Our Verdict: RATING UNKNOWN

4-methyl-2,6-dimethoxyphenol

CAS6638-05-7

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

4-methyl-2,6-dimethoxyphenol โ€” food additive

4-methyl-2,6-dimethoxyphenol is a synthetic flavoring compound used to provide phenolic and smoky flavor notes in food products. Despite its GRAS status not being established by the FDA, it has been used in limited food applications with no reported adverse events or recalls.

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-methyl-2,6-dimethoxyphenol?

4-methyl-2,6-dimethoxyphenol (CAS Number: 6638-05-7) is a synthetic organic compound belonging to the phenolic family of flavor chemicals. Its chemical structure consists of a benzene ring with a methyl group and two methoxy groups attached at specific positions. This compound is classified as a flavoring agent or adjuvant and is used in very small quantities to impart specific taste and aroma characteristics to food products.

Common Uses

This flavoring compound is used primarily in the food industry to provide phenolic, smoky, and complex flavor profiles. It appears in products where such characteristics are desired, though its use is limited due to its non-GRAS regulatory status in the United States. The compound may be encountered in certain specialty foods, seasonings, or processed meat products where smoky or wood-derived flavor notes are desired. As with most synthetic flavoring agents, the actual concentration used in finished food products is typically very low, often measured in parts per million.

Safety Assessment

The FDA has not granted Generally Recognized as Safe (GRAS) status to 4-methyl-2,6-dimethoxyphenol, meaning it does not fall into the category of additives presumed safe through common use or scientific consensus. However, this lack of GRAS designation does not necessarily indicate the substance is unsafeโ€”rather, it reflects that sufficient evidence meeting FDA's specific criteria has not been established or submitted.

The compound has generated zero reported adverse events in the FDA's adverse event reporting system and has been associated with zero food recalls. This absence of safety signals suggests that any use to date has not resulted in documented consumer health complaints or identified food safety issues.

As a phenolic compound, 4-methyl-2,6-dimethoxyphenol shares structural similarities with other phenolic flavor compounds that have been more extensively studied. Phenolic compounds generally undergo metabolism in the body through various enzymatic pathways. The specific toxicological profile of this particular compound would require dedicated safety studies to fully characterize.

Regulatory Status

In the United States, 4-methyl-2,6-dimethoxyphenol is not on the FDA's GRAS list and does not have an established FDA regulation for use as a food additive. This means any use in food products would require either: (1) a Food Additive Petition submitted to and approved by the FDA, or (2) a GRAS Notice providing evidence supporting its safety and common knowledge status.

The compound may have regulatory acceptance or different status in other countries, including European Union member states or other jurisdictions, but this would require separate verification through those regulatory authorities such as EFSA (European Food Safety Authority).

Key Studies

Limited published safety data is available specifically for 4-methyl-2,6-dimethoxyphenol in the scientific literature. The absence of extensive clinical or toxicological studies is notable, particularly compared to more widely-used flavoring agents. Any manufacturer seeking to use this compound would need to conduct or reference appropriate toxicological studies, including absorption, distribution, metabolism, and excretion studies, as well as acute and chronic toxicity assessments.

The lack of adverse events and recalls despite some degree of market use suggests the compound has not presented obvious safety concerns in practical application, but this does not replace the need for comprehensive safety evaluation data that would be expected by regulatory authorities for formal approval.

Frequently Asked Questions

What is 4-methyl-2,6-dimethoxyphenol?

4-methyl-2,6-dimethoxyphenol is a synthetic flavoring compound used to provide phenolic and smoky flavor notes in food products. Despite its GRAS status not being established by the FDA, it has been used in limited food applications with no reported adverse events or recalls.

Is 4-methyl-2,6-dimethoxyphenol safe?

4-methyl-2,6-dimethoxyphenol 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 4-methyl-2,6-dimethoxyphenol banned in any country?

4-methyl-2,6-dimethoxyphenol 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.