1. 07/05/2014
1
Paul Turner
MRC Clinician Scientist & Honorary Consultant in Paediatric Allergy & Immunology,
Imperial College London; Honorary Clinical Lecturer, University of Sydney
How we will manage food allergy in 2024
Adrenaline auto-injector devices
0
50
100
150
200
250
300
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
150mcg
300+mcg
TOTAL
Thousandsofprescriptions
Data: NHS Prescription Cost Analysis for England, 2000-2012
Risk of anaphylaxis
Umasunthar et al, Clin Exp Allergy. 2013;43:1333-41.
Current management… NOW & THEN
• Dietary Avoidance
• Rescue treatment
• Immunotherapy
Allergen Labelling
Ø Allergen disclosure required under law:
• key allergens in ingredients of prepacked foods
Ø Mandatory disclosure applies only to allergens in
ingredients
Ø Until now, no statutory requirement for:
• Label format
• Potential allergens from cross-contamination

2. 07/05/2014
2
Unnecessary avoidance?
• Sensitisation is a poor marker of clinical reactivity:
• Should peanut-allergic patients avoid all nuts?
• 31% of 94 peanut-allergic children were ‘sensitised’ to a
tree nut
• Only 7 (of 29) were allergic at formal OFC
Osborne et al. JACI 2011; 127:668–676.
Ball et al. PAI 2011; 22:808-12.
Improved diagnostics?
New in vitro diagnostics:
• Component resolved
diagnostics (CRD)
• Basophil activation test
Examples of precautionary allergy labelling:
BMJ | 22 OCTOBER 2011 | VOLUME 343 831
ANALYSIS
listing cows’ milk as an ingredient) containing
cows’ milk protein on analysis.11
One UK pro-
ducer began to list milk powder in the ingredi-
ents of its dark chocolate despite this not being
used as a raw ingredient,16
although it has now
stopped this, suggesting a change in policy. There
are also anecdotal reports of some producers
intentionally adding small amounts of allergen to
foods where cross-contamination may be a risk,
so that they can list the allergen as an ingredi-
ent and thus avoid the need to address the issue
altogether (Food Standards Agency, personal
communication).
Alternatives to the status quo
Attempts to standardise the content of advisory
labels using voluntary guidance have not been
successful. Almost two thirds of enforcement
officers and food manufacturers think that the
current voluntary UK guidance should become
compulsory.1
Thelistingofallpotentialallergensasaningre-
dient when cross-contamination is likely might
reduce ambiguity but would further restrict
consumer choice. The best solution would be to
quantify the hazard—that is, whether the degree
of contamination is sufficient to trigger an aller-
gic reaction—and communicate this clearly to
the consumer. However, obtaining robust data
on allergen thresholds has proved difficult. The
minimum eliciting dose varies widely between
individuals, and there will always be a few
highly sensitised individuals who react to minute
amounts of allergen. Furthermore, the threshold
can vary by several orders of magnitude within
the same person, depending on various factors.
These include:
Processing and denaturation of the allergen—
Many people who are allergic to egg or milk
tolerate the allergen in products that have been
baked at high temperature for long periods such
as cakes or biscuits.17
The processing probably
changes the structure of the allergen, making it
less allergenic.
Derived ingredients—Immunoglobulin E medi-
atedfoodallergyreactionsarecausedbyproteins,
and thus products such as wheat derived glucose
syrup (a carbohydrate) do not require allergen
disclosure under current legislation. However,
legislation regarding disclosure of derived ingre-
dients is inconsistent. Soy derived lecithin (a
lipid)andrefinedsoyoilgenerallycontainsimilar
(low) amounts of soy protein, and most people
with soy allergy can tolerate these ingredients.18
Regulatory authorities require products made
with soy lecithin to be labelled as containing soy,
but not those containing refined soy oil.1
Food matrix—Chemical and physical interactions
between allergenic proteins and other proteins,
fats, and carbohydrates within the molecular
structure of the food (known as the food matrix)
altertheabilityofanallergentoinduceanallergic
response. The mechanism for such interactions is
complex and poorly understood.17
Individualfactors—Thelevelsofallergenrequired
totriggeranallergicresponseinapersoncanvary
significantly from day to day. This variation is
probablytheresultofviralillnessesandthestatus
of the lower airways in patients with asthma.19
Thus,atruesafethresholdforanyonefoodand
person is impossible to determine. However, the
aim of quantitative risk assessment is to reduce
the risk of harm from cross-contamination to
a level considered tolerable, rather than to
eliminatetheriskaltogether.13
Researchers
have therefore developed the concept of
the lowest observed adverse effect level
(LOAEL), a threshold below which most
people will not react. Only a few studies
have been published assessing LOAELs for
the more common food allergens by double
blind, placebo controlled food challenges.19
One concern is that highly allergic people may
have been excluded from these studies. The Food
Examples
of advisory
warnings
found on food
labels2
DUETOTHE
METHODSUSEDIN
THEMANUFACTURE
OFTHISPRODUCT,IT
MAYOCCASIONALLY
CONTAIN........
PACKED IN AN
ENVIRONMENT
WHERE........
