About
Fructo-oligosaccharides (FOS) are naturally occurring short-chain carbohydrates composed of fructose units linked to a terminal glucose, found in plants such as chicory, onion, and banana, and also produced commercially from sucrose or inulin hydrolysis. They are used as prebiotic dietary fiber ingredients in foods, beverages, and infant formula to selectively stimulate the growth of beneficial gut bacteria such as bifidobacteria.
Safety summary
FOS has a strong safety profile and no formal Acceptable Daily Intake (ADI) has been established by international regulatory bodies, as it is classified as a food ingredient rather than a food additive. At doses above approximately 10 g/day in adults, FOS can cause dose-dependent gastrointestinal side effects including bloating, flatulence, cramping, and loose stools. Individuals with irritable bowel syndrome (IBS) may be particularly sensitive due to FOS's classification as a high-FODMAP (fermentable oligosaccharide) carbohydrate.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Permitted as a dietary fiber and prebiotic food ingredient; not assigned an E number as it is not classified as a food additive under Regulation (EC) No 1333/2008. Permitted in infant formula in combined GOS/FOS formulations (up to 0.8 g FOS/L) under Regulation (EU) No 609/2013. EFSA NDA Panel evaluated multiple health claims for FOS related to bowel function, gut microbiota, SCFA production, and mineral absorption.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Approved for use in infant formula products containing galacto-oligosaccharides and fructo-oligosaccharides (e.g., FSSAI product approvals 75/Std/PA/FSSAI/2018 and 63/Std/PA/FSSAI/2020). Regulated under FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Functional Food and Novel Food) Regulations, 2016 and the Infant Formula Regulations (IFR) Version-II (2024).source |
| FDA (Food and Drug Administration) (United States) | Approved | GRAS status supported by multiple GRAS Notices: GRN 605 (fructo-oligosaccharides), GRN 623 (fructooligosaccharides), and GRN 1006 (short-chain FOS). Approved for use in a wide range of conventional foods and infant formula with no established maximum use level beyond GMP.source |
Who should approach with care
Research citations
- 1FDA. GRAS Notice 605: Fructo-oligosaccharides. fda.gov
- 2FSSAI. List of product(s)/ingredient(s) applications Approved under Food Safety and Standards (NSF & FI) Regulations, 2017 — as on 2nd May 2025, 2025. fssai.gov.in
- 3FDA. GRAS Notice 1006: Short-chain Fructooligosaccharides, 2021. fda.gov
- 4EFSA. Short-chain fructooligosaccharides from sucrose and maintenance of normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 — EFSA NDA Panel, EFSA Journal 2016, 2016. efsa.europa.eu
- 5EFSA. Scientific Opinion on the substantiation of health claims related to fructooligosaccharides (FOS) from sucrose — EFSA NDA Panel, EFSA Journal 2011;9(4):2023, 2011. efsa.europa.eu
