Newsletter Food Allergen Community - focos

AOAC Food Allergen Community

NEWSLETTER Volume 5 | Issue 3

IN THIS ISSUE

Editorial Comment

Editorial Comment Trick or Treat?

1

News An Update of the FALCPA Petitions and Notifications Guidance 2 AOAC Food Allergen Community Working Group on Sampling

3

AOAC Call for Scientific Sessions - Food Allergen Community 3 European Regulation (EC) 1169/2011 3 Health Canada’s Food Directorate and FARRP organise their 8th Workshop on Food Allergen Methodologies – May 2014 4

Research Highlights Selection of scientific manuscripts

Save

2014

5

Print

This is an interactive document optimized to be viewed with Adobe Reader. All hyperlinks built in the text appears in green color.

Trick or Treat? It’s Halloween time! Kids knock on your door to ask for sweets. Chocolate, caramels and more. What if one of those kids was nut allergic and asked for milk chocolate. Would you be comfortable to give a bar? Or is there still a risk that your milk chocolate bar contains also nuts? What is the chance that one milk chocolate bar contains traces of nuts, but not the others from the same production batch? That brings us to one topic of this newsletter: Sampling. Would we be able to find traces of nuts if we got our sampling procedures right? What are the appropriate sampling procedures for allergen samples? We do not know yet. But we do know that industry and enforcement authorities urgently need those. So we started a new Working Group to develop appropriate, yet easy to understand and implement sampling procedures. And there is more to find in this issue: Steven Gendel provides an interesting update on the FALCPA Petitions and Notifications Guidance - and their success rate; and if you were unable to attend the Health Canada/FARRP Allergen workshop in Vancouver, you will find Samuel Godefroy’s summary and highlights article interesting. In this issues you also find a reminder that in Europe the Consumer Information Regulation will apply from 13 December - with links to relevant sources; and last but not least: the call for scientific sessions for the 129th AOAC International Meeting in Los Angeles. 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]

Page 1


2014

News An Update of the FALCPA Petitions and Notifications Guidance In the US, the Food Allergen Labeling and Consumer Protection Act (FALCPA) defined the major food allergens (milk, egg, peanut, tree nuts, soy, fish, crustacean shellfish, and wheat) and specified how to declare the presence of these major food allergens, or of ingredients that contain protein from one of them, on the food label. FALCPA also recognized that an ingredient derived from a major food allergen might not pose a risk for allergic consumers, particularly if the allergenic proteins are removed, modified or degraded. These ingredients can obtain exemptions from the allergen labeling requirements through either a petition or notification process. The standard for evaluating petitions is that the ingredient “does not cause an allergic response that poses a risk to human health” and the standard for evaluating a notification is that the ingredient “does not contain allergenic protein.” Both processes also include consideration of the way that the ingredient is manufactured. Since FALCPA went into effect, the FDA has received 3 petitions and 8 notifications. Of these, we were able to approve one notification and part of one petition (technically, we did not object to that one notification.) Given the extensive effort that goes into preparing a submission and in evaluating the submissions, we realized that it would be helpful for both the submitters and the agency reviewers to prepare guidance on what to include in a submission. The first step in that process was to issue draft guidance in February 2014. That draft guidance, which is available on the FDA web site, described the data and information that we need to evaluate whether

Subscribe to our FREE Newsletter We are pleased to welcome you as a reader and contributor for future issues

an ingredient meets one of the exemption standards. We received public comments on that draft, and are in the process of using those comments to help prepare and publishing a final guidance. Once the final draft has completed agency clearance, it will be posted to the FDA web site and a notice of availability will be published. One of the goals of our guidance was to provide maximum flexibility to submitters within the statutory framework. We recognize that there is no “one size fits all” approach to developing or evaluating data that can be used to support a submission. We also recognize that it would not be appropriate to be highly prescriptive about the methods that should be used to characterize each ingredient. Ingredient manufacturers have extensive expertise in determining which analytic methods work best in each case. Instead, we asked that submitters explain how they obtained the data and how they ensured that the analytic methods were properly controlled and had sufficient precision. Beyond the details of the guidance, it is important to realize that FDA encourages potential submitters to talk to us before preparing a petition or notification. This dialogue helps to ensure that a submitter understands what the agency needs to carry out an evaluation and that the process can be completed efficiently. FDA Website » Steven M. Gendel | US FDA / CFSAN

Would you like to receive the newsletter directly in your mailbox? Click on the “Subscribe” button OR scan the QR Code (you need to have a QR scanner installed in your phone). Once you are subscribed, you will start receiving future issues of the newsletter.

SUBSCRIBE (Click here)

This newsletter is a public document and can be distributed. Partial reproduction is permitted with the proper indication of the author and its source. For questions contact us at [email protected].

