Safety evaluation of the food enzyme α-amylase from the non-genetically modified Bacillus amyloliquefaciens strain LMG-S 32676

The food enzyme alpha-amylase (4-alpha-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism Bacillus amyloliquefaciens strain LMG-S 32676 by Enmex SA de CV, a Kerry Company. The food enzyme under assessment is intended to be used in six food manufacturing processes: baking processes, brewing processes, distilled alcohol production, starch processing for the production of glucose syrups and other starch hydrolysates, refined and unrefined sugar production and yeast processing. Since residual amounts of total organic solids (TOS) are removed in distilled alcohol production and starch processing for glucose syrups production and other starch hydrolysates, the dietary exposure estimation was made only for the remaining four food processes. It was estimated to be up to 2.998 mg TOS/kg body weight per day in European populations. The production strain meets the requirements for the QPS approach. As no concerns arising from the manufacturing process were identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Automated summary

This article introduces the production and assessment of a food enzyme, alpha-amylase. The enzyme is produced using a non-genetically modified microorganism and used in various food manufacturing processes. The assessment concludes that under the intended conditions of use, the enzyme does not pose safety concerns, except for a low risk of allergic reactions upon dietary exposure.