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Food Allergen Labeling: New Guidance for Exemption

In June 2015, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) issued a guidance document which describes data requirements for petitions and notifications seeking exemption from labeling for the major food allergens (FDA, 2015a). The purpose of this article is to inform readers about the main points covered in the guidance document, to help them submit the correct document with the necessary steps completed. Although FDA guidance documents “do not establish legally enforceable responsibilities”, the FDA expects recommendations in these documents to be followed, as the FDA often refers to guidance documents when disallowing claims or issuing warning letters.

The guidance begins by providing the statutory definition of a major food allergen as “milk, egg, fish (e.g. bass, flounder or cod), Crustacean shellfish (e.g. crab, lobster or shrimp), tree nuts (e.g. almonds, pecans or walnuts), wheat, peanuts and soybeans” or a food ingredient that contains protein derived from these foods. The definition excludes any refined oil derived from a major food allergen and any ingredient derived from such highly refined oil. The FDA provides two mechanisms by which ingredients derived from major food allergens can be exempted from allergen labeling. If the producer provides evidence that an ingredient derived from a major food allergen is altered to the extent that it does not contain allergenic protein, the ingredient may become exempt from allergen labeling through submission and approval of a notification. If the producer cannot show that the allergenic protein is removed, but can show that the level of allergenic protein in the finished food does not cause an allergic response that poses a risk to human health, submission and approval of a petition for an exemption from allergen labeling is recommended unless there has been a previous determination through a premarket approval process that the ingredient does not cause an allergic response that poses a risk to human health.

Rather than focusing on the differences between notifications and petitions, the guidance stresses requirements that are germane to both documents. Either type of submission should provide a complete description of the ingredient including the common and scientific name, major food allergen source, chemical and biological properties, existing food standards (e.g. FDA, Food Chemicals Codex, Codex Alimentarius), composition (including methods of analysis, particularly for the proteins or peptides in the ingredient), the amount and molecular characteristics of allergenic protein or peptides, and batch to batch variation. For ingredients that are or contain peptide fragments, information about the distribution of peptide fragment sizes (and whether they are large enough to be immunologically relevant) should be provided. If the ingredient contains more