PRECAUTIONARY ALLERGEN LABELLING HOW CAN PAL REFLECT ACTUAL RISK? Food Matters Live ExCeL London November René Crevel

Transcription

1 PRECAUTIONARY ALLERGEN LABELLING HOW CAN PAL REFLECT ACTUAL RISK? Food Matters Live ExCeL London November 2016 René Crevel

2 OUTLINE Precautionary allergen labelling: current perspectives Risk and risk assessment Are we there yet?

3 PRECAUTIONARY (ADVISORY MAY CONTAIN ) ALLERGEN LABELLING Introduced in the 1990s First suggested by CFIA/Health Canada Voluntary Twin roles, closely intertwined Risk management and risk communication Effective outcome: people at risk avoid the product Ineffective outcome: people at risk don t believe it and/or are confused by it and disregard it 3

4 THE PROBLEM WITH PRECAUTIONARY LABELLING TODAY»Numerous phrases with different risk implications (although not necessarily associated with real differences in levels of risk)»lack of transparency over its application No generally agreed set of reference values as the basis for precautionary labelling Risk assessment process often unclear»allergic consumers are confused and many do not trust precautionary labelling»significant numbers ignore it at least part of the time, putting themselves at risk

5 VARIETY OF PAL PHRASES Survey of allergen advisory labelling and allergen content of UK retail prepacked processed foods Report for FSA by RSSL (2014)

6 PAL PHRASES: FURTHER VARIATIONS ON A THEME OF MAY CONTAIN and many more Survey of allergen advisory labelling and allergen content of UK retail pre-packed processed foods Report for FSA by RSSL (2014)

7 PRECAUTIONARY (ADVISORY MAY CONTAIN ) ALLERGEN LABELLING TODAY - SUMMARY No consistent 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 PAL statement not expected on product 8 1 Annex II food 10 Annex II foods

8 PAL IS NOT MEETING ITS OBJECTIVES Allergic consumers are disregarding PAL statements to a significant extent 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Ben-Shoshan et al. JACI (2012) 129: % Cochrane et al. Clin Trans Allergy (2013) 3: % 30% 25% 20% 15% 10% 5% 0% Never purchase if labelled 9

9 WHAT DOES/CAN A PAL STATEMENT MEAN? Dunngalvin A, Chan CH, Crevel R et al. Precautionary Allergen Labelling: Perspectives from key stakeholder groups. Allergy 2015, 70,

10 RISK AND RISK ASSESSMENT

11 SO HOW CAN PAL REFLECT ACTUAL RISK? The answer is in the question (at least partly): Base it on risk Some considerations What is risk? What risk are we talking about? What do we need to know in order to base PAL on risk?

12 WHAT DO WE MEAN BY 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 Characterising the hazard is therefore a critical step 13

13 FOOD ALLERGENS: DOSE AND EFFECT Considerations - Zero risk does not exist in practice - What is an acceptable/tolerable risk? - In terms of the nature (severity) of the effects? - In terms of the frequency of effects (how many will be affected)?

14 RISK ANALYSIS IN FOOD Risk Assessment Three parts Interactive and iterative process Risk Analysis Risk Communication Risk Management 2016

15 ASSESSING THE RISK FROM FOOD ALLERGENS: HOW MUCH IS TOO MUCH? How many people are likely to suffer a reaction, and how severe will the reaction be? Hazard identification Risk characterisation Exposure assessment What is the toxicological concern? Hazard characterisation How much are people exposed to? What is the relationship between dose and frequency / severity of response? 16

16 PEANUT DOSE DISTRIBUTION: CHARACTERIZING THE HAZARD Cumulative Percentage of Responses 100% 90% 80% 70% 60% 50% 40% 30% ED 01 ED 05 20% 10% 0% Log-Normal Dose of Protein (mg) Discrete Cumulative 17

