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

l‐lysine sulfate, nutritional additive, Corynebacterium glutamicum KFCC 11043, Safety, efficacy
First published in the EFSA Journal
21 luglio 2020
Adopted
1 luglio 2020
Type
Scientific Opinion

Note or 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

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 sulfate produced by fermentation using Corynebacterium glutamicum KFCC 11043 when used as a nutritional additive in feed for all animal species. The active substance is l‐lysine. The production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment and was not detected in the final product. l‐Lysine sulfate produced using C. glutamicum KFCC 11043 does not pose any safety concern associated with the production strain. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is considered safe for the target species. When using l‐lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is safe for the consumer and for the environment. From the results of studies on the safety for the user of l‐lysine sulfate produced by a different production strain, it was possible to conclude on the safety for the user of the product under assessment. l‐Lysine sulfate produced by C. glutamicum KFCC 11043 is considered non‐toxic by inhalation, non‐irritant to skin or eyes and it is not a skin sensitiser. l‐lysine sulfate is considered as an efficacious source 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 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.2020.6203
EFSA Journal 2020;18(7):6203
Question Number
On request from
European Commission