Scientific Opinion on the safety and efficacy of concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride and L-lysine monohydrochloride technically pure produced using Escherichia coli (FERM BP-11355) for all animal species based on a dossier submitted by Ajinomoto Eurolysine S.A.S.

nutritional additive, amino acids, concentrated liquid L-lysine base, concentrated liquid L-lysine HCl, L-lysine HCl technically pure, safety
First published in the EFSA Journal
18 November 2014
Adopted
28 October 2014
Type
Scientific Opinion

Abstract

L-Lysine is an essential amino acid for all animal species. The products, concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride (HCl) and L-lysine HCl technically pure, as sources of the amino acid L-lysine, are produced by fermentation with a genetically modified strain of Escherichia coli (FERM BP-11355). Neither the production strain nor its recombinant DNA was detected in the final products. Concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure, manufactured by fermentation with E. coli FERM BP-11355, do not give rise to any safety concern with regard to the genetic modification of the production strain. The additives under assessment are considered safe for target species when supplemented in appropriate amounts. Use of concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure produced by E. coli FERM BP-11355 in animal feed do not give rise to safety concerns for the consumer. The products under application are not considered to have the potential to cause respiratory toxicity, skin or eye irritation or skin sensitisation, but respiratory sensitisation cannot be excluded. L-Lysine is a substance naturally occurring in bacteria, plants and animals. The use of the products under application as feed additives does not represent a risk to the environment. The products concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure produced by E. coli FERM BP-11355 are regarded as efficacious sources of the essential amino acid L-lysine for all non-ruminant species. Supplemental free amino acid L-lysine is degraded by ruminal microorganisms, if not given in a protected form.

Panel members at the time of adoption

Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf.
Panel on Additives and Products or Substances used in Animal Feed
Contact
FEEDAP [at] efsa.europa.eu
doi
10.2903/j.efsa.2014.3895
EFSA Journal 2014;12(11):3895
Question Number
On request from
European Commission