Our Verdict: SAFE

Trisodium Citrate

E-numberE331CAS68-04-2FDA 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

Trisodium Citrate — food additive

Trisodium citrate is a sodium salt of citric acid used in food production as a pH control agent, emulsifier, and sequestrant. It helps regulate acidity, improve texture, and prevent spoilage in a wide variety of processed foods and beverages.

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 Trisodium Citrate?

Trisodium citrate (CAS Number: 68-04-2) is the trisodium salt of citric acid, a naturally occurring organic acid found in citrus fruits. It appears as a white crystalline powder or granules and is highly soluble in water. The compound functions as a multi-purpose food additive with several distinct roles in food formulation and processing.

Common Uses

Trisodium citrate is widely used across the food and beverage industry due to its versatility. In cheese production, it serves as an emulsifier salt, helping to create smooth, uniform textures in processed cheese products. It is commonly found in dairy products, including cheese spreads, evaporated milk, and ice cream.

In beverages, trisodium citrate functions as a pH control agent, helping manufacturers maintain the desired acidity level in soft drinks, energy drinks, and juice-based products. The additive also acts as a sequestrant, binding to metal ions that could otherwise cause oxidation and spoilage in foods containing fats or oils.

Additional applications include use in baking, canned vegetables, canned meats, and various processed foods where pH stabilization and shelf-life extension are important. It is also used in some nutritional and pharmaceutical formulations as a nutrient supplement and pH buffer.

Safety Assessment

Trisodium citrate has been extensively evaluated for safety. The FDA recognizes it as Generally Recognized as Safe (GRAS), meaning it is approved for use in food with a reasonable certainty of no harm when used as intended. According to FDA records, there have been zero reported adverse events associated with trisodium citrate in food, and zero product recalls specifically attributed to this additive.

The safety profile of trisodium citrate is supported by its chemical nature: citric acid and its salts are naturally present in many foods and are readily metabolized by the human body. The sodium content is a consideration for individuals managing sodium intake, but the amounts used in food products are generally modest relative to total dietary sodium consumption.

The European Food Safety Authority (EFSA) has also reviewed citrates and citric acid salts and maintains a positive safety assessment for use as food additives across approved applications.

Regulatory Status

Trisodium citrate is approved for use as a food additive in the United States under FDA regulations. It is listed in the Code of Federal Regulations (CFR) as a GRAS substance with no specific limitations on use levels, provided it is used in accordance with good manufacturing practices.

The additive is also approved in the European Union, where it is listed as food additive E331(iii) under EU Regulation (EC) No 1333/2008. It is permitted in numerous food categories with established maximum use levels depending on the product type.

Canada, Australia, Japan, and most other regulatory jurisdictions similarly approve trisodium citrate for food use, reflecting its widespread international acceptance and safety profile.

Key Studies

Scientific literature on citrates and citric acid salts demonstrates their safety and efficacy as food additives. Research supports their use as emulsifiers and stabilizers in dairy applications, with no evidence of adverse health effects at typical dietary exposure levels.

Toxicological studies have established that trisodium citrate does not pose genotoxic or reproductive risks. The compound is metabolized efficiently in the body, and safety margins are substantial between approved use levels and any levels that might produce adverse effects in animal studies.

Frequently Asked Questions

What is Trisodium Citrate?

Trisodium citrate is a sodium salt of citric acid used in food production as a pH control agent, emulsifier, and sequestrant. It helps regulate acidity, improve texture, and prevent spoilage in a wide variety of processed foods and beverages.

Is Trisodium Citrate safe?

Trisodium Citrate 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 Trisodium Citrate banned in any country?

Trisodium Citrate 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.