About
What it is and where it shows up.
Zinc sulphate monohydrate is an inorganic zinc salt used as a source of the essential trace element zinc in food fortification, dietary supplements, and animal feed. It provides bioavailable zinc to support enzymatic function, immune response, and normal growth and development in humans and animals.
Safety summary
The regulatory and scientific consensus.
Zinc is an essential micronutrient with a well-established tolerable upper intake level (UL) of 25 mg/day for adults as set by EFSA and the EU Scientific Committee on Food, above which adverse effects such as copper depletion and gastrointestinal irritation can occur. No concerns for consumer safety are expected at authorised use levels, and there is no evidence of carcinogenicity or genotoxicity at dietary intake levels. Excess supplemental intake is the primary risk for the general adult population, with homeostatic mechanisms maintaining plasma zinc within physiological ranges at normal dietary exposures.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorised as a nutritional feed additive (compound of trace elements, category E6) for all animal species under Commission Implementing Regulation (EU) 2016/1095. The 25 mg/day figure is the Tolerable Upper Intake Level (UL) for zinc in adults established by the EU Scientific Committee on Food and confirmed by EFSA (EFSA Journal 2014;12(10):3844). Zinc sulphate monohydrate is also permitted as a mineral source in food supplements and fortified foods under Regulation (EC) No 1925/2006 and Directive 2002/46/EC.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Permitted as a micronutrient source in health supplements, nutraceuticals, and fortified foods 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, 2016, and the Food Safety and Standards (Fortification of Foods) Regulations, 2018. Quantity of added nutrients must not exceed the RDA specified by ICMR, or in its absence, international standards such as Codex Alimentarius.source |
| FDA (Food and Drug Administration) (United States) | Approved | Zinc sulphate is used as a dietary supplement ingredient and is recognised as an acceptable source of zinc in human nutrition. The FDA's tolerable upper intake level (UL) for zinc, as set by the Institute of Medicine/National Academies, is 40 mg/day for adults. No specific food additive regulation restricts its use in supplements when used at appropriate levels.source |
Who should approach with care
Whose guidance would steer them away.
Infants — Zinc requirements and upper intake levels in infants are much lower than in adults, and supplemental zinc sulphate in infant formula or foods should only be used under medical guidance per FSSAI and EU Directive 2006/141/EC on infant formulae.
Kidney Disease — Impaired renal function can reduce zinc excretion and increase the risk of zinc accumulation above the tolerable upper intake level, potentially leading to copper deficiency and other adverse effects.
Pregnancy — While zinc is essential during pregnancy, supplemental zinc intake above established upper intake levels may pose risk; EFSA notes additional physiological requirements during pregnancy and lactation should be met through diet or medically supervised supplementation only.
Children — Children have lower tolerable upper intake levels for zinc than adults; supplemental zinc sulphate monohydrate should be dosed carefully against age-specific RDA and UL thresholds as set by ICMR, EFSA, or equivalent authorities.
Research citations
The sources behind this verdict.
- 1PubMed. Comparison of the Potential Relative Bioaccessibility of Zinc Supplements—In Vitro Studies, 2023. pmc.ncbi.nlm.nih.gov
- 2other. Commission Implementing Regulation (EU) 2016/1095 of 6 July 2016 concerning the authorisation of Zinc acetate dihydrate, Zinc chloride anhydrous, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate [and others] as feed additives for all animal species, 2016. eur-lex.europa.eu
- 3EFSA. Scientific Opinion on the safety and efficacy of zinc compounds (E6) as feed additives for all animal species (zinc acetate, dihydrate; zinc chloride, anhydrous; zinc oxide; zinc sulphate, heptahydrate; zinc sulphate, monohydrate; zinc chelate of amino acids, hydrate; zinc chelate of glycine, hydrate), based on a dossier submitted by FEFANA asbl, 2015. efsa.europa.eu
- 4EFSA. Scientific Opinion on Dietary Reference Values for zinc, 2014. efsa.europa.eu
- 5EFSA. Scientific Opinion on safety and efficacy of zinc compounds (E6) as feed additive for all species: zinc sulphate monohydrate, based on a dossier submitted by Grillo-Werke AG/EMFEMA, 2012. efsa.europa.eu
Independently researched5 citations