About
D-Allulose is a rare monosaccharide and C-3 epimer of D-fructose that occurs naturally in small amounts in wheat, raisins, dried figs, molasses, maple syrup, and brown sugar. It is approximately 70% as sweet as sucrose but provides negligible calories (~0.4 kcal/g) because it is largely not metabolised by the human body, making it a popular low-calorie sugar substitute.
Safety summary
Extensive toxicological studies, including chronic rodent studies up to 18 months, show no adverse effects at doses up to 1,280 mg/kg bw/day; the FDA has concluded that intake below 0.5–0.6 g/kg bw/day is safe. No ADI has been formally established by an international body. High single-dose intake may cause mild gastrointestinal discomfort in sensitive individuals; the EU/EFSA assessment remains incomplete due to outstanding data gaps submitted by applicants as of 2025.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Approved as a Novel Sugar under FSS (Novel Food and Food Ingredients) Regulations 2017 (Application 05/Std/PA/FSSAI/2018, approval dated 02.04.2018). Also listed under the trade name 'Honeytose' (Application 78/Std/PA/FSSAI/2018, approved 24.01.2020) for use in food category 11.1.1 (sweeteners).source |
| FDA (Food and Drug Administration) (United States) | Approved | FDA has issued 'no questions' responses to multiple GRAS notices (GRN 400, 498, 693, 755, 828, 893, 1029) for D-allulose as a sugar substitute in a broad range of conventional foods and beverages. FDA exercises enforcement discretion to exclude allulose from 'Total Sugars' and 'Added Sugars' declarations, with a caloric factor of 0.4 kcal/g.source |
| EFSA (European Food Safety Authority) (European Union) | Under_review | EFSA NDA Panel published a 2025 opinion concluding safety cannot be established due to unresolved data gaps (identity, production process, proposed use levels, genotoxicity, human data). Novel food dossiers from multiple applicants have been under clock-stop pending additional applicant data. No E number assigned; allulose is not on the EU authorised novel foods list as of 2025.source |
| Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom) | Under_review | Under active review by the Advisory Committee on Novel Foods and Processes (ACNFP) as a novel food. The food enzyme used to produce allulose (d-psicose 3-epimerase) received a positive EU EFSA opinion and can currently be used in Great Britain as no positive enzyme list exists in GB. A final FSA/FSS safety opinion on allulose as a novel food ingredient has not yet been issued. |
Who should approach with care
Research citations
- 1FDA. Aspartame and Other Sweeteners in Food — FDA Overview. fda.gov
- 2EFSA. Safety of D-allulose as a novel food pursuant to Regulation (EU) 2015/2283, 2025. efsa.europa.eu
- 3FSSAI. List of product(s)/ingredient(s) applications Approved under Food Safety and Standards (Novel Food and Food Ingredients) Regulations, 2017, 2022. fssai.gov.in
- 4FDA. Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels, 2020. fda.gov
- 5FDA. GRAS Notice (GRN) No. 755 — D-psicose (D-allulose), 2017. fda.gov