Allergen Management

Each year, millions of Americans have allergic reactions to food. Although most food allergies cause relatively mild and minor symptoms, some food allergies can cause severe reactions, and may even be life-threatening.

Major Food Allergens

FALCPA, a comprehensive food la­beling law, has been in effect since January 1, 2006. Under FALCPA, food labels are required to state clearly whether the food contains a major food allergen.

A major food allergen is defined as one of the following foods or food groups, or is an ingredient that con­tains protein derived from one of the following foods or food groups:

  • Milk
  • Eggs
  • Peanuts
  • Tree nuts such as almonds, wal­nuts, and pecans
  • Soybeans
  • Wheat
  • Fish
  • Shellfish such as crab, lobster, and shrimp

Food allergens may become a part of a food through unintended routes. Examples of these are inadequate scheduling to protect against cross-contamination; improper cleaning between different products without analytical verification methods; use of allergen containing rework in non-allergen containing products. A firm should address these critical control points of manufacturing in an allergen control plan.

Steps for Proper Allergen Management

  • Verify Label Accuracy
  • Ensure packaged foods regulated under the Federal Food, Drug and Cosmetic Act, comply with the Food Allergen
  • Labeling and Consumer Protection Act of 2004. For these requirements, visit www.cfsan.fda.gov/~dms/alrgact.html.
  • Prevent Cross Contamination
  • Cross contact may occur during:
  •  Harvesting
  •  Transportation
  •  Manufacturing
  •  Processing
  • Storage

Many food manufacturers may try to prevent cross contact through the use of dedicated facilities or dedicated production lines. Also, a variety of advisory statements are used on pack­age labels to indicate possible cross contact. For example, a label might indicate: “Produced in a plant that processes nuts.” However, declaration of allergens on labels does not preclude a processor from adherence to GMPs (FDA, 1996).

Employee Training

  • Provide general training on allergen awareness and control for all employees at all levels of the company.
  • Provide specific documented training to employees as dictated by their job responsibilities.

Supplier Control

Your Allergen Control Plan should also outline expectations, documentation and validation to ensure your suppliers are diligent and equally as dedicated to controlling and managing allergens.

  • Require your ingredient suppliers to have a documented Allergen Control Plan.
  • Require letters from suppliers that guarantee the ingredients you purchase do not contain undeclared allergens.
  • Require your suppliers to notify you of any changes to the allergen status of the ingredients they supply prior to any changes.

Sanitation

  • Protocols should be clearly written and easy to follow and understand.
  • Define the scope of the cleaning procedures—range of applications, equipment, products, etc.
  • Define who is responsible for the cleaning operations.
  • Evaluate the allergen cleaning program periodically for effectiveness and compliance.
  • Monitor and verify the Allergen Control Plan frequently with internal and/or external audits
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