NEWSLETTER

AOAC Food Allergen Community

NEWSLETTER

Volume 2 | Issue 3

Summer 2011

Summertime To be or not to be? Time to relax or time to be alert? The heat has arrived to the northern hemisphere and with it the summer holidays and the well deserved time away from work. While this is time for many to relax, it is time to be more alert for those families with food allergic members. Restaurants, ice cream stands, summer parties... a whole world of uncertainties. To all our allergic friends: We wish you an uneventful summer and don’t forget to enjoy it! The Editorial Team of the AOAC Food Allergen Community Newsletter

IN THIS ISSUE

Editorial Comment

Editorial Comment The Essential Importance of Communication

1

Ask the Expert Michael Abbott

2

Spotlight Platform of Food Allergens in Argentina

3

News The Importance of Food Allergens in Turkey

3

Conferences and Workshops Kick off meeting: Validation Protocol for Gluten Immunoassays 4 AOAC Annual Meeting 4

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 [email protected]

The Essential Importance of Communication

Continuous improvement is not an individualistic aspect of life, it is rather a community achievement. Progress in human and animal life in all its levels cannot take place without communication. Communicating with clear objectives and built in trust and transparency is a very powerful tool to move forward and to avoid the always painful delays, especially when decisions or resolutions are of urgent need. The role of communication in decision making processes must be accompanied by negotiations skills and leadership, which include listening and flexibility for reasonably compromising. When communication is aimed to educate or to convey a risk or results (e.g. analytical or diagnosis), the message needs to be clear, transparent, unbiassed and with the understanding of the audience knowledge, situation and/or needs. In many occasions, the lack of the skills and attitudes described above may lead to distorsion of the reality, which typically ends up in misinterpretation and misunderstandings. Nevertheless, the AOAC Food Allergen Community, as continuation and expansion of the AOAC Task Force on Food Allergens, is a forum with a well established and healthy collaborative environment that has been able to achieve proposed goals thanks to the willingness of all stakeholders to communicate in harmony. This issue of the Newsletter brings articles that illustrate how effective communication at different levels can provide all the stakeholders the support they need to perform their duties. The ultimate goal of this communication network is to provide the allergic consumer with safe foods without compromising their food choices and nutritional needs. It is our pleasure to be in continuous communication with you! Carmen Diaz-Amigo Editor in Chief AOAC Food Allergen Newsletter

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NEWSLETTER Volume 2 | Issue 3

Summer 2011

Michael Abbott

Senior Evaluator Food Allergen and Intolerance Assessment Section Chemical Health Hazard Assessment Division Bureau of Chemical Safety, Food Directorate Health Canada Detection methods for food allergens and gluten are part of the tools to enforce the amended regulation. Since HC defines food allergens and gluten as any protein, modified protein or protein fraction from the list of food ingredients, do analytical tests need to provide results as concentration of “protein/s” or “food ingredient” in the product? It does not really matter whether an analytical test provides results as function of protein, allergenic protein, or whole commodity (food ingredient). It is normally a relatively simple matter to convert an analytical result from a concentration expressed as protein to a concentration expressed as whole commodity. In general, Health Canada looks for a response expressed in terms of soluble protein from the food allergen in order to perform a health risk assessment, for cases where undeclared food allergens or gluten are found in prepackaged foods. From the perspective of the food industry, they will generally be looking for non-detect results in order to validate their good manufacturing practices and cleanup procedures. Which analytical methods are used within the Canadian jurisdiction to enforce the allergen/gluten regulation (ELISA, MS, PCR)? Which analytical techniques does Health Canada envision to play a relevant role in the future for regulatory purposes? Which is the main analytical gap that, if resolved, would have higher impact in supporting the allergen regulation? The main analytical methods used for enforcement purposes in Canada are ELISA methods. There is also work being done to develop LC/MS/MS methods for allergen and gluten detection and characterization. LC/MS/MS offers a number of advantages such as the ability to identify specific proteins and the potential to detect hydrolyzed and fermented proteins or proteins that are otherwise modified by the production process for the food. On the downside, LC/MS/MS requires expensive equipment and highly trained operators and can require complicated extraction and cleanup techniques. Quantitation using LC/ MS/MS is also challenging. Progress in the area of method validation and the development of incurred samples (real life food commodities manufactured using a known amount of food allergens which can be used to gauge a methods performance on a specific matrix) will help support the enforcement of the allergen labeling regulations. Page 2

