Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages
MFAL 1: Does TTB require allergen labeling for alcohol beverages?
A: Current regulations under the Federal Alcohol Administration Act (FAA Act) do not require the disclosure of major food allergens on alcohol beverage labels. However, TTB has issued a notice of proposed rulemaking, Notice No. 62, 71 FR 42329, which proposes to make the labeling of major food allergens mandatory. In addition, we have published an interim rule, T.D. TTB-53, 71 FR 42260, which sets forth standards for optional allergen labeling statements.
MFAL 2: When did the interim rule go into effect?
A: The interim rule went into effect on July 26, 2006.
MFAL 3: How does the interim rule affect current alcohol beverage labels?
A: Under the interim rule, producers, bottlers, and importers may declare the presence of major food allergens in their products, but are not required to do so. However, if an industry member chooses to undertake any allergen labeling, the label must comply with the labeling standards specified in the interim rule.
MFAL 4: What are the standards for major food allergen declarations under the interim rule?
A: An allergen declaration must consist of the word “Contains” followed by a colon and the name of the food source from which each major food allergen is derived. For example, a declaration could be “Contains: milk and egg.” If any one major food allergen is declared, all major food allergens used in the production of the alcohol beverage, including major food allergens used as fining or processing agents, must be listed.
MFAL 5: What are the major food allergens?
A: Consistent with the provisions of the Food Allergen Labeling and Consumer Protection Act of 2004, FALCPA, the interim rule defines a “major food allergen” to mean any of the following: milk, egg, fish (for example, bass, flounder, or cod), Crustacean shellfish (for example, crab, lobster, or shrimp), tree nuts (for example, almonds, pecans, or walnuts), wheat, peanuts and soybeans, as well as any food ingredient that contains protein derived from one of these food sources.
MFAL 6: What if the food ingredient used in the alcohol beverage product has already been exempted from allergen labeling requirements by the Food and Drug Administration (FDA)?
A: For purposes of TTB’s labeling provisions, a food ingredient is not considered to be a major food allergen if it is exempt from major food allergen labeling requirements pursuant to a petition for exemption approved by FDA under 21 U.S.C. 343(w)(6) or pursuant to a notice submitted to FDA under 21 U.S.C. 343(w)(7), provided that the food ingredient meets the terms or conditions, if any, specified for that FDA exemption.
MFAL 7: Are there any other exceptions to the definition of a major food allergen?
A: Yes. Consistent with FALCPA, highly refined oils derived from the food sources specified in the rule, as well as ingredients derived from such highly refined oils, do not fall within the definition of a major food allergen. Furthermore, any food ingredient may be exempted from the labeling requirements pursuant to a petition for exemption approved by TTB.
MFAL 8: How should major food allergens be listed on an alcohol beverage label?
A: In the case of a tree nut, the name must be listed as the specific type of nut (for example, almonds, pecans, or walnuts). In the case of Crustacean shellfish, the name must be listed as the species of Crustacean shellfish (for example, crab, lobster, or shrimp). In the case of fish, the species is not listed; the allergen is listed simply as “fish.” The terms “egg” and “peanuts”, as well as the names of the different types of tree nuts, may be expressed in either the singular or plural form. Furthermore, the term “soy,” “soybean,” or “soya” may be used instead of “soybeans.”
MFAL 9: Are there any formatting or placement requirements for adding major food allergen information to my product labels?
A: This additional information may be placed on any label affixed to the container. A major food allergen declaration should be readily legible under ordinary conditions and on a contrasting background.
MFAL 10: If I want to voluntarily declare major food allergens on my label, do I need to submit a new application for label approval?
A: Yes, you must submit an application for a new certificate of label approval if you wish to add this information to your product labels. The label must comply with the requirements of the interim rule. Approval of labels in compliance with the interim rule will be qualified as follows:
The disclosure of major food allergens used in producing this beverage is optional, pending final rulemaking. See T.D. TTB-53 and Notice No. 62. However, any reference made to allergens must declare all major food allergens used in the production of this beverage, including fining or processing agents.
MFAL 11: I use eggs as a fining agent in making wine; however, I do not believe that egg protein is present in the finished product. If I choose to list major food allergens on my label, am I required to include eggs?
A: If you choose to list major food allergens on a wine label, you must include all major food allergens used in the production of the wine, including fining or processing agents, unless TTB has approved a petition for exemption that covers this ingredient.
MFAL 12: What should a petition for exemption include?
A: Any person may petition TTB to exempt a particular product or class of products from the labeling requirements of the interim rule. The burden is on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that the finished product or class of products, as derived by the method specified in the petition, either: (1) does not cause an allergic response that poses a risk to human health; or (2) does not contain allergenic protein derived from milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, or soybeans, even though a major food allergen was used in production.
MFAL 13: How do I submit a petition for exemption to TTB?
A: The petition should be submitted in writing to:
Assistant Administrator, Headquarters Operations
Attn: Petition for Exemption from Major Food Allergen Labeling
Alcohol and Tobacco Tax and Trade Bureau
1310 G Street, N.W., Suite 200E
Washington DC 20220
MFAL 14: How soon will TTB act on petitions for exemption?
A: TTB will approve or deny a petition in writing within 180 days of receipt. If TTB does not provide a written response within the 180-day period, the petition will be deemed denied, unless an extension of time for decision is mutually agreed upon by the appropriate TTB officer and the petitioner.
MFAL 15: Will petitions for exemption automatically be treated as confidential?
A: No. TTB will post on its Web site all petitions received as well as TTB’s response to those petitions. Any information submitted in support of the petition that is not posted to the TTB Web site will be available to the public under the Freedom of Information Act, except where a request for confidential treatment is granted. A person who provides trade secrets or other confidential commercial or financial information in connection with a petition for exemption must request confidential treatment at the time the information is submitted. The standards for according confidential treatment to such information are set forth in the interim rule.
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