Safety evaluation of the food enzyme bacillolysin from the non‐genetically modified Bacillus amyloliquefaciens strain DP‐Cyb74

TL;DR

This study evaluates the safety of bacillolysin, a food enzyme produced by a non-genetically modified bacteria, for use in food manufacturing.

Contribution

The study confirms the safety of bacillolysin under intended use conditions using the QPS approach and allergenicity assessment.

Findings

Dietary exposure to bacillolysin is estimated at up to 1.536 mg TOS/kg body weight per day.

No toxicological studies beyond allergenicity assessment were required due to the QPS-qualified production strain.

No sequence similarity to known allergens was found, though a low risk of allergic reactions cannot be entirely excluded.

Abstract

The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non‐genetically modified Bacillus amyloliquefaciens strain DP‐Cyb74 by Genencor International B.V. The production strain met all requirements for the qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended to be used in six food manufacturing processes. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 1.536 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the QPS approach and no issue of concern arose from the production process of the food enzyme, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.