What is the VITAL science?

vital_landscapeThe VITAL precautionary allergen statement ‘May be present: XXX’ 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.

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”.

Reference Dose –the protein level (total protein in milligrams from an allergenic food) below which only the most sensitive individuals (between 1% and 5% depending on the quality of the data set available) 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)

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.

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.

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 Australian Food and Grocery Council (AFGC)  – Food Industry Guide – Allergen Management and Labelling

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

Release of the VITAL Program Version 2.0 and associated tools, including the VITAL calculator

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

The VSEP reconvened at FAAM, Rome. Conducted the ‘one-shot’ peanut trial.

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.

Worked towards completion of the model averaging project. The VSEP reconvened at EAACI-FAAM, Copenhagen, in October 2018.

Model averaging project completed. The VSEP reconvened at FAMS2019, Melbourne, in May 2019. Results of modelling averaging project presented at FAMS2019.
VSEP Recommendations 2019 to be incorporated by the Allergen Bureau into VITAL Program Version 3.0.

The review process

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 1800 clinical data points were collated. The data included in the review was required to meet defined quality criteria to ensure the resulting allergen thresholds were statistically sound. The data set was analysed by applying three statistical models applied to the individual NOAELs and LOAELs for each allergenic food, and by using a dose-distribution modelling approach so that the results were predictive for the entire population. No additional uncertainty factors were applied because ED01 or lower than 95% confidence intervals of ED05 were used.

The following papers discuss the process for how the Reference Doses within VITAL 2.0 were developed.

The result was the development of Reference Doses, in terms of mg of total protein from the allergenic food below which only the most sensitive individual (between 1-5% depending on the quality of the data) in the allergic population are likely to experience an adverse reaction. Data from large numbers of subjects were available for peanut, milk, egg, and hazelnut. Smaller amounts of individual threshold data were found for soybean, wheat, cashew, mustard, lupin, sesame seed and shrimp. There were insufficient data points available for celery, and no data points available for molluscs, therefore no Reference Dose for celery or molluscs have been included in the VITAL Program at this stage.

As there was insufficient data around (fin) fish, the approach the Allergen Bureau adopted was to use the original data from the US FDA Threshold Working Group’s  Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food, March 2006, which is LOAL 1mg protein and apply a 10-fold safety factor, which when used in combination with the Reference Amount to allows for the determination of an Action Level.

Although the dataset appeared to be representative or skewed towards highly sensitive allergic populations, it is recognised that some exquisitely sensitive people with food allergy may not be fully protected. Therefore, foods for infants and food for special medical purposes do not fall within the scope of the VITAL Program Action Levels.

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 statement required.

Action Level 2: Significant concentration of relevant allergen under evaluation, significant chance of adverse reaction and a precautionary statement is required.

A note on allergen analysis

The data used to establish Action Levels should be viewed within the context of the VITAL Program. As described in the Allergen Bureau Food Industry Guide to the Voluntary Incidental Trace Allergen Labelling (VITAL) Program Version 2.0 (2012), the VITAL Action Level 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 to 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.