1. Allergen Forum Update March 21, 2007 Kirsten Grinter, Nestle Fiona Fleming, GWF

2. Overview AFGC Food Industry Guide to Allergen Management and Labelling Allergen Labelling VITAL Allergen Communication

3. AFGC Food Industry Guide to Allergen Management and Labelling Kim Leighton Feb 2007

4. Overview What does the Guide cover? What’s new? Product Information Form Recommended Labelling Format Precautionary statements VITAL Tools and labelling

5. AFGC Allergen Guide Revision of the AFGC Food Industry Guide to Allergen Management and Labelling

6. Standardised Supplier Questionnaire Acceptable to food companies and their suppliers Consistent with regulatory and consumer information requirements Comprehensive information about ingredients – more than simply allergens Results in improved confidence in allergen statement

7. Standardised Supplier Questionnaire  Supplier & contact details  Product description, ingredients & origin  Product specifications  - physical, chemical, microbial, organoleptic  Allergen and compositional information  Nutrition information & dietary suitability  Pre-market clearance – irradiation / GM  Storage & transport, packaging, coding KEY INFORMATION:

8. Good Manufacturing Practices Training requirements Product formulation Cleaning validation End product testing

9. Labelling Need to develop consistent allergen labelling process to ensure it is: simple easy-to-understand easily identifiable associated with or near the ingredient list

10. VITAL  Decision Tree  Procedure  VITAL Action Level Grid Voluntary Incidental Trace Allergen Labelling - a set of allergen risk assessment tools to assist in determining when and if voluntary allergen labelling statements are used:

11. The AFGC has now released as a consultation paper for comment by industry, government regulators, key consumer organisations and other stakeholders. The consultation paper can be downloaded either from : - AFGC : http://www.afgc.org.au - Allergen Bureau: http://www.allergenbureau.net Closing date for comments: 23rd March 2007 Consultation

12. Allergen Labelling Kirsten Grinter, Nestle Project Team Leader

13. Labelling Project Brief Development of a consistent allergen labelling process appropriate for all industry groups including retail, food service, catering, commercial and point of sale labelling

14. Project Overview AFGC Food Industry Guide to Allergen Management and Labelling Domestic and international labelling review including company policies, benchmark survey Consolidation of allergen labelling attributes Consultation with external stakeholders Preferred allergen labelling format recommendation Allergen Labelling Guideline

15. Allergen Labelling Survey Extensive supermarket category review Allergen information collected for several products within each category (approx 350) Inconsistent representation Summary & Cross Contact statement details location Allergen summary statement (21) Allergen cross contact statements (42) Upper Case (59%), plain English (84%)

16. Allergen Labelling Survey Example Summary Statements! ‘ Contains …’ ‘Contains allergen products’ ‘Warning: Contains …’ ‘This product contains …’ ‘This product contains allergens’ ‘This product contains allergens. People who may be sensitive to allergens should be aware’ ‘Some ingredients contain preservative 220’ ‘ Contains allergens and may contain traces of …’ ‘Contains allergens as indicated in bold type’

17. Allergen Labelling Survey Example Cross Contact Statements! ‘ Made on equipment that also produces allergens ’ ‘ This product may contain allergens ’ ‘ May contain allergen traces ’ ‘ May contain nuts but not peanuts and some dairy’ ‘May contain traces of allergen protein’ This product may contain allergens which are natural foods’ Product manufactured on a line that produces …… Product made on the same equipment that produces …’ Packed on equipment that also packs ……’

18. Preferred Format Recommendation The Preferred Allergen labelling format includes: General requirements Ingredient list allergen declaration Allergen summary statement Cross Contact Statement Preferred alternatives have also been detailed to assist in maintaining consistency

19. Preferred Format Labelling Example (1) Water, vegetable oil, vinegar, cane sugar, tomato paste (5.0%), salt, parmesan cheese, egg yolk, maize thickener (1412), almonds, walnuts, red capsicum, soybean oil, garlic (1.0%), vegetable gum (415), spice, herbs, wheat cornflour, flavour (wheat maltodextrin, sesame, milk), antioxidant (320) Contains milk, egg, tree nuts, soy, wheat and sesame May be present: peanut

