Safety and efficacy of a feed additive consisting of l-isoleucine produced by Corynebacterium glutamicum KCCM 80185 for all animal species (CJ Europe GmbH)

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 the safety and efficacy of a feed additive consisting of l-isoleucine produced by Corynebacterium glutamicum KCCM 80185 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain is genetically modified, does not carry acquired antimicrobial resistance genes and no viable cells of the production strain were detected in the final product. The FEEDAP Panel could not exclude the presence of recombinant DNA from the production strain in the product. However, since no sequences of concern remain in the final production strain, the potential presence of recombinant DNA in the final product does not raise any safety concerns. The Panel concluded that the additive is safe for the target species, for the consumer and for the environment under the proposed conditions of use. Regarding the use in water, the FEEDAP Panel reiterated its concerns over the safety of l-isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. The FEEDAP Panel concluded that l-isoleucine produced by C. glutamicum KCCM 80185 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. However, due to the high dusting potential, exposure to dust per se might be a hazard for the user. l-Isoleucine produced by C. glutamicum KCCM 80185 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.