Assessment of the application for renewal of authorisation of l‐arginine produced by fermentation using Corynebacterium glutamicum NITE SD 00285 for all animal species

nutritional additive, amino acids,L-arginine,Corynebacterium glutamicumNITE SD00285, safety
First published in the EFSA Journal
18 June 2019
14 May 2019
Scientific Opinion

Relevant information or parts of this scientific output have been blackened in accordance with the European Commission decision on the confidentiality requests formulated by the applicant. The full output has been shared with the European Commission, EU Member States and the applicant.


l‐Arginine is an amino acid that is conditionally essential for mammalian neonates, some strict carnivores, birds and fish. The subject of this opinion is a request for renewal of authorisation of l‐arginine produced by a strain of Corynebacterium glutamicum. The strain designation has changed to its new deposition number, NITE SD 00285, but the strain is otherwise unchanged from the previous opinion. It is not genetically modified and possesses no antibiotic resistance of safety concern. Minor changes in downstream processing following fermentation have been made. The FEEDAP Panel notes that two out of five batches did not meet the specification of the current authorisation (minimum 98% on a dry matter basis). The FEEDAP Panel concludes that l‐arginine produced by fermentation to C. glutamicum NITE SD 00285 remains safe for the target species, consumers of products from animals fed the additive and the environment under the approved conditions of authorisation. The additive is considered as irritant to skin, corrosive to eyes and poses a risk by inhalation.

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(6):5720
Question Number
On request from
European Commission