Our Verdict: SAFE

4-hydroxybenzoic Acid

CAS99-96-7

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

4-hydroxybenzoic Acid — food additive

4-hydroxybenzoic acid is an organic compound used as a flavoring agent and flavoring adjuvant in food products. It occurs naturally in some foods and is utilized in the food industry to enhance or modify taste 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 4-hydroxybenzoic Acid?

4-hydroxybenzoic acid, also known as p-hydroxybenzoic acid, is an organic compound with the chemical formula C₇H₆O₃ and CAS number 99-96-7. It belongs to the class of hydroxybenzoic acids and exists as a white crystalline solid at room temperature. The compound is structurally simple, consisting of a benzene ring with a hydroxyl group and a carboxylic acid group. 4-hydroxybenzoic acid occurs naturally in various plants and foods, including berries, wine, and certain vegetables, where it contributes to flavor profiles.

Common Uses

In the food industry, 4-hydroxybenzoic acid is employed as a flavoring agent and flavoring adjuvant. Its primary function is to enhance or modify the taste characteristics of food products. The compound may be used in beverages, condiments, baked goods, and other processed foods where flavor modification is desired. As a naturally occurring compound found in foods, its use in food manufacturing represents a continuation of flavors already present in nature, though in controlled and measured amounts.

Safety Assessment

4-hydroxybenzoic acid has not been designated as Generally Recognized as Safe (GRAS) by the FDA for use as a food additive, meaning it has not undergone the standard GRAS notification process. However, this classification does not indicate a safety concern; rather, it reflects that formal GRAS status has not been established through the regulatory process. The compound's safety profile is supported by its natural occurrence in foods consumed for centuries. The FDA has received zero adverse event reports associated with 4-hydroxybenzoic acid, and no recalls have been initiated involving this additive, suggesting a favorable safety history in practical use. Additionally, the compound has been the subject of toxicological research, with studies generally indicating low toxicity at typical exposure levels.

Regulatory Status

The regulatory status of 4-hydroxybenzoic acid varies internationally. While not GRAS-designated in the United States, the compound is permitted for use in certain applications in various countries. In the European Union, derivatives of 4-hydroxybenzoic acid, known as parabens, have been extensively regulated and studied, establishing significant scientific literature on the safety of this compound class. The lack of FDA GRAS status does not prevent its use in foods but may require manufacturers to follow specific regulatory pathways depending on intended use. Different countries maintain their own food additive regulations, and manufacturers must comply with local requirements where their products are marketed.

Key Studies

Toxicological research on 4-hydroxybenzoic acid and related compounds has been conducted to establish safety parameters. Studies have examined absorption, metabolism, and excretion patterns in laboratory and animal models. The compound has demonstrated low systemic toxicity, and metabolic studies indicate it is readily processed and eliminated by the body. Research on parabens (esters of 4-hydroxybenzoic acid) has been particularly extensive due to their widespread use in cosmetics and pharmaceuticals, providing additional data on the safety profile of this compound class. These studies collectively support the conclusion that 4-hydroxybenzoic acid poses minimal health risk at levels used in food products.

The absence of adverse event reports and regulatory recalls reinforces the practical safety record of this additive in food applications.

Frequently Asked Questions

What is 4-hydroxybenzoic Acid?

4-hydroxybenzoic acid is an organic compound used as a flavoring agent and flavoring adjuvant in food products. It occurs naturally in some foods and is utilized in the food industry to enhance or modify taste profiles.

Is 4-hydroxybenzoic Acid safe?

4-hydroxybenzoic Acid 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-hydroxybenzoic Acid banned in any country?

4-hydroxybenzoic Acid 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.