MANAGING RISK IN THE FREE-FROM SECTOR: HOW CAN MANUFACTURERS AVOID PUTTING CONSUMERS, AND THEMSELVES, AT RISK

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1 MANAGING RISK IN THE FREE-FROM SECTOR: HOW CAN MANUFACTURERS AVOID PUTTING CONSUMERS, AND THEMSELVES, AT RISK Understanding the free-from supertrend Food Matters; London November 2014 René Crevel

2 OUTLINE What is meant and understood by free-from? Risk assessment: a critical requirement Evolution and development of risk assessment for allergens Translation to Free-From products Conclusions

3 WHAT IS UNDERSTOOD BY FREE- FROM? Free-from : not subject to (or affected) by (something undesirable) Oxford Dictionaries online Motivation for seeking and using free-from products varies Ethical Health or health perception of some food constituents Safety/nutritional imperative Etc The consequences of not achieving free-from status differ quite drastically for the users

4 WHAT IS FREE-FROM IN PRACTICE? Zero is a very low number (Steve Taylor, FARRP) In practice, free-from does not (and cannot) denote total absence Gluten 20mg/kg (1981<500ppm) (and 20ppm is not a No Effect Level) Lactose 100mg/kg (in many European countries) Allergens??????? Possibly the biggest challenge

5 For people with food allergies, free-from is NOT a lifestyle or ethical choice It can be a matter of life and death So if you are making an allergen free-from claim, it is critical to be able to decide what makes the difference between safe and unsafe

6 ALLERGENS AND FREE-FROM Analytical methods still very much at developmental stage Uncertainty about thresholds/minimum eliciting doses No agreement among regulators yet Perceived unpredictability of allergic reactions How can we define free-from and provide products which the exquisitely food-allergic can trust?

7 First step is a thorough quantitative assessment of the risk

8 RISK ASSESSMENT OF ALLERGENIC FOODS: EVOLUTION A 20-YEAR JOURNEY Hazard identification Early 1990s Nordic list 1995 FAO-WHO consultation Codex List (1999) Hazard characterisation 1997 Peanut threshold study (Hourihane et al) st Threshold conference 2002 Dose-distribution feasibility (Bindslev-Jensen et al) 2007 Considerations on use and interpretation of dose-distribution data (Crevel et al) Risk assessment 2008 FDA Threshold Working Group: the quantitative risk assessment-based approach provides the strongest, most transparent scientific analyses to establish thresholds for the major food allergens 2009 Europrevall-FSA workshop (Madsen et al) 2011 VITAL Scientific Expert Panel 2012 ILSI-Europe Thresholds to Action Levels workshop 2014 ILSI-Europe Severity vs dose Expert Group 8

9 PRECAUTIONARY (ADVISORY MAY CONTAIN ) LABELLING Introduced in the 1990s First suggested by CFIA/Health Canada Voluntary Very high level of precautionary labelling in some food categories BUT No clarity about standards for application: use dependent on internal company standards and perception of risks Negative perception by consumers and health care practitioners Result: misunderstanding and mistrust, lack of observance and consequently higher risks to allergic consumers 10 Annex II 1 Annex II foods food 9

10 SO, PRECAUTIONARY (ADVISORY) LABELLING on its own is not a definitive answer needs standards to ensure consistent application needs to communicate clearly the risk message to allergic consumers needs to be used sparingly if it is to retain credibility and effectiveness Current implementation doesn t do this, hence the drive for better, more refined assessment of allergen risks 1 0

11 ASSESSING ALLERGEN RISKS Focus of development of risk assessment approaches has been on standards for precautionary allergen labelling ( may contain ) However, knowledge gained and lessons learned can also be usefully deployed in developing standards for free-from specific allergens Indeed the US-FDA s reasoning for adopting a 20ppm limit for gluten-free, rather than a lower one is very similar to the reasoning behind PAL 1 1

12 RISK Fundamental principle of toxicology: The dose makes the poison (Paracelsus, 15 th Century) Implication: the key parameter is risk not hazard Risk» the likelihood that, under particular conditions of exposure, an intrinsic hazard will represent a threat to human health.» Risk = f (hazard, exposure) with a consideration of the nature of the effects This applies as much to allergens as to other substances, although it has taken the best part of 20 years to be accepted 12

13 FOOD ALLERGENS: DOSE IS CRITICAL Lip tingling, Itch Rash, hives Nausea, vomiting, shortness of breath Cardio-respiratory symptoms, severe angioedema, anaphylaxis INCREASING DOSE Probability of no or slight effect Probability of severe effect

14 FOOD ALLERGENS: CHALLENGE DOSE AND DISTRIBUTION OF POPULATION RESPONSES ED10 (mg) ED05 (mg) Dose Lower 95% CI Dose Lower 95% CI LOAEL: 0.5mg ED10 14

15 VOLUNTARY INCIDENTAL TRACE ALLERGEN LABELLING (VITAL) Originally developed under the aegis of the Allergen Bureau of Australia-New Zealand (VITAL 1.0, 2007) Key innovation was definition of quantitative benchmarks (action levels) for precautionary labelling Comprehensive review of VITAL scheme started in 2011 Panel of recognised and independent international external experts (chaired by Prof Steve Taylor (FARRP, University of Nebraska) to revise and update action levels based on most recent science 15

16 VITAL SCIENTIFIC EXPERT PANEL: MODUS OPERANDI Keep original VITAL design principles: Applies to foods for normal consumption Not designed for specific allergen-free foods Not designed for extremely reactive Although would provide protection in many cases Derive reference doses using dose distribution modelling Level of protection» Panel decided to Use ED01 where possible as the basis for reference doses, providing a minimum protection factor of 99% Use lower 95% CI of ED05 where data were insufficient to use ED01 Aim to protect vast majority against mild objective reactions SEAC 16

