VITAL Scientific Expert Panel 2019 Summary Recommendations – the new allergen Reference Doses for VITAL® Program Version 3.0

 

The Allergen Bureau is pleased to make available the Summary of the 2019 VITAL Scientific Expert Panel Recommendations.

The VITAL Scientific Expert Panel (VSEP) met in late 2018 and early 2019 to develop new recommended Reference Doses for the Allergen Bureau VITAL® (Voluntary Incidental Trace Allergen Labelling) Program. The VSEP noted a significant increase in the number of suitable data points from individuals who had undergone challenge studies for most allergens. Sufficient data were available for egg, hazelnut, lupin, milk, mustard, peanut, sesame, shrimp, soy, wheat, cashew, celery, fish and walnut and as a result ED01 doses were identified for all allergens.

The VSEP considered that ED01 best meets the requirements of the Allergen Bureau, including minimising the percentage of the allergic population at risk from cross contact allergens in unlabelled products, increasing the likelihood of global acceptance of VITAL and a level of risk no greater than VITAL 2.0.

Importantly, the VSEP adopted a new Stacked Model Averaging program, which produces a single ‘averaged’ distribution by incorporating five different statistical models (Weibull, Log Logistic, Log Normal, Log Double Exponential, General Pareto) (Wheeler et al 2019). The Stacked Model Averaging methodology is a marked improvement over the previous methodology used in VITAL 2.0 in which Eliciting Doses (EDp) were identified by ‘expert judgement’ of the best fit from three discrete models (Weibull, Log Logistic and Log Normal).

The new recommended Reference Doses are:

  • Unchanged for three allergens: peanut (0.2 mg peanut protein), hazelnut and default for tree nuts other than other than walnut, pecan, cashew and pistachio default (1 mg protein), and mustard (0.05 mg mustard protein);
  • Increased for three allergens: egg (0.03 to 0.2 mg egg protein), milk (0.1 to 0.2 mg milk protein), and shrimp1 (10 to 25 mg shrimp protein);
  • Decreased for four allergens: lupin (4 to 2.6 mg lupin protein), soybean (1.0 to 0.5 mg soy protein), wheat (1.0 to 0.7 mg wheat protein), and sesame (0.2 to 0.1 mg sesame protein); and
  • Four New Reference Doses were recommended: cashew and Pistachio (0.05 mg for cashew and pistachio protein), celery (0.05 mg celery protein), finfish (1.3 mg finfish protein), and walnut and Pecan (0.03 mg walnut and pecan protein).

The VSEP 2019 Reference Dose recommendations will be implemented in the VITAL Program Version 3.0 and will supersede the VSEP 2011 Reference Dose recommendations utilised in VITAL 2.0. VITAL 3.0 is scheduled for release on 24 October 2019.

  1. The shrimp Reference Dose will be applied generically to Crustacea in VITAL 3.0.

Reference.

Wheeler MW, Westerhout J, Baumert JL, Remington BC. Bayesian Stacked Parametric Survival with Frailty Components and Interval Censored Failure Times. August 2019. http://arxiv.org/abs/1908.11334.