Our Verdict: RATING UNKNOWN

2-hydroxy-4-methylbenzaldehyde

CAS698-27-1

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-hydroxy-4-methylbenzaldehyde — food additive

2-hydroxy-4-methylbenzaldehyde is a naturally-derived aromatic compound used as a flavoring agent in food products. It provides vanilla and almond-like sensory notes and is employed in small quantities to enhance flavor profiles 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 2-hydroxy-4-methylbenzaldehyde?

2-hydroxy-4-methylbenzaldehyde, identified by CAS Number 698-27-1, is an organic aldehyde compound with aromatic properties. It belongs to the class of hydroxylated aromatic aldehydes and is structurally related to vanillin and other naturally occurring flavor compounds. The molecule contains a benzene ring with a hydroxyl group, a methyl group, and an aldehyde functional group, which together contribute to its distinctive sensory characteristics.

Common Uses

This compound functions as a flavoring agent and flavoring adjuvant in the food industry. It is typically used in very small concentrations to impart or enhance vanilla, almond, and woody flavor notes in processed foods and beverages. Common applications include dairy products, baked goods, confectionery, beverages, and savory food products. The compound's low usage levels—typically measured in parts per million (ppm)—reflect its potency as a flavoring ingredient. Like other synthetic and naturally-derived flavor compounds, it is formulated to meet specific sensory objectives in product development.

Safety Assessment

According to FDA records, there have been zero adverse events reported in connection with 2-hydroxy-4-methylbenzaldehyde, and no product recalls have been issued related to this additive. The absence of reported safety incidents suggests a favorable safety profile under normal conditions of use in food applications. The compound's structural similarity to vanillin and other approved flavor compounds provides some basis for safety consideration, though each additive is evaluated individually.

The safety of flavor additives is typically assessed based on their intended use levels, which are substantially below levels that would produce toxicological effects. Flavoring compounds are generally recognized as having wide margins of safety when used at concentrations necessary to achieve desired flavor effects. The cumulative exposure from all dietary sources is a consideration in safety evaluation.

Regulatory Status

2-hydroxy-4-methylbenzaldehyde has not been designated as Generally Recognized As Safe (GRAS) by the FDA. This means it has not undergone the formal GRAS determination process, which typically involves either a history of safe use before 1958 or a formal GRAS petition with supporting scientific data. However, the absence of a GRAS designation does not necessarily indicate safety concerns; rather, it reflects the regulatory pathway and documentation status.

Flavor compounds operate under FDA regulations 21 CFR Part 182 (GRAS substances) and 21 CFR Part 184 (direct food substances). Manufacturers using this additive in food products must ensure compliance with applicable regulations and substantiate its safety for intended use. The specific regulatory status may vary by country and region, with some jurisdictions maintaining their own flavor additive approval lists.

Key Studies

Limited published scientific literature is readily available specifically addressing 2-hydroxy-4-methylbenzaldehyde toxicology. Most safety assessments of flavor compounds rely on structural analogy to approved compounds, in vitro testing, and traditional toxicology data. The flavoring industry and regulatory bodies typically utilize databases such as the Flavor and Extract Manufacturers Association (FEMA) GRAS database and European Food Safety Authority (EFSA) assessments of flavor compounds for comparative analysis.

Safety evaluation of aromatic aldehydes generally considers metabolic pathways, potential allergenicity, and genotoxicity potential. Research on related compounds suggests that hydroxylated aromatics are typically metabolized efficiently and do not present significant toxicological concerns at intended use levels. However, specific published studies directly evaluating this particular compound appear limited in the open scientific literature.

Frequently Asked Questions

What is 2-hydroxy-4-methylbenzaldehyde?

2-hydroxy-4-methylbenzaldehyde is a naturally-derived aromatic compound used as a flavoring agent in food products. It provides vanilla and almond-like sensory notes and is employed in small quantities to enhance flavor profiles in various food and beverage applications.

Is 2-hydroxy-4-methylbenzaldehyde safe?

2-hydroxy-4-methylbenzaldehyde 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-hydroxy-4-methylbenzaldehyde banned in any country?

2-hydroxy-4-methylbenzaldehyde 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.