Undeclared Allergen Recall Prevention

The "Big 8"

Mark Frenzel, PhD JRW Texas

Undeclared allergens are still the most common reason for a recall in food products.

The “Big 8” allergens regulated by the USDA-FSIS and FDA are:

  • Milk/Dairy
  • Soy
  • Egg
  • Wheat
  • Peanuts
  • Tree nuts
  • Fish (Fin-fish)
  • Shellfish

For calendar year 2017, 53 of the 131 recalls documented by the USDA-FSIS were due to undeclared allergens.

Allergen Recall Causes

The most glaring note about undeclared allergen recalls are the top 3 root causes:

  • Wrong label or package.
  • Terminology not correct.
  • Ingredient information not communicated throughout the process.

A key similarity of these three root causes is that they can be eliminated or reduced without the purchase of any special equipment, hiring of any highly qualified personnel, or modification of any parts of the actual food processing system. They are careless mistakes that can be easily prevented through attention to detail.

How to Prevent an Allergen Recall

Here are some practices that can help prevent these types of mistakes from occurring as frequently:

  • Line Clearing

    • Establish line clearing procedures between batches of non-allergen and allergen products. This might cause a few more minutes of down-time, but it can help make sure there is no confusion between the different batches.
  • Time of Day

    • Run any product containing allergens at the end of the shift or possibly on a separate day. If different allergens are used, organize the production schedule to keep the same allergens together. Run product with multiple allergens at the very end of the shift.
  • Wash Between Allergens

    • Wash down between each different allergen. If the first product has soy and the second product has dairy, they are still different allergens and should be treated that way.
  • Out with the Old

    • Don’t give yourself an opportunity to mix up old labels with new labels. Discard or use up all old labels once your new labels arrive. It takes more work on the front end to plan a label transition properly but the effort removes headaches and risk when all old labels are out of the facility.
  • Communicate All Information

    • Any formulation change that is made involving allergens should be communicated to all relevant parties. If R&D modifies a formulation and fails to inform the quality team and the packaging lead, the product can very easily get packaged with the incorrect label. All formulation changes and all label changes should be verified and signed off on by multiple team members.


Do you have any allergen questions specific to your business or process? Click here to speak with an expert at JRW about the most current FDA and USDA requirements, guidelines, and best practices.

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