About
Polydextrose is a synthetic, water-soluble glucose polymer produced by high-temperature condensation of dextrose with sorbitol and citric acid; it is used as a bulking agent, low-calorie filler, and soluble dietary fibre in reduced-sugar and reduced-fat foods. It is only partially fermented in the large intestine and contributes approximately 1 kcal/g.
Safety summary
Extensive toxicology studies in animals and humans have found no genotoxic, carcinogenic, reproductive, or developmental toxicity; EFSA concluded no numerical ADI is necessary and there is no safety concern at reported use levels. JECFA similarly assigned an 'ADI not specified' designation. High intakes (approximately 90 g/day) may cause a laxative effect in sensitive individuals, though this is well above typical dietary exposure.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Approved under Regulation (EC) No 1333/2008 (Annex II and III). EFSA 2021 re-evaluation found no need for a numerical ADI. Panel recommended the European Commission introduce limits for arsenic, cadmium, and mercury in EU specifications and verify Polydextrose-N is no longer marketed.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Polydextrose A and N permitted at GMP levels per FSS (Food Products Standards and Food Additives) Regulations, 2011. Products containing ≥10% polydextrose must carry the label declaration 'Polydextrose may have laxative effect' per FSS (Labelling and Display) Regulations.source |
| FDA (Food and Drug Administration) (United States) | Approved | Approved food additive under 21 CFR §172.841. Recognised as a dietary fibre in the 2016 FDA nutrition labelling rules.source |
Who should approach with care
Research citations
- 1FSSAI. Food Safety and Standards (Labelling and Display) Regulations – Compendium (Version IV, September 2022), 2022. fssai.gov.in
- 2EFSA. Re-evaluation of polydextrose (E 1200) as a food additive, 2021. efsa.europa.eu
- 3PubMed. Re-evaluation of polydextrose (E 1200) as a food additive, 2021. pubmed.ncbi.nlm.nih.gov
- 4FSSAI. Appendix A: List of Food Additives – FSS (Food Products Standards and Food Additives) Regulations, 2011, 2011. fssai.gov.in
- 5PubMed. A review of the studies of the safety of polydextrose in food, 1999. pubmed.ncbi.nlm.nih.gov
