About this course
This course covers how to test finished products and raw ingredients for the presence of major food allergens using validated laboratory methods, primarily enzyme-linked immunosorbent assay (ELISA) testing. Learners see how product-level allergen testing differs from surface swabbing — it verifies what's actually in the food, not just what's on the equipment — and where it fits in a facility's allergen control program.
The regulatory driver is the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 and the FASTER Act of 2021, which together define the nine major food allergens the FDA requires to be declared on labels: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Product testing is a key verification tool for confirming that formulation, ingredient sourcing, and cross-contact controls are working as intended, and for investigating consumer complaints or supplier changes.
This course is designed for QA technicians and lab personnel who collect, prepare, or interpret product samples for allergen analysis, as well as QA supervisors who make disposition decisions based on results.
After completing this course, learners will be able to identify the nine major allergens and their common hidden sources, explain how quantitative ELISA testing detects allergenic proteins in a product matrix, understand the difference between a validation study and routine verification testing, and know the correct steps to take when a product sample tests positive for an undeclared allergen.
Topics covered
- The nine major food allergens under FALCPA and the FASTER Act
- How ELISA detects allergenic proteins in product samples
- Sample collection and preparation to avoid false results
- Using testing to verify formulation and supplier changes
- Response steps when a product tests positive for an undeclared allergen
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