Our Verdict: SAFE

Methyl Salicylate

CAS119-36-8

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

Methyl Salicylate — food additive

Methyl salicylate is an organic compound derived from salicylic acid that functions as a flavoring agent in food products. It occurs naturally in many plants and is commonly used to impart wintergreen, mint, or spice-like flavor notes to beverages, candies, 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
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 Methyl Salicylate?

Methyl salicylate (CAS Number 119-36-8) is an ester compound formed from salicylic acid and methanol. It is a colorless to pale yellow liquid with a characteristic sharp, minty aroma reminiscent of wintergreen. The compound occurs naturally in various plants, including wintergreen, birch bark, and certain fruit species. In food manufacturing, it can be either extracted from natural sources or synthesized chemically, though the final product is chemically identical regardless of origin.

Common Uses

Methyl salicylate is primarily employed as a flavoring agent in the food industry. Common applications include:

- Confectionery products (hard candies, gums, lozenges)

- Beverages (flavored waters, syrups)

- Baked goods and desserts

- Chewing gums

- Breath mints and oral care products

- Spice blends and seasoning preparations

Typical usage levels in food products are relatively low, generally in the range of 1-100 ppm (parts per million), depending on the food category and desired intensity of wintergreen or mint flavor.

Safety Assessment

Methyl salicylate has been used in food flavoring for many decades with an established history of use. The compound's safety profile in food applications is generally considered acceptable at normal usage levels. The FDA has recorded zero adverse events and zero recalls associated with methyl salicylate used as a food additive, indicating no documented safety incidents from its use in foods at permitted concentrations.

It is important to distinguish between methyl salicylate's use as a food flavoring at minimal concentrations and its use in topical liniments or medicinal products, where much higher concentrations may be applied directly to skin. The toxic effects associated with methyl salicylate (salicylate poisoning) occur primarily with systemic absorption of large quantities, typically from non-food sources or accidental ingestion of concentrated preparations.

At food flavoring levels, the amount of methyl salicylate ingested is minimal and rapidly metabolized. The body processes ingested methyl salicylate through hydrolysis to salicylic acid and methanol, with subsequent elimination through normal metabolic pathways.

Regulatory Status

Methyl salicylate is not designated as Generally Recognized as Safe (GRAS) by the FDA under current regulations, despite its long history of safe use in food flavoring. This designation does not indicate a safety concern but rather reflects the specific regulatory pathway and approval status. The compound is permitted for use as a flavoring agent in various food categories according to FDA regulations under Title 21 CFR.

In the European Union, methyl salicylate is listed among approved flavoring substances for use in food products under Regulation (EC) No. 1334/2008, with established maximum usage levels depending on the food category. International regulatory bodies including JECFA (Joint FAO/WHO Expert Committee on Food Additives) have evaluated the compound and established acceptable daily intake values.

Key Studies

The safety evaluation of methyl salicylate in food has been based on extensive toxicological data compiled over decades of use. Studies examining acute and chronic toxicity have been conducted, along with assessments of mutagenic and reproductive potential. Available literature indicates no significant concerns when the compound is used at authorized food flavoring levels.

Scientific review of methyl salicylate's metabolism demonstrates efficient processing by the body, with no bioaccumulation in tissues. Research on flavor compounds in general has shown that organoleptic properties (taste and smell perception) often limit intake to safe levels naturally, as these compounds are used in minimal quantities to achieve desired sensory properties.

Frequently Asked Questions

What is Methyl Salicylate?

Methyl salicylate is an organic compound derived from salicylic acid that functions as a flavoring agent in food products. It occurs naturally in many plants and is commonly used to impart wintergreen, mint, or spice-like flavor notes to beverages, candies, and other food items.

Is Methyl Salicylate safe?

Methyl Salicylate 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 Methyl Salicylate banned in any country?

Methyl 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.