MAY BE
PRESENT
NOT SUITABLE
FOR........ALLERGY
SUFFERERS
MAY CONTAIN
TRACES OF
........
MADE IN A
PRODUCTION AREA
THAT ALSO
USES
........
MAY
CONTAIN
........
PRODUCED
ON SHARED
EQUIPMENT WHICH
ALSO PROCESSES
........
PRODUCED IN
A FACTORY
WHICH HANDLES
........
MADE IN A
FACTORY THAT
ALSO
PRODUCES
........
Standards Agency stated in 2007 that “there is a
lack of scientific and clinical evidence on which
to base firm conclusions regarding the mini-
mum amounts of some allergens needed to trig-
ger adverse reactions in sensitive individuals.”1
Nonetheless, for many common food allergens,
there is a high degree of agreement between pub-
lished LOAELs. Further data are expected from
high quality double-blind placebo-controlled
studies, particularly the Euro-PREVALL collabo-
ration, in the next 12 months.13 19
Vital information
Australia and New Zealand have already started
to use LOAEL data to improve labelling. In 2007,
the food manufacturing industry, with the input
of consumer groups and regulatory authori-
ties, developed a standardised risk assessment
tool called voluntary incidental trace allergen
labelling (VITAL).20
This allows manufacturers
to assess potential cross-contamination quan-
titatively and determine the need for advisory
warnings. Threshold levels were based on pub-
lished LOAEL data with a 10-fold safety factor
(this derives from toxicology, where a 10-fold
uncertainty factor is typically applied to account
for intraspecies variation within a population,
although this has not been validated for allergic
responses). When the amount of allergen present
is above the threshold level (but not at sufficient
amounts to be listed as an ingredient), manu-
facturers use an advisory statement with the
format “may be present.” No advisory warning is
recommended if levels are lower than this cut-off.
Although some very sensitive people might react
to levels of allergen below the cut-off, these peo-
ple are in general more likely to avoid potentially
problematic foods. The scheme means that advi-
sory warnings are used only when warranted and
that the warnings are standardised, so providing
clear and simple information to consumers.
A true safe threshold for any one food and person is impossible to determine
BMJ | 22 OCTOBER 2011 | VOLUME 343 831
ANALYSIS
listing cows’ milk as an ingredient) containing
cows’ milk protein on analysis.11
One UK pro-
ducer began to list milk powder in the ingredi-
ents of its dark chocolate despite this not being
used as a raw ingredient,16
although it has now
stoppedthis,suggestingachangeinpolicy.There
are also anecdotal reports of some producers
intentionallyaddingsmallamountsofallergento
foods where cross-contamination may be a risk,
so that they can list the allergen as an ingredi-
ent and thus avoid the need to address the issue
altogether (Food Standards Agency, personal
communication).
Alternatives to the status quo
Attempts to standardise the content of advisory
labels using voluntary guidance have not been
successful. Almost two thirds of enforcement
officers and food manufacturers think that the
current voluntary UK guidance should become
compulsory.1
Thelistingofallpotentialallergensasaningre-
dient when cross-contamination is likely might
reduce ambiguity but would further restrict
consumer choice. The best solution would be to
quantify the hazard—that is, whether the degree
of contamination is sufficient to trigger an aller-
gic reaction—and communicate this clearly to
the consumer. However, obtaining robust data
on allergen thresholds has proved difficult. The
minimum eliciting dose varies widely between
individuals, and there will always be a few
highly sensitised individuals who react to minute
amounts of allergen. Furthermore, the threshold
can vary by several orders of magnitude within
the same person, depending on various factors.
These include:
Processing and denaturation of the allergen—
Many people who are allergic to egg or milk
tolerate the allergen in products that have been
baked at high temperature for long periods such
as cakes or biscuits.17
The processing probably
changes the structure of the allergen, making it
less allergenic.
Derived ingredients—Immunoglobulin E medi-
atedfoodallergyreactionsarecausedbyproteins,
and thus products such as wheat derived glucose
syrup (a carbohydrate) do not require allergen
disclosure under current legislation. However,
legislation regarding disclosure of derived ingre-
dients is inconsistent. Soy derived lecithin (a
lipid)andrefinedsoyoilgenerallycontainsimilar
(low) amounts of soy protein, and most people
with soy allergy can tolerate these ingredients.18
Regulatory authorities require products made
with soy lecithin to be labelled as containing soy,
but not those containing refined soy oil.1
Foodmatrix—Chemicalandphysicalinteractions
between allergenic proteins and other proteins,
fats, and carbohydrates within the molecular
structure of the food (known as the food matrix)
altertheabilityofanallergentoinduceanallergic
response.Themechanismforsuchinteractionsis
complex and poorly understood.17
Individualfactors—Thelevelsofallergenrequired
totriggeranallergicresponseinapersoncanvary
significantly from day to day. This variation is
probablytheresultofviralillnessesandthestatus
of the lower airways in patients with asthma.19
Thus,atruesafethresholdforanyonefoodand
person is impossible to determine. However, the
aim of quantitative risk assessment is to reduce
the risk of harm from cross-contamination to
a level considered tolerable, rather than to
eliminatetheriskaltogether.13
Researchers
have therefore developed the concept of
the lowest observed adverse effect level
(LOAEL), a threshold below which most
people will not react. Only a few studies
have been published assessing LOAELs for
themorecommonfoodallergensbydouble
blind, placebo controlled food challenges.19
One concern is that highly allergic people may
have been excluded from these studies. The Food
Examples
of advisory
warnings
found on food
labels2
DUETOTHE
METHODSUSEDIN
THEMANUFACTURE
OFTHISPRODUCT,IT
MAYOCCASIONALLY
CONTAIN........
