Food allergies, sulphite sensitivity and celiac disease are considered significant public health issues

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1 Why are food allergies important? : Prevalence ILSI SEA Region Seminar on Food Allergens Science and Challenges for Southeast Asia April 7, 2015, Bangkok, Thailand Samuel B. Godefroy, Ph.D. q Food allergies and celiac disease affect over 1.6 Million Canadians o 5 6% of children and 3-4% of adults have food allergies o Asthma is linked to sulphite sensitivity : about 200,000 asthmatics have a sulphite sensitivity o Celiac disease affects about 340,000 Canadians (1% of the population) and is underdiagnosed Food allergies, sulphite sensitivity and celiac disease are considered significant public health issues Senior Executive Food Regulator, in Secondment, Global Food Safety Partnership, Strategic Development and Engagement Agriculture Practice, World Bank 1 2 Why are food allergies important? : Impacts q The health impacts are serious : hospitalisation, anaphylaxis and death ( deaths per year in the US). q About 12% allergic reactions to foods need treatment in emergency rooms q Celiac disease is associated with multiple complications including osteoporosis and cancer q These conditions impact individuals, families and social circles Costs and Burden of food allergies q Costs for emergency room visits / hospital stays due to allergic reactions* estimated to be about $5.4M/ year o Estimate over 14,500 Emergency Room visits and nearly 400 requiring hospital stay q Recent studies suggest $5000 (CAD) of additional direct and indirect costs to households with food sensitivities, for a total of $5.4B ** Food allergies and celiac disease are life long and incurable conditions Avoidance is the only line of defense Prevention of food allergy incidents may help reduce the cost of this burden on individuals, family and society 3 * (not including costs for celiac disease and sulphite induced asthma) 4

2 1. Obesity 2. Cigarettes 3. Stress 4. Chemical Pollution 5. Smog and Air Quality 6. Climate Change 7. Crime & Violence 8. Pesticides 9. Motor Vehicle Accidents 10. Sun Exposure 11. Bacteria in Foods 12. Mould 13. Food Allergies 14. Nuclear Waste 15. Flu Epidemics 16. Additives in Food 17. Non-prescription Drugs 18. Anaphylaxis 19. GMOs 20. Lead in Paint 21. Indoor Air Quality 22. Overhead Power Lines 23. Tap Water 24. Blood Transfusions 25. Vaccines 26. Alternative Health 27. Laser Eye Surgery (From Elliott and al., 2009) Canadians consider food allergy a high risk 0% 20% 40% 60% 80% 100% High/Moderate % Other % In Canadians understanding : food allergies are considered a higher risk than nuclear waste or flu pandemics Food Allergy Incidents qa Food Allergy Incident is preventable qavoidance is the most effective risk management approach for food allergic consumers 5 6 Why are changes to labelling regulations needed? q Labels are the only link for consumers to know the composition of prepackaged foods q 1/3 of those who experienced a food allergy incident attributed it to a problem with the label q Allergic consumers and their caregivers need: o Reliable/accurate labelling (no doubt should be left for allergens) o Clear and consistent labelling (no shopping dictionary should be needed) Stakeholders: Actors Regulations Enforcement Safe Products Government Education Education Information Offer of Choice Food Industry Consumers While ingredient labelling is mandatory for most prepackaged foods, there are instances where allergen ingredients are not readily disclosed and remain «hidden» for consumers Responsibility Choice Action 7 8

3 Objectives qenhanced protection to avoid inadvertant consumption of foods containing the «culprit ingredient»: o Minimize risks associated with inadvertent consumption of undeclared allergens in food; qavoid undue restrictions on choice for a safe and nutritious food supply: o Maximise Choice for food allergic consumers qcodex Connexion with Food Allergens Food labelling : CCFL Nutrition and Foods for Special Dietary Uses : CCNFSDU Methods of Analysis and Sampling: CCMAS 9 10 o The Codex Committee on Food Labelling (CCFL) has considered allergen labelling as an area of priority and has made recommendations adopted by the Codex Alimentarius Commission (CAC) in 1999 (CAC, 1999). o It was recommended that science-based criteria be used to determine which foods or food products should be placed on a priority list of foods o The presence of these priority foods should be always subject to declaration in the list of ingredients on a food label, because of their potential to induce an allergic reaction. Why have a food allergen list? q While many different foods can provoke allergic reactions, a relatively small number of foods are responsible for the majority of severe food allergic reactions q Creating a priority list of food allergens allows a regulator to focus resources on the most dangerous food allergens and makes labelling more manageable for manufacturers and agencies responsible for enforcement activities q Labelling requirements (domestics and international) would require that those food allergens on the list be always indicated on the label (above and beyond any normal labelling requirements), so that people who need to avoid those foods will be able to do so

