Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of L-valine produced by fermentation using the non-genetically modified strain of Corynebacterium glutamicum KCCM 80366 as a nutritional feed additive for all animal species and categories. In the manufacturing process used to obtain the product under assessment, the cells from the production strain are inactivated but not removed from the final product. The FEEDAP Panel concluded that the production strain follows the qualified presumption of safety (QPS) approach to safety assessment, as the strain does not harbour any gene of concern and no viable cells of the strain were detected in the final product. The use of L-valine produced using C. glutamicum KCCM 80366 in animal nutrition is considered safe for all animal species, the consumers of products from animals receiving the additive, and the environment. Regarding the safety for the users, the additive is not considered irritant to skin but was considered a potential skin and respiratory sensitiser. The FEEDAP Panel could not conclude on the potential of the additive to be irritant to eyes. Any exposure to the additive is a risk. The additive was regarded as an effective source of the amino acid L-valine for all non-ruminant species. To be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation.