Our Verdict: SAFE

Ferric Oxide

CAS1309-37-1

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

Ferric Oxide — food additive

Ferric oxide (iron oxide) is a naturally occurring compound used as a colorant and processing aid in food products. It provides red, yellow, or brown coloring depending on its form and is approved for use in specific food applications in many countries.

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 Ferric Oxide?

Ferric oxide, also known as iron oxide or ferric iron oxide (CAS Number: 1309-37-1), is an inorganic compound composed of iron and oxygen. It occurs naturally in mineral form and can also be synthetically produced for food use. The compound appears as a fine powder and is commonly available in three main forms: ferric oxide red (Fe2O3), ferric oxide yellow, and ferric oxide brown. These different forms are used to achieve various color effects in food products.

Common Uses

Ferric oxide is primarily used as a colorant in the food industry, providing shades ranging from red to brown depending on particle size and form. It functions as a color adjunct and processing aid in select food applications. In the United States, ferric oxide has specific approval for certain uses, though its application is more limited compared to some other colorants. The compound is more widely permitted in food manufacturing in some other countries, including members of the European Union where it is listed as a permitted food additive (E172 in the EU system).

Common applications include coloring certain food products where natural or synthetic dyes may be unsuitable, and it is particularly valued in applications requiring heat stability and pH stability during processing and storage.

Safety Assessment

Ferric oxide has a well-documented safety profile when used as a food additive. The compound is poorly absorbed in the gastrointestinal tract, with absorption rates typically less than 10%. Iron itself is an essential element required for human health, particularly for oxygen transport and energy metabolism.

According to FDA records, there have been zero reported adverse events linked to ferric oxide as a food additive, and zero recalls have been initiated based on ferric oxide safety concerns. This absence of reported incidents over decades of use in food manufacturing suggests a favorable safety history in approved applications.

The European Food Safety Authority (EFSA) has assessed iron oxides (E172) and concluded that they are safe for use as food colorants at their current permitted levels. The assessment found that the systemic absorption and toxicological hazard of iron oxides is low, and that dietary exposure from approved food uses does not present a safety concern.

Inhalation of ferric oxide dust in occupational settings has been associated with a condition called siderosis (iron deposition in the lungs), but this is an occupational hazard unrelated to ingestion through food. Food-grade ferric oxide used in products presents a distinctly different risk profile from occupational dust exposure.

Regulatory Status

Ferric oxide is not classified as Generally Recognized as Safe (GRAS) by the FDA, meaning it does not have blanket approval for all food uses. However, it is approved as a color additive for specific food applications in the United States under FDA regulations, subject to limitations on which foods it may be used in and at what concentrations.

In the European Union, iron oxides are permitted as food additive E172 and are approved for use in a broader range of applications than in the United States. Other countries including Canada and Australia also permit ferric oxide in specific food applications.

Regulatory agencies maintain specific use levels and food categories where ferric oxide may be applied, reflecting a risk-benefit assessment approach rather than blanket approval or prohibition.

Key Studies

The safety database for ferric oxide is substantial due to its long history of industrial and food use. Published research consistently demonstrates that ferric oxide has low bioavailability when ingested and does not accumulate in body tissues to levels of concern. Studies on iron oxide pigments have shown they are essentially non-toxic when ingested at levels relevant to food applications.

Research has confirmed that the particle size and form of ferric oxide used in food applications do not present absorption or retention issues in the gastrointestinal tract, and that it is primarily excreted unchanged.

Frequently Asked Questions

What is Ferric Oxide?

Ferric oxide (iron oxide) is a naturally occurring compound used as a colorant and processing aid in food products. It provides red, yellow, or brown coloring depending on its form and is approved for use in specific food applications in many countries.

Is Ferric Oxide safe?

Ferric Oxide 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 Ferric Oxide banned in any country?

Ferric Oxide 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.