Our Verdict: RATING UNKNOWN

3-hydroxybenzoic Acid

CAS99-06-9

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

3-hydroxybenzoic Acid — food additive

3-hydroxybenzoic acid is an organic compound used as a flavoring agent in food products. It occurs naturally in some plants and is utilized to provide specific taste and aromatic characteristics in various food and beverage applications.

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 3-hydroxybenzoic Acid?

3-hydroxybenzoic acid, also known as meta-hydroxybenzoic acid, is an organic compound with the chemical formula C7H6O3 and CAS number 99-06-9. It is a benzoic acid derivative featuring a hydroxyl (-OH) group attached to the benzene ring in the meta position. This compound exists as a white to off-white crystalline solid at room temperature and has a molecular weight of 138.12 g/mol.

The compound can be found naturally in trace amounts in certain plant materials and fermented products. Synthetically, it is manufactured through chemical processes for use in food flavoring applications where it contributes specific aromatic and taste profiles.

Common Uses

3-hydroxybenzoic acid is employed as a flavoring agent or flavoring adjuvant in the food industry. Its primary function is to enhance or modify the flavor and aroma of food and beverage products. It may be used in small concentrations to contribute to complex flavor notes in various applications including beverages, confectionery, baked goods, and processed foods.

As a flavoring adjuvant, it often serves as a supporting ingredient that enhances or modifies the perception of other flavoring components rather than providing a dominant flavor characteristic on its own.

Safety Assessment

The FDA has not granted 3-hydroxybenzoic acid Generally Recognized As Safe (GRAS) status. However, the additive has generated no reported adverse events in the FDA's adverse event reporting system and has not been associated with any FDA recalls.

The lack of GRAS designation does not necessarily indicate unsafe use; rather, it may reflect limited petition submissions or that the ingredient falls outside common regulatory pathways. Some food additives operate in commerce through different regulatory mechanisms, including the Food Contact Substances program or through specific food additive petitions.

Toxicological data on 3-hydroxybenzoic acid remains limited in the public domain. Similar benzoic acid derivatives have been studied for safety, and many are approved for use in various jurisdictions. The absence of reported adverse events and recalls suggests that at typical use levels in food, the compound has not demonstrated observable safety concerns in practical application.

Regulatory Status

3-hydroxybenzoic acid does not have FDA GRAS status and is not listed as a direct food additive in the FDA's Code of Federal Regulations under Title 21 Part 182 or Part 184. This means it cannot be marketed as a food additive in the United States without specific authorization, either through a Food Additive Petition or another regulatory pathway.

The regulatory status varies by jurisdiction. Some international regulatory bodies may have different classifications or permitted use levels for this compound in food applications. Companies using this ingredient in food products intended for US distribution should ensure compliance with applicable FDA regulations.

Key Studies

Published scientific literature on 3-hydroxybenzoic acid's safety in food applications is relatively limited compared to more widely-used additives. Most available data comes from chemical characterization studies rather than dedicated safety assessments. Research on structurally similar compounds, such as other hydroxybenzoic acid isomers and benzoic acid derivatives, provides some context for understanding potential safety profiles, though direct extrapolation requires caution.

The compound's stability, metabolism, and potential for accumulation in food systems have not been extensively documented in peer-reviewed literature accessible to the general public. Further research and toxicological evaluation may be warranted to establish a comprehensive safety database if broader food industry adoption is pursued.

Frequently Asked Questions

What is 3-hydroxybenzoic Acid?

3-hydroxybenzoic acid is an organic compound used as a flavoring agent in food products. It occurs naturally in some plants and is utilized to provide specific taste and aromatic characteristics in various food and beverage applications.

Is 3-hydroxybenzoic Acid safe?

3-hydroxybenzoic Acid 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 3-hydroxybenzoic Acid banned in any country?

3-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.