Food Allergy

Better assessment and management of food allergen risks to protect people with food allergies

Background

Food allergies are of high and growing importance to public health, affecting consumers’ quality of life and the demand for health service resources. Evidence is growing that this impact extends to the global level as developing countries adopt a ‘Western’ lifestyle. Minimising the risk from allergenic foods is a shared responsibility of all stakeholders (e.g. patients, clinicians, risk assessors, food producers, retailers, caterers and regulators).

Upcoming

The task force is currently considering several topics to address:

  • developing guidance to help define what should be a regulated allergen;
  • reviewing the issue of allergenicity of new protein/product sources in the diet and identifying the gaps both in terms of methodology and strategy used to address this issue;
  • or whether it would be possible, given the large inter-individual variability, to identify thresholds of allergenic concern, either general or for certain groupings of allergens that would help

Objectives

This task force aims to foster an international evidence-based consensus on how to assess the risk from allergenic foods and to develop the tools which will help to manage this risk and protect the consumer.

Impact

  • The Food Allergy Task Force were pioneers in proposing dose distribution modelling as an approach for characterising and subsequently assessing the risk posed by food allergens. They created a framework for new thinking on food allergy risks and contributed to the acceptance of risk assessment-based approaches for food allergens.
  • The task force made significant contributions to the VITAL® (Voluntary Incidental Trace Allergen Labelling) scientific panel and to the development of allergen reference doses.
  • In addition, the task force has built a strong network of renowned international experts from leading organisations such as the Food Allergy Research & Resource Program (FARRP) and the European Academy of Allergy and Clinical Immunology (EAACI), and is acknowledged as a reliable and valuable partner by national regulators, leading clinicians, patient organisations and established industry players in the field.
  • K. Verhoeckx et al., 2015 assessed whether food processing is a mitigating or aggravating factor in allergic sensitisation. It has already been cited 50 times with over 30,150 downloads.
  • G. Houben et al., 2016 proposed a framework that allows categorisation and prioritisation of allergenic foods according to their public health importance, with 4 citations and over 3,670 downloads.

For more detailed information, please contact Dr Michela Miani at mmiani@ilsieurope.be.

Task Force Members


* Scientific Advisors

Expert Groups

A Framework to Help Define an Appropriate Level of Protection for Consumers with Food Allergies – NEW

Objectives
Stakeholders increasingly accept that zero risk is unachievable in complex systems like food production. What is tolerable, both in terms of how many are affected and in what way, must therefore be defined if risk management objectives are to be put in place and their effectiveness monitored. The overall objective of the work is to elaborate a framework within which tolerable risk in relation to allergic reactions to food can be defined.

Activity
The expert group will gather relevant stakeholders to consider and define what constitutes tolerable risk in the context of allergic reactions to food attributable to unintended allergen presence (UAP) and decisions on the use of precautionary allergen labelling (PAL). This consideration will focus on the incidence of reactions and their characteristics (symptom severity), but will also include factors such as quality of life considerations. The expert group will identify possible benchmarks from other areas of food safety with similar manifestations of risk (e.g. microbiology). The expert group will then try to develop a consensus on a framework within which tolerable risk arising from UAP can be defined. Where possible, it will attempt to define such a framework in quantitative terms, which can be translated to risk analysis.

Expected Output
The conclusions of the expert group will be captured in one or more peer-reviewed publications, but will also be subjected to critical scrutiny at a wider stakeholder workshop. The work will lead to improved food allergen management and, indirectly, to improved health and quality of life of allergic patients.

Review of Suitability of Analytical Methods for Measuring VITAL® Reference Doses for EU Allergens in Foodstuffs

Objectives
Reliable analytical methods are a pivotal requirement for the introduction and adoption of reference doses in the European Union and beyond. This activity will report on the suitability of current analytical methods to reliably measure proposed allergens at various concentrations resulting from the use of the Voluntary Incidental Trace Allergen Labelling (VITAL)® 2.0 reference doses. The VITAL® 2.0 reference doses were proposed by the VITAL® scientific expert panel and adopted in late 2011 by the Allergen Bureau of Australia and New Zealand.

Activity
The expert group is reviewing the fitness for purpose of current analytical methods to reliably measure the presence of allergens at concentrations resulting from the use of the VITAL® 2.0 reference doses in relevant food matrices. This will include method uncertainty, sensitivity, specificity and reproducibility, for example, challenges resulting from kit and antibody batch consistency (for immunoassays), units of measurement and expression of results. Intra-method reproducibility due to differences in method target specificity should also be considered. Reference will also be made to existing standards for validation of analytical methods for allergen detection and quantification.

Expected Output
This review will identify gaps in existing knowledge and technology, suggest ways to bridge those gaps and identify areas for further research. Apart from the peer-reviewed publication, the conclusions may also serve as a basis to prepare guidance for the analytical community, industry, regulatory stakeholders and patient groups.

Severity versus Dose with Respect to Allergic Reactions – Completed

Objectives
The lack of data on the relationship between dose of allergen and severity of subsequent reaction has been identified as a critical data gap in relation to the definition of benchmarks for allergen management. Since severe reactions are clearly of greater concern, both from the public health perspective and from that of allergic individuals, a better understanding of how severity of reaction relates to the dose of allergen consumed would improve safety for these at-risk people.

