On May 16, U.S. Food and Drug Administration (FDA) released the Sec. 555.250 Major Food Allergen Labeling and Cross-contact Draft Compliance Policy Guide (hereinafter the CPG), involving the labeling requirements for major food allergens, voluntary allergen information on food products, and control measures to prevent or minimize allergen cross-contact.

Stakeholders can submit their comments by July 17. After approved, CPG will replace the existing CPG 555.250 for implementation.

Labeling Requirements for Major Food Allergens

Currently, a major food allergen as any of the following:

• Milk

• Egg

• Fish (e.g., bass, flounder, and cod)

• Crustacean shellfish (e.g., crab, lobster, and shrimp)

• Tree nuts (e.g., almonds, pecans, and walnuts)

• Wheat

• Peanuts

• Soybeans

• Sesame

According to the proposed revision, major food allergens used as ingredients in packaged foods must be declared either in the ingredient list or the "Contains" statement. Besides, the allergen labeling shall be marked by the name of the food source, which brings the major food allergens. It means the name described in section 201(qq)(1) of the FD&C Act (21 U.S.C. 321(qq)(1)).

Voluntary Allergen Information

Allergen Advisory Statements

Enterprises can voluntarily display other information or statements about allergens, alerting consumers to the possible presence of major food allergens due to cross-contact. For example, "may contain [allergen]," or "produced in a facility that also uses [allergen]."

Allergen-free Claims

Enterprises can also display voluntary statements, claiming certain allergens are absent from the product (e.g., "allergen-free"). Other than the term “gluten-free” which is defined in 21 CFR 101.91. (Enforcement policy related to the gluten-free labeling requirements is outside the scope of this CPG)

There are no regulations on specific conditions for a product to be claimed with "free of something", such as allergen levels. If voluntary allergen-free claims are used, they must be truthful and not misleading. For example, if a product label or labeling has a "milk-free" or similar claim, FDA would expect there is no milk allergen in the product.

Allergen cross-contact

Allergen cross-contact is the unintentional incorporation of a food allergen into a food. Adulteration may be occurred if effective actions are not taken to prevent or minimize allergen cross-contact. This including:

• Inadequate current good manufacturing practice (CGMP), failing to ensure that personnel practices, plant equipment and utensils, and other activities do not lead to allergen cross-contact;

• Inadequate sanitation controls, resulting in allergen cross-contact from shared equipment or utensils;

• Inadequate food allergen controls, such as lack of controls during ingredient or product storage, handling, and use;

• Allergen cross-contact not handled in accordance with HACCP regulations.

CPG regulates that when the above four situations do not happen, FDA will still consider a variety of factors for allergen cross-contact, such as, levels of allergen found, product labeling, consumer adverse events, etc.