Is Health Canada contemplating the establishment of thresholds for food allergen labeling? There are currently no labelling threshold levels for allergens, except for sulfites and gluten. This situation will remain until we have a satisfying definition of management thresholds recognizing that total absence of risk is unattainable and that there are some important limitations with current routine methodologies (see above). For numerous reasons, not the least of which is the variability in threshold levels between allergic individuals, it is very difficult to set regulatory thresholds for labeling of food allergens. Cross contamination and precautionary “may contain” labelling are not covered by regulations, even though products can be subject to recalls if they contain undeclared allergens due to cross contamination during production. Why is this issue not addressed by regulations? It is true that the accidental presence of food allergens in a prepackaged product due to cross-contamination is not covered by the new labeling regulations in Canada. Lists of ingredients are designed to provide information to consumers about what ingredients were intentionally added during the production of the food. Food allergens or gluten that find their way into a food by way of cross-contamination were not intentionally added and therefore are not considered ingredients of the food. Like most western countries, Canada decided to separate labeling of ingredients from precautionary labeling about cross-contamination. In Canada, labelling of ingredients is covered by the Food and Drug Regulations, but there are no specific regulations dealing with cross contamination during production. Nonetheless, Section 5.1 of the Food and Drugs Act prohibits the sale of food that is labeled in a manner that it is misleading or unsafe (among other things). Because of this, food manufacturers of products which are cross-contaminated with food allergens or gluten have the responsibility to either eliminate the risk for crosscontamination or ensure that appropriate information is provided to consumers. Use of food allergen precautionary statements is a voluntary measure introduced in Canada years ago as a way for industry to warn allergic consumers about potential cross-contamination in their products. While it is not part of the new allergen labeling regulations, Health Canada has been reviewing its policy with respect to Precautionary Labelling and will be updating this policy in the near future.

NEWSLETTER

Volume 2 | Issue 3

Summer 2011

Spotlight Platform of Food Allergens in Argentina The Platform of Food Allergens was formally created in Argentina in April 2009. It is a multidisciplinary discussion forum formed by professionals from different government institutions such as the National Institute of Agricultural Technology (INTA), National Institute of Industrial Technology (INTI), National Institute of Foods (INAL); School of Pharmacy and Biochemistry (Buenos Aires University), School of Exact Sciences (La Plata University); members of the Argentine Allergy and Clinical Immunology Association and “Forum of parents of allergic children”, medical doctors from the Children’s Hospital “Ricardo Gutierrez”, and an important number of food national and international industry companies. The aims of the Platform, as a nonprofit organization, are: • To anticipate future demands, since this issue is still a vacancy in Argentina. • To act as a link among institutions of health, science, and technology; the industry; the general population; and control organizations • To provide information related to analytical, regulatory and safety issues, good manufacturing practice and health concerns. • To train and qualify the different actors (manufacturers, distributers,

suppliers, consumers, physicians, professionals connected to regulatory norms researchers, technologists, etc.) related to these subjects • To provide the food allergic population with information and guarantees at the time of the selection of foods in order to protect their health. • To provide the food industry with information and guidance for the management of food allergens.

4. “Clinical Topics of Food Allergies” focused on: Epidemiology in Argentina, Diagnostic, Treatment and Prevention, and Forum of Food Allergy (Group of parents whose children suffer from food allergens)

In order to achieve these challenges, the platform was organized in four working groups: 1. “Management of Food Allergens in the Food Industry” focused on: Product development, Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), Training and audits and Validation of Cleaning Programs 2. “Detection Methods of Allergens in Foods”, focused on: Analytical methods for allergen detection and quantification: evaluation and application, Research activities and information regarding commercial kits for allergen quantification 3. “Regulatory framework of Food Allergens” focused on National and International Regulations, Training for the Industry and the Consumer, and Labeling for Food Allergens

Some of the activities carried out by the Platform are: • Response to government public consultation regarding the labeling of food allergens (2009) • Proposal for the revision of GMC 26/03 Resolution “MERCOSUR Technical Regulation on labeling of packaged foods” (2010) • Lecturing of technical courses, seminars and workshops to the food industry and national institutions related to food or health • Application and evaluation of different ELISA techniques for the detection of food allergens • Lecturing in national and international events María Cristina López Instituto Nacional de Tecnología Industrial, Cereales y Oleaginosas Argentina

These four groups work independently and also in mutual collaboration, in order to cover the entire spectrum of requirements.

