EFSA Journal (Apr 2024)

Safety and efficacy of a feed additive consisting of l‐isoleucine produced with Corynebacterium glutamicum CGMCC 20437 for all animal species (Eppen Europe SAS)

  • EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),
  • Vasileios Bampidis,
  • Giovanna Azimonti,
  • Maria de Lourdes Bastos,
  • Henrik Christensen,
  • Mojca Durjava,
  • Birgit Dusemund,
  • Maryline Kouba,
  • Marta López‐Alonso,
  • Secundino López Puente,
  • Francesca Marcon,
  • Baltasar Mayo,
  • Alena Pechová,
  • Mariana Petkova,
  • Fernando Ramos,
  • Roberto Edoardo Villa,
  • Ruud Woutersen,
  • Anna Dioni,
  • Joana Firmino,
  • Matteo Innocenti,
  • Jordi Tarrés‐Call

DOI
https://doi.org/10.2903/j.efsa.2024.8726
Journal volume & issue
Vol. 22, no. 4
pp. n/a – n/a

Abstract

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Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 as a nutritional feed additive for use in feed and in water for drinking for all animal species. The production strain is non‐genetically modified, qualifies for the QPS approach to safety assessment when used for production purposes, is susceptible to the relevant antibiotics and contains no antimicrobial resistance genes of concern. No viable cells of the production strain were detected in the final product. The additive does not give rise to any safety concern regarding the production strain. l‐Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered safe for the target species, the consumer and the environment. Regarding the use in water, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reiterates its concerns over the safety for the target species of l‐isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. In the absence of data, the FEEDAP Panel is not in a position to conclude on the potential of l‐isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 to be irritant to skin and/or eyes, or as a dermal sensitiser. Due to the high dusting potential, exposure by inhalation is likely. l‐Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered as an efficacious source of the essential amino acid l‐isoleucine for non‐ruminant animal species. For the supplemental l‐isoleucine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.

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