VITAL 2.0. What is it, how does it work and the way forward. Geert Houben TNO, The Netherlands

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1 VITAL 2.0 What is it, how does it work and the way forward Geert Houben TNO, The Netherlands

2 This presentation is not about the labelling of allergenic ingredients! Regulation 2003/89/EC &2006/142/EC: for allergens present according to recipe

3 This presentation is not about free from claims!

4 This presentation is about precautionary ( may contain ) labelling!

5 This presentation is about precautionary ( may contain ) labelling! But only about when to warn, and not about how to warn (wording)

6 Although

7 Although

8 Although

9 English Although

10 Although Dutch English

Precautionary labelling is lacking clear quantitative guidance Result: may contain statements lack correlation with actual risks of presence of non-ingredient allergens in a wide variety of products

11 Precautionary labelling is lacking clear quantitative guidance Result: may contain statements lack correlation with actual risks of presence of non-ingredient allergens in a wide variety of products Examples: EU Pele et al, 2007, NL VWA 2007, Spanjersberg 2010; Ireland 2011; USA Remington 2013 Products with a precautionary label : 6.5%-93 % indeed contains allergen Products without a label: Between 11 en 53 % contained allergen

12 expected responders (%) Risks of presence of non-ingredient allergens in food M subj M obj Percentages of predicted responders in the milk-allergic population (users and non-users) F subj F obj TNO: computerized program for allergen risk assessment concentration m ilk protein in product (m g/kg)

13 Precautionary ( May contain ) labelling To warn allergic consumers for possible contamination of a product with allergen and to protect companies from claims Use precautionary labeling (only) when needed: No may contain if risk (chance and severity) is acceptable, to optimize - food choice of consumers - information value of warning Use may contain labeling in case of relevant/unacceptable risk! But: What residual risk is acceptable/unacceptable? What levels of allergens should trigger labelling? There is a need for quantitative guidance!

14 Australian VITAL-grid Voluntary Incidental Trace Allergen Labeling Guidance by the Australian Food and Grocery Council Allergen Forum and supported by the New Zealand Food & Grocery Council June 2007 No labelling Labelling Labelling Values are in mg total protein per kg food (in case allergenic protein is measured, conversion to total protein needed, Kim Leighton & Simon Brooke-Taylor, Australian Food and Grocery Council, March 2008)

Australian VITAL-grid Voluntary Incidental Trace Allergen Labeling Guidance by the Australian Food and Grocery Council Allergen Forum and supported by the New Zealand Food & Grocery Council June 2007

15 Australian VITAL-grid Voluntary Incidental Trace Allergen Labeling Guidance by the Australian Food and Grocery Council Allergen Forum and supported by the New Zealand Food & Grocery Council June 2007 No labelling Labelling Labelling 2007 VITAL Grid Action Levels: Based upon key information in FDA Threshold Working Group Report of 2006 Used LOAELs from FDA tabulation Applied 10-fold UF Expressed action levels in concentration (ppm) based on 5 g serving size (teaspoon) Values are in mg total protein per kg food (in case allergenic protein is measured, conversion to total protein needed, Low AL s Low risks Too much labelling High risk! Kim Leighton & Simon Brooke-Taylor, Australian Food and Grocery Council, March 2008)

Australian VITAL-grid 2007 2010-2012: evaluation and revision as part of that process: VITAL Scientific Expert Panel Assistance Expert Panel: Steve Taylor, Joe Baumert, FARRP Rene Crevel, Unilever

16 Australian VITAL-grid : evaluation and revision as part of that process: VITAL Scientific Expert Panel Assistance Expert Panel: Steve Taylor, Joe Baumert, FARRP Rene Crevel, Unilever Geert Houben, TNO Simon Brooke-Taylor, consultant Katie Allen, Melbourne allergist Goal: Deriving concentration action levels for precautionary labelling VITAL Scientific Expert Panel meeting Sydney, January 19-20, 2011

17 Deriving concentration action levels for precautionary labelling - a stepwise process Risk of contamination at action level Step 4 Step 1 Accepted residual risk level Max. % risk Threshold distribution Food intake Action level Reference dose Step 3 Step 2

18 Step 1&2 - Agreement on accepted risk level and elaboration of reference doses Step 1 Australian VITAL grid evaluation and revision: VITAL 2.0 Risk of contamination at action level Step 4 Accepted residual risk level Max. % risk Threshold distribution Food intake Action level Reference dose Step 3 Step 2

19 Step 1 - Agreement on accepted risk level Risk of contamination at action level Step 4 Step 1 Accepted residual risk level Max. % risk Threshold distribution Food intake Action level Reference dose Step 3 Step 2

20 Australian VITAL-grid : evaluation and revision as part of that process: VITAL Scientific Expert Panel Assistance Accepted residual risk In consultation with stakeholders Aimed at < 1% mild objective reactions incidental effects will in general be mild and transitory, generally requiring no medical intervention

21 Step 2 - Elaboration of reference doses from threshold distributions Risk of contamination at action level Step 4 Step 1 Accepted residual risk level Max. 1 % risk Threshold distribution Food intake Action level Reference dose Step 3 Step 2

22 TNO clinical thresholds datamining project in collaboration with UMCU (AZU & WKZ), UMCG, JBZ Provocation centers; among others: Scientific Literature from adults & children adults & children children other (inter)national clinical centers infants positive outcomes in DBPC-FC Collaboration with US FARRP ~1800 approved DBPC-FC threshold distributions for 14 allergens males-females/adults-children/subjective-objective

23 Probability of allergic reaction Threshold distributions subjective (green) and objective (red) symptoms children (data obtained in collaboration with UMC Groningen) X % accepted residual risk on objective symptoms? Health based reference dose Y mg mg egg protein

24 Reference Doses (in mg protein) 24

25 Step 3 - Calculation of action levels from reference doses and an assumed food intake Risk of contamination at action level Step 4 Step 1 Accepted residual risk level Max. 1 % risk Threshold distribution Food intake Action level Reference dose Step 3 Step 2

Selection of the appropriate intake figure and consistency An example from a workshop with food companies (VMT meeting 11 Oct 2012, Maarssen, The

27 Selection of the appropriate intake figure and consistency An example from a workshop with food companies (VMT meeting 11 Oct 2012, Maarssen, The Netherlands) Variation in assumed intake amount for calculating action levels -> will result in similar variation in action levels for same products on the market 27

28 The importance of selecting an appropriate intake figure Example: peanut residues in brown wheat bread Risk of contamination at action level?? Realistic Food intake Max. 1% risk Action level Threshold distribution Assumed Food intake Reference dose 0.2 mg 1.0 ppm 210 g (P95)

The importance of selecting an appropriate intake figure Example: peanut residues in brown wheat bread Risk of contamination at action level?

29 The importance of selecting an appropriate intake figure Example: peanut residues in brown wheat bread Risk of contamination at action level?? Realistic Food intake Max. 1% risk Action level Threshold distribution Assumed Food intake Reference dose 0.2 mg 1.0 ppm 210 g (P95) 5.7 ppm 35 g (recommend portion size of 1 slice)

30 Step 4 - Validation of action levels Risk of contamination at action level Step 4 Step 1 Accepted residual risk level Max. 1 % risk Threshold distribution Food intake Action level Reference dose Step 3 Step 2

31 Step 4 - Validation of action levels Risk assessment to validate safety of action levels calculated (actual risk < accepted residual risk?) Risk of contamination at action level Step 4 Step 1 Accepted residual risk level Max. 1 % risk?? Threshold distribution Food intake Action level Reference dose Step 3 Step 2

32 The importance of selecting an appropriate intake figure Example: peanut residues in brown wheat bread Risk of contamination at action level?? Realistic Food intake Max. 1% risk Action level Threshold distribution Assumed Food intake Reference dose 0.2 mg 1.0 % 1.0 ppm 210 g (P95) TNO: computerized program for allergen risk assessment

33 The importance of selecting an appropriate intake figure Example: peanut residues in brown wheat bread Risk of contamination at action level?? Realistic Food intake Max. 1% risk Action level Threshold distribution Assumed Food intake Reference dose 0.2 mg 1.0 % 1.0 ppm 210 g (P95) 3.5 % TNO: computerized program for allergen risk assessment 5.7 ppm 35 g (recommend portion size of 1 slice)

34 How do we establish the righ action level at TNO? We consider the food intake volumes per individual eating occasion for: Adults and children Males and females Mean and p95 We select the highest action level that results in a risk <1% for all above combinations It depends on the product whether this action level will be based on adults or children or males or females But in most cases an action level based on mean consumption is ok (no worst case assumption of p95 or higher needed)

35 Example of application of action levels Presence of non-ingredient allergens in food Survey on contamination of potato chips(-like) savory snacks with peanut and milk proteins; repeated analysis Samples taken immediately (0-5 minutes) after change of recipe (allergen containing recipe > allergen free recipe) and routine cleaning Milk protein concentrations: Between <1 and 4 ppm Peanut protein concentrations: Between <2 and 7 ppm After 5 minutes: all samples non-detectable levels (< 1 or 2 ppm)

36 Example of application of action levels Presence of non-ingredient allergens in food Survey on contamination of potato chips(-like) savory snacks with peanut and milk proteins; repeated analysis Samples taken immediately (0-5 minutes) after change of recipe (allergen containing recipe > allergen free recipe) and routine cleaning Milk protein concentrations: Between <1 and 4 ppm Peanut protein concentrations: Between <2 and 7 ppm Action levels: Milk: 1.4 ppm Soy: 13.9 ppm Action required No action required After 5 minutes: all samples non-detectable levels (< 1 or 2 ppm)

37 Example of application of action levels Allergen concentration Typical distribution of allergen concentration during production of product not meant to contain allergen following production of product containing the allergen according to recipe Action level Action required; options: Improve cleaning procedures Discard first part of batch May Contain label Production time

