EU Assessment Validates Safety and Efficacy of L-Isoleucine as an Animal Feed Additive

In a recent development, the European Food Safety Authority (EFSA) conducted an evaluation of L-isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 as an animal feed additive. The assessment, carried out at the request of the European Commission, aimed to determine the safety and effectiveness of L-isoleucine as a nutritional supplement for various animal species. This article highlights the key findings of the EFSA evaluation and its implications for the animal feed industry.

The EFSA's expert panel, known as the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), concluded that the evaluated additive is safe for the target species, consumers, and the environment. The production strain, Corynebacterium glutamicum CGMCC 20437, is non-genetically modified and meets the safety assessment criteria under the Qualified Presumption of Safety (QPS) approach. The strain is also susceptible to relevant antibiotics and does not contain antimicrobial resistance genes of concern.

The assessment confirmed that the final product, which is derived from the fermentation process, does not pose any safety concerns associated with the production strain. However, due to insufficient data, the FEEDAP panel could not conclusively determine the potential irritant effects of the additive on the skin or eyes. Furthermore, it remains necessary to address the risk of nutritional imbalances and hygienic issues when administering L-isoleucine simultaneously through both feed and drinking water.

Importantly, the EFSA evaluation recognized the effectiveness of L-isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 as a source of the essential amino acid for non-ruminant animal species. To ensure its efficacy in ruminants, measures should be taken to prevent its degradation in the rumen.

The recent evaluation by the EFSA reaffirms the safety and efficacy of L-isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 as an animal feed additive. The findings provide valuable insights for the animal feed industry and regulatory authorities in the European Union. With the assurance of its safety, L-isoleucine can continue to be used as a nutritional supplement, contributing to the well-being and optimal growth of various animal species.