Allergen Control and Cross-Contact Prevention
What the exam tests
Allergen hazard identification, segregation and scheduling, cleaning validation, labeling, supplier control, and precautionary allergen labeling.
Core rules
- US major allergens (Big 9): milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, sesame. EU 14 include celery, gluten cereals, lupin, molluscs, mustard, sulphites above 10 mg/kg, and sesame.
- Control hierarchy: eliminate or dedicate, then segregate physically, then schedule allergen-free first, then validate cleaning, then verify labels.
- Allergen cleaning verification uses specific ELISA or PCR; ATP alone does not prove allergen removal.
- Precautionary statements must be risk-based and not a substitute for GMP; overuse undermines credibility.
- Manage rework, dust, shared utensils, maintenance tools, and line crossings.
Worked example
A line changes from peanut butter cookies to plain shortbread. Scheduling puts plain first only if the line is allergen-free at start; otherwise run peanut last, then full wet clean, then ELISA for peanut protein below the validated limit, then label check. If the ELISA result is above limit, re-clean and re-test; do not release on visual inspection.
Traps
Assuming 'may contain' is a legal shield; validating cleaning with ATP only; ignoring allergen dust in air; using shared scoops; missing sesame on a label.