Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species

Abstract

The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a L-lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid L-lysine (base, minimum 50%) produced by genetically modified strains of Corynebacterium glutamicum (NRRL-B-67439 or NRRL B-67535). They are intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains C. glutamicum strains NRRLB-67439 or NRRL B-67535; nor their recombinant DNA were detected in the final products. Therefore, those products do not pose any safety concern associated with the genetic modification of the production strains. L-Lysine HCl and concentrated liquid L-lysine (base) produced by C. glutamicum strains NRRLB-67439 or NRRL B-67535 are considered safe for the target species, for the consumer and for the environment. L-Lysine HCl produced by C. glutamicum strains NRRL B-67439 or NRRL B-67535 is considered not irritant to skin or eyes and not a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential toxicity by inhalation of L-lysine HCl produced by C. glutamicum strains NRRL B-67439 or NRRL B-67535. Concentrated liquid L-lysine (base) produced by C. glutamicum strains NRRL B-67439 or NRRL B-67535, due to its high pH (10.7 and 10.9, respectively) is anticipated to be corrosive to skin and eyes and poses a risk by inhalation. L-Lysine HCl and concentrated liquid L-lysine (base) produced by C. glutamicum strains NRRLB-67439 or NRRL B-67535 are considered as 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, it would require protection against degradation in the rumen.

Safety and efficacy of l‐lysine sulfate produced by fermentation using Corynebacterium glutamicum KFCC 11043 as a feed additive for all animal species

“…With regard to the high content of sulfate in l ‐lysine sulfate, the EFSA FEEDAP Panel (, b, c, d, e, , b) already concluded that the formulation of the complete feed should carefully take into account the maximum tolerable level of total sulfur, as established by NRC () and set in ruminant diets at 3 g S/kg DM (diet rich in concentrate) and at 5 g S/kg DM (diet rich in roughage) and in non‐ruminant diets at 4 g S/kg DM. Also, the contribution of S/sulfate present in water for drinking to the total S intake should be considered, especially when the content is high…”

“…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 C. glutamicum for all animal species (EFSA, 2007a; EFSA FEEDAP Panel , , , b, c, d, e, , b); and three opinions on the safety and efficacy of concentrated liquid l ‐lysine (base), concentrated liquid l ‐lysine monohydrochloride and/or l ‐lysine monohydrochloride produced by Escherichia coli for all animal species (EFSA FEEDAP Panel, , , , b, c, , ).…”

Safety and efficacy of a feed additive consisting of l‐lysine sulfate produced by Escherichia coli CGMCC 7.398 for all animal species (Kempex Holland B.V.)

“…EFSA issued several opinions on the safety and efficacy of l ‐lysine and/or its salts produced by fermentation by different strains of Corynebacterium glutamicum (EFSA, 2007 ; EFSA FEEDAP Panel, 2015b , 2016b , 2019a–e , 2020a , b , c , 2021a , b , c ); Corynebacterium casei (EFSA FEEDAP Panel, 2020d ); or other strains of E. coli (EFSA FEEDAP Panel, 2013 , 2014 , 2015a , b , c , 2016a , 2017a ) when used in feed and/or in water for drinking for all animal species.…”

Safety and efficacy of a feed additive consisting of l‐lysine sulfate produced by Corynebacterium glutamicum KCCM 80227 for all animal species (Daesang Europe BV)

“…EFSA has issued several opinions on the safety and efficacy of l ‐lysine and/or its salts produced by fermentation with different strains of C. glutamicum (EFSA, 2007a; EFSA FEEDAP Panel, 2015b, 2016b, 2019a,b,c,d,e, 2020a,b,c), Corynebacterium casei (EFSA FEEDAP Panel, 2020d) or Escherichia coli (EFSA FEEDAP Panel, 2013, 2014, 2015a,b,c, 2016a, 2017a) when used in feed and/or in water for drinking for all animal species.…”