Ethanol, commonly referred to as alcohol, is one of the oldest and most widely used substances in the food industry. From its role as a fermentation product in beverages to its function as a solvent and processing aid, alcohol has a long history of safe use. But when it comes to regulatory status in the United States, many companies ask: is alcohol recognized as Generally Recognized as Safe (GRAS) for food use?
Under the Federal Food, Drug, and Cosmetic Act, a substance added to food is considered a food additive unless it is exempt. Substances that are generally recognized, among qualified experts, as safe under the conditions of their intended use are exempt and classified as GRAS. This means they do not require premarket approval through a food additive petition. GRAS status can be established either through a long history of safe use in food prior to 1958 or through scientific procedures that demonstrate safety.
Ethanol has been part of the human diet for centuries, both naturally produced in fermented foods and intentionally added during food processing. Its safety is well established through widespread consumption in beverages, as well as in cooking, extracts, flavor preparations, and confectionery. The FDA has affirmed ethanol as GRAS under 21 CFR 184.1293, which states that ethyl alcohol is generally recognized as safe when used in accordance with good manufacturing practice. This regulation provides formal recognition of ethanol’s safe use in food.
Beyond direct addition, ethanol is often used in the production of food ingredients such as plant extracts, flavors, and herbal concentrates. In these applications, ethanol serves as a solvent to extract desirable compounds from raw materials. Importantly, processing with water or alcohol is not considered to result in a chemical alteration of the ingredient under FDA’s definitions. This means extracts produced with aqueous alcohol are not considered chemically altered and retain a straightforward regulatory pathway.
One of the clearest examples is vanilla extract, which has a standard of identity requiring ethanol. According to 21 CFR 169.175 and 169.177, vanilla extract and concentrated vanilla extract must contain not less than 35 percent ethyl alcohol by volume. This requirement shows that FDA not only permits but mandates the presence of ethanol in certain food ingredients. Ethanol’s role here is both functional and traditional, ensuring consistency in the extract’s flavor and stability.
While ethanol is safe for food use, its safety depends on context and exposure. The levels found in extracts, flavors, and processing aids are typically much lower than those consumed in alcoholic beverages, and use must comply with good manufacturing practices. Standards of identity, like those for vanilla extract, define minimum ethanol levels, while other applications allow only trace residual amounts. As with any GRAS substance, ethanol must always be used in a manner consistent with scientific evidence and regulatory limits.
For companies manufacturing or supplying food ingredients, ethanol’s GRAS status offers important flexibility. It allows ethanol to be used as a carrier, solvent, or processing aid without triggering the need for a food additive petition. Companies can emphasize that alcohol-based extraction processes are both traditional and well accepted, and that such processing does not alter the chemical identity of the ingredient. As with all GRAS substances, it remains important to ensure manufacturing practices align with regulatory expectations and that ethanol levels are consistent with good manufacturing practice.
Yes, ethanol is recognized as GRAS for food use in the United States, supported by its long history of safe use and formal recognition under 21 CFR 184.1293. Its role as a safe, effective solvent and processing aid makes it a cornerstone of ingredient manufacturing, particularly for extracts and flavors.
If your company uses alcohol-based extraction or formulation methods, dicentra’s regulatory team can help confirm GRAS alignment, prepare supporting documentation, and advise on FDA expectations. Contact dicentra to learn more about our GRAS consulting and submission services.