Modification of the terms of authorisation regarding the additive consisting of liquid l‐lysine base produced with Corynebacterium glutamicum NRRL B‐67439 and NRRL B‐67535 for all animal species (ADM specialty ingredients (Europe) B.V.)

TL;DR

The paper evaluates the safety and effectiveness of a new strain of Corynebacterium glutamicum for producing l-lysine, a feed additive for all animal species.

Contribution

The study confirms the safety and efficacy of a new C. glutamicum strain for l-lysine production in animal feed.

Findings

The new strain, C. glutamicum NRRL B-68248, is safe and does not pose risks to animals, consumers, or the environment.

The l-lysine produced is effective for non-ruminant animals but needs protection for ruminants to be equally effective.

The strain does not contain antimicrobial resistance genes and no viable cells remain in the final product.

Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of liquid l‐lysine base produced with a genetically modified strain of Corynebacterium glutamicum as a nutritional feed additive for all animal species. The l‐lysine base liquid produced with C. glutamicum NRRL B‐67535 and NRRL B‐67439 is currently authorised as a nutritional additive for all animal species. The present application is aimed at modifying the current authorisation to include C. glutamicum NRRL B‐68248 as a production strain. The new production strain qualifies for the qualified presumption of safety approach when used for production purposes. It was unambiguously identified as C. glutamicum and was shown not to harbour acquired antimicrobial resistance determinants for antibiotics of human and veterinary importance. All the introduced sequences or mutations were considered to be safe, and no viable cells or DNA of the NRRL B‐68248 strain was detected in the final product. Therefore, the final product does not pose any safety concern associated with the production strain. l‐Lysine base produced using C. glutamicum NRRL B‐68248 does not represent a risk for the target species, the consumer or the environment. The additive was considered to be neither irritant to skin or the eyes, nor a dermal sensitiser. l‐Lysine base produced with C. glutamicum NRRL B‐68248 is considered to be an 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.

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