Safety of D-allulose as a novel food pursuant to Regulation (EU) 2015/2283

Dominique Turck; Montaña Cámara; Torsten Bohn; Jacqueline Castenmiller; Stefaan De Henauw; Ángeles Jos; Alexandre Maciuk; Inge Mangelsdorf; Breige McNulty; Androniki Naska; Kristina Pentieva; Alfonso Siani; Frank Thies; Margarita Aguilera-Gómez; Francesco Cubadda; Thomas Frenzel; Marina Heinonen; Helle Katrine Knutsen; Harry J McArdle; Monika Neuhäuser-Berthold; Morten Poulsen; Miguel Prieto Maradona; Josef Rudolf Schlatter; Alexandros Siskos; Henk van Loveren; Salvatore Multari; Annamaria Rossi; Karen Ildico Hirsch-Ernst; EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

doi:10.2903/j.efsa.2025.9468

Safety of D-allulose as a novel food pursuant to Regulation (EU) 2015/2283

Dominique Turck, Montaña Cámara, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Helle Katrine Knutsen, Harry J McArdle, Monika Neuhäuser-BertholdMorten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Salvatore Multari, Annamaria Rossi, Karen Ildico Hirsch-Ernst, 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 D-allulose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data concerned the identity, the production process, proposed uses and use levels, genotoxicity and human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. D-allulose, cannot be established.

Original language	English
Article number	e9468
Number of pages	11
Journal	EFSA Journal
Volume	23
Issue number	6
DOIs	https://doi.org/10.2903/j.efsa.2025.9468 https://doi.org/10.2903/j.efsa.2025.9468
Publication status	Published - 5 Jun 2025

Keywords

D-allulose
D-psicose
monosaccharide
novel food
sugar substitute

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10.2903/j.efsa.2025.9468

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Turck, D., Cámara, M., Bohn, T., Castenmiller, J., De Henauw, S., Jos, Á., Maciuk, A., Mangelsdorf, I., McNulty, B., Naska, A., Pentieva, K., Siani, A., Thies, F., Aguilera-Gómez, M., Cubadda, F., Frenzel, T., Heinonen, M., Knutsen, H. K., McArdle, H. J., ... EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) (2025). Safety of D-allulose as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 23(6), Article e9468. https://doi.org/10.2903/j.efsa.2025.9468, https://doi.org/10.2903/j.efsa.2025.9468

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title = "Safety of D-allulose 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 D-allulose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data concerned the identity, the production process, proposed uses and use levels, genotoxicity and human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. D-allulose, cannot be established.",

keywords = "D-allulose, D-psicose, monosaccharide, novel food, sugar substitute",

author = "Dominique Turck and Monta{\~n}a C{\'a}mara and Torsten Bohn and Jacqueline Castenmiller and \{De Henauw\}, Stefaan and {\'A}ngeles Jos and Alexandre Maciuk and Inge Mangelsdorf and Breige McNulty and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Margarita Aguilera-G{\'o}mez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Knutsen, \{Helle Katrine\} and McArdle, \{Harry J\} and Monika Neuh{\"a}user-Berthold and Morten Poulsen and Maradona, \{Miguel Prieto\} and Schlatter, \{Josef Rudolf\} and Alexandros Siskos and \{van Loveren\}, Henk and Salvatore Multari and Annamaria Rossi and Hirsch-Ernst, \{Karen Ildico\} and \{EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)\}",

note = "{\textcopyright} 2025 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.",

year = "2025",

month = jun,

day = "5",

doi = "10.2903/j.efsa.2025.9468",

language = "English",

volume = "23",

journal = "EFSA Journal",

issn = "1831-4732",

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Turck, D, Cámara, M, Bohn, T, Castenmiller, J, De Henauw, S, Jos, Á, Maciuk, A, Mangelsdorf, I, McNulty, B, Naska, A, Pentieva, K, Siani, A, Thies, F, Aguilera-Gómez, M, Cubadda, F, Frenzel, T, Heinonen, M, Knutsen, HK, McArdle, HJ, Neuhäuser-Berthold, M, Poulsen, M, Maradona, MP, Schlatter, JR, Siskos, A, van Loveren, H, Multari, S, Rossi, A, Hirsch-Ernst, KI & EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) 2025, 'Safety of D-allulose as a novel food pursuant to Regulation (EU) 2015/2283', EFSA Journal, vol. 23, no. 6, e9468. https://doi.org/10.2903/j.efsa.2025.9468, https://doi.org/10.2903/j.efsa.2025.9468

TY - JOUR

T1 - Safety of D-allulose as a novel food pursuant to Regulation (EU) 2015/2283

AU - Turck, Dominique

AU - Cámara, Montaña

AU - Bohn, Torsten

AU - Castenmiller, Jacqueline

AU - De Henauw, Stefaan

AU - Jos, Ángeles

AU - Maciuk, Alexandre

AU - Mangelsdorf, Inge

AU - McNulty, Breige

AU - Naska, Androniki

AU - Pentieva, Kristina

AU - Siani, Alfonso

AU - Thies, Frank

AU - Aguilera-Gómez, Margarita

AU - Cubadda, Francesco

AU - Frenzel, Thomas

AU - Heinonen, Marina

AU - Knutsen, Helle Katrine

AU - McArdle, Harry J

AU - Neuhäuser-Berthold, Monika

AU - Poulsen, Morten

AU - Maradona, Miguel Prieto

AU - Schlatter, Josef Rudolf

AU - Siskos, Alexandros

AU - van Loveren, Henk

AU - Multari, Salvatore

AU - Rossi, Annamaria

AU - Hirsch-Ernst, Karen Ildico

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

PY - 2025/6/5

Y1 - 2025/6/5

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 D-allulose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data concerned the identity, the production process, proposed uses and use levels, genotoxicity and human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. D-allulose, cannot be established.

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 D-allulose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data concerned the identity, the production process, proposed uses and use levels, genotoxicity and human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. D-allulose, cannot be established.

KW - D-allulose

KW - D-psicose

KW - monosaccharide

KW - novel food

KW - sugar substitute

UR - https://pubmed.ncbi.nlm.nih.gov/40487234/

U2 - 10.2903/j.efsa.2025.9468

DO - 10.2903/j.efsa.2025.9468

M3 - Article

C2 - 40487234

SN - 1831-4732

VL - 23

JO - EFSA Journal

JF - EFSA Journal

IS - 6

M1 - e9468

ER -

Safety of D-allulose as a novel food pursuant to Regulation (EU) 2015/2283

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Keywords

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