Where are we in risk assessment of food allergens? The regulatory view

Assessing the risk of exposure to chemicals is done every day worldwide. This assessment includes hazard identification, dose (concentration)-response (effect) assessment, exposure assessment and risk characterization. The present paper discusses the possibilities and limitations of using these procedures when assessing the risk of food allergens. It is concluded that hazard identification is not a problem. The medical literature is full of descriptions of cases of food allergy where the offending food or even allergen is identified. More knowledge on the relationship between dose and response of different allergens in different patient populations is needed. Exposure assessment is possible but may not be easy. Determining the distribution of contamination with an allergen may be crucial. To do risk characterization, and as a consequence to be able to manage risk, knowledge of a threshold for effect is needed and the possibility of using a safety factor. If we do not manage to establish thresholds for elicitation of allergic response in food allergy, risk assessment and management will be very difficult. It will be difficult to avoid labeling like "May contain peanuts" used with and without reason. In the long run, unjustified warnings will not help the allergic consumer but will create more confusion than guidance.