TY - JOUR
T1 - Hazard characterisation in food allergen risk assessment
T2 - The application of statistical approaches and the use of clinical data
AU - Crevel, R. W.R.
AU - Briggs, D.
AU - Hefle, S. L.
AU - Knulst, A. C.
AU - Taylor, S. L.
N1 - Funding Information:
This work was supported by a grant from the Food Allergy Task Force European branch of the International Life Sciences Institute (ILSI Europe). Industry members of this task force are Ajinomoto Europe SAS, Amylum Group, Barilla G&R F.Lli Spa, Bayer CropScience, Coca-Cola Europe, Eurasia and Middle East, Danisco Cultor Innovation, Group Danone, H.J. Heinz, Kraft Foods, MasterFoods, Monsanto UK Ltd., Nestlé, Numico Research, Pepsico International, Unilever Research, Wild Flavour/Ingredients. For further information about ILSI Europe, call +32 2 771 00 14 or email: [email protected] . The opinions expressed herein are those of the authors and do not necessarily represent the views of ILSI and ILSI Europe.
PY - 2007/5
Y1 - 2007/5
N2 - A structured approach to assess the risk to allergic individuals from food allergens requires as a first step the experimental measurement of minimum eliciting doses in a population that is as representative as possible of the relevant allergic population, using a standardised protocol. These doses are established in controlled challenge studies, but logistical and statistical constraints 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. However, statistical modelling of the dose distribution resulting from such challenges permits inferences to be drawn about the proportion of allergic individuals that are likely to react to specified (low) amounts of residual allergen in food. However, different statistical models, which all provide good fits to the experimental data yield different values outside the experimental range. Consequently, the outputs from these models require a form of validation, which demonstrates how close the predictions are to reality. In addition to characterisation of the hazard, 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.
AB - A structured approach to assess the risk to allergic individuals from food allergens requires as a first step the experimental measurement of minimum eliciting doses in a population that is as representative as possible of the relevant allergic population, using a standardised protocol. These doses are established in controlled challenge studies, but logistical and statistical constraints 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. However, statistical modelling of the dose distribution resulting from such challenges permits inferences to be drawn about the proportion of allergic individuals that are likely to react to specified (low) amounts of residual allergen in food. However, different statistical models, which all provide good fits to the experimental data yield different values outside the experimental range. Consequently, the outputs from these models require a form of validation, which demonstrates how close the predictions are to reality. In addition to characterisation of the hazard, 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.
KW - Minimum eliciting dose
KW - Modelling
UR - http://www.scopus.com/inward/record.url?scp=33947528907&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33947528907&partnerID=8YFLogxK
U2 - 10.1016/j.fct.2006.09.005
DO - 10.1016/j.fct.2006.09.005
M3 - Article
C2 - 17343968
AN - SCOPUS:33947528907
SN - 0278-6915
VL - 45
SP - 691
EP - 701
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
IS - 5
ER -