Our Verdict: SAFE

Monoisopropyl Citrate

CAS1321-57-9

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

Monoisopropyl Citrate — food additive

Monoisopropyl citrate is a citric acid derivative used as a sequestrant and formulation aid in food products. It functions to bind metal ions and improve product stability and shelf life.

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
Not EvaluatedHealth 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 Monoisopropyl Citrate?

Monoisopropyl citrate (CAS Number: 1321-57-9) is a chemical compound derived from citric acid, one of the most common organic acids found naturally in citrus fruits. It is an ester formed by the partial esterification of citric acid with isopropanol. This additive belongs to the broader class of citrate-based food additives that have been used in food formulation for decades.

Common Uses

Monoisopropyl citrate functions primarily as a sequestrant and formulation aid in food applications. As a sequestrant, it works by binding trace metals such as iron, copper, and other divalent cations that can otherwise catalyze oxidative degradation in food products. This metal-binding capability helps prevent rancidity in oils and fats, discoloration in beverages, and other quality deterioration caused by metal-catalyzed reactions. It is also used as a synergist, meaning it enhances the effectiveness of other food additives, particularly antioxidants like BHA and BHT. The compound may be employed in margarine, oils, shortenings, and other fat-containing food products where oxidative stability is a concern.

Safety Assessment

Monoisopropyl citrate has an established safety profile based on its chemical similarity to citric acid and other citrate derivatives. The FDA has not designated this additive as Generally Recognized as Safe (GRAS), though this classification does not indicate a safety concern—rather, it reflects that the additive may not have undergone the formal GRAS notification process or may be used in specific regulated categories. Notably, there are zero reported adverse events associated with monoisopropyl citrate in FDA databases and zero product recalls attributed to this substance. This absence of adverse event reports over decades of food use suggests a favorable safety record in practical applications.

The toxicological profile of citrate esters is generally considered favorable. As an ester derivative of citric acid—a naturally occurring compound extensively metabolized in the body—monoisopropyl citrate would be expected to undergo similar metabolic pathways. The isopropanol component is also a compound with established metabolism in humans, present in various food and cosmetic applications.

Regulatory Status

The regulatory status of monoisopropyl citrate varies by jurisdiction. In the United States, while not GRAS-designated through the FDA's notification process, it may be permitted for use in specific food categories under 21 CFR regulations as a direct food additive where its function is documented. Different countries maintain varying approval lists; some regulatory bodies in the European Union and other regions may have specific authorizations for citrate-derived sequestrants. Food manufacturers using this additive must comply with their regional regulatory frameworks and ingredient declaration requirements.

Key Studies

Published research specifically focused on monoisopropyl citrate in isolation is limited in the peer-reviewed literature. Most safety data relies on the established toxicology of citric acid derivatives and the absence of adverse event reports. The safety of citrate-based sequestrants generally has been supported by decades of use in food applications and the extensive research on citric acid metabolism. The chemical structure of monoisopropyl citrate—a partial ester of citric acid—suggests it would follow similar absorption, distribution, and elimination pathways as parent citric acid in human metabolism. Additional research or safety documentation may exist in proprietary manufacturer data or regulatory dossiers submitted to food safety authorities.

Frequently Asked Questions

What is Monoisopropyl Citrate?

Monoisopropyl citrate is a citric acid derivative used as a sequestrant and formulation aid in food products. It functions to bind metal ions and improve product stability and shelf life.

Is Monoisopropyl Citrate safe?

Monoisopropyl Citrate 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 Monoisopropyl Citrate banned in any country?

Monoisopropyl Citrate 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.