About
Sodium alginate is a natural anionic polysaccharide derived from brown seaweed, composed of β-D-mannuronic acid and α-L-guluronic acid units. It is widely used in food processing as a thickener, stabilizer, gelling agent, and emulsifier in products such as dairy-based drinks, frozen desserts, jellies, and fresh fruit coatings.
Safety summary
Both JECFA (1993) and EFSA (2017) determined that no numerical Acceptable Daily Intake (ADI) is required because sodium alginate is practically undigested and not absorbed intact by the human body, with only partial fermentation by intestinal microbiota. No adverse effects were observed in subchronic rodent studies up to 13,500 mg/kg body weight per day, and no carcinogenic effects were observed at doses up to 37,500 mg/kg body weight per day in mice. EFSA noted that available data were insufficient to fully assess safety in infants and young children consuming special medical purpose formulae.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorized as food additive E401 under Regulation (EC) No 1333/2008 and specified in Commission Regulation (EU) No 231/2012. EFSA ANS Panel 2017 re-evaluation confirmed no numerical ADI is required and no safety concern exists at reported use levels. Permitted at quantum satis in most food categories listed in Annex II and III.source |
| Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom) | Approved | E401 retained as an authorized food additive post-Brexit under assimilated Regulation 1331/2008. FSA/FSS 2022 safety assessment (AEJEG, July 2022) concluded no risk to health from extended use as a coating on entire fresh fruit and vegetables (citrus, melons, bananas, avocados, mangoes, etc.) at quantum satis, confirming ADI not specified due to low toxicological concern.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Recognized as a permitted emulsifying and stabilizing agent (INS 401) under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Permitted at GMP levels in various food categories including dairy-based drinks and flavoured milks. Also listed as a permitted diluent in colour preparations.source |
| FDA (Food and Drug Administration) (United States) | Approved |
Who should approach with care
Research citations
- 1FDA. Sodium Alginate – Code of Federal Regulations Title 21, Section 184.1724. accessdata.fda.gov
- 2other. Sodium Alginate Modifications: A Critical Review of Current Strategies and Emerging Applications, 2025. pmc.ncbi.nlm.nih.gov
- 3EFSA. Re-evaluation of alginic acid and its sodium, potassium, ammonium and calcium salts (E 400–E 404) as food additives, 2017. efsa.europa.eu
- 4PubMed. Re-evaluation of alginic acid and its sodium, potassium, ammonium and calcium salts (E 400–E 404) as food additives (EFSA ANS Panel, peer-reviewed publication), 2017. pmc.ncbi.nlm.nih.gov
- 5FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, 2011. fssai.gov.in