Authors: Bampidis, Vasileios (AUTHOR), Azimonti, Giovanna (AUTHOR), Bastos, Maria de Lourdes (AUTHOR), Christensen, Henrik (AUTHOR), Dusemund, Birgit (AUTHOR), Kos Durjava, Mojca (AUTHOR), Kouba, Maryline (AUTHOR), López‐Alonso, Marta (AUTHOR), López Puente, Secundino (AUTHOR), Marcon, Francesca (AUTHOR), Mayo, Baltasar (AUTHOR), Pechová, Alena (AUTHOR), Petkova, Mariana (AUTHOR), Ramos, Fernando (AUTHOR), Sanz, Yolanda (AUTHOR), Villa, Roberto Edoardo (AUTHOR), Woutersen, Ruud (AUTHOR), Dierick, Noёl (AUTHOR), Glandorf, Boet (AUTHOR), Herman, Lieve (AUTHOR)
Source: EFSA Journal. Jul2020, Vol. 18 Issue 7, p1-14. 14p.
Subject Terms: *Sulfates, Corynebacterium glutamicum, Animal species, Feed additives, Essential amino acids
Company/Entity: European Commission
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‐lysine sulfate produced by fermentation using Corynebacterium glutamicum KFCC 11043 when used as a nutritional additive in feed for all animal species. The active substance is l‐lysine. The production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment and was not detected in the final product. l‐Lysine sulfate produced using C. glutamicum KFCC 11043 does not pose any safety concern associated with the production strain. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is considered safe for the target species. When using l‐lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is safe for the consumer and for the environment. From the results of studies on the safety for the user of l‐lysine sulfate produced by a different production strain, it was possible to conclude on the safety for the user of the product under assessment. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is considered non‐toxic by inhalation, non‐irritant to skin or eyes and it is not a skin sensitiser. l‐lysine sulfate is considered as an efficacious source 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. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Safety and efficacy of l‐lysine sulfate produced by fermentation using Corynebacterium glutamicum KFCC 11043 as a feed additive for all animal species.
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  Data: *<searchLink fieldCode="DE" term="%22Sulfates%22">Sulfates</searchLink><br /><searchLink fieldCode="DE" term="%22Corynebacterium+glutamicum%22">Corynebacterium glutamicum</searchLink><br /><searchLink fieldCode="DE" term="%22Animal+species%22">Animal species</searchLink><br /><searchLink fieldCode="DE" term="%22Feed+additives%22">Feed additives</searchLink><br /><searchLink fieldCode="DE" term="%22Essential+amino+acids%22">Essential amino acids</searchLink>
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– Name: Abstract
  Label: Abstract
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  Data: 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‐lysine sulfate produced by fermentation using Corynebacterium glutamicum KFCC 11043 when used as a nutritional additive in feed for all animal species. The active substance is l‐lysine. The production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment and was not detected in the final product. l‐Lysine sulfate produced using C. glutamicum KFCC 11043 does not pose any safety concern associated with the production strain. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is considered safe for the target species. When using l‐lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is safe for the consumer and for the environment. From the results of studies on the safety for the user of l‐lysine sulfate produced by a different production strain, it was possible to conclude on the safety for the user of the product under assessment. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is considered non‐toxic by inhalation, non‐irritant to skin or eyes and it is not a skin sensitiser. l‐lysine sulfate is considered as an efficacious source 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. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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