Our Verdict: SAFE

Choline Chloride

CAS67-48-1

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

Choline Chloride — food additive

Choline chloride is a water-soluble compound containing choline, an essential nutrient required for normal cell function, neurological development, and liver health. It is used as a nutrient supplement in food and animal feed to meet dietary choline requirements.

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 Choline Chloride?

Choline chloride is the chloride salt form of choline, a quaternary ammonium compound with the chemical formula C5H14ClNO. It appears as a white to off-white crystalline powder and is highly soluble in water. Choline is classified as an essential nutrient by the National Institutes of Health and is required for multiple physiological functions including cell membrane structure, neurotransmitter synthesis, and lipid metabolism.

Common Uses

Choline chloride is primarily used as a nutrient supplement in animal feed, particularly for poultry, swine, and aquaculture. It is added to ensure adequate choline intake, which supports proper growth, development, and metabolic function. In human food applications, it appears less frequently as a direct additive but may be present in fortified products and dietary supplements. The compound is also used in pharmaceutical and cosmetic formulations.

Safety Assessment

Choline chloride has been extensively studied for safety. According to the FDA database, there have been zero reported adverse events associated with choline chloride and zero product recalls. The compound is well-tolerated when consumed at levels consistent with dietary recommendations. The National Academy of Medicine has established Adequate Intake (AI) levels for choline across different age groups, with adult women requiring 425 mg/day and adult men requiring 550 mg/day.

Toxicological studies indicate that choline chloride has low acute toxicity. Animal studies have established no observed adverse effect levels (NOAELs) at substantial dose levels. The European Food Safety Authority (EFSA) has assessed choline and determined it to be safe at nutritional levels. Some research suggests that excessive choline intake from supplements may produce fishy odors in sweat and urine in individuals with genetic variations in choline metabolism, but this is not classified as a safety hazard.

Regulatory Status

Choline chloride is not on the FDA's Generally Recognized As Safe (GRAS) list, though this designation does not indicate the substance is unsafe. Rather, the FDA permits choline chloride use in animal feeds and recognizes choline as an essential nutrient. In the European Union, choline is approved for use in animal nutrition under Regulation (EC) 1107/2008. In the United States, the FDA acknowledges choline as an essential nutrient and permits its use in dietary supplements and fortified foods under the Dietary Supplement Health and Education Act (DSHEA).

Key Studies

Research on choline and its various salt forms has consistently demonstrated nutritional importance. The Framingham Heart Study and other epidemiological research have associated adequate choline intake with cognitive health and development. A 2018 literature review in Nutrients journal summarized evidence supporting choline's role in fetal brain development and long-term cognitive function. Animal nutrition studies have documented the effectiveness of choline chloride in supporting growth parameters and feed efficiency in various livestock species.

The Institute of Medicine's 1998 report on Dietary Reference Intakes for folate, vitamin B12, choline, betaine, and related compounds established the scientific basis for choline requirements and determined that deficiency is rare in humans consuming varied diets, though supplementation may benefit specific populations.

Frequently Asked Questions

What is Choline Chloride?

Choline chloride is a water-soluble compound containing choline, an essential nutrient required for normal cell function, neurological development, and liver health. It is used as a nutrient supplement in food and animal feed to meet dietary choline requirements.

Is Choline Chloride safe?

Choline Chloride 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 Choline Chloride banned in any country?

Choline Chloride 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.