Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation with Corynebacterium glutamicum KCCM 80216 as feed additive for all animal species

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DOI
https://doi.org/10.2903/j.efsa.2020.6334
Keywords
nutritional additive, ‘amino acids, their salts and analogues’, concentrated liquid l‐lysine (base), lysine monohydrochloride, Corynebacterium glutamicum, safety, efficacy
On request from
European Commission
Question Number
EFSA‐Q‐2020‐00134
Panel members at the time of adoption
Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon 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.
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 the safety and efficacy of concentrated liquid l‐lysine (base, minimum 50%) and l‐lysine monohydrochloride (HCl, minimum 99%) produced by fermentation with a genetically modified strain of Corynebacterium glutamicum (KCCM 80216) as nutritional additives for all animal species. Neither the production strain nor its recombinant DNA was detected in the final products. The additives do not pose any safety concern associated with the genetic modification of the production strain. Concentrated liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicumKCCM 80216 do not represent a risk for the target species, the consumer and the environment. From the results of studies on the safety for the user of concentrated liquid l‐lysine (base) and l‐lysine HCl produced by a different production strain, it was possible to conclude on the safety for the user of the products under assessment. The concentrated liquid l‐lysine (base) and the l‐lysine HCl are not irritant to skin or eyes or skin sensitiser. l‐lysine HCl is not hazardous by inhalation. l‐lysine HCl and concentrated liquid l‐lysine (base) 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.

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Feed additives