By Allergen Bureau
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Get Ready for VITAL 4.0

As an evidence-based organisation, the Allergen Bureau has always ensured that the VITAL Program is underpinned by the best available scientific evidence. 

Since 2011, a team of scientists, clinicians and risk management professionals have worked together as a part of the VITAL Scientific Expert Panel (VSEP) to make recommendations for Reference Doses in the VITAL® Program.

Members of the VSEP together with other experts – including past VSEP member Dr Ben Remington (FDA, formerly independent consultant & TNO), were part of the FAO/WHO Expert Consultation on Risk Assessment of Food Allergens, who were asked to review and establish allergen threshold levels. This work was part of a larger expert consultation to review the Codex Priority Allergens and provide recommendations to Codex on the application of allergen thresholds to underpin Precautionary Allergen Labelling statements.

The second FAO/WHO Expert Committee Meeting2, resulted in the panel endorsing Allergen Threshold Modelling, the science used by the Allergen Bureau since 2019. Furthermore, the Expert Panel recommended ED05 based Reference Doses (RfD)2.  After extensive discussion with key stakeholders including industry, clinicians, consumer advocacy groups and our own VSEP in relation to the benefits and impact, the VITAL Program including VITAL Online will default to ED05 values from Tuesday 13th August.

On this day organisations will be asked to use the “Update All” feature to update the reports and outcomes currently generated by the system.  The previous versions will be available in revision history and the “Compare” feature can be used to quickly assess the impact. 

To support the transition and assist food safety specialists explain the change in their business a new Guidance document has been produced.    This document shows the difference between the ED01 and ED05 values and addresses the most frequently asked questions we have encountered.  Importantly, the objective of the VITAL Program remains unchanged. The guidance document will be available in early August.

Other important changes in VITAL 4.0. 

  • The Netherlands have recently legislated ED05 thresholds. These differ from those published by the FAO/WHO Expert Committee. These Reference Doses are now included to assist VITAL online users in the EU region, selling both in the Netherlands and other European countries.
  • Recognising Mollusc as an allergen of regional significance for ANZ, the VSEP have recommended a Risk Management Value for Mollusc, which is now included in VITAL 4.0.
  • In response to member feedback that there may be rare occasions when it may be suitable or necessary to consider the labelling outcome if an ED01 value was used, organisations can use the Action Level Grid Report to generate Action Levels for comparative purposes. Businesses are reminded that Action Level Grid function is not intended to be used in isolation or in conjunction with analytical results alone to determine whether a labelling outcome is required. 
  • Addition of Canadian Legislation into VITAL Online.  The food industry in Canada or those selling into Canada, will now be able to complete Quantitative Risks Assessments using VITAL 4.0. This is in support of the recent launch of the Canadian allergen management guidelines.

The relevance, reliability, security, and usability are extremely important to the Allergen Bureau, as is the appropriate use to generate risk-based labelling outcomes that allow consumers to make informed choices.  We are excited to include these enhancements to VITAL Online and assist the food industry as it continues to strive to produce safe and suitable food for the vast majority of consumers. 

2.      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