Ensuring the Safety of α-Glucosidase Enzyme Produced by Non-Genetically Modified Fungal Strain AE-G: EU Assessment

In a recent development, the European Union (EU) has conducted an evaluation regarding the safety of α-glucosidase enzyme, specifically produced by a non-genetically modified fungal strain AE-G. This assessment aims to ensure the safety of this enzyme in various food production processes. The findings of the evaluation provide valuable insights into the use and potential risks associated with this food enzyme.

The α-glucosidase enzyme, also known as glucan 1,4-α-glucosidase, is produced using the non-genetically modified Rhizopus arrhizus strain AE-G by Amano Enzyme Inc. The EU's assessment focused on extending the use of this enzyme to nine additional food manufacturing processes, along with revising the use levels. The evaluation was conducted by a panel of experts who concluded that under the revised intended conditions of use, this food enzyme does not give rise to safety concerns.

The safety evaluation took into account the dietary exposure to the food enzyme-total organic solids (TOS) in European populations. It was estimated that the dietary exposure ranged up to 0.424 mg TOS/kg body weight per day. This exposure level was combined with the highest dose tested (no observed adverse effect level), which was reported as 1868 mg TOS/kg body weight per day. Based on this data, the panel derived a margin of exposure of at least 4406, indicating a significant safety margin.

It is important to note that the food enzyme-TOS is removed from the final foods in two of the food manufacturing processes. Therefore, the dietary exposure estimation was based on the remaining eight processes. Considering the previous evaluation and the revised margin of exposure, the panel concluded that the use of this food enzyme does not pose any safety concerns.

The recent evaluation conducted by the EU provides reassurance regarding the safety of α-glucosidase enzyme produced by the non-genetically modified fungal strain AE-G. The assessment concluded that when used under the revised intended conditions, this food enzyme does not give rise to safety concerns. This evaluation contributes to the comprehensive understanding of the safety aspects associated with the use of food enzymes in various food production processes. The findings of this assessment will aid in ensuring the continued safety of food products in the European market.