04/10/2016

Professor Clare Mills

Food allergies present everyday problems for allergic consumers and food companies alike. Sometimes it seems we simply have to come to terms with these problems and manage them on a daily basis. However, revolutionary scientific work is being carried out behind the scenes that aims to help food companies radically improve their management of allergens with the ultimate aim of protecting consumers at risk.

This article is intended to summarise some of those projects.

Data collected by the EU-funded EuroPrevall project – which looked at the patterns and prevalence of food allergies across Europe and beyond – are now being utilised in a global, EU-funded venture called iFAAM*. The intention is to develop evidence-based approaches to improve the control of allergens by the food industry and also help patients cope better.

Briefly, the aims of iFAAM are:

• To develop evidence-based risk management approaches for food allergens in the food chain
• To better understand analysis of allergens in the food chain and improve the interpretation of test results
• To develop a food allergy knowledge base that ultimately seeks to provide a way forward for the application of precautionary allergen labels. A key outcome would be that phrases on food labels would clearly communicate the degree of risk that low levels of allergens may pose to consumers.

The project’s partners also hope to obtain the scientific evidence necessary to provide recommendations on the introduction of allergenic foods into infants’ diets in order to prevent the development of food allergies later in their lives.

1. Evidence-based risk management approaches for food allergens in the food chain

Most allergen exposures occur in one of two ways: either the consumer makes a mistake and eats a food they should avoid; or a manufacturer or other food supplier fails to manage allergen handling properly and a food expected not to contain an allergen contains enough to trigger an allergic reaction.

There are many anecdotal reports of how people with allergies experience reactions in the community but until now, a systematic approach to studying them has not been widely undertaken.

Working with patient organisations such as the Anaphylaxis Campaign, DAAB in Germany and Anaphylaxis Ireland, iFAAM is systematically collecting details on the reactions experienced by allergic patients in Ireland (AlleRisc) and the UK (AlleRic). Where possible food samples have been collected and analysed for the presence of undeclared allergens.  The study is due to be completed in the coming months and is now being rolled out to other European countries such as Germany.

iFAAM acknowledges that in practice it is not possible to exclude allergens completely from foods otherwise free from a particular allergenic ingredient when shared facilities and processing lines are used. As a result allergen management strategies need to focus on how much residual allergenic ingredient can be tolerated in such foods.  An excellent body of research on how much of an allergenic food is required to cause a reaction is now available for foods such as peanut. These data are being used to build population-level dose distribution models which can predict the dose at which, for example, five per cent of the allergic population (known as the ED 05) might react.  The ED05 level of allergen is thought to combine a good level of patient safety.

The ED05 level is being verified in the iFAAM project for three allergenic foods: hazelnut, egg and milk. Using a study design implemented to validate the ED05 values for peanut, patients are given the allergenic food in a single portion of chocolate dessert. Data from these studies are encouraging and promise to provide a means of validating any dose level chosen that is considered generally safe for the food allergic population.

The amount of allergen eaten by a person with a food allergy is not the only factor that can impact on severity of the reaction. Through a set of integrated studies the iFAAM project is seeking to investigate how the food matrix and medication, such as antacids, may alter a patient’s reactivity to foods through clinical studies undertaken in Switzerland (Zurich), Spain (Madrid) and the UK (London and Manchester). These data will be used to assess whether these factors do indeed need to be taken into consideration in the risk assessment process and contribute to identifying safe allergen doses.

2. Analysis of allergens in the food chain.

In the iFAAM project analytical tools are being developed for allergen analysis which target biologically relevant molecules known to cause allergic reactions, using foods with a defined allergenic activity. Ensuring such “clinical relevance” will aid interpretation of test results which play such a critical role in food allergen management and help to support food allergic consumers to avoid problem foods.  It will also help to provide analysts with much-needed quality control samples which have the potential to be developed into properly-validated reference materials in the future.

