VITAL A practical approach to allergen risk assessment and management

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1 VITAL A practical approach to allergen risk assessment and management Rob Sherlock VP Allergen Bureau Technical Manager DTS FACTA rsherlock@dtsfoodlabs.com.au

2 gov.my/v4/ima ges/filepicker_ users/5ec3527 2cb- 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 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 gov.my/v4/ima ges/filepicker_ users/5ec3527 2cb- 78/Perundang an/akta%20da n%20peratura n/food_regs_ 1985/Regulati on%2011.pdf [Regulation 11 (5)] v.sg/nr/rdonlyres /0CA BB67- C7DF4B96504B/ 26460/2web_Foo dregulations_3s ep2013.pdf [Regulation 4 (ea)] rg.tw/smartkms/filevie wer?id=135404

3 Challenges For the Global Community Legislation, time lines and geographical differences Population variation Reflects the risk of the jurisdiction s population International labelling and safety expectations In this era of globalization, it is not only populations that migrate but also foods, as people adopt foreign diets and import exotic products * Lack of confidence around precautionary labels New studies *

4 Management Tools Guides Industry Regulators Aspirations not achievable goals Traditional Tools and Handy Acronyms GMP SOP HACCP The key is to know your enemy

5 Relative Risk Not all risks are equal Not all allergens are the same Behaviour and characteristics Relative Risk and potential outcome Divergent Raw Material Allergen Profile Unintentional incorporation Cross contact allergen Disaster Mentality Cannot afford to be immobilised by uncertainty

6 The Allergen Bureau Established in 2005 due to industry demand, Management Committee, now a Not for Profit organisation 10 years experience! The food industry are our Members! 28 Full Members; 12 Associate members; and 10 Individual members The Members steer the resources & projects Our Driver 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

7 Voluntary Incidental Trace Allergen Labelling The VITAL (Voluntary Incidental Trace Allergen Labelling) Program is a standardised allergen risk assessment process for food industry

8 VITAL -A Risk Assessment Tool Used to assess the impact of allergen cross contact Uses an action level grid to determine if the presence of residual protein from allergenic substances through cross contact requires precautionary labelling Stipulates a consistent precautionary allergen labelling statement may be present Aims to avoid indiscriminate use of precautionary labelling and preserve a valuable risk management tool.

9 The VITAL Process A systematic approach to processes and allergenic contributors Part of a HACCP based food safety program Considers Ingredient and processing impact Considers the form of allergenic material Determine the amount of cross contact allergen in the finished product ( in terms of protein content ) Consider the VITAL grid and determine the appropriate allergen labelling statement Review significant contributors and reduce cross contact Ongoing Monitoring

10 VITAL Scientific Expert Panel (VSEP) Panel Members are: Dr Steve Taylor (FARRP) Dr Joseph Baumert (FARRP), supported by Mr Benjamin Remington (FARRP), Dr Geert Houben (Program Manager Food Safety,TNO. NL) Dr Rene Crevel (Allergy & Immunology, Unilever) Dr Katie Allen (Paediatric Gastroenterologist/Allergist, Royal Children's Hospital, University of Melbourne), supported by Ms Jennifer Koplin Dr Simon Brooke Taylor (Food Safety & Risk Analysis Consultant, Allergen Bureau) The VSEP received significant support from Astrid Kruizinga (TNO), Ellen Dutman (TNO) & Harrie Buist (TNO)

11 VITAL Scientific Expert Panel Remains an integral part of our structure- they give VITAL scientific credibility & rigour Meetings & interaction are supported as the science evolves Brings a global perspective so VITAL can remain a relevant tool Are positive advocates amongst key stakeholder groups VSEP

12 Publications

13 VITAL PROGRAM Consists of a range of tools: 1. VITAL Procedure (the 10 steps of VITAL) 2. VITAL Decision Tree 3. VITAL Reference Doses 4. VITAL Action Level Grid 5. VITAL calculator (VITAL Online or Excel version) 6. VITAL training materials 7. Guidance documents includes the Food Industry Guide to the Voluntary Incidental Trace Allergen Labelling (VITAL) Program

14 Reference Dose As recommended by the VSEP Based on 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 Allergen Peanut Milk Egg Tree nuts Soy Wheat Mustard Lupin Sesame Crustacea (Shrimp) Fish Reference Dose (mg) NA

15 Action Levels Based on the relationship between Reference Dose and Serving Size or Reference Amount Action levels are the concentrations which define how cross contact allergens should be labelled Action Level One = a low concentration of cross contact allergen protein and a low chance of adverse reaction. No precautionary statement is required. Action Level Two = a significant concentration of cross contact allergen protein and a significant chance of adverse reaction. A precautionary statement is required. The larger the serving size the lower the action level

16 VITAL Action Level Grid Embedded in the Calculator Specific to each product Based on Reference Dose and appropriate Reference Amount/Serving Size Action levels guide labelling Can be applied to ingredients by opting out of serving size

17 Sensitivity is a sensitive issue Some commodities more exposed to risk by the expectation related to serving size Serving size will be critical to risk communication Large serving size Drive the methods Guidelines around serving size (AFGC) Consumption data research gaps to inform company decisions Serving size if often driven by nutrition claims Eg. Increase serving size for fibre claim, or vitamin claim

18 VITAL Program Resources

19 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

20 Site Review Hands on Tools Map Process Flows Walk the line Get in touch with your equipment Real versus perceived risk

21 1. Determination of relevant allergens 2. Identification of intentionally added allergens The 10 Steps of VITAL 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

22 Role of Allergen Testing in a VITAL context Assessment of raw material allergen status Assessment of allergen status of the final product to compare with calculated results from VITAL assessment Monitoring the effect of critical changes Examining allergen status of production surfaces Monitoring of cleaning solutions and flushing On going monitoring of production performance and compliance Validation of the VITAL risk assessment Requires a thorough understanding of analytical limitations and the use of an appropriate sampling plan

23 VITAL Online A web based calculator that uses the Reference Dose information in conjunction with the Reference Amount and provides Action Levels that set out a labelling recommendation for individual foods

24 VITAL Online access through website

25 Features of VITAL Online Create an ingredient library & use these ingredients in multiple recipes Create a processing profile library & use these processing profiles in multiple recipes Store completed recipes Reference Doses controlled by the Allergen Bureau Increased focus on recording assumptions & rationale for key decisions

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27 VITAL Difference Not a regulatory response Supported but not endorsed by government Allows rapid response to changing science Recognise that not all bodies and organisations will follow the same approach

28 Learnings VITAL itself does not convey safety VITAL must be part of a total allergen management package VITAL requires a robust risk assessment and risk management strategies A significant proportion of allergen recalls globally are related to non cross contact issues.

29 VITAL Growth Working Groups 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

30 Allergen Bureau ( Not for Profit ) The Board of Directors Kirsten Grinter (Nestlé) Robin Sherlock (DTS) Karen Robinson (McDonald s) Julie Newlands (Unilever) Thank you Our support network VITAL Coordinator /support (Georgina Christensen & Lisa Warren) Technical expertise (Simon Brooke Taylor & Lyn Davies) VITAL Scientific Expert Panel (VSEP) Allergen Bureau advisors (David Henning & Fiona Fleming) Funded Secretariat: Tom Lewis and Ray Murphy management@allergenbureau.net