Why are food allergies important? : Prevalence
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ILSI SEA Region Seminar on
Food Allergens – Science and
Challenges for Southeast Asia
April 7, 2015,
Bangkok, Thailand
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
Samuel B. Godefroy, Ph.D.
Senior Executive Food Regulator, in Secondment,
Global Food Safety Partnership, Strategic
Development and Engagement
Agriculture Practice, World Bank
1
Why are food allergies important? : Impacts
2
Costs and Burden of food allergies
q The health impacts are serious : hospitalisation, anaphylaxis
and death (100-200 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
Food allergies and celiac disease are life long and incurable
conditions – Avoidance is the only line of defense
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 **
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
Food Allergy Incidents
Canadians consider food allergy a high risk
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
In Canadians’
understanding : food
allergies are
considered a higher
risk than nuclear
waste or flu
pandemics
0%
20%
40%
High/Moderate %
60%
80%
qA Food Allergy Incident is preventable
qAvoidance is the most effective risk
management approach for food allergic
consumers
100%
Other %
(From Elliott and al., 2009)
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Stakeholders: Actors
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:
Safe
fe Products
Pr
Education
Inform
Information
form
rmat
ation
Offer
fer of Choice
Government
Regulations
Enforcement
Education
o Reliable/accurate labelling (no doubt should be left for allergens)
o Clear and consistent labelling (no shopping dictionary should be needed)
Food
od Industry
While ingredient labelling is mandatory for most prepackaged foods,
there are instances where allergen ingredients are not readily
disclosed and remain « hidden » for consumers
7
Consumers
Responsibility
Choice
Action
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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:
qCodex Connexion with Food Allergens
§ Food labelling : CCFL
§ Nutrition and Foods for Special
Dietary Uses : CCNFSDU
§ Methods of Analysis and
Sampling: CCMAS
o Maximise Choice for food allergic consumers
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Why have a food allergen list?
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).
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
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
q Creating a 䇾priority䇿 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
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.
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.
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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.
http://www.fao.org/docrep/meeting/X2670e.htm
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Codex Criteria for additions to FA list
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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.
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Tool Box for Risk management
Canada’s Allergen Labelling Regulations
“Food Allergen” Defined
Application to Canada
Any protein from any of the following foods or any modified protein, including
any protein fraction, that is derived from the following foods:
q Legislative and Regulatory instruments:
• Milk
q Almonds, Brazil nuts, cashews,
hazelnuts, macadamia nuts, pecans, • Soybeans
pine nuts, pistachios, walnuts
• Crustacea (common
o Food and Drugs Act and Regulations and their enforcement
q Education, information dissemination
name)
q Peanuts
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
q Sesame seeds
•
•
q Wheat, triticale
•
Fish (common name)
Shellfish (common
name)
Mustard seeds
q Eggs
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Example of label changes – Cake Mix
Canada’s Allergen Labelling Regulations
Prior to allergen labelling regulations
Label Declaration
Ingredients : Sugar, Flour, Ovalbumin, Monocalcium phosphate
monohydrate, Sodium bicarbonate, Potassium bitartrate
q Sources of priority food allergens and gluten must be
declared either:
Since allergen labelling regulations
o in the list of ingredients, OR
o in the statement: “Contains”
Ingredients : Sugar, Flour (Wheat), Ovalbumin (Egg), Monocalcium
phosphate monohydrate, Sodium bicarbonate, Potassium bitartrate
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”
OR
Ingredients : Sugar, Flour, Ovalbumin, Monocalcium
phosphate monohydrate, Sodium bicarbonate,
Potassium bitartrate
Contains : Egg, Wheat
q In addition to standard requirements for ingredient
declaration
Ovalbumin is a protein found in egg whites
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Ex. of Label Change – Potato Chips
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
Prior to allergen labelling regulations
Ingredients : Potatoes, sunflower oil, salt, seasonings
Since allergen labelling regulations
Ingredients : Potatoes, sunflower oil, salt, seasonings
(mustard)
Since allergen labelling regulations
(if sulphites present at 10ppm or higher)*
OR
Contains : sulphites
Ingredients : Potatoes, sunflower oil, salt, seasonings
*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
Contains : mustard
Seasonings are a multi-component ingredient which are exempt from
component declaration
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Priority List of Food Allergens in Canada
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Need to Revise List of Priority Allergens
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)
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, 1999
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Canadian Criteria for Addition
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.
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.01.009 one and two of the Canadian Food and
Drug Regulations.
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Canadian Criteria for Addition
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.
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.
o
o
o
o
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Systematic Data Collection
Criteria for Assessing the Strength-of-Evidence
Organization and Tabulation of Data
Criteria for Evaluating the Severity of Clinical Reactions
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Systematic Data Collection
Assessing the Strength-of-Evidence
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)
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Organization and Tabulation of Data
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
o
o
o
o
meta-analysis of randomized controlled trials
randomized controlled trials
non-randomized controlled trials
quasi-experimental studies
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
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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
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)
Brown, S.G. (2004) Clinical features and severity grading of anaphylaxis. The
Journal of allergy and clinical immunology, 114, 371-376
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Characterization of Mustard
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
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
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Review of Mustard Data
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
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
Health Canada Mustard Allergy
http://www.hc-sc.gc.ca/fn-an/pubs/label-etiquet/mustard-moutarde/index-eng.php
Pulido Olga M., Gillespie Z, and Godefroy SB, 2010
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Assessment Against Criteria for Inclusion
Assessment against Criteria for Addition
2. Reports of severe systemic reactions following exposure
to the foodstuff.
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
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
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
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Assessment Against Criteria for Inclusion
Prevalence data are not available for Canada or for many
other regions of the world, however:
§
§
§
Assessment against Criteria for Addition
q Consideration of the allergenic potency of the food or
food ingredient
3. Assessment of available prevalence data as
outlined earlier:
§
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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)
39
§ 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
40
Assessment against Criteria for Addition
q Consideration of the potential Canadian exposure to
the food or food ingredient
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
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
41
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.
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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.
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Gluten-free requirements in Codex
« Gluten-Free » 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).
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Food Allergies : Incident management Strategies
Drivers of change
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Food Allergies : Interventions
Incident Management
q Consumer awareness / behaviour:
q Management of Food Allergy Incidents related to prepackaged foods: Corrective
measures
o Risk considerations to allergic consumer / availability of choice to
allergic consumers
o Consumer understanding (Consumer behaviour surveys/ focus
testing)
o Correction of mis-labeling
o Correction of Allergen handling practices:
§ Training, information dissemination to industry
§ Improvement of food processing practices (to support rational allergen handling)
q Industry’s progress / innovation
§ Use of « Allergen Advisory/precautionary statements »
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 Enforcement of labeling regulations:
o Need to have predictability between regulator and regulatee
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Future Directions - Needs
Food Allergies : Collaborative Intervention
Tools for Industry
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:
http://www.allergenbureau.net/all
ergen-guide/vital/
q Allergen Management and Labeling
of Prepackaged foods
http://www.food.gov.uk/foodindustry
/guidancenotes/labelregsguidance/
maycontainguide
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
q Guide to Allergen Labeling and
Advertising : (CFIA):
http://www.inspection.gc.ca/english/fssa/labeti/allerg/a
llerge.shtml
o
www.healthcanada.gc.ca/foodallergies
q Certification Program for food
Allergens: www.certificationallergies.com
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THANK YOU
ü APEC economies could play a
leading role towards enhanced
convergence and harmonisation of
food allergen management
practices and regulatory
requirements
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