Our Verdict: RATING UNKNOWN

2,4-dihydroxybenzoic Acid

CAS89-86-1

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

2,4-dihydroxybenzoic Acid — food additive

2,4-dihydroxybenzoic acid (also known as β-resorcylic acid) is an organic compound used as a flavoring agent or flavor adjuvant in food products. It is not approved as a food additive by the FDA and has limited commercial use in food 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 2,4-Dihydroxybenzoic Acid?

2,4-dihydroxybenzoic acid is an organic aromatic carboxylic acid with the molecular formula C₇H₆O₄ and CAS number 89-86-1. It is also known as β-resorcylic acid or 2,4-dihydroxybenzoic acid. The compound features a benzene ring with two hydroxyl groups and one carboxylic acid group attached. It exists as a white to off-white crystalline solid at room temperature and is sparingly soluble in water.

Common Uses

When used in food applications, 2,4-dihydroxybenzoic acid functions as a flavoring agent or flavor adjuvant. Flavor adjuvants are substances that enhance, modify, or round out the taste profile of food products without necessarily contributing a distinct flavor themselves. This compound may be utilized in the food industry to improve or modulate flavoring in various food and beverage products, though such applications appear limited in commercial food manufacturing.

Safety Assessment

The available safety data for 2,4-dihydroxybenzoic acid in food use is limited. As of current FDA records, there have been zero reported adverse events associated with this additive and zero product recalls involving this substance. This suggests that any current or historical food use has not generated safety concerns significant enough to trigger regulatory action or consumer complaints documented by the FDA.

Toxicological information on this compound is sparse in the peer-reviewed literature specifically addressing food safety. The hydroxyl and carboxylic acid functional groups present on the benzene ring are chemically similar to compounds found in nature and used in food applications, such as salicylic acid derivatives, though direct comparative safety studies are not readily available.

Regulatory Status

2,4-dihydroxybenzoic acid is not approved by the FDA as a GRAS (Generally Recognized As Safe) substance for food use. This means it has not undergone the FDA's GRAS determination process, which typically involves either FDA affirmation or qualified expert consensus review. Without GRAS status or specific FDA approval, the additive cannot be legally added to food products in the United States under current regulations.

The lack of GRAS designation does not necessarily indicate the substance is unsafe; rather, it indicates that sufficient safety data have not been submitted to the FDA or that the agency has not completed its review of such data. In the European Union, this compound is not listed in the approved food additives catalogue, indicating it is not authorized for food use in EU member states.

Key Studies

Limited published research specifically addresses the safety or efficacy of 2,4-dihydroxybenzoic acid as a food additive. The compound has been studied primarily in chemical and pharmaceutical contexts rather than food safety applications. Any manufacturer interested in using this additive would need to generate appropriate safety and efficacy data and submit a petition to the FDA or EFSA, demonstrating that the intended use is safe at proposed levels.

The absence of adverse event reports and recalls, combined with zero documented regulatory actions, suggests this additive has not been a subject of significant food safety concern. However, the lack of comprehensive safety studies and regulatory approval indicates that more data would be needed to support any potential food applications in regulated markets.

Frequently Asked Questions

What is 2,4-dihydroxybenzoic Acid?

2,4-dihydroxybenzoic acid (also known as β-resorcylic acid) is an organic compound used as a flavoring agent or flavor adjuvant in food products. It is not approved as a food additive by the FDA and has limited commercial use in food applications.

Is 2,4-dihydroxybenzoic Acid safe?

2,4-dihydroxybenzoic 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 2,4-dihydroxybenzoic Acid banned in any country?

2,4-dihydroxybenzoic 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.