The U.S. Food and Drug Administration has issued final guidance to help food manufacturers provide adequate data to support exemptions from the labeling requirements for ingredients derived from major food allergens.

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires that food labels identify products containing major food allergens, known as the “Big 8”: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans.

Modern technology gives manufacturers the ability to alter ingredients to eliminate the threat of an allergic reaction. As such, the FDA is giving manufacturers a chance to be exempt from labeling requirements if they can prove the allergen has been removed.

In order to prove this, manufacturers must submit a scientific petition with evidence that the product “does not cause an allergic response that poses a risk to human health” or a notification of scientific evidence that ingredient “does not contain allergenic protein.”

According to this guidance the FDA plans to evaluate this evidence on:

1. the identity or composition of the ingredient;
   2. the methods used to produce the ingredient;
   3. the methods used to characterize the ingredient;
   4. the intended use of the ingredient in food; and
   5a. for a petition, data, and information, including the expected level of consumer exposure to the ingredient, that demonstrate that the ingredient, when manufactured and used as described, does not cause an allergic response that poses a risk to human health; or
   5b. for a notification, data, and information that demonstrate that the ingredient, when manufactured as described, does not contain allergenic protein, or documentation of a previous determination under a process pursuant to section 409 of the FD&C Act that the ingredient does not cause an allergic response that poses a risk to human health.

Allergens continue to be a hot topic in food warehousing. This is the subject of an on-demand webinar produced by the IWLA Food Council. IWLA members can access this session via the IWLA On-demand Resource Center. View the webinar.