Our Verdict: SAFE

Linoleic Acid

CAS60-33-3

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

Linoleic Acid โ€” food additive

Linoleic acid is an essential omega-6 polyunsaturated fatty acid naturally found in many plant oils and seeds. It functions as a flavoring agent and adjuvant in food products, contributing to taste and texture profiles while serving important nutritional roles in human health.

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 Linoleic Acid?

Linoleic acid is a polyunsaturated fatty acid with the chemical formula C18H32O2, identified by CAS Number 60-33-3. It is an omega-6 essential fatty acid that cannot be synthesized by the human body and must be obtained through dietary sources. Linoleic acid is a precursor to arachidonic acid and other bioactive compounds important for cellular function. As a food additive, it is classified as a flavoring agent or adjuvant, though its primary significance is nutritional rather than flavor-based.

Common Uses

Linoleic acid appears in food products derived from natural sources including sunflower oil, safflower oil, corn oil, soybean oil, and various seeds and nuts. In the food industry, linoleic acid and linoleate derivatives may be used as emulsifiers, flavor adjuvants, or nutritional fortification agents. It is naturally present in many foods at substantial levels, making its intentional addition less common than its presence through conventional ingredients. When used as an additive, it typically appears in formulated foods, dietary supplements, and functional food products designed to provide essential fatty acids.

Safety Assessment

Linoleic acid has been recognized as an essential nutrient since the early 20th century and is fundamental to human nutrition. The FDA has not granted GRAS (Generally Recognized As Safe) status for linoleic acid as a food additive, though this reflects regulatory classification rather than safety concernsโ€”many essential nutrients do not require GRAS determinations because they are inherent food components. The European Food Safety Authority (EFSA) recognizes linoleic acid as a naturally occurring nutrient with established nutritional roles.

The FDA Adverse Events database contains zero reported adverse events associated with linoleic acid, and there are no FDA recalls involving this substance. Scientific literature consistently demonstrates that linoleic acid at dietary levels is well-tolerated and essential for human health. Adequate linoleic acid intake supports immune function, skin health, cardiovascular function, and normal growth and development.

Potential concerns with very high isolated linoleic acid supplementation relate to the omega-3 to omega-6 ratio in the diet rather than linoleic acid toxicity per se. However, linoleic acid as naturally consumed in foods does not raise safety concerns at typical dietary levels.

Regulatory Status

Linoleic acid is not approved as a food additive under FDA regulations with specific GRAS status, primarily because it is universally recognized as a natural food component rather than a synthetic additive requiring safety approval. It is subject to all regulations governing food ingredients and must meet purity standards if used in concentrated forms. In the European Union, linoleic acid is permitted as a food additive in various categories under Regulation (EC) No 1333/2008. Health authorities globally recognize linoleic acid as an essential nutrient without restriction on dietary intake from conventional food sources.

Key Studies

Decades of nutritional research have established linoleic acid's essential role in human health. Studies demonstrate that adequate linoleic acid intake supports normal growth, skin integrity, and metabolic function. Research on omega-6 polyunsaturated fats, including linoleic acid, shows benefits for cardiovascular health at moderate dietary levels. The American Heart Association and other health organizations recognize linoleic acid as an important dietary component, typically recommending 5-10% of total calories from linoleic acid and other omega-6 polyunsaturated fats. No studies have identified linoleic acid as a toxicological hazard at food consumption levels.

Frequently Asked Questions

What is Linoleic Acid?

Linoleic acid is an essential omega-6 polyunsaturated fatty acid naturally found in many plant oils and seeds. It functions as a flavoring agent and adjuvant in food products, contributing to taste and texture profiles while serving important nutritional roles in human health.

Is Linoleic Acid safe?

Linoleic Acid 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 Linoleic Acid banned in any country?

Linoleic Acid 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.