Our Verdict: SAFE

Sodium Gluconate

E-numberE576CAS527-07-1

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Sodium Gluconate โ€” food additive

Sodium gluconate is a sodium salt of gluconic acid, a naturally occurring organic compound derived from glucose. It functions as a flavor enhancer, sequestrant, and nutrient supplement in food products, helping to stabilize formulations and improve taste profiles.

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 Sodium Gluconate?

Sodium gluconate (CAS Number: 527-07-1) is the sodium salt of gluconic acid, an organic acid naturally produced through the fermentation of glucose. It appears as a white to off-white crystalline powder and is highly soluble in water. The compound is structurally related to glucose and occurs naturally in small quantities in various foods, particularly fermented products and honey.

Common Uses

Sodium gluconate is utilized in food manufacturing for multiple functional purposes. As a sequestrant, it binds to metal ions such as iron, copper, and calcium, preventing them from catalyzing oxidation reactions that can degrade food quality, flavor, and color. This makes it particularly valuable in beverages, baked goods, and processed foods where shelf-life stability is important.

The additive also functions as a flavor enhancer and flavoring adjuvant, contributing subtle taste characteristics while supporting the overall sensory profile of food products. Additionally, sodium gluconate serves as a nutrient supplement, providing bioavailable sodium in fortified food applications. It is also employed in pharmaceutical and cosmetic formulations outside the food industry.

Safety Assessment

Sodium gluconate has an established safety profile based on its chemical structure and metabolic fate. Once ingested, it is readily metabolized in the body similar to other gluconic acid salts. The compound presents low toxicity in animal studies, with no observed adverse effects at typical dietary exposure levels.

The FDA has not designated sodium gluconate as Generally Recognized as Safe (GRAS), though this classification status does not indicate a safety concernโ€”rather, it reflects the regulatory pathway and available data submission history. Importantly, the FDA database contains zero reported adverse events associated with sodium gluconate consumption, and no food product recalls have been issued due to this ingredient.

The European Food Safety Authority (EFSA) has evaluated gluconic acid and its salts, including sodium gluconate, and affirmed their safety for use in food applications. Typical dietary exposure levels remain well below any theoretical threshold of concern.

Regulatory Status

Sodium gluconate is permitted for use as a food additive in multiple jurisdictions. In the United States, while not GRAS-listed, it is approved for use in specific food categories. The European Union recognizes sodium gluconate (E576) as an approved food additive within defined usage levels. It is also approved in Canada, Australia, and many other countries where food safety standards are rigorously enforced.

The lack of GRAS status in the U.S. does not restrict its use but rather indicates it was not submitted through the GRAS notification process or that such notification was not finalized. Many safe, long-established food additives lack formal GRAS status due to historical or administrative reasons.

Key Studies

Scientific literature on sodium gluconate and gluconic acid salts demonstrates their safety through multiple pathways. Studies on gluconic acid metabolism show rapid absorption and excretion without bioaccumulation. Animal toxicity studies have established no-observed-adverse-effect levels (NOAEL) well above anticipated human exposure. Genotoxicity and reproductive toxicity studies show no concerning findings.

The chemical similarity to naturally occurring gluconic acid supports its safety assessment, as humans regularly consume gluconic acid from fermented foods, kombucha, and other traditional food sources. Comparative studies with other sequestrants and flavor enhancers position sodium gluconate favorably in terms of safety and efficacy.

Frequently Asked Questions

What is Sodium Gluconate?

Sodium gluconate is a sodium salt of gluconic acid, a naturally occurring organic compound derived from glucose. It functions as a flavor enhancer, sequestrant, and nutrient supplement in food products, helping to stabilize formulations and improve taste profiles.

Is Sodium Gluconate safe?

Sodium Gluconate is currently rated "safe" 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 Sodium Gluconate banned in any country?

Sodium Gluconate 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.