PACKED IN AN
ENVIRONMENT
WHERE........
MAY BE
PRESENT
NOT SUITABLE
FOR........ALLERGY
SUFFERERS
MAY CONTAIN
TRACES OF
........
MADE IN A
PRODUCTION AREA
THAT ALSO
USES
........
MAY
CONTAIN
........
PRODUCED
ON SHARED
EQUIPMENT WHICH
ALSO PROCESSES
........
PRODUCED IN
A FACTORY
WHICH HANDLES
........
MADE IN A
FACTORY THAT
ALSO
PRODUCES
........
Standards Agency stated in 2007 that “there is a
lack of scientific and clinical evidence on which
to base firm conclusions regarding the mini-
mum amounts of some allergens needed to trig-
ger adverse reactions in sensitive individuals.”1
Nonetheless, for many common food allergens,
there is a high degree of agreement between pub-
lished LOAELs. Further data are expected from
high quality double-blind placebo-controlled
studies, particularly the Euro-PREVALL collabo-
ration, in the next 12 months.13 19
Vital information
Australia and New Zealand have already started
to use LOAEL data to improve labelling. In 2007,
the food manufacturing industry, with the input
of consumer groups and regulatory authori-
ties, developed a standardised risk assessment
tool called voluntary incidental trace allergen
labelling (VITAL).20
This allows manufacturers
to assess potential cross-contamination quan-
titatively and determine the need for advisory
warnings. Threshold levels were based on pub-
lished LOAEL data with a 10-fold safety factor
(this derives from toxicology, where a 10-fold
uncertainty factor is typically applied to account
for intraspecies variation within a population,
although this has not been validated for allergic
responses). When the amount of allergen present
is above the threshold level (but not at sufficient
amounts to be listed as an ingredient), manu-
facturers use an advisory statement with the
format “may be present.” No advisory warning is
recommended if levelsarelower thanthis cut-off.
Although some very sensitive people might react
to levels of allergen below the cut-off, these peo-
ple are in general more likely to avoid potentially
problematic foods. The scheme means that advi-
sorywarningsareusedonlywhenwarrantedand
that the warnings are standardised, so providing
clear and simple information to consumers.
A true safe threshold for any one food and person is impossible to determine
Turner
et
al,
2011
BMJ | 22 OCTOBER 2011 | VOLUME 343
A
listing cows’ milk as an ingredient) containing
cows’ milk protein on analysis.11
One UK pro-
ducer began to list milk powder in the ingredi-
ents of its dark chocolate despite this not being
used as a raw ingredient,16
although it has now
stopped this, suggesting a change in policy. There
are also anecdotal reports of some producers
intentionally adding small amounts of allergen to
foods where cross-contamination may be a risk,
so that they can list the allergen as an ingredi-
ent and thus avoid the need to address the issue
altogether (Food Standards Agency, personal
communication).
Alternatives to the status quo
Attempts to standardise the content of advisory
labels using voluntary guidance have not been
successful. Almost two thirds of enforcement
officers and food manufacturers think that the
current voluntary UK guidance should become
compulsory.1
Thelistingofallpotentialallergensasaningre-
dient when cross-contamination is likely might
reduce ambiguity but would further restrict
consumer choice. The best solution would be to
quantify the hazard—that is, whether the degree
of contamination is sufficient to trigger an aller-
gic reaction—and communicate this clearly to
the consumer. However, obtaining robust data
on allergen thresholds has proved difficult. The
minimum eliciting dose varies widely between
individuals, and there will always be a few
highly sensitised individuals who react to minute
amounts of allergen. Furthermore, the threshold
can vary by several orders of magnitude within
the same person, depending on various factors.
These include:
Processing and denaturation of the allergen—
Many people who are allergic to egg or milk
tolerate the allergen in products that have been
baked at high temperature for long periods such
as cakes or biscuits.17
The processing probably
changes the structure of the allergen, making it
less allergenic.
