Our Verdict: SAFE

Saccharin, Calcium Salt

E-numberE954CAS6381-91-5

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, Calcium Salt — food additive

Calcium saccharin is the calcium salt form of saccharin, a synthetic non-nutritive sweetener that provides sweetness without calories. It is used in beverages, food products, and tabletop sweeteners to reduce sugar content while maintaining sweet taste.

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 Saccharin, Calcium Salt?

Saccharin, calcium salt (CAS Number: 6381-91-5) is a derivative of saccharin, one of the oldest synthetic sweeteners. In this form, saccharin is combined with calcium to create a salt compound that dissolves readily in beverages and food applications. Saccharin itself is approximately 300-400 times sweeter than sucrose (table sugar) by weight. The calcium salt form is chemically stable and commonly used as an alternative to sodium saccharin in products where sodium content is a concern.

Common Uses

Calcium saccharin is primarily used in:

- Diet and low-calorie beverages

- Tabletop sweetener products

- Sugar-free confectionery and baked goods

- Pharmaceutical products and syrups

- Dairy products with reduced sugar content

- Canned fruits and vegetables packed in light syrup

The calcium salt form is particularly valued in formulations where reducing sodium intake is desired, as it provides the sweetening benefits of saccharin without the sodium content associated with sodium saccharin.

Safety Assessment

Saccharin has been extensively studied since its synthesis in 1878. The FDA has not designated saccharin or its salts as GRAS (Generally Recognized As Safe), instead regulating it as a food additive requiring pre-market approval. However, saccharin was delisted from the National Toxicology Program's Report on Carcinogens in 2001 after extensive review determined that the mechanisms of bladder cancer observed in rodent studies do not apply to humans.

Clinical evidence shows saccharin is poorly absorbed in the human gastrointestinal tract and is primarily excreted unchanged in urine within 24-48 hours. The acceptable daily intake (ADI) established by regulatory agencies varies by jurisdiction but generally ranges from 2-5 mg/kg of body weight per day.

As of the most recent FDA records, there have been zero adverse events reported and zero recalls associated with calcium saccharin, indicating a favorable safety profile in commercial use.

Regulatory Status

Calcium saccharin is approved for use in the United States under FDA regulation 21 CFR 182.1675, though not classified as GRAS. It is approved in the European Union under E954, with maximum use levels specified by food category. In Canada, it is permitted under specific regulatory conditions. Different countries maintain varying maximum permitted levels based on their individual risk assessments.

The additive must be declared on ingredient labels in regions where it is permitted, allowing consumers to make informed choices. Regulatory agencies continue to monitor safety data and reassess saccharin periodically based on emerging scientific evidence.

Key Studies

Major safety evaluations have been conducted by the International Agency for Research on Cancer (IARC), which classified saccharin in Group 3 (not classifiable as to its carcinogenicity in humans). The European Food Safety Authority (EFSA) has reviewed saccharin multiple times, confirming acceptable daily intakes based on available toxicological data. The National Toxicology Program's removal of saccharin from its carcinogen list reflected the scientific consensus that animal study results do not translate to human risk at typical dietary exposure levels.

Pharmacological studies demonstrate that calcium saccharin maintains the same metabolic profile as sodium saccharin, with minimal absorption and rapid urinary excretion. Taste preference and stability studies confirm its effectiveness as a sweetening agent across various food matrices.

Frequently Asked Questions

What is Saccharin, Calcium Salt?

Calcium saccharin is the calcium salt form of saccharin, a synthetic non-nutritive sweetener that provides sweetness without calories. It is used in beverages, food products, and tabletop sweeteners to reduce sugar content while maintaining sweet taste.

Is Saccharin, Calcium Salt safe?

Saccharin, Calcium 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, Calcium Salt banned in any country?

Saccharin, Calcium 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.