The European Food Safety Authority (EFSA) has concluded that the food enzyme bacillolysin, produced with the non-genetically modified Bacillus amyloliquefaciens strain BP by HBI Enzymes Inc., does not give rise to safety concerns under the intended conditions of use. The opinion, adopted on 20 May 2026 and published on 10 June 2026, covers eight food manufacturing processes, including dairy, meat, fish, cereal, and plant-derived products.
Dietary exposure was estimated at up to 1.249 mg total organic solids (TOS) per kg body weight per day for European populations, based on seven processes (one process removes residual TOS). The production strain qualifies for EFSA's Qualified Presumption of Safety (QPS) approach, as it showed no cytotoxicity and no acquired antimicrobial resistance genes. Consequently, the Panel considered no toxicological studies beyond allergenicity assessment necessary.
A search for amino acid sequence homology to known allergens found a match with one respiratory allergen. The Panel concluded that a risk of allergic reactions upon dietary exposure cannot be excluded, but overall, the food enzyme is safe under the proposed uses.
The opinion addresses a data package from a joint dossier originally submitted by the Association of Manufacturers and Formulators of Enzyme Products (AMFEP) in 2016. The European Commission had requested EFSA to carry out the safety assessment as part of the EU authorisation procedure under Regulation (EC) No 1332/2008.
Stakeholder impact: Food manufacturers using bacillolysin gain a safety clearance supporting continued use, while consumers benefit from a scientific assessment confirming no safety concerns, though a residual allergenicity risk is noted. The enzyme producer, HBI Enzymes Inc., receives a positive opinion that facilitates EU market authorisation. EFSA's QPS-based approach reduces the need for extensive toxicological studies, lowering regulatory costs for industry.