# Safety and efficacy of a feed additive consisting of l‐valine produced using Corynebacterium glutamicum KCCM 80365 for all animal species (CJ Europe GmbH)

## TL;DR

This paper evaluates the safety and effectiveness of l-valine produced using a genetically modified bacterium for use in animal feed across all species.

## Contribution

The study confirms the safety of the genetically modified strain and its l-valine product for animal feed use.

## Key findings

- The additive is safe for all animal species and does not pose environmental or consumer risks.
- The additive is effective as a source of l-valine for non-ruminant animals.
- For ruminants, the additive needs protection from ruminal degradation to be equally effective.

## Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐valine produced by fermentation using the genetically modified strain of Corynebacterium glutamicum, KCCM 80365, as a nutritional additive in feed for all animal species and categories. In the manufacturing process used to obtain the product under assessment, the cells from the production strain are inactivated but not removed from the final product. The FEEDAP Panel concluded that the additive does not give rise to any safety concern regarding the genetic modification of the strain. DNA from the strain is present in the final product, but its presence does not raise any safety issue since the strain does not harbour any gene of concern. No viable cells of the strain were detected in the final product. The use of l‐valine produced using C. glutamicum KCCM 80365 in animal nutrition is considered safe for all animal species, the consumers of products from animals receiving the additive and to the environment. With regard to the safety for the user, the additive is not irritant to the eyes or skin, but it should be considered a skin and respiratory sensitiser. The additive l‐valine produced using C. glutamicum KCCM 80365 is regarded as an effective source of the amino acid l‐valine for all non‐ruminant species. To be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation.