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

EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) et al. EFSA J. .

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.

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Figures

FIGURE 1
FIGURE 1
Chemical structure of ‘D‐allulose’.
See this image and copyright information in PMC

References

    1. EFSA NDA Panel (Panel on Dietetic Products Nutrition and Allergies) . (2016). Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of regulation (EU) 2015/2283. EFSA Journal, 14(11), 4594. 10.2903/j.efsa.2016.4594 - DOI
    1. EFSA Scientific Committee . (2011). Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment. EFSA Journal, 9(9), 2379. 10.2903/j.efsa.2011.2379 - DOI
    1. FDA (U.S. Food and Drug Administration) . (2020). The declaration of allulose and calories from allulose on nutrition and supplement facts labels: Guidance for industry .
    1. Oshima, H. , Kimura, I. , & Izumori, K. (2006). Psicose contents in various food products and its origin. Food Science and Technology Research, 12(2), 137–143.

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