Our Verdict: SAFE

Tyramine

CAS51-67-2

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

Tyramine — food additive

Tyramine is a naturally occurring organic compound classified as a flavoring agent that is found in various fermented and aged foods. It functions as a flavor compound in food manufacturing, though it is not approved as a food additive by the FDA.

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 Tyramine?

Tyramine (4-hydroxyphenethylamine) is a naturally occurring monoamine compound with the chemical formula C₈H₁₁NO and CAS number 51-67-2. It is an organic amine that occurs endogenously in foods as a byproduct of amino acid metabolism and bacterial fermentation processes. Structurally, tyramine is derived from the amino acid tyrosine and belongs to the class of trace amines found in the human body and various food sources.

Common Uses

Tyramine is not approved by the FDA as a food additive for intentional addition to foods. However, tyramine naturally occurs in many fermented and aged food products as a result of bacterial action on amino acids. Foods that naturally contain elevated tyramine levels include aged cheeses, cured meats, fermented soy products, certain alcoholic beverages (particularly red wine and beer), and fermented condiments. Due to its natural occurrence rather than intentional use as a flavoring agent, tyramine presence in foods is managed through food processing and storage practices rather than regulated as an intentional food additive.

Safety Assessment

While tyramine itself is naturally produced in the body and found in foods, its safety profile relates primarily to its biological effects rather than toxicity concerns. Tyramine is a trace amine that interacts with monoamine oxidase (MAO) enzymes in the body. For the general population consuming normal dietary levels, tyramine is rapidly metabolized and poses no safety concern. The FDA has received zero adverse event reports specifically attributed to tyramine as a food component.

Tyramine's regulatory and safety considerations differ from typical food additives. Rather than concerns about the compound itself causing direct toxicity, attention focuses on potential interactions with certain medications (particularly monoamine oxidase inhibitors). This is a pharmacological interaction concern rather than a food safety hazard per se. The naturally occurring levels of tyramine in typical foods are not considered dangerous for individuals not taking specific medications that inhibit MAO enzymes.

Regulatory Status

Tyramine is not on the FDA's Generally Recognized As Safe (GRAS) list for use as an intentional food additive. The FDA has not approved tyramine as a food additive, and there are no FDA recalls or enforcement actions related to tyramine in foods. This regulatory stance reflects that tyramine is managed as a naturally occurring food component rather than as an intentional additive requiring approval.

Because tyramine occurs naturally through fermentation and aging processes, it is not subject to the same regulatory requirements as synthetic additives. Food manufacturers focus on controlling tyramine levels through processing conditions and storage practices rather than seeking approval for its intentional addition. The European Food Safety Authority (EFSA) similarly addresses tyramine as a naturally occurring compound in fermented foods rather than as a regulated food additive.

Key Studies

Scientific literature on tyramine focuses primarily on its natural occurrence in fermented foods and its biological metabolism. Research demonstrates that tyramine levels vary significantly depending on fermentation time, temperature, and microbial cultures used in food production. Studies on aged cheeses, soy sauce, and cured meats document tyramine concentrations and identify bacterial species responsible for its formation.

Metabolic studies confirm that dietary tyramine is efficiently broken down by monoamine oxidase enzymes in the intestinal tract and liver in individuals with normal enzyme function. Research on fermented food consumption in general populations shows no adverse health outcomes attributable to naturally occurring tyramine at typical dietary exposure levels.

The scientific consensus supports that tyramine from fermented foods poses no food safety risk for the general population, with regulatory focus remaining on naturally occurring levels rather than concerns about intentional addition.

Frequently Asked Questions

What is Tyramine?

Tyramine is a naturally occurring organic compound classified as a flavoring agent that is found in various fermented and aged foods. It functions as a flavor compound in food manufacturing, though it is not approved as a food additive by the FDA.

Is Tyramine safe?

Tyramine 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 Tyramine banned in any country?

Tyramine 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.