Establishing an Effective Allergen Management Program

Seven steps to a successful allergen-control system.

September 22, 2023

The rate of people with food allergies, particularly in western countries, has been increasing over the past decades. Undeclared allergens now account for nearly half of all U.S. recalls. So it’s vital for food companies to have robust allergen management programs to protect consumers and brand reputation.

A company’s allergen management program should be tailored to the specific products they produce, the allergens they handle, their processes and available resources. To optimize your allergen-management program, steer clear of these common pitfalls and follow these steps to success:

Common pitfalls

  • Not having an allergen management program because you do not have any of the 9 major allergens in your facility (allergen risks can still arise in the supply chain, distribution, and other sources).
  • The program is vague, general, and not tailored to your business model.
  • Not verifying allergen control programs and practices used at your suppliers.
  • Not identifying and controlling sources of cross contact.
  • Ineffective change management procedures when introducing a new product, process, ingredient or supplier. 
  • Inadequate labeling programs.
  • Ineffective training and reinforcement of proper behavior.

Steps to success

1. Purchasing

  • Assess ingredients, processing aids and primary packaging for allergenic ingredients. 
  • Maintain an accurate master allergen listing for everything used in production.
  • Assess suppliers’ allergen control programs and practices.

2. Storage

  • Keep allergenic ingredients physically separated from non-allergenic ingredients.
  • Implement an allergen identification program where ingredients, WIP, rework, and finished products are labeled or color-coded with allergens present, so they are easily identifiable from the floor.
  • Store allergen-containing ingredients and products in packaging that is securely closed or containers with tight-fitting lids.
  • Implement additional control and inspection practices for bulk storage containers.
  • Contain and properly clean allergen spills and damaged packaging.

3. Facility and Production Lines

  • Create separate allergen handling rooms and dedicated lines.
  • When dedicated rooms and lines are not possible,
  • Minimize the number of allergen runs per week or month. 
  • Schedule run order so that non-allergens run before allergen-containing product, then progressive number of shared allergens. For example, Run 1 = no allergens; Run 2 = soy; Run 3 = soy + milk; Run 4 = soy + milk + wheat; full sanitation & testing; Run 5 = wheat + egg
  • Implement a validated sanitation program and changeover procedure
  • Schedule sufficient time for full sanitation and allergen changeovers
  • Assess the risk of allergen-containing dust and airflow patterns. If allergen-containing dust may be a risk, use negative pressure and properly sized air filters.
  • Assess the risk and control allergen-containing rework and work-in-progress (WIP) for allergen cross-contact or erroneous addition to non-allergenic product or materials.

4. Sanitation 

  • Implement effective allergen changeover practices.
  • Validate sanitation procedures effectively remove allergens.
  • Complete full sanitation (including non-food contact surfaces, waste removal, etc.) and verification testing when changing between different allergens or before running non-allergens.
  • Use dedicated cleaning tools or select hygienically designed cleaning tools and verify allergen removal after cleaning. 
  • Include maintenance tools in allergen control and sanitation practices.
  • Avoid sanitation practices that aerosolize or spray allergens from one surface to another. 

5. People and Traffic Flow

  • Control the risk of allergen cross contact during transportation from storage to weighing to production lines and packaging. Avoid line crossovers and consider physical barriers.
  • Control the risk of personnel moving between allergen and non-allergen areas.
  • Include personnel in allergen changeover protocols (uniforms, handwashing, gloves).
  • Assess breakroom practices. For example, don’t stock vending machines with products containing allergens that aren’t permitted in the facility.

6. Label Management

  • Review and approve labels and packaging artwork prior to printing.
  • Review labels against the current specification during receiving.
  • Ensure change management practices include destroying outdated label versions in inventory.
  • Verify the labels issued to production are for the correct product and label version. 
  • Use a label-reconciliation process to track labels issued versus product made.
  • Verify labels prior to shipping. 

7. Training

  • Ensure all employees are well-trained in identifying allergen risks and the controls required to prevent cross contact. Encourage awareness of the food they bring into the facility for personal consumption and the importance of handwashing and uniform changes after allergen handling. 
  • Communicate allergens and emphasize allergen controls ahead of scheduled production runs. 
  • Periodically verify and reinforce employee knowledge during floor walks.

No system is perfect and no allergen management program is ever done. It is important to capture and correct issues when they happen, implement preventive measures, and encourage and recognize input and suggestions for improvement. Whether you are starting or refining, seek to continuously improve programs, procedures and training based on new information, emerging best practices and internal learning. This mentality will help you ensure your products are safe and compliant.

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