EU Evaluates the Safety of α-Amylase Produced by Non-GMO Cellulosimicrobium Funkei Strain AE-AMT

On July 31, 2024, the European Food Safety Authority (EFSA) officially announced an important decision on the safety assessment of a food enzyme called alpha-amylase. This news not only affected the nerve of the food industry, but also triggered the concern of consumers.

Alpha-amylase, commonly known in the scientific community as 4-alpha-D-glucoside glucose hydroxylase, or EC 3.2.1.1 for short, is a biocatalyst widely used in the food industry. What makes the alpha-amylase in question particularly interesting is that it is produced by a non-genetically modified microbe called the Fink strain AE-AMT. This characteristic gives the enzyme a unique advantage in the field of food safety, as the non-GMO source means that it avoids the potential controversies and safety concerns that can come with GM technology.

According to a detailed evaluation report by the European Food Safety Authority, this α-amylase produced by the AE-AMT strain has shown a good safety record in seven previous food manufacturing processes. After a rigorous review, the expert panel confirmed that the enzyme did not pose any safety concerns in any of these use scenarios. It is based on this positive background that the food industry has submitted an application to further expand its use to 10 food manufacturing processes.

In order to verify the legitimacy of this application, EFSA organized an evaluation panel composed of several leading experts in the field of food science to conduct a comprehensive and in-depth evaluation of the safety of α-amylase in the manufacturing process of new foods. In the evaluation process, experts considered not only the nature of the enzyme itself, but also the characteristics of the food manufacturing process, as well as the consumer's likely intake of several factors.

The results showed that in a particular food manufacturing process, that is, one designed to remove the total organic solids (TOS) of enzymes from the final food, the consumption of α-amylase TOS by consumers through the consumption of these foods can be up to 0.049 mg/kg body weight per day. This is significantly lower than the previously reported No observed adverse effect level (NOAEL), which is 230 mg TOS/kg body weight/day. By calculation, the margin of safety of the enzyme is at least 4694 times, which fully indicates the extremely high safety of the enzyme under the conditions of intended use.

After an in-depth analysis of the evaluation data and taking into account various factors, the EFSA panel agreed that α-amylase produced by the non-GMO Fink strain AE-AMT also does not pose safety concerns in the manufacturing process of the expanded 10 food products. This conclusion not only provides strong support for the food industry, but also provides a reassurance for the majority of consumers.

It is worth mentioning that with the progress of science and technology and the increasing attention of consumers to food safety, the application of food enzymes in the food industry is becoming more and more extensive. The European Food Safety Authority's assessment of the safety of alpha-amylase has undoubtedly set a new benchmark in this field. It not only demonstrates the important role of scientific assessment in ensuring food safety, but also provides a strong safety guarantee for the food industry while pursuing innovative development.