ILSI-Europe funds statistical modelling of allergen hazards

For food allergens, a No Observable Effect Level (NOEL) experimentally determined in controlled challenge studies probably still leaves too high a level of uncertainty for risk managers in industry and in public health. Logistical and statistical constraints to challenge studies mean that a proportion of the allergic population may still be at risk of reacting at doses below those which have been or could feasibly be tested.

An alternative approach has been proposed by Rene Crevel and his colleagues in work supported by the Food Allergy Task Force European branch of the International Life Sciences Institute (ILSI Europe). The application of statistical approaches and the use of clinical data offer an alternative whereby the implications of specified amounts of allergenic ingredient in a product can be defined and used as a basis for risk assessment and subsequent aiding risk management. Statistical modelling allows estimation of the proportion of allergic individuals that are likely to react to specified (low) amounts of residual allergen in food. These estimates require a form of validation to demonstrate how close the predictions are to reality. For each allergenic food this validation requires information about exposure to undeclared allergen, the actual number of reactions taking place in the wider allergic population, and the prevalence of allergy to that food.

While there is still a great deal of work required to refine this approach, it will provide information that can be used to examine different allergen control scenarios, in terms of the probability of provoking reactions attached to defined levels of cross-contact allergen.

The full publication is freely available from the ISLI website: http://europe.ilsi.org/publications/Articles/

Citation: Food and Chemical Toxicology 45 (2007) 691–701.