38 Action levels vs sensitivity of analytical methods allergen / reference value / calculated action limits BASED ON MEAN CONSUMPTION adults & children intake shrimp lupin cashew soy wheat peanut sesame milk hazelnut mustard egg Food group a of c? highest mean ,2 0,2 0,1 0,1 0,05 0,03 a 2,3 4347, ,13 869,57 434,78 434,78 86,96 86,96 43,48 43,48 21,74 13,04 a 4,5 2222,22 888,89 444,44 222,22 222,22 44,44 44,44 22,22 22,22 11,11 6,67 c 16,3 613,50 245,40 122,70 61,35 61,35 12,27 12,27 6,13 6,13 3,07 1,84 c 16,3 613,50 245,40 122,70 61,35 61,35 12,27 12,27 6,13 6,13 3,07 1,84 a 18,0 555,56 222,22 111,11 55,56 55,56 11,11 11,11 5,56 5,56 2,78 1,67 a 21,1 473,93 189,57 94,79 47,39 47,39 9,48 9,48 4,74 4,74 2,37 1,42 a 21,8 458,72 183,49 91,74 45,87 45,87 9,17 9,17 4,59 4,59 2,29 1,38 a 21,9 456,62 182,65 91,32 45,66 45,66 9,13 9,13 4,57 4,57 2,28 1,37 c 22,4 446,43 178,57 89,29 44,64 44,64 8,93 8,93 4,46 4,46 2,23 1,34 a 24,6 406,50 162,60 81,30 40,65 40,65 8,13 8,13 4,07 4,07 2,03 1,22 c 26,4 378,79 151,52 75,76 37,88 37,88 7,58 7,58 3,79 3,79 1,89 1,14 a 35,1 284,90 113,96 56,98 28,49 28,49 5,70 5,70 2,85 2,85 1,42 0,85 a 35,6 280,90 112,36 56,18 28,09 28,09 5,62 5,62 2,81 2,81 1,40 0,84 a 43,1 232,02 92,81 46,40 23,20 23,20 4,64 4,64 2,32 2,32 1,16 0,70 a 45,8 218,34 87,34 43,67 21,83 21,83 4,37 4,37 2,18 2,18 1,09 0,66 a 46,7 214,13 85,65 42,83 21,41 21,41 4,28 4,28 2,14 2,14 1,07 0,64 a 47,5 210,53 84,21 42,11 21,05 21,05 4,21 4,21 2,11 2,11 1,05 0,63 a 49,4 202,43 80,97 40,49 20,24 20,24 4,05 4,05 2,02 2,02 1,01 0,61 a 53,0 188,68 75,47 37,74 18,87 18,87 3,77 3,77 1,89 1,89 0,94 0,57 a 58,6 170,65 68,26 34,13 17,06 17,06 3,41 3,41 1,71 1,71 0,85 0,51 a 59,9 166,94 66,78 33,39 16,69 16,69 3,34 3,34 1,67 1,67 0,83 0,50 c 60,1 166,39 66,56 33,28 16,64 16,64 3,33 3,33 1,66 1,66 0,83 0,50 a 62,9 158,98 63,59 31,80 15,90 15,90 3,18 3,18 1,59 1,59 0,79 0,48 a 72,0 138,89 55,56 27,78 13,89 13,89 2,78 2,78 1,39 1,39 0,69 0,42 a 72,0 138,89 55,56 27,78 13,89 13,89 2,78 2,78 1,39 1,39 0,69 0,42 a 77,1 129,70 51,88 25,94 12,97 12,97 2,59 2,59 1,30 1,30 0,65 0,39 a 112,7 88,73 35,49 17,75 8,87 8,87 1,77 1,77 0,89 0,89 0,44 0,27 a 117,5 85,11 34,04 17,02 8,51 8,51 1,70 1,70 0,85 0,85 0,43 0,26 a 132,7 75,36 30,14 15,07 7,54 7,54 1,51 1,51 0,75 0,75 0,38 0,23 a 133,4 74,96 29,99 14,99 7,50 7,50 1,50 1,50 0,75 0,75 0,37 0,22 a 138,1 72,41 28,96 14,48 7,24 7,24 1,45 1,45 0,72 0,72 0,36 0,22 a 143,7 69,59 27,84 13,92 6,96 6,96 1,39 1,39 0,70 0,70 0,35 0,21 a 153,6 65,10 26,04 13,02 6,51 6,51 1,30 1,30 0,65 0,65 0,33 0,20 a 161,1 62,07 24,83 12,41 6,21 6,21 1,24 1,24 0,62 0,62 0,31 0,19 a 186,9 53,50 21,40 10,70 5,35 5,35 1,07 1,07 0,54 0,54 0,27 0,16 a 190,6 52,47 20,99 10,49 5,25 5,25 1,05 1,05 0,52 0,52 0,26 0,16 c 205,5 48,66 19,46 9,73 4,87 4,87 0,97 0,97 0,49 0,49 0,24 0,15 c 216,4 46,21 18,48 9,24 4,62 4,62 0,92 0,92 0,46 0,46 0,23 0,14 a 217,3 46,02 18,41 9,20 4,60 4,60 0,92 0,92 0,46 0,46 0,23 0,14 a 269,7 37,08 14,83 7,42 3,71 3,71 0,74 0,74 0,37 0,37 0,19 0,11 a 315,3 31,72 12,69 6,34 3,17 3,17 0,63 0,63 0,32 0,32 0,16 0,10 a 315,6 31,69 12,67 6,34 3,17 3,17 0,63 0,63 0,32 0,32 0,16 0,10 a 382,7 26,13 10,45 5,23 2,61 2,61 0,52 0,52 0,26 0,26 0,13 0,08 a 507,7 19,70 7,88 3,94 1,97 1,97 0,39 0,39 0,20 0,20 0,10 0,06 a 1341,6 7,45 2,98 1,49 0,75 0,75 0,15 0,15 0,07 0,07 0,04 0,02

