Allergen Forum Update
March 21, 2007
Kirsten Grinter, Nestle
Fiona Fleming, GWF
Overview
• AFGC Food Industry Guide to
Allergen Management and
Labelling
• Allergen Labelling
• VITAL
• Allergen Communication
AFGC Food Industry Guide to
Allergen Management and
Labelling
Kim Leighton
Feb 2007
Overview
What does the Guide cover?
What’s new?
• Product Information Form
• Recommended Labelling
Format
• Precautionary statements
• VITAL Tools and labelling
AFGC Allergen Guide
Revision of the AFGC
Food Industry Guide
to Allergen
Management and
Labelling
Standardised Supplier Questionnaire
Acceptable to food companies
and their suppliers
Consistent with regulatory and
consumer information
requirements
Comprehensive information
about ingredients – more
than simply allergens
Results in improved confidence
in allergen statement
Standardised Supplier Questionnaire
KEY INFORMATION:
Supplier & contact details
Product description, ingredients & origin
Product specifications
 - physical, chemical, microbial, organoleptic
Allergen and compositional information
Nutrition information & dietary suitability
Pre-market clearance – irradiation / GM
Storage & transport, packaging, coding
Good Manufacturing Practices
• Training
requirements
• Product formulation
• Cleaning validation
• End product testing
Labelling
Need to develop consistent
allergen labelling process
to ensure it is:
•
•
•
•
simple
easy-to-understand
easily identifiable
associated with or near the
ingredient list
VITAL
Voluntary Incidental Trace Allergen Labelling
- a set of allergen risk assessment tools to assist in
determining when and if voluntary allergen labelling
statements are used:
 Decision Tree
 Procedure
 VITAL Action Level Grid
Consultation
The AFGC has now released as a consultation paper for
comment by industry, government regulators, key
consumer organisations and other stakeholders.
The consultation paper can be downloaded either from :
- AFGC :
- Allergen Bureau:
http://www.afgc.org.au
http://www.allergenbureau.net
Closing date for comments: 23rd March 2007
Allergen Labelling
Kirsten Grinter, Nestle
Project Team Leader
Labelling Project Brief
Development of a consistent allergen
labelling process appropriate for all
industry groups including retail, food
service, catering, commercial and point
of sale labelling
Project Overview
• AFGC Food Industry Guide to Allergen
Management and Labelling
• Domestic and international labelling review
including company policies, benchmark survey
• Consolidation of allergen labelling attributes
• Consultation with external stakeholders
• Preferred allergen labelling format
recommendation
• Allergen Labelling Guideline
Allergen Labelling Survey
• Extensive supermarket category review
• Allergen information collected for several products
within each category (approx 350)
• Inconsistent representation
• Summary & Cross Contact statement details location
• Allergen summary statement (21)
• Allergen cross contact statements (42)
• Upper Case (59%), plain English (84%)
Allergen Labelling Survey
Example Summary Statements!
• ‘Contains …’
•
•
•
•
•
‘Contains allergen products’
‘Warning: Contains …’
‘This product contains …’
‘This product contains allergens’
‘This product contains allergens. People who may be
sensitive to allergens should be aware’
• ‘Some ingredients contain preservative 220’
• ‘ Contains allergens and may contain traces of …’
• ‘Contains allergens as indicated in bold type’
Allergen Labelling Survey
Example Cross Contact Statements!
