The document discusses risk assessment and management strategies for food allergens in Australia. It outlines regulatory requirements for labeling major food allergens, as well as best practices for identifying allergen risks through supplier information, production processes, cleaning validation, and testing. It also describes the Voluntary Incidental Trace Allergen Labeling (VITAL) program, a risk-based system used to determine when precautionary allergen labeling is required. Mobile apps are highlighted as a way for consumers to easily access product information and make informed choices.

1. Australian Food and Grocery Council
Australian Food and Grocery Council
RISK ASSESSMENT AND
MANAGEMENT STRATEGIES
FOR FOOD ALLERGENS
World of Food Safety 2013
Bangkok, Thailand

2. Australian Food and Grocery Council
• Regulatory Requirements
• Good Manufacturing Practice
• HACCP
• Supplier information
• VITAL risk assessment for labelling
• Labelling for allergens
• Mobile Apps helping consumer choices
OVERVIEW
2

3. Australian Food and Grocery Council
• Cereals containing gluten
• Crustacea and products
• Fish and products
• Eggs and products
• Milk and products
• Peanuts and products
• Soybeans and products
• Tree nuts and products
• Sesame seed and products
• Sulphite when 10 mg/kg or more added.
• proposed for consideration … Lupin
FOOD LAWS
Regulatory requirements
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4. Australian Food and Grocery Council
• ingredient means any substance, including
a food additive, used in the preparation,
manufacture or handling of a food.
• The law does not require precautionary
statements such as “May contain” .
• “May contain” is a voluntary statement to
assist with ‘informed choices’ when there is
a risk of cross-contamination of allergens
that are NOT ingredients.
INGREDIENTS AND OTHER SOURCES
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5. Australian Food and Grocery Council
• Regulatory specified allergenic risks
• Hazard identification of allergenic ingredients:
– Storage, handling, processing lines and equipment, rework
• Hazard identification of allergenic cross contact:
– Equipment and hang-ups, spills, air and water dispersal, packaging,
clothing,
• Hazard control:
– formulation, ingredient specification, supplier information and
certification, internal labelling and tagging, segregation, elimination,
cleaning, scheduling, stock movement, staff movement, packaging
label design, data management
• Monitoring and verification
– Documented plan and record keeping, visual checks, laboratory tests
• Implementation and training
– System requirements, Internal review, customer complaint
notification, crisis management and recall
GUIDING STRATEGY
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6. Australian Food and Grocery Council
GMP – training for staff & contractors
• Awareness of allergens in raw materials
and severity of reaction for consumers
• Procedures for material handling &
storage, equipment design and cleaning,
packaging, production requirements
• Personal requirements on site, staff food
vending machines, hygiene and clothing
• First aid training to use adrenaline auto-
injectors for staff at risk from food allergies
• Supported by Management Policies and
Commitment
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7. Australian Food and Grocery Council
GMP – product formulation
• Supplier management
– Review product information and assess risk
– Imported ingredient and country of origin
– Ensure notification of change for PIF
– Approved supplier list for ingredients
• Raw Material Handling
– Identification and unloading procedures
– Site management plan for storage and segregation
– Cleaning spills, product and waste disposal
• Recipe design and verification
– Ensure allergen use consistent with site policy.
– Verify ingredient requires is as supplied.
– Ensure allergen identified in data for production
