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Food allergies are abnormal responses of the immune system, especially the production of allergen-specific IgE antibodies to naturally occurring proteins in certain foods that most individuals can eat safely. Frequently, such reactions occur because the presence of an allergenic substance in the food is not declared on the food label.
According to FDA, there is scientific consensus that the following foods can cause serious allergic reactions in some individuals and account for more than 90% of all food allergies:
Tree nuts, e.g., walnuts
Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, including potential food allergens, or refuse in the following manner:
When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in receiving, loading, or shipping areas if that handling could result in contamination.
Food transported by conveyor shall be protected against contamination as necessary.
Filling, assembling, packaging, and other operations shall be performed in a way that the food is protected against contamination by utilizing adequate control procedures to prevent allergen cross contact.
Food products not labeled properly with an allergenic ingredient would be considered misbranded due to an undeclared allergen. Food could be considered adulterated if contaminated with an allergen.
It is imperative that critical points in the manufacturing operation be identified and special attention given to areas where allergens may be introduced.
Additional information and guidance is available on the FDA website at:
Compliance Policy Guide: "Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens" April 19, 2001
Inspection Guide: "Guide to Inspections of Firms Producing Products Susceptible to Contamination with Allergenic Ingredients" August, 2001