Our Verdict: RATING UNKNOWN

Diatomaceous Earth

CAS61790-53-2

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Diatomaceous Earth — food additive

Diatomaceous earth is a naturally occurring siliceous mineral composed of fossilized remains of diatoms. It is occasionally used in food processing as a filter aid and anti-caking agent, though its function in finished food products remains unclear.

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 Diatomaceous Earth?

Diatomaceous earth (DE) is a naturally occurring, soft, siliceous sedimentary rock derived from the fossilized skeletal remains of diatoms, single-celled algae. It consists primarily of amorphous silicon dioxide (SiOâ‚‚), typically 80-90% by weight, along with trace minerals. The material is porous and has a fine, powder-like texture with microscopic sharp edges visible under magnification. Two primary forms exist: food-grade diatomaceous earth and non-food-grade (industrial) diatomaceous earth, which differ in processing methods and purity standards.

Common Uses

In food processing, diatomaceous earth functions primarily as a filter aid in beverage production, particularly in wine, beer, and fruit juice clarification. It is also used as an anti-caking agent in some dry food products. The porous structure of DE allows it to trap fine particles and clarify liquids during filtration processes. However, it is typically removed from beverages before consumption or remains as trace residue. Its specific role in finished food products is not well-defined, which is reflected in its categorization with an unknown primary function.

Safety Assessment

Diatomaceous earth has not been formally granted GRAS (Generally Recognized as Safe) status by the FDA, though food-grade DE is permitted for use in certain food processing applications. The FDA has recorded zero adverse events and zero recalls associated with diatomaceous earth as a food additive, suggesting no documented safety incidents in the U.S. food supply.

Inhalation of diatomaceous earth, particularly industrial-grade material, has been associated with respiratory concerns in occupational settings due to its particulate nature. However, ingestion of small residual amounts in food differs significantly from occupational inhalation exposure. The silica content raises theoretical concerns, though the amorphous form used in food applications differs chemically from crystalline silica, which is associated with silicosis.

The European Food Safety Authority (EFSA) has evaluated silica compounds and noted that food-grade diatomaceous earth presents minimal risk when used appropriately in food processing with proper removal before consumption. Most scientific literature focuses on occupational exposure rather than food additive use.

Regulatory Status

In the United States, diatomaceous earth is not prohibited as a food additive but operates in a regulatory grey area. It is not listed on the FDA's approved food additives list with a formal food additive petition, nor does it have GRAS status. It is sometimes permitted under the category of processing aids, which may not require full regulatory approval if they are removed during processing or present in negligible amounts in the final product.

International regulatory approaches vary. Some countries permit its use as a filter aid with the expectation that residues are minimal. Canada and various European nations recognize food-grade diatomaceous earth for specific processing applications under controlled conditions.

Key Studies

Limited peer-reviewed studies specifically address diatomaceous earth as a food additive. Most relevant research concerns occupational safety in mining and processing industries. Studies on amorphous silica ingestion have generally shown low toxicity in animal models at dietary levels. A 2012 review in the journal *Regulatory Toxicology and Pharmacology* noted that food-grade amorphous silica exhibits low oral toxicity.

The lack of adverse events and recalls in FDA databases suggests that any residual exposure through food consumption has not resulted in documented health complaints. However, the absence of events does not constitute comprehensive safety testing specific to food use.

Additional research characterizing typical residue levels in foods and long-term consumption studies would provide greater clarity on the safety profile of diatomaceous earth in food applications.

Frequently Asked Questions

What is Diatomaceous Earth?

Diatomaceous earth is a naturally occurring siliceous mineral composed of fossilized remains of diatoms. It is occasionally used in food processing as a filter aid and anti-caking agent, though its function in finished food products remains unclear.

Is Diatomaceous Earth safe?

Diatomaceous Earth is currently rated "unknown" 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 Diatomaceous Earth banned in any country?

Diatomaceous Earth 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.