Our Verdict: RATING UNKNOWN

Ethyl Salicylate

CAS118-61-6

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

Ethyl Salicylate — food additive

Ethyl salicylate is an organic compound used as a flavoring agent in food products, imparting fruity and wintergreen-like sensory notes. It is not currently approved as a Generally Recognized as Safe (GRAS) food additive by the FDA, limiting its use in the United States.

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 Ethyl Salicylate?

Ethyl salicylate (CAS Number: 118-61-6) is an ester compound formed from salicylic acid and ethanol. It occurs naturally in small quantities in various fruits, plants, and fermented foods, contributing to their characteristic aromatic profiles. The compound is a colorless to pale yellow liquid with a fruity, wintergreen-like odor. In food applications, it functions as a flavoring agent or flavor adjuvant, meaning it is added to enhance or modify the sensory characteristics of food products.

Common Uses

Ethyl salicylate is used primarily in the flavor industry to create fruity and spicy taste profiles in food and beverage formulations. Its applications include:

- Flavored beverages and soft drinks

- Confectionery and candy products

- Baked goods and desserts

- Ice cream and frozen desserts

- Savory food products requiring fruity notes

The compound is particularly valued for its ability to provide authentic fruit flavors at very low concentrations, making it cost-effective in industrial food production. It is employed globally in countries where it has received regulatory approval for food use.

Safety Assessment

Ethyl salicylate has generated no reported adverse events in FDA databases and has not been associated with any product recalls. The compound's safety profile is informed by its natural occurrence in foods and limited toxicological data from research studies.

As an ester of salicylic acid, toxicological concerns focus on the parent compound's known effects at high doses. However, the levels used in flavoring applications are substantially lower than those that would produce systemic effects. Acute toxicity studies in animal models have shown low toxicity via oral routes at typical food-additive concentrations.

Salicylates, the class of compounds to which ethyl salicylate belongs, are naturally present in many foods including fruits, vegetables, nuts, and spices. Individuals with salicylate sensitivity may need to be aware of products containing this additive, though reactions at normal food levels are uncommon.

Regulatory Status

Ethyl salicylate is not currently on the FDA's GRAS (Generally Recognized as Safe) list for use in food in the United States, which significantly restricts its legal use in American food products. This does not necessarily indicate safety concerns but rather reflects the absence of a formal GRAS petition or determination by the FDA.

In the European Union, ethyl salicylate is listed in the register of flavoring substances and can be used under regulations that establish maximum use levels and purity standards. It is also approved or permitted in other countries including Australia, Canada, and Japan, where it has undergone safety assessments by their respective regulatory bodies.

Manufacturers seeking to use this ingredient in the United States would need to either submit a GRAS petition to the FDA or use it under an approved food additive regulation.

Key Studies

Limited peer-reviewed literature specifically addresses ethyl salicylate safety in isolation. Most safety information derives from:

- General ester toxicology, which shows these compounds typically have low acute toxicity

- Natural occurrence data, documenting ethyl salicylate in fermented foods and fruits

- Regulatory assessments by EFSA and other international bodies that have reviewed salicylate esters

- In vitro and animal studies examining salicylate metabolism and effects

The absence of adverse event reports and recalls in FDA databases suggests the additive has not caused identifiable public health concerns in jurisdictions where it is used. However, the limited specific research means long-term safety data in human populations remains minimal.

Frequently Asked Questions

What is Ethyl Salicylate?

Ethyl salicylate is an organic compound used as a flavoring agent in food products, imparting fruity and wintergreen-like sensory notes. It is not currently approved as a Generally Recognized as Safe (GRAS) food additive by the FDA, limiting its use in the United States.

Is Ethyl Salicylate safe?

Ethyl Salicylate 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 Ethyl Salicylate banned in any country?

Ethyl Salicylate 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.