Our Verdict: RATING UNKNOWN

3-methyl-3-butenyl Acetate

CAS5205-07-2

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

3-methyl-3-butenyl Acetate — food additive

3-methyl-3-butenyl Acetate is a synthetic organic compound used as a flavoring agent in food products. It imparts fruity and floral notes characteristic of certain fruits and botanicals, and is employed in small quantities to enhance the sensory profile of beverages, confectionery, and other processed foods.

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 3-methyl-3-butenyl Acetate?

3-methyl-3-butenyl Acetate (CAS Number: 5205-07-2) is a synthetic flavoring compound belonging to the ester family of organic molecules. It is characterized by a fruity and slightly floral odor profile. The compound is formed through esterification reactions and is chemically stable under normal food processing and storage conditions. As a synthetic flavoring agent, it is distinct from naturally-derived flavoring compounds, though it may be designed to replicate or enhance aromas found in nature.

Common Uses

This flavoring agent is primarily used in the food and beverage industry to enhance and create desired taste and aroma profiles. Common applications include:

- Beverage flavoring (soft drinks, fruit juices, flavored waters)

- Confectionery and candy products

- Baked goods and desserts

- Dairy products (yogurts, flavored milks)

- Chewing gum and mints

Typically, this compound is used in very small concentrations—often measured in parts per million (ppm)—as flavoring agents are potent and require minimal quantities to achieve desired sensory effects. The exact usage levels vary depending on the specific food application and desired intensity of flavor.

Safety Assessment

The safety profile of 3-methyl-3-butenyl Acetate is characterized by an absence of reported adverse events in FDA databases and no associated product recalls. This historical record suggests that the compound, at levels used in food applications, has not been associated with consumer harm.

As a flavoring compound used in trace amounts, exposure through food consumption is typically very low. The volatile nature of many flavoring esters means that some degradation may occur during food processing and storage. Standard toxicological considerations for synthetic flavorings include acute toxicity, chronic effects, and potential allergenicity, though specific published studies on this particular compound are limited in publicly available literature.

The lack of FDA GRAS (Generally Recognized As Safe) status indicates that this compound has not undergone the formal GRAS notification process with the FDA. This does not necessarily indicate a safety concern; rather, it reflects that manufacturers may use it under FDA's food additive regulations or that formal GRAS determination has not been pursued. The distinction is important: food additives can be used legally in food without GRAS status if they comply with applicable FDA regulations and food additive tolerances.

Regulatory Status

In the United States, 3-methyl-3-butenyl Acetate is not listed as a GRAS substance. However, the absence of GRAS status does not prohibit its use in food; manufacturers may petition for food additive approval or use the compound under existing food additive regulations if applicable tolerances have been established. The FDA regulates all food additives, whether GRAS or not, to ensure they meet safety standards before reaching consumers.

International regulatory frameworks vary. The European Union maintains its own approval processes for food additives through EFSA (European Food Safety Authority) assessments. Regulatory approval and usage permissions differ by country and region, reflecting varying approaches to food safety assessment and risk management.

Key Studies

Publically available peer-reviewed research specifically examining 3-methyl-3-butenyl Acetate is limited. Most safety evaluations of synthetic flavoring compounds rely on structural analogs, general toxicological principles for similar esters, and historical use data. Flavoring compounds are typically assessed based on their chemical class, metabolic pathways, and use levels in food.

For ester-based flavorings generally, research has established that these compounds are typically metabolized through standard esterase pathways in the body and are generally rapidly cleared. The Flavor and Extract Manufacturers Association (FEMA) maintains an Expert Panel that evaluates flavoring safety based on available scientific evidence, though specific detailed assessments for individual compounds may not be publicly available.

Continued monitoring through post-market surveillance systems ensures that any emerging safety concerns would be identified and addressed by regulatory authorities.

Frequently Asked Questions

What is 3-methyl-3-butenyl Acetate?

3-methyl-3-butenyl Acetate is a synthetic organic compound used as a flavoring agent in food products. It imparts fruity and floral notes characteristic of certain fruits and botanicals, and is employed in small quantities to enhance the sensory profile of beverages, confectionery, and other processed foods.

Is 3-methyl-3-butenyl Acetate safe?

3-methyl-3-butenyl Acetate 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 3-methyl-3-butenyl Acetate banned in any country?

3-methyl-3-butenyl Acetate 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.