Our Verdict: RATING UNKNOWN

Magnesium Palmitate

CAS2601-98-1

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

Magnesium Palmitate — food additive

Magnesium palmitate is a magnesium salt of palmitic acid used primarily as an anti-caking agent, emulsifier, and release agent in food products. It helps prevent clumping in powdered ingredients and improves flow properties in dry food applications.

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 Magnesium Palmitate?

Magnesium palmitate (CAS Number: 2601-98-1) is an organic salt formed from magnesium and palmitic acid, a naturally occurring saturated fatty acid. This compound appears as a white to off-white powder and belongs to the category of magnesium fatty acid salts. It functions as a multi-purpose food additive with properties that make it useful in maintaining product consistency and texture.

Common Uses

Magnesium palmitate is employed in food manufacturing primarily as an anti-caking agent in powdered products such as dried milk, cocoa powder, powdered spices, and dehydrated soups. Its lubricating properties make it effective as a release agent in baking applications, helping prevent dough and batters from sticking to processing equipment. Additionally, it serves as an emulsifier or emulsifier salt, assisting in the stable mixing of oil and water-based ingredients in various food formulations.

The compound's anti-caking function works by absorbing moisture and reducing particle adhesion, extending shelf life and maintaining product flowability in bulk containers. These properties make it particularly valuable in dry mixes and powdered supplements.

Safety Assessment

Magnesium palmitate has generated no reported adverse events in FDA databases and appears in zero FDA recall records. Toxicological concerns are minimal given that both magnesium and palmitic acid are recognized dietary components. Magnesium is an essential mineral required for numerous metabolic functions, while palmitic acid is a fatty acid naturally present in many foods including meat, dairy, and plant oils.

The additive is structurally related to other approved magnesium salts widely used in food and dietary supplements. Digestive tolerance is generally good, as magnesium salts are commonly used in antacids and dietary supplements. The compound is poorly absorbed in the gastrointestinal tract due to its hydrophobic nature, meaning most ingested material passes through the system without significant systemic absorption.

No specific toxicological studies identifying organ-specific concerns have been documented. Acute toxicity risk is considered very low based on the chemical composition and lack of bioaccumulative properties.

Regulatory Status

Magnesium palmitate is not listed as a Generally Recognized as Safe (GRAS) substance by the FDA, meaning it has not received this specific designation. However, this does not indicate the additive is unsafe; rather, it means formal GRAS affirmation or petition has not been completed in the United States. The substance may be permitted in specific food applications under FDA regulations even without GRAS status.

In the European Union, magnesium salts of fatty acids are evaluated under EFSA guidelines. Related magnesium fatty acid salts have been assessed and some are approved for use in specific food categories with defined limits. Regulatory approvals vary by country and food application.

The lack of GRAS status may reflect limited commercial demand, historical use patterns, or incomplete regulatory review rather than safety concerns. Manufacturers using this additive in the United States must ensure compliance with current FDA regulations for their specific food application.

Key Studies

Published literature specifically evaluating magnesium palmitate is limited. Most relevant information derives from general knowledge about magnesium salts, fatty acids, and related food additives rather than dedicated clinical investigations.

The safety profile relies substantially on the known safety of component substances: magnesium compounds are extensively researched due to their widespread use in pharmaceuticals and supplements, and palmitic acid is recognized as a natural dietary constituent. Regulatory agencies have established safety records for numerous magnesium salt additives in food, providing relevant context for evaluating structurally similar compounds.

Future research characterizing magnesium palmitate's bioavailability, gastrointestinal effects, and long-term consumption patterns would provide additional safety data, though current evidence raises no red flags requiring such investigation.

Frequently Asked Questions

What is Magnesium Palmitate?

Magnesium palmitate is a magnesium salt of palmitic acid used primarily as an anti-caking agent, emulsifier, and release agent in food products. It helps prevent clumping in powdered ingredients and improves flow properties in dry food applications.

Is Magnesium Palmitate safe?

Magnesium Palmitate 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 Magnesium Palmitate banned in any country?

Magnesium Palmitate 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.