39 Action levels vs sensitivity of analytical methods - assume an LOD of 1 mg/kg - allergen / reference value / calculated action limits BASED ON MEAN CONSUMPTION adults & children intake shrimp lupin cashew soy wheat peanut sesame milk hazelnut mustard egg Food group a of c? highest mean ,2 0,2 0,1 0,1 0,05 0,03 a 2,3 4347, ,13 869,57 434,78 434,78 86,96 86,96 43,48 43,48 21,74 13,04 a 4,5 2222,22 888,89 444,44 222,22 222,22 44,44 44,44 22,22 22,22 11,11 6,67 c 16,3 613,50 245,40 122,70 61,35 61,35 12,27 12,27 6,13 6,13 3,07 1,84 c 16,3 613,50 245,40 122,70 61,35 61,35 12,27 12,27 6,13 6,13 3,07 1,84 a 18,0 555,56 222,22 111,11 55,56 55,56 11,11 11,11 5,56 5,56 2,78 1,67 a 21,1 473,93 189,57 94,79 47,39 47,39 9,48 9,48 4,74 4,74 2,37 1,42 a 21,8 458,72 183,49 91,74 45,87 45,87 9,17 9,17 4,59 4,59 2,29 1,38 a 21,9 456,62 182,65 91,32 45,66 45,66 9,13 9,13 4,57 4,57 2,28 1,37 c 22,4 446,43 178,57 89,29 44,64 44,64 8,93 8,93 4,46 4,46 2,23 1,34 a 24,6 406,50 162,60 81,30 40,65 40,65 8,13 8,13 4,07 4,07 2,03 1,22 c 26,4 378,79 151,52 75,76 37,88 37,88 7,58 7,58 3,79 3,79 1,89 1,14 a 35,1 284,90 113,96 56,98 28,49 28,49 5,70 5,70 2,85 2,85 1,42 0,85 a 35,6 280,90 112,36 56,18 28,09 28,09 5,62 5,62 2,81 2,81 1,40 0,84 a 43,1 232,02 92,81 46,40 23,20 23,20 4,64 4,64 2,32 2,32 1,16 0,70 a 45,8 218,34 87,34 43,67 21,83 21,83 4,37 4,37 2,18 2,18 1,09 0,66 a 46,7 214,13 85,65 42,83 21,41 21,41 4,28 4,28 2,14 2,14 1,07 0,64 a 47,5 210,53 84,21 42,11 21,05 21,05 4,21 4,21 2,11 2,11 1,05 0,63 a 49,4 202,43 80,97 40,49 20,24 20,24 4,05 4,05 2,02 2,02 1,01 0,61 a 53,0 188,68 75,47 37,74 18,87 18,87 3,77 3,77 1,89 1,89 0,94 0,57 a 58,6 170,65 68,26 34,13 17,06 17,06 3,41 3,41 1,71 1,71 0,85 0,51 a 59,9 166,94 66,78 33,39 16,69 16,69 3,34 3,34 1,67 1,67 0,83 0,50 c 60,1 166,39 66,56 33,28 16,64 16,64 3,33 3,33 1,66 1,66 0,83 0,50 a 62,9 158,98 63,59 31,80 15,90 15,90 3,18 3,18 1,59 1,59 0,79 0,48 a 72,0 138,89 55,56 27,78 13,89 13,89 2,78 2,78 1,39 1,39 0,69 0,42 a 72,0 138,89 55,56 27,78 13,89 13,89 2,78 2,78 1,39 1,39 0,69 0,42 a 77,1 129,70 51,88 25,94 12,97 12,97 2,59 2,59 1,30 1,30 0,65 0,39 a 112,7 88,73 35,49 17,75 8,87 8,87 1,77 1,77 0,89 0,89 0,44 0,27 a 117,5 85,11 34,04 17,02 8,51 8,51 1,70 1,70 0,85 0,85 0,43 0,26 a 132,7 75,36 30,14 15,07 7,54 7,54 1,51 1,51 0,75 0,75 0,38 0,23 a 133,4 74,96 29,99 14,99 7,50 7,50 1,50 1,50 0,75 0,75 0,37 0,22 a 138,1 72,41 28,96 14,48 7,24 7,24 1,45 1,45 0,72 0,72 0,36 0,22 a 143,7 69,59 27,84 13,92 6,96 6,96 1,39 1,39 0,70 0,70 0,35 0,21 a 153,6 65,10 26,04 13,02 6,51 6,51 1,30 1,30 0,65 0,65 0,33 0,20 a 161,1 62,07 24,83 12,41 6,21 6,21 1,24 1,24 0,62 0,62 0,31 0,19 a 186,9 53,50 21,40 10,70 5,35 5,35 1,07 1,07 0,54 0,54 0,27 0,16 a 190,6 52,47 20,99 10,49 5,25 5,25 1,05 1,05 0,52 0,52 0,26 0,16 c 205,5 48,66 19,46 9,73 4,87 4,87 0,97 0,97 0,49 0,49 0,24 0,15 c 216,4 46,21 18,48 9,24 4,62 4,62 0,92 0,92 0,46 0,46 0,23 0,14 a 217,3 46,02 18,41 9,20 4,60 4,60 0,92 0,92 0,46 0,46 0,23 0,14 a 269,7 37,08 14,83 7,42 3,71 3,71 0,74 0,74 0,37 0,37 0,19 0,11 a 315,3 31,72 12,69 6,34 3,17 3,17 0,63 0,63 0,32 0,32 0,16 0,10 a 315,6 31,69 12,67 6,34 3,17 3,17 0,63 0,63 0,32 0,32 0,16 0,10 a 382,7 26,13 10,45 5,23 2,61 2,61 0,52 0,52 0,26 0,26 0,13 0,08 a 507,7 19,70 7,88 3,94 1,97 1,97 0,39 0,39 0,20 0,20 0,10 0,06 a 1341,6 7,45 2,98 1,49 0,75 0,75 0,15 0,15 0,07 0,07 0,04 0,02

