Croscarmellose Sodium

About

What it is and where it shows up.

Croscarmellose sodium is a cross-linked polymer of sodium carboxymethylcellulose, manufactured by acidifying an aqueous suspension of sodium carboxymethyl cellulose (NaCMC) and heating to achieve cross-linking. It is used primarily as a disintegrant in solid dietary supplements and pharmaceutical tablets, enabling rapid tablet break-up upon ingestion at use levels of 0.25–3.0%.

Safety summary

The regulatory and scientific consensus.

Animal studies demonstrate a very high no-observed-adverse-effect level (NOAEL) of 50,000 ppm (approximately 3,922–4,712 mg/kg/day) in 90-day rat feeding studies, with no adverse effects observed. Teratogenicity studies in rats found no effects on embryo-fetal development at up to approximately 4,554 mg/kg/day. JECFA/WHO has not established a numerical ADI, classifying modified celluloses generally as substances of very low toxicity; the EU Scientific Committee for Food estimated extreme human intake at 8.5 mg/kg body weight per day from combined permitted uses.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Approved as E468 under Regulation (EC) No 1333/2008; restricted to use as a disintegrant in dietary supplements and solid tabletop sweetener tablets. EFSA issued a call for technical and toxicological data in August 2023 as part of an active re-evaluation of E460–E469 cellulose derivatives.source
FDA (Food and Drug Administration) (United States)	Approved	GRAS status for use as a disintegrant in dietary supplements; also widely accepted as a pharmaceutical excipient in prescription and OTC drug formulations reviewed under FDA's NDA process.source

Who should approach with care

Whose guidance would steer them away.

Ibs — As an indigestible, water-swelling fiber-like polymer, croscarmellose sodium may contribute to bloating, gas, or altered gut motility in individuals with irritable bowel syndrome who regularly consume multiple supplement tablets per day.

Ibd — Patients with inflammatory bowel disease should consult a physician before regularly consuming products containing croscarmellose sodium, as its bulking and swelling properties in the gastrointestinal tract could potentially exacerbate symptoms in an already inflamed gut environment.

Research citations

The sources behind this verdict.

1EFSA. Opinion on Use of Cross-Linked Sodium Carboxymethyl Cellulose (EU Scientific Committee for Food). food.ec.europa.eu
2WHO. JECFA Food Additives and Contaminants Database — Cross-Linked Sodium Carboxymethyl Cellulose (INS 468). apps.who.int
3EFSA. EFSA Call for Technical Data on Cellulose Derivatives E460–E465, E468, E469 (Re-evaluation 2023), 2023. food.ec.europa.eu
4FDA. Pharmacology Review NDA 022542 (VIOKACE) — Croscarmellose Sodium Excipient Safety Summary, 2012. accessdata.fda.gov
5FDA. Pharmacology Review NDA 022222 (Ultrase) — Croscarmellose Sodium NOAEL and Teratogenicity Data, 2012. accessdata.fda.gov

Independently researched5 citations