Our Verdict: RATING UNKNOWN

Calcium Lactobionate

CAS5001-51-4

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

Calcium Lactobionate — food additive

Calcium lactobionate is a calcium salt derived from lactobionic acid, used as a firming agent in food products to maintain texture and structural integrity. It functions by strengthening cell walls and is primarily utilized in processed foods where firmness retention is desired.

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 Calcium Lactobionate?

Calcium lactobionate (CAS Number: 5001-51-4) is a calcium salt compound formed from lactobionic acid, a naturally occurring organic acid. The ingredient appears as a white to off-white crystalline powder and is soluble in water. As a firming agent, it works by cross-linking with pectin and other polysaccharides in food matrices, thereby strengthening cell wall structures and preventing texture degradation during processing and storage.

Common Uses

Calcium lactobionate is employed in the food industry primarily as a texture modifier in processed fruits and vegetables. It is particularly useful in canned or processed produce where maintaining firmness is critical to product quality and consumer acceptance. The ingredient may also be found in some dairy products and baked goods where structural integrity during shelf life is important. Its use is typically limited to specialty food applications rather than mass-market products.

Safety Assessment

Calcium lactobionate has not been associated with adverse events reported to the FDA, and no FDA recalls have been linked to this ingredient. The compound's safety profile appears favorable, as it is derived from naturally occurring components—calcium and lactobionic acid—both of which have established safety histories in food applications. Lactobionic acid itself is recognized as a mild humectant and preservative in cosmetics and foods. The calcium component is an essential mineral with well-documented nutritional benefits.

The ingredient's chemical structure and metabolism suggest it would be readily broken down into its component parts during digestion, with no evidence of bioaccumulation or systemic toxicity. Animal and in vitro studies have not identified significant toxicological concerns at typical food use levels.

Regulatory Status

Calcium lactobionate is not listed as GRAS (Generally Recognized as Safe) by the FDA, which means it has not undergone the formal GRAS notification process. However, this status does not indicate that the ingredient is unsafe—rather, it reflects that formal GRAS documentation has not been submitted to or accepted by the FDA. The ingredient may still be used in foods under FDA regulations if it meets other approval requirements or falls within established food additive categories.

The ingredient is permitted in certain food applications in various jurisdictions, though specific regulations vary by country and region. In the European Union, similar calcium-based firming agents are evaluated under EFSA frameworks, though calcium lactobionate's specific regulatory status in the EU should be verified for current approvals.

Key Studies

Limited published research specifically addresses calcium lactobionate as a food additive. Most supporting data comes from industry technical literature and manufacturer safety documentation rather than peer-reviewed academic studies. The lack of published research is not uncommon for specialty food additives with established safe-use histories and minimal adverse event reporting.

The ingredient's safety profile is supported indirectly by research on its component materials: calcium salts in food applications have extensive safety documentation, and lactobionic acid has been studied for various food and cosmetic applications with favorable results. The compound's behavior in food matrices has been characterized through food science research on firming agent mechanisms, though not necessarily in peer-reviewed literature specific to this ingredient.

Future research opportunities include comparative efficacy studies with other firming agents and long-term consumption studies, though the current evidence suggests no urgent safety concerns warranting such investigation.

Frequently Asked Questions

What is Calcium Lactobionate?

Calcium lactobionate is a calcium salt derived from lactobionic acid, used as a firming agent in food products to maintain texture and structural integrity. It functions by strengthening cell walls and is primarily utilized in processed foods where firmness retention is desired.

Is Calcium Lactobionate safe?

Calcium Lactobionate 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 Calcium Lactobionate banned in any country?

Calcium Lactobionate 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.