FDA Status
Approved
Iron Gluconate (579) is a food additive additive holding a composite safety score of 4 out of 5 (Low Risk). The U.S. Food and Drug Administration currently classifies it as Approved, while the European Union lists it as Approved. It is most commonly used as Various processed foods.
No U.S. state has enacted specific legislation targeting Iron Gluconate to date, keeping federal FDA classification as the operative standard. State-level food safety legislation remains active nationally, and that picture may shift as new bills advance.
Peer-reviewed research has flagged 1 distinct area of health concern for Iron Gluconate, which factors directly into the assigned safety score. All figures above draw on FDA SAFFA inventory records, EU food additive regulation (EC) No 1333/2008, EFSA scientific opinions where published, and legislative records from individual U.S. states.
Regulatory Snapshot
| Property | Value | Source |
|---|---|---|
| FDA Status | Approved | FDA SAFFA |
| EU Status | Approved | EC 1333/2008 |
| E-Number | 579 | EU additive register |
| CAS Number | — | CAS Registry |
| Category | Food Additive | FDA functional class |
| Composite Safety Score | 4 / 5 (Low Risk) | PlainIngredients methodology |
| EFSA ADI | Not established | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | Not yet tracked | Open Food Facts (US) |
Values reflect official agency classifications as published by the U.S. Food and Drug Administration and the European Union's regulatory framework. See our methodology for scoring details.
4.0 / 5
Composite Safety Low Risk
Safety Score: 4 out of 5
Safety Rating 80.0%
EU Status
Approved
579
U.S. State Regulations
0 states
None enacted
Safety Assessment
Iron Gluconate receives a safety score of 4/5 (Low Risk) based on a composite analysis of FDA regulatory status, EU approval, scientific literature on health effects, and state-level legislative actions. The FDA has approved Iron Gluconate for use in food products under specified conditions.
Research has identified 1 area of health concern associated with Iron Gluconate. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
What is Iron Gluconate?
IRONII GLUCONATE, or ferrous gluconate,[1] is a black compound often used as an iron supplement. It is the iron-II- salt of gluconic acid.
Health Concerns
- No significant concerns identified in EFSA evaluations.
Common Uses
Various processed foods
Frequently Asked Questions
Is Iron Gluconate safe to consume?
Iron Gluconate has a safety score of 4/5 (Low Risk). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is Iron Gluconate used for in food?
Iron Gluconate is commonly used as: Various processed foods. It belongs to the Food Additive category of food additives.
Is Iron Gluconate banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Iron Gluconate. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Iron Gluconate?
The FDA classifies Iron Gluconate as "Approved", while the EU status is "Approved" (579). The FDA and EU use separate evaluation frameworks — the EU often applies the precautionary principle, sometimes banning additives that remain approved in the US. Always check both jurisdictions when evaluating food additive safety.
What health concerns are associated with Iron Gluconate?
Research has identified the following health concerns for Iron Gluconate: No significant concerns identified in EFSA evaluations.. These findings inform its safety score of 4/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
How is the safety score for Iron Gluconate calculated?
The safety score of 4/5 for Iron Gluconate is a composite assessment based on FDA regulatory status, EU approval status, published scientific research on health effects, and state-level legislative actions. A score of 1 means "Banned / Avoid" and 5 means "Generally Safe." The score is updated as new regulatory actions or scientific evidence emerge.
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Related Data Sources
Data Sources
- FDA Substances Added to Food (SAFFA) Inventory
- EU Food Additive Regulations (EC) No 1333/2008
- State food safety legislation and bill records
Related Resources
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Read our methodology — how this data is sourced, computed, and verified.
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Data sourced from official EWG, FDA GRAS, and ingredient toxicology databases. See our methodology for details. Retrieved and formatted by PlainIngredients Editorial