Our Verdict: AVOID

Cobalt Sulfate--prohibited With Exceptions

CAS10124-43-3

Significant regulatory concerns

This additive is banned, restricted, or under active review in one or more major jurisdictions. The data below explains what we know.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Cobalt Sulfate--prohibited With Exceptions — food additive

Cobalt sulfate is an inorganic compound used as a malting or fermenting aid and surface-active agent in food production. It is prohibited for use in most food applications in the United States with limited exceptions, and is not recognized as Generally Recognized as Safe (GRAS) by the FDA.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

Banned in 3 jurisdictions
United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
BannedUK FSA
Canada
BannedHealth Canada
Australia
BannedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
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 Cobalt Sulfate?

Cobalt sulfate (CAS Number: 10124-43-3) is an inorganic chemical compound consisting of cobalt and sulfate ions. It appears as a pink or red crystalline solid and is soluble in water. In industrial and food contexts, cobalt sulfate serves as a source of cobalt, a trace element that plays roles in various biochemical processes. The compound is distinct from cobalt as a nutritional micronutrient; cobalt sulfate is a specific chemical form used in manufacturing and processing contexts.

Common Uses

Historically, cobalt sulfate has been explored for use as a malting aid in beer production, where it may influence yeast fermentation processes. It has also been investigated as a surface-active agent, which refers to substances that modify surface tension and improve mixing or emulsification properties in food systems. However, due to regulatory restrictions, its actual use in food production is extremely limited in most jurisdictions. When cobalt sulfate appears in food-related contexts today, it is primarily in research settings or in countries where specific exemptions may apply.

Safety Assessment

Cobalt is an essential trace element required for vitamin B12 synthesis in the human body, but excess cobalt exposure presents health concerns. Cobalt and its compounds have been associated with various toxic effects at elevated exposure levels, including effects on the cardiovascular system, nervous system, and hematopoietic (blood-forming) system. Animal studies have demonstrated that cobalt exposure can cause myocardial effects and peripheral neuropathy.

The International Agency for Research on Cancer (IARC) has classified cobalt and cobalt compounds as "possibly carcinogenic to humans" (Group 2B) based primarily on evidence from occupational inhalation studies in workers, particularly those exposed to cobalt dust in hard metal manufacturing. However, the relevance of inhalation exposure data to oral food ingestion remains an important distinction.

According to FDA records, there have been zero adverse event reports and zero recalls associated with cobalt sulfate in food applications, suggesting either minimal current use or successful prevention of problematic exposures through regulatory restrictions.

Regulatory Status

In the United States, cobalt sulfate is prohibited as a food additive with exceptions. It is not listed as a GRAS substance by the FDA. The prohibition reflects regulatory caution regarding potential health risks from ingested cobalt compounds. The "with exceptions" designation indicates that limited use may be permitted under specific, defined circumstances, though such exceptions are narrow in scope.

The European Food Safety Authority (EFSA) and most international food regulatory bodies maintain similar cautious positions toward cobalt compounds in food. The Codex Alimentarius Commission has not established a general approval for cobalt sulfate as a food additive.

Key Studies

Research on cobalt toxicity has primarily emerged from occupational health literature, where workers in industries such as hard metal tool manufacturing experienced documented health effects from chronic exposure. These studies informed regulatory decisions about cobalt compounds in consumer products.

Nutrition research distinguishes between cobalt as an essential micronutrient (in forms like cyanocobalamin/B12) and cobalt salts like cobalt sulfate. The distinction is important because the bioavailability, metabolic fate, and toxicity profiles differ significantly between these forms.

Limited published data exists on cobalt sulfate specifically as a food additive, partly because regulatory restrictions have minimized its use in food systems. The precautionary approach taken by regulatory agencies reflects both the lack of clear safety data for food applications and the known toxicity potential of cobalt at elevated exposures.

Frequently Asked Questions

What is Cobalt Sulfate--prohibited With Exceptions?

Cobalt sulfate is an inorganic compound used as a malting or fermenting aid and surface-active agent in food production. It is prohibited for use in most food applications in the United States with limited exceptions, and is not recognized as Generally Recognized as Safe (GRAS) by the FDA.

Is Cobalt Sulfate--prohibited With Exceptions safe?

Cobalt Sulfate--prohibited With Exceptions is currently rated "avoid" 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 Cobalt Sulfate--prohibited With Exceptions banned in any country?

Cobalt Sulfate--prohibited With Exceptions 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.