making vital progress - allergen...

Making VITAL® Progress

our priorities & challenges

Kirsten Grinter, ILSI China 2017

The Allergen Bureau Ltd ACN 162 786 389

Who we are

Established in 2005 due to industry demand, Management

Committee, now a ‘Not for Profit’ organisation

Over 10 years experience!

The food industry are our Members!

• 31 Full Members;

• 23 Associate members; and

• 21 Individual members

The Members steer the resources & projects

Our reason for being

Share information & experience in the management of food

allergens by developing tools to support industry with the

needs of the allergic consumer at the forefront

ILSI China March 2017 2

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


Voluntary Incidental Trace

Allergen Labelling

a standardised allergen risk

assessment process for the food

industry

What we developed - 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.

ILSI China March 2017

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


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 ® Framework:

VITAL Program

VITAL Scientific Expert Panel (VSEP)

VITAL Online

VITAL Training Providers

VITAL Working Groups

VITAL Communication


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

.

http://allergenbureau.net/vital/vital-downloads


Getting to the heart of VITAL® !

Knowledge of all parts of the supply chain

from raw materials, storage, manufacturing &

distribution

harnessing the value of physical risk review and

analysis to validate management decisions and

assumptions

to communicate accurately and

consistently to the allergic consumer


Allergen Risk

Assessment

Decision Tree

the

fundamental

first step

ingredient

specification

already identifies

intended allergens

– in Ingredient List


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

www.allergenbureau.net

* 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


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.


Example of a VITAL® Online Labelling

Outcome Summary

Source: VITAL Online

VITAL

labelling

outcomes

will appear

like this


The VITAL® Scientific Expert Panel (VSEP) Dr Steve Taylor (FARRP) (USA)

Dr Joseph Baumert (FARRP) (USA)

Dr Geert Houben (Program Manager Food Safety, TNO) (NL)

Dr Rene Crevel (Allergy & Immunology, Unilever) (UK)

Dr Katie Allen (Paediatric Gastroenterologist / Allergist, Royal Children's

Hospital, University of Melbourne) (AUS)

Dr Simon Brooke Taylor (Food Safety & Risk

Analysis Consultant, Allergen Bureau) (AUS)

The many supporters (Ben Remington,

Astrid Kruizinga, Marty Blom & others

(FARRP & TNO)

VSEP

VITAL Science –

http://allergenbureau.net/vital/vital-science/ILSI China March 2017

http://allergenbureau.net/vital/vital-science/

VSEP

The VSEP reconvened in 2015 and agreed to:

combine and review the VITAL data with the EUROPREVALL

data & review impacts for VITAL reference doses

establish protocols/criteria to signal a reference dose review

progress work on consumption data

VSEP 2016

VSEP met in Rome 2016

Next meeting in Sydney May 2017

VITAL Science –http://allergenbureau.net/vital/vital-science/



2017 VSEP priorities

Advocacy – data modelling transparency (incl. Publications)

Reference Dose Review – will be completed after the model

averaging exercise, end of 1st quarter 2017

VSEP review new data annually, protocols developed

Peanut one shot challenge, low no. of reactors & mild reactions

Egg, Milk & Hazel one shot statistically underpowered, still progressing, egg has

seen no reactors yet! (though lowest ref dose)

Geographical Criticisms - data available from limited countries

Consumption data – work continues, focus is EU, USA

consumption information is already comprehensive

VITAL Science –http://allergenbureau.net/vital/vital-science/



VITAL ® Online

The user-friendly, web-based VITAL Calculator

Input the results of a VITAL risk assessment

Output a finished product labelling outcome


Expanding VITAL Online to the world

Benefits

a consistent approach to assessing cross contact

allergen risk applied throughout the world

clear, consistent and accurate allergen declaration

(and consistent level of risk) for all consumers

Challenge

one size does not fit all


VITAL® Online usage

At end of 2016

1,270 organisations have registered accounts

over 2,080 individual users

5,500 reports generated since Aug 2015

in any 30 day period, between

250 to 430 active users

64% were returning visitors &

36% were new visitors


VITAL Online - Free 1 Month Trial

22ILSI China March 2017

Free 1 Month Trial

Provides an opportunity for users to:

complete VITAL assessments at no cost!

see how VITAL Online works

assess suitability for their organisation

create Action Level Grid Reports

store recipe and ingredient information

Makes VITAL Online accessible to all (just need email)

Creates potential for ongoing user and paid subscriber

23ILSI China March 2017

Global Partners & Training Collaborations

Partners to support and facilitate VITAL implementation

Goal is for Trainers to be managed though our Partners

Training collaborations growing very quickly

Currently 17 http://allergenbureau.net/vital/vital-training/

Ongoing industry engagement & connection

Critical to long term success

(Global consistency)


http://allergenbureau.net/vital/vital-training/

Phase 1 – Risk Review (expanding and enhancing)

Phase 2 – Risk Communication (labelling review &

pursuing exemptions)

Phase 3 – Certification Investigation

(pursuing a VITAL certification process)

AB & AI Group working together

on risk review anomalies


VITAL® Growth Working Groups

25

has developed a VITAL Verification Model and Foundation

Elements as part of the certification investigation

project commenced to draft the VITAL Program into the ‘VITAL

Scheme’ under ISO 17065

VITAL Certification Working Group

• auditable ‘VITAL

Standard’ plus

• rules and processes

to be followed by

accredited

certification bodies

(to meet ISO 17065)


Food Service Stakeholder Meeting

Approx 40 stakeholder organisations

Inform and guide training resource

development

Funding secured for resource

development (Food Service sector)


National Allergy Strategy

27

What Success Looks Like

The VITAL Program, with its tools, support material &

services, it is globally relevant

The science that underpins the reference dose/action

levels remains current through VSEP ongoing interaction

Growth through global partners and training

collaborations

Continuous development of VITAL as the industry and

the program evolves


Summary

VITAL was developed to ensure a consistent approach to risk assessment/review and precautionary labelling across industry

It has been a successful and positive collaboration between industry and consumer groups and we continue to collaborate

VITAL program provides: Risk assessment & review procedure & Decision Tree, Action Level Grid – Scientific Review, VITAL online

The VSEP underpins the scientific credibility of the system

A basis for strong Industry self-regulation

VITAL journey will continue!


Our Objective

Our Challenge

Our Engagement


Protecting the allergic consumer

Protecting the food industry

Consistency & industry alignment

One Program, Harmonised Action Levels

Scientific Validity, Training and Support

30

Allergen Bureau Management

Allergen Bureau (‘Not for Profit’)

The Board of Directors • Kirsten Grinter (Nestlé)

• Robin Sherlock (DTS)

• Julie Newlands (Unilever) (currently on leave)

• Karen Robinson (Pepsico) (Invited Director)

• David Henning (Wrigley( (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


making vital progress - allergen...

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