About
What it is and where it shows up.
Manganese gluconate is the manganese salt of gluconic acid, used as a source of the essential trace element manganese in food fortification and dietary supplements. It delivers bioavailable divalent manganese (Mn²⁺) to support enzymatic functions, bone formation, and antioxidant defence.
Safety summary
The regulatory and scientific consensus.
Manganese is an essential trace element and dietary intakes from food are generally not associated with adverse effects; however, excess supplemental intake is linked to neurotoxicity (manganism). EFSA (2023) could not establish a formal tolerable upper intake level (UL) due to insufficient dose–response data, but noted that oral exposure to manganese beyond what is normally present in food and beverages could represent a risk without evidence of health benefit. Sensitive subgroups including infants, individuals with liver disease, and those with high occupational exposure warrant particular caution.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | Manganese gluconate is permitted as a nutritive substance in foods under FSANZ Food Standards Code Standard 1.1.1 and Schedule 17. Permitted for use in formulated supplementary foods and dietary supplements.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Manganese salts (including gluconate) are approved as sources of manganese for nutritional use in food supplements and fortified foods under Directive 2002/46/EC and Regulation (EC) No 1925/2006. EFSA (2023) reviewed the tolerable upper intake level for manganese and concluded that a formal UL cannot be set; oral exposure beyond normal dietary levels may pose neurotoxicity risk. Manganese gluconate is not assigned an E-number as it functions as a nutrient rather than a food additive.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Manganese compounds including gluconate are permitted as nutrient supplements under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2022. Specific maximum use levels for manganese gluconate in food are not separately published by FSSAI at the time of this assessment.source |
| FDA (Food and Drug Administration) (United States) | Approved | Listed in FDA's Substances Added to Food (formerly EAFUS) inventory; used as a nutrient supplement (source of manganese) in foods and dietary supplements under 21 CFR. No formal ADI established; the Dietary Reference Intake (DRI) adequate intake for adults is 1.8–2.3 mg/day elemental Mn. |
Who should approach with care
Whose guidance would steer them away.
Infants — Infants, especially neonates receiving parenteral nutrition, are at elevated risk of manganese neurotoxicity due to immature hepatic excretion; supplemental manganese gluconate in infant formulas should be carefully controlled per EFSA and WHO guidance.
Liver Disease — Manganese is excreted primarily via bile; impaired hepatic function dramatically reduces clearance, causing manganese accumulation and increasing the risk of manganism (neurological damage) at otherwise tolerable doses.
Children — EFSA (2023) notes that some subgroups in the general population, including young children, may have higher susceptibility to manganese-induced neurotoxicity; supplemental intake beyond normal dietary levels should be minimised.
Pregnancy — While manganese is essential during pregnancy, excessive supplemental intake should be avoided given EFSA's finding that oral exposure beyond normal food levels may carry neurotoxicity risk without demonstrated benefit.
Kidney Disease — Renal impairment may reduce secondary manganese clearance pathways, potentially increasing systemic accumulation, particularly when supplemental manganese gluconate is used alongside other manganese-containing products.
Research citations
The sources behind this verdict.
- 1PubChem / FDA. Manganese Gluconate – Compound Summary (PubChem CID 22988). pubchem.ncbi.nlm.nih.gov
- 2FDA. Substances Added to Food Inventory – Manganese Gluconate. hfpappexternal.fda.gov
- 3EFSA. Scientific opinion on the tolerable upper intake level for manganese (EFSA NDA Panel, 2023), 2023. efsa.europa.eu
- 4PubMed. Scientific opinion on the tolerable upper intake level for manganese (PMC full text), 2023. pmc.ncbi.nlm.nih.gov
- 5EFSA. Safety and efficacy of Manganese chelates of lysine and glutamic acid as feed additive for all animal species (EFSA FEEDAP Panel, 2020), 2020. efsa.europa.eu
Independently researched5 citations