The VITAL® precautionary allergen labelling statement ‘May be present: allergen x, allergen y.’ for cross contact allergens indicates a defined level of risk based upon scientific principles.
By means of an interactive VITAL Action Level grid, Action Level concentrations (ppm) are calculated using the Reference Dose (mg allergen protein) and a Reference Amount specific to the food.
The Reference Doses are used as the science underpinning the VITAL Program. They form the basis of deciding the appropriateness of precautionary allergen labelling in foods that contain allergen food residues in the form of cross contact.
The VITAL Program and the Reference Doses have been subjected to extensive peer review, most recently by an FAO/WHO Ad Hoc Expert Committee who endorsed the science and recommended adoption at a Codex Level.
Action Levels are the concentrations (of protein) which define the labelling outcomes for each concentration of cross contact allergen in a VITAL assessment. They are determined using the Reference Dose and the Reference Amount.
Action Level 1
Low concentration of the relevant allergen under evaluation, low chance of adverse reaction and no precautionary allergen labelling statement required.
Action Level 2
Significant concentration of relevant allergen under evaluation, significant chance of adverse reaction and a precautionary allergen labelling statement is required.
The maximum amount of a food eaten in a typical eating occasion. This may be the same as the “serving size” on the nutrition information panel or it may be appropriate that the Reference Amount is considered to be the whole product as presented to the consumer. The Reference Amount should never be less than the “serving size”.
The following papers provides guidance on estimating Reference Amounts for food allergy risk assessment.
The milligram protein level (total protein from an allergenic food) below which only the most sensitive (5% for VITAL 4.0) of individuals in the allergic population are likely to experience an objective allergic reaction.
An interactive table stating the Action Level transition points (in ppm total protein) of each allergen for a specific product. The Action Level Grid must be calculated for each individual product. The calculation uses the Reference Amount and the allergen’s Reference Dose and will change depending on the product’s Reference Amount.
The Reference Doses are reviewed by the VITAL Scientific Expert Panel (VSEP), a group of international scientists specialising in allergen management, food allergy and risk assessment. Meet the current and previous members of the VSEP, and read how the panel was established, on the VITAL History page.
Read the VITAL® HistoryFollowing the recommendation from the FAO/WHO Expert Committee, VITAL 4.0 adopts ED05 based Reference Doses. The ED05 is the dose of the total allergen protein that is predicted to produce objective symptoms in 5% of the allergic population.
Information on data sets underpinning these Reference Doses can be found in FAO and WHO. 2022. Risk assessment of food allergens: part 2: review and establish threshold levels in foods for the priority allergens: meeting report. Food Safety and Quality Series No. 15. Rome.
The science (Allergen Threshold Modelling) endorsed by the FAO/WHO Expert Committee, has underpinned the VITAL program since 2019 (VITAL 3.0). The data set analysed by applying Stacked Model Averaging program (Wheeler et al, 2019) was considered the most comprehensive and best described source available, both in terms of curation, with support of peer reviewed publications.
In VITAL 4.0 the data set has been expanded slightly by the FAO/WHO Expert Committee, to consider additional new publications on sesame seed and cow’s milk that improved the robustness of RfD estimates for those allergenic foods. The stacked model Averaging program produces a single curve for each allergen from which Eliciting Doses may be derived.
The decision to use ED05 rather than ED01 was made because the review from the experts’ determined that on balance an ED01 did not meaningfully reduce the health risks to food-allergic individuals but may impact food choices for individuals with food allergies.
For a full history of the recommendations visit the VITAL History page.
This document provides an overview of the updates to the Voluntary Incidental Trace Allergen Labelling (VITAL) program regarding the adoption of ED05-based Reference Doses (RfDs) for determining precautionary allergen labelling (PAL).
The VITAL Reference Doses are designed to be applied within the context of the VITAL Program as described within the Allergen Bureau Food Industry Guide to the Voluntary Incidental Trace Allergen Labelling (VITAL) Program Version 4.0 (2024).
This guide is an essential resource for all VITAL users. The resource covers the science behind VITAL, the use of the program and the procedures and a Decision Tree.
However, the use of allergen analysis directly against the VITAL Action Level grid is not recommended.
The Allergen Bureau Allergen Hub provides further information about the use of allergen analysis within the VITAL Program.
VITAL® Online is the user-friendly, web-based VITAL Calculator. Store the allergen status of ingredients and processing profiles for use in multiple recipes, record the assumptions in your VITAL risk assessment, and create an Action Level report using the interactive VITAL Action Level Grid.