European Food Safety Authority Evaluates Safety of α-Amylase Food Enzyme Introduction

On November 24, 2023, the European Food Safety Authority (EFSA) issued an opinion regarding the safety assessment of α-amylase, a food enzyme produced by genetically modified Bacillus licheniformis strain NZYM-AC. This article provides an overview of the EFSA's evaluation and its findings on the safety of α-amylase for various food manufacturing processes.

The food enzyme α-amylase (1,4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced using the genetically modified Bacillus licheniformis strain NZYM-AC by Novozymes A/S. The genetic modifications applied to the production strain have been deemed safe, meeting the requirements for the qualified presumption of safety (QPS) approach.

The EFSA's assessment concluded that the food enzyme α-amylase, under the intended conditions of use, does not raise safety concerns. The production strain was found to be free from viable cells and its DNA. The enzyme is intended to be used in seven food manufacturing processes, including the processing of cereals and other grains for the production of glucose syrups and starch hydrolysates, processing of fruits and vegetables for the production of juices and non-juice products, and the production of refined and unrefined sugars. Distilled alcohol production was excluded from the assessment.

Dietary exposure to α-amylase was estimated for five remaining food manufacturing processes, as total organic solids (TOS) were removed during two processes. The estimated dietary exposure in European populations was up to 0.167 mg TOS/kg body weight per day. Toxicological studies were not deemed necessary due to the QPS status of the production strain and the absence of concerns arising from the food enzyme manufacturing process.

A search for similarity between the amino acid sequence of the food enzyme and known allergens revealed one match with a respiratory allergen. The EFSA panel acknowledged that the risk of allergic reactions through dietary exposure cannot be completely excluded, except for distilled alcohol production. However, the likelihood of such reactions was considered low.

Based on the data provided, the EFSA panel concluded that the α-amylase food enzyme does not raise safety concerns under the intended conditions of use.

The EFSA's evaluation of α-amylase, a food enzyme produced from genetically modified Bacillus licheniformis strain NZYM-AC, confirms its safety for use in various food manufacturing processes. The assessment considered the absence of safety concerns associated with the production strain and the manufacturing process of the food enzyme. While a potential risk of allergic reactions through dietary exposure was acknowledged, the likelihood of such reactions was deemed low. This evaluation ensures the continued safe use of α-amylase in food production within the European Union, supporting consumer protection and food safety standards.