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Food Chem Toxicol. 2014 Jan;63:9-17. doi: 10.1016/j.fct.2013.10.032. Epub 2013 Oct 30.

Establishment of Reference Doses for residues of allergenic foods: report of the VITAL Expert Panel.

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Food Allergy Research & Resource Program, University of Nebraska, Lincoln, NE, USA. Electronic address:
Food Allergy Research & Resource Program, University of Nebraska, Lincoln, NE, USA.
TNO, Zeist, Netherlands.
Safety & Environmental Assurance Centre, Unilever, Colworth Science Park, Sharnbrook, Bedford, United Kingdom.
The Allergen Bureau, Australia and New Zealand Sydney, NSW, Australia.
Murdoch Childrens Research Institute, Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Parkville, VIC, Australia.


In 2011, an expert panel was assembled to establish appropriate Reference Doses for allergenic food residues as a part of the VITAL (Voluntary Incidental Trace Allergen Labeling) program of The Allergen Bureau of Australia & New Zealand (ABA). These Reference Doses would guide advisory labeling decisions for use on food labels. Individual NOAELs and LOAELs were obtained from clinical challenges of food-allergic subjects. Statistical dose-distribution models (log-normal, log-logistic, Weibull) were applied to the individual NOAELs and LOAELs for each allergenic food. The Reference Doses, in terms of mg of total protein from the allergenic food, were based upon either the ED01 (for peanut, cow's milk), the 95% lower confidence interval of the ED05 (for wheat, soybean, cashew, shrimp, sesame seed, mustard, and lupine), or both (egg, hazelnut) using all appropriate statistical dose-distribution models. Reference Doses were established for 11 allergenic foods ranging from 0.03 mg for egg protein to 10mg for shrimp protein. Reference Doses were not established for fish or celery due to poor model fits with existing data. Reference Doses were not established for other tree nuts beyond hazelnut and cashew because of the absence of data on NOAELs and LOAELs from individual subjects.


Allergy; Food; Labeling; Risk assessment; Threshold

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