Our Verdict: SAFE

Carvone

CAS99-49-0

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Carvone — food additive

Carvone (CAS 99-49-0) is a naturally occurring organic compound responsible for the characteristic flavor of caraway and spearmint. It is used as a flavoring agent in food and beverage products to provide minty or spice-like taste profiles.

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
ApprovedHealth 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 Carvone?

Carvone is an organic compound belonging to the class of monoterpenes, which are naturally derived volatile molecules found in essential oils of various plants. It exists in two enantiomeric forms: (R)-carvone, which has a caraway seed flavor profile, and (S)-carvone, which has a spearmint flavor profile. The compound is liquid at room temperature with a characteristic pungent aroma and is produced through both natural extraction and synthetic chemical synthesis.

Common Uses

Carvone is primarily used in the food industry as a flavoring agent to provide authentic caraway or spearmint notes in products including:

- Chewing gums and mints

- Beverages including soft drinks and spirits

- Baked goods and confectionery

- Dairy products such as yogurt and cheese

- Savory seasonings and spice blends

- Oral care products including toothpastes and mouthwashes

The compound provides both flavor and aroma, making it valued in formulations where these sensory attributes are desired. Its use allows manufacturers to achieve consistent flavor profiles without relying solely on natural plant extracts.

Safety Assessment

Carvone has been evaluated for safety in food applications by multiple regulatory bodies. The FDA has not designated carvone as Generally Recognized as Safe (GRAS), though this designation does not indicate a safety concern but rather reflects the specific regulatory pathway and submission history. The European Food Safety Authority (EFSA) has established an acceptable daily intake (ADI) for carvone in food applications.

Toxicological studies have shown carvone to have low acute toxicity. The compound is metabolized relatively rapidly in the body and does not bioaccumulate. Both acute and subchronic toxicity studies in animal models have failed to identify significant adverse effects at relevant exposure levels. Genotoxicity and mutagenicity studies have been negative.

According to FDA records, there have been zero reported adverse events associated with carvone consumption as a food additive, and zero product recalls have been attributed to this ingredient. This safety record reflects decades of use in food applications with no identified safety signals in consumer populations.

Individual sensitivities or allergies to carvone are rare, though like all flavoring compounds, the theoretical potential for hypersensitivity exists in susceptible individuals. The amount of carvone used in food products is typically very small, further reducing potential for adverse effects.

Regulatory Status

Carvone's regulatory status varies by jurisdiction:

**United States**: While not GRAS-designated, carvone is approved for use as a food additive in flavoring applications under FDA regulations (21 CFR Part 182). It may be used in accordance with Good Manufacturing Practice (GMP) guidelines.

**European Union**: Carvone is permitted as a food additive under Regulation (EC) No 1334/2008, with established safety parameters and usage levels.

**Other Regions**: Carvone is approved for food use in Canada, Australia, and Japan among other countries, reflecting general international acceptance of its safety profile when used as intended.

The compound is listed in the WHO/FAO Database of Flavoring Agents and has undergone evaluation by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Key Studies

Scientific evaluation of carvone has included:

- Acute and subacute toxicity studies establishing safe dose ranges

- Metabolic pathway studies demonstrating rapid clearance from the body

- Genotoxicity assessment confirming absence of mutagenic potential

- Reproductive and developmental toxicity studies showing no adverse effects

- Real-world safety monitoring through adverse event reporting systems

The cumulative evidence from multiple independent research institutions and regulatory agencies supports the safety of carvone when used at typical food application levels. Ongoing monitoring through regulatory systems continues to track any emerging safety concerns.

Frequently Asked Questions

What is Carvone?

Carvone (CAS 99-49-0) is a naturally occurring organic compound responsible for the characteristic flavor of caraway and spearmint. It is used as a flavoring agent in food and beverage products to provide minty or spice-like taste profiles.

Is Carvone safe?

Carvone is currently rated "safe" 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 Carvone banned in any country?

Carvone 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.