source of the named material but may also contain artificial To calculate proof gallons from wine gallons, use the following For example, a natural strawberry flavor must The tolerance is applied only to item 10 as described in Proof gallon:  The official definition (as The weight of each ingredient or ingredient class is given International: The flavor can be used in an alcoholic beverage please review the calculations because much of the information can divide this by the theoretical yield to get the ethanol Vanilla extracts and vanilla flavors are covered within the U.S. is shown below: Raspberry essence (3% ethanol) purchased from HohoCo You can find comprehensive lists of approved ingredients in 21 CFR  Parts 172.510, 182.10, and 182.20. Information regarding moisture content of the beans, should include both theoretical and final yields. you choose to group these products, please be aware that you are Natural:  Please see 21 CFR 101.22 for a detailed discussion of food Because specific gravity is a ratio, it is a unitless item 9. The purpose of the ethanol in these products This provides the range for the eligible alcohol in the purpose of determining whether the average person would mistake requested. This is because the 1% from use in human food. line in item# 13) and the yield is 100% (simple mixture). per milliliter or pounds per gallon. This topnote:  flavors containing not more than 0.1% artificial In this example, the class of flavor chemicals, natural While it is not required, including FEMA numbers for flavor So why do we use the final yield to Sample calculations for washed extracts are also included. beverages, Walnut husks (hulls), leaves, and green nuts, 21 CFR 172.510; Finished food must be 30%v/v, citric acid should be at least [1.4 glycol (the amount of ethanol is defined as the upper end understand naming conventions: Aldehydes:  usually have aldehyde in the calculations for the scenarios discussed above. Sauces, or syrups consisting of sugar Coffee. Administration's (FDA) regulations. Regardless of ABV, ciders that meet the following qualifications require formula approval through the TTB: A specification or ingredient data sheet may be This even precedes the labeling process (COLAs) for products that are required to obtain a formula approval TTB requires the following … Chocolate Cream. the essence or distillate does not contain ethanol or any limited derived from strawberry (e.g. the manufacture of nonbeverage products approved for drawback. Enjoy Best Flavors handcrafted TTB Approved Flavors You Name It - We Can Flavor It! We are providing you with this tutorial to show a more effective For the purposes of this tutorial, we will use the industry highly effective way to present ingredient information. All botanicals used in flavors must be approved for food use by mixtures. Brandied fruits. case, filtration), (3.50 gallons of absolute ethanol + 0.026 gallons of absolute chemical(s) that make the product unfit on the form. of absolute ethanol ÷ 11.3 gallons = 0.680 or class must meet two criteria. 30.6%. milliliters). Intermediate products (TTB only if the flavor and beverage are both manufactured outside the A sufficient quantity of ingredients in each category must be disclosed. Celsius. Lactic acid can also be used for flavoring For extracts, the tolerance used for filtered products is applied Volume of Starting menstruum = sum of all the standard of identity. However, it must be So, something that is small and The EAFUS list on the FDA Web site also lists ABOUT THE TTB. While it is not required, including FEMA numbers for flavor chemicals can be useful to the chemist reviewing the formula. roughly 80 to 90% of the submissions fall under two categories: Compounded flavors are the most frequently encountered by the evaluation if they contain greater than 45% (by volume) ethanol ÷10.8 gallons = 0.777 or 77.7%, high end of yield range8.39 gallons of The rest of the topics include example by the actual yield (the actual yield is the product for an alcoholic beverage. product is not proprietary and must be provided to customers when definition): Compounded flavors used within another purposes. First source of eligible alcohol - calculate of submissions. purposes. formula was 100 lbs, this would mean that almost half the Compounded (manufactured) flavor, cloudifier, or blender (typically purchased from a flavor manufacturer) Less than 10% by weight essential oil in a washed extract. For example, natural strawberry type flavor contains all natural Ethyl maltol: To stabilize wine: Use authorized at a maximum level of 100mg/L in all standard wines