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 and have been recognised by several international authorities as defining a sound level of risk when applying precautionary allergen statements.
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.
- Blom WM et al (2019) Sensitivity analysis to derive a food consumption point estimate for deterministic food allergy risk assessment. Food Chem Toxicol. 125:413-421
- Blom WM et al (2020) Allergen risk assessment: Food intake levels of the general population represent those of food allergic patients. Food Chem Toxicol. 146: 111781
Reference Dose – the milligram protein level (total protein from an allergenic food) below which only the most sensitive (1% for VITAL 3.0 and between 1% and 5%, depending on the quality of data, for VITAL 2.0) of individuals in the allergic population are likely to experience an adverse 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 – Program Manager Food Safety, Netherlands Organisation for Applied Scientific Research (TNO) (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)
- Dr Benjamin Remington – Food Allergy Research & Resource Program (FARRP) and Remington Consulting Group B.V. (NL)
Previous VSEP Members
- (2011 to 2019) Professor Katie Allen – Murdoch Children’s Research Institute (AUS)
The VSEP first met in Sydney, Australia in 2011 and reviewed available clinical evidence to determine Reference Doses for a range of commonly recognised allergens. The VSEP overarching scientific approach included:
- analysing existing published clinical data plus some unpublished data
- performing statistically based risk assessments
- ensuring the data is scientifically and clinically sound, defensible and transparent
- aiming to protect the vast majority of people with food allergy
The recommendations from the VSEP form the scientific framework for the current iteration of the VITAL Program and VITAL Online. The VSEP continues to be a key part of the VITAL Program by evaluating newly available data that will inform any changes to the Reference Doses.
2005 The Allergen Bureau was established. This was an initiative of the AFGC Allergen Forum to provide information, practical tools and contacts for the food industry to improve management of food allergens and derived ingredients.
2007 VITAL (Voluntary Incidental Trace Allergen Labelling) Program, including first version of the VITAL calculator, was launched as a tool for the food industry in Australia and New Zealand. The VITAL Program is managed by the Allergen Bureau
The VITAL Program is included in the Food Industry Guide to Allergen Management and Labelling (2007).
2011 The VITAL Program review commenced, including the establishment of the VITAL Scientific Expert Panel (VSEP)
The VSEP determine References Doses for a range of commonly recognised allergens
2012 Release of the VITAL Program Version 2.0 and associated tools, including the VITAL calculator
2015 The VSEP reconvened at FAMS2015, Sydney, and agreed to: combine and review the VITAL data with the EUROPREVALL data; establish protocols/criteria to signal a Reference Dose review; and progress work on consumption data
2016 The VSEP reconvened at FAAM, Rome. Conducted the ‘one-shot’ peanut trial.
2017 The VSEP reconvened at FAMS2017, Sydney, and agreed to: develop model averaging methodology; continue to gather threshold data; continue to look for clinical data for other allergens; and progress work on consumption data.
2018 Worked towards completion of the model averaging project. The VSEP reconvened at EAACI-FAAM, Copenhagen, in October 2018.
2019 Model averaging project completed. The VSEP reconvened at FAMS2019, Melbourne, in May 2019. Results of modelling averaging project presented at FAMS2019. VSEP Recommendations 2019 were incorporated by the Allergen Bureau into VITAL Program Version 3.0.
The review process
VSEP Recommendations 2019 – VITAL 3.0
The VSEP reviewed the data from clinical (low-dose oral) food challenges from both published and unpublished studies. The papers were sourced from Australia, the United States and the European Union and over 3,400 clinical data points were collated. The data included in the review was required to meet defined quality criteria to ensure that resulting allergen thresholds were statistically sound. The data set was analysed by applying a new Stacked Model Averaging program (Wheeler et al, 2019) for each allergenic food. The Stacked Model Averaging program produces a single curve for each allergen from which Eliciting Doses may be derived. The VSEP identified the ED01 (which is the dose of the total allergen protein that is predicted to produce objective symptoms in 1% of the allergic population) which were adopted as the Reference Doses for VITAL 3.0. Wheeler et al (2021) Bayesian Stacked Parametric Survival with Frailty Components and Interval-Censored Failure Times: An Application to Food Allergy Risk, Risk Analysis, Vol. 41, No. 1, 2021.
The following papers discuss the process for how the Reference Doses within VITAL 3.0 were developed.
- Remington et al (2020) Updated population minimal eliciting dose distributions for use in risk assessment of 14 priority food allergens. Food Chem Toxicol. 2020 Mar 13;139:111259.
VSEP Recommendations 2011 – VITAL 2.0
The following papers discuss the process for how the Reference Doses within VITAL 2.0 were developed.
- Taylor et al (2014) Establishment of reference doses for residues of allergenic foods: report of the vital expert panel, food and chemical toxicology. Food Chem Toxicol 63: 9–17.
- Allen et al (2014) Allergen Reference Doses for precautionary labeling (VITAL 2.0): clinical implications J Allergy Clin Immunol. 2014 Jan 133(1):156-64.
- Allergen Bureau, summary of the VITAL scientific expert panel recommendations 2011.
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 3.0 (2021). 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.