Sodium Starch Glycolate

About

What it is and where it shows up.

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

The regulatory and scientific consensus.

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

What food-safety regulators have decided.

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

Whose guidance would steer them away.

Infants — Sodium starch glycolate has no approved food additive status and has not undergone any safety assessment for infant populations by EFSA, FDA, or FSSAI; its presence in infant food is entirely unsanctioned.

Children — As a substance without food-additive clearance in any major jurisdiction, chronic dietary exposure in children has not been evaluated; caution is warranted until formal safety data are available.

Hypertension — As a sodium-containing modified starch, it may contribute meaningfully to dietary sodium load, warranting caution for individuals on sodium-restricted diets prescribed for blood pressure management.

Kidney Disease — The sodium moiety of sodium starch glycolate is a concern for patients with chronic kidney disease who require strict sodium restriction to limit fluid retention and cardiovascular burden.

Heart Disease — Excess dietary sodium from food ingredients such as sodium starch glycolate may exacerbate fluid retention and hypertension in individuals with heart failure or other cardiovascular conditions.

Research citations

The sources behind this verdict.

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

Independently researched5 citations