Since 2008 there has been a sustained increase in the number of FSIS-regulated products that contain undeclared allergens. Frequently in the news we hear about a company recalling a product due to an undeclared allergen. To help processors understand what it takes to effectively control allergens, in April 2014, FSIS published FSIS Compliance Guidelines – Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control and Declaration Through Labeling. It can be found on the FSIS website

Use of the guidelines is not a requirement. However, if a company does not use the guidelines, they need to provide support that their procedures effectively control allergens.

Allergens are specific components of food or ingredients that cause immunologic reactions. More than 170 foods have been reported to cause allergic reactions, however, eight of the most common allergens account for 90% of all allergic reactions.

The “Big Eight” Allergens are: wheat; crustacean shellfish (e.g. shrimp, crab, lobster); Eggs; Fish; Peanuts; Milk; Tree Nuts (e.g. almonds, pecans, walnuts); and Soybeans

FSIS recommends following three basic principles for allergen control; identify, prevent and control, and declare. In the compliance guidelines, FSIS suggests ways to properly identify allergens in the facility, prevent and control cross contamination and mishandling during processing, and properly declare allergens.


Steps Establishments Can Use to Identify Allergens

  • Review a list of all ingredients and products that you use to determine whether they contain allergens
  • Use an establishment schematic, do a walk-through noting paths of allergenic ingredients and products and areas of concern where cross-contact may occur
  • Keep a list of ingredients used in product formulations and label records at the receiving area to compare against incoming ingredients
  • Ensure that all incoming ingredients containing allergenic material are clearly labeled and identified
  • Use color coding for allergen-containing ingredients and products
  • Store ingredients containing allergenic materials in separate designated areas that are clearly identified and marked
  • Become familiar with letters of guarantee from suppliers
  • Maintain open communication of expectations with suppliers and inquire about suppliers allergen control program

Things an Establishments Can Do to Prevent and Control Cross Contamination and Misbranding

  • Color coding of ingredient packages, supplies, uniforms, and utensils used for products containing allergens throughout processing to facilitate simple identification
  • Documenting cleaning procedures with checklists including procedures for spill clean-up
  • Employing a method for the verification and validation of cleaning
  • Maintaining documented process flow along with mapping the route of allergenic product through the establishment
  • Employing a method for tracking of lot codes through production
  • Carefully evaluating rework and work-in-progress
  • Dedicating equipment, or if not feasible, separate allergenic products by time, space, etc.


Steps an Establishment can Follow to Help Assure They Properly Declare Allergens

  • Systems and checklists in place for the labeling of final product
  • Color coding of products containing allergenic ingredients
  • Procedures in place for labeling discrepancies to ensure product disposition is evaluated
  • Verification of the accuracy of product labels
  • Methods of tracking lot codes through production, storage, and shipping
  • Storage of products containing allergenic materials in areas that are clearly identified and marked
  • An important part of a successful allergen program is employee training. Employee training should be documented and take place annually.


Every establishment must reassess the adequacy of their HACCP Plans at least annually or whenever any changes occur that could affect the hazard analysis. In the HACCP Plan Hazard Analysis allergens should be considered as a potential chemical hazard.

Remember: Allergen control is an important part of food safety.