Newsletter Food Allergen Community - focos

AOAC Food Allergen Community

NEWSLETTER

Volume 3 | Issue 2

Spring 2012

From Risk To Safety

A Long and Rocky Path Worth Walking

The Community has walked for a long time on a difficult path full of obstacles. We have learned a lot about food allergies and there has been new analytical developments that have improved our way of providing safe foods for allergic consumers. But the road is long and requires continuous care and maintenance. To reach our destination we need to be alert and open to new developments in order to make critical decisions on our way. As a community we need to keep moving forward addressing each obstacle in our path...our path to food safety. The Editorial Team of the AOAC Food Allergen Community Newsletter

IN THIS ISSUE

Editorial Comment

Editorial Comment Yours, Mine and Everyone’s Safety

1

Ask the Expert Dr. Ulrich Busch

2

Spotlight Precautionary (may contain) allergen labeling; when to apply? 3

News VITAL 2.0 - An Update

4

Seventh Workshop on Food Allergen Methodologies - Report 5

Analytical Insights Special Section on Gluten – Journal of AOAC International 6

Previous Editions

Yours, Mine and Everyone’s Safety

The goal of allergen risk assessment is to provide risk managers with a rational basis for making decisions in managing the intentional use and unintentional cross contact of allergens in finished products in order to ensure public protection against unacceptable risks whereby benefits outweigh the risks. The decision-making process often involves factors in addition to the dose-response outcome, technical feasibility, labeling and consumer compliance, and economic values. Food safety is everybody’s business. We all say this, but do we mean it in our hearts and minds? For more than a decade, we have used threshold or eliciting dose of allergens in our risk assessments, yet there is still no consensus on threshold levels that are recognized by regulatory agencies, industry, academia and consumers, with perhaps the exception of 20 ppm gluten for gluten free labeling. To level the playing field, let’s continue our journey to establishing thresholds together. I will rely on you, me and everyone to make this happen. Jupiter Yeung AOAC Food Allergen Community Co-chair

6

Editorial Team Save Print

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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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NEWSLETTER

Volume 3 | Issue 2 Spring 2012

Q&Ask the Expert Ulrich Busch, Ph.D.

Senior Government Officer Bavarian Institute for Health and Food Safety Munich, Germany

Dr. Busch, you are the chairman of the German §64 working group for food allergens. How can you explain to the allergen community what this group is and does? The group is based on the official German Food and Feed Law. §64 states that a collection of official methods for the analysis of food needs to be provided. The working groups of the Federal Office of Consumer Protection and Food Safety work on the complementation of the collection of analytical methods. The method collection can be found here: http:// www.methodensammlung-bvl.de/ The §64 working group for food allergens provides methods for the detection of food allergens for the collection of official methods. Who are the members of this working group? Are they all from industry or government? Members from the food industry, food safety authorities and universities are equally represented. Dr. Busch, why is this working group so important? The group produces validated methods for the official collection of analytical methods. The results obtained with the official methods can be used by all involved parties - the food industry

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as well as the food authorities, for example. The big advantage by using these methods is that the obtained results are comparable. The use of an official method does not require full validation in the laboratory since it has already been validated and is an accepted method – also in court.

Have other European countries similar working groups and have they achieved similar targets?

Non-official methods can also be used. However, it needs to be proven that the method performs equally well or better than the corresponding official method.

Are the methods designed to detect allergens at recommended action levels?

Does the §64 LFGB working group for allergens have relevance for Germany or beyond? The methods produced by the working group on food allergens are transformed into European standards via the DIN (Deutsches Institut für Normung – German Standardization Insitute). The first method in the range of food allergen analysis using molecular biology to be transformed into a European code was the real-time PCR method for the detection of celery (Apium graveolens) in food (CEN/TS 15634-2). What are the major achievements of this working group so far? So far, the working group has provided three official methods based on realtime PCR: for the detection of hazelnut, celery and lupine DNA in food.

A similar group exists in Switzerland. In addition, members of the Swiss groups participate in the meetings of the §64 working group as guests.

The methods are designed as sensitive as possible. The to provide methods that the detection of allergens recommended action levels.

to be aim is enable at the

Can the methods be used across all matrices? The methods are validated for a certain matrix, e.g. chocolate or sausages but can also be used for several other matrices after appropriate validation. Will consumers be safer as consequence of this working group? The working group provides methods for the surveillance of the compliance with the European labelling regulations for food allergens and hereby contributes to the safety of food allergic consumers.

