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


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.

SUBMITTER: EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) 

PROVIDER: S-EPMC10801438 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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

Turck Dominique D   Bohn Torsten T   Castenmiller Jacqueline J   De Henauw Stefaan S   Hirsch-Ernst Karen Ildico KI   Maciuk Alexandre A   Mangelsdorf Inge I   McArdle Harry J HJ   Naska Androniki A   Pentieva Kristina K   Siani Alfonso A   Thies Frank F   Tsabouri Sophia S   Vinceti Marco M   Aguilera-Gómez Margarita M   Cubadda Francesco F   Frenzel Thomas T   Heinonen Marina M   Marchelli Rosangela R   Neuhäuser-Berthold Monika M   Poulsen Morten M   Prieto Maradona Miguel M   Schlatter Josef Rudolf JR   Siskos Alexandros A   van Loveren Henk H   Ferreira da Costa Lucien L   Albert Océane O   Knutsen Helle Katrine HK  

EFSA journal. European Food Safety Authority 20240122 1


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 manuf  ...[more]

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