Our Verdict: SAFE

4-hydroxybenzaldehyde

CAS123-08-0

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

4-hydroxybenzaldehyde — food additive

4-hydroxybenzaldehyde is an organic compound used as a flavoring agent in food products. It is a naturally occurring aromatic aldehyde that imparts vanilla-like and almond-like sensory notes to food and beverage formulations.

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 4-hydroxybenzaldehyde?

4-hydroxybenzaldehyde, also known as p-hydroxybenzaldehyde or 4-HBA, is an aromatic aldehyde with the chemical formula C₇H₆O₂. The compound features a benzene ring with both a hydroxyl group and an aldehyde group in the para position. It occurs naturally in small quantities in various plants and food sources, including vanilla, almonds, and some spices. The compound is a white to off-white crystalline solid with a characteristic pleasant odor.

Common Uses

4-hydroxybenzaldehyde is primarily utilized as a flavoring agent or flavoring adjuvant in the food and beverage industry. Its applications include:

- Beverage flavoring, particularly in soft drinks and alcoholic beverages

- Confectionery and candy formulations

- Dairy products and desserts

- Baked goods and snack foods

- Flavor compositions and fragrance applications

The compound contributes vanilla-like, almond-like, and slightly sweet aromatic notes that enhance overall flavor profiles. Due to its natural occurrence in foods, it is often classified as a "natural" flavoring component when derived from botanical sources, though it can also be synthesized chemically.

Safety Assessment

4-hydroxybenzaldehyde has not generated adverse event reports in FDA databases, with zero recorded adverse events and zero product recalls associated with its use. The compound's safety profile reflects its natural presence in commonly consumed foods and its long history of use in food flavoring.

Toxicological studies on 4-hydroxybenzaldehyde have examined acute and subchronic exposure. The compound demonstrates low acute toxicity through oral, dermal, and inhalation routes. In standard safety testing protocols, the compound has shown acceptable toxicological profiles at levels relevant to food use. Metabolic studies indicate that 4-hydroxybenzaldehyde is readily absorbed and metabolized in the body, with pathways similar to other aromatic aldehydes.

The European Food Safety Authority (EFSA) and other regulatory bodies have reviewed flavoring compounds in this chemical class. The absence of genotoxic or carcinogenic potential in standard screening assays supports its use as a food additive at typical flavoring levels.

Regulatory Status

4-hydroxybenzaldehyde is not listed on the FDA's Generally Recognized as Safe (GRAS) list. However, this classification does not indicate a safety concern; rather, it reflects that the compound may not have undergone formal GRAS notification or that its primary regulatory pathway involves direct food additive petition procedures in some jurisdictions.

In the European Union, 4-hydroxybenzaldehyde is permitted as a flavoring substance under Regulation (EC) No 1334/2008. It is listed in the inventory of approved flavorings and is authorized for use in food and beverages within established flavor use levels. Many other countries recognize its use as a food flavoring ingredient through their respective regulatory frameworks.

The permissible use levels are typically established at concentrations consistent with flavoring applications, generally in the range of parts per million in finished food products. Manufacturers are required to comply with labeling requirements and compositional specifications established by their respective regulatory authorities.

Key Studies

Toxicological evaluations of 4-hydroxybenzaldehyde have been conducted under standard safety testing protocols. Research has documented that the compound is rapidly metabolized and does not accumulate in biological tissues. Studies examining the compound's mutagenic potential using standard bacterial and mammalian assays have yielded negative results.

The flavor compound's natural occurrence in foods has been well-documented in scientific literature, supporting its historical use and safety. Comparative safety assessments with other naturally occurring aromatic aldehydes have demonstrated consistent safety profiles at food use levels.

Ongoing monitoring through regulatory databases continues to track any emerging safety information, though the current database shows no reports of adverse health effects associated with dietary exposure at normal food flavoring concentrations.

Frequently Asked Questions

What is 4-hydroxybenzaldehyde?

4-hydroxybenzaldehyde is an organic compound used as a flavoring agent in food products. It is a naturally occurring aromatic aldehyde that imparts vanilla-like and almond-like sensory notes to food and beverage formulations.

Is 4-hydroxybenzaldehyde safe?

4-hydroxybenzaldehyde 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 4-hydroxybenzaldehyde banned in any country?

4-hydroxybenzaldehyde 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.