Our Verdict: SAFE

Ammonium Hydroxide

E-numberE527CAS1336-21-6FDA 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

Ammonium Hydroxide — food additive

Ammonium hydroxide is an inorganic compound commonly used in food processing as a leavening agent, pH control agent, and surface-finishing agent. It is approved as GRAS (Generally Recognized as Safe) by the FDA and has been used in food manufacturing for decades with 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 Ammonium Hydroxide?

Ammonium hydroxide (NHâ‚„OH), also known as aqueous ammonia or ammonia solution, is an inorganic compound formed when ammonia gas dissolves in water. It appears as a colorless liquid with a pungent odor and is commonly available in concentrations ranging from 10-30% in food-grade applications. The CAS number 1336-21-6 identifies this specific chemical compound used in food production.

Common Uses

Ammonium hydroxide serves multiple functions in food manufacturing:

**Leavening Agent**: In baked goods, it acts as a leavening agent by producing ammonia gas during heating, which helps dough or batter rise and creates a light texture in products like cookies and crackers.

**pH Control**: It is used to adjust and maintain pH levels in various food products, helping to stabilize formulations and extend shelf life.

**Surface-Finishing Agent**: In cocoa and chocolate processing, ammonium hydroxide treats cocoa to darken its color and enhance flavor complexity in a process called alkalization or dutching.

The compound is particularly common in industrial baking and confectionery manufacturing, where precise pH control and texture development are critical.

Safety Assessment

Ammonium hydroxide has been designated as GRAS (Generally Recognized as Safe) by the FDA, meaning it is approved for use in food without pre-market approval provided it is used in accordance with established guidelines. This designation reflects decades of safe use in food manufacturing with an established history of safety.

According to FDA records, there have been **zero reported adverse events** associated with ammonium hydroxide used as a food additive. Additionally, there have been **zero FDA recalls** related to this ingredient, indicating a strong safety profile in food applications.

When used in permitted food applications, ammonium hydroxide is present in final products only in very small residual amounts. The ammonia volatilizes during cooking and processing, meaning consumers do not typically consume significant quantities of the compound itself. The pH-adjusted foods in which it is used are well-tolerated by the general population.

Regulatory Status

Ammonium hydroxide is approved for food use in multiple regulatory jurisdictions:

- **United States (FDA)**: Approved as GRAS for use in specific food categories including baked goods, cocoa products, and sugar products

- **European Union (EFSA)**: Approved as a food additive with the designation E527 for similar applications

- **Other Markets**: Permitted in food manufacturing across Canada, Australia, and numerous other countries with established food safety standards

The FDA permits ammonium hydroxide use within specific limitations and applications to ensure consumer safety. Manufacturers must comply with Good Manufacturing Practices (GMP) and labeling requirements where applicable.

Key Studies

The safety of ammonium hydroxide in food has been extensively evaluated:

- **Toxicology Reviews**: EFSA evaluations of ammonia compounds used in food processing have consistently concluded they are safe at permitted levels of use, with rapid metabolism and elimination from the body

- **Historical Use Data**: Decades of documented safe use in industrial baking and cocoa processing provide robust real-world safety evidence

- **Regulatory Assessments**: The FDA's affirmation of GRAS status is based on comprehensive safety evaluations and the long history of safe use

No significant studies have identified health concerns related to the approved food applications of ammonium hydroxide. The compound's rapid volatilization during heating and its well-understood biochemistry support its safety designation.

Frequently Asked Questions

What is Ammonium Hydroxide?

Ammonium hydroxide is an inorganic compound commonly used in food processing as a leavening agent, pH control agent, and surface-finishing agent. It is approved as GRAS (Generally Recognized as Safe) by the FDA and has been used in food manufacturing for decades with no reported adverse events or recalls.

Is Ammonium Hydroxide safe?

Ammonium 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 Ammonium Hydroxide banned in any country?

Ammonium 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.