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

Abstract

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. ABSTRACTThe 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. for the preparatory work on this scientific opinion.L-Lysine HCl and L-lysine sulphate for all animal species EFSA Journal 2015;15 (7):4156 2 SUMMARYFollowing 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 (HCl), technically pure, produced by microbial fermentation using a genetically modified strain of Escherichia coli (CGMCC 3705) and L-lysine sulphate produced by fermentation using a genetically modified strain of strain of Corynebacterium glutamicum (CGMCC 3704), for all animal species.L-Lysine is an essential amino acid for all animal species. L-Lysine and its salts are widely used in the feed industry to optimise dietary protein.With respect to the product L-lysine HCl under assessme...

Safety and efficacy of the feed additives concentrated liquid l‐lysine (base) and l‐lysine monohydrochloride produced by Corynebacterium glutamicum KCCM 80183 for all animal species (CJ Europe GmbH)

“…7,8 L-Lysine hydrochloride is described in a monograph of the European Pharmacopoeia (PhEur, 2019). The Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has published several opinions on the safety and efficacy of L-lysine and/or its salts produced by fermentation using different strains of C. glutamicum for all animal species (EFSA, 2007a;EFSA FEEDAP Panel, 2015b, 2016b, 2019a,b,c,d,e, 2020a; one opinion on the safety and efficacy of concentrated liquid L-lysine (base) and L-lysine HCl produced by fermentation with Corynebacterium casei KCCM 80190 for all animal species (EFSA FEEDAP Panel, 2020d); and others on the safety and efficacy of L-lysine and/or its salts produced by fermentation using different strains of Escherichia coli (EFSA FEEDAP Panel, 2013, 2014, 2015a,b,c, 2016a, 2017a).…”

Safety and efficacy of concentrated liquid l‐lysine (base) and l‐lysine monohydrochloride produced by fermentation with Corynebacterium casei KCCM 80190 as feed additives for all animal species

“…The additives under assessment are concentrated liquid L-lysine (base) and L-lysine monohydrochloride, produced by fermentation using C. casei KCCM 80190. The scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has published several opinions on the safety and efficacy of L-lysine and/or its salts produced by fermentation using different strains of C. glutamicum for all animal species (EFSA, 2007;EFSA FEEDAP Panel, 2015b, 2016b, 2017a, 2019a,-d, 2020a; and other opinions on the safety and efficacy of L-lysine and/or its salts produced by fermentation using different strains of Escherichia coli (EFSA FEEDAP Panel, 2013, 2014, 2015a-c, 2016a.…”

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain KCCM 10227 for all animal species

“…The scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has published several opinions on the safety and efficacy of L-lysine and/or its salts produced by fermentation using different strains of C. glutamicum for all animal species (EFSA, 2007;EFSA FEEDAP Panel, 2015b, 2016b, 2017a, 2019a, and others on the safety and efficacy of L-lysine and/or its salts produced by fermentation using different strains of Escherichia coli (EFSA FEEDAP Panel, 2013, 2014, 2015a,b,c, 2016a). …”