News The importance of food allergens in Turkey Turkey is a European Union applicant country which takes protection of allergic consumers very seriously. Halk Ekmek, with 1.3 billion breads per day Ankara’s largest bakery, recently hosted a Food Scientists Training (FST) on allergen management and detection. The FST was organized by the European Commission project MoniQA, jointly with ELISA kit companies and the Hacettepe University in Ankara. Halk Ekmek produced incurred, allergen containing, bread samples in their pilot plant which were subsequently detected by swabs/LFD and ELISAs. The training course was very well attended by food industry, especially QA managers and some students. The event also caught attention of media and Prof. Hamit Köksel (Hacettepe University), Dr. Anton Alldrick (Camden BRI) and Dr. Bert Popping (Eurofins) were asked to join a 75 min live program on the national television station TRT to report about their experiences with allergen management in Europe. Bert Popping, Eurofins

Interview during the TV program bu topragin sesi on Turkish National TV Channel TRT Anadolu. In the image (from left to right): Umut Ötdil (TRT Anadolu), Prof. Hamit Köksel (Hacettepe University), Dr. Anton Alldrick (Campdem BRI), and Dr. Bert Popping (Eurofins)

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NEWSLETTER Volume 2 | Issue 3

Summer 2011

Conferences and Workshops Kick off meeting to discuss the Validation Protocol for Gluten Immunoassays Work has started on the 2010-12 commitment of the AOAC Food Allergen Community to develop a guidance document on the validation of Gluten Methodologies. A stakeholder engagement event took place on July1st, 2011, in Frankfurt, under the leadership of the AOAC Food Allergen Community and the MoniQA network of Excellence. The meeting allowed to

receive valuable input from Prof. Peter Koehler, representing the Prolamin Working Group, as well as engagement of the European Celiac Society, on current needs and challenges related to Gluten testing. To continue this work, the community is planning a second meeting for analytical experts during the week of August 22, in Ottawa, ON Canada, hosted by Health Canada’s Food Directorate. Members of the community interested in this meeting are requested to mark your

calendars for that week and to monitor information to be made available on the AOAC Allergen Community Facebook page, for more details. We are hoping for some progress on Gluten method validation protocols by the next AOAC annual meeting in New Orleans. Important: For those interested in attending the meeting, please send an e-mail to [email protected] to receive updates (final date and location) about the meeting.

AOAC Food Allergen Community Newsletter

rk Ma dar !!! You can contribute with articles or news items Submission deadline for the October 2011 issue: Sept. 2, 2011 len r ca

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Send your articles to [email protected]

Food Allergen Sessions & AOAC Food Allergen Community Meeting - 125th AOAC Annual Meeting and Exposition New Orleans, Louisiana (USA), September 18-21, 2011 To meet our Community needs, the Allergen Community has organized three scientific sessions on appropriate use of gluten reference material, MS approach for multi-allergens analysis, and importance of validation of cleaning procedure in a food manufacturing facility. Moreover, there will be a poster session on food allergens on Tuesday You can find additional information on the following links: • AOAC Annual Meeting - Main site • Scientific Sessions • Poster Sesion

MONDAY, SEPTEMBER 19, 2011 Roundtable on Comprehensive Screening for Food Allergens in One Shot: Just a Nice Dream or a Feasible Project? Chair: Terry Koerner, Health Canada Speakers: Bert Popping, Eurofins Scientific Group; Petra Silke Lutter, Nestle Research Center; Terry Koerner, Health Canada; Steve Lock, AB SCIEX; Antonietta Gledhill, Waters Corporation; Mark Ross, U.S. Food and Drug Administration; Franz Ulberth, European CommissionInstitute for Reference Materials and Measurements. Roundtable on What Do You Mean You Can’t Clean It? Validation of Allergen Sanitation SOP in Food Establishments Chairs: Samuel Godefroy, Health Canada and James Roberts, National Measurement Institute, Australian Government.

Speakers: Joseph Boumert, FARRP, University of Nebraska - Lincoln, Laure Jackson, US FDA, Thomas Holzhauser, Paul-Ehrlich-Institut, Germany. Allergen Community Meeting The meeting is scheduled on Monday after the scientific sessions. Come to the meeting, get involved, be part of the solution, and shape the future. TUESDAY, SEPTEMBER 20, 2011 Reference Materials for Food Allergens… Heaven Must Wait? Co-Chairs: Carmen Diaz-Amigo, Eurofins CTC and Jupiter Yeung, Nestle Nutrition Speakers: Franz Ulberth, European Commission-Institute for Reference Materials and Measurements; Reiko ADACHI, National Institute of Health Sciences; Joyce Boye, Agriculture and Agri-Food Canada; Bert Popping, Eurofins CTC.

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 4