Severity versus Dose with Respect to Allergic Reactions

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.

The expert group has identified and reviewed available published and unpublished data on severity and dose with the aim to integrate this knowledge into risk assessment methods built on dose distribution modelling.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.

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