The Devil is in the Details: Minimizing the Risk of Allergens
Center for the Global Food Value Chain Blog
If your company is inspected by the Food and Drug Administration (FDA) or by the state, having an effective allergen control program is important for compliance. Under the Food Allergen Labeling Consumer Protection Act and now the Food Safety Modernization Act, allergens are hazards that should be controlled. Here are some leading practices to consider:
- Conduct a hazard evaluation to identify “known or reasonably foreseeable hazards”.
- Implement preventive controls to test that cross-contact of allergens were prevented.
- Focus on proper labeling of products to avoid misbranding of your products, as well as avoiding a possible recall.
- If program gaps are identified, establish corrective action.
- Monitor the preventative controls for effectiveness.
- Maintain records of monitoring and instances of nonconformance, including corrective actions. If the controls are not properly implemented or are found to be ineffective, the likelihood of reoccurrence is reduced and the affected food is evaluated and prevented from entering commerce if it cannot be confirmed that it isn’t adulterated.1
- Verify that the plan is working and includes the use of environmental and product testing programs described by the FDA.2
You may find it helpful to know that the three largest areas of opportunity to reduce allergens are related to verification of ingredients received from suppliers, the prevention of cross-contact and the proper labeling of finished products. As a manufacturer, you rely on supplier-provided records to comply with regulations. These records are often taken at face value without further verification. But they shouldn’t be. If your supplier isn’t compliant, chances are, you may not be either. You need to investigate:
- Are there allergens in your purchased ingredients that aren’t listed on the ingredient label?
- Have you utilized dedicated wet production lines when appropriate?
- Do you know if your food product packaging materials contain allergenic ingredients?
Your allergen management program should include prevention measures to minimize cross-contact of allergenic ingredients.
• Schedule non-allergenic products first and then move towards those products that contain the most allergens.
- Limit production scheduling of line change overs and batching changes using allergens.
- Reduce environmental contamination through facility design and air quality management.
- Limit processing conditions for allergenic product exposure.
- Control rework and/or work in progress with proper storage and labeling of product and ingredients.
- Apply appropriate procedures for warehousing, receiving, storage and separation of allergenic ingredients and products.
Some examples of good manufacturing procedures include: a master sanitation program, employee training, facility environmental controls and design, ingredient procurement, recall & traceability plan.
The bottom line is this: your allergen control program is only effective when it’s implemented and executed by properly trained employees and on-the-job mentoring. Standard operating procedures, policie sand control programs can be written to the smallest detail. However, execution of the details is critical to making the allergen program effective to protect your consumers and your brand.
Manager, Food Safety
Deloitte & Touche LLP
1U.S. Food and Drug Administration Food Safety Modernization Act, Title I – General Food Provisions, Section 106 – Protection Against Intentional Adulteration
2U.S. Food and Drug Administration Food Safety Modernization Act, Title I – General Food Provisions, Section 103 – Hazard Analysis and Risk-Based Preventive