Safety and efficacy of l-lysine monohydrochloride and l-lysine sulfate produced using Corynebacterium glutamicum CGMCC 7.266 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 monohydrochloride and l-lysine sulfate produced using Corynebacterium glutamicum CGMCC 7.266 when used as a nutritional additive in feed and water for drinking for all animal species. The active substance is l-lysine and it is produced in two different forms (monohydrochloride or sulfate salts). None of those forms pose any safety concern associated with the genetic modification of the production strain. l-Lysine HCl and l-lysine sulfate produced by C. glutamicum CGMCC 7.266 are considered safe for the target species, for the consumer and for the environment. For both products, the FEEDAP Panel has concerns regarding the safety for the target species when the additives are administered via feed and water for drinking, simultaneously. In the absence of data, the FEEDAP Panel cannot conclude on the safety of both forms of the additive for the user. The products under assessment are considered efficacious sources of the amino acid l-lysine for all animal species. For these products to be as efficacious in ruminants as in non-ruminant species, they require protection against degradation in the rumen.

Keywords: amino acid; efficacy; lysine monohydrochloride; lysine sulfate; nutritional additive; safety.