Our Verdict: SAFE

Ethyl 3-mercaptobutyrate

CAS156472-94-5

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

Ethyl 3-mercaptobutyrate — food additive

Ethyl 3-mercaptobutyrate is a synthetic chemical compound primarily used as a flavoring agent in a variety of food products. It imparts specific savory, sulfury, and fruity notes, notably reminiscent of blackcurrant and tropical fruits. Its application is typically at very low concentrations to enhance or create desired flavor profiles.

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 3-mercaptobutyrate?

Ethyl 3-mercaptobutyrate is an organic compound with the chemical formula C6H12O2S and CAS Number 156472-94-5. It is an ester containing a thiol (sulfhydryl) group, which is characteristic of many compounds that contribute to distinct aromas and flavors. This additive is synthetically produced for use in the food industry, where it functions exclusively as a flavoring agent. Its unique chemical structure allows it to contribute complex sensory notes to food, often described as a blend of fruity (especially blackcurrant or tropical fruit), sulfury, and savory nuances. Due to its potent flavor profile, it is used in very small quantities, often as part of a more complex flavor blend rather than as a standalone flavor component. The production process involves chemical synthesis, ensuring a consistent and purified product for food applications.

Common Uses

As a versatile flavoring agent, Ethyl 3-mercaptobutyrate is utilized across a broad spectrum of food categories to create or enhance specific taste and aroma characteristics. Its ability to impart fruity, sulfury, and savory notes makes it valuable in developing diverse flavor profiles. Common applications include:

* **Beverages:** Used in fruit-flavored drinks, soft drinks, and alcoholic beverages to contribute to tropical fruit or blackcurrant notes.

* **Confectionery:** Found in candies, chewing gums, and other sweet treats to add fruity or complex savory undertones.

* **Baked Goods:** Incorporated into various baked products to round out flavor profiles or add a unique twist.

* **Dairy Products:** Can be used in flavored yogurts, ice creams, and other dairy desserts.

* **Savory Applications:** Due to its savory and sulfury characteristics, it can contribute to meat analogs, processed meats, soups, sauces, and snack foods, often enhancing umami or roasted notes.

* **Other Food Products:** May be found in prepared meals, seasonings, and certain convenience foods where a specific, potent flavor impact is desired.

Given its potency, Ethyl 3-mercaptobutyrate is typically used at concentrations in the parts per million (ppm) or even parts per billion (ppb) range within the final food product. It is often combined with other flavoring substances to achieve a balanced and desirable overall flavor.

Safety Assessment

The safety of flavoring agents like Ethyl 3-mercaptobutyrate is rigorously evaluated by expert panels and regulatory bodies worldwide. These assessments consider the chemical identity, potential exposure levels, metabolism in the body, and findings from various toxicological studies.

In the United States, the Flavor and Extract Manufacturers Association (FEMA) Expert Panel has evaluated Ethyl 3-mercaptobutyrate. FEMA, an independent scientific body, assesses flavoring substances for their Generally Recognized As Safe (GRAS) status. Ethyl 3-mercaptobutyrate (FEMA No. 4733) has been determined by the FEMA Expert Panel to be GRAS for its intended use as a flavoring ingredient. This determination is widely accepted by the U.S. Food and Drug Administration (FDA) for flavorings used at levels consistent with good manufacturing practices.

The European Food Safety Authority (EFSA) also conducts comprehensive safety evaluations of flavoring substances. Ethyl 3-mercaptobutyrate has been evaluated within the framework of Flavouring Group Evaluation 87 (FGE.87), which pertains to a group of sulfur-containing substances. EFSA's Panel on Food Additives and Flavourings (FAF Panel) reviews data on genotoxicity, metabolism, and potential toxicity, concluding on the safety of these substances at anticipated dietary exposure levels. EFSA's opinions generally permit the use of such flavorings under specified conditions and maximum use levels.

