Our Verdict: SAFE

Cellulose, Microcrystalline

E-numberE460CAS977005-28-9

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

Cellulose, Microcrystalline โ€” food additive

Microcrystalline cellulose is a purified, partially depolymerized cellulose derived from wood pulp or cotton. It functions as an anticaking agent, thickener, and formulation aid in various food products, helping maintain texture and prevent clumping.

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 Microcrystalline Cellulose?

Microcrystalline cellulose (MCC) is a refined form of cellulose, a naturally occurring polysaccharide found in plant cell walls. It is produced by hydrolyzing purified wood pulp or cotton cellulose with dilute mineral acids, followed by mechanical treatment to create fine, white crystalline particles. The process breaks down the cellulose structure into smaller, more uniform microcrystals while maintaining its insoluble nature in water.

Common Uses

Microcrystalline cellulose is widely used across the food industry due to its versatile functional properties. Primary applications include:

- **Anticaking and flow agents**: Prevents clumping in powdered ingredients such as salt, spices, and seasoning blends

- **Thickening and stabilizing**: Improves texture and consistency in sauces, dressings, and processed foods

- **Drying agent**: Helps control moisture content in formulations

- **Formulation aid**: Supports product structure in low-fat or reduced-calorie foods as a bulking agent

- **Humectant**: Retains moisture in certain applications

It appears in products ranging from nutritional supplements and pharmaceuticals to processed meats, baked goods, and dairy products.

Safety Assessment

Microcrystalline cellulose has an extensive safety history. As a plant-derived ingredient, cellulose is a component of normal human diet through fruits, vegetables, and whole grains. The FDA has not classified MCC as Generally Recognized as Safe (GRAS), though it is permitted for use in food under FDA regulations as a direct food additive.

The European Food Safety Authority (EFSA) has evaluated cellulose and its derivatives and considers microcrystalline cellulose safe for consumption at current levels of use. The additive is non-toxic, non-allergenic for the vast majority of consumers, and is not absorbed by the human digestive systemโ€”it passes through largely unchanged.

No adverse events have been reported to the FDA related to microcrystalline cellulose, and no product recalls have been issued due to this ingredient. Some individuals with specific sensitivities to cellulose products may experience mild digestive effects, though this is rare.

Regulatory Status

In the United States, microcrystalline cellulose is regulated as a direct food additive and is approved for use in various food categories. The FDA permits it under 21 CFR 182.1200 as a synthetic flavoring substance and adjuvant, with additional approvals for specific functional roles including as a thickening and stabilizing agent.

Internationally, microcrystalline cellulose is approved in the European Union (E460(i)), Canada, Australia, and most other countries with established food safety frameworks. It is commonly included in the "inactive ingredients" lists of pharmaceutical products and is recognized by pharmacopeias including the United States Pharmacopeia (USP).

Key Studies

Extensive scientific literature supports the safety of microcrystalline cellulose. Toxicological studies have shown no adverse effects in animal models at high doses. Digestive studies confirm that MCC is not absorbed in the gastrointestinal tract and does not bioaccumulate. Its use as a food additive has been evaluated multiple times by international food safety authorities with consistent conclusions of safety.

The ingredient's long history of safe use, combined with its non-absorbable nature and lack of reported adverse events, establishes a strong safety profile for typical food applications.

Frequently Asked Questions

What is Cellulose, Microcrystalline?

Microcrystalline cellulose is a purified, partially depolymerized cellulose derived from wood pulp or cotton. It functions as an anticaking agent, thickener, and formulation aid in various food products, helping maintain texture and prevent clumping.

Is Cellulose, Microcrystalline safe?

Cellulose, Microcrystalline 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 Cellulose, Microcrystalline banned in any country?

Cellulose, Microcrystalline 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.