Our Verdict: RATING UNKNOWN

Ferric Sodium Pyrophosphate

CAS10045-87-1

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

Ferric Sodium Pyrophosphate — food additive

Ferric sodium pyrophosphate (CAS 10045-87-1) is an iron-containing compound that has been studied for potential use in food fortification. Its specific function in food applications remains unclear, and it is not currently approved as a food additive by the FDA.

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 Sodium Pyrophosphate?

Ferric sodium pyrophosphate is a chemical compound containing iron, sodium, and pyrophosphate groups. It exists as a coordination complex where iron is bound to pyrophosphate ligands along with sodium counterions. The compound has the CAS number 10045-87-1 and belongs to the broader category of iron salts and mineral compounds that have been investigated for food science applications.

The molecular structure of ferric sodium pyrophosphate makes it theoretically useful in nutritional fortification due to its iron content. Iron compounds are commonly added to foods to address iron deficiency, a significant public health concern globally. However, the specific advantages or disadvantages of this particular iron compound compared to other approved iron sources remain largely undocumented in publicly available literature.

Common Uses

While ferric sodium pyrophosphate has been examined in research contexts for potential food fortification applications, it is not currently used as an approved food additive in major regulatory jurisdictions. Other iron compounds—such as ferrous sulfate, ferric citrate, and sodium iron EDTA—are well-established and FDA-approved for food fortification purposes.

The lack of widespread commercial use suggests that either the compound has not demonstrated sufficient advantages over existing alternatives, or the regulatory pathway for approval has not been pursued. Patent literature and academic research may contain references to this compound in experimental food fortification studies, but these do not constitute regulatory approval for commercial food use.

Safety Assessment

According to FDA records, there are no reported adverse events associated with ferric sodium pyrophosphate, and no food recalls have been linked to this compound. This absence of reported incidents suggests either minimal exposure in the food supply or an absence of documented safety concerns at typical usage levels.

However, the lack of adverse event reports does not constitute an approval determination or a safety clearance. The FDA has not granted this compound Generally Recognized as Safe (GRAS) status, which is a prerequisite for most food additive uses in the United States. GRAS status requires either a history of safe use before 1958 or substantial scientific evidence of safety.

The biological effects of ferric sodium pyrophosphate would depend on several factors: the bioavailability of iron from this specific compound form, the stability of the complex during food processing and storage, and potential interactions with other food components. Iron bioavailability can vary significantly depending on the chemical form, pH, and presence of enhancers or inhibitors in the food matrix.

Regulatory Status

In the United States, ferric sodium pyrophosphate is not currently listed as an approved food additive. The FDA maintains lists of approved iron compounds for fortification, and this compound is not among them. This means it cannot be legally added to foods intended for the U.S. market without specific FDA approval or a successful GRAS petition.

International regulatory status would vary by country. The European Food Safety Authority (EFSA) and other regional regulatory bodies maintain their own lists of approved food additives. Manufacturers interested in using this compound would need to pursue approval separately in each jurisdiction.

Key Studies

Publicly available scientific literature on ferric sodium pyrophosphate in food applications is limited. Most research on iron fortification focuses on compounds with established GRAS status or regulatory approval. Without significant peer-reviewed research demonstrating advantages over approved alternatives, regulatory agencies have little incentive to evaluate this compound for food use.

Any manufacturer or researcher considering development of this additive would need to conduct toxicological studies, bioavailability research, and stability testing under food processing conditions. Such studies would form the basis of a regulatory submission seeking approval or GRAS status.

The absence of widespread use and approval suggests this compound remains in the research phase rather than being developed for commercial food applications.

Frequently Asked Questions

What is Ferric Sodium Pyrophosphate?

Ferric sodium pyrophosphate (CAS 10045-87-1) is an iron-containing compound that has been studied for potential use in food fortification. Its specific function in food applications remains unclear, and it is not currently approved as a food additive by the FDA.

Is Ferric Sodium Pyrophosphate safe?

Ferric Sodium Pyrophosphate 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 Sodium Pyrophosphate banned in any country?

Ferric Sodium Pyrophosphate 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.