European Union Evaluates the Safety of α-Amylase Produced by Non-GMO Bacillus licheniformis AE-TA

On May 15, 2024, the European Food Safety Authority (EFSA) published its opinion on the safety evaluation of an α-amylase (α-amylase) enzyme. This food enzyme is produced by the non-genetically modified microorganism Bacillus licheniformis strain AE-TA and is intended for use in eight food manufacturing processes.

After a thorough assessment, the EFSA expert panel concluded that under the intended conditions of use, the risk of allergic reactions from dietary exposure to this food enzyme cannot be excluded (except for the production of distilled alcohol), but the likelihood is considered low. Based on the data provided, the panel determined that this food enzyme does not raise any other safety concerns.

The panel noted that residual amounts of the food enzyme-total organic solids (TOS) are removed in two of the food manufacturing processes, and dietary exposure was calculated only for the remaining six processes. The estimated dietary exposure was up to 0.056 mg TOS/kg body weight per day in European populations.

The production strain of the food enzyme fulfills the requirements for the qualified presumption of safety approach, which means that toxicological studies were not deemed necessary for the safety assessment. However, a search for the similarity of the enzyme's amino acid sequence to known allergens revealed two matches with respiratory allergens.

Overall, the EFSA panel concluded that this non-GMO Bacillus licheniformis-derived α-amylase food enzyme does not raisesafety concerns under the intended conditions of use, except for the potential, though low, risk of allergic reactions from dietary exposure.