Safety and efficacy of l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CGMCC 7.266 for all animal species

nutritional additive, amino acid, lysine monohydrochloride, lysine sulfate, safety, efficacy
First published in the EFSA Journal
24 February 2020
Adopted
28 January 2020
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

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 monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CGMCC 7.266 when used as a nutritional additive in feed and water for drinking for all animal species. The active substance is l‐lysine and it is produced in two different forms (monohydrochloride or sulfate salts). None of those forms pose any safety concern associated with the genetic modification of the production strain. l‐Lysine HCl and l‐lysine sulfate produced by C. glutamicum CGMCC 7.266 are considered safe for the target species, for the consumer and for the environment. For both products, the FEEDAP Panel has concerns regarding the safety for the target species when the additives are administered via feed and water for drinking, simultaneously. In the absence of data, the FEEDAP Panel cannot conclude on the safety of both forms of the additive for the user. The products under assessment are considered efficacious sources of the amino acid l‐lysine for all animal species. For these products to be as efficacious in ruminants as in non‐ruminant species, they require protection against degradation in the rumen.

Substances
L-Lysine hydrochloride
Cas: 657-27-2
Inchi: InChI=1S/C6H14N2O2.ClH/c7-4-2-1-3-5(8)6(9)10;/h5H,1-4,7-8H2,(H,9,10);1H/t5-;/m0./s1
Iupac: (2S)-2,6-diaminohexanoic acid;hydrochloride
L-Lysine sulphate
Cas: 60343-69-3
Inchi: InChI=1S/C6H14N2O2.H2O4S/c7-4-2-1-3-5(8)6(9)10;1-5(2,3)4/h5H,1-4,7-8H2,(H,9,10);(H2,1,2,3,4)/t5-;/m0./s1
Iupac: (2S)-2,6-diaminohexanoic acid;sulfuric acid

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, Maria Bastos, Henrik Christensen, Birgit Dusemund, Mojca Kos Durjava, Maryline Kouba, 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.2020.6019
EFSA Journal 2020;18(2):6019
Question Number
On request from
European Commission