41 Action levels vs sensitivity of analytical methods - assume an LOD of 1 mg/kg - allergen / reference value / calculated action limits BASED ON MEAN CONSUMPTION adults & children intake shrimp lupin cashew soy wheat peanut sesame milk hazelnut mustard egg Food group a of c? highest mean ,2 0,2 0,1 0,1 0,05 0,03 a 2,3 4347, ,13 869,57 434,78 434,78 86,96 86,96 43,48 43,48 21,74 13,04 a 4,5 2222,22 888,89 444,44 222,22 222,22 44,44 44,44 22,22 22,22 11,11 6,67 c 16,3 613,50 245,40 122,70 61,35 61,35 12,27 12,27 6,13 6,13 3,07 1,84 c 16,3 613,50 245,40 122,70 61,35 61,35 12,27 12,27 6,13 6,13 3,07 1,84 a 18,0 555,56 222,22 111,11 55,56 55,56 11,11 11,11 5,56 5,56 2,78 1,67 a 21,1 473,93 189,57 94,79 47,39 47,39 9,48 9,48 4,74 4,74 2,37 1,42 a 21,8 458,72 183,49 91,74 45,87 45,87 9,17 9,17 4,59 4,59 2,29 1,38 a 21,9 456,62 182,65 91,32 45,66 45,66 9,13 9,13 4,57 4,57 2,28 1,37 c 22,4 446,43 178,57 89,29 44,64 44,64 8,93 8,93 4,46 4,46 2,23 1,34 a 24,6 406,50 162,60 81,30 40,65 40,65 8,13 8,13 4,07 4,07 2,03 1,22 c 26,4 378,79 151,52 75,76 37,88 37,88 7,58 7,58 3,79 3,79 1,89 1,14 a 35,1 284,90 113,96 56,98 28,49 28,49 5,70 5,70 2,85 2,85 1,42 0,85 a 35,6 280,90 112,36 56,18 28,09 28,09 5,62 5,62 2,81 2,81 1,40 0,84 a 43,1 232,02 92,81 46,40 23,20 23,20 4,64 4,64 2,32 2,32 1,16 0,70 a 45,8 218,34 87,34 43,67 21,83 21,83 4,37 4,37 2,18 2,18 1,09 0,66 a 46,7 214,13 85,65 42,83 21,41 21,41 4,28 4,28 2,14 2,14 1,07 0,64 a 47,5 210,53 84,21 42,11 21,05 21,05 4,21 4,21 2,11 2,11 1,05 0,63 a 49,4 202,43 80,97 40,49 20,24 20,24 4,05 4,05 2,02 2,02 1,01 0,61 a 53,0 188,68 75,47 37,74 18,87 18,87 3,77 3,77 1,89 1,89 0,94 0,57 a 58,6 170,65 68,26 34,13 17,06 17,06 3,41 3,41 1,71 1,71 0,85 0,51 a 59,9 166,94 66,78 33,39 16,69 16,69 3,34 3,34 1,67 1,67 0,83 0,50 c 60,1 166,39 66,56 33,28 16,64 16,64 3,33 3,33 1,66 1,66 0,83 0,50 a 62,9 158,98 63,59 31,80 15,90 15,90 3,18 3,18 1,59 1,59 0,79 0,48 a 72,0 138,89 55,56 27,78 13,89 13,89 2,78 2,78 1,39 1,39 0,69 0,42 a 72,0 138,89 55,56 27,78 13,89 13,89 2,78 2,78 1,39 1,39 0,69 0,42 a 77,1 129,70 51,88 25,94 12,97 12,97 2,59 2,59 1,30 1,30 0,65 0,39 a 112,7 88,73 35,49 17,75 8,87 8,87 1,77 1,77 0,89 0,89 0,44 0,27 a 117,5 85,11 34,04 17,02 8,51 8,51 1,70 1,70 0,85 0,85 0,43 0,26 a 132,7 75,36 30,14 15,07 7,54 7,54 1,51 1,51 0,75 0,75 0,38 0,23 a 133,4 74,96 29,99 14,99 7,50 7,50 1,50 1,50 0,75 0,75 0,37 0,22 a 138,1 72,41 28,96 14,48 7,24 7,24 1,45 1,45 0,72 0,72 0,36 0,22 a 143,7 69,59 27,84 13,92 6,96 6,96 1,39 1,39 0,70 0,70 0,35 0,21 For end product a 153,6 65,10 26,04 13,02 6,51 6,51 1,30 1,30 0,65 0,65 0,33 0,20 a 161,1 62,07 24,83 12,41 6,21 6,21 1,24 1,24 0,62 0,62 0,31 0,19 a 186,9 53,50 21,40 10,70 5,35 5,35 1,07 1,07 0,54 0,54 0,27 0,16 a 190,6 52,47 20,99 10,49 5,25 5,25 1,05 1,05 0,52 0,52 0,26 0,16 c 205,5 48,66 19,46 9,73 4,87 4,87 0,97 0,97 0,49 0,49 0,24 0,15 c 216,4 46,21 18,48 9,24 4,62 4,62 0,92 0,92 0,46 0,46 0,23 0,14 a 217,3 46,02 18,41 9,20 4,60 4,60 0,92 0,92 0,46 0,46 0,23 0,14 a 269,7 37,08 14,83 7,42 3,71 3,71 0,74 0,74 0,37 0,37 0,19 0,11 a 315,3 31,72 12,69 6,34 3,17 3,17 0,63 0,63 0,32 0,32 0,16 0,10 a 315,6 31,69 12,67 6,34 3,17 3,17 0,63 0,63 0,32 0,32 0,16 0,10 a 382,7 26,13 10,45 5,23 2,61 2,61 0,52 0,52 0,26 0,26 0,13 0,08 a 507,7 19,70 7,88 3,94 1,97 1,97 0,39 0,39 0,20 0,20 0,10 0,06 a 1341,6 7,45 2,98 1,49 0,75 0,75 0,15 0,15 0,07 0,07 0,04 0,02