scheduling and product labelling
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8. Australian Food and Grocery Council
GMP – manufacturing process
• Factory design
– Equipment designed for ease of cleaning
– Dedicated lines and equipment if possible
– Airflow and dust controlled to avoid cross-
contact
• Production
– Restricted staff movement between areas
allergen and allergen-free areas
– Production scheduling to avoid cross-
contact
– Use of internal colour codes for materials
– Use of re-work material
– Packaging material
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9. Australian Food and Grocery Council
GMP – cleaning validation
• Documented cleaning system with
validation procedures
• Use dedicated cleaning equipment that is
itself cleaned after use
• Avoid air guns and high pressure water
hoses which can disburse allergens
• Document procedures to clean hidden or
static areas in machinery and equipment
• Dismantle and clean equipment according
to production schedule requirements
• Undertake verification of cleaning
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10. Australian Food and Grocery Council
GMP – end product testing
• Analytical testing - quality assurance
validation of control capability.
• Quantitative values for VITAL assessment.
• Test methods not available for all allergens
• Processing can affect allergen structure –
reducing test specificity
• Testing options:
– ELISA kits (use in house)
– PCR (polymerase chain reaction)
– MS (mass spectrometry)
• Methods must be validated for food matrix
and reference standard
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11. Australian Food and Grocery Council
• Acceptable to food companies and their
suppliers
• Consistent with regulatory and consumer
information requirements
• Comprehensive information about
ingredients
• Assists with accurate and truthful labelling
and improved consumer confidence in
allergen statement
FACT FINDING ABOUT INGREDIENTS
Product Information Form (PIF)
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12. Australian Food and Grocery Council
ALLERGENS – OTHER THAN INGREDIENTS
Allergens present from cross-contact:
 Identify likelihood
 Quantify presence in final product
 Remove / reduce / control presence
 Provide appropriate consumer
advice
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13. Australian Food and Grocery Council
Voluntary Incidental Trace Allergen Labelling
Objectives:
 to provide a risk-based methodology for food
producers to use in assessing the impact of
allergen cross contact & provide appropriate
allergen labelling.
 to avoid the indiscriminate use of
precautionary labelling and thereby preserve
its value as a risk management tool.
VITAL
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14. Australian Food and Grocery Council
VITAL is a risk based precautionary labelling system
which uses action levels underpinned by scientific
evidence
VITAL is a:
• a process, decision tree, grid & calculator and;
• promotes consistent labelling across industry by
prescribing when a precautionary label statement
is to be applied / avoided
• one labelling approach ‘May be present’
Developed BY industry FOR industry and is adopted on a
voluntary basis
Detailed documentation and guidelines.
VITAL PROGRAM
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15. Australian Food and Grocery Council
NO
NO
Does allergen contact
product during processing?
Does allergen contact
ingredients during handling,
storage or packing?
Particulate form
Readily dispersible form
NO CROSS
CONTACT
STATEMENT
REQUIRED
YESNO
Review sources to
prevent or reduce
incidence.
NO
Action Level 2
MAY BE PRESENT
STATEMENT
REQUIRED
Determine level of allergen and
assess against VITAL grid
Action Level 1
Is the allergen above
Persistent
uncontrolled
occurrence?
Action Level 1
Is the allergen aboveYES
YES
VITAL DECISION PROCESS
YES
NO CROSS
CONTACT
STATEMENT
REQUIRED 15