17 VITAL SCIENTIFIC EXPERT PANEL RECOMMENDATIONS AND PROPOSED ACTION LEVELS. Allergen Basis of reference dose Reference dose (mg Protein) 50 g Serving Size: Action Level (ppm) 250 g Serving Size: Action Level (ppm) Peanut ED Milk ED Egg ED Hazelnut ED Soy ED05 95LCI Wheat ED05 95LCI Cashew ED05 95LCI Mustard ED05 95LCI Lupin ED05 95LCI Sesame ED05 95LCI Shrimp ED05 95LCI Celery Insufficient data Fish Insufficient data 18

18 VITAL 2.0 REFERENCE DOSES»Defined by reference to population healthbased outcomes (proportion likely to react)»serve as benchmarks for allergen management Define what is judged safe Define when additional risk management measures are required e.g. PAL 1 9

19 RISK ASSESSMENT: EXPOSURE Crevel RWR, Baumert JL, Baka A, Houben GF, Knulst AC, Kruizinga AG, Luccioli S, Taylor SL, Madsen CB. Development and evolution of risk assessment for food allergens. Food Chem Tox (2014) 67,

20 HOW SAFE ARE VITAL 2.0 REFERENCE DOSES: SINGLE DOSE CHALLENGES Concept Run in routine allergy clinics Challenge every patient attending for the food allergy of interest (no exclusions) Single dose ED05 selected as balance between good safety and numbers needed to be challenged for statistical robustness ED05 Open challenges Information generated for risk assessment Validation of ED05 derived from dose distribution modelling Severity profile at ED05 2 1

21 SINGLE DOSE CHALLENGES: PEANUT STUDY 375 clinic attendees with peanut allergy Three centres: Cork, Melbourne, Boston 6mg whole peanut in a cookie (except for participants allergic to other ingredients in the cookie) Open challenge 2-hour post-challenge follow-up Data support the VITAL ED05 value of 1.5mg for peanut protein Full results expected to be published soon! 2 2

22 ARE WE THERE YET?

23 Chapter V. Article The Commission shall adopt implementing acts on the application of the requirements referred to in paragraph 2 of this Article to the following voluntary food information: (a) information on the possible and unintentional presence in food of substances or products causing allergies or intolerances; 24

24 NEW REQUIREMENTS FOR VOLUNTARY ALLERGEN INFORMATION (REG 1169/2011) Precautionary labelling remains voluntary (Article 36)»However mandatory requirements are introduced (e.g. name of allergenic food)»specific rules apply: 2. Food information provided on a voluntary basis shall meet the following requirements: (a) it shall not mislead the consumer, as referred to in Article 7; (b) it shall not be ambiguous or confusing for the consumer; and (c) it shall, where appropriate, be based on the relevant scientific data.

25 WHAT COULD IT ALL MEAN? (a) shall not mislead: PAL should be accurate, i.e. use must be justified (b)shall not be ambiguous or confusing: terminology should be clear and limited to one (or a few) well-understood terms (c) be based on the relevant scientific data: PAL should be based on a thorough risk assessment (preferably quantitative)

26 DG SANTE-JRC STAKEHOLDER WORKSHOP (GEEL, BELGIUM JUNE 2016) Participants (46): Delegates (19) from Member States' competent authorities and delegates representing relevant stakeholders (e.g. FoodDrinkEurope and the European Federation of Allergy and Airways Disease Patients Association). AIMS (provided by DG SANTE-JRC)»Background: Regulation (EU) 1169 /2011 on the provision of food information to consumers and the observed proliferation of precautionary allergen labelling by food producers.»to identify the sequence of steps required for framing the current use of precautionary allergen information and its enforcement across the EU.

27 DG SANTE-JRC STAKEHOLDER WORKSHOP (GEEL, BELGIUM JUNE 2016) Agenda SESSION 1: Legislative and Allergy Sufferers Requirements (DG SANTÉ, EFA) SESSION 2: Risk Based Approaches to Allergen Management (FoodDrinkEurope, ifaam) SESSION 3: The Role of Analysis in Enforcing Legislation (JRC-IRMM)» Breakout groups after each session SESSION 4: Conclusions from Discussion Topics» Topic 1: Legislative perspective on precautionary labelling, its current wording and conditions of use» Topic 2: Risk based approaches» Topic 3: Comparing results from analytical measurements

