Our Verdict: SAFE

Saccharin, Sodium Salt

E-numberE954CAS128-44-9FDA 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

Saccharin, Sodium Salt — food additive

Sodium saccharin (CAS 128-44-9) is a non-nutritive artificial sweetener that is approximately 300-400 times sweeter than sucrose. It serves multiple functions in food products including sweetening, flavor enhancement, and antimicrobial preservation, and has been approved as Generally Recognized As Safe (GRAS) by the FDA.

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 Sodium Saccharin?

Sodium saccharin is the sodium salt form of saccharin, an organic compound belonging to the benzoisothiazole family. It was first synthesized in 1878 and represents one of the oldest artificial sweeteners in commercial use. The compound is odorless, white, and highly soluble in water, making it practical for beverage and food formulations. As a non-nutritive sweetener, sodium saccharin provides sweetness without contributing calories to food products.

Common Uses

Sodium saccharin is utilized across diverse food categories as a sweetening agent. It commonly appears in diet beverages, sugar-free desserts, tabletop sweeteners, and pharmaceutical formulations. Beyond sweetening, this additive serves as a flavor enhancer in processed foods and functions as a mild antimicrobial agent, helping preserve product shelf life. The compound's stability at various pH levels and temperatures makes it suitable for both hot and cold food applications. In many countries, sodium saccharin is blended with other sweeteners like aspartame or sucralose to achieve optimal taste profiles while minimizing individual sweetener concentrations.

Safety Assessment

The safety profile of sodium saccharin has been extensively evaluated over more than a century of use. The FDA has designated sodium saccharin as Generally Recognized As Safe (GRAS), indicating that qualified experts consider it safe for its intended use. The regulatory database shows zero adverse events reported to the FDA and zero product recalls associated with sodium saccharin, reflecting a strong safety record in commercial food supply.

Historically, saccharin faced scrutiny in the 1970s when laboratory studies in rodents suggested potential carcinogenic effects at extremely high doses. Subsequent comprehensive research and risk assessment determined these findings were not applicable to human consumption at typical dietary levels. International regulatory bodies, including the European Food Safety Authority (EFSA), have reviewed available evidence and established acceptable daily intake (ADI) levels. The EFSA set the ADI for saccharin at 5 mg/kg body weight per day, a level far exceeding typical human consumption.

Regulatory Status

Sodium saccharin maintains approval in multiple major regulatory jurisdictions. The FDA approved saccharin as a food additive and designated it GRAS status. It is approved in the European Union under the E954 designation as a food additive. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated sodium saccharin and confirmed its safety at established levels of use. Different countries maintain varying permitted usage levels, with some applications requiring specific labeling to inform consumers of artificial sweetener content.

The additive is permitted in numerous food categories, though specific applications and maximum usage levels vary by jurisdiction. Manufacturers using sodium saccharin must comply with labeling regulations that typically require disclosure of artificial sweetener content on product packaging.

Key Studies

Comprehensive toxicological studies have examined sodium saccharin's effects across multiple endpoints including acute toxicity, chronic toxicity, genotoxicity, and reproductive effects. Long-term feeding studies in laboratory animals at doses far exceeding human exposure levels have been conducted and reviewed by regulatory agencies. Epidemiological studies in human populations have not established causal links between saccharin consumption at permitted levels and adverse health outcomes. The weight of scientific evidence supports the safety of sodium saccharin for the general population, including sensitive subgroups, when consumed at levels below established ADI values.

Frequently Asked Questions

What is Saccharin, Sodium Salt?

Sodium saccharin (CAS 128-44-9) is a non-nutritive artificial sweetener that is approximately 300-400 times sweeter than sucrose. It serves multiple functions in food products including sweetening, flavor enhancement, and antimicrobial preservation, and has been approved as Generally Recognized As Safe (GRAS) by the FDA.

Is Saccharin, Sodium Salt safe?

Saccharin, Sodium Salt 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 Saccharin, Sodium Salt banned in any country?

Saccharin, Sodium Salt 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.