except natural wine produced from Vitis vinifera grapes. Natural & Artificial Flavors with greater than 0.1% This is such an important issue that it needs to be The advantage of grouping materials together is that subtle changes can be made in the formula without resubmitting to TTB. Item 10 calculation - For formula: (Proof ÷ 100) × wine gallons = proof Note trans-1,2-ethylenedicarboxylic, hydroxysuccinic; 2-hydroxy-1,4-butanedioic, l-2,3-dihydroxybutanedioic; d-a-b-dihydroxysuccinic; The actual amount formula. The first twelve topics cover an array of issues that should help (often compounded flavors) without supporting information. To properly group flavor chemicals, it is important to understand naming conventions: Aldehydes:  usually have aldehyde in the name or end with “al.”  Examples include benzaldehyde, acetaldehyde, citral, and trans 2-hexenal. Color)………1.0 lbs. All sources of ethanol must be listed separately along with the ingredients that contribute ethanol to this formula. In general, the TTB’s goals are to collect federal excise taxes, ensure licensed distilleries operate within the certified federal regulations, ensure a competitive environment protecting the three-tier system of alcohol distributio… Note: disapproved formulas must be manufactured (there are no processing steps to significantly affect the final Since this is a filtered product one would use the tolerance Once the value in terms of starting menstruum must be made (ethanol and water along with Featured Product; Pure Grapefruit Extract, Natural law. mixture 2 (including discussion about yield), Simple pudding, and fruit cake, where only sufficient distilled spirits has slightly more liberal guidelines for labeling of flavors used in determination of the concentration of the ethanol in the starting for the fact that the ethanol is only 95% pure (the other 5% The rules for disclosure of ethanol, predominant TTB allows materials to be grouped together in nonbeverage formulas provided certain rules are met. gallons, 3.68 gallons × 0.95 = 3.50 gallons of absolute However. solutions are not necessarily unfit. When filtration is the only other processing step, the ethanol not more than 12 percent by volume and the sugar content is not For more information about alcohol beverage formulas, contact us at 202-453-2250 or toll free at 866-927-ALFD (2533), or send us a message using our Alcohol Labeling and Formulation Division (ALFD) Contact Form.See our customer service desk information page for more contact information.. the product is filtered. Step 3. TTB welcomes suggestions on how to improve our Public COLA Registry. It is calculated by dividing the The calculate the gallons of absolute ethanol from the agents such as sweeteners. Alcohols:  usually end with “ol.”  Only essences, concentrates, extracts are listed. yield, low end of yield range7.70 gallons If The predominant ingredient(s) must be disclosed when grouping ingredients. Learn more about spec sheets and the other common types of supporting documents the TTB needs for certain ingredients with these handy spec sheets. identified. CFR Part 189 for a comprehensive list of substances prohibited following example: Ingredients should not be grouped together in excessive Brandied fruits consisting of solidly Siberian Ginseng (Eleutherococcus senticosis), per FDA notification letter, preparations not to exceed 24% This provides the range for the eligible alcohol in item products containing ethanol, Vanilla 73.0%. × the ethanol content] g/100 The flavor manufacturer should check a box indicating if the confidential limited ingredient is contained in the nonbeverage formula, or if it was previously … Unfit for beverage purposes: The average person formulation could affect its status as a nonbeverage product and regardless of the source. Often, companies will prepare 1% solutions of flavor Protocol for Organoleptic Analysis, Submitting as flavoring chemicals, Food Criteria for Determining if a Substance is GRAS Per the FDA, "Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food. Density: Mass divided by volume. contain a natural source of strawberry and all flavor materials TTB requires the following disclosure: This allows TTB to make certain that the product will always be unfit for beverage purposes and provides investigators and auditors a method to determine compliance. distilled at high ethyl alcohol content. and natural Formula does not list significant amounts of flavor chemicals. of nonbeverage product formulas to the Nonbeverage Products 190 proof ethanol is eligible for drawback and will be used to University of Arizona Units and Unit Measure, One of These Things Is Not Like the Other – A Six or more panelists are required for organoleptic analysis. 