Formulation

Pre-COLA Product Evaluation

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For many alcohol beverage products, TTB requires a product evaluation to determine whether a proposed label identifies the product in an adequate and non-misleading way. We refer to this requirement as a Pre-COLA Product Evaluation.

Pre-COLA product evaluation entails a review of a product’s ingredients and formulation and also may include a laboratory analysis of the product. Lab analysis involves a chemical analysis of a product.

Pre-COLA product evaluations ensure that:

  • No alcohol beverage contains a prohibited ingredient.
  • Limited ingredients are used within prescribed limitations or restrictions.
  • Appropriate tax and product classifications are made.
  • Alcohol beverages labeled without a sulfite declaration contain less than 10 parts per million (ppm) of sulfur dioxide.

The type of pre-COLA product evaluation required for a particular product depends on that product’s formulation and origin. TTB regulations require formulas most commonly when flavoring or coloring materials are added.

Field investigations can be used to verify the accuracy of these documents. Since TTB does not have access to foreign plants, some imported products are subject to laboratory analysis or pre-import letter approval.

List of Products Requiring Pre-COLA Evaluation

TTB maintains a list of the pre-COLA evaluations required for specific products or product categories. The list is divided into three commodity-specific charts-one each for wine, distilled spirits, and malt beverages.

The commodity-based charts reflect the current pre-COLA evaluation requirements for the listed products. Please be advised that, because the type of pre-COLA product evaluation required for a particular type of product may change, it is important to visit the TTB Web site for the most current information. In addition, the charts are provided as general guidance. Particular circumstances may dictate the need for a pre-COLA product evaluation for a specific product even though no such requirement is listed in the charts.

If a pre-COLA product evaluation is required for a particular product, you must include a copy of the pre-COLA product evaluation when submitting your COLA application for the alcohol beverage product.

CHANGES SINCE INDUSTRY CIRCULAR 2002-2

Statements of Process for Malt beverages

Industry Circular 2002–2 described the pre-COLA evaluation for domestic malt beverage products under the heading "Statement of Process." On January 3, 2005, TTB published TTB TD-21, "Flavored Malt Beverages and Related Regulatory Amendments", which, among other regulatory changes, replaced the statement of process requirements for malt beverage products with formula requirements. Due to that change, information pertaining to pre-COLA evaluations of domestic malt beverage products and sake (rice wine) is now included below under the heading "Formula".

Voluntary Use of Form TTB F 5100.51

TTB has developed a new form that may be submitted in lieu of the prescribed forms and formats for formulas, pre-import letters, and products for laboratory analysis. TTB developed the form, TTB F 5100.51, "Formula and Process for Domestic and Imported Alcohol Beverages," to simplify the formula submission process and to provide a more consistent means of information collection across all commodity areas for both import and domestic products. The Formulas and Process for Domestic and Imported Alcohol Beverages may now be submitted electronically through Formulas Online.

TTB intends to pursue a regulatory change that will make use of this form mandatory, entirely replacing the various industry-specific forms and formats currently appearing in the TTB regulations. Until such a change occurs, this form may be used voluntarily as an alternate procedure authorized under the applicable alternate method or procedure provision in 27 CFR 19.62, 24.22, 25.52, 26.331, or 27.221. A producer or importer who wishes to use TTB F 5100.51 or Formulas Online may submit that form in lieu of the prescribed forms and formats listed below without first requesting approval from TTB to do so.

TYPES OF PRE-COLA PRODUCT EVALUATIONS

There are four (4) types of pre-COLA product evaluations. Please read each of the sections to find out which relates to your product:

Formula | Pre-Import Letter | Laboratory Analysis | Sulfite Anaysis

 

 

1. Formula

This type of pre-COLA evaluation applies to domestically produced wine, distilled spirits, and malt beverages and for such products manufactured in Puerto Rico or the Virgin Islands and shipped to the United States.

