ILSI Workshop on Food Allergy: From Thresholds to Action Levels. The Regulators perspective

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1 ILSI Workshop on Food Allergy: From Thresholds to Action Levels The Regulators perspective September 2012 Reading, UK Sue Hattersley UK Food Standards Agency

2 Public health approach Overview Guidance on allergen management practices Risk assessment of food allergen incidents involving detectable levels of allergen cross contamination Use of reference values in regulatory context when considering: possible exemptions from mandatory allergen labelling requirements free from claims

3 Public Health approach

4 UK Food Standards Agency Strategic Objective - safer food for the nation Specific Outcome is that: o food producers and caterers give priority to consumer interests in relation to food Main priority under this outcome is to increase the provision of information about allergens, including in catering establishments

5 FSA responsibilities in relation to food allergy Food allergen labelling legislation Guidance for food businesses on areas not currently covered by legislation Labelling of allergen cross contamination risks ( May Contain X warnings) Provision of allergen information for non-prepacked foods Risk assessments for food allergy incidents Advice for consumers Research to underpin policy development

6 Public health approach Allergic consumers and clinicians are concerned with possible allergic reactions in an individual But regulators need to consider public health for the population at risk Inherent in this approach is an acceptance that a low level of risk would remain - zero risk at a population level is not achievable

7 Variability Food allergic individuals vary considerably in their sensitivity to a given food allergen (intrinsic variability) Even for one individual, sensitivity can vary on different occasions (extrinsic factors such as exercise, stress, illness) Food properties can affect sensitivity (cooking or processing of the food, the food matrix containing the allergen, etc)

8 What level of allergen cross contamination risk is acceptable? The current uncertainties and inconsistencies are not helpful for industry, for consumers or regulators If zero risk is not achievable at a population level, what level of risk would be acceptable to society as a whole? General agreement that risk tolerance depends on the severity of the effect and frequency of reactions

9 What level of allergen cross contamination risk is acceptable? Inconsistencies and uncertainties lead to: consumer confusion, mistrust and lack of confidence in allergen information provided on labels consumers ignoring precautionary labelling Industry concerns about inconsistencies in enforcement between different regulators Madsen et al (2011): Clin Exp Allergy 42, 30-37

10 What is the way forward? Develop allergen management thresholds (reference values) using modelling of data from clinical challenges in individuals International review, agreement and acceptance Used by industry and enforcement bodies and understood by consumers

11 What do we mean by allergen reference values? Allergen reference values are levels in foods below which we would not expect to elicit significant reactions in people already allergic to that food allergen The aim of such thresholds is to protect consumers at the public health level - not to protect every individual on every occasion against any reaction

12 What can allergen reference values be used for? In the short term: Determining levels below which cross contamination warnings/labelling does not need to be used Dealing with food allergy incidents

13 What can allergen reference values be used for? In the longer term, the same approach could potentially be used to derive different reference values for use in: Setting limits for justifying free-from claims Setting levels of use below which allergenic ingredients do not need to be labelled

14 Guidance on allergen management practices

15 UK FSA s Best Practice Guidance on Allergen Management and Advisory Labelling ( May Contain ) Published July 2006

Aimed at medium/ large businesses enforcement officers leaflet for small and micro businesses Disseminated via the industry and enforcement stakeholders who

16 Aimed at medium/ large businesses enforcement officers leaflet for small and micro businesses Disseminated via the industry and enforcement stakeholders who were involved in drafting the guidance and through Agency training courses for enforcement officers pdfs/maycontainguide.pdf

Aimed at small businesses: http://www.food.gov.

17 Aimed at small businesses: pdfs/publication/allergyjamjar0109. pdf

18 Main Approach of Guidance Encourage food manufacturers and retailers to think about risks of allergen cross-contamination - where they occur and whether they can be reduced or eliminated 1.RISK ASSESSMENT 2.RISK MANAGEMENT 3.RISK COMMUNICATION Only use advisory labelling after a thorough risk assessment

19 Approach taken in the guidance Qualitative not quantitative No allergen thresholds/management levels Think about risks Where they arise Whether they can be controlled/managed Decision tree approach Probable or remote Worked examples

20 Activities and next steps Used as a basis for the development of the FoodDrinkEurope guidance on allergen management ILSI Expert Group: From Thresholds to Action Levels Review and update FSA guidance

21 Risk Assessment of Food Allergy Incidents

22 Food allergy incidents in UK? Number of food allergy incidents notified Number of Food Allergy Alerts issued

23 Which allergens (2011 figures)? Allergen Number Milk/lactose 27 Sulphites 19 Gluten 14 Multiple 12 Nuts 9 Soya 9 Eggs 7 Peanut 5 Others 12

24 What types of incident do we see? Wrong packet/labelling Inconsistent labelling Information in ingredients list does not agree with Contains statement Labelling on outer wrapping of multipacks does not agree with labelling on individual packs Detectable levels of cross contamination With or without advisory labelling Detectable levels of allergen in foods making free from claims (or gluten above 20mg/kg)

25 Risk assessment of allergen cross contamination for enforcement purposes At present, risk assessments for food allergen incidents submitted to the FSA are performed on a case by case basis. Several factors need to be considered: Amount of allergen reported (whole food, allergenic protein, total protein, DNA) Type of food (special diet, food for children?) Clinical threshold data (NOAEL / LOAELs) Portion size Homogenous or heterogeneous contamination Amount of units in affected batch Distribution (local, national, international?) Best before / Use by Dates remaining shelf life

26 Can we use reference values for assessing risk of different types of cross contamination? Yes If the contamination is homogeneous throughout the product If there are variable levels during the production run as long as the highest expected levels are known Not appropriate for discrete pieces of nut / whole seeds

27 Use of reference values in regulatory context

28 Potential uses of reference values in regulatory context Basis for exemptions from allergen labelling legislative requirements for highly processed ingredients derived from allergenic foods Setting limits for making free from claims Gluten free limit set at 20mg/kg Others?

29 Exemptions from allergen labelling in EU legislation Dossiers have to be submitted by industry to support exemption Evaluation by EFSA and opinions published not very likely that XXX will trigger a severe allergic reaction in susceptible individuals under the conditions of production and use stated by the applicant unlikely that YYY will trigger a severe allergic reaction in susceptible individuals ZZZ is unlikely to cause an adverse reaction in individuals with coeliac disease, provided that the value of gluten considered by Codex for foods rendered gluten-free is not exceeded

30 Exemptions from allergen labelling in EU legislation Exemptions based on combination of degree of processing and the particular use of ingredient But no explicit publication of threshold limits for residual protein to support exemptions Recently, EU Regulation 579/2012 set out that fining agents derived from egg and milk used in wine production should be considered to be ingredients if their presence can be detected in the final product by agreed analytical methods (which have an LOD of 0.25mg/l) and would therefore need to be declared

31 Free from claims Gluten free claims in Codex and in EU legislation based on final product not containing more than 20mg/kg gluten Some products that are able to make a gluten free claim nevertheless have to declare the use of a glutencontaining cereal ingredient under the allergen labelling rules (as there are no thresholds in this legislation) Market for products described as dairy free, lactose free or milk free is increasing rapidly - but there are no legislative or advisory definitions of such claims

32 Contact Details Sue Hattersley Address: Food Allergy Branch, Aviation House 125 Kingsway, London, WC2B 6 NH, UK Telephone: +44 (0) sue.hattersley@foodstandards.gsi.gov.uk

REGULATORS PERSPECTIVE ON ALLERGEN MANAGEMENT IN THE FOOD INDUSTRY

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