4 Codex List Codex developed a list of foods and ingredients that are known to cause hypersensitivity and should always be declared: q cereals containing gluten; i.e., wheat, rye, barley, oats, spelt or their hybridized strains and products of these; q crustacea and products of these; q egg and egg products; q fish and fish products; q peanuts, soybeans, and products of these; q milk and milk products (lactose included); q tree nuts and nut products; and q sulfites in concentrations of 10 mg/kg or more. Codex List is meant to be built upon to consider Regional / National Requirements This list was adopted as a final text by the Codex Alimentarius Commission (CAC) in June 1999, with the understanding that future additions and/or deletions from the list will be considered by the CCFL taking into account advice received from JECFA Codex Criteria for additions to FA list Adoption in Domestic Legislation an Regulations Developed by a Food Allergen Labelling Panel convened by the WHO in 1999 to provide guidance to JECFA q The existence of a credible cause-effect relationship, based upon positive double blind, placebo-controlled food challenges (DBPCFC) or unequivocal reports of reactions with typical features of severe allergic or intolerance reactions. q Reports of severe systemic reactions following exposure to the foodstuff. q Assessment of available prevalence data in children and adults, supported by appropriate clinical studies with subjects from the general population of several countries or alternatively available prevalence data from clinical studies with groups of allergy patients from several countries supported as per the first recommendation

5 Tool Box for Risk management Application to Canada q Legislative and Regulatory instruments: o Food and Drugs Act and Regulations and their enforcement q Education, information dissemination q Collaboration between stakeholders: Allergic consumers and the food industry (Government plays a facilitation role) o e.g. Improvement of manufacturing practices: codes of practice o Certification programs Canada s Allergen Labelling Regulations Food Allergen Defined Any protein from any of the following foods or any modified protein, including any protein fraction, that is derived from the following foods: q Almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts q Peanuts q Sesame seeds q Wheat, triticale q Eggs Milk Soybeans Crustacea (common name) Fish (common name) Shellfish (common name) Mustard seeds Canada s Allergen Labelling Regulations Label Declaration q Sources of priority food allergens and gluten must be declared either: o in the list of ingredients, OR o in the statement: Contains q Added sulphites when present at levels of 10 ppm or higher must be declared either: o in the list of ingredients, OR o in the statement: Contains q In addition to standard requirements for ingredient declaration Example of label changes Cake Mix Prior to allergen labelling regulations Ingredients : Sugar, Flour, Ovalbumin, Monocalcium phosphate monohydrate, Sodium bicarbonate, Potassium bitartrate Since allergen labelling regulations Ingredients : Sugar, Flour (Wheat), Ovalbumin (Egg), Monocalcium phosphate monohydrate, Sodium bicarbonate, Potassium bitartrate OR Ingredients : Sugar, Flour, Ovalbumin, Monocalcium phosphate monohydrate, Sodium bicarbonate, Potassium bitartrate Contains : Egg, Wheat Ovalbumin is a protein found in egg whites 19 20

