Article

Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food

U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835, USA.
Journal of food protection (Impact Factor: 1.85). 05/2008; 71(5):1043-88.
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    • "Using individual NOAELs and LOAELs, it is possible to statistically calculate threshold dose distributions for an overall population. International stakeholders , including the UK FSA and the US FDA, agreed that probabilistic modelling is the most favourable approach to use for allergen risk assessment (Madsen et al., 2009) (Gendel et al., 2008). Previous studies used this method for the determination of threshold levels for a number of food allergen (Taylor et al., 2014) (Bindslev-Jensen et al., 2002) (Taylor et al., 2009). "
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    ABSTRACT: Sesame is a relevant food allergen in France. Compared to other allergens there is a lack of food challenge data and more data could help sesame allergy risk management. The aim of this study is to collect more sesame challenge data and investigate the most efficient food challenge method for future studies. Records of patients at University Hospital in Nancy (France) with objective symptoms to sesame challenges were collected and combined with previously published data. An estimation of the sesame allergy population threshold was calculated based on individual NOAELs and LOAELs. Clinical dosing schemes at Nancy were investigated to see if the optimal protocol for sesame is currently used. Fourteenpatients (10 M/ 4 F, 22 ± 14.85 years old) with objective symptoms were added to previously published data making a total of 35 sesame allergic patients. The most sensitive patient reacted to the first dose at challenge of 1.02 mg sesame protein. The ED05 ranges between 1.2 -4.0 mg of sesame protein (Log-Normal, Log-Logistic, and Weibull models) and the ED10 between 4.2 - 6.2 mg. The optimal food challenge for sesame follows semi-log dose increases from 0.3 - 3000 mg protein. This article provides a valuable update to the existing clinical literature regarding sesame NOAELs and LOAELs. Establishment of a population threshold for sesame could help in increasing the credibility of precautionary labelling and decrease the costs associated with unexpected allergic reactions. Also, the use of an optimal dosing scheme would decrease time spent on diagnostic and thereafter on the economic burden of sesame allergy diagnosis. Copyright © 2015. Published by Elsevier Ltd.
    No preview · Article · May 2015 · Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association
    • "For each dataset, the individual No Observed Adverse Effect Levels (NOAEL) and the LOAELs were combined to derive population threshold dose distribution curves for each allergenic food using the dose distribution approach as described in Crevel et al. (2008), together with survival analysis methods as used in Taylor et al. (2009, 2010). This approach is widely accepted as one that uses the available data most effectively (Gendel et al. 2008; Madsen et al., 2009). In selecting the eliciting dose (ED) for the allergic population (in which the EDx represents the dose at which x% of the allergic population would be expected to react with objective symptoms), weight was given to the goodness of fit for each parametric model (determined by the log likelihood) as well as visual examination of the fitted probability distribution. "
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    ABSTRACT: For most allergenic foods, limited availability of threshold dose information within the population restricts the advice on action levels of unintended allergenic foods which should trigger advisory labelling on packaged foods. The objective of this paper is to provide guidance for selecting an optimal sample size for threshold dosing studies for major allergenic foods and to identify factors influencing the accuracy of estimation. A simulation study was performed to evaluate the effects of sample size and dosing schemes on the accuracy of the threshold distribution curve. The relationships between sample size, dosing scheme and the employed statistical distribution on the one hand and accuracy of estimation on the other hand were obtained. It showed that the largest relative gains in accuracy are obtained when sample size increases from N = 20 to N = 60. Moreover, it showed that the EuroPrevall dosing scheme is a useful start, but that it may need revision for a specific allergen as more data become available, because a proper allocation of the dosing steps is important. The results may guide risk assessors in minimum sample sizes for new studies and in the allocation of proper dosing schemes for allergens in provocation studies.
    No preview · Article · May 2014 · Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association
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    • "The VITAL calculator then determines the final allergen content and compares this to Reference Doses which were defined for major allergenic foods. The initial VITAL action levels were based on minimum eliciting doses for regulated allergenic foods (expressed as doses of protein) collated by the 2006 U.S Food & Drug Administration (FDA) Threshold Working Group [66]. Initially, due to limited data on minimum provoking doses existing at that time, a 10-fold uncertainty factor was applied by VITAL to assure that sufficiently conservative action levels were promulgated. "
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    ABSTRACT: Food allergy appears to be on the rise with the current mainstay of treatment centred on allergen avoidance. Mandatory allergen labelling has improved the safety of food for allergic consumers. However an additional form of voluntary labelling (termed precautionary allergen labelling) has evolved on a wide range of packaged goods, in a bid by manufacturers to minimise risk to customers, and the negative impact on business that might result from exposure to trace amounts of food allergen present during cross-contamination during production. This has resulted in near ubiquitous utilisation of a multitude of different precautionary allergen labels with subsequent confusion amongst many consumers as to their significance. The global nature of food production and manufacturing makes harmonisation of allergen labelling regulations across the world a matter of increasing importance. Addressing inconsistencies across countries with regards to labelling legislation, as well as improvement or even banning of precautionary allergy labelling are both likely to be significant steps forward in improved food safety for allergic families. This article outlines the current status of allergen labelling legislation around the world and reviews the value of current existing precautionary allergen labelling for the allergic consumer. We strongly urge for an international framework to be considered to help roadmap a solution to the weaknesses of the current systems, and discuss the role of legislation in facilitating this.
    Full-text · Article · Apr 2014 · World Allergy Organization Journal
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