Safety and efficacy of a feed additive consisting of l-lysine monohydrochloride and l-lysine sulfate produced by Corynebacterium glutamicum CGMCC 14498 for all animal species (Kempex Holland BV).

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 (l‐lysine HCl) and l‐lysine sulfate produced by Corynebacterium glutamicum (C. glutamicum) CGMCC 14498 as a nutritional feed additive for all animal species. The active substance is l‐lysine and it is produced in two different forms (monohydrochloride or sulfate). The production strain C. glutamicum CGMCC 14498 and its recombinant DNA were not detected in the final products. The products l‐lysine HCl and l‐lysine sulfate do not pose any safety concern associated with the production strain. l‐Lysine HCl and l‐lysine sulfate produced by C. glutamicum CGMCC 14498 are 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 HCl and l‐lysine sulfate produced by C. glutamicum CGMCC 14498 are safe for the consumer and the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of l‐lysine HCl produced by the strain C. glutamicum CGMCC 14498 to be toxic by inhalation, and on the potential of l‐lysine HCl and l‐lysine sulfate produced by the above‐mentioned strain to be irritant to skin or eyes, or on their potential to be dermal sensitisers. l‐Lysine HCl and l‐lysine sulfate produced by C. glutamicum CGMCC 14498 are considered efficacious sources 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, this would require protection against degradation in the rumen.