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AOAC Food Allergen Community

NEWSLETTER Volume 5 | Issue 1

IN THIS ISSUE

Editorial Comment

Editorial Comment A price too high to be paid?

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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?

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EFSA is getting ready to update their opinion on the labeling of food allergens4

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

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2014

A price too high to be paid?

In this issue of the Allergen Newsletter we’re 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? Let’s talk about the new EFSA project first: over the past decade a myriad of data on cohort studies for allergen thresholds have been generated, analyzed and reanalyzed. 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 defined with an order of magnitude difference 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 affected 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 benefit of the affected 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 affected 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 suffers better remains to be seen. Bert Popping | Editorial Team Member

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: [email protected]

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2014

News Towards the production of reference materials for food allergen and gluten-free analysis for improved food safety management Effective 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 specific DNA fragment identification – 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 specific peptides in food products. Due to the nature of the analytes and their susceptibility to various processing effects, 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 proficiency 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

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on the specific 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 Australia’s Vital concept group. The aim of MoniQA’s initiative is the publication of a Guidance Document on the special requirements and production of allergen reference materials, following a similar effort 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 fulfill the described requirements to produce and to offer reference material. This material shall receive a certain “certification or labeling” which identifies the material as such, produced according to this “Guidance Paper” (in effect a practical guide to implement ISO Guide 35 applied to the special issue of allergens and gluten). The first priority commodities were identified 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

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2014

8th Workshop on Food Allergen Methodologies Vancouver (Canada), May 5-8, 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-Pacific 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 first 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 scientific 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

quantification 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 specific 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 specific 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 final 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 immunestimulatory peptides in celiac disease and some of the analytical challenges found in hydrolysed sources of gluten. More information » Terry Koerner | Health Canada

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 modifies the definition 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 differs from the 20 mg/kg gluten defined by the Codex Standard 118 and adopted by most jurisdictions regulating gluten, would pose a significant 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 suffering 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 efficiently 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 scientific 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 certificates which implies a confidence level that is not realistic. And food producers will have to remove glutenfree 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 benefits in having a limit in place that is significantly more stringent compared to other jurisdictions.

Bert Popping & Carmen Diaz-Amigo

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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: yy Prevalence of food allergy in different regions of the world and individual European countries. yy Effect of food processing on the allergenicity of regulated allergenic ingredients in Europe. yy 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

128th AOAC Annual Meeting & Exposition

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

September 7 - 10, 2014 Boca Raton Resort & Club Boca Raton, Florida USA www.aoac.org Present your Scientific Work to your colleagues Submit your Poster Deadline July 3, 2014

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Research Highlights Cross contamination of grains: Canadian exposure assessment for naturally gluten-free grains Celiac disease (CD) is a chronic small intestinal immunemediated enteropathy, which requires avoiding exposure to gluten as the only effective 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 flours 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 different 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 flours made from naturally gluten-free grains. It was found that those containing a higher level of fiber could be a concern and only flours 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 GlutenFree Diet. Nutrients 2014, 6, 881-896. [Abstract] Terry Koerner | Health Canada

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Update – New gluten method AACCI approved, AOAC 1st Action status coming soon 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 flour, rice-based chocolate cakes and rice crisp breads with 0, 10, 20, 100 mg/kg of spiked/incurred gluten were used (fig 1). These three sample types nicely depict a range of different food matrices: from non-processed rice flour to processed product samples (chocolate cake: 170°C for 45min; rice crisps: 230°C for 30min). Eighteen out of twenty labs reported usable result sheets, the performance of the method was sufficient 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

Figure 1. (A) Crisp bread produced for the collaborative study, (B) gluten-free chocolate cake mix, and (C) samples as presented to the laboratories for the collaborative study. 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

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 [email protected] 99 Regulatory Updates 99 Food Industry Initiatives 99 Regional developments

99 Upcoming events 99 Questions for our Experts 99 Interested in a topic?

The AOAC Food Allergen Community is a forum serving the scientific community working on Food Allergens: The community is aimed to help AOAC INTERNATIONAL in its consensusbased scientific 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 [email protected]

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