6 Prior to allergen labelling regulations Ex. of Label Change Potato Chips Ingredients : Potatoes, sunflower oil, salt, seasonings Since allergen labelling regulations Ingredients : Potatoes, sunflower oil, salt, seasonings (mustard) OR Ingredients : Potatoes, sunflower oil, salt, seasonings Contains : mustard Seasonings are a multi-component ingredient which are exempt from component declaration Example of Label Change Wine Prior to allergen labelling regulations : No ingredients or Contains statement was required for food allergens, gluten sources or sulphites in wine Since allergen labelling regulations (if sulphites present at 10ppm or higher)* Contains : sulphites *will apply to non vintage wines and vintage wines with a year date of 2012 and later. Older vintage wines will continue to be sold with original labels Priority List of Food Allergens in Canada Initial List adopted in 1999 q Peanut q Almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts q Milk q Eggs q Fish, crustaceans (crab, crayfish, lobster, shrimp ) and shellfish (e.g. clams, mussels, oysters, scallops) q Sesame seeds q Soy q Wheat (including spelt and kamut, triticale) q Sulphites (10 ppm and above) Need to Revise List of Priority Allergens On its proposed allergen labelling regulations HC received comments about the need to consider mustard, onion and garlic as potential food allergens of concern for Canadians from: q the general public q patient groups, health professionals q consumer organizations, and governmental agencies Marion Zarkadas et al. Common Allergenic Foods and Their Labelling in Canada A Review. Canadian Journal of Allergy and Clinical Immunology 4: 3,

7 Canadian Criteria for Addition q The existence of a credible cause-effect relationship, based upon positive double blind, placebo-controlled food challenges (DBPCFC) or unequivocal reports of reactions with typical features of severe allergic or intolerance reactions. q Reports of severe systemic reactions following exposure to the foodstuff. q Assessment of available prevalence data in children and adults, supported by appropriate clinical studies with subjects from the general population of several countries or alternatively available prevalence data from clinical studies with groups of allergy patients from several countries supported as per the first recommendation. Canadian Criteria for Addition q Consideration of the allergenic potency of the food or food ingredient q Consideration of the potential Canadian exposure to the food or food ingredient with specific consideration as to whether the food or food ingredient may become a hidden source of food allergens in prepackaged food products for sale in Canada because it is exempt from declaration in the list of ingredients on food packages, as per subsections B one and two of the Canadian Food and Drug Regulations Canadian Criteria for Addition q Consideration of whether the food or food ingredient is subject to the Canadian proposed definition of a food allergen, which emphasizes that the protein portion of the food is responsible for eliciting an allergic reaction. q Additional consideration will also be given to other factors that are considered applicable to the Canadian scenario and relevant to risk management. For example, these factors may include, but are not limited to, consideration of allergen cross-reactivity. Methods for Assessment The Canadian criteria will be applied to the assessment of scientific information obtained from a systematic review of available literature. Methods for the management and evaluation of available scientific information have been developed in order to ensure a consistent and transparent approach when assessing the potential allergenicity of a food or food ingredient. o Systematic Data Collection o Criteria for Assessing the Strength-of-Evidence o Organization and Tabulation of Data o Criteria for Evaluating the Severity of Clinical Reactions 27 28

8 Systematic Data Collection An electronic database search will be conducted utilizing, but not limited to, current versions of the following databases: Ovid Medline, Ovid Embase, and FSTA Direct. q Include publication if - o Relevant to humans (adults or children) o Relevant to an allergy via oral exposure through foodstuff o Relevant to the identification and characterization of the specific allergenic proteins q Exclude publication if - o Experimental study assessing the allergenicity using animal models or in vitro methods o Relevant to humans but the route of exposure is not via the oral route through foodstuff e.g. occupational exposures (dermal/respiratory) Assessing the Strength-of-Evidence q Study designs follow guidelines established by the Joint Task Force on Practice Parameters comprised of specialists in the field of allergy and immunology (Chapman, J.A et al, 2006 Bernstein, 2008) q The criteria used in descending order from the strongest to weakest, is as follows: o meta-analysis of randomized controlled trials o randomized controlled trials o non-randomized controlled trials o quasi-experimental studies o non-experimental descriptive studies (comparative, correlation, or casecontrolled studies) o expert committee reports or opinions or clinical experience of respected authorities o laboratory-based studies Organization and Tabulation of Data Evidence from publications that fulfilled the strength-ofevidence parameters will be tabulated under the following categories: 1. Pivotal Clinical Studies (evidence from meta-analysis and randomized and non-randomized controlled trials) 2. Non-Pivotal Clinical Studies (evidence from quasiexperimental studies) 3. Other Relevant Studies (evidence from non-experimental descriptive studies (comparative/correlation)) 4. Case reports (evidence from non-experimental descriptive studies) Evaluation: Severity of Clinical Reactions q Severe reactions include symptoms that are strongly associated with hypotension and hypoxia (life-threatening upper airway obstruction) or neurologic compromise: confusion, collapse, loss of consciousness, and incontinence q Moderate reactions include diaphoresis, dizziness, presyncope, dyspnea, stridor, wheezing, chest/throat tightness, nausea, vomiting, and abdominal pain q Mild reactions are limited to the skin (urticaria, erythema, and angioedema). However, when angioedema affects the face and involves the glottis, it is associated with hypoxia and graded as severe Brown, S.G. (2004) Clinical features and severity grading of anaphylaxis. The Journal of allergy and clinical immunology, 114,

