Our Verdict: RATING UNKNOWN

Ferric Sulfate

CAS10028-22-5

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

Ferric Sulfate — food additive

Ferric sulfate (iron(III) sulfate) is an iron-containing compound used as a flavoring agent or adjuvant in food production. It serves primarily to enhance or modify flavor profiles in processed foods and beverages.

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 Sulfate?

Ferric sulfate, also known as iron(III) sulfate or ferric sulphate, is an inorganic chemical compound with the molecular formula Fe₂(SO₄)₃. It consists of iron in the +3 oxidation state combined with sulfate ions. The compound appears as a yellowish or brownish solid and is soluble in water. Ferric sulfate has industrial applications across multiple sectors, including water treatment, textile manufacturing, and food production.

Common Uses

In the food industry, ferric sulfate functions as a flavoring agent or flavoring adjuvant rather than as a direct flavoring substance. Its role is to assist in flavor development, modification, or stabilization in food formulations. While specific food applications are limited in publicly available data, iron compounds in food are typically used in specialized processing applications. The compound may be encountered in certain processed foods, beverages, or food additives where flavor enhancement or modification is required.

Outside the food industry, ferric sulfate is extensively used in water treatment processes, where it serves as a coagulant to remove impurities and suspended particles. It is also utilized in textile dyeing and in the production of pigments.

Safety Assessment

Ferric sulfate has not been granted GRAS (Generally Recognized as Safe) status by the U.S. Food and Drug Administration. This designation does not necessarily indicate a safety concern but rather reflects that the additive has not undergone the formal FDA review process for GRAS affirmation in food applications.

According to FDA records, there have been zero reported adverse events associated with ferric sulfate use in food, and zero product recalls have been issued related to this additive. This absence of reported adverse events suggests that documented health incidents from food exposure are not currently recognized in FDA monitoring systems.

From a toxicological perspective, iron compounds are essential nutrients required by the human body for oxygen transport and cellular function. However, excessive iron intake can be problematic, particularly for individuals with iron storage disorders. The safety profile of ferric sulfate specifically in food applications would depend on the levels of exposure and frequency of consumption.

Regulatory Status

In the United States, ferric sulfate is not currently listed as an approved food additive on the FDA's Color Additives Status List or the Food Additives Status List for direct use in human food. The FDA maintains strict oversight of food additives through the Federal Food, Drug, and Cosmetic Act.

The European Food Safety Authority (EFSA) and other international regulatory bodies maintain their own evaluations of food additives. Regulatory approval and status vary by country and region, reflecting different safety assessment standards and food additive approval processes.

Manufacturers considering the use of ferric sulfate in food products should consult current FDA regulations and may need to petition for food additive approval if the compound is not currently authorized for their intended use.

Key Studies

Scientific literature on ferric sulfate in food applications is limited compared to more widely used food additives. Most published research on ferric sulfate focuses on its industrial applications in water treatment and textile manufacturing rather than food safety or efficacy as a flavoring adjuvant.

Studies on iron compounds in general demonstrate that iron bioavailability and safety depend significantly on chemical form, concentration, and food matrix interactions. Research on iron as a food fortification agent has shown that different iron compounds have varying absorption rates and potential for adverse gastrointestinal effects.

Further research specific to ferric sulfate's use as a flavoring agent or adjuvant would be necessary to establish comprehensive safety and efficacy data for food applications.

Frequently Asked Questions

What is Ferric Sulfate?

Ferric sulfate (iron(III) sulfate) is an iron-containing compound used as a flavoring agent or adjuvant in food production. It serves primarily to enhance or modify flavor profiles in processed foods and beverages.

Is Ferric Sulfate safe?

Ferric Sulfate 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 Ferric Sulfate banned in any country?

Ferric Sulfate 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.