Our Verdict: RATING UNKNOWN

Citral Dimethyl Acetal

CAS7549-37-3

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

Citral Dimethyl Acetal โ€” food additive

Citral dimethyl acetal (CAS 7549-37-3) is a synthetic flavoring agent used to impart lemon and citrus notes to food products. It functions as a flavoring adjuvant in the food industry, though it has not received FDA GRAS (Generally Recognized as Safe) status.

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 Citral Dimethyl Acetal?

Citral dimethyl acetal is a synthetic organic compound classified as a flavoring agent and flavoring adjuvant. It is derived from citral, a naturally occurring terpene aldehyde found in lemon and other citrus oils. The dimethyl acetal form is created through chemical synthesis, where citral undergoes acetalization with methanol. This compound is used in very small quantities in food and beverage applications to provide citrus and lemon flavor notes.

Common Uses

Citral dimethyl acetal is primarily used as a flavor ingredient in the food and beverage industry. Its applications typically include:

- Flavoring in beverages (soft drinks, juices, flavored waters)

- Confectionery and candy formulations

- Baked goods and bakery products

- Dairy products and yogurts

- Desserts and frozen treats

- Flavor compounds in food manufacturing

The compound is used in trace amounts, measured in parts per million, due to its potent flavoring properties. Food manufacturers select citral dimethyl acetal for its stability and ability to deliver consistent citrus flavor profiles across product shelf life.

Safety Assessment

Citral dimethyl acetal has not generated adverse event reports in the FDA's adverse event tracking system, and there are no documented FDA recalls associated with this ingredient. The absence of reported safety incidents suggests a generally benign safety profile at levels of use in food applications.

However, the compound has not achieved FDA GRAS (Generally Recognized as Safe) status, which means it has not undergone the formal FDA notification process or been subjected to the extensive safety review that GRAS designation requires. This designation status does not necessarily indicate a safety concern; rather, it reflects the regulatory pathway and level of formal review the ingredient has received.

As a synthetic flavoring agent, citral dimethyl acetal is subject to FDA regulations under 21 CFR Part 182, which governs the use of flavoring substances. The FDA maintains strict limitations on acceptable daily intake levels for synthetic flavoring agents based on toxicological data.

Regulatory Status

In the United States, citral dimethyl acetal may be used as a flavoring agent in food, though manufacturers must ensure compliance with FDA regulations and use the ingredient in accordance with current Good Manufacturing Practices (cGMP). The compound is not listed as a prohibited or restricted substance by the FDA.

The European Food Safety Authority (EFSA) has also evaluated similar citral-derived flavoring compounds as part of its systematic review of flavoring substances used in food. The regulatory framework in Europe similarly permits the use of citral dimethyl acetal in flavoring applications when used at appropriate levels.

Usage levels are typically very limitedโ€”flavoring agents are used at concentrations of 1-50 ppm (parts per million) depending on the food application and the specific flavor profile desired. These minimal use levels are well below any threshold of toxicological concern.

Key Studies

While extensive published literature specifically on citral dimethyl acetal is limited, the safety assessment of this ingredient builds upon established data for citral and related compounds. Citral itself has been extensively studied and is recognized as a flavoring component in essential oils with a long history of safe use.

Toxicological evaluations of citral and structurally related aldehydes and acetals have demonstrated low acute toxicity and no significant concerns at levels used in food flavoring. The dimethyl acetal form is considered a prodrug that hydrolyzes to citral and methanol in aqueous conditions, further supporting the safety assessment based on citral's established toxicological profile.

Research on synthetic flavoring agents indicates that compounds in this category, when used at approved levels in food, do not present safety concerns for the general population. The conservative use levels in food manufacturing ensure exposures well below levels that would raise toxicological concerns.

Frequently Asked Questions

What is Citral Dimethyl Acetal?

Citral dimethyl acetal (CAS 7549-37-3) is a synthetic flavoring agent used to impart lemon and citrus notes to food products. It functions as a flavoring adjuvant in the food industry, though it has not received FDA GRAS (Generally Recognized as Safe) status.

Is Citral Dimethyl Acetal safe?

Citral Dimethyl Acetal 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 Citral Dimethyl Acetal banned in any country?

Citral Dimethyl Acetal 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.