Safety and efficacy of a feed additive consisting of L‐lysine sulfate produced by fermentation with Corynebacterium glutamicum CGMCC 7.453 for all animal species (Eppen Europe SAS)

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 with a genetically modified strain of <i>Corynebacterium glutamicum</i> (CGMCC 7.453) when used as a nutritional additive in feed for all animal species. The active substance is L-lysine. The FEEDAP Panel concluded that the production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment; therefore, L-lysine sulfate produced with <i>C. glutamicum</i> CGMCC 7.453 does not pose any safety concern associated with the production strain. L-Lysine sulfate produced with <i>C. glutamicum</i> CGMCC 7.453 is considered safe for the target species. The FEEDAP Panel has concerns on the use of L-lysine sulfate in water for drinking. When using L-lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. L-Lysine sulfate produced with <i>C. glutamicum</i> CGMCC 7.453 is safe for the consumer and for the environment. Based on the information provided in the safety data sheet of the additive under assessment, the FEEDAP Panel concludes that the additive should be considered irritant to skin, eyes and the respiratory tract, and that any exposure to the additive is a risk. L-Lysine sulfate is considered 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.