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IN THIS ISSUE
Editorial Team Editor in Chief:
Carmen Diaz-Amigo
Editorial Members:
Terry Koerner
Jupiter Yeung
Michael Abbott
James Roberts
Bert Popping
Graphic Design:
Carmen Diaz-Amigo
AOAC Food Allergen Community Newsletter: aoac.allergens@gmail.com
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Editorial Comment
A price too high to be paid? 1
News
Towards the production of reference
materials for food allergen and
gluten-free analysis for improved
food safety management 2
8th Workshop on Food Allergen
Methodologies Vancouver (Canada),
May 5-8, 2014 3
Gluten-free: Are analytical methods
challenged by regulatory
decisions? 3
EFSA is getting ready to update their
opinion on the labeling of food
allergens 4
Research Highlights
Cross contamination of grains:
Canadian exposure assessment for
naturally gluten-free grains 4
Update New gluten method AACCI
approved, AOAC 1st Action status
coming soon 5
Editorial Comment
A price too high to be paid?
In this issue of the Allergen Newsletter were reporting, inter alia, about two
new developments: the commission of a new project by EFSA for allergen data
assessment and the suggested introduction of a 1 ppm prolamin threshold for
gluten-free labeled products in Chile. And in both cases, the same question applies:
is the price to be paid too high?
Lets talk about the new EFSA project frst: over the past decade a myriad of data
on cohort studies for allergen thresholds have been generated, analyzed and re-
analyzed. The majority of scientists seem to agree: the VITAL 2.0 reference values
are reasonable and help the allergic consumer to make an informed choice. The
work has been done, the scheme implemented. And yet, the EFSA commissioned
a new, very costly project to re-re-analyse the data from literature. Are radical
new insights likely to emerge? Are threshold likely to be defned with an order of
magnitude diference to the recently reported ones? Unlikely. There will never be a
perfect set of data to base an assessment on industry and consumer understand
well that this is a dynamic process. What they do not understand is why until now,
no recommendation has been issued by EFSA. The current situation neither helps
industry nor the afected consumers.
The second surprising development is the suggestion of introducing a 1ppm
threshold for gluten-free labeled products in Chile. While the regulatory body
surely had the beneft of the afected consumer in mind, it remains to be seen if all
the consequences of this had been considered carefully beforehand. For one, food
industry will be able to label even fewer products as gluten free, further limiting
the choice of the consumers afected by celiac disease. And how will the controls
be done? To obtain a reliable result close to the limit of detect of an assay, many
repeats have to be performed on the same sample. Only this delivers a statistically
reliable result. And same holds true for industry laboratories which will also have
to perform many more test on the same sample. This is likely to increase prices
for testing, and ultimately increase prices for the gluten free-product. If it really
protects celiac sufers better remains to be seen.
Bert Popping | Editorial Team Member
NEWSLETTER
Volume 5 | Issue 1 2014
AOAC Food Allergen Community
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NEWSLETTER
Volume 5 | Issue 1 2014
Efective allergenic risk assessment and management are
important to protect allergic consumers and to comply with
allergen labelling regulations. Such approaches require
reliable analytical tools for the detection of allergens in food.
In recent years various allergen-detection methods have
been published, and immune-chemical test kits have become
commercially available and widely used. Alternatively,
methods using specifc DNA fragment identifcation
usually based on PCR (polymerase chain reaction) have also
been employed. More recent developments use also Liquid
Chromatography - Mass Spectrometry (LC-MS) to analyze for
allergen or gluten specifc peptides in food products.
Due to the nature of the analytes and their susceptibility to
various processing efects, reliability and comparability of
results have posed a great challenge. Both reference methods
and reference materials are urgently needed here. It is one of
the aims of MoniQA Monitoring and Quality Assurance in
the Total food Supply Chain (www.moniqa.org) - the global
food safety network registered as MoniQA Association
(initially funded by the European Commission as a Network
of Excellence, 2007-2012) to provide guidelines for method
validation, reference materials and assess the reliability of
methods and obtained results through validation studies and
profciency testing schemes.
