What Are Undeclared Allergens?

What Are Undeclared Allergens?

If you or a loved one live with food allergies, you know that strict avoidance is the key to preventing allergic reactions – some that may be life threatening. In order to maintain such a diet, as a consumer you rely on clear and accurate information about which food allergens are present in the products you buy. Unfortunately, there is still a risk of the presence of undeclared allergens in the foods we purchase.

An undeclared allergen is any allergen that is found to be present in a food that is not listed on the food’s label. The Food and Drug Administration (FDA) has identified eight major food allergens to be the “Big Eight” allergens. These include:

  • Peanuts
  • Milk
  • Fish
  • Eggs
  • Shellfish
  • Tree nuts
  • Wheat
  • Soybeans


Any products containing these undeclared allergens are subject to recall and must be relabeled to identify the allergen.

Food Allergies and Food Recalls Are On the Rise

The prevalence of food allergies is on the rise, which is a growing cause for concern among parents of children with food allergies.

According to Food Allergy Research & Education (FARE), approximately 15 million Americans suffer from food allergies. Of those 15 million, 5.9 million are children under age 18. That means one in every 13 children have a food allergy.

The Centers for Disease Control & Prevention (CDC) reports that food allergies in children are on the rise. The prevalence of food allergies has increased by 50 percent from 1997 to 2011. Furthermore, between 1997 and 2008, peanut and tree nut allergies have more than tripled in American children.

The United States Department of Agriculture’s 2016 report showed that 34 of the 122 food recalls within its jurisdiction were due to undeclared allergens. That number is higher than the numbers for contamination of Salmonella, Listeria and E. coli in the same year, accounting for 27 recalls combined.

According to the most recent 5-year report by the FDA, 95 primary reports related to undeclared allergens occurred in year five. This number rose from 30 percent of reports in year 1 to 47 percent of reports in year 5.

It isn’t any wonder then that the case for undeclared food allergens is a growing concern. The prevalence of these recalls is astounding.

What Happens in the Event of a Recall?

Many foods are made in processing facilities that manufacture high allergen foods. Cross-contact and labeling errors do happen, although many manufacturers take measures to reduce the risk of undeclared allergens going in their products.

Food safety falls under the authority of two agencies in the U.S.: a branch of the United States Department of Agriculture (USDA), known as the Food Safety and Inspection Service (FSIS), and the Food and Drug Administration. The FDA is responsible for anything from food to drugs (about 80 percent of the food supply), with the exception of what is covered by the USDA: meat, poultry and eggs (the remaining 20 percent).

Regulatory agencies (USDA and FDA) are notified if there is a problem in the food supply in one of the following ways:

  • A food manufacturer or distributer finds a food safety issue and makes contact with FDA or FSIS.
  • FDA or FSIS reveals a potential cause for recall during inspection.
  • FDA or FSIS finds a food product or manufacturer fails testing during a sampling program.
  • If an illness arises, local state health departments will contact the CDC, which turns the information over to FDA or FSIS.


Recalls fall into three classifications:

  • Class I – involves a health hazard situation in which there is reasonable probability that the food, when eaten, will cause health problems or death
  • Class II – involves a health hazard situation in which there is remote probability that consumption of the food may bring adverse health consequences
  • Class III – involves a situation in which no adverse health consequences will occur when the food is eaten


Recalls are usually voluntary and are initiated by distributors and manufacturers. If FDA or FSIS requests that a company recalls a product, the responsibility to act falls on the company that manufactures the product. If the company fails to take action, legal action may be taken.

As of 2004, the Food Allergen Labeling and Consumer Protection Act (FALCPA) requires that food manufacturers declare if any of the major food allergens or ingredients coming from these foods have been used as ingredients.

Due to new authorities granted to FDA as of January 2011, the Food Safety Modernization Act gives the FDA authority to shut down operations at any food production facility that fails to adhere to safe food practices.

Once a recall is initiated, it is the responsibility of FDA or FSIS to determine the potential severity, ensuring all reasonable efforts are made to correct or remove the problem. These agencies are also responsible for seeking rapid public awareness when a situation warrants it.

FDA and FSIS also determine when to terminate a recall.

The number of recalls related to undeclared allergens is worrisome to parents of children with food allergies. While the FDA and FSIS work together with manufacturers to bring these numbers down, be proactive by staying on top of the latest information regarding food-related recalls. Find out the latest recalls due to undeclared allergens at Food Allergy Research & Education.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.