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  • Allergen management ∼ it’s all about the consumer safety

    Kirsten Grinter President, Allergen Bureau

    The Allergen Bureau Ltd ACN 162 786 389

  • Discussion

    ∼ Who is the Allergen Bureau

    ∼ The VITAL Program & PAL

    ∼ VITAL growth - Allergen Bureau Working Groups

    ∼ Cross Contact Anomalies

    ∼ What success looks like


  • Who we are ∼ Established in 2005 due to industry demand, a

    ‘Not for Profit’ organisation

    ∼ Manage VITAL® Program, continues to invest & engage broadly

    ∼ Our members steer the resources & projects • 31 Full members • 23 Associate members • 21 Individual members

    Our reason for being to share information & experience across the food industry on the management of food allergens to ensure consumers receive relevant, consistent & easy to understand food allergen information ConTech2017

    PresenterPresentation Notes How the Allergen Bureau started 31 Full Members, 20 associate members and 19 Individual members Our move to become a registered Not for Profit organisation AB Business Structure & Changes, keeping the industry engaged Our Future together with the allergic consumer

  • Allergen landscape ∼ Australia New Zealand

    ∼ Allergen Bureau Industry ‘not for profit’

    ∼ AFGC Allergen Forum

    ∼ FSANZ Allergen Collaboration

    ∼ ASCIA & AAA National Allergy Strategy

    Working together to drive Allergen Management Initiatives


    PresenterPresentation NotesNeed to explain the current work being done across Australia and New Zealand and the key organisations:

    Allergen Bureau (AB) – is a ‘Not for Profit’ organisation made up of the major food industry players specialising in all aspects of allergen management including the risk review tool VITAL. The objective is the protection of the allergic consumer by ensuring that allergen management risk based initiatives are rigorous and underpinned by science and that the industry is informed, agile and strong. So protection of the allergic consumer means protection of the industry

    Australian Food & Grocery Council (AFGC) Allergen Forum – Supports industry allergen management initiatives. The AFGC has a wide group of Members who can be involved in projects and activities and they work closely with the Allergen Bureau

    FSANZ Allergen Collaboration – A whole of Government approach to allergen management, tools and education. It is a partnership approach with the secretariat sitting within the Government (Food Standards Australia New Zealand FSANZ), the membership of the collaboration includes the AB,AFGC, Allergy NZ, Catering Associations, Anaphylaxis Australia, Allergy New Zealand

    ASCIA & AA inc – Australasian Society of Clinical Immunologists and Allergists (ASCIA) and Anaphylaxis Australia (AA INC), idea is to build a national allergy strategy, provides the potential to attract funding to support the gaps identified and ensure food allergy is a recognised National priority.

  • Allergen Bureau - Why

    ∼ May contain ....... Inconsistent use of Allergen Risk Assessment

    ∼ Proliferation of cross contact statements across the industry, survey of 350 products in 2005 revealed 42 creative statements!

    • Made in the same factory/facility..... • Made on the same line.....

    ∼ Allergic consumers were ignoring cross contact statements

    ∼ Action levels varied between manufacturers, no consistency

    So… Industry Guidance and Standards were needed

    ConTech2017 5

    PresenterPresentation NotesLets go back to the beginning and explore why VITAL was developed.

    Every manufacturer used a ‘May Contain’ statement. Well we thought we were clever in the beginning trying to link a level of risk with the statement. So we developed Standardised Statements which then began to be proliferated everywhere, we only caused more consumer confusion

    AB completed a survey of products and captured allergen data and representation of allergen information, how well or bad we were doing as an industry. 42 creative cross contact statements which clearly illustrated that one we were creative with the information and two the understanding of the issue and knowledge across the industry was quite poor

    Allergic consumers ignoring cc statements and some HCP’s advising that they should also continue to ignore cc statements (butt covering)

    We had all types of statements and declarations being made and some not even about allergens! This product may contain allergens which are natural foods

    Biggest problem was around inconsistent risk assessment, everyone doing it differently and basing their assumptions on different information.