9 Characterization of Mustard q Mustard is a herbaceous flowering plant (Angiospermae) belonging to the family Brassicaceae q The major types of mustard seeds used in cooking and food processing are: white (Sinapis alba or yellow mustard), brown (Brassica juncea or oriental mustard) and black (Brassica nigra or black mustard). All three types of mustard seed are available in North America. In fact, Canada is a world leader in the international mustard seed market accounting for about 35% of world production and 50% of global exports q The major allergen of mustard is a 2S albumin seed storage protein composed of one heavy chain and one light chain (39 and 88 amino acids), linked by two disulfide bridges Characterization of Mustard q The major 2S albumin of yellow mustard is Sin a 1 a thermostable protein that is resistant to digestion by trypsin and degradation by other proteolytic enzymes q The major allergen found in oriental mustard isbra j 1 Bra j 1 and Sin a 1 have a homologous epitope implying that individuals sensitive to one species of mustard are likely to show sensitivity to other species q Cross-sensitivity between other Brassicaceae species appears to be rare It has been proposed that proteins in cruciferae leafy vegetables are more susceptible to digestion and thermal degradation than the allergenic proteins in mustard Review of Mustard Data q This assessment followed the method outlined earlier q A total of 358 publications were identified through the database search q Based on the inclusion and exclusion criteria, 42 publications were selected and considered relevant to the objectives of this review: 27 fulfilled the strength-of-evidence categorization and tabulation criteria, including Two double-blind, placebo-controlled food challenge (DBPCFC) studies and one single-blind, placebo controlled food challenge (SBPCFC) study were identified in the literature Health Canada Mustard Allergy Pulido Olga M., Gillespie Z, and Godefroy SB, 2010 Review of Mustard Data q Six non pivotal studies conducted using an open allergenicity assessment q Three non-experimental descriptive studies q 15 case reports of allergic responses to mustard were identified in the literature (2 were Canadian) q 15 publications were not included in the risk analysis, but provided information with regard to the characterization of mustard and were considered relevant to the evaluation 35 36

10 Assessment Against Criteria for Inclusion 1. The existence of a credible cause-effect relationship, based upon positive double blind, placebo-controlled food challenges (DBPCFC) or unequivocal reports of reactions with typical features of severe allergic or intolerance reactions Two DBPCFC studies and one single-blind, placebo controlled food challenge (SBPCFC) study were identified in the literature and assessed as supporting evidence for a credible cause-effect relationship Assessment against Criteria for Addition 2. Reports of severe systemic reactions following exposure to the foodstuff. Information from the case studies confirmed severe systemic reactions to mustard. Anaphylactic reactions are reported in 2% of children and in up to 48% of adults with a confirmed mustard allergy In a Canadian case report, 2 out of 5 children described had severe reactions to the ingestion of mustard, which required emergency medical intervention Assessment Against Criteria for Inclusion 3. Assessment of available prevalence data as outlined earlier: Prevalence data are not available for Canada or for many other regions of the world, however: mustard allergy could be estimated as the 3rd /4th most common food allergy among children in some regions of France mustard allergy is probably the most common allergy among spices mustard is affirmed on the most recent list of 14 allergens to be declared on labels (updated in 2007) by the European Commission mustard is recognized as an allergen by the International Union of Immunological Societies (IUIS, 2009) Assessment against Criteria for Addition q Consideration of the allergenic potency of the food or food ingredient There is evidence within the database to support the conclusion that the amount of mustard required to elicit a reaction may be very small; however there is insufficient information to estimate a dose-threshold One study found that 40 mg of mustard seasoning (equivalent to 13.5 mg mustard seeds and 0.8 mg of protein) provoked a reaction in one child. One case report estimated the concentration of mustard in a dip responsible for causing a reaction as 0.15 mg of mustard in 100 mg of dip, other case reports only indicated that the amount of mustard associated with the allergic response was small or present in trace amounts 39 40