• ‘Made on equipment that also produces allergens’
• ‘This product may contain allergens’
• ‘May contain allergen traces’
• ‘May contain nuts but not peanuts and some dairy’
•
•
•
•
•
‘May contain traces of allergen protein’
This product may contain allergens which are natural foods’
Product manufactured on a line that produces ……
Product made on the same equipment that produces …’
Packed on equipment that also packs ……’
Preferred Format Recommendation
The Preferred Allergen labelling format includes:
• General requirements
• Ingredient list allergen declaration
• Allergen summary statement
• Cross Contact Statement
• Preferred alternatives have also been detailed to
assist in maintaining consistency
Preferred Format
Labelling Example (1)
• Water, vegetable oil, vinegar, cane sugar, tomato
paste (5.0%), salt, parmesan cheese, egg yolk, maize
thickener (1412), almonds, walnuts, red capsicum,
soybean oil, garlic (1.0%), vegetable gum (415), spice,
herbs, wheat cornflour, flavour (wheat maltodextrin,
sesame, milk), antioxidant (320)
• Contains milk, egg, tree nuts, soy, wheat and
sesame
• May be present: peanut
Preferred Format (General
Requirements)
• All allergen labelling information must be presented
together in a block
• Product description and representation should be
accurate
• Allergens must be declared using plain English terms
• Allergen labelling legibility should be optimised using
lower case with a distinct colour contrast to the
background
• Alternative ingredient declaration where one ingredient
is an allergen and the other is not, should be avoided
Preferred Format
(Ingredient List)
• All allergens to be identified in the ingredient list each time
they are used in a product
• Allergens to be declared in bold type in the ingredient list
by either bolding the ingredient or the component
Eg.Parmesan cheese or Parmesan cheese (milk)
• Gluten source (grain source) to be qualified in the ingredient
list at all times. Eg maltodextrin (from Wheat)
• The specific name of the tree nut/s must be declared in
the ingredient list when added as a direct ingredient/s
• The word ‘sesame’ can be used instead of ‘sesame seeds’
• A processing aid derived from an allergenic source which is
present in the final food shall be declared in ingredient list
Preferred Format
(Summary Statement)
• Allergen summary statement to be used and declared using the
terms listed Std 1.2.3 Table to Cl4
• The summary statement to be declared as: ‘Contains xxx…’ and
appear directly below the ingredient list, on a separate line in
bold and using the same font size
• Allergen summary statement required for single ingredient foods
where the product does not include the name of an allergen
• If there is more that one gluten derived ingredient in the
product the summary statement can be declared by naming each
of the source grains or by using the term ‘gluten containing
cereals’
Preferred Format
(Summary Statement)
(Cont)
• If the product contains tree nuts either the specific name
of the tree nut can be declared or the general term ‘tree
nuts’ can be used in the summary statement
• Processing aids derived from an allergenic source and
present in the final food must be declared in the summary
statement
Preferred Format
(Cross Contact Statement)
• Allergen cross contact statement to be declared according
to the allergenic foods listed in the Vital Tool used as part
of the Risk Assessment process
• The cross contact statement to be declared as:
• ‘May be present: xxx’ and
• appear directly below the summary statement on a
separate line in bold
• The statement was reviewed and changed recently as VITAL
needed to address both easily dispersible and particulate
cross contact so the use of the word ‘traces’ became
irrelevant!
Preferred Format
(Cross Contact Statement)
(Cont)
• This statement is only to be used when the vital Tool has
been employed as part of the risk assessment process
• The allergen cross contact statement text declared using
the same font size as the ingredient list information or
1.5mm minimum
Preferred Alternatives
• If no summary statement is used then allergens must
be declared in bold
• If no summary statement is used then allergens must
be declared using the terms in the Table to clause 4
(Std 1.2.3)
• Allergens can be declared once only in the ingredient
list (small label constraints)
• Generic terms like ‘tree nuts’ and ‘Gluten containing
cereals’ can be used in the summary statement but
only when there are more than 1 variety declared in
the ingredient list
Preferred Alternative
Labelling Example (2)
• Water, vegetable oil, vinegar, cane sugar, tomato
paste (5.0%), salt, parmesan cheese, egg yolk, maize
thickener (1412), almonds, walnuts, red capsicum,
soybean oil, garlic (1.0%), vegetable gum (415), spice,
herbs, wheat cornflour, flavour (wheat maltodextrin,
sesame, milk), antioxidant (320)
• Contains milk, egg, tree nuts, soy, wheat and
sesame
• May be present: peanut
Preferred Alternative
Labelling Example (3)
• Water, vegetable oil, vinegar, cane sugar, tomato
paste (5.0%), salt, parmesan cheese (milk), egg yolk,
maize thickener (1412), tree nuts (almonds, walnuts)
red capsicum, soybean oil, garlic (1.0%), vegetable
gum (415), spice, herbs, wheat cornflour, flavour
(wheat maltodextrin, sesame, milk), antioxidant
(320)
• May be present: peanut
Barriers to Implementation
• Company constraints?
• Unable to sell any of the formats
internally?
•
•
•
•
• Lower case vs capitals? Should this be another
preferred alternative?
• Bold vs no bolding?
Resource constraints?
Awaiting formal allergen communication?
Awaiting external endorsement?
Awaiting VITAL completion before
commencing?
Another Preferred Alternative?