20. Preferred Format ( General Requirements) All allergen labelling information must be presented together in a block Product description and representation should be accurate Allergens must be declared using plain English terms Allergen labelling legibility should be optimised using lower case with a distinct colour contrast to the background Alternative ingredient declaration where one ingredient is an allergen and the other is not, should be avoided

21. Preferred Format (Ingredient List) All allergens to be identified in the ingredient list each time they are used in a product Allergens to be declared in bold type in the ingredient list by either bolding the ingredient or the component Eg.Parmesan cheese or Parmesan cheese (milk) Gluten source (grain source) to be qualified in the ingredient list at all times. Eg maltodextrin (from Wheat) The specific name of the tree nut/s must be declared in the ingredient list when added as a direct ingredient/s The word ‘sesame’ can be used instead of ‘sesame seeds’ A processing aid derived from an allergenic source which is present in the final food shall be declared in ingredient list

22. Preferred Format (Summary Statement) Allergen summary statement to be used and declared using the terms listed Std 1.2.3 Table to Cl4 The summary statement to be declared as: ‘Contains xxx…’ and appear directly below the ingredient list, on a separate line in bold and using the same font size Allergen summary statement required for single ingredient foods where the product does not include the name of an allergen If there is more that one gluten derived ingredient in the product the summary statement can be declared by naming each of the source grains or by using the term ‘gluten containing cereals’

23. Preferred Format (Summary Statement) (Cont) If the product contains tree nuts either the specific name of the tree nut can be declared or the general term ‘tree nuts’ can be used in the summary statement Processing aids derived from an allergenic source and present in the final food must be declared in the summary statement

24. Preferred Format ( Cross Contact Statement) Allergen cross contact statement to be declared according to the allergenic foods listed in the Vital Tool used as part of the Risk Assessment process The cross contact statement to be declared as: ‘May be present: xxx’ and appear directly below the summary statement on a separate line in bold The statement was reviewed and changed recently as VITAL needed to address both easily dispersible and particulate cross contact so the use of the word ‘traces’ became irrelevant!

25. Preferred Format ( Cross Contact Statement) (Cont) This statement is only to be used when the vital Tool has been employed as part of the risk assessment process The allergen cross contact statement text declared using the same font size as the ingredient list information or 1.5mm minimum

26. Preferred Alternatives If no summary statement is used then allergens must be declared in bold If no summary statement is used then allergens must be declared using the terms in the Table to clause 4 (Std 1.2.3) Allergens can be declared once only in the ingredient list (small label constraints) Generic terms like ‘tree nuts’ and ‘Gluten containing cereals’ can be used in the summary statement but only when there are more than 1 variety declared in the ingredient list

27. Preferred Alternative Labelling Example (2) Water, vegetable oil, vinegar, cane sugar, tomato paste (5.0%), salt, parmesan cheese, egg yolk, maize thickener (1412), almonds, walnuts, red capsicum, soybean oil, garlic (1.0%), vegetable gum (415), spice, herbs, wheat cornflour, flavour (wheat maltodextrin, sesame, milk), antioxidant (320) Contains milk, egg, tree nuts, soy, wheat and sesame May be present: peanut

28. Preferred Alternative Labelling Example (3) Water, vegetable oil, vinegar, cane sugar, tomato paste (5.0%), salt, parmesan cheese (milk), egg yolk, maize thickener (1412), tree nuts (almonds, walnuts) red capsicum, soybean oil, garlic (1.0%), vegetable gum (415), spice, herbs, wheat cornflour, flavour (wheat maltodextrin, sesame, milk), antioxidant (320) May be present: peanut

32. Barriers to Implementation Company constraints? Unable to sell any of the formats internally? Lower case vs capitals? Should this be another preferred alternative? Bold vs no bolding? Resource constraints? Awaiting formal allergen communication? Awaiting external endorsement? Awaiting VITAL completion before commencing?