Derived ingredients—Immunoglobulin E medi-
atedfoodallergyreactionsarecausedbyproteins,
and thus products such as wheat derived glucose
syrup (a carbohydrate) do not require allergen
disclosure under current legislation. However,
legislation regarding disclosure of derived ingre-
dients is inconsistent. Soy derived lecithin (a
lipid)andrefinedsoyoilgenerallycontainsimilar
(low) amounts of soy protein, and most people
with soy allergy can tolerate these ingredients.18
Regulatory authorities require products made
with soy lecithin to be labelled as containing soy,
but not those containing refined soy oil.1
Food matrix—Chemical and physical interactions
between allergenic proteins and other proteins,
fats, and carbohydrates within the molecular
structure of the food (known as the food matrix)
altertheabilityofanallergentoinduceanallergic
response. The mechanism for such interactions is
complex and poorly understood.17
Individualfactors—Thelevelsofallergenrequired
totriggeranallergicresponseinapersoncanvary
significantly from day to day. This variation is
probablytheresultofviralillnessesandthestatus
of the lower airways in patients with asthma.19
Thus,atruesafethresholdforanyonefoodand
person is impossible to determine. However, the
aim of quantitative risk assessment is to reduce
the risk of harm from cross-contamination to
a level considered tolerable, rather than to
eliminatetheriskaltogether.13
Researchers
have therefore developed the concept of
the lowest observed adverse effect level
(LOAEL), a threshold below which most
people will not react. Only a few studies
have been published assessing LOAELs for
the more common food allergens by double
blind, placebo controlled food challenges.19
One concern is that highly allergic people may
have been excluded from these studies. The Food
Examples
of advisory
warnings
found on food
labels2
DUETOTHE
METHODSUSEDIN
THEMANUFACTURE
OFTHISPRODUCT,IT
MAYOCCASIONALLY
CONTAIN........
PACKED IN AN
ENVIRONMENT
WHERE........
MAY BE
PRESENT
NOT SUITABLE
FOR........ALLERGY
SUFFERERS
MAY CONTAIN
TRACES OF
........
MADE IN A
PRODUCTION AREA
THAT ALSO
USES
........
MAY
CONTAIN
........
PRODUCED
ON SHARED
EQUIPMENT WHICH
ALSO PROCESSES
........
PRODUCED IN
A FACTORY
WHICH HANDLES
........
MADE IN A
FACTORY THAT
ALSO
PRODUCES
........
Standards Agency stated in 2007 t
lack of scientific and clinical evide
to base firm conclusions regard
mum amounts of some allergens n
ger adverse reactions in sensitive
Nonetheless, for many common fo
there is a high degree of agreement
lished LOAELs. Further data are e
high quality double-blind placeb
studies, particularly the Euro-PRE
ration, in the next 12 months.13 19
Vital information
Australia and New Zealand have a
to use LOAEL data to improve label
the food manufacturing industry, w
of consumer groups and regula
ties, developed a standardised ris
tool called voluntary incidental t
labelling (VITAL).20
This allows m
to assess potential cross-contami
titatively and determine the need
warnings. Threshold levels were b
lished LOAEL data with a 10-fold
(this derives from toxicology, wh
uncertainty factor is typically appl
for intraspecies variation within
although this has not been validat
responses). When the amount of al
is above the threshold level (but no
amounts to be listed as an ingred
facturers use an advisory statem
format “may be present.” No advis
recommended if levels are lower th
Although some very sensitive peop
to levels of allergen below the cut-o
ple are in general more likely to avo
problematic foods. The scheme me
sory warnings are used only when w
that the warnings are standardised
clear and simple information to co
A true safe threshold for any one food and person is impossible to determine
BMJ | 22 OCTOBER 2011 | VOLUME 343
listing cows’ milk as an ingredient) containing
cows’ milk protein on analysis.11
One UK pro-
ducer began to list milk powder in the ingredi-
ents of its dark chocolate despite this not being
used as a raw ingredient,16
although it has now
stoppedthis,suggestingachangeinpolicy.There
are also anecdotal reports of some producers
intentionallyaddingsmallamountsofallergento
foods where cross-contamination may be a risk,
so that they can list the allergen as an ingredi-
ent and thus avoid the need to address the issue
altogether (Food Standards Agency, personal
communication).
Alternatives to the status quo
Attempts to standardise the content of advisory
labels using voluntary guidance have not been
successful. Almost two thirds of enforcement
officers and food manufacturers think that the
current voluntary UK guidance should become
compulsory.1
Thelistingofallpotentialallergensasaningre-
dient when cross-contamination is likely might
reduce ambiguity but would further restrict
consumer choice. The best solution would be to
quantify the hazard—that is, whether the degree
of contamination is sufficient to trigger an aller-
gic reaction—and communicate this clearly to
the consumer. However, obtaining robust data
on allergen thresholds has proved difficult. The
minimum eliciting dose varies widely between
individuals, and there will always be a few
highly sensitised individuals who react to minute
amounts of allergen. Furthermore, the threshold
can vary by several orders of magnitude within
the same person, depending on various factors.
These include:
Processing and denaturation of the allergen—
Many people who are allergic to egg or milk
tolerate the allergen in products that have been
baked at high temperature for long periods such
as cakes or biscuits.17
The processing probably
changes the structure of the allergen, making it
less allergenic.
