Our Verdict: SAFE

Zinc Sulfate

CAS7446-20-0

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Zinc Sulfate — food additive

Zinc sulfate is an inorganic compound used as a nutrient supplement and processing aid in food production. It provides bioavailable zinc, an essential mineral required for immune function, protein synthesis, and enzymatic processes in the human body.

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 Zinc Sulfate?

Zinc sulfate (CAS Number 7446-20-0) is an inorganic salt composed of zinc and sulfate ions. It appears as a white crystalline powder and is highly soluble in water. In food applications, zinc sulfate serves as a source of elemental zinc, delivering this essential micronutrient to fortified food products. The compound is chemically stable and maintains its nutritional value when incorporated into various food matrices.

Common Uses

Zinc sulfate functions primarily as a nutrient supplement in food fortification programs. It is added to grain products, cereals, flour, and other staple foods to address zinc deficiency in populations where dietary intake may be inadequate. The compound also serves as a malting or fermenting aid in brewing and fermentation processes, where it supports yeast metabolism and fermentation efficiency. Food manufacturers select zinc sulfate for fortification due to its bioavailability, cost-effectiveness, and stability in food systems.

Safety Assessment

Zinc sulfate has an established safety profile when used at appropriate levels in food. The FDA has not designated it as GRAS (Generally Recognized as Safe), though this classification does not indicate a safety concern but rather reflects the regulatory pathway and review status. No adverse events related to zinc sulfate consumption from fortified foods have been reported to the FDA, and no recalls involving this additive have been issued.

The tolerable upper intake level (UL) for zinc in adults is 40 mg per day, established by the National Institutes of Health and the EFSA. Food fortification with zinc sulfate is designed to supplement dietary intake without exceeding these safety thresholds. Acute toxicity from food-grade zinc sulfate is extremely low; toxicity concerns are associated with extremely high doses far exceeding normal consumption levels.

Individuals with specific zinc metabolism disorders or those taking certain medications that affect zinc absorption should consult healthcare providers, though this is not specific to zinc sulfate as a food additive but rather relates to zinc intake generally.

Regulatory Status

Zinc sulfate is authorized for use in food fortification in many countries, including the United States, European Union, and Canada. In the U.S., it appears in the FDA's list of acceptable nutrients for food fortification. The European Food Safety Authority has evaluated zinc compounds used in food fortification and established safety parameters for their use. International Codex Alimentarius standards permit zinc sulfate in fortified foods at levels consistent with nutritional requirements and safety margins.

The compound is also permitted in animal feed applications as a nutritional supplement, further demonstrating its recognized safety when used appropriately.

Key Studies

Nutritional research has established zinc sulfate's bioavailability in human subjects. Studies comparing various zinc compounds for fortification applications have shown zinc sulfate to be efficiently absorbed and utilized by the body. Research on grain fortification programs utilizing zinc sulfate has documented significant improvements in zinc status among populations in developing regions.

The WHO and FAD have supported zinc fortification initiatives using zinc sulfate as part of comprehensive strategies to address micronutrient deficiencies. Stability studies of fortified foods containing zinc sulfate demonstrate the compound's consistency and effectiveness throughout product shelf life under standard storage conditions.

Frequently Asked Questions

What is Zinc Sulfate?

Zinc sulfate is an inorganic compound used as a nutrient supplement and processing aid in food production. It provides bioavailable zinc, an essential mineral required for immune function, protein synthesis, and enzymatic processes in the human body.

Is Zinc Sulfate safe?

Zinc Sulfate is currently rated "safe" 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 Zinc Sulfate banned in any country?

Zinc Sulfate 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.