Allergen management in production encompasses all measures ensuring that allergens in food are correctly declared, cross-contamination is prevented, and production processes are controlled so that sensitive consumers are not exposed to unintended allergens. For food manufacturers, allergen management is not a voluntary best practice—it is a legal obligation, a core component of all GFSI standards, and a "Knock-Out" (KO) criterion in IFS Food and BRCGS audits.
The consequences of allergen errors range from customer complaints and recalls to fatalities. Unquoted allergens are one of the most common causes of food recalls in Europe—and the primary cause of severe or fatal food-related incidents.
The EU Food Information Regulation (EU 1169/2011) is the legal basis for allergen labeling in the EU. It mandates the declaration of 14 major allergens when used in food, applicable to both pre-packed and non-prepacked products.
The 14 Major Allergens according to FIC:
Manufacturers must evaluate every product based on its recipe and manufacturing process to determine if allergens are intentionally added or unintentionally introduced via cross-contamination.
Cleaning validation is the core of operational allergen management. It answers: Is our cleaning process between an allergen run and an allergen-free run actually effective?
For production documentation, every cleaning cycle before an allergen-sensitive changeover must be batch-recorded with a timestamp, the method used, the responsible person, and the release result.
Strategic scheduling is a highly effective, low-cost control measure. Producing allergen-free products before allergen-containing products eliminates the risk of cross-contamination for those batches. An MES (Manufacturing Execution System) that "knows" the allergen profile of each item and incorporates this into sequence planning reduces risks structurally rather than just procedurally.
What is the difference between "Contains" and "May Contain"?
How often should the allergen risk assessment be updated? Every time a change occurs that affects the risk profile: recipe changes, raw material substitutions, new products on the line, or changes in cleaning procedures. An annual review is recommended even if no changes occurred.
What happens if an allergen is misdeclared? Misdeclared allergens are reportable via the RASFF (Rapid Alert System for Food and Feed). Authorities may mandate a public recall. Manufacturers face recall costs, reputational damage, and liability claims. Detailed batch-tracking data allows a manufacturer to limit the recall to specific batches rather than pulling months of production.
Do allergens need to be declared in staff canteens? Yes. The FIC applies to all non-prepacked food sold or provided to consumers, including company canteens, restaurants, and catering services.