rob sherlock & georgina christensen - dts facta - allergens risk management

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The 15 th Annual Food Regulations and Labelling Standards Conference Sydney Allergens Risk Management Dec 3 rd 2013 Rob Sherlock DTS FACTA Technical Manager & Georgina Christensen Allergen Bureau VITAL® Coordinator

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Rob Sherlock & Georgina Christensen delivered this presentation at the Food Regulations and Labelling Standards Conference. Informa's annual Food Regulations and Labelling Standards Conference is now in its 15th year and continually provides a platform to discuss the ongoing issues in food policy For more information about the event, please visit the conference website: http://www.informa.com.au/foodregs2013

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Page 1: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

The 15 th Annual Food Regulations and

Labelling Standards Conference Sydney

Allergens Risk Management Dec 3rd 2013

Rob Sherlock

DTS FACTA Technical Manager

&

Georgina Christensen

Allergen Bureau VITAL® Coordinator

Page 2: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

DTS FACTA is a unit within DTS Food Laboratories and was formed to provide

analysis and expert advice and consultative services on food borne allergens for the

food manufacturing, food service and associated supply industries. We provide training in food allergen awareness, analysis services for food borne allergens and

consultation in strategies for allergen control within factory and food service

environments.

We are endorsed by the Allergen Bureau to deliver VITAL training and also provide

specialised allergen risk assessment in food production facilities.

We have over 10 years experience in this area and hold the broadest range of

National accreditation ( National Association of Testing Authorities ) - for the

performance of a range of allergen analysis.

We work closely with both industry and regulatory laboratories and have been

involved in Industry working groups both nationally and internationally.

DTS FACTA

Page 3: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

• As food allergen related recalls increase

internationally and the rate of reported food

allergy rises, it is becoming apparent that the

management of food allergens is one of the

most significant challenges for the global food

market. The session will look at the VITAL

risk assessment tool and the impact of the

VITAL Scientific Expert Panel and the release

of VITAL2.0.

Page 4: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Overview

• Incidence – global

• Legislation, time lines and geographical

differences

• Management tools

• Thresholds and action levels

• Analytical challenges

• Global agreement on guidelines or legislative

responses

Page 5: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Food Allergy – a mystery

Page 6: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Challenges

• Geographical differences

• International labelling and safety expectations

• Lack of confidence around precautionary

labels

• New studies • “In this era of globalization, it is not only populations that migrate but

also foods, as people adopt foreign diets and import exotic products”

• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1679775/

Page 7: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Incidence

• Variable data

• Variable mechanisms for recording

• Variable definitions

• Allergy Nation

Page 8: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Recalls

Page 9: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Positive Rates

Page 10: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Legislation , time lines and

geographical differences

• Reflects the risk of the jurisdiction’s

population

• International community expects an

international approach

– A chocolate is a chocolate is a chocolate

Page 11: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Codex United

States

Japan Canada

The EU Australia

China Malaysia Singapore Thailand

Cereals containing gluten

Crustacea

Egg

Fish

Peanuts and soybeans

Milk

Tree nuts

( and all their products )

Sulphites

As per Codex

But states wheat

Tree nut defn includes

Coconut

Mandatory by ministerial ordinance–

Eggs

Milk

Wheat

Buckwheat Peanuts.

Recent changes

As per Codex

And sesame seeds

As per Codex

And sesame seeds

• Added

Celery

Mustard

Molluscs

Lupin

As per Codex

And sesame seeds

Changes coming

AS per Codex

Codex

Variation cereal including wheat, rye, barley and oat

nut and nut product including peanut and soybean;

fish and fish product;

milk and milk product (inc lactose)

Egg and egg product.

Codex

cereals

containing

gluten

crustacea

eggs

fish

peanuts,

soybeans

milk

including

lactose

tree nuts

sulphites

Codex

Implementation Pending

General STD for Labelling of Prepackaged Foods

Codex Alimentarius

Food Allergen and Consumer Protection Act 2004

Law concerning Standardization and Proper Quality Labeling of Agricultural and Forestry Products April 2002 (Law No.175 of 1950, hereinafter referred to as "JAS Law"),

Amendment to Food Allergen Labelling regulations published in 2011. in force in August 2012

EC Directive:

2000/13/EC

Introduced in 2003

FSANZ 2000 (enforced in 2002)

General Administration of Quality Supervision, Inspection and Quarantine

http://fsq.moh.gov.my/v4/images/filepicker_users/5ec35272cb-78/Perundangan/Akta%20dan%20Peraturan/Food_Regs_1985/Regulation%2011.pdf [Regulation 11 (5)]

http://fsq.moh.gov.my/v4/images/filepicker_users/5ec35272cb-78/Perundangan/Akta%20dan%20Peraturan/Food_Regs_1985/Regulation%2020.pdf [Regulation 20 (6) for sulphites]

http://www.ava.gov.sg/NR/rdonlyres/0CA18578-7610-4917-BB67-C7DF4B96504B/26460/2web_FoodRegulations_3Sep2013.pdf [Regulation 4 (ea)]

http://www.wtocenter.org.tw/SmartKMS/fileviewer?id=135404

Page 12: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Management Tools

• Guides

• Industry

• Regulators

• Aspirations not achievable goals

Page 13: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Australia and New Zealand's Industry

