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3 Potential Failure Points That Could Lead to Undeclared Allergens

Denis Storey
May 4, 2020

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Undeclared allergens were the second-leading cause of recalls in the United States in 2019, according to the United States Department of Agriculture, which can lead to significant consumer health issues, scrap costs, and sourcing problems. Extraneous material is the top cause of U.S. recalls.

What leads to undeclared allergens? 

Summary of Recall Cases in 2019recall-cases_blog

(Source: USDA Food Safety and Inspection Service)

Why are Undeclared Allergens a Class I Recall?

Food allergies stem from the body’s immune response to specific food proteins. When consumed, the body produces an immune reaction that’s often life-threatening.

According to Food Allergy Research & Education Inc., “Food allergy is the most common cause of anaphylaxis, although several other allergens – insect stings, medications, or latex – are other potential triggers.”

Recall Class Definitions

  • Class I - A Class I recall involves a health hazard situation where there’s a reasonable probability that eating the food will cause health problems or death.

  • Class II - A Class II recall involves a potential health hazard situation in which there’s a remote probability of adverse health consequences from eating the food.

  • Class III - A Class III recall consists of a condition in which eating the food won’t cause adverse health consequences.

The Big 8 Allergens in the United States

If you’re a manufacturer that exports out of the United States, other countries might have a different set of allergens for that population based on their collective immune responses.

Allergen Control Program

The Food Safety Modernization Act (FSMA) revised good manufacturing practices, and the one area that received the most attention is allergen control. The new good manufacturing practices require facilities to have an allergen control program.

Elements of an allergen control program include:

  • Ingredient Supplier Verification – Ensures ingredient supplier doesn’t have cross-contact issues and is adequately labeling their ingredients.

  • Storage – “Like over like” approach in which companies only store an allergen above a product that contains that same allergen if there’s spillage.

  • Scheduling – Minimizes the amount of downtime needed between allergens for cleanup (e.g., you may start your day with a product that contains just soy, and then you run a product that contains soy and wheat, and then you run a product that contains soy, corn, and egg. Experts call these building allergens.

  • Formula and Rework Control – Know which formulas or recipes contain allergens and have a plan for reworking. For example, if you’re using a “like over like” method for storage, your rework should be “like into like,” so only products that contain the same allergens could be reworked into another formula.

  • Sanitation and Changeovers – Ensures that personnel properly clean shared equipment, utensils, and even employee uniforms when changing from one allergen to another or from an allergen to a non-allergen.

  • Label Verification – Ensures labels include the proper allergen statement.

In essence, there are two main goals of an allergen control program, which are very simple on paper but can be tough to execute:

  • Goal No. 1: If you make a product with an allergen in it, you need to declare it on the label. 

  • Goal No. 2: If you make a product that’s not supposed to have an allergen in it, you need to do everything possible to prevent cross-contact. 

3 Potential Failure Points 

In an allergen control program, three potential failure points could lead to an undeclared allergen reaching the marketplace. 

  1. Purchasing.

  2. Receiving.

  3. Packaging.

During purchasing, the goal is to have the correct statement at the time of labeling or package creation. At receiving, the goal is to have an accurate statement at the time of receipt. And at packaging, the goal is to align the correct package or label with the right product. 

What could go wrong at these points? 

Dig into the three potential failure points throughout the rest of this series.  

Next up, Potential Failure Point 1: Purchasing.

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