Labelling Example (4)
• WATER, VEGETABLE OIL, VINEGAR, CANE SUGAR, TOMATO
PASTE (5.0%), SALT, PARMESAN CHEESE (MILK), EGG YOLK,
MAIZE THICKENER (1412), TREE NUTS (ALMONDS,
WALNUTS), RED CAPSICUM, SOYBEAN OIL, GARLIC (1.0%),
VEGETABLE GUM (415), SPICE, HERBS, WHEAT CORNFLOUR,
FLAVOUR (WHEAT MALTODEXTRIN, SESAME, MILK),
ANTIOXIDANT (320)
• CONTAINS MILK, EGG, TREE NUTS, SOY, WHEAT AND
SESAME
• MAY BE PRESENT: PEANUT
VITAL
Fiona Fleming, GWF
Project Team Leader
What does it mean?
V
I
T
A
L
VITAL
Voluntary
Incidental
Trace
Allergen
Labelling
What am I going to talk about???
• VITAL – the Project
• What this is and isn’t
• VITAL
• Issues
• Next Steps
The Team
Fiona Fleming, GWF
Kirsten Grinter, Nestle
Julie Newlands, Unilever
Robyn Banks, Nestle
Kim Leighton, AFGC
Olivia Martyn, GWF
Chris Preston, Legal
Finesse
Kevin Norman, PCA
Maria Said, AAInc
Robin Sherlock, facta
Bill Porter, NSW Food
Authority
Debbie Hawkes, Danisco
Dr Simon Brooke-Taylor
Allergen Risk Assessment Project
Objective:
Development of a
standardised allergen
risk assessment tool
for food producers to
use when assessing the
impact of allergen cross
contact and in provision
of appropriate
precautionary labelling
Cross Contact:
The term "cross-contact" describes
the inadvertent introduction of an
allergen into a product that would
not intentionally contain that
allergen as an ingredient. (USFDA)
What VITAL Is
• A tool for industry intended to be used as
part of your HACCP process when conducting
the risk assessment for allergenic hazards
• 3 level grid to assist in determining if the
presence of residual protein from allergenic
substances requires a precautionary
statement
• Reflects best evidence currently available
Who have we consulted with?
Industry via project team
• Local and international (Nestle, Unilever, ABF, Heinz)
Industry – pilots
• Sydney: Kellogg, Uncle Tobys, Heinz, Coles, Campbell
Arnott, Danisco, Cerebos, Kraft, NSW Food
Authority, George Weston Foods, Masterfoods,
Unilever.
• Auckland: Goodman Fielder, Hansells NZ Ltd, Cerebos
Greggs, George Weston Foods, Agriquality, Nestle,
Sanitarium, Griffins, Manufactured Foods Database,
NZ Food Safety Authority, Tegal Foods, Danisco, Mc
Foodies, Lion Nathan
The VITAL PROCESS
ELEMENTS OF VITAL
•
•
•
•
VITAL
VITAL
VITAL
VITAL
Decision Tree
Procedure
Grid, with explanatory notes
excel calculation tool
The VITAL procedure should be followed for each
allergen that may be present in the final product due
to cross contact via ingredients or processing.
VITAL is not applicable to ingredients intentionally
formulated into the product.
VITAL requires
• the assessment of likely sources of cross
contact allergenic substances from raw
materials and the processing environment,
• an evaluation of the amount present,
• a review of the ability to reduce the
allergenic material from all contributing
sources and
• ongoing monitoring and verification.
VITAL
Decision
Tree
1
Ingredient and Processing Impact
VITAL requires the assessment of
likely sources of cross contact
allergenic substances from raw
materials and the processing
environment.
2.1
Review the Ingredient Allergen Impacts
• Assess the allergen status of the raw materials using
the information from the Product Information Form
(PIF).
• If allergenic potential exists from cross contact,
determine if the presence of allergenic protein is in
particulate form or a readily dispersible form.
• Particulate form:
• review contributors with the supplier to prevent occurrence
OR
• a precautionary allergen cross contact statement will be
required.
2.1
Review the Ingredient Allergen Impacts
If the allergenic protein is present in a readily
dispersible form determine with the supplier if
it is feasible to reduce the level of allergen
cross contact
Determine the maximum amount of protein from
the allergen and calculate in parts per million
(ppm) or mg/kg of protein in a unit or lot of the
final product.
2.2
Review the Manufacturing Process
Allergen Impacts
Determine if there are allergens present on the production line
through cross contact of ingredients or product that are not
formulated into the product.
