Nutrition Hotline

Reed Mangels, PhD, RD

QUESTION: Long-time VRG members recently asked us why almost every item they pick up to read the ingredients has a disclaimer saying that the item was made on shared equipment that also processes eggs, soy, peanuts, and wheat.

ANSWER: According to VRG’s Research Director Jeanne Yacoubou, MS, The Food Allergen Labeling and Consumer Protection Act of 2004, (FALCPA), is the reason why manufacturers must list on food labels any of the eight allergens, (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans), determined by the Food and Drug Administration (FDA) to be potentially harmful to the majority of allergy sufferers. Because highly sensitive individuals could have adverse reactions to even very small quantities of allergen present in food due to cross-contamination from equipment on which food containing the allergen was previously manufactured, some companies voluntarily indicate that shared equipment was used. Doing so may protect the manufacturer from legal liability if an adverse reaction occurs from a food product that does not contain the allergen as an intended ingredient, but was produced on shared equipment.

Currently FALCPA does not require a “may contain” statement or anything similar, such as a shared equipment disclaimer. The FDA warned that advisory labeling such as “may contain [allergen]” should not be used as a substitute for adherence to current Good Manufacturing Practices (cGMPs). In addition, any advisory statement such as “may contain [allergen]” must be truthful and not misleading. However, in the statement of the Act, there is a paragraph that says that the FDA is aware of cross-contamination of major allergens due to shared equipment and requires further research into the subject.

Is a major food allergen that has been unintentionally added to a food as the result of cross-contact subject to FALCPA’s labeling requirements? No. FALCPA’s labeling requirements do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact. In the context of food allergens, “cross-contact” occurs when a residue or other trace amount of an allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food. Cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment.

The FDA provides current information about undeclared allergens in specific food products on its website: For example, according to Food Safety News, undeclared allergens accounted for more than one in three food recalls during the last quarter of 2011.