33. Another Preferred Alternative? Labelling Example (4) WATER, VEGETABLE OIL, VINEGAR, CANE SUGAR, TOMATO PASTE (5.0%), SALT, PARMESAN CHEESE ( MILK), EGG YOLK, MAIZE THICKENER (1412), TREE NUTS ( ALMONDS, WALNUTS), RED CAPSICUM, SOYBEAN OIL, GARLIC (1.0%), VEGETABLE GUM (415), SPICE, HERBS, WHEAT CORNFLOUR, FLAVOUR ( WHEAT MALTODEXTRIN, SESAME, MILK ), ANTIOXIDANT (320) CONTAINS MILK, EGG, TREE NUTS, SOY, WHEAT AND SESAME MAY BE PRESENT: PEANUT

34. VITAL Fiona Fleming, GWF Project Team Leader

35. What does it mean? V I T A L

36. VITAL Voluntary Incidental Trace Allergen Labelling

37. What am I going to talk about??? VITAL – the Project What this is and isn’t VITAL Issues Next Steps

38. The Team Fiona Fleming, GWF Kirsten Grinter, Nestle Julie Newlands, Unilever Robyn Banks, Nestle Kim Leighton, AFGC Olivia Martyn, GWF Chris Preston, Legal Finesse Kevin Norman, PCA Maria Said, AAInc Robin Sherlock, facta Bill Porter, NSW Food Authority Debbie Hawkes, Danisco Dr Simon Brooke-Taylor

39. Allergen Risk Assessment Project Objective: Development of a standardised allergen risk assessment tool for food producers to use when assessing the impact of allergen cross contact and in provision of appropriate precautionary labelling

40. Cross Contact: The term "cross-contact" describes the inadvertent introduction of an allergen into a product that would not intentionally contain that allergen as an ingredient. (USFDA)

41. What VITAL Is A tool for industry intended to be used as part of your HACCP process when conducting the risk assessment for allergenic hazards 3 level grid to assist in determining if the presence of residual protein from allergenic substances requires a precautionary statement Reflects best evidence currently available

42. Who have we consulted with? Industry via project team Local and international (Nestle, Unilever, ABF, Heinz) Industry – pilots Sydney: Kellogg, Uncle Tobys, Heinz, Coles, Campbell Arnott, Danisco, Cerebos, Kraft, NSW Food Authority, George Weston Foods, Masterfoods, Unilever. Auckland: Goodman Fielder, Hansells NZ Ltd, Cerebos Greggs, George Weston Foods, Agriquality, Nestle, Sanitarium, Griffins, Manufactured Foods Database, NZ Food Safety Authority, Tegal Foods, Danisco, Mc Foodies, Lion Nathan

43. The VITAL PROCESS

44. ELEMENTS OF VITAL VITAL Decision Tree VITAL Procedure VITAL Grid, with explanatory notes VITAL excel calculation tool The VITAL procedure should be followed for each allergen that may be present in the final product due to cross contact via ingredients or processing. VITAL is not applicable to ingredients intentionally formulated into the product.

45. VITAL requires the assessment of likely sources of cross contact allergenic substances from raw materials and the processing environment, an evaluation of the amount present, a review of the ability to reduce the allergenic material from all contributing sources and ongoing monitoring and verification.

46. VITAL Decision Tree

47. 1Ingredient and Processing Impact VITAL requires the assessment of likely sources of cross contact allergenic substances from raw materials and the processing environment.

48. 2.1Review the Ingredient Allergen Impacts Assess the allergen status of the raw materials using the information from the Product Information Form (PIF). If allergenic potential exists from cross contact, determine if the presence of allergenic protein is in particulate form or a readily dispersible form. Particulate form: review contributors with the supplier to prevent occurrence OR a precautionary allergen cross contact statement will be required.

49. 2.1Review the Ingredient Allergen Impacts If the allergenic protein is present in a readily dispersible form determine with the supplier if it is feasible to reduce the level of allergen cross contact Determine the maximum amount of protein from the allergen and calculate in parts per million (ppm) or mg/kg of protein in a unit or lot of the final product.

