Scientific opinion on the safety and efficacy of concentrated liquid L‐lysine (base), concentrated liquid L‐lysine monohydrochloride and L‐lysine monohydrochloride produced by Escherichia coli (FERM BP‐10941) for all animal species, based on three dossiers submitted by Ajinomoto Eurolysine SAS

Abstract

Concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride (HCl) and L-lysine HCl technically pure are produced by fermentation with a genetically modified Escherichia coli (FERM BP-10941). Neither the production strain nor its recombinant DNA was detected in any of the final products. The final products do not raise any safety concern with regard to the genetic modifications. Concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure are considered safe for target species when supplemented in appropriate amounts. Lysine produced by E. coli (FERM BP-10941) is not genotoxic and the results of subchronic studies do not indicate any specific concerns. As there are no lysine metabolites associated with safety concerns in the animal tissues and products, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) considers that the use of L-lysine and its hydrochloride salts in animal feed does not pose a risk for the consumer. Concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure are not considered to have the potential to cause respiratory toxicity, skin or eye irritation or skin sensitisation, but respiratory sensitisation cannot be excluded. L-Lysine is a substance naturally occurring in bacteria, plants and animals. The use of L-lysine-containing feed additives does not represent a risk to the environment. Concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure are considered equivalent in terms of L-lysine availability to the target animals. The efficacy of supplementing L-lysine and its hydrochloride salts is extensively demonstrated in the literature for mammals (except ruminants), poultry and fish, including its use in a liquid or a powder form. Therefore it does not require any further demonstration. Response in ruminants requires some degree of protection of L-lysine from ruminal degradation.