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Home > Food from Farm to Table > Business, Economics & Agricultural Marketing > Managing Food Allergen Risks - A Guide for Manufacturers

Managing Food Allergen Risks - A Guide for Manufacturers


Approximately 2 percent of adults and up to 8 percent of children experience true food allergies. True food allergens are proteins. The difference between an allergy and intolerance is how the body handles the offending food.

In a true food allergy, the body's immune system recognizes a reaction-provoking substance, or allergen, as foreign and produces antibodies to halt the "invasion." As the battle rages, symptoms appear throughout the body. The most common sites are the mouth (swelling of the lips), digestive tract (stomach cramps, vomiting, diarrhea), skin (hives, rashes or eczema), and the airways (wheezing or breathing problems). There is no cure for food allergies; the only course is strict avoidance of an offending food. For an individual with food allergies, the biggest problem is knowing whether an allergen is contained in a particular food. Food intolerance is due to a chemical deficiency (commonly lack of a specific enzyme) and causes problems with digestion. Lactose intolerance is an example of food intolerance.

The United States Food and Drug Administration has identified eight foods (or food ingredients) that are responsible for 90 percent of the food allergic reactions. Those foods are milk and milk products, eggs, legumes (peanuts and soy), tree nuts, wheat, crustaceans, fish, and mollusks.

Food manufacturers need to evaluate their operations to recognize and develop plans to control unidentified allergens. All aspects of a manufacturing operation must be evaluated to ensure that control points have been identified. Evaluation for allergen hazards (a chemical hazard) should be a part of your HACCP plan. In addition, training of personnel from management and researchers to line production employees will help ensure that risks associated with allergens are fully understood. Understanding the potential consequences to a consumer with a food allergy will reinforce the importance of following the proper control procedures. It will also be important to have an ongoing monitoring system to verify that all control points are being consistently met.

Following are areas where allergen risks occur and can likewise be controlled and managed:

Product Research & Development / Engineering and System Design

  • Consider the allergenic nature of an ingredient, is there a non-allergenic ingredient that could be used instead
  • Design the product flow so that allergenic ingredients are added at the end of a production line thereby limiting equipment exposure
  • Design and install equipment for easier cleaning, inspection and maintenance
  • Design production lines to isolate allergen addition points, dedicate re-feed systems, ensure product containment and eliminate crossover of conveyor lines
  • Dedicate production systems to handle only allergen or non-allergen products

Raw Material / Ingredients Purchasing, Transportation and Storage

  • Ensure suppliers have a documented and implemented allergen control plan
  • Know the ingredients, consider processing aids and rework that goes into the product
  • Don't purchase reconditioned ingredients or oils
  • Ensure proper sanitation or dedicated use in transportation of bulk ingredients or shipping containers that are re-used
  • Review specifications or ingredient statements before substituting raw materials
  • Manage raw materials in storage to minimize cross-contact between allergenic and non-allergenic ingredients
  • Clearly label raw materials to indicate they contain an allergen

Production and Scheduling

  • Dedicate production systems, use separate lines, equipment, rooms or even facilities where necessary
  • Production scheduling: make products with allergenic ingredients all at one time or at the end of a production run, then perform a complete clean-up before running other products
  • Develop an allergen matrix or changeover grid to identify what practices or production changes need to be made between flavors or products (spray down or full clean up)
  • Do not allow reuse of single service articles such as tray liners
  • Provide lockouts on equipment that uses or supplies allergenic ingredients
  • Protect work-in-process from cross-contact from other products on adjacent carts, conveyors, etc.
  • When sampling the product in-process, be certain that the sampling device is sanitized appropriately between products
  • Allow adequate clean up time between production runs

Use of Rework

  • Have a documented rework plan including designated uses for re-work, maintaining usage record and other rework controls to track allergens
  • Reuse like into like product; encourage no rework of product containing certain allergenic ingredients
  • Clearly label all rework; use of color tags, containers, plastic liners or bar coding to identify allergen ingredient containing products
  • Ensure that re-feed systems are properly contained

Labeling and Packaging Materials

  • Check labels on incoming ingredients; supplier may have sent the wrong product or used the wrong label
  • Verify label accuracy; update to reflect current formula
  • Ensure compliance to labeling regulations which generally requires declaration of all ingredients; exception to this include spices, some colors, flavors and processing aids and incidental additives at insignificant levels or that have no technical function or effect. If an incidental additive or processing aid is derived from an allergenic ingredient, it must be included on the label.
  • Limit use of precautionary labeling (such as 'may contain') in lieu of good manufacturing practices. Do not list ingredients that are not in the formula.
  • Manage excess packaging materials; remove outdated containers or labels from the plant
  • Consider cross-contact potential on packaging equipment
  • For packaged, unlabeled products (such as individual granola bars), develop systems, to assure that the correct product in packaged into the containers with ingredient declarations
  • Verify product traceability; use a lot numbering system on raw materials to finished products to ensure recovery of all product in event of a recall, conduct a mock recall to verify

Sanitation

  • Have standardized procedures for sanitation operations (SSOP's) and ensure they are followed
  • Use appropriate cleaning methods (wipe/scrape, vacuum, soap and water wash, proper chemicals).
  • Have proper equipment and tools available
  • Focus on hard to clean areas - valves, pumps, dead spots
  • Ensure adequate lighting in the proper locations (including flashlights to check inside equipment)
  • Move equipment as necessary to make it easily accessible for cleaning; disassemble where necessary
  • Focus on results, not necessarily the time or process
  • Evaluate sanitation effectiveness; validation of cleaning by sight, bioluminescence testing, ELISA testing
  • Ensure proper storage of clean items
  • Ensure that maintenance tools used in raw and finished product areas are potential sources of cross contamination (consider color coding for specific areas or products, or cleaning procedures for reduce contamination)
  • Specify employee practices - hand washing at appropriate times (for example after handling a product that contains allergens, such as peanuts); proper hand washing procedures; clean clothing/aprons

Training and Education

  • Ensure all employees have an understanding of the allergen prevention program so they believe in its importance as a part of the facility's food safety program.
  • Points to include: define allergens, consequences to sensitive people, importance of allergen control, most common areas where problems occur, and control measures
MDA Contact

Dairy & Food Inspection Division