EFSA Journal (Jan 2024)

Safety of isomaltulose syrup (dried) as a novel food pursuant to Regulation (EU) 2015/2283

  • EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA),
  • Dominique Turck,
  • Torsten Bohn,
  • Jacqueline Castenmiller,
  • Stefaan De Henauw,
  • Karen Ildico Hirsch‐Ernst,
  • Alexandre Maciuk,
  • Inge Mangelsdorf,
  • Harry J. McArdle,
  • Androniki Naska,
  • Kristina Pentieva,
  • Alfonso Siani,
  • Frank Thies,
  • Sophia Tsabouri,
  • Marco Vinceti,
  • Margarita Aguilera‐Gómez,
  • Francesco Cubadda,
  • Thomas Frenzel,
  • Marina Heinonen,
  • Rosangela Marchelli,
  • Monika Neuhäuser‐Berthold,
  • Morten Poulsen,
  • Miguel Prieto Maradona,
  • Josef Rudolf Schlatter,
  • Alexandros Siskos,
  • Henk vanLoveren,
  • Lucien Ferreira da Costa,
  • Océane Albert,
  • Helle Katrine Knutsen

DOI
https://doi.org/10.2903/j.efsa.2024.8491
Journal volume & issue
Vol. 22, no. 1
pp. n/a – n/a

Abstract

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Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on isomaltulose syrup (dried) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of a mixture of mono‐ and disaccharides in powder form, mainly composed of isomaltulose (≥ 75%) and trehalulose (< 13%). The applicant intends to use the NF as a replacement for sucrose already on the market. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. No absorption, distribution, metabolism and excretion (ADME) or toxicological data were provided for the NF. Instead, the safety of the NF was assessed based on literature data available on isomaltulose and mixtures of isomaltulose and trehalulose. In addition, considering the nature, compositional characterisation and production process of the NF, the Panel considered that such data were sufficient to conclude that the NF is as safe as sucrose.

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