Ingredient Lists and Labelling Laws

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On February 16th 2011 Health Canada
Published Amendments to the Food Allergen
Labelling Regulations in Canada Gazette , Part
II (CGII)
The new Regulations were designed to enhance labelling requirements for specific priority allergens, gluten sources and added sulphites in prepackaged foods sold in Canada
The new food allergen labelling regulations came into force on August 4, 2012 http://www.hc-sc.gc.ca/fn-an/label-etiquet/allergen/index-eng.php
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Health Canada's policy for enhancing the protection of food-allergic consumers in
Canada is based on two guiding principles:
 Prevent the inadvertent consumption of undeclared allergens by sensitive consumers
 Enable a variety of safe and nutritious food choices for the allergic consumer
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The list of priority allergens now includes:
 Peanuts
 Tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts)
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Milk
Eggs
Seafood (fish, crustaceans, shellfish)
Soy
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Wheat
Sesame seeds
Mustard
Sulphites
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Previously, food labels did not have to declare when a priority allergen was used to make an ingredient like spices or flavours
Now, labels on products will have to let consumers know when these allergens are in the product, either in the ingredient list or in a "contains" statement
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The allergen may appear in the ingredient list
Components of an ingredient like spices may be in brackets
 And/or the allergen may appear in a "contains" statement after the ingredients, like "Contains: XX”
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Previously a number of names for an ingredient, some of which were unfamiliar to the general public, could appear on labels
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E.g. “casein”, whey”, “lactalbumin”, “lactose”, etc
With the new food labels, companies will have to use commonly understood names for the priority allergens
 E.g. for the ingredients above,
“milk” must appear on the label
The names, such as "wheat" or "milk," will have to be used either in the ingredient list or in the "contains" statement
Some manufacturers include them in both
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Previously a number of precautionary statements appeared on labels, eg:
 May contain trace amounts of [X]
 Produced on shared equipment with [X]
 Manufactured in a facility that also manufactures [X]
Health Canada and the CFIA are recommending that food manufacturers and importers begin to use only one precautionary statement on food labels:
"may contain [X]" where X is the name by which the allergen is commonly known
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Nature", "natural", "Mother Nature", "Nature's Way" are terms often misused on labels and in advertisements
“Advertisements should not convey the impression that "Nature" has, by some miraculous process, made some foods nutritionally superior to others or has engineered some foods specially to take care of human needs”
 Some consumers may consider foods described as
"natural" of greater worth than foods not so described http://www.inspection.gc.ca/english/fssa/labeti/guide/ch4ae.shtml
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 Foods or ingredients of foods submitted to processes that have significantly altered their original physical, chemical or biological state should not be described as "natural“
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 E.g: the removal of caffeine from coffee
A natural food or ingredient of a food is not expected to contain, or to ever have contained, an added vitamin, mineral nutrient, artificial flavouring agent or food additive.
 A natural food or ingredient of a food does not have any constituent or fraction thereof removed or significantly changed , except the removal of water
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Some food additives, vitamins and mineral nutrients may be derived from natural sources
Some of these additives may be regarded as natural ingredients, in which case the acceptable claim would be that this food contains
"natural ingredients“
If the additive is derived from a priority allergen, the allergen must be listed on the label
Note that while the ingredient can be described as
"natural", the food itself cannot, since it contains an added component.
The list of ingredients of such foods must declare acids, bases, salts or sweeteners which are present by their proper common names
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 Food additives are considered ingredients in any prepackaged food and must be:
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Included in the ingredients’ list
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 Listed by the common name associated with the active ingredient in the preparation
In general, food ingredients are listed in descending order of proportion by weight
However, food additives, spices, seasonings, herbs
(except salt), natural and artificial flavours, flavour enhancers, vitamins and mineral nutrients and their derivatives and salts, may be placed at the end of the ingredients list in any order
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 Foods meant for human consumption may contain additives under the GRAS (generally recognized as safe) designation
 Level of food additives may be allowed according to “good manufacturing practices”:
 Amount determined by standards for the product
 E.g: annatto is added to butter to the amount required to bring it to an established standard yellow colour
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 Others will have upper limits determined for each food type, e.g.