Tools

• AFGC Food Industry Guide to Allergen

Management and Labelling

• Product Information Form

• Allergen Bureau

• VITAL® and VITAL® support tools

Page 14: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

VITAL® -A Risk Assessment Tool

• Used to assess the impact of allergen cross contact

• Stipulates a consistent precautionary allergen

labelling statement

• Uses an action level grid to determine if the presence

of residual protein from allergenic substances

through cross contact requires precautionary labelling

Page 15: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

VITAL® Scientific Review

• Established that the Level of acceptable risk, protection for vast majority

• Reiterated that exquisitely allergic consumers are not accounted for in VITAL® , continue to assume they do not eat processed foods

• Established principles to be used in selecting ‘Action Levels’ that are;

• Scientifically & clinically sound, defensible and transparent

• Set ‘Action Levels’ with the highest degree of safety

• The more data the more confidence in the model

• Lack of data drives research

Page 16: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

VSEP Recommendations – Reference

Doses & VITAL® Application

Allergen

•Peanut

•Milk

•Egg

•Hazelnut

•Soy

•Wheat

•Cashew

•Mustard

•Lupin

•Sesame

•Shrimp

•Celery

•Fish

Protein Level (mg)

•0.2

•0.1

•0.03

•0.1 (Level used as generic tree nut value)

•1.0 (Soy protein isolates not soy milk)

•1.0 (GCC (Coeliac & wheat allergic population)

•2.0 *(Hazelnut as generic tree nuts value)

•0.05

•4.0

•0.2

•10.0 (initially 1ppm)

•NA

•NA

• (original 0.1 mg value applied))

Page 17: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Introducing VITAL® 2.0

• New procedure (Guidance document)

• Provides more information and support

• Aimed at reducing misunderstandings and inconsistencies

• New Decision tree and Calculator

• New VITAL ® Action Level Grid (incorporated in the Calculator) (VSEP Reference Dose)

• New FAQ’s and support documentation

• Development of facilitator’s guide

• Recognition of training providers

• Industry engagement & connection

• Trademarked

Page 18: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

VITAL® Evolving

• VITAL ® 3 phases

• Phase 1 – Risk Review

• Phase 2 – Risk Communication (Labelling)

• Phase 3 – Certification Investigation

Page 19: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

VITAL®

• Always more than the grid

• Numbers alone can be misleading

• Requires knowledge of all parts of the supply chain

• From raw materials, storage, manufacturing &

distribution

• Harnesses the value of physical risk review and analysis to validate management decisions and assumptions

• Results in consistent and accurate communication

to the allergic consumer

Page 20: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Analysis and Risk Assessment

• The danger if industry is hunting the numbers

alone

• Need to consider

– Sensitivity

– Suitability i.e. Fit for purpose

– Matrix effect

– Extraction efficiency

– Additive suppression action

– Differing calibrators

Page 21: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Analytical Don'ts

– Don’t take an analytical snap shot

– Don’t consider analysis as the only option

– Don’t simply compare a number to the grid

– Don’t examine analytical results in the absence of

a thorough risk assessment .

– Always more than the grid

• Numbers alone can be misleading

Page 22: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Analytical Dos

– Do use analysis to confirm assumptions

– Do use analysis for assessment of allergen profile of

raw materials

– Do use analysis to confirm validation of cleaning and

critical control points

– Do use analysis for monitoring of change impact

Page 23: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Best Practise

• Map

• Monitor

• Modify

Page 24: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Workshop One

What are the challenges for you at a corporate or

regulatory level

Resources ?

Trust ?

Tools ?

Gaps ?

Page 25: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Workshop Two

At the coal face

what do you see your staff or

regulatory implementers needing / facing

Page 26: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Wrap Up

Issues ?

Local

Global

How do we best address these issues ?

Page 27: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

The Future

AFGC

Allergen Bureau

Allergy Portal

ASCIA

K . Allen research (Murdoch Childrens Research Institute)

Steve Taylor

Global

EFSA

FDA

iFAAM

Page 28: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Directions and Tools

Harmonisation Paper

Reference groups

Working groups

ATSIG

iFAAM working groups

MoniQA – Food Allergens Reference Materials

Page 29: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Global agreement on guidelines or legislative

responses

FDA

FSA

EFSA

IFAAM

Page 30: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Publications Establishment of References

Doses for Residues of Allergenic

Foods: Report of the VITAL

Expert Panel" has been

accepted for publication in

Food and Chemical Toxicology.

Taylor S et al

Page 31: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

The future

Harmonisation

What might that look like

Where do we as food safety experts want to go

REGULATION VERSUS VOLUNTARY GUIDELINES

Best if we all walk in step

Page 32: Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management

Thank you

DTS FACTA Staff and colleagues

Allergen Bureau Board

Roger Bektash -MARS Kirsten Grinter – Nestle

Robin Sherlock - DTS FACTA Julie Newlands – Unilever

Allergen Bureau Mangement

[email protected]

VITAL® Co-ordinator Georgina Christensen

[email protected]

Information [email protected]