Ensuring the Safety of 4-α-Glucanotransferase Produced from Non-Genetically Modified Strain AE-SAS of Aeribacillus pallidus: EU Evaluation

In a recent development, the European Union (EU) has conducted an evaluation on the safety of 4-α-glucanotransferase, a food enzyme produced from the non-genetically modified strain AE-SAS of Aeribacillus pallidus. This evaluation aims to assess the suitability of this enzyme for use in various food production processes. The findings of the evaluation shed light on the safety considerations associated with this enzyme and its potential impact on consumer health.

According to the EU Food Safety Authority, the food enzyme 4-α-glucanotransferase is derived from the non-genetically modified strain AE-SAS of Aeribacillus pallidus, produced by Amano Enzyme Inc. The evaluation considered the safety of this enzyme for use in four different food manufacturing processes. Previous assessments had already concluded that the enzyme did not raise any safety concerns when used in two specific food processes.

The evaluation extended the scope of the assessment to include two additional processes. As part of the evaluation, the dietary exposure to the enzyme was estimated for three processes, as the enzyme was removed from the final foods in one process. The estimated dietary exposure to the enzyme was found to be up to 0.040 mg total organic solids (TOS) per kilogram of body weight per day in European populations.

To determine the safety of the enzyme, the evaluation compared the estimated dietary exposure with the no observed adverse effect level (NOAEL) established in the previous opinion. The NOAEL, based on the highest tested dose, was reported as 900 mg TOS per kilogram of body weight per day. The evaluation panel derived a margin of exposure of at least 22,500, indicating a significant safety factor.

Based on the data provided and the revised margin of exposure, the panel concluded that the use of this food enzyme does not raise any safety concerns under the intended conditions of use. The evaluation provides valuable insights into the safety of 4-α-glucanotransferase derived from the non-genetically modified strain AE-SAS of Aeribacillus pallidus, ensuring consumer confidence in its application within the food industry.

The recent evaluation conducted by the EU on the safety of 4-α-glucanotransferase, produced from the non-genetically modified strain AE-SAS of Aeribacillus pallidus, reaffirms its suitability for use in food production processes. The assessment concluded that, under the intended conditions of use, this food enzyme does not give rise to any safety concerns. The findings provide a comprehensive understanding of the safety considerations associated with the use of this enzyme, contributing to the assurance of consumer safety in the European food market.