42 If LOD is not low enough: assess ingredients! Presence of non-ingredient allergens in a food ingredient Basic approach the same. Producer of ingredient needs to perform a risk analysis to assess the risk of presence of a non-ingredient allergen in the ingredient and its potential maximal concentration. Possibly present allergen and its potential maximal concentration needs to be specified in the product specifications. Producer of end food product needs to calculate the potential maximal concentration of the allergen in the end food product on the basis of recipe (% of the ingredient in the end food product). The calculated potential maximal concentration of the allergen in the end food product is to be compared with the action level. below action level > No action required above action level > Action required

43 Action levels vs sensitivity of analytical methods - assume an LOD of 1 mg/kg - allergen / reference value / calculated action limits BASED ON MEAN CONSUMPTION adults & children intake shrimp lupin cashew soy wheat peanut sesame milk hazelnut mustard egg Food group a of c? highest mean ,2 0,2 0,1 0,1 0,05 0,03 a 2, , , , , ,13 347,83 347,83 173,91 173,91 86,96 52,17 a 4,5 8888, , ,78 888,89 888,89 177,78 177,78 88,89 88,89 44,44 26,67 c 16,3 2453,99 981,60 490,80 245,40 245,40 49,08 49,08 24,54 24,54 12,27 7,36 c 16,3 2453,99 981,60 490,80 245,40 245,40 49,08 49,08 24,54 24,54 12,27 7,36 a 18,0 2222,22 888,89 444,44 222,22 222,22 44,44 44,44 22,22 22,22 11,11 6,67 a 21,1 1895,73 758,29 379,15 189,57 189,57 37,91 37,91 18,96 18,96 9,48 5,69 a 21,8 1834,86 733,94 366,97 183,49 183,49 36,70 36,70 18,35 18,35 9,17 5,50 a 21,9 1826,48 730,59 365,30 182,65 182,65 36,53 36,53 18,26 18,26 9,13 5,48 c 22,4 1785,71 714,29 357,14 178,57 178,57 35,71 35,71 17,86 17,86 8,93 5,36 a 24,6 1626,02 650,41 325,20 162,60 162,60 32,52 32,52 16,26 16,26 8,13 4,88 c 26,4 1515,15 606,06 303,03 151,52 151,52 30,30 30,30 15,15 15,15 7,58 4,55 a 35,1 1139,60 455,84 227,92 113,96 113,96 22,79 22,79 11,40 11,40 5,70 3,42 a 35,6 1123,60 449,44 224,72 112,36 112,36 22,47 22,47 11,24 11,24 5,62 3,37 a 43,1 928,07 371,23 185,61 92,81 92,81 18,56 18,56 9,28 9,28 4,64 2,78 a 45,8 873,36 349,34 174,67 87,34 87,34 17,47 17,47 8,73 8,73 4,37 2,62 a 46,7 856,53 342,61 171,31 85,65 85,65 17,13 17,13 8,57 8,57 4,28 2,57 a 47,5 842,11 336,84 168,42 84,21 84,21 16,84 16,84 8,42 8,42 4,21 2,53 a 49,4 809,72 323,89 161,94 80,97 80,97 16,19 16,19 8,10 8,10 4,05 2,43 a 53,0 754,72 301,89 150,94 75,47 75,47 15,09 15,09 7,55 7,55 3,77 2,26 a 58,6 682,59 273,04 136,52 68,26 68,26 13,65 13,65 6,83 6,83 3,41 2,05 a 59,9 667,78 267,11 133,56 66,78 66,78 13,36 13,36 6,68 6,68 3,34 2,00 c 60,1 665,56 266,22 133,11 66,56 66,56 13,31 13,31 6,66 6,66 3,33 2,00 a 62,9 635,93 254,37 127,19 63,59 63,59 12,72 12,72 6,36 6,36 3,18 1,91 a 72,0 555,56 222,22 111,11 55,56 55,56 11,11 11,11 5,56 5,56 2,78 1,67 a 72,0 555,56 222,22 111,11 55,56 55,56 11,11 11,11 5,56 5,56 2,78 1,67 a 77,1 518,81 207,52 103,76 51,88 51,88 10,38 10,38 5,19 5,19 2,59 1,56 a 112,7 354,92 141,97 70,98 35,49 35,49 7,10 7,10 3,55 3,55 1,77 1,06 a 117,5 340,43 136,17 68,09 34,04 34,04 6,81 6,81 3,40 3,40 1,70 1,02 a 132,7 301,43 120,57 60,29 30,14 30,14 6,03 6,03 3,01 3,01 1,51 0,90 a 133,4 299,85 119,94 59,97 29,99 29,99 6,00 6,00 3,00 3,00 1,50 0,90 a 138,1 289,65 115,86 57,93 28,96 28,96 5,79 5,79 2,90 2,90 1,45 0,87 a 143,7 278,36 111,34 55,67 27,84 27,84 5,57 5,57 2,78 2,78 1,39 0,84 For an ingredient used at 25% a 153,6 260,42 104,17 52,08 26,04 26,04 5,21 5,21 2,60 2,60 1,30 0,78 a 161,1 248,29 99,32 49,66 24,83 24,83 4,97 4,97 2,48 2,48 1,24 0,74 a 186,9 214,02 85,61 42,80 21,40 21,40 4,28 4,28 2,14 2,14 1,07 0,64 a 190,6 209,86 83,95 41,97 20,99 20,99 4,20 4,20 2,10 2,10 1,05 0,63 c 205,5 194,65 77,86 38,93 19,46 19,46 3,89 3,89 1,95 1,95 0,97 0,58 c 216,4 184,84 73,94 36,97 18,48 18,48 3,70 3,70 1,85 1,85 0,92 0,55 a 217,3 184,08 73,63 36,82 18,41 18,41 3,68 3,68 1,84 1,84 0,92 0,55 a 269,7 148,31 59,33 29,66 14,83 14,83 2,97 2,97 1,48 1,48 0,74 0,44 a 315,3 126,86 50,75 25,37 12,69 12,69 2,54 2,54 1,27 1,27 0,63 0,38 a 315,6 126,74 50,70 25,35 12,67 12,67 2,53 2,53 1,27 1,27 0,63 0,38 a 382,7 104,52 41,81 20,90 10,45 10,45 2,09 2,09 1,05 1,05 0,52 0,31 a 507,7 78,79 31,51 15,76 7,88 7,88 1,58 1,58 0,79 0,79 0,39 0,24 a 1341,6 29,82 11,93 5,96 2,98 2,98 0,60 0,60 0,30 0,30 0,15 0,09

