What is a Food Allergen?

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2 What is a Food Allergen? An abnormal or pathological reaction to food substances in amounts that do not affect most people. Foods contain protein and an allergic reaction occurs when the body s immune system reacts to a this foreign protein that has been ingested.

3 The Big 8 United States Milk & milk-based products Eggs & egg-based products Soy & soy-based products Wheat & wheat-based products Peanuts Tree nuts Shellfish Fish

4 The Big 9 Australia, New Zealand, Canada Milk and milk-based products Egg and egg-based products Soy and soy-based products Wheat and wheat-based products Peanuts Tree nuts Shellfish Fish Sesame seeds

5 The Big 11 European Union Milk and milk-based products Egg and egg-based products Soy and soy-based products Wheat and wheat-based products Peanuts Tree nuts Shellfish Fish Sesame seeds Celery seeds Mustard

6 Why is this Important? 30,000 individuals require emergency room treatment 2000 hospitalizations and 150 individuals die each year because of allergic reactions to food. Approximately 2% of adults and about 5% of infants and children suffer from allergens.

7 Why is this Important? Avoidance of food allergies is the only way to prevent a reaction. Currently, food allergies cannot be cured. Even trace amounts of a food allergen can cause a reaction. FDA has issued guidance to industry that covers labeling and industry practices to deal with allergens to prevent cross contact.

8 Cross Contact The inadvertent introduction of an allergen into a product. How does this occur: Improper rework addition Product carry over due to use of common equipment and production sequencing. Presence of an allergic product above exposed product lines.

9 Cross Contact For example, an item with peanuts cannot come into any contact with an item with tree nuts without contaminating that peanut item with a new allergen.

10 Cross Contact What happens if someone who has a food allergy ingests an allergen? Hives Flushed Skin or Rash Tingly or itchy mouth sensation Face, tongue or lip swelling Vomiting or diarrhea Abdominal Cramps Coughing or Wheezing Dizziness Swelling of throat and vocal cords Difficulty breathing

11 Cross Contact Those that have a severe food allergy can suffer anaphylactic shock Constricted airways in the lungs Severe lowering of blood pressure Suffocation by swelling of the throat

12 What can we do?

13 Allergen Control Plan Scheduling We can schedule items of like allergens as often as possible on the same line and equipment. We can schedule items that are unlike allergens with odd allergens running last. (i.e. Run Caramel (Milk, Soy) prior to Crème (Milk, Soy, Egg)).

14 Allergen Control Plan Develop Allergen Changeover Procedures Anytime there is a change over on a line going from one food allergen to another, a thorough inspection needs to be performed to ensure there are no remaining contaminants left from the previous item. Develop Allergen Matrix by department to determine when change over inspection must occur.

15 Allergen Control Plan Labeling We can ensure that all products are labeled with all allergens in plain language Allergen Alert Labeling

16 What can YOU do! If gloves worn while working with one food allergen come into contact with another food allergen, they must be changed before continuing to work with the original item. Monitor production to see if any allergen contained product is being mixed. Pay attention to utensils, buckets, containers and brushes to prevent cross contact. Notify supervisor or manager if cross contact is observed.

17 CONTROL STRATEGIES FOOD ALLERGENS

18 Allergen Control Program: elements to consider Multi-disciplinary approach Assessment of entire process Product development [formulation] Raw material & ingredients

19 Allergen Control Program: elements to consider Production scheduling Cleaning of equipment (including air handling systems) & utensils Labeling Training

20 Multi-disciplinary Approach Research & Development (Control must start here!) Manufacturing Quality/Food Safety Engineering/Maintenance

21 Product Development Identify those ingredients that can be allergenic. Avoid use of commonly allergenic ingredients if other ingredients will work just as well. Where possible, use ingredients that are already included in other products.

22 Product Development Know other products made in facility and their allergen/sensitive ingredient content. Minimize potential for cross contamination by: Production scheduling Managing Rework Control and staging of ingredients

23 Flow Charting of Process Diagram of process including equipment. Include storage & transport of ingredients. Show point of allergen introduction. Highlight areas where cross contamination can occur.

24 Raw Materials & Ingredients Assess allergen content of all ingredients. Audit suppliers. Be vigilant about changes in ingredient specifications. Maintain records on allergens in ingredients. Store allergenic ingredients in specific areas and that they are well marked. Consider packaging - latex

25 Production Controls Minimize changeovers. Schedule allergenic products after nonallergenic products. Introduce allergenic components as late in the process as possible. Avoid cross contamination between lines.

26 Cleaning Sanitary design of equipment ex. No dead ends in pipes/conveyors/augers. Establish appropriate procedures for cleaning SOP s.

27 Cleaning Thorough clean-up is required between products when first product is allergenic. Include maintenance tools, sampling devices, utensils, etc. Visual assessment. Checklist for documentation of cleaning.

28 Testing Detection of residues of protein or allergen from the allergenic food. Specific immunoassays are available. Can test for total protein in some applications.

29 Labeling Ingredient statement must comply with regulations. Label will appropriately communicate all allergens that are present in the product. An example:

30 For more information, please mail us: You may also reach us on our 24X7 Toll Free Food Safety Helpline

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