Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-lysine monohydrochloride produced by fermentation with a genetically modified strain of Corynebacterium glutamicum (CGMCC 7.453) as nutritional feed additive for all animal species. Neither viable cells nor recombinant DNA of the production strain were detected in the final product. Therefore, the FEEDAP Panel concluded that the additive does not pose any safety concern regarding the production strain. The FEEDAP Panel concluded that the use of l-lysine HCl produced by fermentation with the strain C. glutamicum CGMCC 7.453 is safe for the target species when administered via feed. However, the FEEDAP Panel expressed concerns on the use of l-lysine HCl in water for drinking. The Panel concluded that the use of l-lysine HCl produced by fermentation with C. glutamicum CGMCC 7.453 in animal nutrition is considered safe for the consumers and for the environment. With regards user safety, the additive should be considered irritant to skin, eyes and the respiratory tract. Any exposure to the additive is a risk. l-Lysine HCl is considered as efficacious source of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.