Our Verdict: RATING UNKNOWN

D-xylose

CAS58-86-6

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

D-xylose — food additive

D-xylose is a naturally occurring five-carbon sugar (pentose) derived from plant materials like corn cobs and hardwoods. It functions as a nutritive sweetener and flavoring agent in food products, offering approximately 40% of the sweetness of sucrose with fewer calories.

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-xylose?

D-xylose is a naturally occurring monosaccharide, specifically a pentose sugar containing five carbon atoms. The compound occurs naturally in fruits, vegetables, and plant cell walls. It can be produced commercially through hydrolysis of xylan-containing materials, particularly corn cobs, hardwood, and agricultural residues. The chemical structure of D-xylose makes it distinct from common six-carbon sugars like glucose and sucrose.

Common Uses

D-xylose is used in food manufacturing primarily as a sweetener and flavoring agent. Due to its lower caloric content compared to sucrose and its lower glycemic impact, it has been incorporated into sugar-free and reduced-calorie food products. The sweetener is used in beverages, baked goods, confectionery, and dietary supplements. D-xylose is also employed in research and pharmaceutical applications. In some European and Asian markets, it appears in functional foods marketed for blood sugar management, though such health claims are regulated differently across jurisdictions.

Safety Assessment

D-xylose has been studied for gastrointestinal tolerance and metabolic effects. The FDA has not granted D-xylose Generally Recognized as Safe (GRAS) status, which means it does not have blanket approval for all food categories in the United States. However, the absence of FDA GRAS status does not indicate the substance is unsafe; rather, it reflects the specific regulatory pathway and available safety documentation.

The European Food Safety Authority (EFSA) has evaluated D-xylose in certain applications. Published research indicates that high intakes of D-xylose may cause osmotic laxative effects similar to other sugar alcohols and polyols, potentially leading to digestive discomfort including bloating, gas, and diarrhea. The degree of tolerance varies among individuals. Single-dose studies and repeated-dose toxicity studies have not identified significant systemic toxicity at tested levels.

According to FDA records, there have been zero reported adverse events and zero recalls associated with D-xylose, suggesting a favorable safety profile in commercial use. This lack of adverse event reporting does not constitute approval but reflects the safety experience in the market.

Regulatory Status

In the United States, D-xylose does not hold GRAS status and is not approved as a food additive through the FDA's food additive petition process for general use. Manufacturers wishing to use D-xylose in food products would typically need to follow applicable regulatory pathways, which may include food additive petitions or compliance with specific ingredient regulations.

In the European Union, D-xylose has been evaluated and approved for use in certain food categories under Regulation (EC) No 1333/2008. It appears on the EU's additives list with specific use levels and food categories specified.

In Japan, Canada, and other jurisdictions, regulatory status varies. Some countries permit its use in specific applications while others have different approval pathways.

Key Studies

Studies on D-xylose have primarily focused on gastrointestinal tolerance and absorption. Research published in nutrition journals has examined the osmotic effects and caloric availability of D-xylose compared to glucose and other sweeteners. Metabolic studies have shown that D-xylose is absorbed more slowly than glucose and does not significantly elevate blood glucose levels, which forms the scientific basis for its use in reduced-calorie and diabetic-friendly products.

Limited long-term safety studies are available in the published literature. Most available data derives from European safety assessments and individual product manufacturer submissions. The absence of adverse events in FDA records and the lack of recalls suggest acceptable real-world safety at current usage levels, though individual sensitivity to gastrointestinal effects remains possible.

Frequently Asked Questions

What is D-xylose?

D-xylose is a naturally occurring five-carbon sugar (pentose) derived from plant materials like corn cobs and hardwoods. It functions as a nutritive sweetener and flavoring agent in food products, offering approximately 40% of the sweetness of sucrose with fewer calories.

Is D-xylose safe?

D-xylose 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 D-xylose banned in any country?

D-xylose 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.