28 DG SANTE-JRC STAKEHOLDER WORKSHOP (GEEL, BELGIUM JUNE 2016): CONCLUSIONS 1 Legislative perspective on precautionary labelling, its current wording and conditions of use.» PAL terminology: should be simple, easy for consumers to understand may contain recommended» Use of PAL should be subject to defined conditions and transparent:» Documented risk assessment» Allergen management procedures in place» No PAL statement below reference dose» Benchmarks need to balance degree of protection/safety and choice for allergic consumerss (reference doses) need endorsement by EFSA» Communication to users (both consumers and health care practitioners) is crucial

29 DG SANTE-JRC STAKEHOLDER WORKSHOP (GEEL, BELGIUM JUNE 2016): CONCLUSIONS 2 Risk-based approaches»guidance on good risk assessment practice EU-wide required»protein is the hazard and should be basis of the risk assessment»stakeholders want acceptance (by the authorities) of the RDs defined by VITAL» They wish to encourage FBOs to use them and evaluate how well they work.»commission role to develop a framework based on general principles» detail to be developed by other stakeholders (e.g. authorities, trade associations)»questions on readiness of FBOs for application of RDs (VITAL/iFAAM)

30 DG SANTE-JRC STAKEHOLDER WORKSHOP (GEEL, BELGIUM JUNE 2016): CONCLUSIONS 3 Comparing results from analytical measurements» Expressed results in units that can be directly applied to the risk assessment, i.e. mg total protein/kg of food» This links analysis to the materials used for clinical food challenges.» Could be looked at in the context of Infrastructure to support framework: existing structures may provide a possible model e.g. Veterinary Medicines» Priority allergens: wheat, milk and egg, based on frequency of RASFF notifications for these allergens» Guidance to good analytical practice for food allergens should be developed Nordic group could lead, based on their experience» Further workshops likely needed as work developed

31 CONCLUDING REMARKS Precautionary allergen labelling (PAL) continues to fail allergic consumers PAL needs to be based on transparent, understood and accepted risk assessment The VITAL 2.0 scheme proposed scientifically sound and transparent reference doses, based on a human data which form a basis for this risk assessment Developing scientific and regulatory perspectives offer opportunities to introduce a robust framework for the application of PAL Acting on these opportunities can restore the value of PAL and thereby help allergic consumers as well as FBOs

32 THANK YOU FOR YOUR ATTENTION 33

33 Seven secrets to successful nutritional labelling...and the seven sins commonly made with health and nutrition claims Mike Peters Dr Andy Bowles

34 Seven secrets to successful nutritional labelling Mike Peters

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36 Despite Brexit! Nutritional labelling is here to stay!

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38 What s in a label take a holistic approach! Nutritional analysis Portion & cooking instructions Fortification Functional Formulation Widen appeal Food trends Product Development On pack comments/claims Nutrient reduction or increase

39 The UK s nutrition imbalance Too much Saturated fat Sugar Salt Weight! Not enough F&V, Fibre Omega 3 Vitamins/ minerals* *Vitamin A, riboflavin, iron, calcium, magnesium, potassium, zinc, iodine

40 Sampling Matters! Eurofoods trial 1985: Leading European laboratories Egg Milk Rye Wheat Biscuits French beans No. of labs Mean (g/100g dry wt) Range CV (within) CV (between) Hollman & Katan, 1988, Journal of the American Medical Association Within labs the same methods are used Different labs use different methods Less repeatable at lower concentrations Less accurate at lower concentrations

41 Variation in nutrient content of foods Analytical values are a snapshot of what was analysed and composition of any individual sample may differ considerably. There are two main reasons for the variability, in addition to analytical variation. Natural variation Different animals/plants Season Feeding regime Country of origin Growing conditions Storage Extrinsic differences Change in recipe Fortification practices Home prepared dishes not regulated Length of cooking time Water used to cook with Cooking utensils

