# Zinc Stearate

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**Safety rating:** SAFE
**CAS number:** 557-05-1
**Category:** nutrient
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-04

## Summary

Zinc stearate is a zinc salt of stearic acid used as a nutrient supplement in food products. It provides bioavailable zinc, an essential mineral important for immune function, wound healing, and protein synthesis.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | approved |
| Canada | approved |
| Australia | approved |
| Japan | approved |
| South Korea | approved |
| Brazil | approved |
| China | approved |
| India | approved |

## Detailed analysis

## What is Zinc Stearate?

Zinc stearate (CAS Number 557-05-1) is an inorganic compound formed from zinc and stearic acid, a saturated fatty acid. It appears as a fine white powder and serves as a source of bioavailable zinc in nutritional applications. The compound is distinct from zinc oxide and other zinc salts due to its fatty acid composition, which may influence its absorption and bioavailability in the gastrointestinal tract.

## Common Uses

Zinc stearate is primarily used as a nutrient supplement in fortified food products, dietary supplements, and specialized nutritional formulations. It is employed to increase the zinc content of foods where zinc deficiency is a public health concern. Common applications include infant formulas, breakfast cereals, nutritional beverages, and fortified grain products. The stearate form may offer advantages in terms of shelf stability and texture properties compared to other zinc salts, though its nutrient bioavailability profile requires consideration in formulation.

## Safety Assessment

Zinc is an essential trace mineral required for numerous enzymatic processes and physiological functions in humans. The Food and Drug Reference Daily Value for zinc is 11 mg for adults. The FDA has established Tolerable Upper Intake Levels (UL) of 40 mg per day for adults, above which zinc supplementation may pose risks including copper deficiency, reduced immune function, and neurological effects with chronic excess exposure.

Zinc stearate specifically has not been associated with adverse events in the FDA database. No adverse event reports or product recalls involving zinc stearate have been documented with the FDA. However, zinc stearate is not on the FDA's GRAS (Generally Recognized as Safe) list, meaning it has not undergone the formal GRAS affirmation process. This designation does not indicate safety concerns but rather reflects the regulatory pathway and review status.

The stearic acid component is widely recognized as safe and is ubiquitously present in foods. Zinc salts generally demonstrate good safety profiles when used within established dietary limits. Individual zinc bioavailability from zinc stearate depends on factors including stomach pH, concurrent nutrient intake (particularly phytates and calcium), and individual digestive health status.

## Regulatory Status

Zinc stearate is permitted for use as a nutrient supplement in various food categories under different regulatory frameworks globally. While not GRAS-affirmed in the United States, it may be used in foods through the dietary supplement regulations or food additive approval pathways depending on the specific application. The European Food Safety Authority and other international regulatory bodies have evaluated zinc compounds for safety and efficacy in nutrition.

Manufacturers using zinc stearate must ensure compliance with labeling requirements that accurately reflect the zinc content and daily value percentage. Products must include appropriate warnings regarding upper intake limits and potential interactions with medications.

## Key Studies

Research on zinc bioavailability from various zinc salts indicates that absorption efficiency varies by compound. Studies on stearate-based mineral supplements show comparable absorption to other common zinc forms. The safety of zinc supplementation has been extensively studied, with established safe intake ranges well-documented in the scientific literature. Long-term safety monitoring of fortified foods containing various zinc sources continues through regulatory surveillance programs.

The nutritional importance of adequate zinc intake is supported by extensive research demonstrating its critical role in immune competence, wound healing, protein synthesis, and gene expression. Public health recommendations support zinc fortification in populations at risk for deficiency.

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Zinc Stearate — Safety, regulation, and evidence." https://additivefacts.com/additives/zinc-stearate. Accessed 2026-05-20.