Our Verdict: RATING UNKNOWN

Methyl Linoleate (48%) Methyl Linolenate (52%) Mixture

CAS977136-80-3

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Methyl Linoleate (48%) Methyl Linolenate (52%) Mixture — food additive

Methyl Linoleate (48%) Methyl Linolenate (52%) Mixture is a combination of two methyl ester derivatives of essential polyunsaturated fatty acids. This compound functions as a flavoring agent and flavor enhancer in food applications, leveraging the organoleptic properties of omega-6 and omega-3 fatty acid derivatives.

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 Methyl Linoleate (48%) Methyl Linolenate (52%) Mixture?

This additive is a standardized mixture combining methyl linoleate and methyl linolenate in a 48:52 ratio. Methyl linoleate is the methyl ester form of linoleic acid (an omega-6 polyunsaturated fatty acid), while methyl linolenate is the methyl ester of linolenic acid (an omega-3 polyunsaturated fatty acid). Both parent compounds are naturally occurring fatty acids found in various plant and seed oils. The methylation process converts these free fatty acids into ester forms, which can have different sensory and functional properties in food applications.

Common Uses

This mixture is utilized in the food industry as a flavoring agent and flavor enhancer. Its application typically focuses on products where fatty acid-derived flavor compounds contribute to overall taste profiles. The specific blend of omega-3 and omega-6 derived compounds suggests potential use in foods targeting nutritional enhancement or in formulations where these fatty acid derivatives contribute desirable sensory characteristics. However, specific commercial food products utilizing this particular mixture are not widely documented in public databases.

Safety Assessment

The additive has not been formally established as GRAS (Generally Recognized as Safe) by the FDA, meaning it has not undergone the standard GRAS notification process. However, the FDA has not recorded any adverse events or recalls associated with this substance, which suggests limited commercial use history or satisfactory safety profiles in applications where it has been used.

The parent compounds—linoleic and linolenic acids—are well-established as safe fatty acids with established roles in human nutrition. Methyl esters of fatty acids have been studied for various applications and are generally recognized as low-toxicity compounds. The safety profile of methyl ester derivatives typically mirrors that of their parent fatty acids, though the methylation process can alter bioavailability and metabolic fate.

Because this specific mixture lacks formal GRAS status, its use in the United States is restricted to situations where a food additive petition has been approved or where it qualifies under alternative regulatory pathways. Manufacturers must ensure compliance with applicable regulations in their target markets.

Regulatory Status

In the United States, this additive does not have GRAS status and must comply with FDA food additive regulations if used. This typically requires either an approved food additive petition or use under an exemption such as being a component of a GRAS substance or prior-sanctioned food ingredient.

Regulatory approaches vary internationally. The European Food Safety Authority (EFSA) would evaluate this substance according to EU additives regulations if a petition were submitted. Other regions maintain their own regulatory frameworks for food flavoring agents and additives.

Manufacturers and importers should verify the regulatory status in their specific jurisdictions before incorporating this additive into food products.

Key Studies

Literature on this specific mixture is limited in publicly available scientific databases. Most safety information can be extrapolated from research on linoleic acid, linolenic acid, and their methyl esters as individual compounds rather than as a standardized mixture. General toxicology studies on fatty acid methyl esters indicate these compounds are not associated with significant toxicological concerns at typical food use levels. However, specific pharmacokinetic and safety studies on this exact 48:52 mixture would strengthen the safety evidence base if regulatory approval were pursued.

Frequently Asked Questions

What is Methyl Linoleate (48%) Methyl Linolenate (52%) Mixture?

Methyl Linoleate (48%) Methyl Linolenate (52%) Mixture is a combination of two methyl ester derivatives of essential polyunsaturated fatty acids. This compound functions as a flavoring agent and flavor enhancer in food applications, leveraging the organoleptic properties of omega-6 and omega-3 fatty acid derivatives.

Is Methyl Linoleate (48%) Methyl Linolenate (52%) Mixture safe?

Methyl Linoleate (48%) Methyl Linolenate (52%) Mixture is currently rated "unknown" 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 Methyl Linoleate (48%) Methyl Linolenate (52%) Mixture banned in any country?

Methyl Linoleate (48%) Methyl Linolenate (52%) Mixture 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.