Safety and efficacy of l‐arginine produced by fermentation with Corynebacterium glutamicum KCCM 80182 for all animal species

nutritional additive, amino acids, L-arginine, genetically modified production strain, C. glutamicum KCCM 80182, Safety, efficacy
First published in the EFSA Journal
2 May 2019
2 April 2019
Scientific Opinion

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.


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‐arginine produced by fermentation with a genetically modified strain of Corynebacterium glutamicum KCCM 80182 when used as a nutritional additive in feed and water for drinking for all animal species categories. Viable cells of the production strain and its recombinant DNA were not detected in the additive. The product l‐arginine, manufactured by fermentation with C. glutamicum, KCCM 80182, does not give rise to any safety concern with regard to the production strain. l‐Arginine produced using C. glutamicum KCCM 80182 is considered safe for the target species. The FEEDAP Panel has concerns regarding the safety of the simultaneous oral administration of l‐arginine via water for drinking and feed. l‐Arginine produced using C. glutamicum KCCM 80182 is safe for the consumer and for the environment. The additive is not hazardous by inhalation, is not a skin sensitiser, but is corrosive to skin and eyes. The product under assessment is considered an efficacious source of the amino acid l‐arginine for all animal species. For l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against microbial 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
feedap [at]
EFSA Journal 2019;17(5):5696
Question Number
On request from
European Commission