Ashraf Shehata Head of Scientific & Regulatory Affairs Africa, India & Middle East

1. Allergens Management: A Mars PerspectiveDIFSC Ashraf Shehata Head of Scientific & Regulatory Affairs Africa, India & Middle East 1

2. Mars Inc. • > $30 billion global revenue annually • 6 business segments: Chocolate, Pet care, Wrigley Gum and Confections, Food, Drinks, and Symbioscience • > 65,000 associates at 230+ sites, including 135 factories in 68 countries • 10 brands worth billion-dollar-plus • 3 brands over 100 years old • 7 brands over 50 years old

3. Outline • What is a food allergy ? • What are the globally recognised Allergens? • Allergens labelling • Mars Allergens principles • Allergens Control Plans

4. Reactions range from mild to severe What is a food Allergy? • A response where the body's immune system overreacts to the protein of a normal food Cutaneous Respiratory Anaphylactic shock Gastrointestinal Oropharyngeal Allergy is different from Intolerance, (does not involve the immune system, far less severe)

5. Allergens Allergens in the Spotlight • Significant increase in allergen related product recalls Increase in prevalence of food allergies More sensitive allergen detection methods developed Increased use of common manufacturing lines

6. CRUSTACEAN SHELLFISH FISH COWS MILK EGGS SOYA GLUTEN PEANUTS TREE NUTS Top 8 Most Common Food Allergens

7. International Food Allergen List Sesame Sulfites Sesame Sulfites Celery Mustard Lupin 4 of Top 8 + Buckwheat Wheat (not Gluten) Sulfites Goat’s Milk Sesame Sulfites Only crustacea Sulfites

8. Prevalence of Food Allergies* • On the increase in developed countries • Depends on genetic factors, age, dietary habits, geography, • Perceived prevalence 25-30% • 2-4% of adults • Up to 8% of preschool children (many outgrow this, except peanut) • *US/ Europe statistics

9. Allergen Threshold Levels • No globally accepted allergen threshold levels • Differs from person to person • Regulatory authorities • 5-10ppm for recall enforcement • Leading scientists • 10ppm • Manufacturers • more conservative limit of 5ppm

10. Prevention of Allergic Reactions • Avoidance of the food is key !! • Total exclusion of food allergens from one’s diet is difficult (especially for milk, eggs, wheat and peanuts) • Depend entirely on the food preparer or the food label

11. Global Allergen Labeling Regulations • Allergens labeling regulations exists in number of markets • Disclose allergenic ingredients in commonly understood terms • For Recipe Ingredients: • Listed as the common name within the ingredient listing: • Examples: “wheat flour”, “milk fat” , “milk”, “egg yolk” • In parentheses following the name of the ingredient: Examples: "lecithin (soy)," “casein (milk)," "whey (milk)” • Immediately after the list of ingredients • Example: "Contains Wheat, Milk, and Soy."

12. Allergen Advisory or Precautionary Labeling • Applied to products when, • despite due diligence in cleaning, it is still impossible to eliminate cross contamination risk • the allergen is not in the ingredient list • Examples: • May Contain <allergen> (most effective) • Made on same equipment as <allergen> • Manufactured in the same facility as <allergen>

13. What happens if all products have allergen warning statements? ` Over-labelling Increased Incidence Consumer Consumer Risk-Taking Consumer Frustration

14. Allergen Management Principles • Always indicate the presence of a major food allergen that is part of the recipe in the ingredient list • The goal is to eliminate/minimise allergen cross contact in products to provide the consumer with more choice • Allergen Advisory Statements will only be used on products after all means for eliminating allergen cross contact have been considered • An allergen will not intentionally be added to the recipe unless it is part of the product design • Mars allergen practices are based on the latest and best peer-reviewed science

15. Mars Allergen Management Process Arrow Process • Identify allergens being used on site • Perform a hazard analysis to determine if extra controls are needed • Verify that the controls and labeling are appropriate Step 1 Step 2 Step 3 Step 4 Step 5 • Put all mandatory GMPs in place • Where a hazard analysis can not be managed to NEGLIGIBLE, apply the labeling requirements Approach to Manage Identified Allergen Risks

16. Elements Of An Effective Allergen Control Plan 1. Fundamentals 2. Product Design 3. Suppliers 4. Segregation 5. Minimize Cross Contact 6. Label Review 7. Validated Cleaning

17. Elements Of An Effective Allergen Control Plan 1. Fundamentals • Team • Risk assessment • Plan • Training

18. Elements Of An Effective Allergen Control Plan 2. Product Design • Real difference in taste or functionality • Question ingredient suppliers on allergens

19. Elements Of An Effective Allergen Control Plan 3. Suppliers • Allergen Management begins with raw materials • Documented allergen control plan • Audit • Validate cleaning procedures

20. Elements Of An Effective Allergen Control Plan 4. Segregation • Raw materials carrying an allergen advisory label must be treated as containing the allergen • Avoid combined storage • Sufficient separation/isolation • Spill control procedure specified

21. Elements Of An Effective Allergen Control Plan 5. Minimize Cross Contact • Dedicate separate production areas • Schedule longer runs of allergenic products • Add allergenic ingredients as late in the process as possible • Design airflow to minimize cross contact • Restrict personnel who work with allergenic products from coming in contact with non-allergenic products • Whenever allergenic and non-allergenic products are made in close proximity, put barriers in place to minimize cross contact • Design equipment for easy cleaning and accessibility • Consider wet-cleaning of equipment when possible.

22. Elements Of An Effective Allergen Control Plan 6. Label Review • Understand and follow government allergen labeling regulations • Allergen advisory statements should NOT be used in place of GMP’s have been applied. • Monitor, document and verify the correct label at all changeovers as they occur • Discard all out-of-date labels

23. Elements Of An Effective Allergen Control Plan 7. Validated Cleaning • Well-defined • Records • Internal/external audits

24. Summary • Food allergies affect a small percent of most populations but can potentially result in life-threatening reactions. • Major allergens have been defined in numerous markets • No threshold levels identified • Accurate allergen labeling is critical to help consumers make an informed choice • It is critical to have an allergen management program in place for all food manufacturing facilities • Use an allergen advisory statement only when the: • Presence of allergen is documented • Risk of presence is unavoidable even when following GMP’s • Allergen is present in some but not all products

25. Thank you