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

## TL;DR

The European Food Safety Authority could not confirm the safety of D-allulose as a novel food due to insufficient data provided by the applicant.

## Contribution

The paper reports the outcome of a safety evaluation of D-allulose under EU regulations, highlighting data gaps preventing a safety conclusion.

## Key findings

- The applicant failed to provide requested data on D-allulose's identity, production, and safety.
- EFSA could not establish the safety of D-allulose due to missing information.
- The risk assessment identified genotoxicity and human data as critical areas needing clarification.

## 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.