Our Verdict: SAFE

Oleic Acid, From Tall Oil Fatty Acids

CAS977047-39-4

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

Oleic Acid, From Tall Oil Fatty Acids — food additive

Oleic acid from tall oil fatty acids is a naturally-derived lubricant and release agent used in food manufacturing to prevent sticking and aid in formulation. It functions as a surface-active agent in processed foods.

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
Not EvaluatedUK FSA
Canada
Not EvaluatedHealth Canada
Australia
Not EvaluatedFSANZ
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 Oleic Acid, From Tall Oil Fatty Acids?

Oleic acid derived from tall oil fatty acids is a monounsaturated omega-9 fatty acid extracted from tall oil, a byproduct of kraft pulping in paper manufacturing. Tall oil is a natural mixture of fatty acids and rosin acids collected during wood pulp production. The CAS number 977047-39-4 identifies this specific formulation. As a naturally-derived ingredient, oleic acid is chemically identical to oleic acid found in olive oil, avocados, and other plant sources, though the source material distinguishes this particular classification.

Common Uses

In food manufacturing, oleic acid from tall oil fatty acids primarily functions as a lubricant and release agent. It is used to prevent processed foods from sticking to manufacturing equipment, conveyor belts, and molds during production. As a formulation aid, it helps improve the texture and processing characteristics of various food products. Its surface-active properties allow it to reduce surface tension between ingredients, facilitating better mixing and consistency in emulsified products. Common applications include baked goods, confectionery items, and processed snack foods where equipment release and smooth production flow are essential.

Safety Assessment

Oleic acid has a well-established safety profile based on its presence in numerous food sources and its chemical similarity to common dietary fatty acids. The FDA has recorded zero adverse events associated with this additive in its adverse event reporting system. Additionally, no product recalls have been attributed to this ingredient, indicating a strong safety record in commercial use. Oleic acid from tall oil fatty acids is absorbed and metabolized by the body similarly to oleic acid from conventional food sources, meaning the human body has established metabolic pathways for processing this compound.

As a lubricant and processing aid, the quantity used in finished food products is typically minimal, further reducing potential exposure. The ingredient is generally recognized as safe when used appropriately in manufacturing processes. It is not classified as a known allergen or sensitizer at typical use levels.

Regulatory Status

Oleic acid from tall oil fatty acids does not hold formal FDA GRAS (Generally Recognized As Safe) status, which means it has not undergone the specific GRAS notification process with the FDA. However, this does not indicate a safety concern; rather, it reflects that many food processing aids and lubricants operate under different regulatory frameworks. The FDA permits its use as a formulation aid and lubricant in food manufacturing under 21 CFR 178.1010 for use as a lubricant or release agent in food contact applications. The European Food Safety Authority (EFSA) has similarly evaluated tall oil-derived products as acceptable food processing aids. Its regulatory acceptance is based on decades of safe use in food manufacturing without documented safety issues.

Key Studies

While specific clinical studies on oleic acid from tall oil fatty acids are limited, extensive research on oleic acid generally demonstrates its safety profile. Oleic acid is one of the most studied fatty acids due to its prominence in Mediterranean diets. Research published in peer-reviewed journals confirms oleic acid's role in normal lipid metabolism and its lack of toxicological concern at dietary exposure levels. Studies on tall oil composition confirm that food-grade tall oil fatty acids contain minimal levels of impurities or harmful contaminants when properly processed and refined.

The safety of processing aids used in food manufacturing is additionally supported by the low migration potential of oleic acid from food contact surfaces into food products themselves, meaning actual dietary intake from this source is negligible.

Frequently Asked Questions

What is Oleic Acid, From Tall Oil Fatty Acids?

Oleic acid from tall oil fatty acids is a naturally-derived lubricant and release agent used in food manufacturing to prevent sticking and aid in formulation. It functions as a surface-active agent in processed foods.

Is Oleic Acid, From Tall Oil Fatty Acids safe?

Oleic Acid, From Tall Oil Fatty Acids 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 Oleic Acid, From Tall Oil Fatty Acids banned in any country?

Oleic Acid, From Tall Oil Fatty Acids 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.