Transcript Mars Template - Biege Accent

Allergens Management:
A Mars Perspective
DIFSC
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Ashraf Shehata
Head of Scientific & Regulatory Affairs
Africa, India & Middle East
Mars Inc.
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> $30 billion global revenue annually
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6 business segments: Chocolate, Pet care, Wrigley Gum
and Confections, Food, Drinks, and Symbioscience
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> 65,000 associates at 230+ sites, including
135 factories in 68 countries
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10 brands worth billion-dollar-plus
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3 brands over 100 years old
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7 brands over 50 years old
Outline
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What is a food allergy ?
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What are the globally recognised Allergens?
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Allergens labelling
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Mars Allergens principles
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Allergens Control Plans
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
Gastrointestinal Oropharyngeal
Anaphylactic shock
Allergy is different from Intolerance, (does not involve the
immune system, far less severe)
Allergens in the Spotlight
Increase in prevalence of
food allergies
Increased use of common
manufacturing lines
Allergens
More sensitive allergen detection
methods developed
Significant increase in
allergen related product
recalls
Top 8 Most Common Food Allergens
CRUSTACEAN
SHELLFISH
SOYA
FISH
GLUTEN
COWS MILK
EGGS
PEANUTS
TREE NUTS
International Food Allergen List
Sesame
Sulfites
Sesame
Sulfites
Celery
Mustard
Lupin
4 of Top 8
+ Buckwheat
Wheat (not
Gluten)
Sulfites
Goat’s Milk
Only crustacea
Sulfites
Sesame
Sulfites
Prevalence of Food Allergies*
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On the increase in developed countries
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Depends on genetic factors, age, dietary habits, geography,
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Perceived prevalence 25-30%
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2-4% of adults
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Up to 8% of preschool children (many outgrow this, except peanut)
*US/ Europe statistics
Allergen Threshold Levels
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No globally accepted allergen threshold levels
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Differs from person to person
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Regulatory authorities
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Leading scientists
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5-10ppm for recall enforcement
10ppm
Manufacturers
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more conservative limit of 5ppm
Prevention of Allergic Reactions
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Avoidance of the food is key !!
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Total exclusion of food allergens from one’s diet is difficult (especially
for milk, eggs, wheat and peanuts)
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Depend entirely on the food preparer or the food label
Global Allergen Labeling Regulations
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Allergens labeling regulations exists in number of markets
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Disclose allergenic ingredients in commonly understood terms
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For Recipe Ingredients:
1.
2.
3.
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."
Allergen Advisory or Precautionary Labeling
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Applied to products when,
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despite due diligence in cleaning, it is still impossible to eliminate cross
contamination risk
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the allergen is not in the ingredient list
Examples:
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May Contain <allergen>
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Made on same equipment as <allergen>
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Manufactured in the same facility as <allergen>
(most effective)
What happens if all products have allergen
warning statements?
Over-labelling
Increased Incidence
Consumer
`
Consumer RiskTaking
Consumer Frustration
Allergen Management Principles
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Always indicate the presence of a major food allergen that is part of
the recipe in the ingredient list
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The goal is to eliminate/minimise allergen cross contact in products
to provide the consumer with more choice
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Allergen Advisory Statements will only be used on products after all
means for eliminating allergen cross contact have been considered
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An allergen will not intentionally be added to the recipe unless it is
part of the product design
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Mars allergen practices are based on the latest and best peerreviewed science
Mars Allergen Management Process
Arrow
Process
1.
Identify
3.
allergens
being used
on site
Step 1
Step 2
2.
Perform a
hazard
analysis to
determine if
extra controls
are needed
Step 3
Put all mandatory
GMPs in place
5.
Step 4
4.
Verify that the
controls and
labeling are
appropriate
Step 5
Where a hazard analysis
can not be managed to
NEGLIGIBLE, apply the
labeling requirements
Approach to Manage Identified Allergen Risks
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
Elements Of An Effective Allergen Control Plan
1. Fundamentals
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Team
Risk assessment
Plan
Training
Elements Of An Effective Allergen Control Plan
2. Product Design
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Real difference in taste or functionality
Question ingredient suppliers on allergens
Elements Of An Effective Allergen Control Plan
3. Suppliers
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Allergen Management begins with raw
materials
Documented allergen control plan
Audit
Validate cleaning procedures
Elements Of An Effective Allergen Control Plan
4. Segregation
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Raw materials carrying an allergen
advisory label must be treated as
containing the allergen
Avoid combined storage
Sufficient separation/isolation
Spill control procedure specified
Elements Of An Effective Allergen Control Plan
5. Minimize Cross Contact
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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 nonallergenic 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.
Elements Of An Effective Allergen Control Plan
6. Label Review
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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
Elements Of An Effective Allergen Control Plan
7. Validated Cleaning
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Well-defined
Records
Internal/external audits
Summary
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Food allergies affect a small percent of most populations but can
potentially result in life-threatening reactions.
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Major allergens have been defined in numerous markets
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No threshold levels identified
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Accurate allergen labeling is critical to help consumers make an
informed choice
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It is critical to have an allergen management program in place for all
food manufacturing facilities
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Use an allergen advisory statement only when the:
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Presence of allergen is documented
Risk of presence is unavoidable even when following GMP’s
Allergen is present in some but not all products
Thank you