Safety and efficacy of l-lysine sulfate produced by fermentation using Corynebacterium glutamicum KFCC 11043 as a feed additive for all animal species

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 l-lysine sulfate produced by fermentation using Corynebacterium glutamicum KFCC 11043 when used as a nutritional additive in feed for all animal species. The active substance is l-lysine. The production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment and was not detected in the final product. l-Lysine sulfate produced using C. glutamicum KFCC 11043 does not pose any safety concern associated with the production strain. l-Lysine sulfate produced by C. glutamicum KFCC 11043 is considered safe for the target species. When using l-lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. l-Lysine sulfate produced by C. glutamicum KFCC 11043 is safe for the consumer and for the environment. From the results of studies on the safety for the user of l-lysine sulfate produced by a different production strain, it was possible to conclude on the safety for the user of the product under assessment. l-Lysine sulfate produced by C. glutamicum KFCC 11043 is considered non-toxic by inhalation, non-irritant to skin or eyes and it is not a skin sensitiser. l-lysine sulfate is considered as an 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.