Our Verdict: SAFE

D-sorbitol

E-numberE420CAS50-70-4FDA 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

D-sorbitol — food additive

D-sorbitol is a sugar alcohol derived from glucose that functions as a sweetener, humectant, and texturizer in food products. It is FDA GRAS (Generally Recognized as Safe) and serves multiple roles including moisture retention, sweetness, and texture modification in various food applications.

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 D-sorbitol?

D-sorbitol, also known as glucitol, is a naturally occurring sugar alcohol (polyol) with the chemical formula C6H14O6. It is produced through the hydrogenation of glucose and occurs naturally in small quantities in fruits such as apples, pears, and berries. The additive is a white, crystalline powder that is approximately 60% as sweet as sucrose (table sugar) and contains about 2.6 calories per gram, compared to 4 calories per gram for sugar.

Common Uses

D-sorbitol is used extensively in the food industry due to its multifunctional properties. As a nutritive sweetener, it provides sweetness with a lower caloric content than sugar, making it attractive for reduced-calorie and diabetic-friendly products. Its humectant properties help retain moisture in baked goods, confections, and soft candies, extending shelf life and maintaining texture. In chewing gum and hard candies, sorbitol prevents crystallization and improves mouthfeel. It also functions as a texturizer and stabilizer in ice cream, yogurt, and other dairy products. Additionally, sorbitol serves as a solvent and vehicle for flavorings and other food components, and can act as a pH control agent in certain formulations.

Safety Assessment

D-sorbitol has an extensive safety history in food applications. The FDA has classified it as GRAS (Generally Recognized as Safe) for use in food, and it has been used in food products for decades without documented adverse events in the FDA database. The substance is metabolized differently than glucose, requiring no insulin for initial metabolism, which contributes to its use in diabetic products, though it is not a non-caloric sweetener.

The primary consideration with sorbitol consumption is its laxative effect when consumed in large quantities. This is a well-documented characteristic of sugar alcohols and occurs because sorbitol is slowly absorbed in the small intestine and reaches the colon where it exerts an osmotic effect. The European Food Safety Authority (EFSA) and other regulatory bodies acknowledge this property and do not classify it as a safety concern at normal consumption levels, though products containing sorbitol may include labeling to indicate potential laxative effects if consumed excessively.

Sorbitol does not cause the sharp blood sugar spikes associated with sucrose and has been evaluated for use in products marketed to individuals managing blood glucose levels. It is also non-cariogenic, meaning it does not promote dental cavities like sugar does, making it suitable for use in sugar-free confections and oral care products.

Regulatory Status

D-sorbitol is approved for use as a food additive in the United States under FDA regulations with GRAS status. It is also approved in the European Union (E420), Canada, Australia, and most other countries with established food safety frameworks. No recalls or documented adverse events related to sorbitol are recorded in the FDA database. The additive is permitted for use in multiple food categories including baked goods, confections, beverages, and processed fruits.

Key Studies

Numerous safety studies have evaluated sorbitol's use in food applications. Research demonstrates that sorbitol is metabolically distinct from glucose and does not significantly impact insulin secretion in normoglycemic individuals. Studies on sorbitol's laxative threshold indicate that individual tolerance varies, but effects typically occur at consumption levels exceeding 20-30 grams per day in single servings, well above typical food additive use levels. Long-term toxicity studies in animal models have not identified carcinogenic, mutagenic, or reproductive toxicity concerns. The WHO and various national regulatory bodies have reviewed sorbitol safety data and maintain approval for its use in food products at current levels.

Frequently Asked Questions

What is D-sorbitol?

D-sorbitol is a sugar alcohol derived from glucose that functions as a sweetener, humectant, and texturizer in food products. It is FDA GRAS (Generally Recognized as Safe) and serves multiple roles including moisture retention, sweetness, and texture modification in various food applications.

Is D-sorbitol safe?

D-sorbitol 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 D-sorbitol banned in any country?

D-sorbitol 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.