Our Verdict: SAFE

(z)-4-dodecenal

CAS21944-98-9

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

(z)-4-dodecenal — food additive

(Z)-4-dodecenal is a naturally occurring aldehyde compound used as a flavoring agent in food products. It provides fruity, fatty, and green notes to enhance food flavor profiles.

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 (Z)-4-dodecenal?

(Z)-4-dodecenal, also known as cis-4-dodecenal, is an unsaturated aldehyde with the CAS number 21944-98-9. This organic compound belongs to the class of aldehydes and is characterized by a 12-carbon chain with a double bond at the fourth position. The compound occurs naturally in various fruits and vegetables, contributing to their characteristic aromatic profiles. As a synthetic flavoring agent, (Z)-4-dodecenal is manufactured for use in food and beverage applications where it provides sensory enhancement.

Common Uses

(Z)-4-dodecenal is employed as a flavoring agent in the food industry, where it contributes fruity, fatty, and slightly green aromatic notes. It is used in trace amounts in various food products including beverages, baked goods, dairy products, and confectionery items. The compound's flavor profile makes it particularly useful in formulations designed to enhance natural fruit flavors or create complex flavor combinations. As with most synthetic flavoring compounds, the actual concentrations used in food products are very low, typically measured in parts per million (ppm), reflecting both efficacy and regulatory consideration of food safety principles.

Safety Assessment

The safety profile of (Z)-4-dodecenal has not generated significant concerns in regulatory agencies. The FDA has received zero adverse event reports associated with this additive, and there are no documented recalls involving this compound. While (Z)-4-dodecenal has not been granted Generally Recognized As Safe (GRAS) status by the FDA, this classification status does not inherently indicate a safety concern. GRAS designation is one pathway for regulatory approval, but many food additives operate under alternative regulatory frameworks, such as the Food Additive Petition process or inclusion in the FDA's Color Additives Status List.

The lack of adverse event reports and recalls suggests that this compound, when used in food applications at typical flavoring levels, has not been associated with documented safety incidents in the United States food supply. The compound's naturally occurring status in foods also provides some reassurance regarding its general safety profile, though natural origin does not automatically guarantee safety at higher concentrations.

Regulatory Status

(Z)-4-dodecenal's regulatory status varies by jurisdiction. In the United States, it is not listed as a GRAS substance, meaning it does not fall under the self-affirmed GRAS category. However, it may be used under the Food Additive Petition (FAP) process if manufacturers have submitted and obtained approval for specific food uses. The European Union maintains its own regulations regarding food flavorings through the EU Flavouring Regulation, which establishes different approval pathways for flavoring substances.

The absence of GRAS status should not be interpreted as indicating safety concerns; rather, it reflects that the specific regulatory pathway used for this ingredient may differ from the GRAS process. Manufacturers using this additive are responsible for ensuring compliance with applicable regulations in their target markets.

Key Studies

Limited peer-reviewed literature is publicly available specifically addressing (Z)-4-dodecenal's safety assessment. The absence of significant research output regarding this compound may reflect its established use history and the lack of identified safety concerns that would trigger formal investigation. General safety assessments of C12 aldehydes and similar flavoring compounds have been conducted by regulatory bodies and flavor industry toxicology organizations, typically indicating that such compounds at food-use levels do not present significant health risks.

Regulatory agencies including the FDA and international bodies such as the European Food Safety Authority rely on submission data from manufacturers, historical use data, and scientific literature when evaluating flavoring substances. The zero adverse event reports for (Z)-4-dodecenal suggest that its use in food has not generated safety signals requiring additional investigation or restriction.

Frequently Asked Questions

What is (z)-4-dodecenal?

(Z)-4-dodecenal is a naturally occurring aldehyde compound used as a flavoring agent in food products. It provides fruity, fatty, and green notes to enhance food flavor profiles.

Is (z)-4-dodecenal safe?

(z)-4-dodecenal 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 (z)-4-dodecenal banned in any country?

(z)-4-dodecenal 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.