Our Verdict: SAFE

Silicon Dioxide

E-numberE551CAS7631-86-9FDA GRAS

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

Silicon Dioxide — food additive

Silicon dioxide (SiO2) is a naturally occurring compound used as an anti-caking agent in food products to improve flow and prevent clumping. It is recognized as safe by the FDA and is widely used in powdered foods, seasonings, and supplements at very low concentrations.

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 Silicon Dioxide?

Silicon dioxide, also known as silica, is a naturally occurring mineral compound (CAS Number 7631-86-9) consisting of silicon and oxygen. In food applications, it is typically used in highly purified, amorphous forms rather than crystalline forms. The compound is one of the most abundant minerals on Earth, found in sand, quartz, and many other natural sources. When used as a food additive, silicon dioxide particles are extremely fine, often in the nanometer to micrometer range, allowing it to function effectively at very low concentrations.

Common Uses

Silicon dioxide serves multiple functions in food manufacturing, though its primary role is as an anti-caking agent. It is commonly added to powdered products such as table salt, powdered sugar, spice blends, baking mixes, protein powders, and nutritional supplements. In these applications, it absorbs moisture and reduces friction between particles, preventing clumping and maintaining product flowability during storage and transport. The additive also functions as a drying agent, anti-caking agent, and in some formulations as an emulsifier aid. It is used at very low concentrations, typically ranging from 0.5% to 2% by weight, depending on the specific food product and intended function.

Safety Assessment

Silicon dioxide has an extensive safety record in food applications. The FDA has designated it as Generally Recognized as Safe (GRAS) for use in food, and the European Food Safety Authority (EFSA) has also approved its use as a food additive (E551). According to FDA records, there have been zero documented adverse events associated with silicon dioxide as a food additive, and zero product recalls linked to this substance.

Toxicological studies on amorphous silicon dioxide (the form used in food) indicate it has low oral bioavailability, meaning the body does not absorb significant quantities. Ingested particles are largely excreted through the gastrointestinal tract without metabolic processing. Inhalation concerns exist in occupational settings where workers are exposed to crystalline silica dust over extended periods, but ingestion of food-grade silicon dioxide does not present the same hazard profile. The distinction between crystalline and amorphous silicon dioxide is important: food-grade silicon dioxide is amorphous, while occupational silicosis concerns relate to crystalline forms.

Regulatory agencies have established acceptable daily intake (ADI) levels, and typical food consumption patterns result in exposures well below these thresholds. Studies on laboratory animals have not identified significant toxicity at dietary levels relevant to food use.

Regulatory Status

Silicon dioxide is approved for food use in multiple major regulatory jurisdictions. In the United States, the FDA classifies it as GRAS, permitting its use in foods without pre-market approval requirements, provided manufacturers follow established guidelines for purity and concentration. The European Union permits it under the designation E551, with specific permitted uses and maximum levels defined in food regulations. Canada, Australia, Japan, and many other countries similarly permit silicon dioxide in food products. International Codex standards recognize its use as a food additive, facilitating international trade in products containing this ingredient.

Key Studies

Multiple scientific reviews have evaluated the safety of food-grade silicon dioxide. A 2018 EFSA re-evaluation confirmed the safety of amorphous silicon dioxide as a food additive at approved use levels. Pharmacokinetic studies demonstrate minimal absorption of amorphous silica particles through the gastrointestinal tract in humans and animals. Long-term dietary studies in rodents at levels substantially exceeding typical food exposures have not identified adverse effects on organs or systems. The distinction between amorphous food-grade silicon dioxide and crystalline forms used in other industries remains crucial to safety assessments, as occupational exposure to crystalline silica presents different hazard characteristics.

Frequently Asked Questions

What is Silicon Dioxide?

Silicon dioxide (SiO2) is a naturally occurring compound used as an anti-caking agent in food products to improve flow and prevent clumping. It is recognized as safe by the FDA and is widely used in powdered foods, seasonings, and supplements at very low concentrations.

Is Silicon Dioxide safe?

Silicon Dioxide 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 Silicon Dioxide banned in any country?

Silicon Dioxide 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.