Scientific Opinion on the safety and efficacy of L-lysine monohydrochloride, technically pure, produced with Escherichia coli CGMCC 3705 and L-lysine sulphate produced with Corynebacterium glutamicum CGMCC 3704 for all animal species, based on a dossier submitted by HELM AG

The products L-lysine monohydrochloride (HCl) and L-lysine sulphate are feed additives produced by fermentation with genetically modified strains of Escherichia coli (CGMCC 3705) and Corynebacterium glutamicum (CGMCC 3704), respectively. Neither the E. coli production strain nor its recombinant DNA was detected in the final product. Therefore, the product L-lysine HCl does not give rise to any safety concern with regard to the genetic modification of the production strain. The product L-lysine HCl is considered safe for target species when supplemented in appropriate amounts. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concerns about the safety of L-lysine HCl for target species when administered via water for drinking. The use of concentrated L-lysine HCl does not give rise to safety concerns for the consumer. L-lysine HCl produced by E. coli CGMCC 3705 is not considered as a skin or eye irritant or skin sensitiser. The product should be considered a hazard by inhalation. With respect to L-lysine sulphate, the insufficient characterisation of the genetic modification of the production strain and uncertainties about the possible absence/presence of its recombinant DNA, including antibiotic resistance genes, in the product do not allow to conclude on the safety of L-lysine sulphate product for target species, consumers, users and the environment. L-Lysine sulphate produced by C. glutamicum CGMCC 3704 is not a skin or eye irritant or skin sensitiser. The product should be considered a hazard by inhalation. The products L-lysine HCl and L-lysine sulphate are regarded as efficacious sources of the supplemental amino acid L-lysine for maintaining or restoring the adequate balance of dietary amino acids, for all non-ruminant species. For the supplemental L-lysine to be as efficacious in ruminants as in non-ruminant species, it must be protected from degradation in the rumen.