Comprehensive Safety Assessment: Challenges with Bacillus Protease from Nagase (Europa) GmbH

Nagase (Europa) GmbH has produced the food enzyme Bacillus protease (EC 3.4.21.62) using a non-genetically modified variant of the bacterium Bacillus licheniformis, strain AP-01. It is believed that this enzyme does not contain viable cells of the production strain during the manufacturing process. The food enzyme is intended to be used in five food manufacturing processes. Since one of the processes removes the residues of the food enzyme-total organic solids (TOS), the dietary intake was only calculated for the remaining four food manufacturing processes. The estimated maximum daily dietary exposure to the food enzyme-TOS in the European population was up to 0.875 mg/kg body weight.

However, the production strain of this food enzyme has the ability to produce bacillopeptins, and therefore, it did not meet the requirements of the qualified presumption of safety (QPS) approach. Although bacillopeptins were detected in the industrial fermentation medium, they were not found in the food enzyme itself. However, the analytical method used to detect bacillopeptins had a limited detection capability, which was not sufficient to rule out the potential presence of bacillopeptins at levels that could lead to the development of antibiotic-resistant bacteria.

Furthermore, a search of the amino acid sequence of the food enzyme revealed 28 matches with respiratory allergens, 1 match with contact allergens, and 2 matches with food allergens (such as cantaloupe and pomegranate). The expert panel acknowledged that, while the risk of allergic reactions upon dietary intake of this food enzyme, particularly for those sensitive to cantaloupe or pomegranate, cannot be excluded, this risk is not expected to exceed the risk associated with the consumption of cantaloupe or pomegranate.

In conclusion, due to the inability to rule out the presence of the medically important antibiotic bacillopeptins, the expert panel was unable to confirm the safety of this food enzyme.