About
Sorbitol is a sugar alcohol (polyol) that occurs naturally in fruits such as apples, pears, and plums, and is commercially produced by the hydrogenation of glucose. It is widely used in food as a sweetener, humectant, and bulking agent in sugar-free confectionery, baked goods, pharmaceuticals, and cosmetics.
Safety summary
JECFA has assigned sorbitol an ADI of 'not specified,' indicating no numerical daily limit is required at typical food-use levels. However, consumption exceeding approximately 50 g per day is documented to cause laxative effects and gastrointestinal discomfort, including bloating, gas, and diarrhea, particularly in sensitive individuals such as those with IBS. The EU has restricted sorbitol in beverages specifically because young consumers could more readily exceed the laxative threshold, and EFSA's safety re-evaluation is currently ongoing.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Approved as E420 under Regulation (EC) No 1333/2008; use in beverages is not permitted in the EU because young consumers could more easily exceed the laxative threshold; EFSA genotoxicity re-evaluation is currently ongoing under the food additives re-evaluation programme (Commission Regulation (EU) No 257/2010)source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Permitted under FSS (Food Products Standards and Food Additives) Regulations, 2011 as INS 420 at GMP (Good Manufacturing Practice) levels across multiple food categories including bread and bakery products; listed as a permitted nutritive sweetener in FSSAI Labelling and Display Regulationssource |
| FDA (Food and Drug Administration) (United States) | Approved | Listed as GRAS under 21 CFR 184.1835 as a multipurpose food substance (sweetener, humectant, sequestrant, texturizer); products providing more than 50 g of sorbitol per day must bear a labeling statement about its laxative effectsource |
Who should approach with care
Research citations
- 1FDA. 21 CFR Part 184.1835 – Sorbitol (Code of Federal Regulations Title 21). accessdata.fda.gov
- 2WHO. Codex Alimentarius – Comment Compilation on Polyol Sweeteners in Food Categories (CX-711-52). fao.org
- 3EFSA. Call for data on genotoxicity data on sorbitol (E 420 i), 2023. efsa.europa.eu
- 4FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 – Appendix A: List of Food Additives, 2011. fssai.gov.in
- 5EFSA. Sugar replacers xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose related health claims, 2011. efsa.europa.eu