    Why I am telling you this is: We recognised that there was a gap and that allergen labelling cross contact decisions needed to be based on something

    That ‘something’ was different dependent on many factors, your organisation intelligence and maturity level on the subject, the understanding of your obligations under a duty of care

    So we were all making decisions but basing them on different information

  • Voluntary Incidental Trace Allergen Labelling

    a standardised allergen risk assessment process for the food industry

    The VITAL Program

    Developed by industry for industry and is adopted on a voluntary basis


  • What is the VITAL Program?

    The VITAL Program provides a consistent methodology for food industry to assess the impact of allergen cross contact and provide appropriate precautionary allergen labelling on their products

    The VITAL precautionary allergen statement ‘May be present: XXX’ for cross contact allergens indicates a defined level of risk based upon scientific principles.


    PresenterPresentation NotesTraining Slide Deck - What is the VITAL Program? July 2015

  • The VITAL® Program

    ∼ consistent approach to assessing cross contact allergen risk

    ∼ clear, consistent and accurate allergen declaration

    ∼ assists consumers in making safer food choices

    ∼ encourages the elimination of cross contact allergens where possible within manufacturing or via material supplier

    ∼ standard precautionary allergen labelling statement is used


    PresenterPresentation NotesTraining Slide Deck – Allergen Labelling August 2015

  • Benefits to the allergic consumer

    ∼ cross contact allergens are declared based upon a standardised risk assessment process

    ∼ founded upon scientific principles

    ∼ clear, accurate and consistent information about the allergen status of the product

    Allows the consumer to trust the information


  • Benefits to the food industry

    ∼ standardised risk review process

    ∼ labelling outcomes are based upon science

    ∼ VITAL Online - user-friendly

    Provides reassurance by virtue of informed decision making


  • VITAL Program



    Training Providers

    VITAL Online (WG2) Communication

    (WG3) Certification

    (WG1) Risk Review

    Risk Review Anomalies



    PresenterPresentation NotesThe Allergen Bureau was created to provide best practice guidance to the Australian and New Zealand (ANZ) food industry in allergen risk assessment, management and communication (labelling). In developing VITAL Program we have identified some specific areas/issue of allergen management where further guidance is required

  • The 10 Steps of VITAL® 1. Determination of relevant allergens 2. Identification of intentionally added allergens 3. Identification and quantification of cross contact allergens

    due to ingredients 4. Identification & quantification of cross contact allergens due

    to processing 5. Calculation of total cross contact allergen in finished product 6. Determination of Action Levels 7. Review of labelling recommendations and sources of cross

    contact 8. Recording of Assumptions 9. Validation of VITAL assessment 10. Ongoing Monitoring



    PresenterPresentation NotesTraining Slide Deck - What is the VITAL Program? July 2015 Not a new concept and things a lot of us already do however the need to standardise it is important and base our decisions on the same information.

  • Allergen Risk Assessment

    Decision Tree

    the fundamental

    first step

    ingredient specification

    already identifies intended allergens – in Ingredient List

    ILSI China March 2017

  • Allergen Reference Dose (mg of total protein)

    Peanut 0.2

    Milk 0.1

    Egg 0.03

    Tree nuts 0.1

    Soy 1

    Wheat 1

    Mustard 0.05

    Lupin 4

    Sesame 0.2

    Crustacea (shrimp) 10

    Fish * 0.1

    Reference Dose

    * Original VITAL value applied

    The total protein from an allergic food below which only the most sensitive individual (between 1 and 5% depending on the quality of the data) in the allergic population are likely to experience an adverse reaction


    PresenterPresentation NotesTaken from Training Slide Deck - VITAL Theory July 2015 Original VITAL value applied – LOAL of USFDA – Approaches to establish thresholds for major food allergens and for gluten in food. ( mar 2006) , with an uncertainty factor applied – 10 fold safety

  • Action Levels guide labelling recommendations

    Action Level 1 a low concentration of allergen protein and a low chance of

    adverse reaction. No precautionary statement is required.