Derived ingredients—Immunoglobulin E medi-
atedfoodallergyreactionsarecausedbyproteins,
and thus products such as wheat derived glucose
syrup (a carbohydrate) do not require allergen
disclosure under current legislation. However,
legislation regarding disclosure of derived ingre-
dients is inconsistent. Soy derived lecithin (a
lipid)andrefinedsoyoilgenerallycontainsimilar
(low) amounts of soy protein, and most people
with soy allergy can tolerate these ingredients.18
Regulatory authorities require products made
with soy lecithin to be labelled as containing soy,
but not those containing refined soy oil.1
Foodmatrix—Chemicalandphysicalinteractions
between allergenic proteins and other proteins,
fats, and carbohydrates within the molecular
structure of the food (known as the food matrix)
altertheabilityofanallergentoinduceanallergic
response.Themechanismforsuchinteractionsis
complex and poorly understood.17
Individualfactors—Thelevelsofallergenrequired
totriggeranallergicresponseinapersoncanvary
significantly from day to day. This variation is
probablytheresultofviralillnessesandthestatus
of the lower airways in patients with asthma.19
Thus,atruesafethresholdforanyonefoodand
person is impossible to determine. However, the
aim of quantitative risk assessment is to reduce
the risk of harm from cross-contamination to
a level considered tolerable, rather than to
eliminatetheriskaltogether.13
Researchers
have therefore developed the concept of
the lowest observed adverse effect level
(LOAEL), a threshold below which most
people will not react. Only a few studies
have been published assessing LOAELs for
themorecommonfoodallergensbydouble
blind, placebo controlled food challenges.19
One concern is that highly allergic people may
have been excluded from these studies. The Food
Examples
of advisory
warnings
found on food
labels2
DUETOTHE
METHODSUSEDIN
THEMANUFACTURE
OFTHISPRODUCT,IT
MAYOCCASIONALLY
CONTAIN........
PACKED IN AN
ENVIRONMENT
WHERE........
MAY BE
PRESENT
NOT SUITABLE
FOR........ALLERGY
SUFFERERS
MAY CONTAIN
TRACES OF
........
MADE IN A
PRODUCTION AREA
THAT ALSO
USES
........
MAY
CONTAIN
........
PRODUCED
ON SHARED
EQUIPMENT WHICH
ALSO PROCESSES
........
PRODUCED IN
A FACTORY
WHICH HANDLES
........
MADE IN A
FACTORY THAT
ALSO
PRODUCES
........
Standards Agency stated in
lack of scientific and clinica
to base firm conclusions
mum amounts of some alle
ger adverse reactions in sen
Nonetheless, for many com
there is a high degree of agre
lished LOAELs. Further da
high quality double-blind
studies, particularly the Eu
ration, in the next 12 month
Vital information
Australia and New Zealand
to use LOAEL data to impro
the food manufacturing ind
of consumer groups and
ties, developed a standard
tool called voluntary incid
labelling (VITAL).20
This al
to assess potential cross-c
titatively and determine th
warnings. Threshold levels
lished LOAEL data with a
(this derives from toxicolo
uncertainty factor is typical
for intraspecies variation w
although this has not been
responses). When the amou
is above the threshold level
amounts to be listed as an
facturers use an advisory
format “may be present.” N
recommended if levelsarelo
Although some very sensitiv
to levels of allergen below t
ple are in general more likel
problematic foods. The sche
sorywarningsareusedonly
that the warnings are stand
clear and simple informatio
A true safe threshold for any one food and person is impossible to determine
Turner
et
al,
2011
VOLUNTARY
NOT LEGISLATED FOR
Ø 69% of cereals and 56% of confectionery labelled
‘may contain’ despite not listing nut as an ingredient1
Ø Shopping for a nut-allergic person took:
• 40% longer
• cost an average of 11% more
Ø Adversely impacts on quality of life
1FSA report 2007, available at www.food.gov.uk/multimedia/pdfs/maycontainguide.pdf
Impact on the consumer Do PALs contribute to anxiety?
• Paediatric food allergy causes more anxiety than
other chronic diseases such as DM 1
• Labelling is a particular concern: 2,3
“…considerable confusion over the extent to
which parents should exclude allergens…
including whether foods labelled ‘‘may contain
traces’’ should be avoided…” 4
1 Avery et al, PAI 2003;14:378-82
2 Cummings et al. PAI 2010;21:586-94;
3 Sheth et al, Ann Allergy Asthma Immunol 2010;104:60-5
4 Hu et al, Arch Dis Child 2007;92:771-5

3. 07/05/2014
3
Ø PALs helpful if they provide reliable information,
but use is widespread1
Ø Phrasing is confusing
1FSA report 2007, available at www.food.gov.uk/multimedia/pdfs/
maycontainguide.pdf
2Imamura et al. PAI 2008;19:270-4
So why bother? Do allergic individuals heed PAL?
UK
(n=184)
Australia
(n=246)
“May contain nuts” 80% avoid 75% avoid
“May contain traces of nuts” 60% avoid 45% avoid
“Does not contain nuts but made
in a factory that uses nuts”
40% avoid 35% avoid
Noimark et al. PAI 2009 Zurzolo et al. MJA 2013
But wording used bears no relation to risk of contamination1,2
1Pele et al. Food Add Contam 2007; 24:1334-44. 2Hefle et al. JACI 2007; 120:171-6.
Ø Consumers less likely to heed more ambiguous
warnings2
• Can labelling lead to increased risk taking?
1FSA report 2007, available at www.food.gov.uk/multimedia/pdfs/
maycontainguide.pdf
2Imamura et al. PAI 2008;19:270-4
So why bother?
