Our Verdict: RATING UNKNOWN

2,5-dimethylpyrrole

CAS625-84-3

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

2,5-dimethylpyrrole — food additive

2,5-dimethylpyrrole is an organic compound used as a flavoring agent in food products. It imparts a characteristic aroma and taste profile to various food applications. The compound has not been formally approved by the FDA as GRAS (Generally Recognized as Safe).

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 2,5-dimethylpyrrole?

2,5-dimethylpyrrole (CAS Number: 625-84-3) is a heterocyclic organic compound belonging to the pyrrole family of chemicals. It consists of a five-membered aromatic ring containing one nitrogen atom, with two methyl groups attached at the 2 and 5 positions. The compound is a volatile organic molecule with a distinctive aromatic profile that makes it useful in flavoring applications.

Common Uses

2,5-dimethylpyrrole is employed as a flavoring agent and flavoring adjuvant in the food industry. Flavoring adjuvants are substances that enhance, modify, or contribute to the overall sensory profile of food products. This compound is typically used in trace amounts to contribute to complex flavor profiles in various food and beverage applications, though specific commercial products utilizing this ingredient are not widely documented in public databases.

Like many pyrrole-based compounds, it may be used in both natural and synthetic flavor formulations to achieve desired taste and aroma characteristics in processed foods.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 2,5-dimethylpyrrole, and no recalls have been issued involving this ingredient. However, it is important to note that the absence of reported adverse events does not necessarily indicate comprehensive safety data has been generated for this substance.

The compound has not received GRAS (Generally Recognized as Safe) status from the FDA. GRAS status requires either a history of safe use in food prior to 1958, or substantial scientific evidence of safety. The lack of GRAS status suggests that either adequate safety data has not been submitted to the FDA, or the evidence provided was insufficient to meet GRAS criteria.

Toxicological data specific to 2,5-dimethylpyrrole appears limited in publicly available scientific literature. As a pyrrole derivative, the compound shares structural characteristics with other flavoring compounds, some of which have undergone safety evaluation by regulatory bodies like EFSA (European Food Safety Authority). However, extrapolation from structurally similar compounds should not substitute for direct safety testing of this specific substance.

Regulatory Status

In the United States, 2,5-dimethylpyrrole is not listed as a GRAS substance. This means it would generally require FDA approval through the Food Additive Petition process before it can be legally used in food products intended for U.S. commerce, unless it qualifies under other regulatory pathways.

The regulatory status in other jurisdictions (EU, Canada, Japan, etc.) is not clearly documented in readily available sources. The European Food Safety Authority (EFSA) and other regional regulatory bodies may have different approval statuses for this compound.

Use of non-approved food additives in food products is subject to enforcement by the FDA, which maintains authority to determine whether ingredients are lawfully used in foods.

Key Studies

Publicly available toxicological and safety studies specifically evaluating 2,5-dimethylpyrrole are not prominent in major scientific databases. The limited research profile for this compound compared to more widely-used flavoring agents suggests that comprehensive safety dossiers may not have been published or made publicly available.

This contrasts with more established flavoring compounds, for which EFSA and FDA maintain comprehensive scientific assessments. For anyone considering the use of 2,5-dimethylpyrrole in food products, consultation with regulatory experts and review of any proprietary safety data would be essential before commercial implementation.

Frequently Asked Questions

What is 2,5-dimethylpyrrole?

2,5-dimethylpyrrole is an organic compound used as a flavoring agent in food products. It imparts a characteristic aroma and taste profile to various food applications. The compound has not been formally approved by the FDA as GRAS (Generally Recognized as Safe).

Is 2,5-dimethylpyrrole safe?

2,5-dimethylpyrrole 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 2,5-dimethylpyrrole banned in any country?

2,5-dimethylpyrrole 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.