The methods include tests suitable for in-factory analysis (e.g. immuno-based) and confirmatory in-laboratory tests (e.g. mass spectrometry-based) for peanut, hazelnut, walnut, egg and milk.

Processing-induced changes to allergens (for example, heat-induced chemical modifications) and the food matrix may alter the allergenicity of food proteins. It can also modify the effectiveness of extraction and detection methods used for allergen determination. These factors are being taken into account in iFAAM so that the analytical methods being developed are robust and suitable for use in a number of different food matrices such as chocolate and baked goods such as cookies.

As part of this activity an inter-laboratory comparison of both immunoassay and mass spectrometry methods is being undertaken, involving analytical laboratories from Europe, the USA, Australia and Japan. This initiative is also supporting the harmonisation of reporting units, since allergen risk assessment is undertaken using a measure of protein – the component in foods that causes allergies – rather than on a commodity basis.

3. The development of a food allergy knowledgebase

The project involves a comprehensive risk analysis of food production, which takes into account all the components in the food supply chain from the raw materials to the finished products, and including manufacturing and processing steps.

In order to take account of variations in portion size, the iFAAM risk assessment builds on food consumption data collected from individual allergic consumers.

The project leaders hope that knowledge gained from this part of iFAAM’s work will lead to a transparent way forward for the application of precautionary allergen labels and will seek to ensure phrases on labels clearly communicate the level of risk that low levels of allergens may pose to consumers.

*iFAAM stands for the Integrated Approaches to Food Allergen and Allergy Risk Management. The €9million project involves the world’s leading experts in the UK, Europe, Australia and US. Together they mark the biggest study of food allergy in the world. The project leader is Professor Clare Mills, of the Institute of Inflammation and Repair and Manchester Institute of Biotechnology, Manchester Academic Health Science Centre, University of Manchester.

Reference

Methods for managing allergens in food production: advances from the global iFAAM project. E. N. Clare Mills¹, K. Beyer², L. K. Poulsen³, S. Taylor⁴, S. Baumgartner⁵, R.W.R. Crevel⁶, S. Schnadt⁷, R van Ree⁸

 ¹Institute of Inflammation and Repair and Manchester Institute of Biotechnology, Manchester Academic Health Science Centre, University of Manchester, 131 Princess Street, Manchester M1 7DN, UK; ²University Children’s Hospital Charité of Humboldt University, Berlin, Germany; ³Allergy Clinic, Copenhagen University Hospital, Gentofte, Denmark; ⁴Food Allergy Research and Resource Program, Department of Food Science and Technology, University of Nebraska-Lincoln, Lincoln, USA; ⁵ Universität für bodenkultur, Vienna, Austria; ⁶SEAC, Unilever Colworth, Sharnbrook, UK; ⁷Deutscher Allergie- und Asthmabund, Mönchengladbach, Germany; ⁸Academic Medical Centre, Amsterdam, The Netherlands.

Consumers in 16 countries, including the UK, provide insights into views on allergen thresholds and purchasing habits

Results of the first-ever international survey on perceptions of food allergen thresholds and consumer habits surrounding precautionary labeling were published online in Allergy, the journal of the European Academy of Allergy and Clinical Immunology (EAACI). The study, spearheaded by Food Allergy Research & Education (FARE), Food Allergy Canada (formerly Anaphylaxis Canada), and others, were presented at the EAACI Congress in Vienna, Austria this week.

This study is the first to examine differences in the international food allergy community’s perceptions about thresholds (the lowest amount of a food allergen that can elicit a reaction) and precautionary labeling from the perspective of consumers in 16 countries. Results show that in most countries, the vast majority of individuals managing food allergies would still not buy foods that contained an allergen, even if the amount were reliably determined to not cause an allergic reaction per validated allergen thresholds.

Neither the U.S. nor Canada has established allergen thresholds. Precautionary labeling – often seen as a “may contain” statement – warns consumers about the potential for a food product to contain trace amounts of an allergen due to shared equipment lines or other manufacturing practices. This type of labeling, which is voluntary, is widely used across the manufacturing industry.

