Our Verdict: SAFE

Choline Chloride(also Includes Choline)

CAS977188-01-4

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(also Includes Choline) — food additive

Choline chloride is a water-soluble compound containing choline, an essential nutrient required for various metabolic processes. It is used as a flavoring agent and nutritional supplement in food and animal feed products.

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
ApprovedUK FSA
Canada
ApprovedHealth Canada
Australia
ApprovedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
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 water-soluble compound structurally similar to B vitamins. Choline itself is an essential nutrient that plays critical roles in cell membrane integrity, neurotransmitter synthesis, and lipid transport in the body. The chloride salt form (CAS Number 977-18-8-01-4) is commonly used in food manufacturing because of its stability and solubility properties. Choline is naturally present in many foods including eggs, meat, fish, and legumes, though commercial choline chloride is typically synthesized chemically.

Common Uses

Choline chloride functions primarily as a flavoring agent and nutritional adjuvant in food formulations. It appears in a variety of products including:

- Animal feed and pet food (primary application)

- Nutritional supplements and fortified foods

- Infant formulas

- Medical nutrition products

- Functional beverages

- Dietary supplement ingredients

Beyond its flavoring role, choline chloride serves as a source of choline to support adequate intake of this essential nutrient. The compound is particularly valued in animal nutrition where choline deficiency can impact growth, reproduction, and metabolic function.

Safety Assessment

Choline chloride has an established safety profile supported by decades of use in food and animal feed applications. The FDA has recorded zero adverse events related to choline chloride and zero recalls associated with this ingredient, indicating a strong safety history in commercial use.

Choline itself is recognized as an essential nutrient by major health organizations. The National Academies of Sciences, Engineering, and Medicine has established Adequate Intake (AI) levels for choline across different age groups, ranging from 125 mg/day for infants to 550 mg/day for adult males. These guidelines recognize choline as necessary for normal physiological function.

Toxicological studies in animals have demonstrated that choline chloride is well-tolerated at levels significantly exceeding typical dietary exposures. The compound is readily absorbed and metabolized, with excess choline being excreted through urine. At very high supplemental doses (several grams daily), some individuals may experience mild side effects such as fishy odor or gastrointestinal effects due to bacterial metabolism of excess choline, though this is not a safety concern at food-level concentrations.

Regulatory Status

Choline chloride does not hold FDA GRAS (Generally Recognized As Safe) status, though this does not indicate a safety concern. Instead, it is regulated as a food additive when used as a flavoring agent. The lack of GRAS status typically reflects administrative or classification considerations rather than safety issues. In the European Union, choline is listed as a permitted nutrient, and choline chloride is accepted for use in various food categories.

The ingredient has been safely used in animal feed for decades and is approved by feed regulatory agencies globally. Its use in human food products is permitted under established regulatory frameworks in multiple countries.

Key Studies

Numerous scientific studies have examined choline's role in human health and safety. Research demonstrates choline's importance for fetal development, cognitive function, and liver health. Metabolic studies confirm that choline chloride is efficiently absorbed and utilized by the body when consumed as part of food or supplements.

Animal studies have established high margins of safety, with no organ toxicity observed at multiples of typical dietary intake levels. The comprehensive safety data accumulated over decades of use supports the practical safety profile reflected in the absence of FDA adverse events or recalls.

Frequently Asked Questions

What is Choline Chloride(also Includes Choline)?

Choline chloride is a water-soluble compound containing choline, an essential nutrient required for various metabolic processes. It is used as a flavoring agent and nutritional supplement in food and animal feed products.

Is Choline Chloride(also Includes Choline) safe?

Choline Chloride(also Includes Choline) 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(also Includes Choline) banned in any country?

Choline Chloride(also Includes Choline) 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.