 Benzoic acid in jams and juices not to exceed
1,000 ppm
 Nitrites in preserved meats not to exceed 200 ppm
 Whatever the limit, the presence of the additive will be indicated on the food label http://www.hc-sc.gc.ca/fn-an/securit/addit/list/11-preserv-conserv-eng.php
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 Three colours must be listed by name:
 Annatto
 Allura red
 Sunset yellow
 One or more of the other allowed food colours may be listed in the ingredients simply as “colour”
 Regulations provide food manufacturers with the choice of declaring added colours by either their common name or simply as "colour"
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Alkanet
Allura red
Aluminum metal
Amaranth
Anthocyanin
Brilliant blue
Canthaxanthine
Carbon black
Citrus red #2
Cochineal
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Erythrosine
Fast green
Indigotine
Iron oxide
Orchil
Ponceau
Saunderswood
Sunset yellow
Tartrazine
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The following sulphites, singly or in combination may be listed as “sulphiting agents” or “sulphites”:
 Potassium bisulphite
 Potassium metabisulphite
 Sodium bisulphite
 Sodium metabisulphite
 Sodium sulphite
 Sodium dithionite
 Sulphurous acid
 Sulphur dioxide
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 There are no regulations requiring this flavour to be identified specifically
 Manufacturers can list the additive by the source, e.g.
 Hydrolysed vegetable protein (HVP)
 Hydrolysed plant protein (HPP)
 Hydrolysed soy protein (HSP)
 If the hydrolysate is derived from a priority allergen it should appear on the label
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HSP should identify “soy” as an allergen
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Chicken noodle soup mix
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Grissol
Melba Toast
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Chicken noodle soup mix
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 Role of the dietitian is to ensure all meals provided to identified food allergic individuals are free from their offending allergens
 Concern when patients designate food aversions as “allergies”
 Request confirmation of allergy from medical practitioner if necessary
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 Computer coding, example:
 List of ingredients with allergens identified in side-by-side columns
 List priority allergens
 List allergens of common concern, e.g.
 Corn
 Rice
 Individual meats, fruits, vegetables
 List additives of concern, e.g.
 Sulphites
 MSG
 Tartrazine
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 If not listed on label, need not include as allergens, e.g.
 Sulphite in fruit purée
 If label identifies a priority allergen in a precautionary statement (as “may contain”) list as allergen present
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 Is it practical to designate areas as allergenfree?
 Which allergens should be excluded?
 All priority allergens?
 Are all prepackaged and preprepared foods entering the facility adequately labelled?
 How can meals on an assembly line be considered “allergen-free”
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 Dietitian can only ensure that an allergic patient’s meals are free from known sources of the allergen
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 Contamination from foods prepared in the same area cannot be avoided
“Prepared in a facility that also processes foods containing [X]”
 New labelling rules suggest this should read,
“may contain [X]”
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Recent Changes in Direction

Historical Perspective
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Measures of prevention were all designed to avoid sensitization to allergens during what were considered the most vulnerable periods:
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Intra-uterine life
From birth to 2-3 years
This meant reduction in exposure to highly allergenic foods:
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Mother’s diet during pregnancy and lactation
 Delay in introduction of highly allergenic foods during weaning
In spite of these stringent measures to prevent allergy, incidence of all types of allergies have increased significantly
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 Understanding of the importance of immunological sensitization and tolerance
 Recognition that tolerance not sensitization is the critical step in allergy prevention
 Finding that exposure to the allergenic food at an optimum stage is probably a critical step in allergy prevention
 Recognition that tolerance can be induced after allergy has been established – leading to important measures for allergy management
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Allergy is a Response of the Immune System
 Our immune systems are designed to protect the body from invasion by foreign materials
 All foods contain proteins – derived from plants and animals – all of which are foreign to the human body
 In order for food to be absorbed, metabolized, and utilized by the body, the immune system needs to be “educated” that the foreign material is safe
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Herz 2008
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“
Education” of the T cells to not respond to that food protein when it enters via the oral route – called
 Contrasts with the
needed to protect the gut against continual bombardment by invading pathogens and their products
(toxins, etc)
