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Allergen reference doses for precautionary labeling (VITAL 2.0): Clinical implications - 25/12/13

Doi : 10.1016/j.jaci.2013.06.042 
Katrina J. Allen, MD, PhD, FAAAAI a, b, c, , Benjamin C. Remington, BS d, Joseph L. Baumert, PhD d, Rene W.R. Crevel, DIBT e, Geert F. Houben, PhD f, Simon Brooke-Taylor, PhD g, Astrid G. Kruizinga, MSc f, Steve L. Taylor, PhD d
a Murdoch Childrens Research Institute, Parkville, Australia 
b Department of Paediatrics, University of Melbourne, Melbourne, Australia 
c Department of Allergy and Immunology, Royal Children's Hospital, Parkville, Australia 
d Food Allergy Research & Resource Program (FARRP), University of Nebraska, Lincoln, Neb 
e Safety & Environmental Assurance Centre, Unilever, Colworth Science Park, Sharnbrook, Bedford, United Kingdom 
f TNO, Zeist, The Netherlands 
g Allergen Bureau of Australia, Hobart, Australia 

Corresponding author: Katrina J. Allen, MD, PhD, FAAAAI, Murdoch Childrens Research Institute, Royal Children's Hospital, Flemington Rd, Parkville, Victoria 3052, Australia.

Abstract

Background

There has been a dramatic proliferation of precautionary labeling by manufacturers to mitigate the perceived risk from low-level contamination from allergens in food. This has resulted in a significant reduction in choice of potentially safe foods for allergic consumers.

Objectives

We aimed to establish reference doses for 11 commonly allergenic foods to guide a rational approach by manufacturers based on all publically available valid oral food challenge data.

Methods

Reference doses were developed from statistical dose-distribution modeling of individual thresholds of patients in a dataset of more than 55 studies of clinical oral food challenges. Sufficient valid data were available for peanut, milk, egg, and hazelnut to allow assessment of the representativeness of the data used.

Results

The data were not significantly affected by the heterogeneity of the study methodology, including little effect of age on results for those foods for which sufficient numbers of adult challenge data were available (peanut and hazelnut). Thus by combining data from all studies, the eliciting dose for an allergic reaction in 1% of the population estimated for the following were 0.2 mg of protein for peanut, 0.1 mg for cow's milk, 0.03 mg for egg, and 0.1 mg for hazelnut.

Conclusions

These reference doses will form the basis of the revised Voluntary Incidental Trace Allergen Labeling (VITAL) 2.0 thresholds now recommended in Australia. These new levels will enable manufacturers to apply credible precautionary labeling and provide increased consumer confidence in their validity and reliability, as well as improving consumer safety.

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Key words : Food allergy, allergen thresholds, peanut, egg, cow's milk, soy, hazelnut, precautionary labeling

Abbreviations used : ED, FARRP, GLRT, LOAEL, NOAEL, VITAL


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 This study was conducted within the framework of the Food Safety Knowledge Development program of TNO, with financial support from the Dutch Ministry of Health, the Allergen Bureau of Australia (www.allergenbureau.net), the Victorian Government's Operational Infrastructure Support Program, Australia, and the Food Allergy Research & Resource Program (FARRP), University of Nebraska, Lincoln, Nebraska. K.J.A. is a Charles and Sylvia Viertel Senior Medical Research Fellow.
 Disclosure of potential conflict of interest: K. J. Allen is a board member for Ilhan food allergy foundation, and has received payment for lectures, including service on speakers' bureaus, from Pfizer, Nutricia, Annual Women's Update, and Abbott. B. C. Remington, J. L. Baumert, and S. L. Taylor have received grants from multiple food companies (70 in total; the Food Allergy Research & Resource Program is an industry-funded consortium. This funding was used to support this study and publication, but food companies do not control the design or results of the study). R. W. R. Crevel is employed by and has stock in Unilever PLC. G. F. Houben has received money for his institution from the Dutch Ministry of Health. S. Brooke-Taylor has received a consulting fee or honorarium from and has consultant arrangements with The Allergen Bureau, Australia. A. G. Kruizinga has received research support from the Dutch Ministry of Health and is employed by TNO.


© 2013  American Academy of Allergy, Asthma & Immunology. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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