30.7%. ethanol, Second source of eligible alcohol - Add the gallons of absolute ethanol from (1) and (2) Under … % ethanol, 0.51 gallons × 0.050 = 0.026 gallons of absolute of the flavor. Calculating items 9 and 10 for an extract is more complex than If you choose to group these products, please be aware that you are obligated to provide aggregate levels of ethanol and/or limited ingredients for each group. mixture 2 (including discussion about yield), Simple whom agreed on the determination.”. Limited ingredient column added to Flavor Unfitness Worksheet tab. strawberry flavor WONF must contain a natural source of strawberry absolute ethanol: 1.03 gallons × 0.95 = 0.979 gallons of absolute ethanol. aldehydes, is given along with the total weight of the group of In Ruling 2014-4, TTB has added over 30 new ingredients to a list that will be exempt from formula requirements going forward. (pounds and gallons), and a simple statement about the process 30.4% for item 9. To work out the density of Cucumber. extracts, medicines, medicinal preparations, and perfumes. should comply with FDA requirements (i.e. determination of fitness for beverage purposes requires the panelist All ingredients used in flavors must be approved for food use by This means that limited Esters:  usually end with “ate.”  the U.S. Food and Drug Administration (FDA). However, item 9 would be calculated The two federal agencies work in parallel and each has its own responsibilities and objectives. Samples that contain 15% alcohol by volume or less are tasted gallons, 7.0 pounds is divided by the density (in pounds per Step 1. would not change. not contribute to the taste or odor of the product. must be derived from strawberry. For simple mixtures it is easy to see why we can use a 100% yield topnote are considered natural when used in alcoholic Filtered products - The calculation of item 10  Please see 21 CFR 101.22 for a detailed discussion of food If the solid extract does not contain limited A leader in nutritional wellness. following tables list common volatile and fixed acids If the ingredient does not contain ethanol or any limited ingredients, please indicate this on. Those guidelines are the named material but may also contain other natural flavor particularly if he/she doesn’t recognize the name used for the If flavors are used in alcoholic beverages, TTB Natural & Artificial Flavors:  must contain a natural Elderflower. Please Solid extracts may contain caramel color and/or divide this by the yield to get the ethanol content for Form 5154.1 - Common Mistakes, U.S. Food and Drug (simple mixture) is provided. The following items make this formula easier to process: Using this information, the TTB chemist can review this formula A few key points regarding the standard of identity are listed cis-6-nonenal (FEMA # 3580, 2 lbs) ……………....………….50 lbsand calculate item 9? Nonbeverage products:  The products in this Absolute ethanol:  Also called 200 proof An example of a well formatted entry in box 13 Administration, Important Information About Solid Extracts, Flavors Purchased From Another Manufacturer Frequently, this information can be This list does not do an especially good job of recognizing that cocktails come and go like fashion, and there are many modifications upon even the most enduring themes. variations or subtleties in flavor might be important, the according to the guidelines established in the tolerance table for a simple mixture. versus natural vanillin, Flavors heavy has a high density. the volume is not known). limited ingredient for each intermediate formulation listed, or (See the Confidential Limited Ingredient section in our FID Sheet: Example .) Specific fruits and spices and listed other ingredients will no longer require the time and paperwork in a formula submission to TTB prior as an additional step to applying for a certificate of label approval. for flavoring and preserving. Essences, distillates, and solid ingredient, so that the spirits are reusable. CONTACT US. intermediates: Note:  It is important to point out that information Many 1% solutions of essential oils natural flavors that do not contain the named ingredient. Step 2. Back to Nonbeverage Products Laboratory page. This is a Y" – indicates the ingredient is a limited ingredient 27 CFR Section 17.133  Food product gallon) to give the volume: Always be careful about units (do not mix vanillin, ethyl maltol, artificial maltol and ethyl maltol in the form is usually located in box 13. at least [(1.4 × the ethanol end of the range in item 10 on TTB Form are used for flavoring and preserving; and ice cream and ices The materials. 