Our Verdict: SAFE

Sucralose

E-numberE955CAS56038-13-2

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

Sucralose — food additive

Sucralose is a non-nutritive artificial sweetener approximately 600 times sweeter than sugar. It is widely used in beverages, baked goods, and other food products as a sugar substitute to reduce caloric content.

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.

Key Studies

Long-term feeding studies in rats and mice conducted at doses up to 20,000 ppm showed no treatment-related adverse effects. A two-year carcinogenicity study in rats exposed to sucralose showed no increased tumor incidence. Developmental and reproductive toxicity studies in rats and rabbits demonstrated no adverse effects on fetal development or reproductive function at tested doses. Human studies examining postprandial glucose response confirmed sucralose does not significantly affect blood glucose or insulin levels in diabetic and non-diabetic subjects. Pharmacokinetic studies in humans confirmed rapid urinary excretion with minimal systemic absorption and no bioaccumulation.

Frequently Asked Questions

What is Sucralose?

Sucralose is a non-nutritive artificial sweetener approximately 600 times sweeter than sugar. It is widely used in beverages, baked goods, and other food products as a sugar substitute to reduce caloric content.

Is Sucralose safe?

Sucralose 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 Sucralose banned in any country?

Sucralose 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

FDASubstances Added to Food (EAFUS)

Comprehensive list of 3,971 substances added to food, maintained by the U.S. Food & Drug Administration.

OpenFDAFood Adverse Events & Recalls Database

Public API providing access to FDA adverse event reports and food recall enforcement actions.

EFSAOpenFoodTox Chemical Hazards Database

European Food Safety Authority's open database of chemical hazards in the food and feed chain.

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.

People also look up