Our Verdict: RATING UNKNOWN

12-methyltridecanal

CAS75853-49-5

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

12-methyltridecanal — food additive

12-methyltridecanal is a synthetic organic compound used as a flavoring agent in food products. It is not approved as a GRAS (Generally Recognized As Safe) substance by the FDA, though no adverse events or recalls have been associated with it.

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 12-methyltridecanal?

12-methyltridecanal is a branched-chain aldehyde compound with the CAS number 75853-49-5. It is a synthetic flavoring agent belonging to the class of organic compounds used to impart or enhance flavor characteristics in food and beverage products. As an aldehyde, it contains a carbonyl group (C=O) attached to a carbon chain, which contributes to its aromatic properties. The compound's 13-carbon backbone with a methyl branch at the 12th position gives it its distinctive structure and flavor profile.

Common Uses

12-methyltridecanal is utilized in the food industry as a flavoring agent or flavoring adjuvant. Aldehyde-based flavorings are commonly employed to create complex flavor notes in various food applications, including beverages, confectionery, baked goods, and other processed foods. The specific organoleptic properties of 12-methyltridecanal make it useful for creating fruity, fatty, or waxy flavor notes that enhance the sensory appeal of final food products. The actual concentrations used in foods are typically very small, as is standard practice with synthetic flavor compounds.

Safety Assessment

According to FDA records, 12-methyltridecanal has not been associated with any adverse events or recalls. This indicates no documented safety incidents in the food supply related to this compound. However, it is important to note that the absence of reported adverse events does not automatically establish safety equivalence with GRAS-approved ingredients. The lack of adverse events may also reflect limited widespread use or limited reporting mechanisms.

The toxicological profile of structurally similar aldehydes suggests that compounds in this class are generally metabolized and eliminated from the body relatively quickly. However, comprehensive safety data specific to 12-methyltridecanal, including studies on absorption, distribution, metabolism, and excretion (ADME), as well as subchronic and chronic toxicity studies, may be limited in the public domain.

Regulatory Status

12-methyltridecanal is not listed on the FDA's GRAS (Generally Recognized As Safe) inventory. This means it has not undergone the formal GRAS affirmation process or notification pathway that many food additives have completed. In the United States, flavoring agents that are not GRAS-listed may still be used in food if they are food additives that comply with FDA regulations and receive appropriate food additive approval, or if they fall under specific regulatory exemptions for flavoring ingredients.

The regulatory approach varies internationally. The European Food Safety Authority (EFSA) maintains separate approval processes for flavoring substances, and 12-methyltridecanal's status in the EU food additive system may differ from its FDA status. Users and manufacturers should verify compliance with specific jurisdictional regulations before use.

Key Studies

Public peer-reviewed literature specifically examining 12-methyltridecanal is limited. Most safety assessments of synthetic flavor compounds rely on structural analogies with well-characterized aldehydes, general knowledge of metabolic pathways for similar compounds, and in vitro or animal toxicity data when available. The flavor and extract manufacturers' industry associations, along with regulatory bodies, maintain databases and assessment procedures for evaluating the safety of flavoring ingredients.

For manufacturers or those considering use of this ingredient, consultation with flavor safety databases and regulatory authorities is recommended to ensure compliance with intended use jurisdictions. Additional proprietary safety data may be held by suppliers or manufacturers of this ingredient.

Frequently Asked Questions

What is 12-methyltridecanal?

12-methyltridecanal is a synthetic organic compound used as a flavoring agent in food products. It is not approved as a GRAS (Generally Recognized As Safe) substance by the FDA, though no adverse events or recalls have been associated with it.

Is 12-methyltridecanal safe?

12-methyltridecanal 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 12-methyltridecanal banned in any country?

12-methyltridecanal 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.