42 Vitamin and mineral declarations The following vitamins and minerals may be added to the nutrition table but only if they are present in significant amounts Vitamin A (µg) Folic acid (µg) Iron (mg) Vitamin D (µg) Vitamin B12 (µg) Zinc (mg) Vitamin E (mg) Biotin (µg) Copper (mg) Vitamin K (µg) Pantothenic acid (mg) Manganese (mg) Vitamin C (mg) Potassium (mg) Fluoride (mg) Thiamin (mg) Chloride (mg) Selenium (µg) Riboflavin (mg) Calcium (mg) Chromium (µg) Niacin (mg) Phosphorus (mg) Molybdenum (µg) Vitamin B6 (mg) Magnesium (mg) Iodine (µg)

43 See the bigger picture coming!

44 Seven sins commonly made with health and nutrition claims Dr Andy Bowles Specialist food law solicitor

45 Health and Nutrition claims Nutrition claims Energy Nutrition Health claims Any statement about a relationship between food and health

46 Health claims the law Types of health claims Function Risk reduction Childrens development Non-specific health claims Only made where approved health claim listed

47 Register of nutrition and health claims

48 Other claims Natural Fresh Traditional Home made

49 Main principles Claims must be Substantiated Accurate Truthful Not misleading Not just on labels!

50 Most common sins 1. Packed with.. bursting with. for source of claims. 2. Non-specific health claims Good for you 3. Health claims on unhealthy foods. 4. Natural with refined ingredients 5. Free from applies to all similar products 6. Non- approved health claims. 7. Non-approved wording.

51 Come and see us ABC Food Law Stand 592 ABC Legal Labels Stand 642 IFR Extra - Stand RP20

52 Our Contact Details Name & Company Mike Peters Nutritional Information Solutions Contact Details Tel / What we can help you with Inexpensive nutrition label information from your product recipe, for front and back of pack, independently checked and verified to meet regulations Dr Andy Bowles ABC Food Law Tel: Any food law issue including Food label/reviews HACCP Allergen control Import/export Traceability Novel foods

53 The impact of EU FIC Regulation for business and consumers Sarah Howarth 22 nd November

54 Agenda Impact Implementation Enforcement Conclusions

55 Aims of EU No 1169/ A harmonised approach across the EU - Free movement of safe and wholesome food - Allow more informed consumer choice - Drive healthier food choices - Simplify legislation

56 Impact for business

57 Significant changes Name of the Food List of Ingredients Naming of certain ingredients/categories Quantity of certain ingredients Allergens Nutritional information Net quantity of the food Date of minimum durability Special storage conditions/conditions of use Business name (FBO) and address in the EU Font size Distance selling Country of Origin

58 Impact for business

59 EU No 1169/2011Timescales 30 January 2008: Commission proposal 24 Oct 2011: Published 13 Dec 2014: Application Further reports 2013 : meat ingredients 2015 : TFA s ; extension COOL 13 Dec 2016: Mandatory Nutritional information

60 Key ingredients for implementation FIC Guidance Supplier/manufacturing information Marketing and Sales New Label

61 Common challenges Lack of clarity and guidance on the changes Resources - budget ; skills ; time Delay in obtaining supplier information Inadequate in-house data/specifications Amending internet sites Fitting all mandatory information on pack Packaging right-offs

62 Common areas of confusion

63 Allergens????

64 Enforcement officers - Possess guidance to determine and ensure that their actions are reasonable, proportionate and commensurate with good practice - Use a gradual and educative approach UNLESS they determine that there is Significant Risk for the public - May move to formal actions if the desired change is not achieved in a reasonable time period

65 Where are we now? - Business

66 Understanding NI Consumer Needs Around Food Labelling (July 2016) Overall, participant attention to labelling information appeared to be driven by a particular need; for example, if participants were following a specific diet or had specific dietary or allergen requirements. Outside of these circumstances, participants tended only to use labels to check the use by or best before dates, and occasionally checked labels when buying new or unfamiliar products. Source : FSA Website

67 Conclusions - Have the aims of EU No 1169/2011 been achieved? - A harmonised approach across the EU - Free movement of safe and wholesome food - Allow more informed consumer choice - Drive healthier food choices - Simplify legislation

68 Impact for Consumers?

69 Thank you!