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) also provides international safety assessments. JECFA has evaluated groups of sulfur-containing flavoring agents, including Ethyl 3-mercaptobutyrate. Their assessments typically involve reviewing available toxicological data and estimating dietary exposure, often leading to an Acceptable Daily Intake (ADI) of “not specified” for many flavorings, indicating a very low safety concern at typical use levels.

According to FDA data, there have been zero reported adverse events and zero recalls associated with Ethyl 3-mercaptobutyrate. This lack of reported issues, combined with extensive expert panel reviews, supports its safety when used as intended as a flavoring agent.

Regulatory Status

The regulatory status of Ethyl 3-mercaptobutyrate varies slightly by region, though it is generally recognized as safe for use as a flavoring agent in major food markets.

**United States:** While the provided information indicates "FDA GRAS: No," this specifically refers to a formal FDA GRAS notification. However, Ethyl 3-mercaptobutyrate is considered GRAS by the Flavor and Extract Manufacturers Association (FEMA) Expert Panel (FEMA No. 4733). The FDA generally accepts FEMA's GRAS determinations for flavoring substances. This means it can be legally used in food products in the U.S. as a flavoring agent, provided it is used in accordance with good manufacturing practices and at levels that do not exceed what is reasonably required to achieve the desired flavoring effect.

**European Union:** In the EU, Ethyl 3-mercaptobutyrate is permitted for use as a flavoring substance in accordance with Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties. Its safety has been assessed by the European Food Safety Authority (EFSA) as part of FGE.87, and it can be used at specific maximum levels in various food categories as outlined in the Union list of authorized flavorings.

**International:** The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has also reviewed Ethyl 3-mercaptobutyrate within groups of sulfur-containing flavoring agents. JECFA's conclusions provide a basis for national food additive regulations in many countries outside the U.S. and EU.

Key Studies

The safety assessments for Ethyl 3-mercaptobutyrate, conducted by expert panels such as FEMA, EFSA, and JECFA, rely on a comprehensive review of scientific literature and studies. While specific individual studies on Ethyl 3-mercaptobutyrate are numerous and typically proprietary to flavor manufacturers or part of larger group evaluations, the key findings summarized by these bodies include:

* **Metabolism Studies:** These studies investigate how the body processes and eliminates the compound, often showing that sulfur-containing flavorings are rapidly metabolized and excreted, minimizing potential for accumulation.

* **Genotoxicity Studies:** Standard tests, such as the Ames test, are performed to assess whether the substance can damage genetic material. Ethyl 3-mercaptobutyrate has not shown evidence of genotoxic potential in these assays, which is a critical aspect of safety evaluation.

* **Acute and Subchronic Toxicity Studies:** These studies assess the potential for adverse effects after single or repeated exposure over shorter periods. The evaluations typically conclude that at the very low levels used in food, Ethyl 3-mercaptobutyrate does not pose a significant toxicological risk.

* **Exposure Assessments:** These are crucial for determining realistic dietary intake levels from food consumption, which are then compared against no-observed-adverse-effect levels (NOAELs) from animal studies. Such assessments consistently show that typical exposure to Ethyl 3-mercaptobutyrate from food sources is well below levels of concern.

The collective evidence reviewed by these esteemed scientific bodies supports the safety of Ethyl 3-mercaptobutyrate for its intended use as a flavoring agent in food products at currently established use levels. The absence of reported adverse events or recalls further corroborates its safety record in practical application.

Frequently Asked Questions

What is Ethyl 3-mercaptobutyrate?

Ethyl 3-mercaptobutyrate is a synthetic chemical compound primarily used as a flavoring agent in a variety of food products. It imparts specific savory, sulfury, and fruity notes, notably reminiscent of blackcurrant and tropical fruits. Its application is typically at very low concentrations to enhance or create desired flavor profiles.

Is Ethyl 3-mercaptobutyrate safe?

Ethyl 3-mercaptobutyrate 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 Ethyl 3-mercaptobutyrate banned in any country?

Ethyl 3-mercaptobutyrate 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.