rob sherlock & georgina christensen - dts facta - allergens risk management
DESCRIPTION
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/foodregs2013TRANSCRIPT
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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
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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
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• 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.
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Overview
• Incidence – global
• Legislation, time lines and geographical
differences
• Management tools
• Thresholds and action levels
• Analytical challenges
• Global agreement on guidelines or legislative
responses
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Food Allergy – a mystery
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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/
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Incidence
• Variable data
• Variable mechanisms for recording
• Variable definitions
• Allergy Nation
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Recalls
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Positive Rates
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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
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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
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Management Tools
• Guides
• Industry
• Regulators
• Aspirations not achievable goals
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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
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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
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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
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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))
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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
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VITAL® Evolving
• VITAL ® 3 phases
• Phase 1 – Risk Review
• Phase 2 – Risk Communication (Labelling)
• Phase 3 – Certification Investigation
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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
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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
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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
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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
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Best Practise
• Map
• Monitor
• Modify
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Workshop One
What are the challenges for you at a corporate or
regulatory level
Resources ?
Trust ?
Tools ?
Gaps ?
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Workshop Two
At the coal face
what do you see your staff or
regulatory implementers needing / facing
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Wrap Up
Issues ?
Local
Global
How do we best address these issues ?
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The Future
AFGC
Allergen Bureau
Allergy Portal
ASCIA
K . Allen research (Murdoch Childrens Research Institute)
Steve Taylor
Global
EFSA
FDA
iFAAM
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Directions and Tools
Harmonisation Paper
Reference groups
Working groups
ATSIG
iFAAM working groups
MoniQA – Food Allergens Reference Materials
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Global agreement on guidelines or legislative
responses
FDA
FSA
EFSA
IFAAM
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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
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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
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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
VITAL® Co-ordinator Georgina Christensen
Information [email protected]