Evaluates safety of bacillolysin in food enzyme applications, suggesting potential allergenic risks.
strain BP by HBI Enzymes Inc. The food enzyme is intended to be used in eight food manufacturing processes. Since residual amounts of total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining seven food manufacturing processes. It was estimated to be up to 1.249 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the Qualified Presumption of Safety approach to safety assessment and no issues of concern arising from the production process of the food enzyme were identified, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A search for the homology of the amino acid sequence of the bacillolysin to known allergens was made, and a match with one respiratory allergen was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. 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.
No takes yet. Share an insight, caveat, or question.
(FEZ) et al. (2026) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: