Our Verdict: RATING UNKNOWN

Sulfopropyl Cellulose

E-numberE460CAS37325-18-1

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Sulfopropyl Cellulose โ€” food additive

Sulfopropyl cellulose (CAS 37325-18-1) is a chemically modified cellulose derivative created by introducing sulfopropyl groups into cellulose chains. While its specific food applications remain unclear, it belongs to a class of cellulose derivatives used in various industrial and pharmaceutical formulations.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Sulfopropyl Cellulose?

Sulfopropyl cellulose is a synthetic polymer derived from cellulose, the structural carbohydrate found in plant cell walls. The compound is created through chemical modification where sulfopropyl functional groups are attached to the cellulose backbone. This modification alters the physical and chemical properties of the base cellulose material, potentially enhancing solubility, viscosity control, or binding characteristics.

The CAS Registry Number 37325-18-1 uniquely identifies this specific cellulose derivative in chemical databases. Like other cellulose derivatives (such as carboxymethyl cellulose and hydroxypropyl methylcellulose), sulfopropyl cellulose represents an example of how natural polymers can be chemically tailored for industrial applications.

Common Uses

While sulfopropyl cellulose's specific function in food applications has not been clearly established in available regulatory documentation, cellulose derivatives broadly are used in the food industry as thickeners, binders, emulsifiers, and stabilizers. These modified celluloses help improve texture, consistency, and shelf stability in various food products.

In pharmaceutical and cosmetic industries, sulfopropyl cellulose and similar derivatives may serve as excipientsโ€”inactive ingredients that facilitate drug delivery or product formulation. However, its particular role in food manufacturing remains undocumented in mainstream food additive databases.

Safety Assessment

As of the available FDA records, sulfopropyl cellulose has generated zero reported adverse events and zero product recalls. This absence of reported incidents suggests either minimal use in the U.S. food supply, a strong safety profile, or both.

The compound has not received GRAS (Generally Recognized As Safe) status from the FDA, indicating either that a formal safety petition has not been submitted, the petition was withdrawn, or the additive does not meet criteria for GRAS designation. GRAS status is not a prerequisite for food ingredient safety; rather, it represents one regulatory pathway for ingredient approval.

Cellulose derivatives in general have an established history of safe use across multiple industries. Related compounds like carboxymethyl cellulose (CMC) have undergone extensive safety evaluations and are approved in numerous countries. However, each derivative requires individual assessment based on its unique chemical structure and potential biological activity.

Regulatory Status

Sulfopropyl cellulose's regulatory status differs across jurisdictions. In the United States, the additive is not listed on the FDA's approved food additives list under its specific CAS number or name, nor does it carry GRAS status. This suggests it is either not intentionally used in FDA-regulated food products, or its use has not been formally approved through established regulatory channels.

International regulatory bodies, including the European Food Safety Authority (EFSA), maintain their own approved additives lists. The presence or absence of sulfopropyl cellulose in these lists would depend on regional regulatory submissions and safety evaluations.

Manufacturers wishing to use this additive in food products would typically need to submit safety data and a formal petition to the FDA or equivalent regulatory authority in their country.

Key Studies

Current publicly available literature on sulfopropyl cellulose's safety profile in food applications is limited. Most scientific research on cellulose derivatives focuses on established compounds with commercial food applications like CMC, methylcellulose, and hydroxypropyl methylcellulose.

The lack of published adverse event reports or recalls associated with this specific compound suggests either that comprehensive safety studies exist but are proprietary, or the additive has minimal commercial food market presence. Toxicological studies typical for food additive approval would assess acute toxicity, chronic toxicity, genotoxicity, and allergenicity across animal models before human consumption approval.

Frequently Asked Questions

What is Sulfopropyl Cellulose?

Sulfopropyl cellulose (CAS 37325-18-1) is a chemically modified cellulose derivative created by introducing sulfopropyl groups into cellulose chains. While its specific food applications remain unclear, it belongs to a class of cellulose derivatives used in various industrial and pharmaceutical formulations.

Is Sulfopropyl Cellulose safe?

Sulfopropyl Cellulose is currently rated "unknown" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Sulfopropyl Cellulose banned in any country?

Sulfopropyl Cellulose is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.