Ø From Dec 2014, allergen labelling will be a legal
requirement for non-prepacked foods too
e.g. delicatessens, restaurants, take-aways
Ø Potential cross-contamination will still not be
legislated for
New legislation:
Do foods with / without PAL contain allergen? So…
Ø Most foods with PAL don’t contain the allergen
• … but some do, and enough to trigger reactions
• Snack/confectionery items at particular risk
(nut contamination)
Ø Some foods without PAL do contain the allergen

4. 07/05/2014
4
The reality:
• Wide inconsistencies in labelling
• Significant increase in awareness of the
hazards posed by food allergens
…but understanding is still far from complete
• Foods can become contaminated with residues
of allergenic foods at multiple points:
• Harvesting on farms
• Storage & transportation
• Manufacture: shared equipment
• Measures to reduce cross-contamination not
uniform across manufacturers
The future…
Hypoallergenic foods
Not a novel concept: e.g. hydrolysed cow’s milk-based formula
Current management… NOW & THEN
• Dietary Avoidance
• Rescue treatment
• Immunotherapy
Accidental/inadvertent reactions are common:
• 1 in 8 peanut-allergic children experienced at least
one accidental reaction every year1
• Over 50% of 512 infants had at least one reaction
over 3 years follow-up2
Avoidance is, therefore, inadequate on its own
All food-allergic children need:
• Personalised Allergy Management Plan
• Rescue treatment (which may include AAI)
1Nguyen-Luu et al, PAI 2012; 23:133–139. 2Fleischer et al. Pediatrics 2012; 130:e25–32.
Management of accidental reactions…
Allergy Action Plan
Name:
DOB:
Parent / Carer details:
1)
2)
THIS CHILD HAS THE FOLLOWING ALLERGIES:
AIRWAY: Persistent cough, hoarse voice,
difficulty swallowing, swollen tongue
BREATHING: Difficult or noisy breathing,
wheeze or persistent cough
CONSCIOUSNESS: Persistent dizziness / Pale or floppy
Suddenly sleepy, collapse, unconscious
If ANY ONE of these signs are present:
1. Lie child flat. If breathing is difficult, allow to sit
2. Give EpiPen®
or EpiPen®
Junior
3. Dial 999 for an ambulance* and say
ANAPHYLAXIS (“ANA-FIL-AX-IS”)
If in doubt, give EpiPen®
After giving Epipen:
1. Stay with child, contact parent/carer
2. Commence CPR if there are no signs of life
3. If no improvement after 5 minutes, give a further EpiPen®
or alternative adrenaline autoinjector device, if available
Photo
Keep your EpiPen device(s) at room temperature,
do not refrigerate.
For more information and to register for a free
reminder alert service, go to www.epipen.co.uk
Patient support groups:
http://www.allergyuk.org or www.anaphylaxis.org.uk
The British Society for Allergy & Clinical Immunology
www.bsaci.org
*You can dial 999 from any phone, even if there is no credit left on a mobile.
Medical observation in hospital is recommended after anaphylaxis.
Watch for signs of ANAPHYLAXIS
(life-threatening allergic reaction):
Child’s
Weight: Kg
Mild-moderate allergic reaction:
Swollen lips, face or eyes
Itchy / tingling mouth
Hives or itchy skin rash
ACTION:
Stay with the child, call for help if necessary
Give antihistamine:
Contact parent/carer
Abdominal pain or vomiting
Sudden change in behaviour
(if vomited, can repeat dose)
This is a medical document that can only be completed by the patient's treating health professional and cannot be
altered without their permission.
This plan has been prepared by:
Hospital/Clinic:
Date:
British Society for Allergy and
Clinical Immunology
Additional instructions:
Clinic details

5. 07/05/2014
5
We need:
1. Recognition
2. Appropriate management in community
3. Appropriate management by healthcare
professionals
1) Recognition
• Symptoms of anaphylaxis (DIB, LOC, pharyngeal
swelling) are poorly recognized by adolescents1
• One in 7 report difficulty in knowing when to use
their AAI in a US survey (n=1885)3
1Sampson et al. JACI 2006: 117: 1440–5.
2Simons et al JACI 2009: 124: 301–6.
2) Appropriate Management
• 83% of (204) teenagers
with anaphylaxis don’t
use their AAI1
1Noimark et al. CEA 2012: 42:284–92
Allergy Action Plan
Name:
DOB:
Parent / Carer details:
1)
2)
THIS CHILD HAS THE FOLLOWING ALLERGIES:
AIRWAY: Persistent cough, hoarse voice,
difficulty swallowing, swollen tongue
BREATHING: Difficult or noisy breathing,
wheeze or persistent cough
CONSCIOUSNESS: Persistent dizziness / Pale or floppy
Suddenly sleepy, collapse, unconscious
If ANY ONE of these signs are present:
1. Lie child flat. If breathing is difficult, allow to sit
2. Dial 999 for an ambulance* and say
ANAPHYLAXIS (“ANA-FIL-AX-IS”)
3. Stay with child, contact parent/carer
4. Commence CPR if there are no signs of life
Photo
This BSACI Action Plan for Allergic Reactions is for
children with mild to moderate allergies, who need
to avoid certain allergens.
For people with severe allergies (and at risk of
anaphylaxis) there are BSACI Action Plans which
include adrenaline autoinjector instructions. These
are available at our website, www.bsaci.org
For further information consult NICE Clinical
Guidance CG116 Food allergy in children and young
people at http://guidance.nice.org.uk/CG116
Patient support groups:
http://www.allergyuk.org or www.anaphylaxis.org.uk
The British Society for Allergy & Clinical Immunology
www.bsaci.org
*You can dial 999 from any phone, even if there is no credit left on a mobile.
Medical observation in hospital is recommended after anaphylaxis.
Watch for signs of ANAPHYLAXIS
(life-threatening allergic reaction):
Mild-moderate allergic reaction:
Swollen lips, face or eyes
Itchy / tingling mouth
Hives or itchy skin rash
Abdominal pain or vomiting
Sudden change in behaviour
ACTION:
Stay with the child, call for help if necessary
Give antihistamine:
Contact parent/carer
(if vomited, can repeat dose)
Child’s
Weight: Kg
This is a medical document that can only be completed by the patient's treating health professional and cannot be
altered without their permission.
This plan has been prepared by:
Hospital/Clinic:
Date:
British Society for Allergy and
Clinical Immunology
Additional instructions:
Clinic details
NOT JUST PATIENTS….
NOT JUST PATIENTS….
Anaphylaxis Knowledge and Practice Preferences of Pediatric
Emergency Medicine Physicians: A National Survey
Sandra L. Grossman, MD1,2
, Brigitte M. Baumann, MD, MSCE2
, Barbara M. Garcia Pe~na, MD, MPH1
,
Marc Y.-R. Linares, MD1
, Barry Greenberg, PhD3,4
, and Vivian P. Hernandez-Trujillo, MD5
Objectives To assess the knowledge and practice preferences of anaphylaxis in pediatric emergency medicine
(PEM) physicians by practice setting, and to identify factors associated with intramuscular (IM) epinephrine admin-
istration and admission of patients with anaphylaxis.
Study design The cohort was a cross-sectional convenience sample; potential participants were recruited using
contact information obtained from the American Board of Pediatrics and American Board of Medical Specialties
membership databases and were asked to complete a 12 item survey. Board-certified PEM physicians were
categorized by practice setting: university hospital, non-university hospital with a residency training program, or
community hospital with no residency training program. Management practices based on practice setting are
presented as proportions. Multivariate logistic regression identified factors associated with IM epinephrine
administration and admission of patients with anaphylaxis for observation.
Results Of the 1114 PEM physicians solicited, 620 (56%) completed the survey. The majority (93.5%) correctly
identified epinephrine as the treatment of choice for anaphylaxis, yet only 66.9% used the IM route of administra-
tion, and only 37.4% admitted affected patients for observation. Factors associated with the use of IM epinephrine
included the presence of a residency program at the site of care (OR, 2.28, 95% CI, 1.3-4.04) and higher volume of
anaphylaxis cases (OR, 1.21; 95% CI, 1.06-1.38). Increasing anaphylaxis case volume was associated with
decreased likelihood of admission of patients with anaphylaxis (OR, 0.81; 95% CI, 0.72-0.92).
Conclusion Even though the majority of PEM physicians correctly report using epinephrine in pediatric anaphy-
laxis, not all use the preferred administration route, and many discharge patients home after an abbreviated period.
(J Pediatr 2013;-:---).
A
naphylaxis, a life-threatening medical emergency requiring prompt recognition and treatment, has been described var-
ious ways since it was first reported in the early 1900s. In an attempt to provide a simpler yet comprehensive definition,
allergy and immunology experts convened in 2005 and published an update in 2010, both times defining anaphylaxis as
1 of 3 clinical scenarios: (1) the acute onset of a reaction involving the skin, mucosal tissue, or both and at least 1 of the fol-
lowing: respiratory compromise, reduced blood pressure, or symptoms of end-organ dysfunction; (2) 2 or more of the follow-
ing occurring soon after exposure to a likely allergen for that patient: involvement of the skin/mucosal tissue, respiratory
compromise, reduced blood pressure or associated symptoms, and/or persistent gastrointestinal symptoms; or (3) reduced
blood pressure after exposure to a known allergen.1,2
This broad definition may account for the wide range of reported inci-
dence of anaphylaxis. In the general US population, this reported incidence ranges from 100 000 to as high as 500 000 annually,
of which two-thirds are new cases and almost 1% are fatal.3,4
It is estimated that anaphylaxis occurs in 1 of every 170 children,
compared with a rate of 30 per 100 000 person-years in adults.5,6
Considering the increasing incidence of food allergies, a rise in the prevalence of allergic reactions and anaphylaxis is
anticipated.7
Fatal outcomes have been associated with a delay in administering or failure to administer epinephrine.8-11
Yet despite the prevalence and severity of anaphylaxis, this condition remains
underrecognized and underreported.3,12
A case-based survey revealed that
a large percentage of pediatricians (46%) had difficulty recognizing and treat-
ing food-induced anaphylaxis, and nearly one-third underestimated its sever-
ity.13
Another study documented pediatricians’ concerns regarding their ability
to appropriately care for children with food allergies and devise effective man-
agement plans.14
The aim of this investigation was to assess anaphylaxis knowledge and practice
preferences of pediatric emergency medicine (PEM) physicians by practice
From the 1
Department of Emergency Medicine, Miami
Children’s Hospital, Miami, FL; 2
Department of
Emergency Medicine, Cooper Medical School of Rowan
University, Camden, NJ; 3
Department of Educational
Research, 4
Division of Research & Information Herbert
Wertheim College of Medicine, Florida International
University; and 5
Department of Allergy and Immunology,
Miami Children’s Hospital, Miami, FL
V.H.-T. is on the speaker’s bureaus of Baxter Healthcare
and CSL-Behring, and serves as a spokesperson for the
Claritin Council and Schering-Plough/Merck. The other
authors declare no conflicts of interest.
Portions of this study were presented as an oral abstract
at the annual meeting of the American College of Allergy,
Asthma, and Immunology, Phoenix, Arizona, November
14, 2010.
0022-3476/$ - see front matter. Copyright ª 2013 Mosby Inc.
All rights reserved. http://dx.doi.org/10.1016/j.jpeds.2013.02.050
ED Emergency department
IM Intramuscular
PEM Pediatric emergency medicine
1
• Only two doctors (2%) demonstrated use correctly.
• Most frequent errors:
§ 57% - not holding pen in place for >5 seconds
§ 21% - failure to apply pressure to activate
§ 16% - self-injection into thumb
• 60% failed to use device correctly even after reading
instructions
• In 37% NO adrenaline would have been administered

6. 07/05/2014
6
Do we need to shift our focus? Current management… NOW & THEN
• Dietary Avoidance
• Rescue treatment
• Immunotherapy
Immunotherapy to food
Nowak-Wegrzyn & Sampson. JACI 2011; 127(3):558-73
Nowak-Wegrzyn & Fiocchi, Curr Opin Allergy Clin Immunol. 2010; 10:214-9.
Studies completed or underway…
Egg Milk Peanut Other
Subcutaneous ✓
Baked, oral ✓ ✓
Native, oral ✓ ✓ ✓ ✓
SLIT ✓ ✓ ✓
Epicutaneous ✓ ✓
Tolerising peptides ✓
Studies completed or underway… Safety
• Desensitisation typically achieved in >80%
• High rate of adverse events during SOTI:
• 70-80% experience adverse events
• Rates of ‘anaphylaxis’ vary
• Severity of anaphylaxis vary
• Up to 10% of patients withdraw

7. 07/05/2014
7
• 49/85 (58%) desensitised to 1400mg protein (~6 PN)
• 75 (88%) partially desensitised to 800mg protein
• Cumulative safety data not reported
• At least 81% of children experienced an adverse event
• Most of these mild, but at least 1 in 5 children
developed wheeze
• One child ‘required’ IM adrenaline twice (child
subsequently withdrawn)
NB: Most OIT protocols for peanut utilise higher dosing
regime, up to 5000mg protein (~20 peanuts)
Desensitisation vs long term tolerance…
Nowak-Wegrzyn & Sampson. JACI 2011; 127(3):558-73
Desensitisation vs long term tolerance…
Peanut 12 (50%) of 24 children who completed
SOTI were tolerant after 2 months1
Egg 11 (37%) of 30 children who completed
SOTI were tolerant after 2 months2
Cow’s
Milk
10 (31%) of 32 children were able to
tolerate at least one portion of CM daily
1-5 years after completing SOTI3
1Vickery et al. JACI 2014 Feb;133(2):468-475.e6.
2Burks et al. N Engl J Med 2012; 367:233–243.
3Keet et al. JACI 2013; 132:737–739; e6.
Some clinical concerns…
• How to select those suitable for SOTI
• Risk of increasing sensitisation?
• Risk of inducing a false sense of security in
those only temporarily desensitised
• Effect on QoL of patient
• Potential for causing other problems e.g. EoE
THE FUTURE: Dietary avoidance
• Accurate diagnosis and therefore appropriate
avoidance
• Clearer food labelling
• Apps to help avoid potential allergens
• Better understanding when eating out
• Hypoallergenic foods

8. 07/05/2014
8
THE FUTURE: Rescue treatment
• Recognition of symptoms
• More intuitive AAI
• Apps to aid AAI use/emergency services
• More training for HCPs
THE FUTURE: Treatment options
• Use of baked CM / egg
• More research into SOTI:
• Safer protocols
• Better understanding of long-term
tolerance induction
• SOTI as primary prevention
THE FUTURE… is already here?
• Accurate diagnosis and therefore appropriate avoidance
• Clearer food labelling
• Apps to help avoid potential allergens
• Better understanding when eating out
• Hypoallergenic foods
• Recognition of symptoms
• More intuitive AAI
• Apps to aid AAI use/emergency services
• More training for HCPs
• Baked CM / Egg
• More research into SOTI:
• Safer protocols
• Better understanding of long-term tolerance induction
• SOTI as primary prevention