In 2013 MoniQA initiated a Task Force on the development
of food allergen and gluten-free reference materials. The Task
Force is an international group comprised of several SDOs
(Standardization Organizations), industry representatives,
policy makers, test kit providers and method developers,
analytical companies, as well as representatives from various
universities. This international group works towards consensus
on the specifc requirements and the design of global food
allergen reference/testing materials and gluten-free standard
materials. For this purpose MoniQA has liaised with the EU
funded project iFAAM, the Prolamin Working Group and
Australias Vital concept group.
The aim of MoniQAs initiative is the publication of a Guidance
Document on the special requirements and production of
allergen reference materials, following a similar efort by the
same group in 2010 publishing a globally harmonized Guidance
and Best Practice Document on validation procedures for
quantitative food allergen ELISA methods (Abbott et al. 2010).
The new document shall allow everyone who is able to fulfll
the described requirements to produce and to ofer reference
material. This material shall receive a certain certifcation or
labeling which identifes the material as such, produced
according to this Guidance Paper (in efect a practical guide
to implement ISO Guide 35 applied to the special issue of
allergens and gluten). The frst priority commodities were
identifed as being gluten, milk, egg, peanut, hazelnut, and
soy. The plan is to provide well characterized commodity
materials for the further production of incurred reference
materials, spiked samples and extracts.
The need for appropriate analytical tools to assure food
safety for allergic consumers requires the collaboration of
various disciplines, such as food technology, clinical research,
consumer and social sciences, analytical chemistry and others,
and various stakeholder groups bridging from research and
training at the university and industry level, to international
organizations (Codex, CEN, ISO, a.o.) and regulators.
Roland Poms | ICC & MoniQA Association
Towards the production of reference materials for food allergen and
gluten-free analysis for improved food safety management
News
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NEWSLETTER
Volume 5 | Issue 1 2014
Health Canada and the Food Allergy Research and Resource
Program (FARRP) are pleased to announce the 8th Workshop
on Food Allergen Methodologies to be held in beautiful
Vancouver, British Columbia. This international workshop
is also proud of the involvement and co-sponsorship of the
Asia-Pacifc Economic Corporation (APEC). This two and a
half day workshop has become popular with regulatory
agencies, food industry, academia, method developers, and
consumer associations as an educational resource providing
opportunities for discussion and networking with those
interested in food allergies and gluten intolerance.
The frst day of the workshop will provide an overview of food
allergen prevalence, priorities, and how priority allergens are
set. Dr. Ann Clarke from the University of Calgary will discuss
what we know about the prevalence of food allergies and
Dr. Steve Taylor from FARRP will give an overview of priority
allergen lists around the world. Additional talks on food
allergen potency, severity and thresholds will round out the
morning discussions about the scientifc foundation for current
food allergen risk management priorities. Dr. Clare Mills and
Dr. Sabine Baumgartner will lead the afternoon discussions
devoted to the iFAAM-project (Integrated Approaches to Food
Allergen and Allergy Risk Management). This session will focus
on the development of multi-analyte tools for detection and
quantifcation of allergens as well as how these tools can be
integrated into clinical and industrial practice.
The second day of the workshop (Industry Day) will focus on
specifc aspects of food allergens from an industrial perspective.
The morning session will be devoted to preventative controls
and enforcement strategies for food allergens. The initial
talk in this session will focus on the new U.S. Food Safety
Modernization Act with regard to preventative allergen
controls. Speakers from Canada, US and Australia will then
discuss allergen control and enforcement programs specifc to
each jurisdiction. The afternoon session will provide an update
on new developments for both qualitative and quantitative
food allergen detection methodologies, which are important
to support allergen control and enforcement programs. These
updates will include both immunological based methods
(ELISA and LFD) and the latest mass spectrometry techniques.
The fnal half day of the workshop will be dedicated to
gluten-free regulation and analytical challenges. The session
will start with new regulatory updates from the US and
Canada, which will be followed by discussions on immune-
stimulatory peptides in celiac disease and some of the
analytical challenges found in hydrolysed sources of gluten.
More information
Terry Koerner | Health Canada
8th Workshop on Food Allergen Methodologies
Vancouver (Canada), May 5-8, 2014
Gluten-free: Are analytical methods challenged by regulatory decisions?
The Chilean Ministry of Health has
recently held a public consultation to
request comments on the proposed
text that modifes the defnition of
gluten-free (Article 518 of the food
regulation, Decree 977/96). The text
indicates that the term Gluten-free
and its symbol shall be used only when
the analytical result of the food sample
is not higher than 1 mg/kg prolamin.