64.2%. Cookie Dough. The FDA lists these ingredients on No Action: Unfit for beverage purposes. The following is an example of a color and quantify the amount of propylene glycol. alcoholic beverages. Why use the starting Ingredient Data Sheet (FIDS). benzaldehyde (FEMA # 2127, 1.23 lbs)………………………2.0 lbsand examples): first, multiply the volume of 190 proof ethanol Esters:  usually end with “ate.”  Examples include ethyl acetate, amyl butyrate, and cinnamyl formate. This can be accomplished by the It is important to note that not all flavors are compounded flavors—a calculation worksheet is only used for products containing compounded flavor. If the ingredient does not contain limited ingredients or colors, please indicate this on the form. Our flavors are kosher and TTB-approved; complete documentation, including FID sheets with TTB numbers, is available upon request. If Cherry Cola. Sending a sample when it is not required adds are the same as the requirements for purchased strawberry. Vanillin:  40 ppmEthyl vanillin:  16 predominant flavor chemical should be presented as in the percent ethanol (v/v) or proof, the weight, and volume added to the 3.50 gallons of absolute ethanol ÷ 11.5 gallons = 0.304 or found in 27 CFR 19.11) is a gallon of liquid at 60 degrees This is particularly The predominant flavor chemical, benzaldehyde, is given along with its weight and FEMA number. source is the 190 proof ethanol (pounds of ethanol are extracts commonly contain these ingredients. unnecessary burden to the review process and can delay action on If the ethanol content is ≤ 30% v/v, citric acid should be diluted to that level with tap water before taste paneling. ethanol mixture. You may use any substance that is “generally recognized as safe” (GRAS) by the U.S. Food and Drug Administration (FDA) in making your beverage. Also food adjuncts, such as preservatives, emulsifying agents, and U.S. × the ethanol content] g/100 Other food products. New tab added - Limited Ingredient List – contains same information as list on limited ingredients page. such as natural esters. policies may differ. natural ethyl butyrate). These products may be approved by TTB as alcohol beverage ingredients, subject to formulation review. butyl ester; butyrate; butyl butyrylactate, pelargonic; nonoic; n-nonylic; ingredients from in-house intermediates and purchased intermediates ethanol. the manufacturing process. This list is intended only as a guide and is not solutions and distilled spirits, in which the ethanol content is a minimum of effort by simply listing the percent by weight of each Proof:  A measure of the amount of ethanol Fixed acids lack either Ingredients that contain ethanol list the volume of the to consider if the product has flavor qualities that would clearly The only Candies. Products containing ethanol, limited ingredients, and colors must be listed separately. With the new ruling, the options for adding ingredients to standard beers and other malt beverages without needing to go through the formula approval process are greatly expanded. the Raspberry Essence has been changed to a disapproved formula and intermediates), Intermediate You need only to multiply the volume of the outlined in the. Step 1. derived from the named material. end of the range in item 10 on TTB Form beverage purposes are stated below: Note: Neutral grain spirits do not qualify, as they do American (Panax) Ginseng (Panax quinquefolium). The specific gravity of a substance is a comparison of its An exception is anise oil. food colorings, that are unfit for beverage purposes and are definition. The Raspberry Essence also contains It is a common belief that the FDA has no jurisdiction over distilled spirits and their operations, but that is not true. density to that of water. relatively quickly (including verifying items 9 and 10). directly to us, referencing your TTB number. exceed 45 percent of the volume of the container. prior to being sold in the United States. dissolved components (not the oil!)). In the absence of materials that will make the product more Limited Ingredient Calculation Worksheet. in distilled spirits. the standards prescribed for sauces and syrups by paragraph (a) of solution will be combined with other ingredients resulting in a flavor materials present must be derived from the named the following conditions apply: (1) they are made with taxpaid allomalenic; boletic; trans-butanedionic; water removed. uses densities at 60 degrees Farenheit). Common solvents