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Allergen Management 101

Out of 337 total food recalls in 2019, 52% were due to undeclared allergens. These results are generally determined through laboratory testing, and include the “Big Eight” allergens:

  • Peanuts
  • Milk
  • Eggs
  • Fish
  • Shellfish
  • Wheat
  • Tree nuts
  • Soybeans

Products containing undeclared allergens pose a serious threat to those with food allergies. In fact, F.A.R.E. (Food Allergy Research & Education) estimates that 32 million Americans have food allergies, with 5.6 million of those being under 18. That’s 1 in every 13 children!

With an increased frequency of severe allergic reactions (377% from 2007 to 2016), and the significant impact undeclared allergens can have on your business, it’s crucial for food manufacturers to take proper precautions to protect consumers and the reputation of their company.

Here are 4 areas to focus on that will help you prevent allergen-related recalls.


Cross-contact can occur throughout any point in the manufacturing process. To prevent the contamination of raw materials, workers should visually inspect each new shipment for the presence of contaminates. A list of ingredients and label records to compare against incoming ingredients should be maintained. Outside food should not be permitted into production areas. Clean uniforms should be worn and hands should be washed before entering. In the event that an unintended allergen is found within the production area, immediate steps should be taken to segregate, investigate, dispose of, and report any adulterated products. As well, regular facility inspections should be conducted to ensure adherence to GMPs and Allergen Control procedures.

During the storage process, the use of color-coded signifiers is helpful to identify products and ingredients containing allergens. These items should be stored in separate, designated areas that are clearly marked. If stored together, storing items containing allergens above ingredients without allergens or with different allergens should be avoided.

During mixing and processing, equipment, utensils, and food contact surfaces should be thoroughly cleaned after each use. Dedicating equipment to allergen-containing products and separating production lines by time and space is vital. (Many manufacturers designate allergenic foods to separate rooms, and sometimes even separate facilities.) Avoid using the same cooking medium (such as oil or water) when processing ingredients with and without allergens.


One common reason for allergen-related recalls occurs as a result of mispacking, or packaging a product in the wrong container or with the wrong label. This can happen when an incorrect roll of packaging film is used during the process (especially if the graphics look very similar to another product’s) or if primary packaging (for instance, an individually-wrapped pouch of cinnamon-almond oatmeal) gets placed into an incorrect secondary packaging (such as a box of cinnamon-raisin oatmeal).

These types of common errors can be prevented through checks-and-balances such as vision systems and barcode scanners that can identify and reject mismatches.


When mispacking isn’t the cause, many allergen-related recalls are often attributed to an oversight in the design process, long before the product reaches the line.

To prevent this, label designs should receive approval from several departments, such as Marketing, Procurement, Packaging Engineering, Production, Quality Assurance, Research & Development, and Regulatory. The Food Allergen Consumer Protection Act (FALCPA) requires allergens be listed in parentheses following the name of the ingredient or immediately after the list of ingredients in a “contains” statement.  Nuts and seafood must also indicate the specific source of allergen, for example Tree Nuts(Almonds) and Shellfish(Shrimp). Failure to list allergens properly is an easy error to make with expensive ramifications.


Often times, recalls can result from a failure to carry over allergen information from suppliers to manufacturing facilities. Sourcing flour from a vendor that utilizes milk in their process, unbeknownst to you, can create an issue long before the item reaches the production floor. Getting to know your suppliers and maintaining an open line of communication with them can ensure you’re receiving what you expect. Don’t be afraid to inquire about your supplier’s allergen control program and set clear expectations of required labeling and packaging for all incoming allergenic material.

Avert Has Your Back

With so much opportunity for error, we know staying detail-oriented can be overwhelming. That’s why Avert utilizes over 20 years of food safety expertise to guide and support commercial manufacturers, keeping their customers protected and their reputation intact. Our knowledgeable team can help you navigate the ins and outs of labeling, packaging, and the many other facets of commercial food manufacturing.

Visit our website to learn how Avert can assist you!


Matthew McClure provides sound strategies that instill cost-effective methods for building robust food safety, operational and quality assurance programs. Along with a Bachelor of Applied Science in Microbiology from The University of Akron and an MBA in Finance from Louisiana State University, Matthew brings over 20 years of experience in the food safety industry to AVERT Food Safety Advisors. His knowledge spans many areas including FDA food processing facilities, USDA meat and poultry plants, dietary supplement manufacturers, retail, cannabis manufacturing, and food service operations.

Contact us for more information: | Tel: +1 702.706.6574

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