Our Verdict: SAFE

L-limonene

CAS5989-54-8

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

L-limonene — food additive

L-limonene is a naturally occurring organic compound found in citrus fruits that serves as a flavoring agent in food products. It provides characteristic lemon and orange flavors and aromas to beverages, confections, and other food items.

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
ApprovedUK FSA
Canada
ApprovedHealth Canada
Australia
ApprovedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
ApprovedANVISA
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 L-limonene?

L-limonene (CAS Number 5989-54-8) is a monocyclic monoterpene, a class of organic compounds derived from plant sources. It is the naturally occurring left-handed enantiomer of limonene, the primary component of citrus peel essential oils. The compound has the molecular formula C₁₀H₁₆ and exists as a clear, colorless to pale yellow liquid with a strong lemon odor. L-limonene can be isolated from citrus fruit processing or synthesized chemically for use as a food flavoring agent.

Common Uses

L-limonene is employed primarily as a flavoring agent and flavoring adjuvant in the food and beverage industry. Common applications include:

- Beverages: citrus-flavored soft drinks, juices, and flavored waters

- Confectionery: candies, chewing gums, and lozenges

- Dairy products: yogurts and flavored milk drinks

- Baked goods: cookies, cakes, and pastries

- Seasonings and condiments

The compound contributes both flavor and aroma, making it valuable for creating authentic citrus taste profiles in products where natural citrus ingredients may be impractical or inconsistent.

Safety Assessment

L-limonene has been extensively studied for safety purposes. The FDA has not granted GRAS (Generally Recognized as Safe) status to L-limonene specifically, though limonene as a class has been studied extensively. The EFSA (European Food Safety Authority) has evaluated limonene and its enantiomers, concluding that they are safe for use as flavoring agents at levels typically found in food products.

In preclinical and clinical studies, L-limonene has demonstrated low acute toxicity. Oral LD₅₀ values in rodents exceed 5,000 mg/kg, placing it in the low-toxicity category. Skin irritation potential is minimal at typical use levels. L-limonene does not appear to be genotoxic or carcinogenic based on available scientific evidence.

No adverse events have been reported to the FDA related to L-limonene, and no food recalls associated with this ingredient have been documented. The compound is volatile and metabolized readily in the body, with limonene known to undergo hepatic metabolism.

Regulatory Status

L-limonene is permitted for use as a flavoring agent in the European Union under Regulation (EC) No 1334/2008 on flavorings. It appears on the EU List of Flavoring Substances. In the United States, while not GRAS-designated specifically, it may be used as a flavor ingredient in accordance with 21 CFR Part 182. The regulatory status reflects its long history of use in foods and the absence of safety concerns at typical exposure levels.

The compound is also approved in numerous other jurisdictions including Canada, Australia, and Japan, typically under flavoring or flavoring agent classifications.

Key Studies

Relevant scientific assessment includes:

- EFSA evaluation of limonene as a flavoring agent, which examined both enantiomers and concluded safety at typical dietary exposure levels

- Absorption, distribution, and metabolism studies showing rapid hepatic metabolism and elimination

- Toxicological studies establishing the absence of genotoxic potential

- Skin sensitization studies indicating low allergenic potential for the general population

The compound's safety profile is supported by decades of use in food products and cosmetics without documented safety incidents at typical levels of exposure.

Frequently Asked Questions

What is L-limonene?

L-limonene is a naturally occurring organic compound found in citrus fruits that serves as a flavoring agent in food products. It provides characteristic lemon and orange flavors and aromas to beverages, confections, and other food items.

Is L-limonene safe?

L-limonene 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 L-limonene banned in any country?

L-limonene 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.