Ashraf Shehata

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Allergens Management A Mars PerspectiveDIFSC

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

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Mars Inc.

• gt 30 billion global revenue annually
• 6 business segments Chocolate, Pet care, Wrigley
  Gum and Confections, Food, Drinks, and
  Symbioscience
• gt 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

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Outline

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

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What is a food Allergy?
A response where the body's immune system
overreacts to the protein of a normal food

• Reactions range from mild to severe

Cutaneous
Respiratory
Anaphylactic shock
Gastrointestinal
Oropharyngeal
Allergy is different from Intolerance, (does not
involve the immune system, far less severe)
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Allergens in the Spotlight
Increase in prevalence of food allergies
More sensitive allergen detection methods
developed

• Significant increase in allergen related product
  recalls

Increased use of common manufacturing lines
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Top 8 Most Common Food Allergens
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International Food Allergen List
Sesame Sulfites
Sesame Sulfites Celery Mustard Lupin
4 of Top 8 Buckwheat
Wheat (not Gluten) Sulfites
Goats Milk
Sesame Sulfites
Only crustacea Sulfites
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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

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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

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Prevention of Allergic Reactions

• Avoidance of the food is key !!
• Total exclusion of food allergens from ones diet
  is difficult (especially for milk, eggs, wheat
  and peanuts)
• Depend entirely on the food preparer or the food
  label

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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."

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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 ltallergengt (most effective)
• Made on same equipment as ltallergengt
• Manufactured in the same facility as ltallergengt

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What happens if all products have allergen
warning statements?

Over-labelling
Increased Incidence
Consumer
Consumer Risk-Taking
Consumer Frustration
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Allergen Management Principles

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

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Mars Allergen Management Process
Arrow Process

1. Identify allergens being used on site

1. Perform a hazard analysis to determine if extra
   controls are needed

1. Verify that the controls and labeling are
   appropriate

Step 4
Step 3
Step 5
Step 2
Step 1

1. Put all mandatory GMPs in place

1. Where a hazard analysis can not be managed to
   NEGLIGIBLE, apply the labeling requirements

Approach to Manage Identified Allergen Risks
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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
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Elements Of An Effective Allergen Control Plan
1. Fundamentals

• Team
• Risk assessment
• Plan
• Training

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Elements Of An Effective Allergen Control Plan
2. Product Design

• Real difference in taste or functionality
• Question ingredient suppliers on allergens

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Elements Of An Effective Allergen Control Plan
3. Suppliers

• Allergen Management begins with raw materials
• Documented allergen control plan
• Audit
• Validate cleaning procedures

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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

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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.

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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 GMPs have been applied.
• Monitor, document and verify the correct label at
  all changeovers as they occur
• Discard all out-of-date labels

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Elements Of An Effective Allergen Control Plan
7. Validated Cleaning

• Well-defined
• Records
• Internal/external audits

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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 GMPs
• Allergen is present in some but not all products

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Thank you