Our Verdict: SAFE

Magnesium Hydroxide

E-numberE528CAS1309-42-8FDA GRAS

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

Magnesium Hydroxide — food additive

Magnesium hydroxide is an inorganic compound that functions as a pH control agent, drying agent, and nutrient supplement in food processing. It is approved by the FDA as GRAS (Generally Recognized as Safe) and has no reported adverse events or recalls.

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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 Hydroxide?

Magnesium hydroxide (chemical formula Mg(OH)₂, CAS number 1309-42-8) is an inorganic white powder compound that occurs naturally and can be synthesized for industrial use. In its natural form, it is found as the mineral brucite. The compound is commonly known as milk of magnesia when suspended in water, though food-grade magnesium hydroxide used in food processing is a purified form.

Common Uses

In food manufacturing, magnesium hydroxide serves multiple functions. Its primary role is as a pH control agent, helping to neutralize acidity and maintain optimal pH levels in food products. This is particularly valuable in processed foods where pH stability affects shelf life and product quality. The compound also functions as a drying agent in food processing, helping to remove moisture and maintain product texture. Additionally, magnesium hydroxide serves as a nutrient supplement, contributing dietary magnesium to food products. It may also act as a processing aid to improve the efficiency of manufacturing procedures.

Specific applications include its use in various processed foods where pH adjustment is necessary, such as certain dairy products, confections, and baked goods. The magnesium content can be beneficial in fortified food products designed to enhance nutritional value.

Safety Assessment

The FDA has designated magnesium hydroxide as GRAS (Generally Recognized as Safe) for use in food, meaning it has met the agency's rigorous safety standards. This determination is based on a long history of safe use and scientific evidence supporting its safety profile. According to FDA records, there have been zero adverse events reported in connection with magnesium hydroxide use in food, and zero recalls have been issued related to this additive.

Magnesium hydroxide is poorly absorbed in the gastrointestinal tract, which limits systemic exposure when consumed in food amounts. The compound has been used for decades in pharmaceutical and food applications without establishing a significant safety concern profile.

Toxicological studies have not demonstrated significant health hazards when magnesium hydroxide is used at levels typical in food processing. The acceptable daily intake and usage levels are well-established and considerably exceed typical dietary exposure from food products.

Regulatory Status

Magnesium hydroxide is approved by the U.S. FDA as a GRAS food additive with no specific use limitations beyond standard food safety practices. The European Food Safety Authority (EFSA) also permits its use in food products under certain conditions. It is permitted in food in many countries worldwide, reflecting its recognition as a safe food ingredient when used appropriately.

The additive is subject to the same quality and purity standards as other food-grade chemicals, ensuring that industrial products meet strict specifications for use in food manufacturing.

Key Studies

The safety profile of magnesium hydroxide is supported by decades of use data and toxicological research. While magnesium hydroxide itself has not been the subject of extensive recent clinical trials specifically in food applications, its safety as a pharmaceutical ingredient has been well-documented. Studies on magnesium absorption and metabolism provide additional context for understanding the safety of magnesium hydroxide in food.

The lack of adverse event reports in FDA databases over many years of widespread use provides empirical evidence supporting its continued safe application in food manufacturing. Regulatory agencies periodically review safety data for approved additives, and magnesium hydroxide has maintained its approved status through these ongoing assessments.

Frequently Asked Questions

What is Magnesium Hydroxide?

Magnesium hydroxide is an inorganic compound that functions as a pH control agent, drying agent, and nutrient supplement in food processing. It is approved by the FDA as GRAS (Generally Recognized as Safe) and has no reported adverse events or recalls.

Is Magnesium Hydroxide safe?

Magnesium Hydroxide 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 Magnesium Hydroxide banned in any country?

Magnesium Hydroxide 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.