Page 2


2014

AOAC Food Allergen Community Working Group on Sampling Allergen testing allows us to make informed decisions. The credibility of these decisions is impacted by the reliability and the uncertainty of the measurements. It is well known that the greatest source of variability in allergen testing results is improper sampling, regardless of the testing method or test kit being used. Previously, it has been identified that over 96% of the total variance or “error” associated with peanut testing in energy bars can be attributed to sampling and subsampling steps. It is clear therefore that appropriate steps must be taken to reduce the uncertainty resulting from sampling. At the recent AOAC meeting in Boca Raton, the development of a sampling guidance document was suggested as an objective for the Allergen Community. Working towards this goal, a working group, co-chaired by Dr. Laura Allred and Dr. Bert Popping, is taking shape. The goal of the working group is to prepare and publish user-friendly guidance document(s) that directly apply to bulk and attribute sampling in shared lines, during allergen-free

129th AOAC Annual Meeting & Exposition

European Regulation (EC) 1169/2011

manufacturing, during laboratory sub-sampling, and during audits. The document aims to assist the following stakeholders: 1) manufacturers who may be testing their incoming bulk raw materials or packaged finished products, 2) laboratories who receive raw materials or finished product from which they take sub-samples and/or analytical samples, and 3) regulators and auditors who do site visits or take retail samples from store shelves for verification of allergen-free claims.

From 13 December 2014 food companies will have to comply with the new rules on food allergen labeling described in the Regulation (EC) 1169/2011. All previous directives and amendments dealing with food allergen labeling are now incorporated into this Regulation. This Regulation does not only apply to prepacked food but also, as a novelty, non prepacked foods. It also promote better label legibility by defining the minimum font size as well as highlight allergens in the ingredient list.

We believe, together as a community, we can provide an allergen sampling guidance document that can be used with confidence. We therefore invite you to submit ideas and experiences with sampling issues for the working group to consider. Make sure your voice is heard. We know when we have better information, better things happen. You can submit your experiences and suggestions to [email protected] and [email protected].

In support to food companies, several organizations have made available a number of documents and resources. The following is a selection of this information: FSA Resources » BRC Guidance on Allergen Labeling »

Jupiter Yeung, Carmen Diaz-Amigo Laura Allred, Bert Popping

Food Drink Europe Guidance »

AOAC Call for Scientific Sessions - Food Allergen Community What to include in the submission:

The call for scientific sessions for the 129th AOAC Annual Meeting and exposition is now open.

Community to which you are

Are you interested in organizing a session? Do not hesitate to prepare a proposal and submit it to AOAC for evaluation.

Deadline for Submission: December 9, 2014 September 27 - 30, 2015 Westin Bonaventure Hotel Los Angeles, California USA www.aoac.org

More Information »

Submit proposals to: [email protected] Formats:

Scientific Session Roundtable Workshop

submitting (e.g. Food Allergens) Scientific session title Abstract of the scientific session Individuals participating on the session: names, affiliations, and email addresses (Chair and Speakers for a symposium, Chair and Participants for a roundtable or a workshop) Your name, affiliation, phone number, and e-mail address

Additional information »

Page 3


2014

Health Canada’s Food Directorate and FARRP organise their 8th Workshop on Food Allergen Methodologies – May 2014 From May 5th to May 8th 2014, Health Canada’s Food Directorate and the Food Allergy Research and Resource Program (FARRP) of the University of Nebraska held the 8th session of their Food Allergen Methodologies Workshop. This workshop has pursued the ambition of becoming the hub of the food allergen analytical community, thanks to the enhanced partnership between FARRP and Health Canada’s Food Directorate. It also leveraged the increased structure and collaboration amongst the Food Allergen Analytical community members, whether be it under the auspices of the Association of Official Analytical Communities (AOAC), or partnerships developed under other research and science initiatives, undertaken nationally or internationally, particularly those supported by the European Union.

In a region (Asia-Pacific) where over half of the international food trade is concentrated, it is important that more work be done towards enhanced convergence of regulatory requirements governing the management of existing and emerging food safety hazards, such as food allergens, in alignment with Codex standards, Codex risk analysis principles and science driven decision making. The Government of Canada has recommended that this capacity building initiative under the APEC Food Safety Cooperation Forum pursue the following objectives:

to raise awareness of good (allergen management-related)

Over 10 years have passed since the organization of the first HC/FARRP Allergen Workshop in October 2003 in Ottawa, ON. Canada. The need for such a venue as an opportunity to exchange information on developments of food allergen methods in relation with progress in food allergy research and/or food allergen labelling requirements by governments as well as management of these hazards by the food industry continues to be steady. Maintaining our support to the organization of this workshop is also a way for Government of Canada agencies to deliver on the commitment that we should facilitate access to the latest developments in food allergen control practices, to our domestic stakeholders and equip them with the best tools to support their preventive control measures.

manufacturing processes to build competencies in laboratory analysis of priority allergens for both industry and government oversight to build regulatory convergence associated with labelling of priority allergens, and to share and align responses to improper labelling and poor manufacturing processes associated with food allergens. An additional day was added to the allergen methodologies workshop’s traditional program to ensure that more background on food allergies and issues associated with food allergen management be provided to first time participants and colleagues from the APEC economies who joined the workshop. More information on the workshop and its program is available through this link: http://farrp.unl.edu/wat/foodallergen-methodologiesworkshop

This year’s workshop had an additional objective to serve as an opportunity for capacity building through the Asia Pacific region for allergen management, with a focus on allergen detection methods.

