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

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 van Loveren; Lucien Ferreira da Costa; Océane Albert; Helle Katrine Knutsen; EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

doi:10.2903/j.efsa.2024.8491

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

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-BertholdMorten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Lucien Ferreira da Costa, Océane Albert, Helle Katrine Knutsen, EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

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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.

Original language	English
Article number	e8491
Journal	EFSA Journal
Volume	22
Issue number	1
DOIs	https://doi.org/10.2903/j.efsa.2024.8491
Publication status	Published - 22 Jan 2024

Keywords

isomaltulose
isomaltulose syrup
novel foods
trehalulose

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Turck, D., Bohn, T., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K. I., Maciuk, A., Mangelsdorf, I., McArdle, H. J., Naska, A., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Aguilera-Gómez, M., Cubadda, F., Frenzel, T., Heinonen, M., Marchelli, R., ... EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) (2024). Safety of isomaltulose syrup (dried) as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 22(1), Article e8491. https://doi.org/10.2903/j.efsa.2024.8491

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title = "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.",

keywords = "isomaltulose, isomaltulose syrup, novel foods, trehalulose",

author = "Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Hirsch-Ernst, {Karen Ildico} and Alexandre Maciuk and Inge Mangelsdorf and McArdle, {Harry J.} and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-G{\'o}mez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Rosangela Marchelli and Monika Neuh{\"a}user-Berthold and Morten Poulsen and {Prieto Maradona}, Miguel and Schlatter, {Josef Rudolf} and Alexandros Siskos and {van Loveren}, Henk and {Ferreira da Costa}, Lucien and Oc{\'e}ane Albert and Knutsen, {Helle Katrine} and {EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)}",

note = "Publisher Copyright: {\textcopyright} 2024 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.",

year = "2024",

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day = "22",

doi = "10.2903/j.efsa.2024.8491",

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Turck, D, Bohn, T, Castenmiller, J, De Henauw, S, Hirsch-Ernst, KI, Maciuk, A, Mangelsdorf, I, McArdle, HJ, Naska, A, Pentieva, K, Siani, A, Thies, F, Tsabouri, S, Vinceti, M, Aguilera-Gómez, M, Cubadda, F, Frenzel, T, Heinonen, M, Marchelli, R, Neuhäuser-Berthold, M, Poulsen, M, Prieto Maradona, M, Schlatter, JR, Siskos, A, van Loveren, H, Ferreira da Costa, L, Albert, O, Knutsen, HK & EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) 2024, 'Safety of isomaltulose syrup (dried) as a novel food pursuant to Regulation (EU) 2015/2283', EFSA Journal, vol. 22, no. 1, e8491. https://doi.org/10.2903/j.efsa.2024.8491

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T1 - Safety of isomaltulose syrup (dried) as a novel food pursuant to Regulation (EU) 2015/2283

AU - Turck, Dominique

AU - Bohn, Torsten

AU - Castenmiller, Jacqueline

AU - De Henauw, Stefaan

AU - Hirsch-Ernst, Karen Ildico

AU - Maciuk, Alexandre

AU - Mangelsdorf, Inge

AU - McArdle, Harry J.

AU - Naska, Androniki

AU - Pentieva, Kristina

AU - Siani, Alfonso

AU - Thies, Frank

AU - Tsabouri, Sophia

AU - Vinceti, Marco

AU - Aguilera-Gómez, Margarita

AU - Cubadda, Francesco

AU - Frenzel, Thomas

AU - Heinonen, Marina

AU - Marchelli, Rosangela

AU - Neuhäuser-Berthold, Monika

AU - Poulsen, Morten

AU - Prieto Maradona, Miguel

AU - Schlatter, Josef Rudolf

AU - Siskos, Alexandros

AU - van Loveren, Henk

AU - Ferreira da Costa, Lucien

AU - Albert, Océane

AU - Knutsen, Helle Katrine

AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

PY - 2024/1/22

Y1 - 2024/1/22

N2 - 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.

AB - 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.

KW - isomaltulose

KW - isomaltulose syrup

KW - novel foods

KW - trehalulose

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ER -

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

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Keywords

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