Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

nutritional additive, amino acids, concentrated liquid L-lysine base, L-lysine monohydrochloride, safety
First published in the EFSA Journal
31 gennaio 2019
Adopted
28 novembre 2018
Type
Scientific Opinion

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 a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. glutamicum NRRL B‐50775 nor its recombinant DNA was detected in the final product. Therefore, the product does not pose any safety concern associated with the genetic modification of the production strain. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum NRRL B‐50775 are considered safe for the target species, for the consumer and for the environment. l‐Lysine HCl produced by C. glutamicum NRRL B‐50775 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 NRRL B‐50775. Concentrated liquid l‐lysine (base) produced by C. glutamicum NRRL B‐50775, due to its high pH (11) it 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 NRRL B‐50775 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.

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, Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5537
EFSA Journal 2019;17(1):5537
Question Number
On request from
European Commission
Disclaimer
Relevant information or parts of this scientific output have been blackened in accordance with the European Commission decision on the confidentiality requests formulated by the applicant. The full output has been shared with the European Commission, EU Member States and the applicant.