11 Assessment against Criteria for Addition q Consideration of the potential Canadian exposure to the food or food ingredient o with specific consideration as to whether the food or food ingredient may become a hidden source of food allergens in pre-packaged food products for sale in Canada There is potential for mustard to be hidden in a product and not appear on the ingredient list if that mustard is part of a spice mixture, seasoning mixture or food flavour-enhancer preparation Assessment Against Criteria for Inclusion q Consideration of whether the food or food ingredient is subject to the Canadian proposed definition of a food allergen, which emphasizes that the protein portion of the food is responsible for eliciting an allergic reaction Supporting evidence for mustard: Sin a 1 is the seed storage protein in yellow mustard associated with allergic reactions. It is resistant to degradation by heat and digestive enzymes. The major allergen found in oriental mustard is Bra j 1. Bra j 1 and Sin a 1 have a homologous epitope. These findings imply that individuals known to be sensitive to one species of mustard seed are likely to show sensitivity to other species Assessment against Criteria for Addition q Additional consideration will also be given to other factors that are considered applicable to the Canadian scenario and relevant to risk management. For example, these factors may include, but are not limited to, consideration of allergen crossreactivity. Additional factors which make mustard allergy relevant to the Canadian scenario include q the potential cross reactivity between mustard and rape seed q that Canada is a major producer of both these crops q sensitization to mustard can be acquired through dermal and respiratory exposure. Conclusion of Assessment of Mustard q Based on all the evidence presented it was concluded that mustard had met the Canadian criteria required to add new allergens to the list of priority allergens. Mustard was added to the list of priority allergens in Canada

12 «Gluten-Free» in Codex Gluten-free requirements in Codex Gluten is a series of protein present in the following cereals q Wheat, spelt, kamut (triticum species) q Barley q Rye ü Food that do not contain these grains or that have been processed to eliminate these ingredients are eligible to the Gluten-free claim ü Presence is determined through an analytical threshold set at 20 ppm of Gluten (as defined in the standard) ü Reference method is an immunochemical-based method using «R5 Mendez method» - 10 ppm LOD or below. ü Inclusion of Oats (pure oats) is left at the discretion of national jurisdictions ü Standard also defines «Low Gluten» claims : Gluten present btw. 20 and 100 ppm) Food Allergies : Incident management Strategies Drivers of change q Consumer awareness / behaviour: o Risk considerations to allergic consumer / availability of choice to allergic consumers o Consumer understanding (Consumer behaviour surveys/ focus testing) q Industry s progress / innovation o Improvement of food processing practices (allergen handling) o Development of new products destined to food allergic consumers (and their social circles) o Feasibility of implementation / Costs q Management of Food Allergy Incidents related to prepackaged foods: Corrective measures o o Correction of mis-labeling Correction of Allergen handling practices: Training, information dissemination to industry Improvement of food processing practices (to support rational allergen handling) Use of «Allergen Advisory/precautionary statements» q Enforcement of labeling regulations: o Food Allergies : Interventions Incident Management Need to have predictability between regulator and regulatee 47 48

13 q VITAL: (Voluntary Incidental Trace Allergen Labelling) o Guidance on Risk Assessment and Decision making process in the context of allergen handling o Tool to be used within the context of allergen handling practices: ergen-guide/vital/ Food Allergies : Collaborative Intervention Tools for Industry q Allergen Management and Labeling of Prepackaged foods /guidancenotes/labelregsguidance/ maycontainguide q Guide to Allergen Labeling and Advertising : (CFIA): llerge.shtml o q Certification Program for food Allergens: Future Directions - Needs v While significant progress has been accomplished in managing allergens in food, more progress in guidance is still needed: o Guidance on thresholds for various food allergens o Guidance related to the use of «advisory / precautionary» statements e.g. «may contain» o Guidance on analytical methods used to support food allergen control THANK YOU ü APEC economies could play a leading role towards enhanced convergence and harmonisation of food allergen management practices and regulatory requirements 51 52