Action levels vs sensitivity of analytical methods - assume an LOD of 1 mg/kg - allergen / reference value / calculated action limits BASED ON MEAN CONSUMPTION adults & children intake shrimp lupin

44 Action levels vs sensitivity of analytical methods - assume an LOD of 1 mg/kg - allergen / reference value / calculated action limits BASED ON MEAN CONSUMPTION adults & children intake shrimp lupin cashew soy wheat peanut sesame milk hazelnut mustard egg Food group a of c? highest mean ,2 0,2 0,1 0,1 0,05 0,03 a 2, , , , , , , ,13 869,57 869,57 434,78 260,87 a 4, , , , , ,44 888,89 888,89 444,44 444,44 222,22 133,33 c 16, , , , , ,99 245,40 245,40 122,70 122,70 61,35 36,81 c 16, , , , , ,99 245,40 245,40 122,70 122,70 61,35 36,81 a 18, , , , , ,11 222,22 222,22 111,11 111,11 55,56 33,33 a 21,1 9478, , ,73 947,87 947,87 189,57 189,57 94,79 94,79 47,39 28,44 a 21,8 9174, , ,86 917,43 917,43 183,49 183,49 91,74 91,74 45,87 27,52 a 21,9 9132, , ,48 913,24 913,24 182,65 182,65 91,32 91,32 45,66 27,40 c 22,4 8928, , ,71 892,86 892,86 178,57 178,57 89,29 89,29 44,64 26,79 a 24,6 8130, , ,02 813,01 813,01 162,60 162,60 81,30 81,30 40,65 24,39 c 26,4 7575, , ,15 757,58 757,58 151,52 151,52 75,76 75,76 37,88 22,73 a 35,1 5698, , ,60 569,80 569,80 113,96 113,96 56,98 56,98 28,49 17,09 a 35,6 5617, , ,60 561,80 561,80 112,36 112,36 56,18 56,18 28,09 16,85 a 43,1 4640, ,15 928,07 464,04 464,04 92,81 92,81 46,40 46,40 23,20 13,92 a 45,8 4366, ,72 873,36 436,68 436,68 87,34 87,34 43,67 43,67 21,83 13,10 a 46,7 4282, ,06 856,53 428,27 428,27 85,65 85,65 42,83 42,83 21,41 12,85 a 47,5 4210, ,21 842,11 421,05 421,05 84,21 84,21 42,11 42,11 21,05 12,63 a 49,4 4048, ,43 809,72 404,86 404,86 80,97 80,97 40,49 40,49 20,24 12,15 a 53,0 3773, ,43 754,72 377,36 377,36 75,47 75,47 37,74 37,74 18,87 11,32 a 58,6 3412, ,19 682,59 341,30 341,30 68,26 68,26 34,13 34,13 17,06 10,24 a 59,9 3338, ,56 667,78 333,89 333,89 66,78 66,78 33,39 33,39 16,69 10,02 c 60,1 3327, ,11 665,56 332,78 332,78 66,56 66,56 33,28 33,28 16,64 9,98 a 62,9 3179, ,86 635,93 317,97 317,97 63,59 63,59 31,80 31,80 15,90 9,54 a 72,0 2777, ,11 555,56 277,78 277,78 55,56 55,56 27,78 27,78 13,89 8,33 a 72,0 2777, ,11 555,56 277,78 277,78 55,56 55,56 27,78 27,78 13,89 8,33 a 77,1 2594, ,61 518,81 259,40 259,40 51,88 51,88 25,94 25,94 12,97 7,78 a 112,7 1774,62 709,85 354,92 177,46 177,46 35,49 35,49 17,75 17,75 8,87 5,32 a 117,5 1702,13 680,85 340,43 170,21 170,21 34,04 34,04 17,02 17,02 8,51 5,11 a 132,7 1507,16 602,86 301,43 150,72 150,72 30,14 30,14 15,07 15,07 7,54 4,52 a 133,4 1499,25 599,70 299,85 149,93 149,93 29,99 29,99 14,99 14,99 7,50 4,50 a 138,1 1448,23 579,29 289,65 144,82 144,82 28,96 28,96 14,48 14,48 7,24 4,34 a 143,7 1391,79 556,72 278,36 139,18 139,18 27,84 27,84 13,92 13,92 6,96 4,18 For an ingredient used