Our Verdict: SAFE

D-gluconic Acid

E-numberE574CAS526-95-4

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

D-gluconic Acid — food additive

D-gluconic acid is an organic acid derived from the oxidation of glucose, commonly used as a nutrient supplement and pH regulator in food products. It provides a source of gluconic acid, which can be metabolized by the body, and is generally recognized as safe by scientific consensus despite lacking formal FDA GRAS status.

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
Not EvaluatedUK FSA
Canada
ApprovedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
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 D-gluconic Acid?

D-gluconic acid (CAS Number: 526-95-4) is a naturally occurring organic acid produced through the oxidation of D-glucose. It is the gluconic form of glucose and exists as a six-carbon sugar acid. D-gluconic acid occurs naturally in fermented foods, honey, and other food sources, making it a compound the body recognizes and can readily metabolize. The acid is colorless to pale yellow and highly soluble in water, making it suitable for various food applications.

Common Uses

D-gluconic acid serves primarily as a nutrient supplement in food and beverage formulations. It is used in:

- Nutritional supplements and fortified foods to enhance mineral bioavailability

- Beverages as a source of organic acid and potential energy source

- Chelating agent applications where it binds minerals like calcium, iron, and zinc

- pH adjustment in food processing, particularly in fermented products

- Functional food products targeting digestive and metabolic health

The acid is particularly valued in nutritional contexts because gluconic acid salts (gluconates) are well-absorbed and utilized by the human body. Many mineral supplements use gluconate forms specifically for enhanced bioavailability.

Safety Assessment

D-gluconic acid has an excellent safety profile based on available evidence:

- **FDA Adverse Events:** Zero reported adverse events in FDA databases

- **FDA Recalls:** Zero product recalls associated with this ingredient

- **Natural Occurrence:** The compound exists naturally in foods and fermentation processes, suggesting inherent safety

- **Metabolism:** D-gluconic acid is readily metabolized through normal glucose metabolic pathways

- **Toxicology:** No significant toxicological concerns have been identified in scientific literature

The absence of adverse event reports and recalls reflects both its safe use history and appropriate application levels in food products. As an organic acid naturally present in many foods, the body has established metabolic mechanisms for its processing.

Regulatory Status

D-gluconic acid does not currently hold FDA GRAS (Generally Recognized as Safe) status, though this reflects classification gaps rather than safety concerns. The ingredient is permitted in food use in many countries including the European Union, where it is recognized as a food additive (E574 for gluconic acid and its salts). The lack of FDA GRAS designation may indicate the ingredient has not been formally petitioned for this status rather than any safety objection.

In the EU, gluconic acid and gluconate salts are evaluated and approved food additives with established acceptable daily intake levels. Regulatory bodies in multiple countries have evaluated this compound without identifying safety concerns at typical use levels.

Key Studies

Scientific literature on D-gluconic acid focuses primarily on:

- **Mineral Bioavailability:** Research demonstrates that gluconate forms of minerals enhance absorption compared to other salt forms, supporting its use in nutritional supplements

- **Metabolic Studies:** Studies confirm D-gluconic acid follows normal glucose metabolism pathways without accumulation

- **Fermentation Applications:** Extensive research documents gluconic acid production during natural fermentation, establishing its presence in traditional foods

- **Safety History:** Long history of safe use in fermented foods and supplements with no documented adverse effects

While formal toxicology studies specific to food-use levels are limited in public databases, the ingredient's natural occurrence, metabolic fate, and use history across multiple countries provide strong evidence of safety. The zero adverse event reports from FDA databases across all food applications further support its safe use profile.

Frequently Asked Questions

What is D-gluconic Acid?

D-gluconic acid is an organic acid derived from the oxidation of glucose, commonly used as a nutrient supplement and pH regulator in food products. It provides a source of gluconic acid, which can be metabolized by the body, and is generally recognized as safe by scientific consensus despite lacking formal FDA GRAS status.

Is D-gluconic Acid safe?

D-gluconic Acid 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 D-gluconic Acid banned in any country?

D-gluconic Acid 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.