# Safety and efficacy of a feed additive consisting of l‐lysine monohydrochloride produced with Corynebacterium glutamicum CGMCC 7.453 for all animal species (Eppen Europa SAS)

## TL;DR

This paper evaluates the safety and effectiveness of a genetically modified feed additive for all animal species, finding it safe for most uses but with some concerns.

## Contribution

The paper provides a scientific evaluation of a genetically modified l-lysine monohydrochloride feed additive for animal species.

## Key findings

- The additive is safe for non-ruminant animals when administered via feed.
- The additive is considered irritant to skin, eyes, and respiratory tract.
- l-Lysine HCl is an efficacious source of l-lysine for non-ruminant species but requires protection for ruminants.

## Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐lysine monohydrochloride produced by fermentation with a genetically modified strain of Corynebacterium glutamicum (CGMCC 7.453) as nutritional feed additive for all animal species. Neither viable cells nor recombinant DNA of the production strain were detected in the final product. Therefore, the FEEDAP Panel concluded that the additive does not pose any safety concern regarding the production strain. The FEEDAP Panel concluded that the use of l‐lysine HCl produced by fermentation with the strain C. glutamicum CGMCC 7.453 is safe for the target species when administered via feed. However, the FEEDAP Panel expressed concerns on the use of l‐lysine HCl in water for drinking. The Panel concluded that the use of l‐lysine HCl produced by fermentation with C. glutamicum CGMCC 7.453 in animal nutrition is considered safe for the consumers and for the environment. With regards user safety, the additive should be considered irritant to skin, eyes and the respiratory tract. Any exposure to the additive is a risk. l‐Lysine HCl is considered as efficacious source 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.