The proposed level, which difers from
the 20 mg/kg gluten defned by the
Codex Standard 118 and adopted by
most jurisdictions regulating gluten,
would pose a signifcant challenge
to current analytical methods
and laboratories, if adopted. Such
detection methods, mostly ELISA and
dipsticks, have not been developed
and validated to reach such low levels
reliably.
What are the consequences for food
producers, for consumers sufering
from celiac disease and, last but not
least, the analytical laboratories?
There is no doubt that it certainly is
the intention of the Chilean regulatory
body to efciently protect their
celiac population. But the question
has to be asked if the new limit
further reduces the range of already
limited products for celiacs without
necessity. In addition, enforcement
actions will inevitably be also based
on scientifc evidence which may not
in all cases be substantiated. This is
due to the fact that many assays have
a high variability at the lower end of
detection. To determine if a sample
is positive or negative at or around
the limit of detection, numerous
subsamples of the same sample will
have to be analyzed for a statistically
sound determination. This will incur
additional work and cost. Industry
laboratories will be pressured to issue
certifcates which implies a confdence
level that is not realistic. And food
producers will have to remove gluten-
free labels from products that may
still be suitable for celiacs. Moreover,
it will impact on international trade as
imported, gluten-free, products would
also have to comply with the Chilean
regulation.
Time will tell how enforceable this
suggested regulatory amendment
truly is and if there are tangible
benefts in having a limit in place
that is signifcantly more stringent
compared to other jurisdictions.
Bert Popping &
Carmen Diaz-Amigo
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NEWSLETTER
Volume 5 | Issue 1 2014
Celiac disease (CD) is a chronic small intestinal immune-
mediated enteropathy, which requires avoiding exposure to
gluten as the only efective treatment. These gluten sources
comprise wheat (including spelt and kamut), barley, rye,
and triticale (a cross between wheat and rye). The daily diet
of people with celiac disease will partially rely on naturally
gluten-free grains (e.g., rice, buckwheat, soy, ...) or fours and
starches derived from these grains. Given the ubiquitous
presence of gluten containing cereals in our food supply there
is a potential for inadvertent cross-contamination of naturally
gluten-free cereals, which is allowed in Canada under the
Canadian Grain Standards. Current evidence suggests that the
vast majority of people with celiac disease could tolerate some
gluten in the diet (< 10 mg/day) with no histological changes
to the intestinal mucosa. The objective of this study was to
use Canadian consumption patterns to estimate the level of
incidental gluten potentially present in the diet of people with
celiac disease.
Canadian consumption information was collected as part of
a large health survey conducted in 2004. Usual food intakes
were determined from an initial 24 hour recall for individuals
responding to the survey (n=35,107) and correlated with a
subsequent survey conducted a few days later on a portion
of the initial group (n=10, 786). The estimated consumption
of grain-containing foods was determined by identifying all
of the foods that contained cereal grains as both a major or
minor ingredient. Because all of the information was obtained
from cereals for a general diet the individual ingredients
needed to be converted and correlated to cereals used for a
gluten-free diet. Once this was done gluten intake estimations
from foods derived from naturally gluten-free cereals, taking
into consideration the various rates of food consumption by
diferent sex and age groups were calculated. These estimates
have concluded that if gluten was present at levels not
exceeding the CODEX recommended level for gluten-free
foods (20 ppm), exposure to gluten would remain below 10
mg per day for all age groups studied. In reality the actual
level of gluten found in naturally gluten-free ingredients is not
static and there may be some concerns related to the fours
made from naturally gluten-free grains. It was found that
those containing a higher level of fber could be a concern and
only fours and starches labelled gluten-free should be used
for homemade preparations.