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Significant change in directives within the past 5 years:
 Previously:
Avoidance of allergen to prevent sensitization (allergen-specific IgE)
 Current:
Active stimulation of the immature immune system to induce tolerance of the antigens in food
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Rautava et al 2005
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Factors Predictive of Allergy:
High and Low risk Groups
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Many factors investigated as possible predictive markers for allergy
Only significant variable in studies:
Family history of allergy (all types)
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High risk for allergy:
One first degree relative with diagnosed allergy (IgE-mediated) of any type
First-degree relative: parent or sibling
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 Food proteins demonstrated to cross the placenta and can be detected in amniotic fluid
 Exposure to small quantities of food antigens from mother’s diet thought to tolerize the fetus , by means of IgG1 and
IgG3, within a “protected environment”
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Current directive: the atopic mother should strictly avoid her own allergens and replace the foods with nutritionally equivalent substitutes
There are no indications for mother to avoid other foods during pregnancy
A nutritionally complete, well-balanced diet is essential
Authorities recommend avoidance of excessive intake of highly allergenic foods such as peanuts and nuts to prevent “allergen overload”, but there is no scientific data to support this
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Kramer et al 2006
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Sicherer et al 2010
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Implications of Research Data
 Exclusive breast-feeding with exclusion of mother’s and baby’s allergens will reduce signs of allergy in the first 1-2 years; specifically:
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Cow’s milk allergy
 Eczema (atopic dermatitis)
 Reduction or prevention of early food allergy by breast-feeding does not seem to have long-term effects on the development of:
 Asthma
 Allergic rhinitis (hay fever)
 Exclusive breast-feeding for 4-6 months is strongly encouraged
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Summary of 2008 AAP Guidelines for Allergy
Management
[Greer et al 2008]
 There is no convincing evidence that women who avoid highly allergenic foods, or other foods during pregnancy and breast-feeding lower their child’s risk of allergies
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Greer et al 2008
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 For high-risk for allergy infants (one first-degree relative with established allergy), exclusive breast-feeding for at least 4 months prevents or delays the occurrence of:
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Atopic dermatitis (eczema)
Cow’s milk allergy (CMA)
 Wheezing
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Sicherer and Burks 2008
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Longer duration of breastfeeding is associated with lower risk for eczema in non-atopic mothers
Slightly lower risk for mothers with allergy but no asthma
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Longer duration of breastfeeding reduced risk for wheezing in infants: possibly due to reduction in respiratory infections
There is a lack of evidence that exclusive or prolonged breast-feeding has any positive effect on the development of asthma in older children
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Snijders et al 2007 KOALA study
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continued
 In infants at high risk for allergy who are not exclusively breast-fed for 4-6 months there is modest evidence that the onset of allergy, especially eczema , may be delayed or prevented by the use of hydrolyzed formulas
 There is no good evidence that soy-based infant formulas have any preventive effect on the development of allergy
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No evidence of any reduction in allergy with hydrolyzed formula compared to breastfeeding
Limited evidence that prolonged feeding with hydrolyzed formula compared to cow’s milk reduces incidence of CMA and eczema
No evidence that hydrolyzed formulas have any effect on the development of rhinitis and asthma later
Extensively hydrolyzed cow’s milk (Ehf) formulas better than partially hydrolyzed whey (Phf) in prevention
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Osborn and Sinn 2009 Cochrane Review
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Von Berg et al GINI Study 2009
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Current Recommendations
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Cow’s milk based formula if there are no signs of milk allergy
 Partially hydrolysed (phf) whey-based formula if there are no signs of milk allergy in high risk for allergy group
 Extensively hydrolysed (ehf) casein based formula if milk allergy is proven
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Greer et al AAP 2008
Von Berg et al 2007
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Recommendations for Introduction of Solids to High Risk for Allergy Infants
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Little evidence that delaying the introduction of complementary foods beyond 4-6 months of age prevents allergy
Introduction of solid foods should be individualized
 Foods should be introduced one at a time in small amounts
