VITAL Science

What is the VITAL science?

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.

Reference Amount – 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.

Reference Dose – 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.

VITAL Action Level Grid – 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.

Establishing the VITAL scientific framework

Cross contact allergens, when present in a food, can trigger an allergic reaction in sensitive individuals. However, scientific evidence has shown that there are levels of allergenic food residues that are small enough not to trigger an allergic reaction in most individuals with food allergy under normal circumstances.

Recognising a need for these levels to be identified through sound and robust science, the Allergen Bureau invited international scientists specialising in allergen management, food allergy and risk assessment to form the VITAL Scientific Expert Panel (VSEP). The objective being to review the underpinning science around food allergen thresholds.

Members of the VSEP

  • Dr Steve Taylor (Chair of Panel) – Food Allergy Research & Resource Program (FARRP) (USA)
  • Dr Joseph Baumert – Food Allergy Research & Resource Program (FARRP)
  • Dr Geert Houben – Principal Scientist Food Allergy and Immunotoxicology (TNO) & Professor (Utrecht University and University Medical Centre Utrecht) (NL)
  • Dr Rene Crevel (RENE CREVEL Consulting Ltd) (UK) (formerly of Allergy & Immunology, Unilever)
  • Dr Simon Brooke Taylor (Food Safety & Risk Analysis Consultant, Allergen Bureau) (AUS)
  • Prof Dianne Campbell  – Academic Paediatric Immunologist (Sydney University, Children’s Hospital Westmead, DBV-Technologies)

Members of the VSEP were a part of the FAO/WHO Ad Hoc Expert Consultation on Risk Assessment of Food Allergens, asked to review and establish allergen threshold levels. The Expert Committee endorsed the Allergen Threshold Modelling recommended by the VSEP and used by the VITAL Program since 2019. Furthermore, the Expert Committee recommended ED05 based Reference Doses (RfD). Risk assessment of food allergens: part 2: review and establish threshold levels in foods for the priority allergens: meeting report.

The review process

VITAL 4.0 2024

Following the recommendation from the FAO/WHO Expert Committee, VITAL 4.0 will adopt 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. https://doi.org/10.4060/cc2946en

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.

The application of Reference Doses for food product labelling

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). The VITAL Action grid is intended to be used only after the implementation of a robust allergen management plan in which cross contact allergens are eliminated and, where this is not practicable, then they should be controlled and managed at the lowest level possible. The basis of determining the presence of cross contact allergens is by physical assessment. Allergen analysis can be used to validate the assumptions used for the allergen management plan and may be used to validate the results found using physical assessment. However, the use of allergen analysis directly against the VITAL Action Level grid is not recommended. The Allergen Bureau Food Allergen Analysis webpage provides further information about the use of allergen analysis within the VITAL Program.