NEWSLETTER Volume 3 | Issue 2

Spring 2012

Spotlight Precautionary (may contain) allergen labeling; when to apply? Allergens in food are a risk for the allergic consumers. For a food manufacturer a main question is how to deal with potential cross-contamination of the end product with allergens and how and when to communicate about this potential risk. The present legislation does not provide clear action levels for labeling in the case of cross-contamination. Though, the manufacturer clearly has the aim to avoid allergic reactions of the consumers of their products and to minimize consumer complaints. TNO has developed an allergen risk assessment methodology. This method is a probabilistic risk assessment that quantifies the risks of allergens based on data from food consumption and sensitivity of patients for food allergens. Starting with a certain amount of an allergen in a food product it can be calculated how many allergic consumers may react to this amount. In recent years, extensive

information is collected on the sensitivity of patients (thresholds) for most major food allergens. By international cooperation with clinical centers, this database is continuously updated with more data on thresholds and new food allergens. Conversely, this method can be easily used to calculate the maximum concentration of an allergen in a specific product subjecting it to a risk limit the manufacturer or society is willing to accept. TNO is working with international parties to establish limits and develop international guidelines for more uniform and transparent allergen risk information. The TNO risk assessment methodologies together with the thresholds database is seen as the best way forward. Currently, the Australian- New Zealand Allergen Bureau is revising their VITAL guideline, in cooperation with international food allergy experts from TNO and the Food Allergy Research and Resource Program

(FARRP) from the University of Nebraska. Reference doses for may contain labeling were elaborated, based on the latest threshold information available to the experts. In the revised VITAL action levels will be calculated from these reference doses based on the consumption of a specific product. Here, the choice of reference amount for the consumption is the responsibility of the producer. Hence, if a company chooses to use VITAL, the risk management strategy for allergens will become more evidence based and the risk management will include the latest scientific insights regarding allergen risk assessment. [Additional information on the TNO activities on allergen risk assessment] W.M. (Marty) Blom TNO, The Netherlands

Related References Schematic presentation of probabilistic risk assessment

Spanjersberg MQI et al. (2007) Risk assessment and food allergy: the probabilistic model applied to allergens. Food and Chemical Toxicology 45, 49–54 [Abstract] Kruizinga AG et al. (2008) Probabilistic risk assessment model for allergens in food: sensitivity analysis of the minimum eliciting dose and food consumption. Food and Chemical Toxicology 46, 1437 [Abstract] Madsen CB et al. (2009) Approaches to risk assessment in food allergy: Report from a workshop ‘‘developing a framework for assessing the risk from allergenic foods”. Food and Chemical Toxicology 47, 480 [Abstract] Spanjersberg MQI et al. (2010) Concentrations of undeclared allergens in food products can reach levels that are relevant for public health. Food Additives and Contaminants 27, 169 [Abstract]

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Spring 2012

News VITAL 2.0 - An Update In 2010 the Allergen Bureau commissioned a review of VITAL which included an examination of the risk assessment tool and the science that supported it. As a result, a full scientific review was initiated and the recommendations from the VITAL Scientific Expert Panel (VSEP) were released in November 2011. The VSEP was formed in collaboration between the Allergen Bureau (Australia & New Zealand), the Food Allergy Research & Resource Program (FARRP) of the University of Nebraska (USA) & the Netherlands Organization for Applied Scientific Research (TNO) to review data relating to levels of allergens that are likely to trigger an allergic response in sensitive individuals. The panel included Steve Taylor (FARRP, chair of Panel), Joseph Baumert (FARRP), Rene Crevel (Unilever), Geert Houben (TNO), Simon BrookeTaylor (Allergen Bureau consultant), and Katie Allen (Paediatric Allergist, Australia.) The Panel identified that sufficient new clinical oral challenge threshold data now existed (from published literature, unpublished clinical records in the Netherlands and Germany and partially completed FARRP studies), for the major allergens of concern, to allow the development of dose distribution

relationships using statistical modeling as described by Crevel et al (2007) Food Chem Toxicol 2007;45:691–701 [Abstract]. The derived dose response curves enable the identification of an eliciting dose of an allergen (EDp) at which a proportion of the allergic population (p) would be likely to react. The work of the VSEP is expected to be peer reviewed and published in 2012 however a summary of the expert panel findings is available at http://allergenbureau.net/downloads/ vital/VSEP-Summary-Report-Oct-2011. pdf. Levels were established for a range of allergens and are expressed as mg protein levels and referred to as Reference Dose Levels .They can be summarized as: Peanut 0.2; Milk 0.1; Egg 0.03; Hazelnut 0.1; Soy 1; Wheat 1; Cashew 2 (provisional); Mustard 0.05; Lupin 4; Sesame 0.2; Shrimp 10. It is critical to consider not only the levels determined but also the quantitative risk they represent and the quality of the database used to determine them. (Refer VSEP-Summary Report. Table One).

of the panel recommendations and as part of the overall review, the new VITAL process (VITAL 2.0) will utilize an interactive grid which relates to a Reference quantity of food consumed and the Reference Dose (in mg allergen protein). The grid has been remodeled to provide a two tier action level table to determine the requirement for precautionary labelling based on the outcome of a quantitative risk assessment. The Allergen Bureau is supporting a pilot phase to ensure stakeholders will be able access the VITAL Guidance document, new procedure and calculator and provide input and feedback before VITAL 2.0 goes live. Key manufacturing facilities are involved in the Pilot and feedback is being collated on the impact of VITAL 2.0. It is expected that once the feedback has been viewed and changes applied where appropriate, VITAL 2.0 will go live in April 2012. For further information please contact the Allergen Bureau on info@allergenbureau. net , or Robin Sherlock on robin.sherlock@ factaaustralia.com.au.

