Safety and efficacy of a feed additive consisting of l-leucine produced with Corynebacterium glutamicumKCCM 80421 for all animal species (CJ Europe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-leucine produced with a genetically modified strain of Corynebacterium glutamicum (KCCM 80421) when used as nutritional (amino acid) and/or sensory (flavouring compound) feed additive in feed and water for drinking for all animal species and categories. The l-leucine manufactured by fermentation with C. glutamicum KCCM 80421 did not give rise to any safety concern regarding the genetic modifications of the production strain. No viable cells nor DNA of the production strain were detected in the final product. The use of l-leucine produced with C. glutamicum KCCM 80421 in feed was considered safe for the target species when used as amino acid to supplement in appropriate amounts the diet, according to the nutritional needs of the target species; or when used as a flavouring compound. The FEEDAP Panel had concerns on the use of l-leucine in water for drinking. The use of l-leucine produced by fermentation with C. glutamicum KCCM 80421 in animal nutrition as amino acid or a flavouring compound was considered safe for the consumers of products from animals receiving the additive and for the environment. Regarding the user safety, the additive was not considered irritant to skin or eyes and was not considered a potential skin sensitiser. The additive was regarded as an effective source of the amino acid l-leucine for all non-ruminant species. To be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation. l-Leucine was considered efficacious when used as a flavouring compound in animal nutrition.