Our Verdict: RATING UNKNOWN

Iron Polyvinylpyrrolidone

E-numberE1201CAS977125-47-5

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

Iron Polyvinylpyrrolidone — food additive

Iron Polyvinylpyrrolidone is a complex formed between iron and polyvinylpyrrolidone (PVP), a synthetic polymer. Its specific function in food applications remains unclear, and it has not been 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 Iron Polyvinylpyrrolidone?

Iron Polyvinylpyrrolidone (Iron PVP) is a coordination complex combining elemental iron with polyvinylpyrrolidone, a water-soluble synthetic polymer. The compound is identified by CAS Number 977125-47-5. Polyvinylpyrrolidone itself has been used in pharmaceutical and cosmetic applications for decades as a binder, film-former, and stabilizing agent. When complexed with iron, this compound theoretically combines the polymer's functional properties with iron's nutritional significance, though the specific mechanism and purpose in food systems remain undefined.

Common Uses

The intended function of Iron Polyvinylpyrrolidone in food products is not clearly documented in available regulatory or scientific literature. While iron compounds are commonly used as nutritional fortification agents in food, and PVP is utilized in various industrial applications, the specific application of this particular iron-PVP complex has not been established. It does not appear to be widely used in commercial food production, and its presence in the food supply is not well-documented.

Safety Assessment

Safety data for Iron Polyvinylpyrrolidone is limited. The compound has generated zero adverse event reports to the FDA and has not been subject to any food recalls. However, the absence of adverse reports does not necessarily indicate comprehensive safety assessment, as usage appears minimal or non-existent in the commercial food market.

Polyvinylpyrrolidone itself has a long history of use in pharmaceuticals and is generally recognized as safe in those applications. Iron compounds used for food fortification have extensive safety records when used at appropriate levels. However, the specific properties, bioavailability, and safety profile of the Iron PVP complex require dedicated toxicological study.

Key safety considerations would include: iron bioavailability and absorption rates, potential interactions with other nutrients, polymer degradation and excretion patterns, and whether the complex maintains stability during food processing and storage.

Regulatory Status

Iron Polyvinylpyrrolidone has not been approved by the FDA as a Generally Recognized As Safe (GRAS) food additive. It does not appear on the FDA's approved food additives list and is not authorized for use in food products under current U.S. regulations. This designation does not indicate the substance is unsafe; rather, it has not undergone or completed the regulatory approval process required for food use in the United States.

The European Food Safety Authority (EFSA) has not published safety assessments for this specific compound in food applications. Without regulatory approval in major markets, commercial use of this additive in food is not permitted in the U.S., EU, and most other jurisdictions with established food safety frameworks.

Key Studies

A comprehensive literature search reveals minimal published scientific research specifically addressing Iron Polyvinylpyrrolidone as a food additive. No peer-reviewed studies examining its safety, efficacy, or performance in food matrices appear to be readily available in scientific databases.

Research on polyvinylpyrrolidone in pharmaceutical contexts demonstrates good tolerability and biocompatibility, but these findings cannot be directly extrapolated to food applications or to the iron-complexed form. Similarly, extensive literature exists on iron fortification compounds, but does not specifically address this particular complex.

To establish this compound as a viable food additive would require manufacturers to submit safety data including acute and chronic toxicity studies, genotoxicity testing, and nutritional bioavailability research to regulatory agencies for evaluation.

Frequently Asked Questions

What is Iron Polyvinylpyrrolidone?

Iron Polyvinylpyrrolidone is a complex formed between iron and polyvinylpyrrolidone (PVP), a synthetic polymer. Its specific function in food applications remains unclear, and it has not been approved as a food additive by the FDA.

Is Iron Polyvinylpyrrolidone safe?

Iron Polyvinylpyrrolidone 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 Iron Polyvinylpyrrolidone banned in any country?

Iron Polyvinylpyrrolidone 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.