May contain' traces" of useful information - Can we make precautionary allergen labelling work better?

Transcription

1 May contain' traces" of useful information - Can we make precautionary allergen labelling work better? Paul Turner MRC Clinician Scientist & Hon. Consultant in Paediatric Allergy & Immunology, Imperial College London & Clinical Associate Professor, University of Sydney

2 Allergen Labelling

3 Allergen Labelling Allergen disclosure required under law: key allergens in ingredients of prepacked foods Mandatory disclosure applies only to allergens in ingredients No statutory requirement for potential allergens from cross-contamination

4 Turner et al, BMJ 2011

5 Not helpful to allergic consumers Helpful to allergic consumers Product with PAL 1. Product with PAL with a real risk of inducing an allergic reaction i.e. unsafe to consume Proper risk assessment by the food manufacturer Conclusion that the allergen may be present in the product (despite allergen management and Good Manufacturing Practice). Product without PAL 4. Product without PAL with low or no risk of inducing an allergic reaction i.e. safe to consume Proper risk assessment by the food manufacturer Conclusion that the allergen is not present in the product at a level that is likely to cause an allergic reaction 2. Product with PAL with unknown risk of inducing an allergic reaction i.e. may be safe or unsafe to eat No proper risk assessment No conclusion about allergen presence can be drawn 3. Product with PAL with low or no risk of inducing an allergic reaction i.e. safe to consume Proper risk assessment undertaken Manufacturer uses PAL nonetheless No conclusion about allergen presence can be drawn 5. Product without PAL, with unknown risk of inducing an allergic reaction i.e. may be safe or unsafe to consume No proper risk assessment No conclusion about allergen presence can be drawn

6 Impact on the consumer 69% of cereals and 56% of confectionery labelled may contain despite not listing nut as an ingredient 1 Shopping for a nut-allergic person took: 40% longer cost an average of 11% more Adversely impacts on quality of life 1 FSA report 2007, available at

7 Do PALs contribute to anxiety? Paediatric food allergy causes more anxiety than other chronic diseases such as DM 1 Labelling is a particular concern: 2,3 considerable confusion over the extent to which parents should exclude allergens including whether foods labelled may contain traces should be avoided 4 1 Avery et al, PAI 2003;14: Cummings et al. PAI 2010;21:586-94; 3 Sheth et al, Ann Allergy Asthma Immunol 2010;104: Hu et al, Arch Dis Child 2007;92:771-5

8 Self-efficacy in food allergy recognising a reac on trea ng a reac on reading labels iden fying cross contamina on safe at school safe with others can control environment to prevent reac on teach others have resources and support needed very confident confident somewhat confident not at all confident DunnGalvin, Hourihane, Greenhawt, et al., JACI in press

9 Do allergic individuals heed PAL? UK (n=184) Australia (n=246) May contain nuts 80% avoid 75% avoid May contain traces of nuts 60% avoid 45% avoid Does not contain nuts but made in a factory that uses nuts 40% avoid 35% avoid Noimark et al. PAI 2009 Zurzolo et al. MJA 2013 But wording used bears no relation to risk of contamination 1,2 1 Pele et al. Food Add Contam 2007; 24: Hefle et al. JACI 2007; 120:171-6.

10 Healthcare Professionals beliefs... Australia+UK-based survey of 161 HCPs (2014) PAL is and can increase anxiety: Turner et al., JACI-IP 2015 (in press)

11 Risk Perception disconnect Which of the following PAL statements indicates a real risk of allergen cross-contamination? Which ONE of the following statements is the BEST wording for precautionary allergen labelling? Turner et al., JACI-IP 2015 (in press)

12 What do Healthcare Professionals recommend? UK-based survey of 239 HCPs (2013) Should a nut-allergic child avoid foods labelled may contain nuts? Avoidance less important where PAL was made in factory where nuts are processed vs may contain Allergy specialists were less likely to recommend stringent avoidance. Turner et al. PAI 2013; 25:

13 DO FOODS WITH PAL CONTAIN ALLERGEN?

14 Do foods with PAL contain allergen? FSA, 2014 (n=508) UK Robertson et al, 2013 (n=38) Eire Zurzolo et al, 2013 (n=43) Australia Remington et al, 2013 (n=352) USA FSAI, 2011 (n=108) Eire Crotty et al, 2010 (n=81) USA Ford et al, 2010 (n=228) USA Pele et al, 2007 (n=569) Europe Hefle et al, 2007 (n=179) USA } 0% Peanut Hazelnut Milk Egg Soya % pre-packed food products with PAL containing allergen

