The presence of unintentional allergens in foods presents a significant food safety risk to those with allergies. Allergen Quantitative Risk Assessment (QRA) is a tool for estimating the risk presented to allergic consumers by the unintentional presence of an allergen in a food, which can be used to inform allergen management.

To promote consistency in the documentation, decision-making, and application of allergen QRA, the Institute of Life Sciences Europe (ILSI Europe) has developed a new guidance to help harmonize the data-gathering processes for food allergen risk assessment among industry, and to aid implementation.

The guidance introduces allergen QRA and an overview of inputs that may be required for different QRA methods, when QRA is appropriate and feasible. The document focuses on:

1. Proactive assessments for food production under normal conditions to understand cross-contact
2. Hazards and appropriate risk mitigation, both in the upstream ingredient supply chain and in the management of operations of food production facilities under the control of the user
3. Reactive risk assessments as a part of responding to an allergen incident, wherein product previously produced and possibly at market is implicated with new information requiring an assessment.

In theory, all sources of allergen cross-contact and unanticipated incidents are amenable to QRA; however, QRA is only necessary when the risk presented to consumers is not immediately clear, and when it is feasible based on the quality of data or time available. The guidance will help industry members decide when allergen QRA is appropriate and necessary, if it is feasible, and how it can be performed.

The guidance can be accessed here.