 Mixed foods containing various potential food allergens should not be given unless tolerance to each ingredient has been assessed
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Greer et al AAP 2008
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Thygaran and Burks 2008
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Introduction of Solid Foods in
Relationship to Celiac Disease
 Results suggest that in high risk for celiac disease infants introduction of gluten-containing grains before 3 months or after 7 months increases incidences of development of CD 1
 Introduction of gluten while breast-feeding offers protection or delays onset of celiac disease in at-risk infants 2
 Recommendations:
 Introduce gluten grains in small amounts between 4 and 6 months while infant is breastfed
 Continue breast-feeding for a further 2-3 months
 Similar results for wheat allergy 3
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1 Norris et al 2005
2 Guandalini 2007
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3 Poole et al 2006
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Directives from pediatric societies (1998 - 2007) recommended avoidance of peanuts by mothers during pregnancy and lactation, and delaying introduction of peanuts until after 2 or even 3 years of age
Research indicates that incidence of peanut allergy in children rose dramatically in the years following release of these directives
Recent research suggests:
 Avoidance of peanuts reduced development of tolerance
 Early exposure leads to reduced incidence of peanut allergy
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Hourihane et al 2007
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Du Toit et al 2008
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 Historically, fish consumption during infancy was considered to be a risk factor for allergy
 Recent research indicates otherwise:
 Regular fish consumption during the first year of life associated with a reduced risk for allergic disease by age 4 years (n=4089) 1
 Babies of mothers who frequently consumed fish (2-3 times per week or more) during pregnancy had one third less food sensitivities than those whose mothers did not consume fish during pregnancy 2
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1 Kull et al 2006
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2 Calvani et al 2006
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 Food allergy most often begins in the first 1 to
2 years of life
 Child is sensitized to the food protein by the immune system developing allergen-specific
IgE to that protein
 Sensitization does not necessarily mean that the child will develop symptoms when that food is eaten
 Over time most food allergy is lost
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Wood 2003
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Most children outgrow early food allergy
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John’s Hopkins Children’s Center USA
 Milk allergy outgrown:
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20% by 4 years
42% by 8 years
79% by 16 years
 Egg allergy outgrown:
 4% by 4 years
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37% by 10 years
68% by 16 years
Allergy to some foods more often than others persists into adulthood :
 Peanut  Tree nuts  Seeds
 Shellfish  Fish
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Skripak et al 2007
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 Tolerance to a specific food can be induced by oral administration of the offending food by process of “low dose continuous exposure”
 Designated (SOTI: specific oral tolerance induction)
 Starting with very low dosages
 Gradually increasing daily dosage up to the equivalent of the usual daily intake
 Followed by daily maintenance dose
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Niggemann et al 2006
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Calvani et al 2010

 36% of children with IgE-mediated allergy to cow’s milk and hen’s egg developed permanent tolerance of the foods after a median 21 months specific oral tolerance induction (SOTI) 1
 4 peanut-allergic children underwent SOTI:
 Daily doses of peanut flour starting at 5 mg peanut protein
 2-weekly dosage increase up to 800 mg protein
 All subjects tolerated at least 10 whole peanuts (2.38 g protein) on post-intervention challenge 2
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1 Staden et al 2007
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2 Clark et al 2009

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Peanut allergy, like many early food allergies, can be outgrown
In 2001 pediatric allergists in the U.S. reported that about 21.5 per cent of children will eventually outgrow their peanut allergy 1
Those with a mild peanut allergy, as determined by the level of peanut-specific IgE in their blood, have a
50% chance of outgrowing the allergy 2
 Only about 9% of patients are reported to outgrow their allergy to tree nuts 3
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1 Skolnick et al 2001
2 Fleischer et al 2003
3 Fleischer et al 2005

 When there is no longer any evidence of symptoms developing after a child has consumed peanuts, it is preferable for that child to eat peanuts regularly , rather than avoid them, in order to maintain tolerance to the peanut
 Children who outgrow peanut allergy are at risk for recurrence, but the risk has been shown to be significantly higher for those who continue to avoid peanuts after resolution of their symptoms
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Fleischer et al 2004