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

2. 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.

3. 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.

4. 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

5. 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)

6. 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

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

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

9. 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”

10. 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

11. 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

12. 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”

13. 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.

14. 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.

15. 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.