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

nutritional additive, amino acid, lysine monohydrochloride, lysine base, safety, efficacy, Corynebacterium glutamicum
First published in the EFSA Journal
7 novembre 2019
Adopted
7 ottobre 2019
Type
Scientific Opinion

Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.

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.

Substances
lysine
Cas: 56-87-1
Inchi: InChI=1S/C6H14N2O2/c7-4-2-1-3-5(8)6(9)10/h5H,1-4,7-8H2,(H,9,10)/t5-/m0/s1
Iupac: (2S)-2,6-diaminohexanoic acid
lysine
Cas: 56-87-1
Inchi: InChI=1S/C6H14N2O2/c7-4-2-1-3-5(8)6(9)10/h5H,1-4,7-8H2,(H,9,10)/t5-/m0/s1
Iupac: (2S)-2,6-diaminohexanoic acid

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5886
EFSA Journal 2019;17(11):5886
On request from
European Commission