Activity
The expert group has identified and reviewed available published and unpublished data on severity and dose with the aim to integrate this knowledge into risk assessment methods built on dose distribution modelling. On 15-16 September 2016, a stakeholder workshop was held in Brussels, Belgium, in order to reach a consensus on the likelihood that any given dose of a particular allergen would produce a reaction of a defined degree of severity. Alongside plenary talks on related initiatives pursued by EAACI, iFAAM and the multi-centre Peanut Allergen Threshold Study, the main outcomes of the expert group were discussed in break-out roundtable sessions. A total of 45 delegates attended the workshop, with participation of relevant stakeholder groups (16% health care practitioners, 29% industry experts, 11% regulatory experts, 18% scientists and risk assessors, 13% patient groups, 13% NGOs) including representatives of Health Canada, FARRP, US FDA, EFSA, EC JRC-IRMM, EAACI, UK FSA and other national food authorities.

Expected Output
The principal aim of the activity was to critically review evidence on the relationship between allergen dose (exposure) and the severity of reactions (outcome) and consider the extent to which severity could be integrated into quantitative risk assessments. The findings will soon be submitted for publication; they provide an evidence base that health practitioners can use to advise patients living with food allergies about management of their allergy. Likewise, food manufacturers and legislators are given further evidence on which to base decisions about precautionary allergen labelling and management of allergens in food businesses.

Expert Group Members

A Framework to Help Define an Appropriate Level of Protection for Consumers with Food Allergies – NEW

Review of Suitability of Analytical Methods for Measuring VITAL® Reference Doses for EU Allergens in Foodstuffs

Severity versus Dose with Respect to Allergic Reactions – Completed

*New affiliation as of mid-August 2017: Rene Crevel Consulting

Publications

All Publications

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Citation: https://doi.org/10.5281/zenodo.6651934

Allergen cross-contact and unintended allergen presence (UAP) are a significant challenge for food operators.

The aim of this document is to translate the findings of the Expert Group on 'Food Allergen Quantitative Risk Assessment (QRA)' into a Guidance document which provides tools and approaches to help harmonize the data gathering process for food allergen risk assessments and therefore aid with their implementation. This Guidance aims to promote consistency in documentation, decision making and the application of allergen QRA.

The purpose of this Guidance is not to take an allergen labelling or risk management decision for the user, but rather is intended to help them decide when allergen QRA is appropriate or necessary, and how to decide if it can actually be performed and, if it is to be undertaken, what is the most suitable methodology.

The intended audience is mainly industry wishing to understand and conduct food allergen risk assessments, and potentially QRA. However, it should be noted, that this guide could also be useful for others, including official control agencies.

Watch the webinar here.

ILSI Europe Guidance Report Series: download here.

Tools and documents developed for use with the Guidance

  • Cross-contact / Contamination estimate calculator: A practical calculator to estimate the UAP in a product can be found here. This tool was initially developed by the EU project iFAAM and is kindly provided by TNO. It can be used for free after initial registration.
  • QRA calculation worksheet v4.4: download here.
  • Incidents form: For download here. See Chapter 4 of the Guidance for more information.
  • Sampling & Analysis form: download here.

Training videos for this Guidance

  • Management of Operations: to be published soon
  • Incidents: to be published soon

For more information about the Food Allergy Task Force click here.

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Food Allergy Task Force

NEW APPROACHES FOR FOOD SAFETY

Quantitative risk assessment (QRA) for allergens exists in many different forms with different requirements placed on the risk assessor depending on the question that needs to be answered. An electronic workshop held in October 2020 and comprising representatives from a wide range of food allergy and allergen stakeholder groups identified that a summary of current best in class guidance, identified gaps, potential improvements & harmonization of allergen QRA arising largely from cross contact would be very beneficial. The current manuscript provides an introduction to allergen QRA and an overview of inputs potentially needed for different QRA methods, when deemed feasible and necessary. It also introduces the European branch of the International Life Sciences Institute (ILSI Europe) Expert Group (EG), created to attempt to achieve consensus on the methodologies needed for allergen QRAs by food business operators, and their implementation. Areas of focus include proactive assessments for food production under normal conditions, both in the upstream supply chain and in food production facilities, and reactive assessments as part of an allergen incident response. As a follow-up report to the October 2020 electronic workshop, the current manuscript provides an overview of allergen QRA and insights into the guidance being developed. This manuscript will itself be followed by more detailed guidance for allergen QRA published open access as an ILSI Europe report.

Link to download the full-text

Keywords Expand

Allergens; Quantitative risk assessment (QRA); Supply chain; Incidents; Cross-contact; Precautionary allergen labelling (PAL)

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Citation: https://doi.org/10.5281/zenodo.6651934

Allergen cross-contact and unintended allergen presence (UAP) are a significant challenge for food operators.

The aim of this document is to translate the findings of the Expert Group on 'Food Allergen Quantitative Risk Assessment (QRA)' into a Guidance document which provides tools and approaches to help harmonize the data gathering process for food allergen risk assessments and therefore aid with their implementation. This Guidance aims to promote consistency in documentation, decision making and the application of allergen QRA.

The purpose of this Guidance is not to take an allergen labelling or risk management decision for the user, but rather is intended to help them decide when allergen QRA is appropriate or necessary, and how to decide if it can actually be performed and, if it is to be undertaken, what is the most suitable methodology.

The intended audience is mainly industry wishing to understand and conduct food allergen risk assessments, and potentially QRA. However, it should be noted, that this guide could also be useful for others, including official control agencies.

Watch the webinar here.

ILSI Europe Guidance Report Series: download here.

Tools and documents developed for use with the Guidance

  • Cross-contact / Contamination estimate calculator: A practical calculator to estimate the UAP in a product can be found here. This tool was initially developed by the EU project iFAAM and is kindly provided by TNO. It can be used for free after initial registration.
  • QRA calculation worksheet v4.4: download here.
  • Incidents form: For download here. See Chapter 4 of the Guidance for more information.
  • Sampling & Analysis form: download here.

Training videos for this Guidance

  • Management of Operations: to be published soon
  • Incidents: to be published soon

For more information about the Food Allergy Task Force click here.

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