EU Confirms Safety of Thermophilic Protease Produced by Non-GMO Bacillus Strain AE-TP

On 24 July 2024, the European Food Safety Authority (EFSA) conducted a detailed safety assessment of a specific food enzyme, thermolysin, produced by a non-GMO pyrolytic protein anaerobic bacillus strain AE-TP. The purpose of this assessment is to ensure the safety of this enzyme in food processing and to protect the health rights of consumers.

EFSA's expert panel, following a rigorous scientific assessment, has clearly stated that this food enzyme does not raise any safety concerns under the intended conditions of use. This conclusion is based on in-depth analysis and research on the biochemical properties, mechanisms of action, and their intended uses in food processing. EFSA said that based on the results of the previous evaluation and the re-examination of the safety margin in this evaluation, the food enzyme was found to be safe under the adjusted conditions of use.

Specifically, the thermophilic protease is planned to be used in seven different food production processes. In these processes, the role of enzymes is mainly to accelerate the processing of food, improve production efficiency, and may improve certain characteristics of food, such as taste, color and so on. However, EFSA's assessment specifically states that in two specific production processes, this food enzyme and its associated total organic solids (TOS) are completely removed, so only the remaining eight production processes need to be considered when assessing the intake of residues in food.

When assessing the intake of residues in food, EFSA uses strict criteria and calculation methods. Based on the assessment results, the highest estimated intake is 0.424 mg TOS per kg of body weight. This data shows a significant margin of safety compared to the no-adverse dose mentioned in the previous report (1,868 mg TOS/ kg body weight/day), specifically a margin of safety of at least 4,406 times. This data not only demonstrates the safety of thermophilic proteases in food processing, but also demonstrates the rigor and science of EFSA's food safety assessment.

It is worth mentioning that EFSA's assessment also takes into account the long-term effects that food enzymes may have on human health. By reviewing the extensive scientific research literature and conducting in-depth empirical studies, EFSA has found that this food enzyme does not have any adverse effects on human health under long-term use. This conclusion further strengthens consumer confidence in the safety of this food enzyme.

EFSA has conducted a comprehensive and in-depth safety assessment of thermophilic proteases produced by a non-transgenic strain of Bacillus AE-TP and has come to a positive conclusion. This assessment not only provides the food processing industry with a new and safe processing tool, but also provides consumers with safer and healthier food choices. It also demonstrates EFSA's expertise and responsibility in ensuring food safety.