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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

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 aL-lysine monohydrochloride (HCl, minimum 98.5%)and of a concentrated liquidL-lysine (base, minimum 50%) produced by genetically modified strains ofCorynebacterium glutamicum(NRRL-B-67439 or NRRL B-67535). They are intended to be used in feedor water for drinking for all animal species and categories. Neither viable cells of the production strainsC. glutamicumstrains NRRLB-67439 or NRRL B-67535; nor their recombinant DNA were detected inthefinal products. Therefore, those products do not pose any safety concern associated with thegenetic modification of the production strains.L-Lysine HCl and concentrated liquidL-lysine (base)produced byC. glutamicumstrains NRRLB-67439 or NRRL B-67535 are considered safe for the targetspecies, for the consumer and for the environment.L-Lysine HCl produced byC. glutamicumstrainsNRRL B-67439 or NRRL B-67535 is considered not irritant to skin or eyes and not a skin sensitiser. Inthe absence of data, the FEEDAP Panel cannot conclude on the potential toxicity by inhalation ofL-lysine HCl produced byC. glutamicumstrains NRRL B-67439 or NRRL B-67535. Concentrated liquidL-lysine (base) produced byC. glutamicumstrains 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 byinhalation.L-Lysine HCl and concentrated liquidL-lysine (base) produced byC. glutamicumstrainsNRRLB-67439 or NRRL B-67535 are considered as efficacious sources of the essential amino acidL-lysine for non-ruminant animal species. For the supplementalL-lysine to be as efficacious in ruminantsas in non-ruminant species, it would require protection against degradation in the rumen.



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