Safety and efficacy of l‐valine produced by fermentation using Corynebacterium glutamicum KCCM 11201P for all animal species

nutritional additive, amino acids, L-valine, C. glutamicum KCCM 11201P, safety, efficacy
First published in the EFSA Journal
31 January 2019
28 November 2018
Scientific Opinion


The product subject of this assessment is l‐valine produced by fermentation using a non‐genetically modified strain of Corynebacterium glutamicum (KCCM 11201P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations below thresholds specified by EFSA, thus C. glutamicum KCCM 11201P may be considered safe by the qualified presumption of safety (QPS) approach. No viable cells of C. glutamicum were detected in the final product. The amount of identified material exceeded ■■■■■% on ‘as is’ basis, and no impurities of concern were detected. The use of l‐valine produced by C. glutamicum KCCM 11201P is safe for target species when supplemented to diets in appropriate amounts, for the consumer and the environment. The product l‐valine produced by C. glutamicum(KCCM 11201P) is considered not to be an irritant or a dermal sensitiser, and does not cause acute inhalation toxicity. The additive is an effective source of valine for all species. For the supplemental l‐valine 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(1):5538
Question Number
On request from
European Commission
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.