at 5% a 153,6 1302,08 520,83 260,42 130,21 130,21 26,04 26,04 13,02 13,02 6,51 3,91 a 161,1 1241,46 496,59 248,29 124,15 124,15 24,83 24,83 12,41 12,41 6,21 3,72 a 186,9 1070,09 428,04 214,02 107,01 107,01 21,40 21,40 10,70 10,70 5,35 3,21 a 190,6 1049,32 419,73 209,86 104,93 104,93 20,99 20,99 10,49 10,49 5,25 3,15 c 205,5 973,24 389,29 194,65 97,32 97,32 19,46 19,46 9,73 9,73 4,87 2,92 c 216,4 924,21 369,69 184,84 92,42 92,42 18,48 18,48 9,24 9,24 4,62 2,77 a 217,3 920,39 368,15 184,08 92,04 92,04 18,41 18,41 9,20 9,20 4,60 2,76 a 269,7 741,56 296,63 148,31 74,16 74,16 14,83 14,83 7,42 7,42 3,71 2,22 a 315,3 634,32 253,73 126,86 63,43 63,43 12,69 12,69 6,34 6,34 3,17 1,90 a 315,6 633,71 253,49 126,74 63,37 63,37 12,67 12,67 6,34 6,34 3,17 1,90 a 382,7 522,60 209,04 104,52 52,26 52,26 10,45 10,45 5,23 5,23 2,61 1,57 a 507,7 393,93 157,57 78,79 39,39 39,39 7,88 7,88 3,94 3,94 1,97 1,18 a 1341,6 149,08 59,63 29,82 14,91 14,91 2,98 2,98 1,49 1,49 0,75 0,45

45 Future plans: development of an internet tool Welcome This tool provides you with the action level for your specific product to guide in using a precautionary statement. An action level is the maximal level for the unintended presence of allergens in your product for which no precautionary label is needed. Above this level it is recommended to label your product. 1. Select a product category: 2. Select the allergen for which you want to calculate the action level Start calculation Meantime: tailor-made support of companies

46 Future plans: maintenance of the system TNO Shared Research Program Food Allergy Towards a Food Allergy Free World Protection of the food allergic consumer Sensitivity of allergic consumers Prediction and modelling of contamination (including peak contamination) Food intake modelling and choices Risk assessment and management International application / guidance development and update

47 Future plans TNO Shared Research Program Food Allergy Towards a Food Allergy Free World Interested in this program? Feel free to contact me!

48 Thank you for your attention! Dr. Geert F. Houben Principal Scientist TNO Earth, Life and Social Sciences PO Box 360, NL 3700 AJ Zeist, The Netherlands Tel: Acknowledgements: Center for Food Allergy TNO/UU/UMCU UMCU-AZU; UMCU-WKZ; UMCG; JBZ; FARRP Ministry of Health, Welfare and Sports of the Netherlands ILSI Europe Expert Groups, Allergen Bureau Australia, VITAL Expert Panel, Dutch May Contain Working Group, FoodDrinkEurope Ad Hoc Allergen Expert Group

Food Allergen Thresholds & Probabilistic Risk Assessment: Current State of the Science. Joe Baumert, Ph.D.

Food Allergen Thresholds & Probabilistic Risk Assessment: Current State of the Science Joe Baumert, Ph.D. Food Allergy Research & Resource Program Department of Food Science & Technology University of