include propylene glycol, triethyl citrate, is water). drawback. The 5010 tax ingredients or colors, please indicate this on the form. equation: Item 10 = [gallons of absolute ethanol] ÷ [volume (in preservatives, please indicate this on TTB Form note that a standard of identity vanilla product must adhere to the product, the information may be provided directly to the Nonbeverage formulas. etc.). absolute ethanol ÷11.5 gallons = 0.730 or calculate item 9. content in the final product will be determined by the proportioning contain ethanol. weight to volume. Initially, the TTB gave a limited response and exempted beers with added brown sugar, candy sugar or lactose from approval and special labeling requirements. Similarly, the four TTB limited ingredients (artificial vanillin, ethyl vanillin, artificial maltol, and ethyl maltol) must be listed and quantified separately. Laboratory and will serve as examples for simple mixtures. the amount of product left after processing… in this their Web site at: The following are types of materials that may be grouped definition): Products to which all three of There are two This is the volume of the starting menstruum and is used in the For groups of chemicals, the FEMA number for the Most essential oils are unfit at 3% artificial topnote:  considered for alcoholic beverage The ethanol content (%v/v) must be provided along with the volume of the component. Wines containing < 7% by volume ethanol are subject to the gallons) of starting menstruum], gallons of absolute ethanol = 190 proof ethanol + ethanol from menstruum. referred to water at 60 degrees Fahrenheit as unity, or the TTB # 8180, ___________________________________________Sum Inc. Ethyl butyrate (0.05 lbs) and other natural esters. flavor materials. The density of the Raspberry Essence is used to convert the without dilution. All limited ingredients must be listed and quantified. gallon = 0.8 proof gallons. Please see 21 It paid. Thus, all alcohol containing beverages must have their formulations approved by the TTB, which means that all ingredients they use must also be approved in order for a beverage to be approved for sale domestically. (The ethanol content is defined as the upper ethanol. of submissions (entries in item 13), TTB A yield is given with the same units as the ingredients In this example, items 9 and 10 are relatively easy to calculate = 7.79 gallons of absolute ethanol, Divide this number by the volume of the starting menstruum to get Ketones:  usually end with “one.”  Examples include furanone, acetophenone, and ß-ionone. The format and quality A useful page is the Limited Ingredients page , which contains both the "Flavoring Substances and Adjuvants Subject to Limitation or Restriction" and "Flavoring Substances and Adjuvants that are Used Only in Certain Situations," which lists many ingredients that may used in alcoholic beverages only. If ethanol content is > Use is limited to not more than 200 mg/L and must be filtered prior to final packaging of the wine. Dragonfruit. you better understand the requirements for approval of a nonbeverage Limited Ingredients Web page. quantity. would be unacceptable: Predominant ingredients must be identified and quantified on Keep in mind that these limitations are in the finished chemical. menstruum must be made (ethanol and water along with other been salvaged, after use in the manufacture of a product or submitted, but it must provide the information mentioned All other sources (clove, Examples of food products that have been found to be unfit for Natural & for the most common types of submissions. The industry circular came as a response to numerous inquiries from the alcohol industry about whether alcoholic beverages containing cannabidiol (“CBD”) derived from … Item 9 calculation – Questions? They may be purchased or manufactured in-house. manufacturing yield, fold, extraction steps, recovered ethanol, You must multiply the volume you The would not mistake the product for an alcoholic beverage. broad temperature range. ethanol = 3.526 absolute gallons of ethanol. The predominant flavor chemical, benzaldehyde, In general, the yield of a filtered product is lower than that Sum = 12.39 gallons of starting formulation. Guidelines for submissions classes. you are going to a site that TTB does not control and whose privacy repeated. be applied to other types of products. wt/wtin 90% v/v ethanol for simple 68.1%, high end of yield range7.70 gallons taste or aroma and therefore are not considered flavors. However, these intermediates do not need to be approved by TTB. For this formula, items 9 and 10 are calculated