La Vieille, S.; Dubois, S.; Hayward, S.; Koerner, T.B. Estimated
Levels of Gluten Incidentally Present in a Canadian Gluten-
Free Diet. Nutrients 2014, 6, 881-896. [Abstract]
Terry Koerner | Health Canada
Cross contamination of grains: Canadian exposure
assessment for naturally gluten-free grains
Research Highlights
September 7 - 10, 2014
Boca Raton Resort & Club
Boca Raton, Florida USA
www.aoac.org
Present your Scientifc Work
to your colleagues
Submit your Poster
Deadline July 3, 2014
More Information
128th AOAC
Annual Meeting & Exposition
EFSA is getting ready to update their opinion on the
labeling of food allergens
The European Food Safety Authority
(EFSA) has recently published on its
website an extensive review covering
the following 3 main points:
y Prevalence of food allergy in
diferent regions of the world and
individual European countries.
y Efect of food processing on the
allergenicity of regulated allergenic
ingredients in Europe.
y Availability of analytical methods for
the detection of food allergens in
processed foods.
The data included in the work were
selected after a systematic database
search and the evaluation of the
information according to established
criteria and data quality assessment.
This work will be used by the EFSA
Panel on Dietetic Products, Nutrition
and Allergies to update its opinion
on the evaluation of allergenic foods
for labeling purposes, published in
2004. With the new available clinical
and analytical data generated since
then, including those resulting from
3 projects funded by the European
Commission, EuroPrevall, MoniQA and
the on-going iFAAM, the community
expects that EFSA addresses the still
open issue of thresholds values.
More information
Carmen Diaz-Amigo
Page 5
NEWSLETTER
Volume 5 | Issue 1 2014
In 2013 the Protein & Enzymes Technical Committee of AACC
International initiated a collaborative study of a method for
gluten quantitation in selected foods using a G12 antibody
sandwich ELISA system. For the collaborative study: rice four,
rice-based chocolate cakes and rice crisp breads with 0, 10, 20,
100 mg/kg of spiked/incurred gluten were used (fg 1). These
three sample types nicely depict a range of diferent food
matrices: from non-processed rice four to processed product
samples (chocolate cake: 170C for 45min; rice crisps: 230C
for 30min). Eighteen out of twenty labs reported usable result
sheets, the performance of the method was sufcient on
analyte recoveries, hence the report was forwarded for review
by the Approved Methods Technical Committee Chairs (AMTC
Chairs). Recently, the AMTC Chairs approved this method
as AACC International Method 38-52.01: Immunochemical
measurement of Intact Gluten in Rice Flour and Rice Based
products by G12 Sandwich ELISA. Currently, the Codex
advised threshold for gluten-free labeling is 20 mg/kg
gluten, according to Codex 118-1979 rev. 2008 on analytical
methods: The detection limit has to be appropriate according
to the state of the art and the technical standard. It should be
10 mg gluten/kg or below. Based on all the collaborative
study results (linear regression analysis), a detection limit of 4
mg gluten /kg was calculated for rice-based products analysis
with the G12 antibody gluten ELISA method. The full report on
AACCI 38-52.01 will appear soon in an upcoming issue of Cereal
Foods World in 2014. In March this year, at the AOACI mid-year
meeting, the G12 Sandwich ELISA has been adopted as an
AOACI 1st Action Method. The G12 ELISA method has been
developed to conform to international thresholds for gluten
in gluten-free products. ELISA methods are an important tool
to measure low levels of allergens in foods, contributing to the
safety of foods and food production.
Clyde Don | CDC Foodphysica, The Netherlands
Update New gluten method AACCI approved,
AOAC 1st Action status coming soon
The AOAC Food Allergen Community
is a forum serving the scientifc
community working on Food Allergens:
The community is aimed to help AOAC
INTERNATIONAL in its consensus-
based scientifc and advisory capacity
on methods of analysis for allergens in
foods and other commodities. It is also
meant to serve the broader Stakeholder
Community whose objectives it is to
enhance the protection of food allergic
consumers worldwide.
Contact us at
AOAC.Allergens@gmail.com
Mark your calendar !!!
AOAC Food Allergen Community Newsletter
You can contribute with articles, news items or suggestions.
Submission deadline for the 2nd Issue of 2014: June 30,

2014
Send your articles to AOAC.Allergens@gmail.com
Figure 1. (A) Crisp bread produced for the collaboratve
study, (B) gluten-free chocolate cake mix, and (C) samples as
presented to the laboratories for the collaboratve study.
9 Regulatory Updates
9 Food Industry Initiatives
9 Regional developments
9 Upcoming events
9 Questions for our Experts
9 Interested in a topic?