Our Verdict: SAFE

Potassium Sorbate

E-numberE202CAS24634-61-5FDA 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

Potassium Sorbate — food additive

Potassium sorbate (CAS 24634-61-5) is a potassium salt of sorbic acid widely used as an antimicrobial preservative in food products. It functions to inhibit the growth of molds, yeasts, and some bacteria, extending shelf life while maintaining food safety and quality.

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 Potassium Sorbate?

Potassium sorbate is the potassium salt form of sorbic acid, a naturally occurring organic compound. It appears as a white to off-white crystalline powder and is highly soluble in water, making it suitable for use in a wide variety of food and beverage applications. The compound has been used in food preservation since the 1950s and remains one of the most widely used food preservatives globally.

Common Uses

Potassium sorbate is primarily used as an antimicrobial agent to prevent spoilage caused by molds, yeasts, and certain bacteria. It is commonly found in:

- Baked goods and breads

- Cheese and dairy products

- Beverages including wine, beer, and soft drinks

- Fruit juices and concentrates

- Jams, jellies, and preserved fruits

- Dried fruits and vegetables

- Salad dressings and condiments

- Personal care products and cosmetics

The additive works by disrupting cellular membranes in microorganisms, preventing their growth and reproduction. This preservation function is particularly valuable in products that may be stored at room temperature or have extended shelf lives.

Safety Assessment

Potassium sorbate has an extensive safety record based on decades of use and scientific evaluation. According to FDA records, there have been zero reported adverse events associated with potassium sorbate and zero recalls attributed to its use. The compound is recognized as Generally Recognized As Safe (GRAS) by the FDA, a status granted after rigorous safety review.

Toxicological studies have consistently demonstrated that potassium sorbate is safe at levels used in food. The compound is metabolized by the body similarly to sorbic acid, with the potassium component following normal physiological pathways. Acute toxicity studies show very low toxicity, with LD50 values in rodents indicating it would require consumption of impractically large quantities to produce adverse effects.

Chronic toxicity studies in laboratory animals at levels well above human dietary exposure have not produced adverse effects. Genotoxicity and carcinogenicity studies have not identified concerning findings at food-relevant exposure levels. Individual sensitivity or allergic reactions are extremely rare, though documented cases exist in the medical literature.

Regulatory Status

Potassium sorbate holds regulatory approval in numerous jurisdictions worldwide:

- **United States**: FDA GRAS status; approved as a food additive under 21 CFR 182.3640

- **European Union**: Approved as food additive E202; maximum levels specified in Regulation (EC) No 1333/2008

- **Canada**: Permitted food additive under Food and Drugs Act

- **Australia/New Zealand**: Approved under Food Standards Australia New Zealand (FSANZ)

- **Japan**: Approved as a food additive

Typical maximum permitted levels range from 0.1% to 0.3% in food products, depending on the food category and jurisdiction. These limits are established to provide effective preservation while maintaining wide safety margins below any levels of concern.

Key Studies

Extensive scientific literature supports the safety of potassium sorbate:

- The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated sorbic acid and its salts multiple times, establishing an acceptable daily intake (ADI) of 0-25 mg/kg body weight, indicating a high safety margin.

- A 2015 review in Food and Chemical Toxicology concluded that potassium sorbate "presents no safety concern at current levels of use in food."

- Studies on metabolic fate demonstrate that sorbate is rapidly metabolized via beta-oxidation, similar to naturally occurring fatty acids, producing harmless end products (CO2 and water).

- Microbiological efficacy studies confirm potassium sorbate's effectiveness against food-spoilage organisms at permitted use levels, providing documented antimicrobial activity.

Frequently Asked Questions

What is Potassium Sorbate?

Potassium sorbate (CAS 24634-61-5) is a potassium salt of sorbic acid widely used as an antimicrobial preservative in food products. It functions to inhibit the growth of molds, yeasts, and some bacteria, extending shelf life while maintaining food safety and quality.

Is Potassium Sorbate safe?

Potassium Sorbate 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 Potassium Sorbate banned in any country?

Potassium Sorbate 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.