15 Do foods without PAL contain allergen? Study and allergens % (No.) of food products with PAL % (No.) of food products without PAL Europe, 2007* Peanut 33% (109/333) 25% (52/211) Hazelnut 60% (175/291) 31% (64/209) USA, 2010 Peanut 4% (5/112) 0% (0/120) Egg 2% (1/57) 3% (3/117) Cow s Milk 10% (6/59) 3% (4/134) Eire, 2011 Peanut 7% (5/75) 2% (2/106) Egg 6% (1/18) 5% (5/106) Soya 3% (1/30) 5% (5/106) UK, 2014 Peanut 0.4% (1/226) 0% (0/249) Hazelnut 7% (15/228) 0% (0/266) Cow s Milk 28% (16/57) 3% (6/181) *This study assessed contamination in biscuits and cookies, which may be at higher risk of nut cross-contamination than other food products

16 So Most foods with PAL don t contain the allergen but some do, and enough to trigger reactions Snack/confectionery items at particular risk (nut contamination) Some foods without PAL do contain the allergen

17 Not just manufacturers being lazy 1. Audit trail for all ingredients can be difficult 2. Unintentional cross-contamination when same machinery is used for different products 3. Economic and health safety reasons that mean shared equipment unavoidable 4. Technical difficulties in measurement Especially with heterogenous/particulate contamination

18 Hazelnut cookie Cleaning Cookie not containing HN Analyse cookie to see how much HN protein is present NB: Wet cleaning takes extra half-day - machinery not designed to be cleaned in this way.

19 Protocol 1 Protocol 3 Manual scrape Scrape + wash With standard cleaning, 50% of individuals allergic to hazelnut could suffer an allergic reaction to just 2 cookies

20 Dark chocolate a particular problem: Over ¾ of dark chocolate (not listing cow s milk as an ingredient) contains cow s milk 1 1 Crotty et al, JACI 2010;125:935-7

21 UK FSA Survey (2014) 508 products Remington et al. Allergy. 2015;70:813-9.

22 Risk of anaphylaxis

23 IS THERE A BETTER SYSTEM? - can thresholds be used to improve labelling?

24 Population thresholds For individuals: Obtained by oral challenges starting from very low doses Defines individual thresholds of reactivity in mg protein For populations: Dose distribution modelling ED 10 dose predicted to provoke a reaction in 10% of the population

25 ED 10 for Peanut-allergic population ED 10 for peanut = 14.4mg 1/70 of a peanut Taylor et al, 2010

26 Voluntary Incidental Trace Allergen Labelling (VITAL)

27 Other foods Confectionery Potential benefits Amount of allergen Peanut (USA 2007) 1 Peanut (Europe 2007) 2 Hazelnut (Europe 2007) 2 Peanut (USA 2010) 3 Egg (USA 2010) 3 Cow s Milk (USA 2010) 3 Cow s Milk (USA 2010) 4 Any 11% 33% 60% 6% 5% 19% 43% >VITAL 8% 23% 52% 1% 0% 13% 34% Any 0% 0% 0% 7% 41% >VITAL 0% 0% 0% 0% 22% Turner et al, BMJ Hefle et al, JACI 2007;120: Pele et al, Food Add Contam 2007;24: Ford et al, JACI 2010;126: Crotty et al, JACI 2010;125:935-7

28 So why hasn t a system based on MEDs been implemented?

29 Availability of robust thresholds

30 How robust are thresholds? Ideally determined by DBPCFC May exclude more sensitive individuals Clinic patients vs general allergic public Food vehicle vs real life Matrix used Other food (proteins) consumed at same time Is procedure sensitive enough to determine MED? Interval in between doses? Is the MED stable? Endpoint / outcome: Symptoms: subjective vs objective Priming effect of prior doses Symptom severity

31 The perfect label? Both HCPs and food-allergic individuals prefer: Not suitable for someone with X allergy - Just ingredients? - What about allergens which may be present due to cross-contamination? - What level of contamination?

32 The challenge ahead UK Food-anaphylaxis fatalities: 27% caused by allergen in prepacked foods. 59% due to products from catering establishments