    Action Level 2 a significant concentration of allergen protein and a significant

    chance of adverse reaction. A precautionary statement is required.


    PresenterPresentation NotesTraining Slide Deck - VITAL Theory July 2015

  • Example of a VITAL® Online Labelling Outcome Summary

    Source: VITAL Online

    VITAL labelling outcomes will appear like this


    PresenterPresentation NotesTraining Slide Deck - VITAL Theory July 2015

  • ∼ National Allergy Strategy – Food service working group

    ∼ Phase 3 – Certification (pursuing a VITAL certification process)

    ∼ Phase 2 – Risk Communication (labelling & pursuing exemptions)

    ∼ Phase 1 – Risk Review (expanding & enhancing)

    ∼ Risk Review Anomalies working with the Ai group

    VITAL growth ∼ Allergen Bureau Working Groups


    PresenterPresentation NotesThe Allergen Bureau working groups are our way of developing the VITAL Program further. The AB is continually investing in the VITAL Program and its associated toolsPhase 1 – Risk Review Expand the Risk Assessment part of VITAL Guidance specifically around physical risk reviewDevelop the ‘how to’? Lost sight of basic principles!Drive alignment in approachWorking group activity

    Phase 2Labelling review and exemptions working group.

    Phase 3 Investigation of a Certification mark based on verification of appropriate VITAL® implementation (Product or Site, still to be decided TBD)

    External verification of specific products showing VITAL® process is in control? Can we achieve this?

    Development of a programme that could be followed independently or embedded in existing programs (such as HACCP based programmes) to reduce cost and time impact

    separate audits by a specialist in the area to focus on the VITAL® component may be required

    Current audits may include VITAL based on retailer requirements

  • Phase 1 ∼ Risk Review Working Group

    ∼ Expanding guidance on how to do risk review & what that means

    ∼ New team using the foundations already built by the initial WG1

    ∼ Implementing strategies to communicate this new information to the food industry


    PresenterPresentation NotesLISARisk Review is one area where further guidance is required – this is what we have done though WG1

  • VITAL Phase 2 ∼ Risk Communication (Labelling) Working Group

    ∼ 2016 success

    ∼ Allergen labelling exemptions in regulation

    ∼ VITAL Best Practice Labelling Guide for Australia and New Zealand launched


    PresenterPresentation NotesLISAAnother example food industry collaboration Clear, accurate and consistent communication to the allergic consumer

  • ∼ Has developed a VITAL Verification Model and Foundation Elements as part of the certification investigation

    ∼ Project completed a draft the VITAL Program into the ‘VITAL Scheme’ under ISO 17065

    VITAL Phase 3 ∼ Certification Working Group

    • auditable ‘VITAL Standard’ plus

    • rules and processes to be followed by accredited certification bodies (to meet ISO 17065)


    PresenterPresentation NotesThe VITAL Scheme ("VITAL Standard" + "rules and procedures") is the outcome of the Certification WG. A food product is certified against the VITAL Standard.They are now with JAS-ANZ for initial feedback to WG3 before we finalise the draft VITAL Scheme.If directed by the Board, the next steps for us will be to trial the VITAL Scheme with industry and Certification Bodies. We would then decide whether we want to apply to JAS-ANZ for accreditation of the Scheme.

  • Working Group ∼ Risk Review Anomalies

    A working group collaboration between

    ∼ Allergen Bureau ∼ Australian Industry Group (Ai Group

    representing the Confectionary Sector; and

    ∼ in consultation with the AFGC

    Developing best practice guidance specifically with regard to allergen risk review anomaly & food labelling


    PresenterPresentation NotesRisk review anomalies is one issue where further guidance is required – this is what we have done though anomalies WG

  • Working Group ∼ Risk Review Anomalies

    Addressing what to do when cross contact is identified at levels above Action Level 2 where even under conditions of Good Manufacturing Practice (GMP) allergen cross contact may be difficult to eliminate

    Anomalies where allergens are known to be present but are:

    ∼ not formulated as an ingredient; and

    ∼ inappropriate to label as cross contact, such as VITAL ‘May be present: XXX’


    PresenterPresentation NotesThis group is investigating anomalies where allergens are known to be present but are:»» not formulated as an ingredient (as per ANZFSC definition); and»» inappropriate to label as per VITAL® ‘May be present’.These anomalies occur where the process or environment cannot be altered or impacted throughgood manufacturing practices. The group will consider options and approaches for declaring thistype of cross contact to protect consumer safety.

