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

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 concentrated liquid L-lysine (base) produced using Corynebacterium glutamicum KCCM 10227 when used as nutritional additives in feed and water for drinking for all animal species. The active substance is L-lysine. L-lysine HCl and concentrated liquid L-lysine (base) produced by the strain C. glutamicum KCCM 10227 do not represent a risk for the target species, the consumer and the environment. L-lysine HCl produced by C. glutamicum KCCM 10227 is hazardous by inhalation, it is not irritant to skin but mildly irritant to eyes and it is not a skin sensitiser. Concentrated liquid L-lysine (base) produced by C. glutamicum KCCM 10227 is hazardous by inhalation, not irritant to skin and eyes and it is not a skin sensitiser. L-lysine HCl and concentrated liquid L-lysine (base) 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 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)

“…31 In all those studies, however, the test item was concentrated liquid L-lysine (base) produced by a different species (C. glutamicum KCCM 10227). Those studies had been assessed in a previous opinion (EFSA FEEDAP Panel, 2019d). As the production process is the same and the product characteristics are very similar, the FEEDAP Panel considers that the results of those studies can be applicable to the product under assessment.…”

“…The acute inhalation toxicity studies, in vitro skin irritation studies, in vitro eye irritation studies, and skin sensitisation studies submitted were conducted using as a test item the concentrated liquid L-lysine (base) or L-lysine HCl of a different production strain (C. glutamicum KCCM 10227). 44 These studies had been evaluated in a previous opinion (EFSA FEEDAP Panel, 2019d). As the characteristics of the products L-lysine HCl and concentrated liquid L-lysine (base) of the two different production strains are very similar, the production process is the same and the production strains qualify for the QPS assessment, the FEEDAP Panel considers that the results of these studies are applicable to the L-lysine HCl and concentrated liquid L-lysine (base) under assessment.…”

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 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.…”