  • For domestically produced wine and for wine shipped from Puerto Rico or the Virgin Islands, a formula must be submitted on TTB F 5120.29, except when the new TTB F 5100.51, which may now be submitted electronically through Formulas Online is submitted as an alternative (see "CHANGES SINCE INDUSTRY CIRCULAR 2002–2" above).
  • For domestically produced distilled spirits and for distilled spirits shipped from Puerto Rico or the Virgin Islands, a formula must be submitted on TTB F 5110.38, except when the new TTB F 5100.51, which may now be submitted electronically through Formulas Online is submitted as an alternative (see "CHANGES SINCE INDUSTRY CIRCULAR 2002–2" above).
  • Formulas for malt beverage and sake (rice wine) products may be submitted on the new TTB F 5100.51, which may now be submitted electronically through Formulas Online.
  • Each formula must include a detailed and specific quantitative list of each and every ingredient in the product, and a detailed description of the entire production process. At a minimum it must include:
    • Information on the agricultural source of alcohol for any distilled spirits used in the product;
    • The percentage of alcohol by volume/proof at distillation of any distilled spirits used in the product;
    • Identification and source of any flavoring material used in the product;
    • A specific description of when flavoring material is added in the production of the product; and
    • The total volume and alcohol content of the finished product.
  • For malt beverages, a formula must also include, at a minimum:
    • Alcohol content: The alcohol content of the fermented product after fermentation and the alcohol content of the finished product.
    • Beer base formulas: Information on any approved formula number that covers the production of any beer base used in producing the formula product. If the beer base was produced by another brewery of the same ownership, the formula must include the name and address or name and registry number of that brewery.
    • Ingredient information for fermented products that include the use of flavorings, which must include:
      1. The name of any flavor;
      2. The product number or TTB drawback number and approval date of the flavor;
      3. The name and location (city and State) of the flavor manufacturer;
      4. The alcohol content of the flavor; and
      5. The point at which the flavor was added (that is, before, during, or after fermentation).
    • Ingredient information for formulas of malt beverages that include the use of flavors and other nonbeverage ingredients containing alcohol, which must include:
      1. The volume and alcohol content of the beer base;
      2. The maximum volumes of the flavors and/or other nonbeverage ingredients containing alcohol to be used;
      3. The alcoholic strength of the flavors and other nonbeverage ingredients containing alcohol;
      4. The overall alcohol contribution to the finished product provided by the addition of any flavors or other nonbeverage ingredients containing alcohol; and
      5. The final volume and alcohol content of the finished product.
  • Two (2) copies of each formula must be submitted to the TTB Advertising, Labeling, and Formulation Division at the address shown below.
  • To facilitate the processing of formulas, you may wish to verify the following facts prior to submitting your formula:
    • There is no conflict between the list of ingredients and the method of manufacture;
    • The submission lists the proof of distillation (proof of the alcohol after it comes off of the still before any water is added) for any distilled spirit contained in the product;
    • Any products requiring special consideration are accompanied by background information, such as Generally Recognized as Safe (GRAS) approvals from the U.S. Food and Drug Administration or further technical documentation, and the like, as needed; and
    • Any product for which there are special class and type designation requirements (for example, liqueurs must contain at least 2.5 percent sugar by weight in the final product) are accompanied by all necessary class and type information.

2. Pre-Import Letter

This type of pre-COLA evaluation applies to imported wine, distilled spirits, and malt beverage products. This does not include such products manufactured in Puerto Rico or the U.S. Virgin Islands and shipped to the United States.

  • An importer must submit a formula on either the producer’s letterhead or the new TTB F 5100.51, which may now be submitted electronically through Formulas Online. (see "CHANGES SINCE INDUSTRY CIRCULAR 2002–2" above), in English or accompanied by an English translation.
  • The formula must include a detailed and specific quantitative list of each and every ingredient in the product and a step-by-step description of the production process. At a minimum it must include:
    • Information on the agricultural source of alcohol for any distilled spirits used in the product;
    • The percentage of alcohol by volume/proof at distillation of any distilled spirits used in the product;
    • Identification and source of any flavoring material used in the product;
    • A specific description of when flavoring material is added in the production of the product; and
    • The total volume and alcohol content of the finished product.
  • For malt beverages, a formula must also include, at a minimum:
    • Alcohol content: The alcohol content of the fermented product after fermentation and the alcohol content of the finished product.
    • Beer base formulas: Information on any approved formula number that covers the production of any beer base used in producing the formula product. If the beer base was produced by another brewery of the same ownership, the formula must include the name and address or name and registry number of that brewery.
    • Ingredient information for fermented products that include the use of flavorings, which must include:
      1. The name of any flavor;
      2. The product number or TTB drawback number and approval date of the flavor;
      3. The name and location (city and State) of the flavor manufacturer;
      4. The alcohol content of the flavor; and
      5. The point at which the flavor was added (that is, before, during, or after fermentation).
    • Ingredient information for formulas of malt beverages that include the use of flavors and other nonbeverage ingredients containing alcohol, which must include:
      1. The volume and alcohol content of the beer base;
      2. The maximum volumes of the flavors and/or other nonbeverage ingredients containing alcohol to be used;
      3. The alcoholic strength of the flavors and other nonbeverage ingredients containing alcohol;
      4. The overall alcohol contribution to the finished product provided by the addition of any flavors or other nonbeverage ingredients containing alcohol; and
      5. The final volume and alcohol content of the finished product.
  • Two (2) copies of each statement of production must be submitted to the TTB Advertising, Labeling, and Formulation Division at the address shown below, along with a transmittal letter identifying the importer and requesting a pre-COLA product evaluation.

