Is Leucyl Aminopeptidase, a Food Enzyme, Safe for Consumption?

On December 21, 2023, the European Food Safety Authority (EFSA) released a scientific opinion on the safety assessment of a food enzyme called leucyl aminopeptidase. This food enzyme is produced by a non-genetically modified strain of Aspergillus oryzae known as NZYM-EX. It is intended for use in eight food manufacturing processes, including the production of flavoring preparations, modified milk proteins, protein hydrolysates, soy sauce, protein hydrolysates for meat and fish products, baked products, brewed products, and yeast and yeast products.

After a thorough evaluation, the expert panel concluded that, under the anticipated conditions of use, the risk of allergenic reactions due to dietary exposure to leucyl aminopeptidase cannot be completely ruled out, but it is considered to be low. The data provided indicated that this food enzyme does not raise safety concerns under the intended conditions of use.

The assessment estimated that dietary exposure to the total organic solids (TOS) of the food enzyme is up to 0.577 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate any safety concerns. Additionally, a 90-day oral toxicity study conducted on rats identified a no observed adverse effect level of 440 mg TOS/kg bw per day, the highest dose tested. When compared with the estimated dietary exposure, this resulted in a margin of exposure of at least 763, indicating a wide safety margin.

Furthermore, a search for similarity between the amino acid sequence of the food enzyme and known allergens did not yield any matches. While the possibility of allergic reactions from dietary exposure cannot be completely ruled out, the likelihood is considered to be low.

In light of these findings, the question arises: Is leucyl aminopeptidase, a food enzyme, safe for consumption? The EFSA's scientific opinion suggests that based on the data provided, leucyl aminopeptidase does not raise safety concerns under the intended conditions of use. Although a low risk of allergenic reactions from dietary exposure exists, the overall safety profile of the enzyme is considered satisfactory. These findings contribute to ensuring the safety of food enzymes and help support the development of innovative food processing techniques.