Our Verdict: RATING UNKNOWN

Butyl Salicylate

CAS2052-14-4

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

Butyl Salicylate โ€” food additive

Butyl salicylate is an organic compound used as a flavoring agent and flavor enhancer in food products. It is not currently approved as Generally Recognized As Safe (GRAS) by the FDA, though it has no recorded adverse events or recalls associated with its use.

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 Butyl Salicylate?

Butyl salicylate (CAS Number 2052-14-4) is an organic ester compound derived from salicylic acid and butanol. It belongs to the salicylate family of compounds and is used primarily in the food industry as a flavoring agent and flavor enhancer. The compound has a characteristic fruity aroma, making it useful in creating or enhancing flavors in various food and beverage products.

Common Uses

Butyl salicylate is employed in the food industry as a flavoring component in products such as beverages, confectionery, baked goods, and other processed foods where fruity or aromatic flavor profiles are desired. As a flavor enhancer and flavoring adjuvant, it works to amplify or modify existing flavors in formulations. The compound's aromatic properties make it particularly useful in creating complex flavor blends that would be difficult to achieve through natural ingredients alone.

Safety Assessment

The safety profile of butyl salicylate appears favorable based on available data. According to FDA records, there have been zero reported adverse events associated with its consumption, and no product recalls have been linked to this additive. These metrics suggest that if the compound is being used in foods, it has not generated safety concerns significant enough to warrant regulatory action or consumer health alerts.

However, it is important to note that butyl salicylate is not on the FDA's GRAS (Generally Recognized As Safe) list. This designation does not necessarily indicate that the substance is unsafe; rather, it means that the FDA has not formally reviewed and approved it for use as a food additive under the GRAS provision. Food manufacturers using this additive would need to either obtain FDA approval through the food additive petition process or rely on alternative regulatory pathways in jurisdictions where it is permitted.

As a salicylate compound, butyl salicylate is chemically related to acetylsalicylic acid (aspirin) and naturally occurring salicylates found in many foods. Individuals with documented salicylate sensitivity may theoretically be more cautious with products containing this ingredient, though the levels used in food are typically very small.

Regulatory Status

In the United States, butyl salicylate does not hold FDA GRAS status, meaning it cannot be marketed as a food additive under the GRAS exemption. Its regulatory status in other major markets such as the European Union may differ. Food manufacturers seeking to use this ingredient in the U.S. market would need to submit a food additive petition to the FDA or work within the regulations of other countries where it may have been evaluated and approved.

The absence of GRAS status does not prohibit its use in all contextsโ€”some food manufacturers may use it under specific regulatory provisions in certain jurisdictions, or it may be present in imported food products where it is permitted in the country of origin.

Key Studies

Limited published research specifically addresses butyl salicylate's safety in food applications. The lack of recorded adverse events and recalls suggests that if the compound is present in foods consumed by the public, it has not generated sufficient concern to warrant formal safety studies or regulatory action. More comprehensive toxicological data would be needed to support GRAS status or formal FDA approval.

The compound's chemical structure and relationship to other salicylate esters suggests it would likely be absorbed and metabolized similarly to related compounds, though specific pharmacokinetic data for butyl salicylate in humans appears limited in publicly available literature.

Additions to the food supply are evaluated based on their intended use levels, potential exposure, and any identified hazards. For flavoring agents used in small quantities, the margin of safety is typically substantial due to the low concentrations employed in food products.

Frequently Asked Questions

What is Butyl Salicylate?

Butyl salicylate is an organic compound used as a flavoring agent and flavor enhancer in food products. It is not currently approved as Generally Recognized As Safe (GRAS) by the FDA, though it has no recorded adverse events or recalls associated with its use.

Is Butyl Salicylate safe?

Butyl 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 Butyl Salicylate banned in any country?

Butyl 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.