  • The Anomaly


  • Examples ∼ cross contact anomalies

    ∼ Background cross contact level of allergens are not sporadic (and can be at levels quite high); or

    ∼ Sporadic cross contact level of allergens where initial levels are high but deplete; or

    ∼ Sporadic cross contact level of allergens higher than the level that triggers PAL (VITAL® Action Level 2)


  • Cross contact anomalies ∼ confectionery

    ∼ Example: dark chocolate products manufactured on same equipment following milk chocolate manufacture

    ∼ Representatives from The Australian Industry Group (Ai Group) Confectionery Sector Technical Committee:

    • Mondelez International, • Mars Chocolate Australia, • Nestle Confectionery & Snacks • Fyna Foods Australia


  • Driving consistency and safety How should this type of allergen cross contact be declared to protect consumer safety?

    Options Ingredient list declaration?

    ∼ first consumer touch point for allergen information ∼ the definition of ‘ingredient’ has been removed from the

    regulation Industry Best Practice?

    ∼ key guiding principles

    Risk Review Anomalies Working Group Objective


  • What success looks like

    ∼ The VITAL Program, with its tools, support material & services, that is globally relevant

    ∼ The science that underpins the reference dose/action levels remains current through VSEP ongoing interaction

    ∼ Growth through global partners & training collaborations

    ∼ Continuous development of VITAL as the industry and the program evolves


    PresenterPresentation NotesOutputs of both WGs will contribute to Allergen Bureau mission of providing “Consistent, science-based, allergen risk assessment & labelling”

  • Allergen Bureau Management Allergen Bureau (‘Not for Profit’)

    The Board of Directors ∼ Kirsten Grinter (Nestlé) ∼ Robin Sherlock (DTS) ∼ Julie Newlands (Unilever) ∼ Karen Robinson (Invited Director) ∼ David Henning (Invited Director)

    Our support network ∼ VITAL® Coordinator /support (Georgina Christensen & Lisa Warren) ∼ Technical expertise (Simon Brooke Taylor & Lyn Davies) ∼ VITAL® Scientific Expert Panel (VSEP)

    Funded Secretariat


  • ∼ Visit the Allergen Bureau website

    ∼ Join us & enjoy the benefits of the Allergen Bureau membership

    ∼ Subscribe to our free monthly Allergen Bureau eNews

    ∼ Access the Allergen Bureau Helpline

    • email: [email protected]

    • Phone: +61 437 918 959 (International)

    For further engagement & information

    ConTech2017[email protected]

    Allergen management it’s all about the consumer safetyDiscussionWho we are �Allergen landscape Australia New Zealand�Allergen Bureau - Why�Voluntary Incidental Trace Allergen LabellingWhat is the VITAL Program?The VITAL® ProgramBenefits to the allergic consumerBenefits to the food industryThe���FrameworkThe 10 Steps of VITAL®Allergen Risk Assessment Decision Tree��the fundamental first step��ingredient specification already identifies intended allergens – in Ingredient ListSlide Number 14Action Levels guide labelling recommendationsSlide Number 16Slide Number 17Phase 1 Risk Review Working GroupVITAL Phase 2 Risk Communication (Labelling) Working GroupVITAL Phase 3 Certification Working GroupWorking Group Risk Review AnomaliesWorking Group Risk Review AnomaliesSlide Number 23Examples cross contact anomaliesCross contact anomalies confectioneryRisk Review Anomalies Working Group Objective What success looks likeAllergen Bureau Management��Slide Number 29