Determine if there are any hang-up points in the process that
may cause accumulation of residues or particulate material
which may result in significant variations in the quantity of
allergens present in the product.
Determine the maximum amount of protein from the allergen
due to manufacturing cross contact and calculate in ppm
or mg/kg of protein in a unit or lot of product.
3. Form of Allergenic Material
3.1
Particulate
3.2
Readily Dispersible
4
Determine Amount of Cross Contact
Allergen
4.1 Manual Calculation
Determine the total level of allergenic protein in the
finished product in mg of total protein.
Convert the mg of total protein to mg/kg of product.
4.2 VITAL calculation tool
The VITAL calculation tool is an Excel spreadsheet
which has been specifically designed to guide the user
through the VITAL process and removes the need for
manual calculations.
VITAL
VOLUNTARY INCIDENTAL TRACE
ALLERGEN LABELLING TOOL
Danisco capabilities
Spring 2006
CONTENTS OF TOOL
ThreeTOOL
key worksheets for entering data, calculations
VITAL
then all summarised to find total picture.
STEP 1.
Raw Material Impact
– Allergen intentionally added
STEP 2.
Raw Material Cross Contact
– Allergen cross contact from RM suppliers
STEP 3.
Processing Impact
– Allergen cross contact from own
processing.
STEP 4.
Summary
5 The VITAL Grid
Action level 1
Cross Contact allergen labelling NOT
required
Cross contact allergen labelling IS
required
May be present: egg
Action level 2
Labelling of allergen as an ingredient is
required
Contains: milk, tree nuts, soy, wheat and
sesame
Action level 3
The VITAL GRID
6
Review Contributors and Reduce Cross
Contact
6.1
6.2
6.3
Ingredient Impact Manufacturing Process
Impact
Particulates
7
Allergen Labelling Statement
‘May be present: XXX’
• To appear directly below the summary statement on a
separate line in bold.
• No other cross contact statements are to be used
• The VITAL cross contact statement should only be used
where cross contact is:
• documented using VITAL, and
• unavoidable, and
• sporadic.
Cross contact statements should NEVER be used as a
substitute for good manufacturing practice (GMP) or as a
generic disclaimer.
8
Ongoing Monitoring
The VITAL process should be reviewed when:
• Consumer complaints are received regarding
allergic reactions;
• New ingredient or ingredient supplier
• Changes to equipment or process of manufacture
• Changes to cleaning procedure
OR
Every six to 12 months
whichever occurs sooner.
9
Review of Procedure
Procedure to be reviewed annually,
with the first review to occur no
later than February 2008.
VITAL in practice
Scenario – Malt Extract
Malt extract (product A) that does not
contain wheat is manufactured on a line
that also produces malt extract made
from wheat (product B)
This Scenario discounts the fact that
barley is used as a raw material and
focuses on wheat contamination
Review the ingredient and processing allergen
impacts.
Ingredient Impact-Assess allergen status of raw
materials
Does the Raw Material Specification from the supplier
indicate the possibility of cross contact with allergen/s
and the level of cross contact?
No – raw materials for each product indicate no cross
contact. The raw materials used in product A are sourced
from a NZ supplier, the wheat used in product B is sourced
from Australia. All suppliers are required to certify that
their products are allergen free (obviously except for
wheat).
Processing Impact – Review the production line used to
manufacture the product.
Determine the allergens present on the line through
cross contact that are not formulated into the product.
Where is/are the allergen/s being introduced?
• When malt extract containing wheat is produced
prior to the malt extract not made from wheat
• Is the source of the cross contact through
line/people/tools etc
• Production equipment – mill etc
Are there any hang up points in the process?
• Yes, the mill rollers and surrounding area.
Establish the quantity of product likely to occur at
these designated points
There is a possibility that 2kg of grain may
contaminate the following batch.
This grain is a 1:1 mixture of wheat and
barley – therefore 1kg of wheat.
Determine the amount of protein in the wheat. and
calculate in ppm.
• Wheat contains 12% protein (wheat
gluten)
• Therefore in 1 kg wheat there is 120g
of wheat “gluten”
• To calculate ppm in the subsequent
batch(5000kg)
• (120g/1000)*100=12%
• 12*10000=120000ppm
• 1kg wheat crossed with a 5000kg
batch = 0.02% ((1/5000)*100)
• Therefore 0.02%of the
120000ppm=24ppm of the raw
materials.
Determine the amount of protein in the wheat and calculate in
ppm.
