Newsletter Food Allergen Community

AOAC Food Allergen Community

NEWSLETTER Volume 4 | Issue 3

IN THIS ISSUE

Editorial Comment

Editorial Comment Christmas, time to reflect

1

News The Allergen Bureau

2

Eighth Workshop on Food Allergen Methodologies2 Food Allergy Labeling in Japan: Threshold Level and Supporting System for the Regulation

3

Call for papers

3

Research Highlights Comparison of ELISA test kit performance for analysis of cow’s milk and egg

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Selection of scientific manuscripts

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Detection of Residual Barley Gluten in Beer by Immunoassay and LC/MS 5

2013

Christmas, time to reflect

It’s Christmas time. Time for get together with family and friends. Time to slow down, time to reflect. Certainly the food allergen community had a very eventful and exciting year, with many new developments. The year started with FDA’s request for information for a potential food allergen threshold risk assessment and numerous methods updates (ELISA and mass spectrometry). It continued with FDA’s final definition of ‘gluten-free’ and a clarification of Health Canada’s position on highly refined oils derived from allergen sources. Later in the year we saw the new and long awaited guidance document on gluten validation, and last but not least the kick-off of the world’s largest food allergen project iFAAM. An eventful year so far! In this Christmas issue, we have some more and exciting news for you: clarifications on VITAL from the Allergen Bureau and new information on labelling in Japan. You will also learn about a new publication on the findings of a UK FSA-sponsored multi-laboratory study using clinical material as well as method comparison (immunoassay vs. LC-MS/MS) for gluten detection in beer. We hope you enjoy this new issue and wish you and your family a wonderful Christmas time and all the best for 2014! Bert Popping | Editorial Team Member

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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]

Page 1

NEWSLETTER Volume 4 | Issue 3

2013

News The Allergen Bureau The Allergen Bureau is an industry based stakeholder organisation that grew out of a recognised need to centralise information and resources to equip the Australian and New Zealand food industry to manage the challenges raised by legislative changes regarding allergen labelling. The Bureau was established in 2005 and became incorporated as a not for profit organisation in 2013. The role of the Allergen Bureau is to share information within the food industry to ensure that tools for best practise for allergen management and ongoing clinical data and research is made freely available, and to ensure that consumers are protected and receive relevant and consistent information regarding the allergen status of food. The membership of the Bureau is predominantly food production companies but includes analytical laboratories, and individual members. Information is made available to both members and nonmembers, in order to ensure access to the best and most current information is not restricted, but available to food companies of all sizes and complexities. While the organisation is an industry initiative, it has an open and supportive relationship with both federal and state government bodies in both Australia and New Zealand and consumer stakeholder groups. One of the key initiatives of the Allergen Bureau was to establish a working group to develop a consistent and science-based risk assessment process to consider allergen cross contact issues and establish criteria for the use of precautionary labels. The tool developed was VITAL ®, (Voluntary Incidental Trace Allergen Labelling) and was released in 2007. While many guidelines and support documents were developed internationally, VITAL® was unique in its proposal of science based action levels to guide the application of precautionary labelling for potential cross contact risk. After the establishment of the VITAL Scientific Expert Panel (VSEP), a critical review of action levels in 2011, and the publication of its findings:

Allen et al. (2013) Allergen reference doses for precautionary labelling (VITAL 2.0): Clinical implications. J. Allergy Clin. Immunol. (doi:10.1016/j.jaci.2013.06.042) [Abstract] Taylor et al. (2014) Establishment of References Doses for Residues of Allergenic Foods: Report of the VITAL Expert Panel. Food Chem. Toxicol. 63, 9-17. [Abstract] VITAL ® continues to prove itself to be a powerful tool for allergen risk assessment and management despite its voluntary status. Understandably this program has attracted a degree of interest internationally and was identified by a number of organisations as a positive step forward in this complex area. Many organisation have adopted some of the processes and features of the program but it is critical to remember that VITAL® was designed as a stringent science based program and any deviation from its structure or adjustment of levels, means that the full principles of the VITAL® risk assessment are not being applied. The enthusiasm of these organisations, which may claim association with the VITAL® tool, needs to be balanced with the very real risk of deviating from the science based levels. While the work of the VSEP indicates action levels that may in some cases strain the ability of current analytical methodologies for confirmation of VITAL® assumptions, it is important that analytical methods are informed by established clinical data, rather than modifying the action levels to conform to current methods. The work of the VSEP and its incorporation into VITAL® will, I believe, be pivotal at a time when the global food industry strives to establish internationally harmonised levels which protect the consumer. For further information regarding the VSEP, the Allergen Bureau and VITAL® please see http://allergenbureau.net/ and the Food Allergen Community Newsletter Vol 3. Issue 2. Robin Sherlock | Allergen Bureau, DTS FACTA

Eighth Workshop on Food Allergen Methodologies Vancouver (Canada), May 5-8, 2014 Health Canada and FARRP are co-organizing the Eighth Workshop on Food Allergen Methodologies. This workshop will be taking place at the Sheraton Vancouver Wall Center Hotel in Vancouver, British Columbia (Canada) on May 5-8, 2014. These workshops are always very informative and provide opportunities for discussion and networking with others who share an interest in food allergens and particularly allergen detection methods. Additional information and registration will be soon available. More information »

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NEWSLETTER Volume 4 | Issue 3

2013

Food Allergy Labeling in Japan: Threshold Level and Supporting System for the Regulation Food allergy labeling started in Japan in 2002. At present, the labeling of egg, milk, wheat, buckwheat, peanut, shrimp/ prawn, and crab, which are referred to as “specific allergenic ingredients”, is mandatory by Cabinet Office Ordinance. Also, the Consumer Affairs Agency notification recommends the labeling of another 20 ingredients. Two of these, cashew nuts and sesame seeds, were newly added to the list in September 2013. The threshold dose for an allergic reaction is often considered to be zero. However, zero tolerance for the offending food would create enormous practical problems for the food industry. When the labeling system was first discussed, the Japanese government (Ministry of Health, Labour and Welfare; MHLW) organized two groups to consider the implementation of the system. From the viewpoints of clinical facts and practical feasibility, the labeling study group stated that “if more than a few micrograms of allergenic protein per gram of food are present, labeling of that allergen is necessary”. The detection method study group presumed that the limits of detection for ELISA and PCR are generally 0.1–1 and 5 μg protein/g food, respectively. Considering these factors, MHLW designated 10 μg allergenic protein/g food as the threshold in monitoring food allergy labeling.

The Japanese official methods for the detection of specific allergenic ingredients consist of screening and confirmation tests. For the screening test, two or three kinds of ELISA kits with the same reference materials are used for each ingredient. For the confirmation test, western blotting and PCR are used. The practical tests to monitor food allergen labeling are performed by local government, with combination of the screening test, investigation of manufacturing records, and the confirmation test. As a result, if necessary, administrative guidance on correcting the labeling is issued. It has been 11 years since the food allergy labeling system was introduced in Japan. The system has functioned with the common understanding that, in cases with very sensitive patients, the food allergy symptoms may develop upon ingestion of food containing the allergenic protein at a concentration