3. Laboratory Analysis

TTB must perform a product evaluation of certain imported alcohol beverage products before issuing a Certificate of Label Approval (COLA). Since TTB does not have access to foreign production plants, some imported products are subject to either laboratory analysis or a pre-import letter approval. The Industry Circular, titled "Pre-COLA Product Evaluation" (2007-4), lists all imported alcohol beverage products that require laboratory analysis. An alcohol beverage importer in the United States who has been issued an import permit by TTB, and wants to import alcohol beverages that require laboratory analysis must submit the following to the laboratory:

  • A 750-ml sample of the product.
  • A list of ingredients of the product submitted on the official letterhead of the manufacturer, signed, and dated (if in a foreign language, submit the original along with a copy of the English translation). Please note that a report of chemical analysis for a product is not a substitute for a "list of ingredients." The "list of ingredients" is a list of the materials used to manufacture the product (e.g., agricultural source of alcohol, additives, colors, herbs, and spices, etc.).
  • A description of the manufacturing method of the product submitted on the manufacturer's official letterhead, signed, and dated (if in a foreign language, submit the original along with a copy of the English translation).
  • The BAL is now accepting TTB F 5100.51 with pre-COLA sample submissions. However, a list of the ingredients and the method of manufacturing on the producer's official letterhead is still required to accompany the submission. This form may now be submitted electronically through Formulas Online.
  • A copy of the TTB-issued Basic Importers Permit is required for first-time importers.
  • Submit all pre-import samples along with documentation to: National Laboratory Center, Beverage Alcohol Laboratory, 6000 Ammendale Road, Beltsville, MD 20705.

The Beverage Alcohol Laboratory sends a letter to the importer confirming receipt of the sample. Incomplete or incorrect submissions will be returned for further information from the importer, which may delay the sample analysis. Analysis may take up to 30 calendar days from the date of receipt of all complete/correct documents. Upon completion of the analysis, the Laboratory sends a report to the Advertising, Labeling and Formulation Division (ALFD) for further processing.

4. Sulfite Analysis

This type of pre-COLA product evaluation requires submission of a product sample. TTB will also accept the results of a sulfite analysis conducted by a TTB-certified laboratory. A listing of laboratories certified by TTB is available on the web or by contacting the TTB Compliance Laboratory.
Samples submitted for sulfite analysis must be:

  • At least 750 ml volume.
  • Identified with its vintage, batch or lot, and class and/or type designation (e.g., cabernet sauvignon, white wine).
  • Accompanied by a transmittal letter requesting a sulfite analysis that identifies the submitter and the name and address of the company to which the analytical results should be sent.
  • Sent to the TTB Compliance Laboratory if the sample is of a domestic product. For a sulfite analysis of an imported product, submit the sample to the TTB National Laboratory Center.

This type of pre-COLA product evaluation requires submission of a product sample. TTB will also accept the results of a sulfite analysis conducted by a TTB-certified laboratory. A listing of laboratories certified by TTB is available on the web or by contacting the TTB Compliance Laboratory.

CONTACT INFORMATION

You may direct questions on pre-COLA product evaluations and submit Formulas and Pre-Import letters to the TTB Advertising, Labeling and Formulation Division (ALFD). An ALFD Customer Service Specialist can be reached by:

Mail:

Alcohol and Tobacco Tax and Trade Bureau
Advertising, Labeling, and Formulation Division
1310 G Street, NW., Box 12
Washington, DC 20005

Phone:

(202) 453-2250 or (866) 927-2533 (toll free number)

Choose:

Option #1 for our address, fax number and hours of operation
Option #2 for technical questions regarding COLAs Online andfor COLAs Online password reset
Option #3 for questions regarding COLAs Online registrations
Option #4 for questions regarding statements of process,formulas, pre-import letters, malt beverage labels and distilled spirits labels
Option #5 for questions regarding alcohol advertising
Option #6 for questions regarding wine labeling or the status of your wine label application

E-mail:

alfd@ttb.gov

For laboratory analysis (domestic and imported products) and sulfite analysis (imported products only), submit samples to:

Mail:

Alcohol and Tobacco Tax and Trade Bureau
National Laboratory Center
Beverage Alcohol Laboratory
6000 Ammendale Road
Beltsville, MD 20705

Phone:

(240) 264-1665

E-mail:

laboratory@ttb.gov

For sulfite analysis (domestic products only), send samples to:

Mail:

Alcohol and Tobacco Tax and Trade Bureau
Compliance Laboratory
490 North Wiget Lane
Walnut Creek, CA 94598

Phone:

(925) 280-3625

Note: All forms used for pre-COLA product evaluation and for COLA submissions may be downloaded from the Forms page on the TTB Web site at http://www.ttb.gov/forms/5000.shtml.

Page last reviewed/updated: 09/03/2013

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