But only about 40% of the protein is
water soluble, which reduces the level
to 10ppm, and the majority of that is
degraded during the boiling stage of
the process.
Hence the final amount is somewhat
less than 5ppm
But the liquid is concentrated into a
syrup so the amount in the final
product would be approximately four
times that - say 20ppm
Determine the amount of cross contact allergen in
the product
≤20ppm (<20) thus action level 1 or 2 of the Vital
matrix)
Level 1 – Cross Contact allergen labelling is not
required
Level 2 – Cross Contact allergen labelling IS
required.
(on the borderline so better to do something about
it!)
Review and Reduce Cross Contact Contributors
Determine if it is feasible to reduce the level of allergen
cross contact.
• Production can be scheduled so that product
containing wheat is produced at the end of the
week, immediately before a full CIP
• Production can be scheduled so that wheat free
product is produced at the start of the week,
immediately after a full CIP.
• Milling of the wheat containing product can be
programmed so that the last part of the grind is
non wheat, reducing the risk of residual flour
being wheat.
• SOP can include inspection of the mill after CIP to
ensure it is clean.
Solution
These procedures
eliminate the risk
Issues
• Robustness of the Action Level numbers
• Assume homogenous distribution of
“cross contact” allergen
• Variable production schedules
• Cross contact information from suppliers
of ingredients
• Protein levels in allergenic foods
• Limits of detection for test kits
• Product “as sold” or “as consumed”
Issues
• Communication to small manufacturers
• Imported products
• How do consumers know which companies
are using the process?
• Does the use of the process need to be
audited to ensure compliance?
• Who will manage and update?
Next Steps
• Further consultations with Key Stakeholders
• ASCIA; DAA; Coeliac Society; FSANZ; ISC;
Allergy NZ; NZDAA; NZFSA; NZ Coeliac
Society; FARRP; FAAN; FDF
• Finalise Excel tool
• Develop communication and implementation
strategy
• VITAL Grid must be regularly reviewed
Acknowledgements
As Project Team leader I wish to acknowledge the huge amount of time
and effort that the team have put into completing this project - all
members of the team have contributed their time and expertise in
addition to their day to day roles within their respective companies
and I thank them for their support.
As a Project Team we would like to thank David Roberts and Kim Leighton
from AFGC for their support via the AFGC Allergen Forum and the
involvement of Kim in this project. We would also like to acknowledge
AFGC for their financial support for this project. The NZFGC also
contributed financially to the project by covering costs for Fiona
Fleming and Kirsten Grinter to travel to NZ to facilitate the pilot
program in late 2006.
We would also like to thank the Allergen Bureau for their financial
support to assist in the completion of this project by contributing
towards the cost of Dr Simon Brooke -Taylor.
Last but not least, we would like to acknowledge the work of Mr Frank
Lee who developed the original Allergen Grid upon which we have
based the VITAL Grid. Frank saw the need for such a tool and we are
indebted to the early work that he did in this area and his
commitment to both allergic consumers and the food industry
supplying them.
Contacts
Allergen Bureau
 www.allergenbureau.net
Project Leaders
AFGC – Kim Leighton
Allergen Forum Chair
Fiona Fleming
Communication Project
Industry and Allergic Community
Allergen Communication Project Brief
Communication and education program
developed to inform industry stakeholders
of the allergen forum project outcomes
and to encourage implementation and
consistency with regard to allergen
management initiatives. Communication to
the allergic consumers also needs to be
considered
Report due Nov 07
Why a Communication team?
• Communicate project outcomes to stakeholders
required to encourage implementation of allergen
initiatives
• Small to medium size businesses can be difficult
to identify! Allergen communication necessary for
all size businesses
• Communication pathways to be developed to
support industry uptake to drive consistency
• Success will be dependent on our ability to
communicate
Communication Timeline
• Development of a register (Ongoing)
• Development of communication material (Jan –
May 07)
• Disseminate communication material (May 07
onwards)
Next Steps
Labelling
•
Obtain feedback from workshop participants to complete to AFGC
Allergen Management & Labelling Guide
•
Ongoing monitoring of allergen labelling with regard to adoption of
the labelling process and meeting the requirements and needs of
the allergic community
• Your feedback is vital!
Allergen Communication
•
Development of a contact register to reach major stakeholders
•
Development of training & information material
•
Formal communication on allergen labelling initiatives to be
disseminated through Allergen Communication team