About
Sodium starch glycolate is the sodium salt of carboxymethyl starch, produced by treating natural starch with monochloroacetic acid under alkaline conditions. It is primarily used as a superdisintegrant in pharmaceutical tablet and capsule formulations to promote rapid tablet breakdown; it carries no approved food-additive status in any major regulatory framework.
Safety summary
Sodium starch glycolate is generally well tolerated at pharmaceutical excipient use levels and has no IARC carcinogenicity classification. It is not approved as a direct food additive by the FDA, EFSA, or FSSAI, meaning no food-specific Acceptable Daily Intake (ADI) has been established and formal food-focused safety assessments are absent. Individuals on sodium-restricted diets—due to hypertension, heart disease, or kidney disease—should note its sodium content; infants and young children are a special concern given the complete absence of food regulatory clearance.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Restricted | Sodium starch glycolate is absent from the EU list of permitted food additives under Regulation (EC) No 1333/2008. EFSA's 2017 re-evaluation covered 12 approved modified starches (E 1404–E 1452); sodium starch glycolate was not among them and holds no E-number for food use. Its use in pharmaceuticals is governed separately under EU pharmaceutical law.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Restricted | Sodium starch glycolate does not appear in FSSAI Food Safety and Standards (Food Products Standards and Food Additives) Regulation 2011 Appendix A as a permitted food additive. Its use in foods in India therefore lacks regulatory sanction.source |
| FDA (Food and Drug Administration) (United States) | Restricted | Sodium starch glycolate does not appear on the FDA Food Additive Status List (formerly EAFUS) or in any GRAS notification for direct food use. It is recognised only as a pharmaceutical excipient under the FDA's drug regulatory framework (21 CFR), not as a food ingredient.source |
Who should approach with care
Research citations
- 1ECHA. Sodium Starch Glycolate – Substance Information (EC / List no. 100.119.599). echa.europa.eu
- 2other. European Chemicals Agency (ECHA) – Pre-Registration and C&L Inventory entry for Sodium Starch Glycolate. echa.europa.eu
- 3FDA. Food Additive Status List – Substances Added to Food (formerly EAFUS), 2026. fda.gov
- 4FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulation, 2011 – Compendium (updated Oct 2021), 2021. fssai.gov.in
- 5EFSA. Re-evaluation of oxidised starch (E 1404) … and starch aluminium octenyl succinate (E 1452) as food additives, 2017. efsa.europa.eu
