Our Verdict: SAFE

Undecanal

CAS112-44-7

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

Undecanal — food additive

Undecanal is a naturally occurring aldehyde compound used as a flavoring agent in food products. It provides fruity and citrus-like aromatic notes and is employed in small quantities to enhance flavor profiles in various processed foods and beverages.

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 Undecanal?

Undecanal (CAS Number 112-44-7) is an eleven-carbon aldehyde belonging to the class of organic compounds known as aliphatic aldehydes. It occurs naturally in various fruits, plants, and essential oils, including orange peel, lemon, and other citrus sources. The compound is colorless to pale yellow liquid with a characteristic fruity, citrus-like odor. In food manufacturing, undecanal is utilized in its synthetic form as a flavoring agent and flavor adjuvant to create or enhance the sensory profile of food and beverage products.

Common Uses

Undecanal is employed primarily in the flavor industry as a component of complex flavor formulations. It is used in small concentrations in beverages, including soft drinks and alcoholic drinks, to contribute fruity and citrus notes. The compound also appears in confectionery products, baked goods, dairy products, and other processed foods where enhanced fruit flavoring is desired. As with most synthetic flavoring agents, undecanal is used at very low levels—typically in the parts per million (ppm) range—to achieve the desired sensory effect without imparting an overly concentrated taste.

Safety Assessment

Undecanal has not been formally evaluated by the FDA as a Generally Recognized As Safe (GRAS) substance through the formal petition process. However, the absence of GRAS status does not indicate safety concerns; rather, it reflects that the compound may operate under different regulatory frameworks or that formal GRAS notification has not been pursued. The FDA database records zero adverse events and zero recalls associated with undecanal, indicating no documented safety incidents from consumer exposure through food products.

As a naturally occurring compound found in citrus and other food sources, undecanal has a history of limited human dietary exposure through natural food consumption. Toxicological data on aldehydes in general suggest that these compounds are typically metabolized efficiently by the body when ingested in the small quantities used in flavoring applications. The European Food Safety Authority (EFSA) and other international regulatory bodies have evaluated similar aldehyde-based flavoring compounds and generally recognize them as safe at typical use levels in food.

Regulatory Status

Undecanal operates in a complex regulatory environment that varies by jurisdiction. In the United States, while not GRAS-listed, the compound may be used as a flavoring substance under FDA regulations for food additives, provided it complies with applicable use restrictions and good manufacturing practices. The FDA's Color and Flavor Additive Regulations (Title 21 Code of Federal Regulations, Part 172) establish permitted use levels and applications for various flavoring substances.

In the European Union, undecanal may be regulated under flavoring regulations, and its use would need to comply with EU flavor legislation. Other countries and regions maintain their own regulatory frameworks for flavoring agents. Food manufacturers using undecanal must ensure compliance with applicable regulations in each market where their products are sold.

Key Studies

Limited peer-reviewed literature specifically addresses undecanal in isolation, as it is typically evaluated as part of broader assessments of aldehyde flavoring compounds. Toxicological studies on structurally similar aliphatic aldehydes have demonstrated that these compounds do not present significant safety concerns at levels used in food flavoring. Absorption, distribution, metabolism, and excretion (ADME) studies on related compounds show rapid hepatic metabolism and elimination. The absence of reported adverse events in the FDA database over decades of food product use provides practical evidence of safety at current exposure levels. Continued monitoring through post-market surveillance ensures any emerging safety signals would be identified and addressed.

Frequently Asked Questions

What is Undecanal?

Undecanal is a naturally occurring aldehyde compound used as a flavoring agent in food products. It provides fruity and citrus-like aromatic notes and is employed in small quantities to enhance flavor profiles in various processed foods and beverages.

Is Undecanal safe?

Undecanal 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 Undecanal banned in any country?

Undecanal 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.