While the original VITAL grid presented protein levels in a 5 gm sample, as a result

Robin Sherlock FACTA, Australia

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Spring 2012

News Seventh Workshop on Food Allergen Methodologies - Report The 7th Workshop on Food Allergen Methodologies took place in Montreal, Canada from May 6-9, 2012. Health Canada, the Food Research and Resource Program (FARRP) and the Australian National Measurements Institute support this workshop, which has become a popular meeting, drawing government regulators, industry stakeholders, academics, food allergen method developers and scientists from around the world to discuss the latest developments pertaining to food allergens and food sensitivities. The morning of the first day comprised three presentations centred on gluten sensitivities. Peter Koehler of the German Research Institution for Food Chemistry spoked about the current perspectives and analytical challenges of gluten in food, which was followed by a talk on the current status of gluten measurement in Australia and a presentation on a gluten-free certification program from the Canadian Celiac Association. The final presentation of the morning described some progress towards allergen method standardization in Europe. The afternoon brought a full session on the alternative detection methodology of mass spectrometry. There were three presentations that showed how different techniques could be used to collect information on toxic gluten fragments in vitro and information on hydrolysed fragments of gluten in food and alcoholic beverages. The final two presentations showed the potential of mass spectrometry for screening multiple allergens in one assay with an example of milk and egg allergen in wine and multiple allergens in model food matrices. The second day brought the first ever “Industry Day” to the workshop and set a new attendance record. Presentations of specific interest to industry stakeholders

Workshop Organizing Committee (from left to right): James Roberts, Samuel Godefroy, Steven Taylor, Michael Abbott, Jean-Marc Gelinas, Terry Koerner, Joe Baumert. included recent updates on food allergen labelling in Canada and survey results on severe food allergies and potential demographic predictors for the Canadian population. Presentations on clinical thresholds, their use in industrial risk assessment and the VITAL system of food allergen action levels in Australia provided insight into the area of setting thresholds and action levels for food allergens. Other presentations included AOAC work in developing harmonized validation procedures for qualitative assays and another on how these methods could be used in allergen control programs. The remainder of the talks focused on a comparison of existing technologies for the detection of allergens and the latest developments from the major ELISA kit developers.

The final day of the workshop had presentations on the importance and need for continual validation of methods for Canadian enforcement purposes and efforts to harmonize allergen testing in Australia. The final presentations focused on the development of reference and incurred materials. The success of the 7th Workshop on Food Allergy Methodologies in Montreal was apparent in the record attendance and the lively discussions during and after each session. The workshop wrapped up with an announcement of the 8th workshop in Vancouver Canada in 2014. Terry Koerner Health Canada

Looking forward to meeting you in 2014 at the 8th Workshop on Food Allergens Methodologies. Stay tuned!

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Spring 2012

Analytical Insights Special Section on Gluten – Journal of AOAC International Jurisdictions around the world follow Codex Alimentarius and the recommendation to indicate if certain products are suitable for consumers with celiac disease. Since gluten is a very complex mixture of proteins and to date no single assay can truly determine the gluten content in food, it is essential to continue to strive for better and improved analytical systems. This special section (J. AOAC Int. 2012, 95, 2) describes the significant analytical progress that has been made and puts it in context of regulatory requirements. It allows food industry and enforcement bodies to make better risk assessment and management, ultimately for the benefit of the consumer. Bert Popping | Eurofins

Diaz-Amigo & Popping. Gluten— Current Status and New Analytical Developments in Support of the Regulatory Requirements. [Abstract]

Halbmayr-Jech et al. Characterization of G12 Sandwich ELISA, a Next-Generation Immunoassay for Gluten Toxicity. [Abstract]

Diaz-Amigo & Popping. Labeling Regulations, Detection Methods, and Assay Validation. [Abstract]

Haas-Lauterbach et al. Gluten Fragment Detection with a Competitive ELISA. [Abstract]

Rallabhandi. Gluten and Celiac Disease—An Immunological Perspective. [Abstract]

Bugyi et al. Development of Incurred Reference Material for Improving Conditions of Gluten Quantification. [Abstract]

Wieser & Koehler. Detoxification of Gluten by Means of Enzymatic Treatment. [Abstract]

Heick et al. Influence of sample extraction solutions on the detection of wheat proteins by mass spectrometry. [Abstract]

Girdhari. Immunoreactivity and Detection of Wheat Proteins by Commercial ELISA Kits. [Abstract]

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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 consensus-based 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] Find us on Facebook under AOAC Food Allergen Community Page 6