50. 2.2Review the Manufacturing Process Allergen Impacts Determine if there are allergens present on the production line through cross contact of ingredients or product that are not formulated into the product. Determine if there are any hang-up points in the process that may cause accumulation of residues or particulate material which may result in significant variations in the quantity of allergens present in the product. Determine the maximum amount of protein from the allergen due to manufacturing cross contact and calculate in ppm or mg/kg of protein in a unit or lot of product.

51. 3. Form of Allergenic Material 3.1Particulate 3.2Readily Dispersible

52. 4Determine Amount of Cross Contact Allergen 4.1Manual Calculation Determine the total level of allergenic protein in the finished product in mg of total protein. Convert the mg of total protein to mg/kg of product. 4.2 VITAL calculation tool The VITAL calculation tool is an Excel spreadsheet which has been specifically designed to guide the user through the VITAL process and removes the need for manual calculations.

53. Danisco capabilities Spring 2006 VITAL VOLUNTARY INCIDENTAL TRACE ALLERGEN LABELLING TOOL

54. CONTENTS OF TOOL

55. VITAL TOOL Three key worksheets for entering data, calculations then all summarised to find total picture. STEP 1.Raw Material Impact – Allergen intentionally added STEP 2. Raw Material Cross Contact – Allergen cross contact from RM suppliers STEP 3.Processing Impact – Allergen cross contact from own processing. STEP 4.Summary

56. 5 The VITAL Grid Cross Contact allergen labelling NOT required Cross contact allergen labelling IS required Labelling of allergen as an ingredient is required May be present: egg Contains: milk, tree nuts, soy, wheat and sesame

57. The VITAL GRID

58. 6Review Contributors and Reduce Cross Contact 6.1Ingredient Impact - 6.2Manufacturing Process Impact 6.3Particulates

59. 7Allergen Labelling Statement ‘May be present: XXX’ To appear directly below the summary statement on a separate line in bold. No other cross contact statements are to be used The VITAL cross contact statement should only be used where cross contact is: documented using VITAL, and unavoidable, and sporadic. Cross contact statements should NEVER be used as a substitute for good manufacturing practice (GMP) or as a generic disclaimer.

60. 8Ongoing Monitoring The VITAL process should be reviewed when: Consumer complaints are received regarding allergic reactions; New ingredient or ingredient supplier Changes to equipment or process of manufacture Changes to cleaning procedure OR Every six to 12 months whichever occurs sooner.

61. 9Review of Procedure Procedure to be reviewed annually, with the first review to occur no later than February 2008.

62. VITAL in practice

63. Scenario – Malt Extract Malt extract (product A) that does not contain wheat is manufactured on a line that also produces malt extract made from wheat (product B) This Scenario discounts the fact that barley is used as a raw material and focuses on wheat contamination

64. Review the ingredient and processing allergen impacts. Ingredient Impact-Assess allergen status of raw materials Does the Raw Material Specification from the supplier indicate the possibility of cross contact with allergen/s and the level of cross contact? No – raw materials for each product indicate no cross contact. The raw materials used in product A are sourced from a NZ supplier, the wheat used in product B is sourced from Australia. All suppliers are required to certify that their products are allergen free (obviously except for wheat).

65. Processing Impact – Review the production line used to manufacture the product. Determine the allergens present on the line through cross contact that are not formulated into the product. Where is/are the allergen/s being introduced? When malt extract containing wheat is produced prior to the malt extract not made from wheat Is the source of the cross contact through line/people/tools etc Production equipment – mill etc Are there any hang up points in the process? Yes, the mill rollers and surrounding area.

66. Establish the quantity of product likely to occur at these designated points There is a possibility that 2kg of grain may contaminate the following batch. This grain is a 1:1 mixture of wheat and barley – therefore 1kg of wheat.

67. Determine the amount of protein in the wheat. and calculate in ppm. Wheat contains 12% protein (wheat gluten) Therefore in 1 kg wheat there is 120g of wheat “gluten” To calculate ppm in the subsequent batch(5000kg) (120g/1000)*100=12% 12*10000=120000ppm 1kg wheat crossed with a 5000kg batch = 0.02% ((1/5000)*100) Therefore 0.02%of the 120000ppm=24ppm of the raw materials.