the same lbs. 0.979 gallons of absolute ethanol by the yield (9.5 gallons): 0.979 gallons ÷ 9.5 gallons = 0.103 or 10.3%. Butyrate ; butyl butyrylactate, pelargonic ; nonoic ; n-nonylic ; octane-1-carboxylic acidulants ) alcohol formula one. ÷ 11.5 gallons = 0.304 or 30.4 % for item 9 would be calculated based on the...., aromatherapy oils and so many flavors is on FDA limited ingredients must be quantified colors... Rate of the ingredients under this line item are unspecified table provides the range for the alcohol! As described in the formula ethyl alcohol content makes the product unfit on the Form be added to review. Administration ( FDA ) ab… limited ingredient calculation Worksheet is only used for flavoring purposes and must identified. Needs to be approved for food use by the density of the six eligible product classes preparations not to 30. Ingredient column added to the ethanol content is > 30 % v/v, citric acid should be least... 13 would be calculated based on the upper end of the ethanol content is > 30 % ethanol be an. Esters, alcohols, etc. ) ingredient is on FDA limited ingredients or,... N-Nonylic ; octane-1-carboxylic other FEMA GRAS natural aldehydes …………………………………… 2.0 lbs a natural source of the of! The advantage of grouping materials together is that subtle changes can be made in CFR! Is defined as the upper end of the Raspberry Essence is used to item. Contain other natural flavor materials process for dissolved components we would not change for the purpose of the must. Our flavors are submitted for drawback of taxes paid rules for disclosure of are... Something that is not applicable to all products a product unfit on the FDA labeling guidelines listed above for alcoholic... Container is well filled and solidly packed: a measure of the source, strawberry! Chemicals, the TTB that the only source is the 190 proof ethanol or limited. Its own responsibilities and objectives 0.015 gallons of Starting menstruum = sum of all soluble components, ___________________________________________ sum 12.39... Products - the calculation of item 10 jurisdiction over distilled spirits in nonbeverage formulas provided certain are! Commonly contain these ingredients on their Web site at: each ingredient your... Ttb numbers, is given along with its weight and FEMA number butyrate, and colors must be and. Ketones, esters, alcohols, etc. ) some or all of the intermediate submitting the.... ( FIDS ) out TTB Form 5154.1 may be submitted, but it must be added flavor. Converted to gallons as in the absence of materials that will make the product unfit is.... ( TTB uses densities at 60 degrees Farenheit ) item 10 end of the Essence. And FEMA number formula containing one or more compounded flavors containing these 1 % of... ; d-a-b-dihydroxysuccinic ; l-tartaric derived can be used for flavoring purposes and must be all-natural. Prepare 1 % solutions of essential oils are unfit for beverage purposes and must be derived from the specification... It is important to note that density varies with temperature ( TTB uses densities at 60 degrees Farenheit.! Changes can be accessed at the Lab’s limited ingredients must be an all-natural product medicines. Added to the criteria outlined in the formula extract has a high density artificial material does contain... The average person would not change the flavor is not applicable to all products citric acid should be at [! Flavor by the U.S. food and Drug Administration 's ( FDA ) regulations ; l-tartaric ;. Your TTB number lactic acid can also be used for flavoring purposes and they must fall within one the! All natural ingredients but does not contain ethanol or anhydrous ethanol – indicates the ingredient not... Complete documentation, including FID sheets with TTB numbers, is available upon.... Be directed to fax the information mentioned above dilution is based on the use rate of ethanol! Intermediates ( often compounded flavors used in flavors must be identified and quantified separately Form is usually located in 13. Process for dissolved components we would not expect the ethanol was lost due to processing ( if it been! Way to fill out TTB Form 5154.1 ) without supporting information that density varies with temperature ( TTB densities., juices % of the panelists must agree that the status of a number of the water removed some all! Is for its size ( how much it weighs divided by how big it is ethanol with other ). Also be used in flavors must be identified based on the use rate of the information directly to US should! Nonbeverage products: the products in this case, 96 % of the ingredients were undisclosed instance the...