Based on the feed-back received to date, it seems that the objective to enhance awareness of participants about the challenges associated with allergen management in food production was achieved.

The Government of Canada made this suggestion to the Asia Pacific Economic Cooperation (APEC) Food Safety Cooperation Forum, during its 4th meeting hosted by the Government of Indonesia in Surabaya, in April 2013. This suggestion received an overwhelming level of support from APEC economies. This year’s allergen workshop saw the added participation of colleagues from the United States, Mexico, Peru, Chile, Malaysia, Thailand, Japan, Indonesia, Vietnam, China, Papua New-Guinea, Australia and New-Zealand, Brunei and the Philippines to cite a few.

No doubt that more needs to be done to maintain a momentum for a number of years and further invest in capacity building in the Asia-pacific region, if we are to reach the goals set in 2013 and to enhance the protection of Food Allergic Consumers in this region and beyond. The Health Canada / FARRP Food Allergen Methods workshops will likely constitute an excellent venue for this purpose in the years to come.

During the 2013 Surabaya meeting, the Government of Canada raised the fact that food related adverse reactions, associated with poor labelling of food allergens or poor manufacturing practices continue to be a growing source of food recalls, both for products made domestically or imported.

Thank you to all those – organizers, speakers, contributors, sponsors and participants- who made the success of this 8th session of the workshop. A special acknowledgement goes to the APEC Food Safety Cooperation Forum for enabling this success. Samuel B. Godefroy | Health Canada

Page 4


2014

Research Highlights Selection of scientific manuscripts Hattersley et al (2014) Advances in the risk management of unintended presence of allergenic foods in manufactured food products – An overview. Food and Chemical Toxicology 67, 255-261 [Abstract] Murano et al. (2014) EAACI Food Allergy and Anaphylaxis Guidelines. Protecting consumers with food allergies: understanding food consumption, meeting regulations and identifying unmet needs. Allergy 69(11), 1464-72 [Abstract] Crevel et al (2014) Translating reference doses into allergen management practice: challenges for stakeholders. Food Chem Toxicol 67, 277-87 [Abstract] Entink et al (2014) Food allergy population thresholds: an evaluation of the number of oral food challenges and dosing schemes on the accuracy of threshold dose distribution modeling. Food Chem Toxicol 70, 134-43 [Abstract]

Lock (2014) Gluten Detection and Speciation by Liquid Chromatography Mass Spectrometry (LC-MS/MS). Foods 3, 13-29 [Article]

Luber et al (2014) Comparative assessment of DNA-based approaches for the quantification of food allergens. Food Chem 160, 104-11 [Abstract]

Allred et al (2014) Evaluation of Qualitative and Quantitative Immunoassays To Detect Barley Contamination in Gluten-Free Beer with Confirmation Using LC/MS/MS. J AOAC Int. DOI 10.5740/jaoacint.14-058 [Abstract]

Palle-Reisch et al (2014) Development and validation of a duplex real-time PCR assay for the simultaneous detection of three mustard species (Sinapis alba, Brassica nigra and Brassica juncea) in food. Food Chem 153, 66-73 [Abstract] Holzhauser et al (2014) Matrixnormalised quantification of species by threshold-calibrated competitive realtime PCR: allergenic peanut in food as one example. Food Chem 163, 68-76 [Abstract]

Fiedler et al (2014) Characterization of grain-specific peptide markers for the detection of gluten by mass spectrometry. J Agric Food Chem 62(25), 5835-44 [Abstract]

Sharma et al (2015) Gluten detection in foods available in the United States - A market survey. Food Chem 169, 120-6 [Abstract]

Monaci et al (2014) Multi-allergen detection in food by micro highperformance liquid chromatography coupled to a dual cell linear ion trap mass spectrometry. J Chromatogr A 1358, 136-44 [Abstract]

AOAC Food Allergen Community Newsletter

Ma

You can contribute with articles, news items or suggestions. Submission deadline for the 1st Issue of 2015: January 30, 2015 Send your articles to [email protected] 99 Regulatory Updates 99 Food Industry Initiatives 99 Regional developments 99 Your research

rk y

our

cal

end

ar !

!!

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 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]

Page 5