EFSA Journal (Feb 2024)

Safety evaluation of the food enzyme bacillolysin from the non‐genetically modified Bacillus amyloliquefaciens strain NZYM‐NB

  • EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP),
  • Claude Lambré,
  • José Manuel Barat Baviera,
  • Claudia Bolognesi,
  • Pier Sandro Cocconcelli,
  • Riccardo Crebelli,
  • David Michael Gott,
  • Konrad Grob,
  • Evgenia Lampi,
  • Marcel Mengelers,
  • Alicja Mortensen,
  • Gilles Rivière,
  • Inger‐Lise Steffensen,
  • Christina Tlustos,
  • Henk Van Loveren,
  • Laurence Vernis,
  • Holger Zorn,
  • Lieve Herman,
  • Yrjö Roos,
  • Magdalena Andryszkiewicz,
  • Daniele Cavanna,
  • Simone Lunardi,
  • Eleonora Marini,
  • Francesco Pesce,
  • Andrew Chesson

DOI
https://doi.org/10.2903/j.efsa.2024.8615
Journal volume & issue
Vol. 22, no. 2
pp. n/a – n/a

Abstract

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Abstract The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non‐genetically modified Bacillus amyloliquefaciens strain NZYM‐NB by Novozymes A/S. The production strain meets the requirements for qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended to be used in eleven food manufacturing processes. Since residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was estimated only for the remaining nine food manufacturing processes. Exposure was estimated to be up to 1.327 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the QPS approach and no issue of concern arising from the production process of the food enzyme was identified, 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 (except for distilled alcohol production), 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.

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