Our Verdict: RATING UNKNOWN

Ammonium Citrate, Dibasic

CAS3012-65-5

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

Ammonium Citrate, Dibasic — food additive

Ammonium citrate, dibasic (CAS 3012-65-5) is an inorganic salt compound used as a lubricant and release agent in food processing. It helps prevent sticking during manufacturing and handling of food products.

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 Ammonium Citrate, Dibasic?

Ammonium citrate, dibasic is an inorganic compound derived from citric acid and ammonia. It has the chemical formula (NH4)2HC6H5O7 and appears as a white crystalline powder. The compound is hygroscopic, meaning it absorbs moisture from the air. Unlike some food additives that provide nutritional or flavor benefits, ammonium citrate, dibasic serves a technical function in food manufacturing.

Common Uses

In food processing, ammonium citrate, dibasic functions primarily as a lubricant and release agent. These agents are applied to food contact surfaces, machinery, and molds to prevent products from sticking during manufacturing, processing, or packaging. This application is particularly common in:

- Baked goods production

- Candy and confectionery manufacturing

- Dried fruit processing

- Tablet and capsule production for nutraceuticals

- Non-stick coatings on food processing equipment

By reducing friction and adhesion, lubricants and release agents improve manufacturing efficiency, reduce product waste, and help maintain consistent product quality and appearance.

Safety Assessment

Ammonium citrate, dibasic has not generated adverse event reports in FDA databases. Additionally, no FDA recalls have been associated with this additive. The absence of documented safety concerns in regulatory surveillance systems suggests that the additive, when used as intended in food manufacturing, does not pose identified risks to consumers at typical exposure levels.

The citrate component of this compound is well-established as safe; citric acid and citrate salts have been used in food for decades with extensive safety histories. Ammonia, the other primary component, is naturally present in foods and is metabolized through normal biochemical pathways. The dibasic ammonium citrate form combines these recognized food components into a functional additive.

As with most food additives used as processing aids, exposure to consumers is typically minimal because the compound remains on equipment surfaces or is present in very small quantities in finished products. Processing aids are often substantially removed or transformed during cooking or further processing steps.

Regulatory Status

Ammonium citrate, dibasic is not on the FDA's GRAS (Generally Recognized as Safe) list, meaning it has not received formal GRAS affirmation. However, this does not indicate the substance is unsafe; rather, it indicates that a formal GRAS petition or review was not submitted to or approved by the FDA.

Food manufacturers using this additive would typically do so under FDA's Food Additive Petition process (if marketed as a direct food additive) or as a processing aid with appropriate documentation supporting its safe use. The regulatory pathway depends on whether the compound remains in the finished food product or is substantially removed during processing.

International regulatory status varies. Some countries' food safety authorities may have evaluated this compound under their own additive approval processes, while others may permit it under general provisions for processing aids.

Key Studies

Limited published peer-reviewed research specifically addresses ammonium citrate, dibasic. The absence of dedicated safety studies in published literature is not unusual for compounds in this category, particularly processing aids used at very low levels. Regulatory decisions typically rely on:

- Chemical composition and known toxicology of component substances (citric acid and ammonia)

- Manufacturing data and specifications ensuring purity

- Use conditions and estimated dietary exposure levels

- Lack of adverse event signals in post-market surveillance

The safety profile of citrate salts generally is well-documented in scientific literature, providing confidence in the citrate portion of this compound. Further research specific to ammonium citrate, dibasic would strengthen the evidence base, though the lack of reported adverse events or regulatory actions suggests it has maintained an acceptable safety margin in current use.

Frequently Asked Questions

What is Ammonium Citrate, Dibasic?

Ammonium citrate, dibasic (CAS 3012-65-5) is an inorganic salt compound used as a lubricant and release agent in food processing. It helps prevent sticking during manufacturing and handling of food products.

Is Ammonium Citrate, Dibasic safe?

Ammonium Citrate, Dibasic 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 Ammonium Citrate, Dibasic banned in any country?

Ammonium Citrate, Dibasic 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.