Safety of D‐allulose as a novel food pursuant to Regulation (EU) 2015/2283
2025
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) | 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 vanLoveren | Salvatore Multari | Annamaria Rossi | Karen Ildico Hirsch‐Ernst
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.
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