Our Verdict: RATING UNKNOWN

Valeraldehyde Dibutyl Acetal

CAS13112-65-7

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

Valeraldehyde Dibutyl Acetal — food additive

Valeraldehyde dibutyl acetal (CAS 13112-65-7) is a synthetic flavoring compound used to create fruity and floral flavor notes in food products. It functions as a flavoring agent or adjuvant and has not been formally approved as GRAS 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 Valeraldehyde Dibutyl Acetal?

Valeraldehyde dibutyl acetal is a synthetic organic compound classified as a flavoring agent. It is the dibutyl acetal derivative of valeraldehyde (pentanal), a naturally occurring aldehyde found in some plants and foods. In its acetal form, the compound exhibits enhanced stability compared to its aldehyde precursor, making it suitable for use in food applications where shelf-life and flavor persistence are important considerations.

Common Uses

This flavoring compound is primarily used in the food industry to impart fruity and floral flavor characteristics to various products. Typical applications include beverages, confectionery, baked goods, and dairy products. The acetal structure provides improved stability during processing and storage, allowing manufacturers to achieve consistent flavor profiles across their product lines. As with other synthetic flavor compounds, it is typically used in very small quantities, measured in parts per million (ppm).

Safety Assessment

According to FDA records, valeraldehyde dibutyl acetal has generated zero documented adverse events and has not been associated with any food recalls. No significant safety concerns have been identified in available scientific literature. However, it is important to note that this compound has not been formally designated as Generally Recognized as Safe (GRAS) by the FDA, which means it has not undergone the specific GRAS notification process that some flavor compounds complete.

The lack of adverse events and recalls suggests that when used in typical food flavoring applications at standard concentrations, the compound has not posed demonstrable public health concerns. The absence of formal GRAS status does not necessarily indicate a safety problem; rather, it reflects the regulatory pathway and submission status of the ingredient.

Regulatory Status

In the United States, valeraldehyde dibutyl acetal is not listed as a GRAS substance. This means it does not benefit from the GRAS exemption to the FDA's food additive approval requirement. However, it may be used in food products under FDA's food additive petition process or other regulatory pathways, depending on specific use cases and food categories. The ingredient's regulatory standing may vary in other countries and regulatory jurisdictions.

The European Food Safety Authority (EFSA) maintains separate regulations for flavoring compounds, and approval status in Europe may differ from FDA status in the United States. Manufacturers intending to use this compound should verify compliance with applicable regulations in their target markets.

Key Studies

Limited published scientific literature is available specifically examining valeraldehyde dibutyl acetal's toxicological profile. Most safety data for synthetic flavor compounds of this class comes from structural similarity assessments with related aldehydes and acetals that have undergone more extensive evaluation. The chemical class of aliphatic aldehydes and their derivatives has been studied extensively, and most members show low toxicological concern when used in appropriate food flavoring concentrations.

The absence of adverse event reports and recalls provides empirical evidence of safety in practical use, though this does not replace formal toxicological studies. For comprehensive safety information, manufacturers and regulatory bodies may refer to structure-activity relationship (SAR) assessments common in flavor compound evaluation.

As with all food additives, appropriate concentration limits and intended use applications are critical safety considerations. The quantity used—typically parts per million in finished products—is significantly below levels that would cause concern based on chemical properties and related compound data.

Frequently Asked Questions

What is Valeraldehyde Dibutyl Acetal?

Valeraldehyde dibutyl acetal (CAS 13112-65-7) is a synthetic flavoring compound used to create fruity and floral flavor notes in food products. It functions as a flavoring agent or adjuvant and has not been formally approved as GRAS by the FDA.

Is Valeraldehyde Dibutyl Acetal safe?

Valeraldehyde Dibutyl 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 Valeraldehyde Dibutyl Acetal banned in any country?

Valeraldehyde Dibutyl 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.