Madison chemical food division Allergen control Terry Willis-Senior Advisor-Food Division

Food allergens A food allergen is a product or ingredient containing natural proteins that can potentially cause severe and occasionally fatal allergic reactions in some people.

facts All food allergens are proteins, BUT not all proteins are allergens. Eight (8) food proteins account for 90% of allergic reactions. There is no known limit to the amount of allergenic protein there must be in a food to elicit an allergic reaction. There is no known cure for food allergies.

Allergic reactions Itching, rash or hives Abdominal pain, nausea, gas or diarrhea Wheezing or trouble breathing Swelling of lips, face, tongue or other body parts Dizziness Rapid or irregular breathing

The big “8” Peanuts Milk Wheat Eggs Tree Nuts (walnuts, almonds, pecans, hazelnuts, pistachios, cashews, pine nuts, macadamia nuts, Brazil nuts) Soy Fish Shellfish (crab, crawfish, lobster, shrimp, clams, mussels, oysters)

Testing for allergens HOW? WHERE? ELISA Test Kits are the approved method WHERE? Ingredients Finished products Food contact surfaces C.I.P. final rinse water

Allergen control program basics Identify Prevent and Control Declare Implement Enforce Audit Update

Areas of focus Raw Materials Operations Production Scheduling Labeling and Packaging Engineering/Design Rework Practices Sanitation Practices

Raw material program Identify your allergenic ingredients and assess risk levels Auditing of Suppliers Segregated upon receipt Clearly identified Separate storage areas Stored on bottom location or “like above like”

Operations Clearly identify all ingredient containers. Segregation is important in receiving, storage, processing and all handling. Use dedicated scoops, measuring cups, stirring devices, etc. used for allergens Use non-permeable clothing/aprons/gloves and change after running allergens Use dedicated lines and personnel if possible Formula identification and label verification Use physical barriers such as shields, covers or catch pans to prevent cross contamination. Also be aware of traffic flow patterns. Employee training Enforce use of proper GMP’s

Production scheduling Increase run times or minimize changeovers Produce allergen containing products at the end of the production day Allow adequate time for cleaning between changeovers

Rework Procedures Clearly identify all rework containers Rework product containing allergens should only be on the production floor when running that particular product Double check that “like is being used with like”

Equipment engineering Equipment should not have dead spots, rough surfaces and voids. Recommend reviewing the “Sanitary Design” power point. Eliminate equipment crossovers such as conveyors crossing over top of other processing equipment. Use physical barriers such as shields, covers, catch pans, etc. to prevent cross contamination. Isolate all points where you will be adding allergen product to the system. Air handling system filters should be checked and changed on a frequent, regularly scheduled program. Maintenance should clean tools after working on equipment, especially that used for allergen products.

sanitation Develop appropriate, written cleaning procedures specific to product lines, equipment and formulations to effectively remove allergenic product. Include splash zones, indirect product surfaces and utensils in the program. Any absorbent material such as sanitary cloths that contact allergen materials must be changed and laundered. Cleaning by employing the use of blown air is prohibited. Identify all equipment, conveyors and surfaces requiring cleaning after an allergenic product run.

Sanitation (cont.) A chemical cleanup should take place between an allergen to non-allergen changeover or between two different allergens. The cleaning procedure should include either an oxidizing cleaner (chlorinated alkaline product) or an oxidizing sanitizer (sodium hypochlorite or peroxyacetic acid) All allergen cleaning must be validated using an ELISA test kit.