68. Determine the amount of protein in the wheat and calculate in ppm. But only about 40% of the protein is water soluble, which reduces the level to 10ppm, and the majority of that is degraded during the boiling stage of the process. Hence the final amount is somewhat less than 5ppm But the liquid is concentrated into a syrup so the amount in the final product would be approximately four times that - say 20ppm

69. Determine the amount of cross contact allergen in the product ≤20ppm (<20) thus action level 1 or 2 of the Vital matrix) Level 1 – Cross Contact allergen labelling is not required Level 2 – Cross Contact allergen labelling IS required. (on the borderline so better to do something about it!)

70. Review and Reduce Cross Contact Contributors Determine if it is feasible to reduce the level of allergen cross contact. Production can be scheduled so that product containing wheat is produced at the end of the week, immediately before a full CIP Production can be scheduled so that wheat free product is produced at the start of the week, immediately after a full CIP. Milling of the wheat containing product can be programmed so that the last part of the grind is non wheat, reducing the risk of residual flour being wheat. SOP can include inspection of the mill after CIP to ensure it is clean.

71. Solution These procedures eliminate the risk

72. Issues Robustness of the Action Level numbers Assume homogenous distribution of “cross contact” allergen Variable production schedules Cross contact information from suppliers of ingredients Protein levels in allergenic foods Limits of detection for test kits Product “as sold” or “as consumed”

73. Issues Communication to small manufacturers Imported products How do consumers know which companies are using the process? Does the use of the process need to be audited to ensure compliance? Who will manage and update?

74. Further consultations with Key Stakeholders ASCIA; DAA; Coeliac Society; FSANZ; ISC; Allergy NZ; NZDAA; NZFSA; NZ Coeliac Society; FARRP; FAAN; FDF Finalise Excel tool Develop communication and implementation strategy VITAL Grid must be regularly reviewed Next Steps

75. Acknowledgements As Project Team leader I wish to acknowledge the huge amount of time and effort that the team have put into completing this project - all members of the team have contributed their time and expertise in addition to their day to day roles within their respective companies and I thank them for their support. As a Project Team we would like to thank David Roberts and Kim Leighton from AFGC for their support via the AFGC Allergen Forum and the involvement of Kim in this project. We would also like to acknowledge AFGC for their financial support for this project. The NZFGC also contributed financially to the project by covering costs for Fiona Fleming and Kirsten Grinter to travel to NZ to facilitate the pilot program in late 2006. We would also like to thank the Allergen Bureau for their financial support to assist in the completion of this project by contributing towards the cost of Dr Simon Brooke -Taylor. Last but not least, we would like to acknowledge the work of Mr Frank Lee who developed the original Allergen Grid upon which we have based the VITAL Grid. Frank saw the need for such a tool and we are indebted to the early work that he did in this area and his commitment to both allergic consumers and the food industry supplying them.

76. Contacts  Allergen Bureau  www.allergenbureau.net  Project Leaders  AFGC – Kim Leighton  Allergen Forum Chair  Fiona Fleming

77. Communication Project Industry and Allergic Community

78. Allergen Communication Project Brief Communication and education program developed to inform industry stakeholders of the allergen forum project outcomes and to encourage implementation and consistency with regard to allergen management initiatives. Communication to the allergic consumers also needs to be considered Report due Nov 07

79. Why a Communication team? Communicate project outcomes to stakeholders required to encourage implementation of allergen initiatives Small to medium size businesses can be difficult to identify! Allergen communication necessary for all size businesses Communication pathways to be developed to support industry uptake to drive consistency Success will be dependent on our ability to communicate

80. Communication Timeline Development of a register (Ongoing) Development of communication material (Jan – May 07) Disseminate communication material (May 07 onwards)

81. Next Steps Labelling Obtain feedback from workshop participants to complete to AFGC Allergen Management & Labelling Guide Ongoing monitoring of allergen labelling with regard to adoption of the labelling process and meeting the requirements and needs of the allergic community Your feedback is vital! Allergen Communication Development of a contact register to reach major stakeholders Development of training & information material Formal communication on allergen labelling initiatives to be disseminated through Allergen Communication team