Safety and efficacy of the feed additives consisting of l-isoleucine ≥ 90% and l-isoleucine ≥ 65% produced with Corynebacterium glutamicum KCCM 80388 for all animal species (CJ Europe GmbH)

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-isoleucine ≥ 90% and l-isoleucine ≥ 65% produced with a genetically modified strain of Corynebacterium glutamicum (KCCM 80388), as nutritional and sensory additives for use in feed and water for drinking, for all animal species and categories. l-Isoleucine ≥ 90% and l-isoleucine ≥ 65% manufactured by fermentation with C. glutamicum KCCM 80388 do not give rise to any safety concern with regard to the genetic modification of the production strain. No viable cells nor DNA of the production strain were detected in the final products. The use of l-isoleucine ≥ 90% and ≥ 65% produced with C. glutamicum KCCM 80388 in feed was considered safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the species. The FEEDAP Panel had concerns on the use of l-isoleucine ≥ 90% and ≥ 65% in water for drinking. The use of l-isoleucine ≥ 90% and ≥ 65% produced by fermentation with C. glutamicum KCCM 80388 in animal nutrition was considered safe for the consumers of products from animals receiving the additives, and for the environment. Regarding user safety, the additives were considered not irritant to skin and are not considered skin sensitisers. l-Isoleucine ≥ 90% was not irritant to eyes. No conclusions could be reached on the eye irritation potential of l-isoleucine ≥ 65%. The additives were regarded as an effective source of the amino acid l-isoleucine for all non-ruminant species. To be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation.