This document discusses the socioeconomic aspects of food allergens. It provides statistics on the prevalence of food allergies and intolerances. It outlines key food allergen labeling regulations in the US and EU. It also examines the significant economic costs of food allergies from both healthcare and household perspectives. The document notes that producing "free-from" foods has become a major business opportunity but also presents increased production costs. It reviews various methods for food allergen testing and factors that influence testing costs and accuracy.

1. Socio-economical aspects of food allergens | October 2020 | Darmstadt
How to guarantee safe food for
consumers with food allergies?
Ronald Niemeijer

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Stakeholders in the context of „allergen free“ and gluten free
Food allergies & food allergens
Consumers
(Individuals with food allergy or intolerance) (Family & Friends)
Society
(Healthcare)
(Legislation)
Food Industry
„Service Suppliers“
(e.g. Laboratories, Testkit Suppliers)

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Food allergies, food intolerances - Prevalences
Prevalences:
• Food allergies (adults)*: 2% - 4%
• Food allergies (children)**: 5% - 8%
* Young et al., 1994; A population study of food intolerance. Lancet 343, 1127-1130.
** Sampson H.A., 2005; Food allergy – accurately identifying clinical reactions. Allergy, 60 (Suppl 79), 19-24
• Celiac Disease: 1%
“Globally” i.e. mainly Europe, US, Mexico,
Brazil, India with regional differences
• Food intolerances: 15% - 20%
Total population
And considering the family situation….
Food allergies & food allergens

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Food allergen legislations – Labeling requirements ingredients
About 90% of all food allergies are caused by 8 food types (“The big 8”)
• milk, eggs, fish, crustacean shellfish, wheat, soy, peanuts, and tree nuts
Food Allergen Labeling and consumer Protection
Act of 2004 (FALCPA)
Regulation (EU) No 1169/2011 on the provision of
food information to consumers…
Food allergens legislation

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
“Free from” Legislations?
There is no “allergen-free” legislation
“Allergen Free” claims would be covered by EC 178/2002 (“General Food Law”) and
EU 1169/2011 (Article 7: “Food information shall not be misleading”)
“Gluten free” is defined in legislation (and for infant formulae “lactose free”):
• “Commission Implementing Regulation (EU) 828/2014” defines “gluten free” (i.e. ≤ 20
mg/kg) and “very low gluten” (i.e. ≤ 100 mg/kg)
• This also applies to non pre-packed food (e.g. restaurants)
• U.S. FDA Final Rule for the (voluntary) use of “gluten free” if
a product contains ≤ 20 ppm gluten
• “Gluten free” may be used for products that are naturally free from gluten
(In the USA, the EU is a more restrictive: e.g. “Gluten Free” on water is not allowed )
Food allergens legislation

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Food allergies & food allergens
Economic impact of childhood food allergy in US (Study in 2011 – 2012)
• Overall annual costs are app. 25.000 M$ (or app. 4.200 $ per child)
• Direct medical costs: app 5.000 M$ annually (app. 750 $ / child)
Source: Economic impact of childhood food allergy in US, :- Gupta e.a. JAMA Pediatrics vol 167, nr. 11 (2013)
Food allergies & celiac disease – costs involved (health care)
Costs of allergic diseases (0 – 2 yrs. Infants) in Finland (Study in 2012)
• Median costs per infant € 3.182,- (or app. 3.600 $ per child))
Source: Costs of allergic diseases from birth to two years in Finnland, Alanne e.a. Public Health, 2012, Oct. 126 (10): 866-72
Unfortunately very limited data are available for celiac disease – a few data address the
costs of screening and diagnosis (between $ 1.300 in Canada and € 44.000 in the
Netherlands) and an additional $ 6.000 annually for ambulatory care
Source: Mearns, ES., Taylor, A., Boulanger, T., e.a (2018). Systematic Literature Review of the Economic Burden of Celiac Disease.
Health loss due to allergens in DALY : 37.350 (E.g. microbes: 1.000 – 4.000)
Source: TNO Innovation for life, 2016

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Food allergies & food allergens
Household costs associated with food allergy in Sweden (Study in 2014)
• Additional household costs: € 4.000,- / child (0 – 12) annually
• Direct costs: + € 2.085
• Indirect costs: + € 1.876
• Additional household costs: € 4.800,- / adolescent (13 – 17) annually
• Direct costs: + € 2.892
• Indirect costs: + € 1.900
This study also showed a significant decrease in health related quality of life;
What about the loss in QALY for celiac disease?
Source: Household costs associated with objectively diagnosed allergy to staple foods in children and adolescents, Protudjer e.a.
J. Allergy Clin Immunol Pract, Volume 3, nr. 1 (2015)
Food allergies & food allergens – costs involved (consumer)

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Food allergies & food allergens
A gluten free diet – costs involved (consumer)
• For a consumer with celiac disease
avoidance of gluten is the only option!
• The additional „indirect costs“ are mainly
based on the special food products
required („Free From“)
• And „Allergen Free“ or „Gluten Free“
products are significantly more
expensive (125% - 500%)
• The good news is: The availability of
Gluten Free has improved spectacularly!

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Food industry business opportunities – “Free-From”
Producing “Allergen free” / “Gluten free” food has become big business and is likely to
show double digit growth the coming years………
(“Milk Free” or “Lactose Free” being the most important group, followed by “Gluten Free)
Food allergies & food allergens

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
“Gluten Free” is rocketing…
• US Gluten Free sales grew between 13% and 20%
annually from 2012 and 2017; the size of “Gluten
Free” market in is estimated to be 7.600 M$ in 2020
• For 2018 – 2023 the growth is forecasted to slow
down, but still significant (6%)
• 75% of the gluten free products are bakery products
and breakfast cereals
• 6,5% of all food sold (retail) in the US was labeled
“Gluten Free”
• 8% of the US consumers follow a gluten free diet,
up to one third reduces or avoids gluten
Food allergies & food allergens

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
“Free From” in the food industry – A two edged sword….
A business opportunity
“Free From” products are
premium products and sold with
higher margins
• A UK study showed prices
of gluten free products
sold in retail may be
between 50% and 500%
higher
“Free From” is one of the fastest
growing segments in the food
industry
Food allergies & food allergens

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
“Free From” in the food industry – A two edged sword….
Increased production costs
Product development
Sourcing
Logistic separation of ingredients
Production process
• Dedicated facility
• Dedicated production lines
• Cleaning procedures
• Logistics
Additional risk to manage
Costs of testing
Food allergies & food allergens
A business opportunity
“Free From” products are
premium products and sold with
higher margins
• A UK study showed prices
of gluten free products
sold in retail may be
between 50% and 500%
higher
“Free From” is one of the fastest
growing segments in the food
industry

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Methods for allergen detection..
LC-MS/MS
PCR
ELISA
LFD
Food allergen testing

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Besides the analytical method sampling plays an important role
Food allergen testing
Taking several smaller, incremental
samples is better than just 1 large sample
You are often looking for the “needle in
the haystack“

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Allergen testing – Costs of testing and the effect of the quality of methods
No surprise  - but the quality of your analytical method contributes largely to the costs..
There are 4 outcomes of testing (“positive” means here at or above level of acceptance):
• Test +/ Sample +
• Test - / Sample -
and
• Test - / Sample +: False negative or consumers risk
• Test + / Sample -: False positive or producers risk
A false negative results may cause additional costs further
down the production chain (rejected products, recall or worse)
A false positive result is a direct financial loss (product gets
rejected, although within limits)
Food allergen testing

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Some thoughts from mycotoxin testing that may apply to allergen testing..
The quality of your result is only to a limited extent determined by the actual “analytical
tool” itself.
Sampling, sample preparation and sample size
typically play a much bigger role!
Food allergen testing

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Which method to choose?
Choose the method that meets your needs:
• Type of samples
• Finished products (typically processed)
• In-line samples from production
• Incoming goods (raw materials)
• Number of samples to be expected
• Laboratory capabilities, investments
• Validations available –
validations for your products!
Food allergen testing
LC-MS/MS
PCR
ELISA
LFD

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
And the consumer?
Quotes published on: www.freefromeatingoutawards.co.uk/
Food allergen testing

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Is food testing by the consumer a good plan?
What is next?
Testing wine would be easy –
that is homogeneous.
But where to sample that
pizza?
Put the entire pizza
in a blender?
Probably
not such a
good idea

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Socio-economical aspects of food allergens | October 2020 | Darmstadt
Towards a food-allergy-free world….
Food allergies & food allergens
Consumers (with a food allergy)
Healthcare,
Regulators,
Science
Food Industry
„Service Suppliers“
(e.g. Laboratories, Testkit Suppliers)

21. Socio-economical aspects of food allergens | October 2020 | Darmstadt
Thank you
for your attention!