16. Australian Food and Grocery Council
• Collects and assesses
information about
allergen risk in
ingredients, equipment
and control processes
• PC compatible only
• Summary page for
customers
• PDF report
• Long term plan to move
to web-based
application
VITAL CALCULATOR (V2.1.18)
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17. Australian Food and Grocery Council
Action Level 1 -
precautionary cross
contact statement is
not required
Action Level 2 -
precautionary cross
contact statement
is required
“May be Present:”

18. Australian Food and Grocery Council
EXAMPLE VITAL REPORT
Exceeds Action level 1Particulate
form
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19. Australian Food and Grocery Council
VITAL ADVANTAGE
 Guides review and management of allergen risk
 Consistent and systematic approach to:
 Assess allergens and cross contact allergens present
in ingredients.
 Assess manufacturing process for cross contact
allergens.
 Demonstrates due diligence for supply chain
 Reduce time/cost in responding to consumer
complaints and product recall
 Consistent risk assessment and
labelling across industry
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20. Australian Food and Grocery Council
VITAL AND CONSUMERS
• VITAL provides a consistent approach to
assessing cross contact allergen risk
• VITAL encourages the elimination of cross
contact allergens where possible within
manufacturing or via material supplier
• Promotes consistency in allergen labelling
• Assist in making safe food choices
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21. Australian Food and Grocery Council
Essential information for allergic
consumers to manage dietary risk
Need allergen labelling format that
helps consumers by ensuring it is:
– simple plain language
– unambiguous
– easily identifiable
– associated with or near the
ingredient list
LABELLING – A CONSUMER PERSPECTIVE
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22. Australian Food and Grocery Council
RECOMMENDED LABELLING FORMAT
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INGREDIENTS
Water, vegetable oil, vinegar, cane sugar, tomato paste (5%), salt,
parmesan cheese (2%), egg yolk, maize thickener (1412), almonds, red
capsicum, soybean oil, garlic (1.0%), vegetable gum (415), spice, herbs,
wheat cornflour, flavour (wheat maltodextrin, sesame oil), antioxidant
(320)
Contains milk, egg, almonds, soy, wheat and sesame
May be present: xxx, xxx, xxx
Tree nuts
specifically
identified
Allergenic ingredients &
derivatives declared in bold
each time they appear
Gluten source (grain source)
qualified in ingredient list
Summary statement listing all allergenic
ingredients in the product as per the table
to clause 4 Statement should start with
‘Contains…’
Precautionary statement declared if
appropriate. This statement must only be
used in conjunction with the VITAL
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23. Australian Food and Grocery Council
RECOMMENDED ALTERNATIVE FORMAT
• Recognise that limited space or packaging may limit
ability to adopt all.
• Acceptable variations are:
– bolding and qualifying allergenic substances
optional when summary statement is present
– if summary statement NOT present then allergenic
substances should be bolded and qualified in
ingredient list.
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24. Australian Food and Grocery Council
• A free to use iPhone application that delivers
trusted, authorised product data to consumers
• Wide collaboration with NGOs, universities,
industry associations, retailers and manufacturers
• Provides consumers ease of use and readability,
alert warnings, searchability extended information
• Supports all food and beverage products in the
market, branded products & private label, local &
imported
• Manufacturer direct information, irrespective of
retail outlet, maintained and updated by
manufacturer as new products released to market
MOBILE PHONE APPLICATION
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25. Australian Food and Grocery Council
EXTENDED LABELLING – CONSUMER CHOICE
Consumer/Product Mobile phone Brand/Retailer
Key concept: Consumers access to trusted product information or related services
via their mobile phone
They receive the answer
from a trusted source
A consumer has a question
about a product they are
buying.
They use their mobile
phone to scan the barcode
on the label.
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26. Australian Food and Grocery Council
CATEGORIES
• Once a product record has been found on
GS1 Databank (the database that GS1
GoScan relies on for product data) the
categories screen is displayed
• All categories for which the brand owner
has provided data are enabled
• From this screen, the consumer can
navigate to the section which contains the
data of interest…
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27. Australian Food and Grocery Council
 Consumer profile ensure that
Allergen Alert screen displays
first when product is scanned
 All Allergens declared as
“Contains” will be shown at the
top of the screen
 All Allergens declared as “May
contain” will be shown
underneath
 Large easy to read font, which
can be further expanded on
screen and, can be read using
audio assist program.
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ALLERGEN SCREENS

28. Australian Food and Grocery Council
 Extended labelling information
providing detailed information
about the type of allergens and
clarifying terms.
 Provides advice on foods to
avoid, symptoms, variety of
foods that contain the allergen,
managing food in the home,
etc.
 Allergen information sourced
from Anaphylaxis Australia,
Coeliac Australia and FSANZ
EXTENDED INFORMATION
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29. Australian Food and Grocery Council
CONSULTATION AND SUPPORT
Special thanks
Georgina Christensen
vital@allergenbureau.net

30. Australian Food and Grocery Council
Australian Food and Grocery Council
KIM LEIGHTON
DIRECTOR, POLICY AND REGULATION

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