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Rob Sherlock & Georgina Christensen - DTS FACTA - Allergens risk management


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Rob Sherlock & Georgina Christensen delivered this presentation at the Food Regulations and Labelling Standards Conference. …

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:

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  • 1. 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
  • 2. DTS FACTA 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.
  • 3. • 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.
  • 4. Overview • Incidence – global • Legislation, time lines and geographical differences • Management tools • Thresholds and action levels • Analytical challenges • Global agreement on guidelines or legislative responses
  • 5. Food Allergy – a mystery
  • 6. 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” • /
  • 7. Incidence • Variable data • Variable mechanisms for recording • Variable definitions • Allergy Nation
  • 8. Recalls
  • 9. Positive Rates
  • 10. 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
  • 11. Codex United Japan Canada The EU Australia China Malaysia Singapore Thailand Mandatory by ministerial ordinance– As per Codex As per Codex As per Codex Codex And sesame seeds And sesame seeds Changes coming Codex cereals containing gluten crustacea eggs fish peanuts, soybeans milk including lactose tree nuts sulphites Codex And sesame seeds AS per Codex States Cereals containing gluten Crustacea Egg Fish Peanuts and soybeans As per Codex But states wheat Eggs Tree nut defn includes Milk Wheat • Added Coconut Buckwheat Peanuts. Celery Milk nut and nut product including peanut and soybean; Mustard Tree nuts fish and fish product; Molluscs ( and all their products ) Lupin milk and milk product (inc lactose) Sulphites Recent changes 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"), Variation cereal including wheat, rye, barley and oat Implementation Pending Egg and egg product. 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 Administr ation of Quality Supervisi on, Inspectio n and Quarantin e http://fsq.moh. ges/filepicker_ users/5ec3527 2cb78/Perundang an/Akta%20da n%20Peratura n/Food_Regs_ 1985/Regulati on%2011.pdf [Regulation 11 (5)] http://fsq.moh. ges/filepicker_ users/5ec3527 2cb- http://www.ava.go /0CA18578-76104917-BB67C7DF4B96504B/ 26460/2web_Foo dRegulations_3S ep2013.pdf [Regulation 4 (ea)] http://www.wtocenter.o wer?id=135404
  • 12. Management Tools • Guides • Industry • Regulators • Aspirations not achievable goals
  • 13. 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
  • 14. 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
  • 15. 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
  • 16. VSEP Recommendations – Reference Doses & VITAL® Application Allergen Protein Level (mg) •Peanut •Milk •Egg •Hazelnut •Soy •Wheat •Cashew •Mustard •Lupin •Sesame •Shrimp •Celery •Fish •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))
  • 17. 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
  • 18. VITAL® Evolving • VITAL ® 3 phases • Phase 1 – Risk Review • Phase 2 – Risk Communication (Labelling) • Phase 3 – Certification Investigation
  • 19. 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
  • 20. 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
  • 21. 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
  • 22. 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
  • 23. Best Practise • Map • Monitor • Modify
  • 24. Workshop One What are the challenges for you at a corporate or regulatory level Resources ? Trust ? Tools ? Gaps ?
  • 25. Workshop Two At the coal face what do you see your staff or regulatory implementers needing / facing
  • 26. Wrap Up Issues ? Local Global How do we best address these issues ?
  • 27. The Future AFGC Allergen Bureau Allergy Portal ASCIA K . Allen research (Murdoch Childrens Research Institute) Steve Taylor Global EFSA FDA iFAAM
  • 28. Directions and Tools Harmonisation Paper Reference groups Working groups ATSIG iFAAM working groups MoniQA – Food Allergens Reference Materials
  • 29. Global agreement on guidelines or legislative responses FDA FSA EFSA IFAAM
  • 30. 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
  • 31. 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
  • 32. 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