“Families and adults managing food allergies face a number of challenges in their daily lives, not the least of which is finding safe foods to eat, and relying on accurate ingredient labels,” said James R. Baker, Jr., MD, CEO and chief medical officer of FARE. “This is an important topic among stakeholders in the community, and FARE has led efforts to ensure that the consumer’s perspective on this issue is heard and understood.”

FARE has recommended to the U.S. Food and Drug Administration (FDA) that it not establish a threshold for any food allergen unless the FDA is in possession of reliable scientific data that clearly identifies a quantity of the allergen that is so small that it will not cause an allergic reaction in even the most sensitive individuals, and also a reliable analytical method for determining compliance with the threshold that can be easily used by food companies and the FDA.

FARE and Food Allergy Canada facilitated the distribution of the consumer survey to 14 other countries: Australia, Chile, France, Germany, Ireland, Israel, Italy, Japan, Mexico, New Zealand, South Africa, Spain, the Netherlands and the United Kingdom. Surveys were conducted between February 2013 and April 2014. Nearly 10,000 people managing food allergies participated in the survey, which was translated into eight languages and posed hypothetical questions about thresholds.

“We will continue to work together with other countries to enhance our educational efforts to ensure that consumers are making informed choices,” said Laurie Harada, executive director of Food Allergy Canada.

“Many families surveyed did not understand that precautionary allergen labeling statements do not correspond with the likelihood of a potential allergen in a food and that these labels are voluntary and at the manufacturer’s discretion,” said Ruchi Gupta, M.D., MPH, study co-author, of Northwestern University’s Feinberg School of Medicine. “Similarly, it was difficult for families to understand the meaning of thresholds and how they may potentially make an impact. It’s clear that we need more consistency and transparency in labeling that correspond to a demonstrable level of risk in consuming these foods and allergen amounts that may occur through cross-contact.”

Among the study findings:

• Less than 20 percent of participants in 11 of 16 countries reported they would be willing to purchase foods containing their allergen if the amount would be incapable of causing an allergic reaction. Respondents in Italy were least willing (14 percent) and in Japan were most willing (44 percent).
• An average of 3 percent of participants across the board reported they would purchase a food containing their allergen if it was capable of only triggering a mild
• Consumers seemed to assess risk based on the wording of the precautionary warning –
  • About 16 percent of participants reported they would be willing to purchase foods with the “may contain allergens” label (respondents in South Africa reported the highest rate – 53 percent – and Spain reported the lowest rate – 6 percent).
  • When asked whether they would buy a food labeled “may contain traces of allergen,” the weighted average rate of affirmative responses was slightly higher (25 percent).
  • When asked whether they would buy a food with the label “manufactured in a facility that also processes allergen,” the weighted average rate of affirmative responses was the highest – 41
• Peanut was the most common allergen reported in nine of 16

The authors note that previous studies analyzing the content of allergens in products with precautionary labeling have shown there is little correlation between the amount of allergen present in a food product and the type of precautionary statement that is used. A study published in 2010 in the Journal of Allergy and Clinical Immunology analyzed a number of U.S. products with precautionary labels for milk, peanut and egg. Ten percent of these products contained milk, 4.5 percent contained peanut and 1.8 percent contained egg, respectively.

More work continues to be done in the area of food allergen thresholds. In the meantime, consumers throughout the world report confusion about precautionary statements. FARE has previously documented that U.S consumers continue to take risks when buying such products.

The study published this month advocates for the inclusion of consumers in discussions around standardisation of precautionary statements and validated allergen thresholds.

“Through its Patient Organisation Committee, EAACI has long advocated to ensure the patient voice is present and heard,” said Antonella Muraro, president of EAACI. “We were very pleased when leaders of patient organisations developed and completed this global survey to help inform research on a complicated but important issue and look forward to supporting future collaborations on this and other advocacy priorities.”