Dataset Information

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

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.

SUBMITTER: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

PROVIDER: S-EPMC7372484 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Bampidis Vasileios V Azimonti Giovanna G Bastos Maria de Lourdes ML Christensen Henrik H Dusemund Birgit B Kos Durjava Mojca M Kouba Maryline M López-Alonso Marta M López Puente Secundino S Marcon Francesca F Mayo Baltasar B Pechová Alena A Petkova Mariana M Ramos Fernando F Sanz Yolanda Y Villa Roberto Edoardo RE Woutersen Ruud R Dierick Noёl N Glandorf Boet B Herman Lieve L Anguita Montserrat M Galobart Jaume J Holczknecht Orsolya O Manini Paola P Pettenati Elisa E Pizzo Fabiola F Tarrés-Call Jordi J

EFSA journal. European Food Safety Authority 20200721 7

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 <i>Corynebacterium glutamicum</i> 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 ...[more]

PMID: 32704318

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Project description: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 the safety and efficacy of l-glutamine (? 98.0%) produced by fermentation using a genetically modified strain of Corynebacterium glutamicum (NITE BP-02524). It is intended to be used in feed for all animal species and categories as nutritional additive (amino acid) and as sensory additive (flavouring compound). Viable cells of the production strain and its recombinant DNA were not detected in the additive. l-Glutamine manufactured by fermentation using C. glutamicum NITE BP-02524 does not give rise to any safety concern with regard to the genetic modification of the production strain. The use of l-glutamine produced by fermentation using C. glutamicum NITE BP-02524 in animal nutrition is considered safe for all animal species when applied as a nutritional additive to achieve an adequate amino acid profile in feed and to overcome potential glutamine shortages during critical periods of life. The proposed use level (25 mg/kg feed) when used as sensory additive (flavouring compound) is safe for all animal species. The uses of l-glutamine produced using C. glutamicum NITE BP-02524 as nutritional additive or as flavouring compound are considered safe for the consumer. l-Glutamine produced using C. glutamicum NITE BP-02524 is not toxic by inhalation, is non-irritant to skin and eyes and is not a skin sensitiser. l-Glutamine produced using C. glutamicum NITE BP-02524 is considered safe for the environment. l-glutamine is a non-essential amino acid and it plays a physiological role as such. Recent evidence shows that glutamine may act as conditionally essential amino acid mainly in growing animals and has some specific effects e.g. in improving intestinal development and immune response. This amino acid produced by fermentation using C. glutamicum NITE BP-02524 is regarded as an efficacious source of glutamine for all animal species. For supplemental l-glutamine to be as efficacious in ruminants as in non-ruminants, it would require protection against degradation in the rumen. The use of l-glutamine as sensory additive at 25 mg/kg feed is considered efficacious.

Dataset Information

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

Publications

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

Similar Datasets

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