Our Verdict: RATING UNKNOWN

3,4-dihydroxybenzoic Acid

CAS99-50-3

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

3,4-dihydroxybenzoic Acid — food additive

3,4-dihydroxybenzoic acid, also known as protocatechuic acid, is a naturally occurring organic compound used as a flavoring agent and adjuvant in food products. It is found in various plants and foods and is utilized to enhance or modify flavor profiles in beverages and food 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 3,4-dihydroxybenzoic Acid?

3,4-dihydroxybenzoic acid (CAS Number: 99-50-3) is an organic compound belonging to the benzoic acid family, characterized by two hydroxyl groups attached to a benzene ring. Commonly known as protocatechuic acid, this compound occurs naturally in numerous plant sources including fruits, vegetables, spices, and fermented foods. It is a phenolic acid and a type of benzoic acid derivative that has been identified in foods such as berries, nuts, tea, and wine.

Common Uses

In the food industry, 3,4-dihydroxybenzoic acid functions as a flavoring agent and flavoring adjuvant. Its applications are primarily in beverage formulations and food products where it contributes to flavor complexity or enhancement. The compound is used in small quantities to modify or augment existing flavors in processed foods and drinks. Its natural occurrence in foods suggests a long history of consumption through traditional dietary sources.

Safety Assessment

The safety profile of 3,4-dihydroxybenzoic acid appears favorable based on available data. The FDA has recorded zero adverse events associated with this additive and zero product recalls related to its use. These metrics indicate no documented safety incidents reported to the FDA in connection with this substance. The compound's presence as a naturally occurring component in commonly consumed foods suggests a level of dietary familiarity.

As a benzoic acid derivative with natural origins, 3,4-dihydroxybenzoic acid shares structural characteristics with other approved food components. However, the absence of FDA GRAS (Generally Recognized As Safe) status indicates that this compound has not undergone the specific GRAS determination process, which requires either a long history of safe use or substantial scientific evidence demonstrating safety.

Regulatory Status

3,4-dihydroxybenzoic acid does not currently hold FDA GRAS status in the United States. This classification means it is not approved for unrestricted use in food products. Where it is permitted, its use would be subject to specific regulatory provisions and limitations. Different regulatory jurisdictions worldwide may have varying approval statuses for this ingredient.

The lack of GRAS status does not necessarily indicate safety concerns; rather, it reflects that the formal regulatory determination process has not been completed or that sufficient evidence meeting GRAS criteria has not been established through the FDA's evaluation process.

Key Studies

Limited published research specifically addresses 3,4-dihydroxybenzoic acid's use as a food additive. The compound has been studied primarily in the context of naturally occurring phenolic compounds in foods rather than as an intentional food additive. Studies on protocatechuic acid have generally focused on its antioxidant properties when present in food matrices.

The natural occurrence of this compound in widely consumed foods provides some basis for safety assessment. However, the absence of specific toxicological studies evaluating this substance as an intentional food additive represents a gap in the available scientific literature. Additional research characterizing its safety profile at typical use levels would help inform regulatory decisions.

Frequently Asked Questions

What is 3,4-dihydroxybenzoic Acid?

3,4-dihydroxybenzoic acid, also known as protocatechuic acid, is a naturally occurring organic compound used as a flavoring agent and adjuvant in food products. It is found in various plants and foods and is utilized to enhance or modify flavor profiles in beverages and food formulations.

Is 3,4-dihydroxybenzoic Acid safe?

3,4-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 3,4-dihydroxybenzoic Acid banned in any country?

3,4-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.