17 ALLERGENS ANALYSED BY VITAL SCIENTIFIC EXPERT PANEL Assembled and evaluated clinical data on almost all priority allergenic foods on the EU list Peanut Milk Egg Hazelnut Soybean Wheat Cashew Mustard Lupine Sesame seed Shrimp Celeriac/celery Fish No data at all: Molluscs 17

18 PEANUT DOSE DISTRIBUTION: ADULTS AND CHILDREN COMBINED Cumulative Percentage of Responses 100% 90% 80% 70% 60% 50% 40% ED 01 30% 20% 10% 0% Log-Normal Dose of Protein (mg) Discrete Cumulative SEAC 18

19 VITAL SCIENTIFIC EXPERT PANEL RECOMMENDATIONS AND PROPOSED ACTION LEVELS. Allergen No of data points Basis of reference dose Reference dose (mg Protein) 50 g Serving Size: Action Level (ppm) 250 g Serving Size: Action Level (ppm) Peanut 750 ED Milk 351 ED Egg 206 ED Hazelnut 202 ED Soy 80 95%LCI ED Wheat 40 95%LCI ED Cashew 31 95%LCI ED Mustard 33 95%LCI ED Lupin 24 95%LCI ED Sesame 21 95%LCI ED Shrimp 48 95%LCI ED Celery 39 Insufficient data Fish 19 Insufficient data 19

20 CONCLUSIONS OF THE VSEP The VITAL reference values, also adopted by the ILSI Expert Group Thresholds to Action Levels provide a high level of protection to allergic consumers: will protect a minimum of 95-99% of allergic consumers against mild objective reactions reactions in the more sensitive individuals are likely to be mild, transitory objective reactions typically requiring no pharmacological intervention They are transparent and can be used to communicate risk meaningfully to allergic consumers and health care practitioners They provide a consistent standard for precautionary labelling across industry, which can drive Improved allergen management Improved consumer safety 20

21 WHAT DO THESE REFERENCE VALUES MEAN? THE CLINICAL DATA (1) Anaphylaxis developed at a cumulative dose of peanut of 0.02g to 11.7g (i.e. from 5mg to 2750mg of peanut protein) VITAL 2.0 Reference dose for peanut is at least 25-fold lower than the lowest dose to provoke an anaphylactic reaction SEAC 21

22 WHAT DO THESE REFERENCE DOSES MEAN? THE CLINICAL DATA (3) 869 children challenged Starting doses 3-5mg protein for cows milk, wheat, soy, hen s egg 8-10% first dose reactors for milk and hen s egg 0.5-1% at risk of severe reactions starting doses were 33 and 166-fold higher than VITAL Reference Doses for milk and egg respectively 22

23 MOVING FORWARD The ILSI-Europe Food Allergy Task Force Expert Group Thresholds to Action Levels The ILSI Thresholds to Action Levels workshop Reading September 2012 SEAC 23

24 CONCLUSIONS ENDORSED BY THE WORKSHOP PARTICIPANTS A transparent set of reference doses (as a basis for action levels) would be a desirable outcome, in principle. Data from food challenge studies provide the appropriate foundation from which these action levels can be derived Sufficient data exist to move forward and better estimate the risk to the allergic population for the allergens specified in the report The proposed reference doses, based on the work of the VITAL Scientific Panel, constitute a reasonable first pass to minimise risk to the allergic consumer while maintaining food choices 24

25 FREE-FROM : HOW CAN WE TRANSLATE RISK ASSESSMENT KNOWLEDGE Action Levels and Reference Doses are critical to the concept of freefrom, but are they the threshold for free-from NO, because they have been developed to apply to everyday foods, manufactured using everyday sanitation processes, etc WHY? The Reference Doses are NOT No Effect Levels Free-from are specially prepared for and used by people who are at the very sensitive end of the spectrum and enhanced procedures need to be used to ensure that the risk remains low However they can be used as a benchmark SEA C 25

26 FREE-FROM, ALLERGEN MANAGEMENT AND PUBLIC HEALTH OUTCOMES ALLERGEN STATUS FREE FROM SUITABLE FOR MAY CONTAIN NOT SUITABLE FOR PUBLIC HEALTH OUTCOME No mild reactions in the vast majority of highly sensitive allergic Individuals No reactions In the vast majority of allergic Individuals No severe reactions in the vast majority of allergic individuals Manufacturing facility IN CONTROL MANAGEMENT PARAMETER Lower limit of analytical detection Action Level Allergen analytically absent to a high degree of confidence, GMPs to ensure absence of specific allergen Allergen management cross-contact control well-managed to a low level Allergen management controls managed, with unavoidable traces present despite efforts lower AMOUNT OF ALLERGENIC PROTEIN higher Ward R, Crevel R, Bell I, Khandke N, Ramsay C, Paine S. A vision for allergen management best practice in the food industry. Trends Food Sci Tech 21 (2010)

27 CONCLUDING REMARKS Effective definition of free-from hinges on a good understanding of allergen risks, grounded in quantitative approaches Considerable progress has been made in developing and using methodologies to assess allergen risks in general allergen management, in particular for the application of PAL Translation of this knowledge will enable the development of robust quantitative benchmarks for the design and operation of facilities to supply products free-from specific allergens with a high assurance of safety. 27

28 THANK YOU FOR YOUR ATTENTION 28