EFSA Journal (Aug 2023)

Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus licheniformis strain T74

  • 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,
  • Yrjö Roos,
  • Jaime Aguilera,
  • Magdalena Andryszkiewicz,
  • Kyriaki Apergi,
  • Daniele Cavanna,
  • Silvia Peluso,
  • Rita Ferreira deSousa,
  • Yi Liu,
  • Andrew Chesson

DOI
https://doi.org/10.2903/j.efsa.2023.8160
Journal volume & issue
Vol. 21, no. 8
pp. n/a – n/a

Abstract

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Abstract The food enzyme α‐amylase (4‐α‐D‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified microorganism Bacillus licheniformis strain T74 by Novozymes A/S. The production strain met the qualifications of the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in eight food manufacturing processes: starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, refined and unrefined sugar production, brewing processes, cereal‐based processes, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices and the production of dairy analogues. Since residual amounts of total organic solids (TOS) are removed during two food processes (starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production), dietary exposure was calculated only for the remaining six food manufacturing processes. It was estimated to be up to 0.291 mg TOS/kg body weight per day in European populations. Since the production strain meets the requirements for the QPS approach and no issues of concern arose from the production process of the food enzyme, the Panel considered that toxicological studies were unnecessary. 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, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme 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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